Hysteroscopy: Office Evaluation and Management of the Uterine Cavity

1600 John F. Kennedy Blvd. Ste 1800 Philadelphia, PA 19103-2899

HYSTEROSCOPY: OFFICE EVALUATION AND MANAGEMENT OF THE UTERINE CAVITY Copyright © 2009 by Mosby, Inc., an affiliate of Elsevier Inc.

ISBN: 978-0-323-04101-0

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Notice Knowledge and best practice in this field are constantly changing. As new research and experience broaden our knowledge, changes in practice, treatment, and drug therapy may become necessary or appropriate. Readers are advised to check the most current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and duration of administration, and contraindications. It is the responsibility of the practitioner, relying on their own experience and knowledge of the patient, to make diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions. To the fullest extent of the law, neither the Publisher nor the Authors assume any liability for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this book. The Publisher Library of Congress Cataloging-in-Publication Data Hysteroscopy : office evaluation and management of the uterine cavity / [edited by] Linda Bradley, Tommaso Falcone.—1st ed. p. ; cm. ISBN 978-0-323-04101-0 1. Hysteroscopy. I. Bradley, Linda D. II. Falcone, Tommaso. [DNLM: 1. Hysteroscopy. 2. Uterine Diseases–diagnosis. 3. Uterine Diseases–therapy. WP 440 H9985 2009] RG304.5.H97H968 2009 618.1′407545—dc22 2007043936

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This book is dedicated to Dr. Jay Cooper, who was an icon in the field of hysteroscopy. It honors the legacy of a man whose career embodied a commitment to the power and possibilities of hysteroscopy.

Contributors Andrew I. Brill, MD

EDITORS

Director of Minimally Invasive Gynecology and Reparative Pelvic Surgery Department of Obstetrics and Gynecology California Pacific Medical Center

Linda D. Bradley, MD Director Hysteroscopic Services Director Center for Menstrual Disorders, Fibroids and Hysteroscopic Services Vice Chair Obstetrics, Gynecology and Women’s Health Institute Cleveland Clinic

Oronzo Ceci, MD Department of General and Specialistic Surgical Sciences Section of Obstetrics and Gynaecology University of Bari, Italy

Teresa E. Dews, MD, FIPP

Vice Chair Office of Professional Staff Affairs Professor and Chair Obstetrics, Gynecology and Women’s Health Institute Cleveland Clinic

Medical Director Cleveland Clinic Pain Management Center Hillcrest Hospital Staff, Department of Pain Management Institute of Anesthesiology, Critical Care Medicine and Pain Management Clinical Associate Professor Cleveland Clinic Lerner College of Medicine

CONTRIBUTORS

Jonathan Emery, MD

Brenda Andrews, BS, RDMS, RDCS

Assistant Professor Cleveland Clinic Willoughby Hills Family Health Center

Gynecologic Ultrasonographer Cleveland Clinic

Ruth M. Farrell, MD, MA

Tommaso Falcone, MD

Assistant Professor Department of Obstetrics, Gynecology and Bioethics Cleveland Clinic

Marjan Attaran, MD Section Head Pediatric & Adolescent Gynecology Department of Obstetrics and Gynecology Cleveland Clinic

Sandra Fluharty Medical Assistant Cleveland Clinic

Stefano Bettocchi, MD

Jeffrey M. Goldberg, MD

Associate Professor, OB/GYN Department of Obstetrics, Gynecology and Neonatology University of Bari, Italy

Section Head Reproductive Endocrinology & Infertility Cleveland Clinic

Daniel M. Breitkopf, MD

Franklin D. Loffer, MD

Associate Professor Department of Obstetrics and Gynecology University of Texas Medical Branch

Executive Vice President/Medical Director American Association of Gynecologic Laparoscopists (AAGL)

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Contributors Andrea S. Lukes, MD, MHSc

Attilio Di Spiezio Sardo, MD

President & CEO Carolina Women’s Research and Wellness Center Founder Ob/Gyn Alliance

Department of Gynaecology and Obstetrics Department of Pathophysiology of Human Reproduction University of Naples “Federico II”, Italy

Amy VanBlaricom, MD Steven F. Palter, MD

Associate Professor University of Washington Department of Obstetrics and Gynecology Assistant Residency Program Director Medical Director, Gynecology Clinic Seattle, WA

Founder and Medical Director Gold Coast IVF Syosset, New York

Sejal Dharia Patel, MD Center for Reproductive Medicine Orlando, Florida

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Foreword

Although various mechanical plugs were also proposed to block the ostia, none literally stayed in long enough to be considered for clinical trials. Other intrauterine surgical procedures such as septum resection and adhesiolysis were starting to be done but the average gynecologist saw few of these patients and the interest in learning hysteroscopy diminished. The value of hysteroscopy as a diagnostic tool was not widely appreciated during this time and most physicians relied on the blind D&C to evaluate their patients with abnormal uterine bleeding. Next, a small surge of interest in hysteroscopy again occurred with the potential of another sterilization technique—the silicone plug. This procedure never became available to general gynecologists in the United States and soon died because of the lack of a commercial sponsor. The next huge upswing of interest in learning hysteroscopy occurred with the description of the Nd:yag laser endometrial ablation technique as a method of managing menorrhagia. This was a procedure for which every gynecologist had patients in the need of help and they were eager to remain competitive. But the equipment was expensive and the necessary skill level for good results was a drawback that discouraged its advancements. The recognition that the urological resectoscope, an instrument available for years in every operating room, could be used for endometrial ablation and other intrauterine surgical procedures caused another increase in those learning operative hysteroscopy. But hysteroscopic endometrial ablation remained a deceptively skill-dependent procedure and produced marginal results along with the potentially significant complications for poorly trained surgeons was a draw back and the initial enthusiasm for this procedure soon waned. When global endometrial ablation techniques were developed they were quickly accepted since they required little skill and could be done by most gynecologists. While the global endometrial ablation techniques resulted in no new enthusiasts for the resectoscope they did require surgeons to know what the uterine cavity looked like and resulted in more gynecologists performing hysteroscopy at the time of tissue sampling. This had the positive results of increasing physician’s comfort level for doing diagnostic hysteroscopy and has probably been a platform for further growth in this procedure. The probable reason that hysteroscopy has been slow in being incorporated into gynecologic practice as a diagnostic procedure lies in the competition of supposedly equally effective procedures. The sonohysterogram is commonly used in place of diag-

Even though hysteroscopy has been available since 1869 when Pantaleoni visualized and treated an endometrial polyp, it has struggled to be widely adapted as a gynecological surgical tool. This would see counterintuitive in view of the fact that the uterus is a major organ in gynecology and direct visualization of its interior should be an advantage to the gynecologist. When one looks at the history of hysteroscopy there have been periods when enthusiasm for its use has increased only to either plateau or decline. Why were there ups and downs and will these swings in popularity hold in the future? While this introduction is basically seen through the eyes of a physician from the United States, many of the reasons for the variability of acceptance of hysteroscopy are probably universal. Unmet expectations and competition from other procedures are past factors that are still in play. But in spite of these continued pressures, I believe it will continue to become an even greater part of the arsenal of every gynecologist. But let’s look back over modern hysteroscopy starting with the mid 1950s. Early reports of distention of the uterine cavity by a balloon or no distention with the hysteroscope directly in contact with the endometrial surface did not allow a direct view or the potential to operate. Because of these limitations hysteroscopy did not achieve wide popularity. It is interesting to note that many of the early papers dealt with hysteroscopy during pregnancy, for which it is not currently used. By the 1960s the problems of uterine distention had been worked out and technical advances in endoscopes and fiber optic light made direct visualization of the uterine cavity more easily accomplished and surgical procedures feasible. Reports began to appear in the literature describing what could be seen and therefore diagnosed by the hysteroscope but little about operative possibilities. It was the easy access to the tubal ostia and the potential of developing a transcervical sterilization technique that, in the early 1970s, captured the imagination of some early users of hysteroscopy. And it was the possibility of transcervical sterilizations that caused the first real spurt of interest and growth among general gynecologists to learn hysteroscopy. Unfortunately electrical energy was used in the attempt to close the tube. This resulted in poor closure rates as well as patient injuries. It is generally stated that electrical methods were dropped because of these risks. However, even if technical advances might have provided better control and overcome these problems, it was the high interstitial ectopic pregnancy rate resulting from tubal damage without necessarily closure that condemned this method of sterilization to failure.

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Foreword But at this time the first big driving force for learning hysteroscopy has come full circle—a transcervical sterilization technique has been the impetus. But this alone would not have been enough to encourage physicians to bring sterilizations as well as endometrial ablations into their practice. It has been the ease of doing these procedures and the better reimbursement for office procedures that will make hysteroscopy attractive to forward thinking gynecologists.

nostic hysteroscopy because most gynecologists already have ultrasound equipment and it is better reimbursed. But with hysteroscopy, direct visualization is more accurate and allows a directed biopsy to be taken. The need to be experienced in the use of the resectoscope has further decreased because there are now competing techniques for the destruction of submucosal myomas. So there continues to be the inevitable ebb and flow of uses for the hysteroscope.

FRANKLIN D. LOFFER, MD

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Preface

The role of hysteroscopy in the care of the patient with abnormal uterine bleeding, postmenopausal bleeding, infertility, sterilization, and in patients desiring endometrial ablation is emerging. Detection of intracavitary lesions is possible with hysteroscopy with high sensitivity. We undertook this project with you in mind. It is practical, illustrated, and authoritative. Accompanying videos further clarify the important role of hysteroscopy in the care of our patients. Together our contributors share myriad clinical pearls to improve patient care and to minimize complications of hysteroscopy. To our residents and fellows, who are our future doctors, this book is also was conceived with you in mind. Learn to love,

breathe, and consider hysteroscopy when imaging technology is not enough. Trust your eyes. Listen to your patients. Master hysteroscopy, so that you too can offer this excellent technique to your patients. We thank all of our patients who have entrusted their care to us. Their stories, improved quality of life, and excellent outcomes from operative hysteroscopic and minimally invasive surgical procedures keeps us inspired. Finally, to our families who support our careers and life outside of our home, we thank you.

LINDA D. BRADLEY, MD TOMMASO FALCONE, MD

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Acknowledgments cologic care for patients presenting with menstrual disorders, fibroids, or in need of infertility evaluation. We thank our families for their support.

We are indebted to our patients who have entrusted their care to us. This book is dedicated to our medical students, residents, and fellows who will ultimately follow in our footsteps. May this textbook guide you in providing the most comprehensive gyne-

LINDA D. BRADLEY, MD TOMMASO FALCONE, MD

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Chapter

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Instrumentation in Office Hysteroscopy: Rigid Hysteroscopy Stefano Bettocchi, Attilio Di Spiezio Sardo, and Oronzo Ceci

Hysteroscopy can be arguably regarded as the definitive procedure for evaluating the uterine cavity.1,2 Diagnostic hysteroscopy is a safe and simple procedure that can almost always be carried out successfully in an office setting. The challenge is to increase the number of operative procedures. Office hysteroscopy has already shown good results as compared with outpatient hysteroscopy, with lower health care costs, less time off work, and equal patient acceptability.3-5 Although the literature suggests that office-based operative hysteroscopy without any form of analgesia or anesthesia is a well-tolerated procedure with a high success rate,2,4-9 it continues, in general, to be considered by most gynecologists and patients to be an invasive and painful technique. Pain experienced during hysteroscopy continues to represent the most common reason for failure,10 and this can occur even if local anesthesia is used.5 It is the main limiting factor to a large-scale use of office hysteroscopy, and many patients still prefer the inpatient approach, believing that it will be pain-free. In the last few years, to minimize patient discomfort and maximize the chance of success of the procedure and its widespread use, a new technique based on employing a small-diameter rigid or flexible hysteroscope, a liquid distention medium, and an atraumatic insertion technique (vaginoscopic approach) has been developed. This technique can completely eliminate any kind of premedication for diagnostic procedures and has a similar potential for many operative procdures.11-14 A thorough knowledge of the instrumentation is required to perform office-based hysteroscopy successfully. This chapter also reviews the personal approach used to carry out diagnostic and therapeutic procedures successfully.

uterine cavity. Unlike distention of the uterus, distention of the vagina does not provoke pain. The telescope is then driven to the posterior fornix to visualize the portio and slowly backwards to identify the EUO. When the EUO is visible, the scope is introduced into the cervical canal, and after distending it, the scope is carefully moved forward to the internal uterine orifice (IUO) and then into the uterine cavity with the least possible trauma. A number of retrospective and randomized, controlled studies have demonstrated that this technique is faster and is associated with significantly less pain, permitting complete elimination of any type of premedication, analgesia, or anesthesia.11,15-17 However, this approach requires a good knowledge of anatomy and of the instrumentation, as well as dexterity on the part of the operator (i.e., the correlation between what is seen on the screen and the actual position of the forward-oblique scope).18 The view through the forward oblique view lens, with a deflected view of 12 to 30 degrees (typical of all the modern lens-scope–based hysteroscopes), although particularly useful for examining the uterine cavity, can seriously impede the introduction of the scope into the EUO and into the narrow cervical canal. In fact, when the endoscopist sees a panoramic view in the middle of the monitor with a 12-degree or 30-degree hysteroscope, the angle is incorrect. The required image (the EUO or the cervical canal) should appear in the lower half of the screen and not in its center (Fig. 1–1). In this way the scope will be located in the middle of the canal, avoiding stimulation of the muscle fibers.

VAGINOSCOPIC APPROACH

MINIHYSTEROSCOPES

A new technique for introducing the hysteroscope into the external uterine orifice (EUO) (vaginoscopic or no-touch technique) was developed by Bettocchi and Selvaggi in 1995 to reduce patients’ pain and discomfort.11 This technique avoids the need to introduce a vaginal speculum to visualize the cervix and a cervical tenaculum to grasp the cervix. The vagina can be distended by introducing the distention medium through the hysteroscope placed in the lower vagina, at the same pressure (30-40 mm Hg) used for the subsequent distention of the

Two different types of hysteroscopes are used worldwide: flexible or rigid, which are made in different sizes. The standard rigid hysteroscopes, used for decades, had a diameter greater than 5 mm, with a 4-mm telescope. Over the last few years, smaller-diameter hysteroscopes have been introduced, reflecting the trend toward less-invasive diagnostic and operative procedures in all fields of medicine. The trend toward smaller instruments has largely contributed to the ability to perform hysteroscopy in the physician’s office.14

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Chapter 1

Instrumentation in Office Hysteroscopy: Rigid Hysteroscopy Eyepiece

Light attachment Objective lens

0°

A

Variations in viewing angle

12°– deflection

30°– deflection

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B

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Figure 1–1. The view obtained from the telescope depends on the angle of the objective lens. A, Different angled telescopes. B, Correct view of an angled telescope inserted into the cervical canal. C, Incorrect view of the cervical canal from an angled scope.

The new hysteroscopes have a diameter ranging between 1.2 and 3 mm (minitelescopes). It has been possible to produce very thin diagnostic sheaths and very thin operative sheaths with a diameter no greater than 5 mm. These small-diameter hysteroscopes include the working-channel and continuous-flow features.18 At the beginning, there were concerns about the quality of vision and illumination of the minitelescopes compared with standard 4-mm telescopes. However, it has been demonstrated that new lens-based minitelescopes (2.0-2.9 mm) have a very high visual quality with comparable or better brightness, angle of view, and field of view to those of standard 4-mm telescopes.14 Thus, the miniaturization of the scopes has enabled the physician to use, for a diagnostic procedure, an operative scope equipped with mechanical instruments and with a final diameter not exceeding 5 mm. The possibility of making a visual examination of the uterine cavity and at the same time exploiting the contextual operative facilities has provided endoscopists with the perfect diagnostic tool. They can examine the cavity and take biopsies or treat benign intrauterine pathologies such as polyps and synechiae relatively rapidly without any premedication or anesthesia.18

C Figure 1–2. Typical instruments feature two sheaths, one for irrigation and another for suction. A, 4-mm and 5-mm sheaths. B, 2.9-mm and 2.0-mm rod lens telescope. C, The oval tip allows atraumatic introduction.

One of the most commonly used rigid hysteroscopes worldwide is the Office Continuous Flow Operative Hysteroscope, size 5, (Karl Storz, Tuttlingen, Germany), based on a 2.9-mm rod–lens system with 30-degree forward oblique view and an outer diameter corresponding to 5.0 mm (Fig. 1–2A). A thinner version has been developed based on a 2.0-mm rod–lens system scope that reduces the final diameter of the hysteroscope to 4.0 mm (Office Continuous Flow Operative Hysteroscope, size 4, Karl Storz) (Fig. 1–2B). Both instruments feature two sheaths (one for irrigation and another one for suction) and an operative 5-F canal (approximately 1.6 mm). They are oval, which is ideal for atraumatic insertion of the scope into the cervix (Fig. 1–2C).18 The IUO is normally oval, with a transverse main axis and a diameter of approximately 4 to 5 mm. Therefore, if we want to

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Chapter 1

Instrumentation in Office Hysteroscopy: Rigid Hysteroscopy However, because the compressed liquid cannot flow out of the cervical canal, it is forced into the abdomen through the uterine tubes, potentially causing pain and risk to the patient. Liquid distention is normally used together with an electronically controlled irrigation and suction device (e.g., Endomat; Karl Storz). The different parameters on the device (flow, pressure, aspiration) are set to obtain an average distention of 24 to 45 mm Hg. In the past, before the continuous-flow sheath became available, we were compelled to use the single-flow sheath designed for CO2 examinations. In these cases the saline solution was insufflated at atmospheric pressure (two 5-1iter bags connected by a urologic Y outflow and hung 1.5 m above the patient). By so doing we obtained a flow of 150 to 200 mL/ min with a resulting endouterine pressure of around 40 mm Hg, which created no problems. This technique worked if there was a positive difference between the diameter of the instrument and the diameter of the cervical canal. The liquid could flow out of the uterine cavity through the small space between the sheath and the cervical canal. In most cases, however, the size of the cervical canal was insufficient to obtain this effect, and so the result was stagnation of the liquid and consequently a poor view. Moreover, to perform even basic operative procedures (biopsies), the use of a continuous-flow system together with an electronic suction–irrigation device is extremely important to ensure a clear view in cases of bleeding or debris.18

insert a round hysteroscope measuring 5 mm in diameter through it, we need to modify the spatial disposition of the muscle fibers, potentially causing pain to the patient. These two hysteroscopes have an oval profile and a total diameter of between 4 and 5 mm that conform more strictly to the anatomy of the cervical canal. Thus a simple rotation of the scope on the camera by 90 degrees is adequate to align the longitudinal main axis of the scope with the transverse axis of the IUO.

FLEXIBLE HYSTEROSCOPES Flexible hysteroscopes with a smaller diameter have demonstrated some advantages over the standard rigid ones in several studies. Above all, they are less invasive because there is no need for cervical dilation and no need to use a tenaculum if the uterus is acutely anteflexed. These features are associated with less pain. However, use of flexible hysteroscopes is potentially hampered by higher costs for purchase and maintenance of the equipment; increased effort for cleaning, disinfection, and sterilization; a reduced image size on the monitor screen compared with full-size standard hysteroscopy; and greater fragility of the equipment.14 A semirigid 3.2-mm fiberoptic minihysteroscope (Versascope, Gynecare, Ethicon Inc., Somerville, N.J.) has been developed. It consists of a 1.8-mm telescope with a 0-degree angle of vision and a single disposable outer sheath. This sheath has an additional expanding plastic collapsible outer sheath that permits insufflation of CO2 gas or low-viscosity fluids under a continuous-flow system for uterine distention. Additionally, it provides operative capabilities with 7-F semirigid instruments (biopsy cup, scissors, and graspers) or 5-F bipolar electrodes.

OFFICE OPERATIVE HYSTEROSCOPY Since the 1980s, operative hysteroscopy using scissors, resectoscopic monopolar electrodes, and laser fibers has offered the only chance to treat intrauterine septa, adhesions, myomas, and polyps in women with abnormal uterine bleeding, infertility, or recurrent pregnancy loss. This approach required cervical dilation, nonelectrolytic solutions, local or general anesthesia, and an operating room, resulting in elevated health care costs. In our institution we developed a system to treat these abnormalities in the office setting without cervical dilation and consequently with no need for anesthesia or analgesia. This new philosophy (see-and-treat hysteroscopy) reduces the distinction between a diagnostic and an operative procedure, introducing a single procedure in which the operative part is perfectly integrated in the diagnostic work-up.18 Mechanical operative instruments (scissors, biopsy cup, grasping, corkscrew) have long been the only way to apply the see-and-treat procedure in an outpatient setting (Fig. 1–3).25 The advent of bipolar technology, with the introduction of several types of 5-F electrodes (Fig. 1–4), has increased the number of pathologies that can be treated by office operative hysteroscopy, reserving the use of the resectoscope and operating room to a few particular cases.26

ELECTRONIC SUCTION–IRRIGATION PUMP AND CONTINUOUS FLOW SYSTEM The uterine cavity can be distended with CO2 gas or liquid solution. Normal (0.9%) saline is often preferred in office hysteroscopy, particularly when operative procedures have to be performed. Although some expert hysteroscopists prefer CO2, most prefer a liquid-based distending medium. Patient tolerance appears to be better, visibility is better, clearing of blood and debris is easier, and it is possible to use bipolar 5-F instruments.19-24 A correct flow of between 200 and 350 mL/min, together with a negative aspiration pressure of around 0.2 bar, is normally sufficient to obtain good dilatation of the uterine cavity with an intrauterine pressure of approximately 30 to 40 mm Hg. These pressures are lower than the 70-mm Hg pressure within the tubes, thus preventing the distention medium from passing into the abdomen and potentially causing pain or triggering a vagal reflex.18 A problem can occur when the cervical canal and the IUO are the same size as or smaller than the hysteroscope. The liquid enters the uterine cavity but cannot flow out or pass through the uterine tubes into the abdomen. The view will be unclear due to the presence of mucosal debris. In these cases, many endoscopists raise the flow and therefore also the pressure.

The Versapoint System The advantages of bipolar over monopolar technology are well accepted in the medical field. The most important benefit in hysteroscopy is the use of saline solution rather than nonionic distention media (e.g., glycine, sorbitol, mannitol), as well as the

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Chapter 1

Instrumentation in Office Hysteroscopy: Rigid Hysteroscopy There are three types of electrodes: the Twizzle, specifically for precise and controlled vaporization (resembling cutting), the Spring, used for diffuse tissue vaporization, and the Ball, to coagulate tissues. The Twizzle electrode is preferred to the others because it is a more precise cutting instrument and it can work closer to the myometrium with a lower power setting and consequently with less patient discomfort. The generator provides different modes of operation (waveform): the vapor cut waveform, resembling a cut mode (the acronyms are VC1, VC2, and VC3, where VC3 corresponds to the mildest energy flowing into the tissue), the blend waveform (BL1, BL2), and the desiccation waveform (DES), resembling a coagulation mode. The generator is connected to the 5-F electrode via a flexible cable. Once connected, the generator automatically adjusts to the default setting (VC1 and 100 W). The Versapoint system has been used to treat a variety of intrauterine lesions after administering conscious sedation, with or without a paracervical block; general anesthesia; and recently, even without any analgesia or anesthesia. Bettocchi and colleagues have demonstrated that by lowering the power of the generator from the default setting of VC1/100 W down to the mildest level, VC3, and reducing the power setting to half (50 W), with the Twizzle electrode it is possible to produce minimal dissection of the tissue (resembling a precise cut), with minimal generation of bubbles obscuring the visual field, and with high patient tolerance.26

A

B Figure 1–3

A, Biopsy and grasping forceps (5 F). B, Scissors (5 F).

Figure 1–4

Bipolar electrodes.

Other Miniaturized Bipolar Electrodes A new generation of electrical generators, allowing the use of bipolar energy on miniaturized electrodes, has been produced (Autocon 400 II, Karl Storz). Because of the increased efficiency and the different quality of the energy produced, it has been possible to develop a second generation of 5-F bipolar electrodes (Karl Storz). The main advantage of these instruments is that they are reusable and therefore reduce the costs of office operative procedures. The application of this electrode and the technique used to perform the procedures is the same of those described for the Versapoint system.

reduction of energy spread to the tissue during resection. A versatile electrosurgical system dedicated to hysteroscopy, the Versapoint Bipolar Electrosurgical System (Gynecare; Ethicon) was introduced in 1997. It consists of a high-frequency bipolar electrosurgical generator and coaxial bipolar electrodes that cut, desiccate (coagulate), and vaporize tissue. The flexible bipolar electrode, 1.6 mm in diameter (5 F) and 36 cm long, can be used through any operating hysteroscope. Each electrode consists of an active electrode located at the tip and a return electrode located on the shaft, separated by a ceramic insert. The coaxial bipolar mode involves the completion of the circuit from the active tip to the coaxial return (2 mm proximally), using normal saline distending solution. When the electrode is activated in a conducting solution such as saline, an extremely high impedance vapor pocket is generated that surrounds and insulates the active electrode, preventing completion of the circuit until tissue contact is achieved. After tissue contact, the circuit is completed and the tissue between the active and return electrode is cut, desiccated, or vaporized accordingly. This system avoids both stray electrical energy and the risks of nonelectrolyte distending media. Because the device vaporizes the tissue, the procedure can be accomplished more quickly, because vision is not obscured by chips. More precise vaporization also avoids cutting into the myometrium. Although the tissue is vaporized, it is possible to obtain tissue for pathologic examination.

OPERATIVE TECHNIQUES Biopsy The availability of the new smaller hysteroscopes, including a 5-F operative channel, has enabled the surgeon to perform targeted hysteroscopic biopsies to confirm the endoscopic visual diagnosis. In the standard, widely used punch biopsy technique, the biopsy forceps are pushed into the endometrium and are closed. The instrument is extracted through the operative channel while the hysteroscope remains inside the uterine cavity. After years of confusion about the value of targeted hysteroscopic biopsies and their inadequacy in terms of the quantity of tissue biopsied (with the standard technique, the final amount of tissue available to be sent to the pathologist is strictly related to the internal volume of the two jaws of the forceps), Bettocchi and colleagues proposed the grasp biopsy technique as a means

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Chapter 1

Instrumentation in Office Hysteroscopy: Rigid Hysteroscopy of collecting enough endometrium for a correct histologic examination. The biopsy forceps are placed, with the jaws open, against the endometrium to be biopsied; then they are pushed into the tissue and along it for about 0.5 to 1 cm, avoiding touching the muscle fibers. Once a large portion of mucosa has been detached, the two jaws are closed and the whole hysteroscope is pulled out of the uterine cavity, without pulling the tip of the instrument back into the channel. In this way, not only the tissue inside the forceps jaws but also the surrounding tissue protruding outside the jaws can be retrieved, thus providing the pathologist with a larger amount of tissue.18

with teeth. To remove the entire base of the polyp without going too deep into the myometrium, in some cases the Twizzle electrode is bent by 25 to 30 degrees, enough to produce a kind of hook electrode.26

Myomectomy A technique similar to polypectomy is applied on submucosal myomas, with the difference that, because of their higher tissue density, they are first divided into two half-spheres and then each of these is sliced as described for polyps. Particular attention has to be paid to the intramural part of the myoma, if present. To avoid any myometrial stimulation or damage, the myoma is first gently separated from the pseudocapsule using mechanical instruments (grasping forceps or scissors) as for cold loop resectoscopic myomectomy. Once the intramural section becomes submucosal, it is sliced with the Versapoint Twizzle electrode.26

Polypectomy Small polyps (<0.5 cm) can be removed using 5-F mechanical instruments (sharp scissors and/or crocodile forceps). Cervical polyps have to be treated with sharp scissors because of their fibrotic base, which precludes the use of grasping forceps. For endometrial polyps, the technique consists of grasping the base with open jaws, closing the jaws, and gently pushing toward the uterine fundus. The procedure has to be repeated several times until the polyp is detached from its implant in the endometrium.25 Larger polyps can be removed intact with the Versapoint Twizzle electrode if the internal cervical os size is wide enough for their extraction. Otherwise, they are sliced from the free edge to the base into two or three fragments large enough to be pulled out through the uterine cavity using 5-F grasping forceps

SUMMARY This chapter has reviewed the rigid instruments required for proper in-office hysteroscopy. Furthermore, instruments are available that allow in-office operative hysteroscopy. Although flexible hysteroscopy is also a popular form of office-based diagnostic hysteroscopy, this approach does not allow operative procedures of any significance. For these, rigid instrumentation will be required.

REFERENCES 1.

Serden SP: Diagnostic hysteroscopy to evaluate the cause of abnormal uterine bleeding. Obstet Gynecol Clin North Am 2000;27:277-286. 2. Nagele F, O’Connor H, Davies A, et al: 2500 Outpatient diagnostic hysteroscopies. Obstet Gynecol 1996;88:87-92. 3. Marana R, Marana E, Catalano GF: Current practical application of office endoscopy. Curr Opin Obstet Gynecol 2001;13:383-387. 4. Kremer C, Duffy S, Moroney M: Patient satisfaction with outpatient hysteroscopy versus day case hysteroscopy: Randomised controlled trial. BMJ 2000;320:279-282. 5. Yang J, Vollenhoven B: Pain control in outpatient hysteroscopy. Obstet Gynecol Surv 2002;57:693-702. 6. Lau WC, Ho RYF, Tsang MK, Yuen PM: Patient’s acceptance of outpatient hysteroscopy. Gynecol Obstet Invest 1999;47:191-193. 7. De Iaco P, Marabini A, Stefanetti M: Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc 2000;7:7175. 8. Cameron ST, Walker J, Chambers S, Critchley H: Comparison of transvaginal ultrasound, saline infusion sonography and hysteroscopy to investigate postmenopausal bleeding and unscheduled bleeding on HRT. Aust NZ J Obstet Gynaecol 2001;30:291-294. 9. Finikiotis G: Outpatient hysteroscopy: Pain assessment by visual analogue scale. Aust NZ J Obstet Gynaecol 1990;30:89-90. 10. Campo R, Molinas CR, Rombauts L, et al: Prospective multicentre randomized controlled trial to evaluate factors influencing the success rate of office diagnostic hysteroscopy. Hum Reprod 2005;20: 258-263. 11. Bettocchi S, Selvaggi L: A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc 1997;4(2):255258.

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21.

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Campo R, Van Belle Y, Rombauts L, et al: Office mini-hysteroscopy. Hum Reprod Update 1999;5:73-81. Cicinelli E, Parisi C, Galantino P, et al: Reliability, feasibility, and safety of minihysteroscopy with a vaginoscopic approach: Experience with 6,000 cases. Fertil Steril 2003;80:199-202. Cicinelli E: Diagnostic minihysteroscopy with vaginoscopic approach: Rationale and advantages. J Minim Invasive Gynecol 2005;12:396400. Paschopoulos M, Paraskevaidis E, Stefanidis K, et al: Vaginoscopic approach to outpatient hysteroscopy. J Am Assoc Gynecol Laparosc 1997;4:465-467. Sharma M, Taylor A, Di Spiezio Sardo A, et al: Outpatient hysteroscopy: Traditional versus the “no-touch” technique. BJOG 2005;112:963967. Guida M, Di Spiezio Sardo A, Acunzo G, et al: Vaginoscopic versus traditional office hysteroscopy: A randomized controlled study. Hum Reprod 2006;21(12):3253-3257. Bettocchi S, Nappi L, Ceci O, Selvaggi L: What does “diagnostic hysteroscopy: mean today? The role of the new techniques. Curr Opin Obstet Gynecol 2003;15:303-308. Wieser F, Tempfer C, Kurz C, Nagele F: Hysteroscopy in 2001: A comprehensive review. Acta Obstet Gynecol Scand 2001;80:773-783. Nagele F, Bournas N, O’Connor H, et al: Comparison of carbon dioxide and normal saline for uterine distension in outpatient hysteroscopy. Fertil Steril 1996;65:305-309. Pellicano M, Guida M, Zullo F, et al: Carbon dioxide versus normal saline as a uterine distension medium for diagnostic vaginoscopic hysteroscopy in infertile patients: A prospective, randomized, multicenter study. Fertil Steril 2003;79:418-421.

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Instrumentation in Office Hysteroscopy: Rigid Hysteroscopy 22. Litta P, Bonora M, Pozzan C, et al: Carbon dioxide versus normal saline in outpatient hysteroscopy. Hum Reprod 2003;18:2446-2449. 23. Shankar M, Davidson A, Taub N, Habiba M: Randomised comparison of distension media for outpatient hysteroscopy. BJOG 2004;111: 57-62. 24. Brusco GF, Arena S, Angelini A: Use of carbon dioxide versus normal saline for diagnostic hysteroscopy. Fertil Steril 2003;79:993-997.

25. Bettocchi S, Ceci O, Nappi L, et al: Operative office hysteroscopy without anesthesia: Analysis of 4863 cases performed with mechanical instruments. J Am Assoc Gynecol Laparosc. 2004;11(1): 59-61. 26. Bettocchi S, Ceci O, Di Venere R, et al: Advanced operative office hysteroscopy without anesthesia: Analysis of 501 cases treated with a 5 Fr. bipolar electrode. Hum Reprod 2002;17(9):2435-2438.

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy Linda D. Bradley

Flexible hysteroscopy has revolutionized the practice of office gynecology. Early hysteroscopists used rigid hysteroscopes. In the 1980s and 1990s, most hysteroscopic procedures were performed with rigid hysteroscopes ranging in size from 3 mm to 10 mm. With improved optics, reduction in size of hysteroscopes, and improved light sources, office flexible hysteroscopy became more practical. Thin, flexible hysteroscopes with outer diameters ranging from 3 mm to 5 mm permit quick and comfortable inspection of the uterine cavity and endocervix (Fig. 2–1). The distal tip of the flexible hysteroscope consists of a glass fiber bundle that transmits images from the objective lens at the distal end of the hysteroscope to the ocular piece. Either low-viscosity fluids or CO2 can be used as the distention medium. Choice of distention medium depends on physician preference. Many novice office hysteroscopists like the many benefits of flexible hysteroscopy as a first-line tool to evaluate menstrual disorders, infertility, and postmenopausal bleeding. Rigid hysteroscopy in an office setting requires more experience due to the inability to navigate the endocervix and can cause more patient comfort due to the need to rotate the scope within the cervix to view some lesions (Fig. 2–2). When large intracavitary masses are present, it is more difficult to navigate or steer around lesions than with the flexible hysteroscope. Additionally, rigid hysteroscopy performed in patients who have a markedly anteverted or retroverted uterus may be difficult. Flexible hysteroscopy circumvents many of the difficulties with rigid hysteroscopy. Bradley and Widrich documented patient acceptability, diagnostic accuracy, and cost-effectiveness in 417 patients undergoing office flexible hysteroscopy.1 Flexible hysteroscopy is comfortable, quick, well tolerated, and excellent for the office setting. The flexible tip can maneuver around obstructions, adhesions, and intracavitary pathology in order to visualize the tubal ostia (Figs. 2–3 and 2–4). Even in patients with a markedly retroverted or anteverted uterus, the cornual regions can be well seen because of the 0-degree angle of view, which offers excellent visualization and maneuverability. Compared to rigid hysteroscopy, navigating through the endocervical canal is easy.2 Cross-fertilization between specialties is evident when we consider flexible fiberoptic technology. Initially, pulmonary and

colorectal specialties used flexible bronchoscopes, flexible gastroscopes, and flexible sigmoidoscopes or colonoscopes. Urologists, too, use flexible cystoscopes. Technology is similar for all users of flexible scopes. Like all specialties, the small diameter, clarity of view, and maneuverability of a flexible scope make it appealing. This is especially true for gynecologists and their patients. Flexible hysteroscopy is well suited for endometrial evaluation. The advantages of office flexible hysteroscopic visualization include excellent patient acceptance and comfort, office evaluation, direct visualization of the endometrium and endocervix, the ability to detect minute focal endometrial pathology (Fig. 2–5), the ability to perform directed endometrial biopsies (with some hysteroscopes), and the ability to lyse filmy adhesions with the distal tip of the flexible hysteroscope.3 Hysteroscopy is particularly useful for identifying focal lesions, which are often missed with blind endometrial sampling. Office hysteroscopy until recently was not performed routinely due to concerns about pain. Pain can be associated with introduction of the speculum, placement of a tenaculum on the cervix, paracervical block, or introduction of the hysteroscope into the cervical canal. Flexible hysteroscopy overcomes many of these barriers. One rarely needs to place a tenaculum on the cervix, the long working length permits easy navigation of the working distal element, it is easy to navigate the cervix, and most importantly one can navigate around intracavitary lesions and identify the tubal ostia without difficulty. The long working length is advantageous in the obese population. The operator can be far away from the patient’s buttocks and remain unencumbered by the patient’s body habitus.

EQUIPMENT Modern flexible hysteroscopy equipment has improved tremendously. Newer fiberoptics, video systems, cameras, and illumination have improved the quality such that they relate comparably to the rod system. Gridlike patterns and poor resolution are no longer present. Many flexible hysteroscopes now have replaced the fiber bundles with a video chip that provides excellent optics. Newer devices that integrate the chip, light source, and optics will be available in the near future.

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Myoma

Flexible hysteroscope

Figure 2–1 Two Olympus flexible hysteroscopes of differing size, 3.3 mm and 4.9 mm in outer diameter.

Myoma Figure 2–3 Schematic view of a flexible hysteroscope easily navigating around an intracavitary lesion. The long working length is also helpful.

Rigid hysteroscope

Figure 2–2 Schematic view of difficulty navigating around a lesion using a rigid hysteroscope.

Inexpensive video systems, DVD and CD systems, and printers now make it possible for physician and patient to view the images concurrently and provide photo and video documentation (Fig. 2–6). Examples of flexible systems are seen in Figures 2–7 to 2–9. These hysteroscopes are manufactured by Olympus (Orangeburg, N.Y.) and Karl Storz (Tuttlingen, Germany). With the bidirectional and broad range of angulation spans (100 degrees/100 degrees down) and the wide field of view (120 degrees), the physician can fully visualize the entire uterine cavity with minimal manipulation, with the added benefit of patient comfort. An adaptor added to the sheath makes it possible to create a working channel and obtain directed biopsies. Recanalization of proximal tubal ostia, retrieval of intrauterine device (IUD) strings, directed biopsies, and removal of small

Figure 2–4 View of the tubal ostia with a flexible hysteroscope.

polyps is possible with a flexible hysteroscope outfitted with an ancillary port. Flexible hysteroscopes range in size from 3.1 mm to 5 mm in outer diameter, and some include a working channel. Uterine distention may be accomplished with saline, lactated Ringer, or CO2. Components of the flexible hysteroscope include: ●

●

8

A light connection that plugs into a light source that is either halogen or xenon An angle of view of zero degrees

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy

Figure 2–8 Olympus HYP flexible hysteroscope.

Figure 2–5 Flexible hysteroscopy of a focal lesion consistent with endometrial hyperplasia without atypia.

Figure 2–9 Karl Storz flexible hysteroscope.

●

●

●

●

Figure 2–6 Office hysteroscopy tower and components, including monitor, hysteroinsufflator, printer, and recorder.

A bendable distal tip that bends 100 degrees in a bidirectional mode and that is controlled by a lever A 100-degree active deflection and a 100- to 120-degree field of vision A main long working sheath that contains fiberoptic bundles, an operating channel, a channel for distending media, and lighting bundles A proximal ring containing a focusing element, movable lever, proximal ocular system, and attachment for a camera

Center the triangle mark in the eyepiece at zero degrees before starting. This will keep you oriented.

PREPROCEDURE PREPARATION You and your office staff create the ambience for performing this procedure comfortably in the office. Your staff is your best ally in making your flexible hysteroscopy program successful and seamless. Patient education is crucial in making flexible hysteroscopy most accurate, enjoyable, and less prone to cancellation once the patient has arrived. When possible, written and verbal information about the procedure should be provided in advance of the procedure. Encourage the patient to eat and drink before the procedure. A nonsteroidal antiinflammatory drug (NSAID) such as ibuprofen, naprosyn, or mefenamic acid is advised 1 to 2 hours before the procedure.

Figure 2–7 Olympus flexible hysteroscope.

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy tous and may be confused with endometrial polyps or hyperplasia. Additionally, when hysteroscopy is scheduled right after menstruation, there is less chance of interrupting an early gestation. When in doubt, perform a urine pregnancy test or reschedule after the next menstruation. Women with irregular menstruation must be accommodated on their less-heavy days of flow and informed before the procedure that incomplete visualization due to heavy bleeding might require rescheduling of the procedure. However, postmenopausal patients should be seen any time that bleeding occurs. For some patients with menometrorrhagia, ideal scheduling can be difficult.

Scheduling For patients in their reproductive years, it is ideal to perform office flexible hysteroscopy 1 week after menstruation in ovulating patients. Teach your receptionist to inquire about the last menstrual cycle when scheduling the procedure. Procedures performed in the early proliferative phase are less likely to be overinterpreted (fewer false-positive results). Proliferative endometrium is smooth and flat (Fig. 2–10) compared with secretory endometrium (Fig. 2–11), which is lush and edema-

Informed Consent Before performing office hysteroscopy, the physician must obtain informed consent. Review the indications, contraindications, and complications of the procedure with the patient. Answer any questions. Inform the patient of possible pelvic cramping, pressure, or shoulder pain, if CO2 is used. Inform the patient that you will stop the procedure if the procedure becomes intolerable. If she asks you to stop, stop as requested. Fortunately, most women find office hysteroscopy quite tolerable. Using a visual analogue scale, Bradley and colleagues1 documented minimal pain with office flexible hysteroscopy. Most patients rated the pain similar to mild menstrual cramps.

Procedural Tips The findings of office flexible hysteroscopy must be taken in the context of the patient’s menstrual cycle, menstrual history, hormonal medication history, and surgical and pregnancy history. Interpretation of the endometrial cavity requires knowledge of the last menstrual period. The gynecologic and reproductive history is important in understanding the presence of focal lesions or defects noted. Scars from cesarean sections, recent uterine perforation, and prior myomectomy leave footprints. Subtle indentations or deformations in the uterine cavity may be seen. Focal adhesions from a therapeutic abortion, missed abortion, foreign bodies, and IUDs can also be identified. Imaging results, particularly from transvaginal ultrasound (TVUS), saline infusion sonography (SIS, also known as sonohysterography [SHG]), or magnetic resonance imaging (MRI), with specific attention to the description of the endometrium, should be correlated with the flexible hysteroscopy findings. Abnormalities of the endometrium, equivocal endometrial results, or nonvisualized endometrium can be correlated with hysteroscopic findings. Most importantly, patients of reproductive age should be asked about the last menstrual period, exposure to sexually transmitted diseases (STDs), herpes infection, and pregnancy. The procedure should not be performed in a patient with a history of a prodromal herpes flare. A relaxed patient is your best ally. Informed consent, the hand of a caring nurse, and a realistic explanation of the procedure as it is being performed helps the patient anticipate each step of the procedure. Use vocal-local liberally. Many patients ask if they will be able to see the procedure. Because anesthesia

Figure 2–10. Flexible hysteroscopy performed during the early proliferative phase. The endometrium is flat and smooth. Scheduling hysteroscopy within 1 week after conclusion of menses is best.

Figure 2–11 Flexible hysteroscopy performed during the secretory phase in reproductive-aged women produces more false-positive results. The lush endometrium can be confused with endometrial polyps or endometrial hyperplasia.

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy pausal women with patent fallopian tubes. If the patient complains of shoulder pain, keep her lying flat and encourage deep breathing. Dissipation of the shoulder pain within 5 to 20 minutes is the norm. An attendant should remain with the patient if undue pain is present. Vasovagal reactions occur in less than 1% of patients. Gynecologists should be prepared to resuscitate patients who develop symptomatic bradycardia. Using the continuous-flow technique, introduce the flexible office hysteroscope under direct visualization with the distention medium (fluid or CO2) of choice (Fig. 2–12). Introducing the flexible hysteroscope with the distention medium obviates the need for a tenaculum because the distending medium helps to dilate the cervix during the procedure. Follow the path of least resistance and watch the monitor as the flexible hysteroscope is introduced. With a zero-degree flexible hysteroscope, the image visualized is straight ahead in your view. The cervix will appear as a dark hole in front of your view. If only white is seen, the hysteroscope is adjacent to the cervix, endometrium, or fundus. If the cervix is stenotic, then place a cervical tenaculum and perform gentle sounding of the endocervix to overcome stenosis. Using a tenaculum in a retroverted or anterverted uterus is helpful in some cases. Using the no-touch technique, Sharma and colleagues4 detected differences between multiparous and nulliparous patients. They found decreased pain scores for multiparous patients, no difference in pain with nulligravid patients, and similar satisfaction scores. Sharma and colleagues clearly demonstrated that vaginoscopic hysteroscopy was quicker to perform than the traditional hysteroscopic procedure.4 Although most women tolerate speculum examination, consider the no-touch technique in women with limited tolerance for pelvic examination. Although Sharma and colleagues evaluated the no-touch technique with a rigid hysteroscope, similar findings are likely with flexible hysteroscopy.

is not used, patients can relax and look at the anatomic findings on a video monitor. Becoming engaged in the procedure often relaxes the patient. Additionally, when pathology is encountered, it becomes easier to explain the proposed operative procedure. When cancer is highly suspected, the patient is also informed while awaiting final histologic confirmation of the endometrial biopsy. In privacy, the patient is placed in the dorsal lithotomy position, and a speculum examination and a bimanual examination are performed. Viewing the cervical discharge is important before performing flexible hysteroscopy. Likewise, a bimanual examination can detect uterine or adnexal tenderness. If pelvic inflammatory disease (PID) is suspected, do not perform hysteroscopy that day. Take cultures, start the patient on antibiotics, and reschedule the procedure. Depending on physician preference, a no-touch vaginoscopic approach may be employed. If traditional office hysteroscopy is performed, introduce the speculum and cleanse the cervix with a disinfectant. Attach all ancillary equipment, including light source and camera, to the flexible hysteroscope. White balance the image before introducing the office hysteroscope. Flush the tubing with CO2 or saline (physician preference) to decrease the risk of air embolism.

Distention Media and Procedural Steps If some bleeding is present, office hysteroscopy should be attempted using a liquid fluid medium. Manual distention with a syringe helps dilate the endometrial cavity. Aspiration of the clots, blood, and debris is possible, facilitating visualization. When CO2 is used in the presence of minimal bleeding, excellent visualization is possible. Diaphragmatic irritation from CO2 causes referred pain to the shoulder in 2% to 5% of patients. Shoulder pain occurs in both premenopausal and postmeno-

Figure 2–12. Schematic view of options for uterine distention with the flexible hysteroscope. A bag of normal saline (A), a 60-mL syringe attached to IV tubing for manual distention with saline (B), or a CO2 hysteroinsufflator (C) used at pressures between 50 and 100 mm Hg provide excellent uterine distention.

A

B

C 11

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy

Figure 2–14 Moving the proximal flexible hysteroscope engages and moves the distal tip.

Figure 2–13. Improper technique of handling a flexible hysteroscope. The tip is fragile. Never grasp it with instruments. Insert it gently into the cervix.

Cervical stenosis is more likely to occur among menopausal and nulligravid women. Women with prior cesarean section, loop electrosurgical excision procedure (LEEP), or cone biopsy are also at increased risk for cervical stenosis. Traditionally, laminaria tents placed the evening before the procedure facilitated cervical dilation. Misoprostol (Cytotec) administered before the procedure significantly improves cervical dilation. Dosing is 200 to 400 mcg orally or vaginally 8 to 12 hours before the procedure and in some cases 2 days before the procedure. Misoprostol is a prostaglandin E1 (PGE1) analogue. It helps facilitate cervical dilation, primes the cervix, and decreases the force needed to introduce a dilator or hysteroscope. If cervical stenosis is encountered, tapered dilators are helpful. Misoprostol is particularly helpful in the patient at high risk for cervical stenosis and facilitates the introduction of the flexible hysteroscope. Flexible hysteroscopes are delicate. Never grab the distal tip of the flexible hysteroscope with ring forceps or uterine-packing forceps (Fig. 2–13). Never use the distal tip of the flexible hysteroscope as a dilator. If the distal tip does not easily traverse the endocervix, it is better to use a tapered dilator first. Once the cervix is dilated, guide the hysteroscope into the cervix under direct visualization. Once the flexible hysteroscope is introduced, using the distal tip of the lever, guide the flexible hysteroscope into the endocervix under direct view (Figs. 2–14 and 2–15). Because the angle of view is 0 degrees, keep the cervix in the center of view. The endocervical columnar epithelium appears as clefts of tissue circumferentially. The uterine cavity can be viewed in its entirety from the lower uterine segment. Rotating the lever rotates the distal tip such that the anterior and posterior endometrial walls and lateral walls are easily visualized. Tubal ostia are located eccentrically at the 10 o’clock and 2 o’clock positions. The fundus appears saddle shaped. Avoid touching the endometrium or fundus; by so doing, less artifact and pain is encountered. It is important to view the endocervix in addition to the endometrial cavity. A systematic inspection of the uterine cavity and endocervix is advisable.

Figure 2–15 Proper handling of the flexible hysteroscope.

Generally, preparing the patient for the procedure takes longer than performing the procedure. The total procedure, beginning with the bimanual examination and ending with removing the flexible hysteroscope, takes 5 to 10 minutes from start to finish. Actual viewing of the endometrium takes 30 to 90 seconds. If a directed biopsy is taken, the procedure can take up to 15 minutes.

What Is Visible with Flexible Hysteroscopy Lesions that may be visualized hysteroscopically include endometrial polyps, submucosal and intramural fibroids, synechiae, retained products of conception, foreign bodies, endocervical lesions, endometrial atrophy, endometrial hyperplasia, endometrial cancer, gestational trophoblastic disease, cesarean scar defects, incomplete abortion, and pregnancy. Less commonly detected is adenomyosis (Figs. 2–16 to 2–27). Hysteroscopy coupled with endometrial biopsy is highly accurate in diagnosing intrauterine pathology.3 Theoretically, the specificity and positive predictive value of hysteroscopy in cases

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy

Figure 2–16. Flexible hysteroscopic view of tubal ostia. This patient had a previous uterine fibroid embolization. The surrounding endometrium is pale.

Figure 2–17 Flexible hysteroscopic view of an endometrial polyp.

Figure 2–18 Flexible hysteroscopic view of adendocervical polyp.

Figure 2–19 Flexible hysteroscopic view of a leiomyoma and an endometrial polyp.

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy

Figure 2–20 Flexible hysteroscopic view of a vascular leiomyoma.

Figure 2–21 Flexible hysteroscopic view of kissing leiomyomas.

Figure 2–22 Flexible hysteroscopic view of dense synechiae.

Figure 2–23 Flexible hysteroscopy of endometrial atrophy.

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy

Figure 2–24 Flexible hysteroscopy of retained products of conception.

Figure 2–25 Flexible hysteroscopy of endometrial hyperplasia without atypia.

Figure 2–26 Flexible hysteroscopy of endometrial cancer.

Figure 2–27 Flexible hysteroscopic depiction of an intramural fibroid abutting the endometrium.

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy

Figure 2–29 Proper hand position on the hysteroscope.

Figure 2–28. Flexible hysteroscopy depicting the disappearing phenomenon. False-negative views can be obtained when fluid or CO2 is used. Always decompress the uterine cavity and reinspect the uterine cavity when hysteroscopy is completed to obtain the most accurate view.

plaining of bleeding, staining, and leukorrhea may have small lesions in these locations, and those are easily missed if the operator rapidly inserts and removes the flexible hysteroscope too quickly. Likewise, if the hysteroscope is quickly placed above the intracavitary lesion, the lesion can be missed and a normal hysteroscopy suspected. Perform hysteroscopy slowly and carefully. Navigate the flexible hysteroscope under and around lesions. Office hysteroscopy is comfortable, quick, and associated with low complication rates. Preprocedure NSAIDs or misoprostol (oral or vaginal) can make the procedure more tolerable, especially in women at risk for cervical stenosis. A low (<1%) complication rate is noted when hysteroscopy is performed by skilled physicians. Complications including uterine perforation, infections, and excessive bleeding, as well as complications related to the distending medium, have been recorded.

of abnormal uterine bleeding should be 100%. In practice, however, the false-negative rate is 2% to 4% and is the result of operator error in detecting abnormal endometrial lesions. The hysteroscopist must remember that the sizes of lesions noted with hysteroscopy are not as accurate as with transvaginal ultrasound. The eyepiece is focused at infinity, thereby making the closer objects appear magnified and objects viewed further away appear smaller.5 This phenomenon can lead to surprises in the operating room, especially when the size of a lesion, particularly submucosal fibroids, is underestimated. False-negative views can occur during hysteroscopy when using higher CO2 intrauterine pressures, ranging from 60 to 100 mm Hg. Likewise, false-negative results occur using fluid media. Increased uterine pressures occur with manual or IV tubing supported above the patient, potentially flattening subtle endometrial pathology including hyperplasia, polyps, or leiomyoma. This has been called the “disappearing phenomena,” whereby higher pressures flatten an endometrial lesion, rendering a negative hysteroscopic view (Fig. 2–29). When using lower intrauterine pressures, the color, undulation, vascular patterns, and subtle projections are more easily visualized. One clinical caveat worth remembering: Deflate the endometrial pressure before concluding and reinspect the endometrial surfaces slowly. Look circumferentially for subtle lesions. This clinical pearl, if followed consistently, will result in more accurate findings, fewer false-negative findings, fewer missed lesions, and ultimately better outcomes. Additionally, a slow, thorough evaluation aimed at identifying the endocervix, fundus, and tubal ostia is critical. Women com-

Vaginoscopic Approach Any time imaging of the endometrial cavity or endocervix would help solve a menstrual mystery or uterine conundrum, consider office hysteroscopy. Office hysteroscopy is quick, comfortable, and easily performed within your practice. Although most clinicians have used a speculum to perform office hysteroscopy, Bettocchi and Selvaggi have advocated vaginoscopic hysteroscopy.6 Vaginoscopic hysteroscopy is performed without medication, cervical dilation, vaginal speculum, or cervical tenaculum. Vaginoscopic hysteroscopy is particularly suitable for young, celibate, virginal, or older women who find the no-touch speculum technique more comfortable.7 Consider introducing this technique into your practice for routine hysteroscopy. You will increase your skill set, making hysteroscopy easy to use for the more difficult patient.

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy RECORD KEEPING

FUTURE INSTRUMENTATION FOR HYSTEROSCOPY

While the patient rests comfortably for several minutes, record your impressions of the procedure. Note taking immediately following the procedure minimizes forgetting important information. The note should include: ● ●

● ● ● ●

● ●

A number of limitations are presented by today’s state-of-theart fiberoptic scopes. Most importantly, the use of a coherent fiber bundle limits the ultimate resolution of the system, and the fiber bundles degrade over time due to deflection of the scope in normal use. In addition, the need for an external light source and camera complicates the setup and requires multiple cables running to the visualization system. A distal tip digital sensor coupled with an integral light source overcomes many of the shortcomings of fiber scopes. First, the integrated distal tip digital camera system eliminates the need for an external camera head attachment. More importantly, because there is no delicate coherent fiberoptic bundle limiting the resolution of the system, the digital sensor–based scope offers a clearer image of the uterine cavity as compared to a flexible fiber scope and provides a theoretically more durable system. Integrated light-emitting diodes (LEDs) as a light source eliminates the external light source as well as the bulky light cord from an already overcrowded surgical site. Also, there is no need for white balancing because the scope is already white balanced for the integrated LEDs. Gyrus ACMI (Southborough, Mass.) is developing a hysteroscope using complementary metal oxide semiconductor (CMOS) digital distal sensor technology (Invisio Digital Flexible Hysteroscope) (Fig. 2–30). This scope will be a fully integrated, alldigital endoscope for hysteroscopy that contains a miniature 3-mm CMOS video color sensor and digital camera system housed in the distal tip of the scope. The scope will have integrated LEDs for illumination. It will plug directly into the camera control unit for simplified setup and use. Images illustrated here compare the Gyrus ACMI Invisio Digital scope versus a traditional flexible fiberscope in an animal model. The CMOS sensor technology provides a significantly larger image with resolution that is superior resolution to that of the fiberoptic scope (Figs. 2–31 and 2–32). Unlike a traditional flexible scope, the Invisio Digital Flexible Hysteroscope has a more rigid shaft to aid insertion into the cervix and four-way deflection to facilitate visualization of the entire uterine cavity without rotation of the scope. With a working channel greater than 5 F, the scope will be compatible with all hysteroscopic sterilization devices as well.

Indications for the procedure Summary of pertinent findings (including the bimanual examination) Size of hysteroscope used Fluid medium used Duration of the procedure Patient tolerance of the procedure ● If the patient had a vasovagal reaction, note vital signs and corrective measures taken (e.g., Trendelenburg, spirits of ammonia, atropine) ● Patient rating of the pain of the procedure on a visual analogue scale of 0 to 10 Type of biopsies taken and number Plans and follow-up care discussed

HOME-GOING INSTRUCTIONS When no anesthesia is used, the patient is allowed to drive home alone or return to work immediately after the procedure. She is likely to experience a mild vaginal discharge, and she should abstain from coitus until the discharge stops. She may shower, swim, and exercise without restrictions. The patient should be encouraged to call if bleeding persists or if fever or pelvic pain develops.

RISKS AND CLINICAL CONSIDERATIONS Complication rates of office hysteroscopy are extremely low. Uterine perforation, the most common complication of all hysteroscopic procedures, is minimized with the flexible scope. The small diameter (3 mm) enhances the ability to visualize the entrance into the curved cervix with a flexible hysteroscope compared to a rigid hysteroscope. Antibiotics are not routinely prescribed for flexible hysteroscopy. Patients with increased risk of infection include those with hydrosalpinx, recent PID, or recent uterine instrumentation. Remember that patients with cardiac valves, joint replacement, or history of rheumatic heart disease should receive prophylaxis. Endometritis, although rare following flexible hysteroscopy, should be considered if the patient complains of pelvic pain, fever, or pelvic tenderness following the procedure. Phone calls from patients are rare with flexible hysteroscopy. See the patient if pain, fever, or discharge occurs following the procedure.

SUMMARY Office flexible hysteroscopy is an excellent tool for evaluating menstrual disorders, pregnancy complications, and infertility and as a complementary tool in evaluating an abnormal TVUS. Easily mastered and comfortable for the patient, it can quickly be incorporated into an office setting. Office hysteroscopy is an essential tool that should be mastered by all gynecologists.

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Instrumentation in Office Hysteroscopy: Flexible Hysteroscopy Deflection right

Deflection left

3X activation buttons

Top view Figure 2–30. The Gyrus ACMI Invisio hysteroscope. This is a fully integrated, all-digital endoscope containing a miniature 3-mm complementary metal oxide semiconductor (CMOS) video color sensor and digital camera system housed in the distal tip of the hysteroscope.

Instrument channel Deflection top

Irrigation port Deflection control

Deflection control Deflection bottom

Deflection control brake

Integrated leak tested valve

Side view

Figure 2–31 Flexible hysteroscopic image with a traditional flexible fiber scope.

Figure 2–32 CMOS sensor technology, which demonstrates a larger image and enhanced resoultion.

REFERENCES 5. Apgar B, Dewitt D: Diagnostic hysteroscopy. Am Fam Physician 1999;46(5 Suppl):19S-24S, 29S-32S, 35S-36S. 6. Bettocchi S, Selvaggi L: A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc 1997;4:225-258. 7. Sagiv R, Sadan O, Boaz M: A new approach to office hysteroscopy compared with traditional hysteroscopy: A randomized controlled trial. Obstet Gynecol 2006;108:387-392.

1. Bradley L, Widrich T. State-of-the-art flexible hysteroscopy for office gynecologic evaluation. J Am Assoc Gynecol Laparosc 1995;2(3): 263-267. 2. Baxter A, Beck B, Phillips K: A randomized prospective trial of rigid and flexible hysteroscopy in an outpatient setting. Gynaecol Endosc 2002;11:357-364. 3. Nagele F, O’Connor H, Davies A, et al: 2500 Outpatient diagnostic hysteroscopies. Obstet Gynecol 1996;88(1):87-92. 4. Sharma M, Taylor A, di Spiezio S, et al: Outpatient hysteroscopy: Traditional versus the “no-touch” technique. BJOG 2005;112:963-967.

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3

Indications and Contraindications for Office Hysteroscopy Linda D. Bradley

D.C. Pantaleoni performed the first hysteroscopy in 1869 to evaluate postmenopausal bleeding and discovered an endometrial polyp. Unfortunately the lesion could not be removed. But that first glimpse of the uterine cavity obtained by Pantaleoni was censored by his peers for “undue curiosity.” Now an entire generation of gynecologists are mesmerized by the view within the uterus and, most importantly, by their ability to see, treat, and cure numerous maladies within the uterus with operative hysteroscopy. New generations of gynecologists have undue curiosity, thankfully, finding myriad indications to use their hysteroscopic skill. We now encourage gynecologists who do not perform hysteroscopy to learn this important skill. Office hysteroscopy is a critical component of a modern gynecologic practice.1 It is easy to learn and simple to incorporate into a busy gynecologic group practice, and the popularity of this office approach to endometrial evaluation is steadily increasing. Certainly, the benefits of office evaluation compared to inpatient or ambulatory surgery are easily discerned: reduced anesthesia risks, decreased costs, effective time management for the physician, and patient preference for having a procedure performed in familiar surroundings. Patient outcome is improved when office hysteroscopy is incorporated to clarify a patient’s narrative concerning menstrual dysfunction, and it is an essential component of the preoperative evaluation. In the toolbox of every gynecologist today should be an office hysteroscope. All gynecologists should learn and master office hysteroscopy and use it to triage gynecologic and obstetric conditions. Remember that hysteroscopy and saline infusion sonography (SIS, also called sonohysterography [SHG]) are complementary. Most obstetrician–gynecologists have an ultrasound machine in the office. Ultrasound does not replace office hysteroscopy. Hysteroscopy does not replace ultrasound. Incorporating both technologies provides state-ofthe-art care for your patient. When ultrasound is equivocal or nondiagnostic, office hysteroscopy inevitably solves the diagnostic dilemma. Although magnetic resonance imaging (MRI) is considered the gold standard, having the least interobserver variability, MRI of the uterus does not characterize endometrial lesions well, and patients having MRI might also require office hysteroscopy.2

OVERVIEW OF INDICATIONS The list of indications for office hysteroscopy is exhaustive and usually focuses on abnormalities of menstruation, infertility, localization of foreign bodies, or postoperative evaluation of the endometrium and cervix. It can also be helpful in evaluating women for leukorrhea, postcoital staining, and dysmenorrhea or to clarify a questionable hysterosalpingogram (HSG), transvaginal ultrasound (TVUS), SIS, or MRI result. Hysteroscopy is particularly helpful when an endometrial biopsy is not diagnostic, or does not contain endometrial cells, or when hormonal therapy is tried and the patient continues to have abnormal bleeding. Hysteroscopic indications have expanded to include diagnosis and treatment of missed abortion and of cervical and interstitial pregnancies.3 Hysteroscopy permits full visualization of the endometrial cavity, endocervix, and proximal tubal ostia and is helpful in diagnosing focal lesions that are missed with endometrial sampling. A hysteroscope can also function as a vaginoscope when the labia are gently occluded. When the vagina is gently occluded by compressing the labia, a hysteroscope inserted into the vagina also allows quick visualization of the vaginal fornices. Visualization with CO2 or saline distention of the vagina permits excellent vaginal visualization such that small particulate debris, foreign bodies, and lesions within the vagina may be visualized. This modification of the hysteroscope is particularly helpful in the geriatric (dementia) population and pediatric population, who are prone to insert small items vaginally, causing leukorrhea, vaginal odor, or bleeding. Thin diagnostic hysteroscopes, either flexible or rigid, with outer diameter sizes ranging from 3 mm to 5 mm, can easily and comfortably be used in the office (Fig. 3–1). Rapid visual inspection permits accurate diagnosis of congenital uterine anomalies, atrophy, endometrial hyperplasia, polyps, fibroids, retained products of conception, endometrial cancer, and postprocedural complications from uterine fibroid embolization (UFE). Targeted and directed endometrial biopsies are possible with some hysteroscopes (Fig. 3–2). Office hysteroscopy allows accurate diagnosis of many conditions associated with abnormal bleeding. The likelihood of

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Indications and Contraindications for Office Hysteroscopy hysteroscopy or rigid hysteroscopy attest to the ease of performing hysteroscopy in the office. Most gynecologists perform diagnostic hysteroscopy with a narrow-lumen hysteroscope in the office and perform more complicated procedures in an outpatient surgical setting. Minimal anesthesia can be used in the outpatient surgery environment. Outpatient surgery is necessary when the patient has multiple intracavitary lesions or extensive pathology requiring long surgical procedures that demand an intrauterine fluid management system. Small pedunculated (<2 cm) polyps or a directed biopsy often can be retrieved in the office with an ancillary hysteroscopic port. Lysis of filmy adhesions is possible with the distal tip of the diagnostic hysteroscope. Any time that imaging of the endometrial cavity or endocervix would help solve a menstrual mystery or uterine conundrum, consider office hysteroscopy. Office hysteroscopy is quick, comfortable, and easily performed in your practice. Although most clinicians have used a speculum to perform office hysteroscopy, Bettocchi and Selvaggi have advocated vaginoscopic hysteroscopy.5 Vaginoscopic hysteroscopy is performed without medication, cervical dilation, vaginal speculum, or cervical tenaculum. Vaginoscopic hysteroscopy is particularly suitable for young, celibate, virginal, or older women who find the no-touch speculum technique more comfortable.6 Consider introducing this technique into your hysteroscopic practice. Vaginoscopic hysteroscopy is helpful for women who find speculum examinations uncomfortable.

Figure 3–1. Karl Storz office flexible hysteroscopes. Thin 3.1 mm (left) and 4.9 mm (right) flexible hysteroscopes are excellent for office evaluation.

SPECIFIC INDICATIONS FOR HYSTEROSCOPY Specific indications for office hysteroscopy are listed in Box 3–1. This section gives an overview of specific indications that are covered in detail in later chapters.

Abnormal Uterine Bleeding Abnormal bleeding continues to be the most common indication for performing office hysteroscopy. It has been estimated that a woman has a 1 in 20 lifetime risk of seeing a doctor for evaluation of a menstrual disturbance. Despite the widespread availability of TVUS, SIS, and office hysteroscopy to evaluate abnormal bleeding, practically speaking, most clinicians use a trial of medical therapy initially for 1 to 3 months before using imaging or hysteroscopy. Drug therapy most commonly prescribed for menstrual dysfunction includes hormonal contraception, progesterone therapy, or nonsteroidal antiinflammatory drugs (NSAIDs). When medical therapy fails or abnormal bleeding reoccurs, office hysteroscopy helps to triage the patient. Patients with continued menstrual aberrations following a blind procedure such as a dilation and curettage (D&C) should undergo direct visualization of the endometrium, because focal lesions are often missed with blind curettage (Fig. 3–3). If an endometrial biopsy is nondiagnostic, contains no endometrial cells, or contains a polyp fragment, perform hysteroscopy to identify a focal lesion and to determine if a residual lesion is present.

Figure 3–2 Karl Storz office flexible hysteroscope with optional biopsy forceps are excellent for obtaining targeted tissue biopsies in the office or for retrieving small foreign bodies.

endometrial cancer diagnosis after a negative hysteroscopy is 0.4% to 0.5%. Diagnostic and operative hysteroscopy can be performed in the office depending upon the skill of the gynecologist, reimbursement protocols, nursing support, and a cooperative patient.4 Fear of hurting the patient or concern that hysteroscopy is too difficult to add to an obstetrics and gynecology practice is unsupported by the literature. Numerous studies using either flexible

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Indications and Contraindications for Office Hysteroscopy BOX 3–1 Indications for Office Hysteroscopy ●

Evaluation of abnormal bleeding ● ● ●

Premenopausal anovulatory women Premenopausal ovulatory women Postmenopausal bleeding

Classification of submucosal fibroids ● ●

Evaluation of Infertility

● ● ● ● ●

Routine infertility work-up Abnormal HSG Pre-IVF evaluation Recurrent spontaneous abortion

● ● ● ●

● ● ●

Not visualized Indeterminate Indistinct Not visualized in its entirety

● ● ● ●

●

Evaluate Evaluate Evaluate Evaluate

complaints of amenorrhea complaints of post-UFE cramping complaints of chronic or episodic leukorrhea the endometrium for submucosal fibroids when MRI is equivocal

Evaluation of the pregnant patient

Localization of foreign body ●

Class I Class II Class III

Evaluation of the endometrium following UFE

Evaluation of abnormal TVUS or SIS when endometrium is: ●

Inspection of Essure device if migration of the device suspected or for irregular bleeding

Lost IUD Migration of cerclage

● ●

IUD localization in early pregnancy Retained products of conception Postpartum hemorrhage Ectopic pregnancy (tubal or interstitial) Failed termination of pregnancy Persistent bleeding after termination of pregnancy

Postoperative evaluation

Endometrial cancer

●

●

● ● ● ● ● ●

Inspection of cavity following hysteroscopic myomectomy or polypectomy Inspection of cavity following abdominal myomectomy entrance into endometrial cavity Difficult postpartum D&C to evaluate for Asherman syndrome After removal of indwelling Foley catheter following adhesiolysis Inspect of cesarean scar Inspection following septum repair Recurrent bleeding after endometrial ablation

● ●

Staging Evaluation of cervical involvement Second look after nonsurgical treatment

Hysteroscopic Tubal Occlusion ● ●

Determine if there is any obstruction to tubal ostia Determine if there are other intracavitary lesions that need removal

D&C, dilation and curettage; IUD, intrauterine device; HSG, hysterosalpingogram; IVF, in vitro fertilization; MRI, magnetic resonance imaging; SIS, saline infusion sonography; TVUS, transvaginal ultrasound; UFE, uterine fibroid embolization.

Benign pathology, including polyps and fibroids, are found in 10% to 20% of asymptomatic women. However, the number of endometrial lesions detected increases to 60% to 80% in women who are symptomatic. Among premenopausal women who have menorrhagia or anemia and who do not have a chronic disease, it is estimated that 70% to 80% also have an intracavitary lesion.7 Anovulatory patients who continue to bleed erratically despite progesterone therapy or hormone therapy also need evaluation of the endometrium for intracavitary lesions and to determine if a focus of nonresponsive hyperplastic tissue is present. Remember that anovulatory bleeding can coexist with intracavitary pathology (Fig. 3–4). One of the largest case series tabulating indications for hysteroscopy was authored by Bettocchi and colleagues8; in this study, more than half of the women had abnormal uterine bleeding. In a study by Bradley and colleagues, in 417 cases of office flexible hysteroscopy, 60% of cases were performed for the evaluation of abnormal uterine bleeding.9

Nondiagnostic Biopsies or Prior Blind Dilation and Curettage A D&C is not diagnostic, it is rarely therapeutic, and it generally does not offer long-term improvement in menstrual bleeding. Certainly the hormonal status of the endometrium can be assessed by curettage, but little else is gained. Most importantly, the end point of the procedure cannot be determined. Does the physician stop when he or she “feels the uterine cry?” Does residual tissue remain in situ within the endometrial cavity after curettage? Results from several studies demonstrate that submucosal fibroids are rarely removed by D&C. Polyps might be identified, but without visualizing the endometrium after a blind D&C, it will be impossible to note if the full polyp is removed or whether a remnant persists. Lesions near the tubal ostia, lesions smaller than 2 cm, endocervical lesions, and lesions located near the fundus are more easily missed with blind sampling (Fig. 3–5).

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Figure 3–5 This patient presented with episodic spotting despite lowdose oral contraceptive pill use. A hemorrhagic polyp was found near the left tubal ostia. Direct hysteroscopic polypectomy resolved spotting. Histology identified a benign endometrial polyp.

Figure 3–3 This patient had three prior blind dilation and curettage procedures for abnormal bleeding but no prior imaging. An intracavitary leiomyoma surrounded by adhesions was successfully treated with operative hysteroscopic myomectomy resection. Blind biopsies and curettage are unlikely to treat or diagnose this pathology.

ered the final one. In summary, 80% of the women (84 of 105) had pathology in the uterine cavity, and 98% (82 of 84) of the pathological lesions manifested a focal growth pattern at hysteroscopy. In 87% of the women with focal lesions in the uterine cavity, the whole or parts of the lesion remained in situ after D&C. D&C missed 58% of polyps (25 of 43), 50% of hyperplasias (5 of 10), 60% of complex atypical hyperplasias (3 of 5), and 11% of endometrial cancers (2 of 19). The agreement between the D&C diagnosis and the final diagnosis was excellent (94%) in women without focally growing lesions at hysteroscopy. Another study noted that polyps greater than 2 cm in diameter were missed more often than polyps smaller than 1 cm if only a blind curettage was used. When there are focal lesions in the uterine cavity, hysteroscopy with endometrial resection is superior to D&C for obtaining a representative endometrial sample in women with postmenopausal bleeding and endometrium 5 mm or thicker.10 For all of these reasons, D&C offered simply for diagnosis or cure should be abandoned as a sole procedure. Hysterectomy specimens evaluated after a vigorous D&C demonstrate that 10% to 35% of intrauterine pathology is missed, it samples only 50% of the endometrium, and it cannot retrieve fragmented tissue.11 It is archaic to perform D&C alone, and this practice should be abandoned completely. D&C should be performed in concert with hysteroscopy. Surgeons performing hysteroscopy followed by blind sampling should reinspect the endometrium. If residual tissue is still present, then operative hysteroscopic resection of any residual lesions should be undertaken. Office hysteroscopic evaluation will help determine the amount of surgery required, degree of difficulty of surgery, and the pathology likely to be encountered. If a patient has been treated by a blind D&C or if the operative note determines poor visualization during an attempted operative hysteroscopy, office

Figure 3–4 A patient with anovulatory cycles was treated with progestin therapy, but her metrorrhagia continued. Office hysteroscopy demonstrated a polyp. Once the polyp was removed and the patient continued with progestin therapy, bleeding resolved. Pathology demonstrated a benign endometrial polyp.

In a prospective study, 105 women with postmenopausal bleeding and endometrium at least 5 mm at TVUS examination underwent diagnostic hysteroscopy, D&C, and hysteroscopic resection of any focally growing lesion still left in the uterine cavity after D&C. Twenty-four women also underwent hysterectomy. If the histologic diagnosis differed between specimens from the same patient, the most relevant diagnosis was consid-

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Indications and Contraindications for Office Hysteroscopy hysteroscopic evaluation several weeks after the operative procedure, to re-evaluate the endometrium, is prudent. Poor visualization during hysteroscopy cannot be equated with a normal hysteroscopic view.

Endometrial Atrophy In reproductive-age women, the hallmark of normal menstrual bleeding is the final result of fluctuations in the hypothalamic– pituitary–adrenal–ovarian axis leading to predictable denudation and sloughing of the endometrium. Estrogen primes the endometrium, creating a proliferative and thickened endometrium. Progesterone, when exposed to a primed endometrium, causes pseudodecidual secretory changes, edema, and increased endometrial thickening; decreases vascular fragility; and supports the endometrial stroma. Hemorrhage followed by prompt hemostasis and repair causes stabilization and regrowth of the endometrium. Prolonged estrogen deprivation causes endometrial thinning, whereas prolonged progesterone exposure, depending upon the estrogen status of the endometrium, ultimately results in endometrial thinning. Medications such as gonadotropin-releasing hormone (GnRH) agonists, depot medroxyprogesterone acetate (DMPA, Depo-Provera), or danazol decrease endometrial thickness, and endometrial echo is decreased when they are used for more than 2 or 3 consecutive months. When GnRH therapy causes hypoestrogenism and pseudomenopausal symptoms, endometrial thickness by ultrasound is usually less than 3 mm. Oral contraceptive pill (OCP) users also develop a thin endometrium. When compared to danazol or GnRH therapy, OCP use is nearly as effective in thinning the endometrium for endometrial ablation. In fact, Grow and colleagues12 report a thin endometrium (<4 mm) when OCPs are started in the early follicular phase, menstrual days 1 to 3. Hysteroscopic visualization performed after several cycles of OCP was described as pristine. OCP-primed endometrium was well visualized, and the uterine cavity appeared flat, pale, and uniform, making identification of a polyp, septum, or fibroid very easy. Prolonged use of OCPs facilitates hysteroscopic or global endometrial ablation procedures or any hysteroscopic procedure requiring excellent visualization. Long-time OCP users can develop thin, fragile endometrium that bleeds erratically. Reproductive-age patients who bleed incessantly can develop a thin, fragile endometrium due to atrophy. Likewise, prolonged use of OCPs, GnRH, danazol, or DMPA can lead to endometrial thinning, exposing the basalis layer of the endometrium. Diffuse petechial hemorrhages are often seen hysteroscopically and are easily recognized. Atrophic endometrium may also be associated with a chronic endometritis, which also causes fragile endometrium that bleeds spontaneously (Fig. 3–6). Women using intrauterine contraceptive devices (IUDs), such as the progestin-releasing intrauterine system (Mirena) or other IUDs, can require office hysteroscopy to evaluate abnormal menstruation (Fig. 3–7). Although most women using Mirena experience amenorrhea or hypomenorrhea, some develop erratic bleeding. Molecular theories for the atrophy, fragility,

Figure 3–6 Hysteroscopy demonstrates a thin, pale endometrial cavity consistent with endometrial atrophy.

Figure 3–7 Office flexible hysteroscopy of a patient with irregular menstruation and a lost intrauterine device. Flexible hysteroscopy demonstrates a Lippes loop embedded within the endometrium.

and irregular bleeding that occur with Mirena have been described.13 With an IUD in place, office hysteroscopy can still be performed. With care, visualization of the endometrium and location of the IUD frame and IUD string is possible without disturbing the IUD. Atrophy and suspected endometritis may be confirmed visually with hysteroscopy. Intracavitary lesions can also coexist with IUD use.

Polyps Endometrial polyps are commonly found during evaluation of abnormal bleeding.14 When polyps are associated with irregular bleeding or leukorrhea, most gynecologists recommend removal to treat symptoms and document the histology in order to

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Figure 3–9 Polyp with complex endometrial hyperplasia without atypia.

Figure 3–8 Postmenopausal bleeding and endometrial polyp. (Final pathology was consistent with an endometrial polyp with cystic hyperplasia without atypia.)

exclude occult premalignant or malignant disease. Occult malignancy occurs in less than 2% of polyps. Operative hysteroscopic polypectomy is a relatively easy procedure to perform and has few complications. When hysteroscopy is used as a triage method for evaluating abnormal uterine bleeding, high positive predictive values (PPVs) are mandatory. Hysteroscopy and SIS are equivalent diagnostic tools for detecting intrauterine polyps.15 The PPV of both hysteroscopy and SIS were higher in premenopausal women than in postmenopausal women. Detection of pathology is skill dependent and relies heavily on the experience of the individual ultrasonographer or surgeon. Identification of uterine polyps is important in symptomatic patients. Endoscopic removal has a high success rate in treating abnormal uterine bleeding and alleviating symptoms. Most importantly, histologic evaluation is possible and excludes malignancy or premalignancy (Figs. 3–8 and 3–9).16

Figure 3–10. Extirpative view of leiomyomas of variable locations. Gross evaluation clearly delineates the ease of hysteroscopically removing intracavitary lesions. Additionally, the inability to remove subserosal fibroids hysteroscopically is evident.

Submucosal Fibroids more easily defined hysteroscopically than type 1 and type 2 myomas (Fig. 3–11). It is more difficult to hysteroscopically determine the difference between type 1 and type 2 myomas using the European Society Hysteroscopic Classification system (ESHRE) (Fig. 3–12), most likely because intrauterine fluid distention or CO2 can cause the fibroid to migrate into the myometrium, whereas the SIS classification system (Fig. 3–13) more objectively identifies the depth of myometrial involvement of the leiomyoma. In the office setting, diagnostic hysteroscopy has high negative predictive value (NPV) and is well tolerated. The PPV of SIS and diagnostic hysteroscopy are equivalent. Therefore, many factors must be taken into consideration when considering whether hysteroscopy or SIS should be the initial diagnostic test

Why submucosal fibroids cause abnormal bleeding is debatable. Theories include abnormal uterine contractions, inefficient expulsion of uterine contents, increased surface area, increased secretion of vasoactive factors, and aberrations of the fibrinolytic system. Fibroids can be located purely within the endometrial cavity, can abut the endometrium with the majority of fibroid intramural, or can be subserosal (Fig. 3–10). Localization of uterine fibroids is essential to determine the surgical route. If an intramural fibroid abuts the endometrium but extends deeply within the myometrium, hysteroscopic myomectomy performed in two surgical stages may be necessary for complete resection. The ability to determine fibroid location using hysteroscopy and SIS has been described. Fibroids that are purely within the endometrium are termed type 0 (pedunculated), and they are

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Indications and Contraindications for Office Hysteroscopy 50 years. Bruchim and colleagues17 found that time since the menopause and endometrial thickness together predict endometrial cancer risk. Specifically, among 95 women with postmenopausal bleeding, the incidence of endometrial cancer increased with the number of years since menopause. No patient had endometrial cancer when the endometrium was less than 5 mm thick, but 18.5% had cancer when the endometrium exceeded 9 mm. The incidence of cancer was 2.5% in women who had been menopausal for 5 years or less but was 21.4% in those who had been menopausal more than 15 years. The likelihood of endometrial cancer increases with increasing thickness of the endometrium and the number years since menopause. Blind endometrial pipelle biopsies in the menopause can miss focal lesions, including focal hyperplasias or cancer. Perform hysteroscopy when a patient continues to bleed after a negative endometrial biopsy. Easy detection of focal lesions is possible with the hysteroscope (Fig. 3–15). Younger women with bleeding that does not respond to medical therapy or with a history of prolonged unopposed estrogen stimulation resulting from chronic anovulation are also candidates for endometrial sampling. Independent risk factors for endometrial hyperplasia include diabetes, prolonged steroid use, obesity, long history of irregular cycles, unopposed estrogen therapy, tamoxifen use, suspected polycystic ovarian syndrome (PCOS), and a strong family history of ovarian, breast, or colon cancer. American College of Obstetricians and Gynecologists (ACOG) guidelines recommend endometrial biopsy in women older than 35 years with uterine bleeding to rule out endometrial hyperplasia or cancer. Hysteroscopy should certainly be considered when patients continue to bleed despite negative endometrial biopsy or equivocal results.

Figure 3–11 ESHRE type O leiomyoma. Pedunculated leiomyoma with cystic changes on the surface.

performed, including patient acceptance, physician experience, cost, and pain. Hysteroscopy, although helpful in detecting fibroids, might only be able to detect the tip of the iceberg as it relates to fibroids with a deeper penetration into the myometrium. If hysteroscopy detects only a bulge of fibroids that might abut the endometrium, it would be helpful to perform SIS to obtain a panoramic view of the endometrium and myometrium. When the stalk or attachment of a fibroid is visualized, then operative resection is likely to be performed in one stage. When in doubt about the extent of fibroid involvement with the myometrium, perform SIS. To prevent creating a negative hysteroscopic view of the endometrium during hysteroscopy, it is crucial to decrease the CO2 pressure or intrauterine fluid pressure after performing hysteroscopy and re-evaluate the endometrium. Higher intrauterine pressures can artificially flatten the endometrium, compressing subtle lesions into the endometrium or myometrium. Fibroids, too, may be compressed, thus preventing classification of a lesion as type 0, 1 or 2.

Equivocal Ultrasound Results We have entered a new era with the ability to directly visualize the endometrium, endocervix, and proximal tubal ostia with a hysteroscope. Many gynecologists still use TVUS as the first option to evaluate the endometrium of patients with abnormal bleeding. Although TVUS is widely available and minimally invasive, it misses focal lesions in premenopausal and postmenopausal women. Endocervical lesions and subtle lesions in the tubal ostia and cornua are easily missed with TVUS. Lesions in both locations can cause bleeding or leukorrhea. Vaginal ultrasound has a sensitivity of 85% and a specificity of 84%, compared to hysteroscopy, which has a sensitivity of 99% and specificity of 95% (Figs. 3–16 and 3–17).18 The endometrial echo has a wide range of normal measurements ranging from 4 mm to 15 mm in reproductive-age patients. Hormonal fluctuations, ovulation, and anovulation affect the endometrial glands and stroma, which compromise the endometrial echo. Breitkopf and colleagues19 evaluated the sensitivity of TVUS to detect benign endometrial masses in premenopausal women. The use of endometrial stripe alone did not perform well in the detection of benign endometrial masses in premenopausal women regardless of the endometrial echo cutoff value chosen. In this study of 206 consecutive SISs, endometrial

Adenomyosis Adenomyosis may be a cause of severe dysmenorrhea, menorrhagia, or menometrorrhagia. Clinical symptoms can also include a tender, enlarged, and boggy uterus. The use of pelvic MRIs and histologic workups sets the gold standard for diagnosing adenomyosis. Hysteroscopy can detect adenomyosis in 10% to 20% of cases. However, hysteroscopy cannot detect whether focal or extensive adenomyosis exists. Classic hysteroscopic findings include diffuse gland openings, hemosiderin deposits within the endometrium, and glands with blood seen entering the gland-like openings (Fig. 3–14).

Endometrial Hyperplasia and Endometrial Cancer Endometrial cancer most commonly occurs in the sixth and seventh decades of life, and 75% occurs in women older than

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A

B

C

Figure 3–12 European Society Hysteroscopic Classification system (ESHRE) of myomas. A, Type 0; B, Type 1; C, Type 2.

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A

C

B

Figure 3–13 A, SIS class 1, the fibroid is purely intracavitary. B, SIS class 2, the fibroid involves less than 50% of the myometrium. C, SIS class 3 is a transmural fibroid.

who have a normal TVUS result and who experience abnormal bleeding after a failed trial of medical therapy, office hysteroscopy is recommended when SIS is not available. In the menopause, a normal endometrial echo is less than 5 mm. Meta-analysis of 35 studies involving 5892 women using an endometrial thickness cutoff found that the sensitivity of a 5-mm cutoff was greater than 92% for detecting endometrial disease (polyps, atypical hyperplasia, or cancer) and was 96% for detecting endometrial cancer. Thus a postmenopausal woman with a 10% pretest probability of endometrial cancer had a 1% probability of cancer if her TVUS had an endometrial echo smaller than 5 mm.20 Although cancer is rare when the endometrial echo is less than 5 mm, other endometrial lesions are not uncommon within

polyps and leiomyomas were not detected by TVUS in 1 of 6 women with an endometrial stripe thickness less than 5 mm. This represented a sensitivity of 74%. These authors postulated that failure to detect intracavitary lesions with TVUS alone could be because the endometrial echo is not enlarged in the longitudinal plane with narrow intracavitary lesions, thus escaping detection by solely relying on endometrial stripe thickness. Polyps are often long and narrow in contour, conforming to the shape of the endometrial cavity, and lack of intracavitary fluid decreases the sensitivity for detection of endometrial lesions. This sandwiching concept creates a negative or nondiagnostic view of the endometrium. Without distention of the endometrium, these defects may be easily missed, despite an apparently normal measurement. Particularly in reproductive-age women

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Figure 3–16 Transvaginal ultrasound sagittal image of a 42-year-old patient with profound menorrhagia shows an indistinct endometrial echo.

Figure 3–14 Office hysteroscopy demonstrated fundal adenomyosis. Gland-like openings and blue-black appearance of adenomyosis are evident. The diagnosis was confirmed by magnetic resonance imaging.

HDI

FIB

0:49:14

[2D] G42 / 105dB FA2 / P95

+D 1.73cm

Figure 3–17 Transvaginal ultrasound coronal view with indistinct endometrial echo.

Figure 3–15. Diffuse endometrial adenocarcinoma in a 38-year-old morbidly obese patient with abnormal uterine bleeding. Treatment was with total abdominal hysterectomy and bilateral salpingoophorectomy.

SIS enhances visualization of the endometrium compared to TVUS. However, SIS has a failure rate of 5% to 17% and a falsepositive rate of 10%.21 Failures may be due to intramural leiomyomas compressing the endometrium, blood clots, or inability to distend the endometrial cavity. Additionally, when the uterine size is greater than 12 to 14 weeks’ gestational size, SIS may be impractical because uterine distention is more difficult. When these problems occur, office hysteroscopy should be scheduled to clarify equivocal SIS results or in cases where SIS cannot be performed (Figs. 3–18 and 3–19).

this range of endometrial echo. When the endometrial echo is less than 5 mm, patients can still have endometrial polyps, submucosal fibroids, endometritis, intrauterine synechiae, or endometrial hyperplasia, all of which are associated with bleeding. Most importantly, a small focus of endometrial cancer located near the tubal ostia, or in the lower uterine canal, is often missed by TVUS and even SIS. Patients with a normal endometrial echo should have an office hysteroscopy if SIS cannot be performed, regardless of their menstrual status and especially if they have failed a trial of medical therapy and continue to have abnormal bleeding.

Preoperative Evaluation If you wish to avoid surprises at surgery, plan ahead by performing office hysteroscopy (Figs. 3–20 to 3–22). Preoperative

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Indications and Contraindications for Office Hysteroscopy HDI

0:49:14

[2D] G42 / 105dB FA2 / P95

+D 0.08cm ×D 0.12cm #D 3.30cm *D 1.44cm

Figure 3–20 This 34-year-old patient presented with bulk symptoms and menorrhagia. The cavity was evaluated preoperatively, and an abdominal ultrasound was performed. Laparotomy identified a 1.9-kg exophytic pedunculated leiomyoma, measuring 23-25 cm.

Figure 3–18. Saline infusion sonography. Sagittal view demonstrates a 3.3 cm × 1.4 cm fundal leiomyoma. This lesion is a SIS class 1 leiomyoma arising from the fundus. It is hysteroscopically resectable. The lesion weighed 12 g.

Figure 3–21 Close-up view of vascular pedicle.

uterine walls from occluding after extensive hysteroscopic resection. Likewise, the degree of difficulty that may be encountered with adhesiolysis can be ascertained before surgery. What did the endometrial cavity look like before surgery? Were footprints from prior surgical procedures present before extensive myomectomy or polypectomy? Just think about it. If a patient with a menstrual disorder, who desires fertility, has had prior therapeutic abortions, is it possible that she already has pre-existing synechiae? Likewise, for the patient with abnormal bleeding who has undergone multiple blind D&Cs before you astutely determined that operative hysteroscopic, laparoscopic, or abdominal intervention is necessary: Could she have preexisting intrauterine adhesions? Consider hysteroscopy preoperatively in patients who desire fertility and who have undergone prior blind D&Cs to rule out preexisting uterine synechiae. Document the landscape of the endometrium preoperatively and postoperatively in women desiring fertility.

Figure 3–19. Saline infusion sonography. Coronal view demonstrates an intracavitary leiomyoma that originates from the fundus.

evaluation with hysteroscopy is invaluable. By knowing what to expect at surgery, you can request the equipment needed, prepare your anesthesiologist and surgical team, inform your patient of likely findings, and give a concise informed consent of the risks of surgery, length of time it will take to complete surgery, and the likelihood of completing the procedure with one operation. Especially among reproductive-age patients with suspected leiomyomas, you can determine if the patient has numerous intracavitary fibroids that might be better treated with a planned two-staged operative hysteroscopic myomectomy or whether the patient might require placement of a pediatric Foley catheter or similar catheter to prevent the

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Figure 3–23 This patient had bleeding for 2 years following postpartum hemorrhage and manual removal of the placenta. Hysteroscopy demonstrates a circumferential view of the lower endocervix with necrotic tissue. Hysteroscopic resection demonstrates an atypical placental nodule.

Figure 3–22. Same patient 8 weeks later, with persistent complaints of menorrhagia. Bulk symptoms were better since the pedunculated leiomyoma was removed. However, office hysteroscopy revealed approximately five intracavity leiomyomas and endometrial polyps. Hysteroscopic evaluation was neglected before abdominal myomectomy. Once these intracavitary lesions were resected, the patient’s bleeding resolved.

Postoperative Evaluation of the Uterine Cavity Most hysteroscopic procedures are associated with few complications or development of intrauterine synechiae. Except for endometrial ablation, adhesions and tubal occlusions are rare sequelae of operative hysteroscopy or D&C. Postoperative hysteroscopic evaluation should be strongly considered to evaluate the endometrium in the following scenarios: ●

●

●

●

●

● ●

Manual removal of the placenta after delivery, with continued postpartum bleeding, to evaluate for retained placenta fragments (Fig. 3–23) Continued bleeding after cesarean section to evaluate for retained products of conception, suture, or a cesarean section pouch in the lower uterine segment Incomplete abortion, treated initially with suction D&C, with continued bleeding to evaluate for retained products of conception (Fig. 3–24) Extensive laparoscopic, hysteroscopic, or abdominal myomectomy to evaluate for completeness of resection or removal of uterine fibroids and to evaluate the surgical site as well as to determine if postoperative adhesions are present Recurrent bleeding after endometrial ablation to determine if new lesions are present and to check the status of the endometrium Evaluation of the endometrium after extensive adhesiolysis Evaluation of the endometrium after a pediatric Foley catheter is removed to exclude recurrent adhesions

Figure 3–24. Retained products of conception following a therapeutic abortion. Patient had two additional suction curettages, blood transfusion, and incessant bleeding that persisted despite multiple interventions. Hysteroscopy clearly identified the retained products of conception, which could be removed hysteroscopically, with resolution of abnormal bleeding.

scopic or abdominal myomectomy can cause adhesions. Postoperative inspection will confirm complete resection and detect postoperative adhesions.

Hysteroscopic Sterilization Hysteroscopic sterilization is an excellent method of tubal occlusion. Proper scheduling of the procedure during the early proliferative phase and lack of obstruction to the fallopian tubes is necessary for bilateral placement of tubal inserts. Easy

After extensive hysteroscopic resection of leiomyomas, entrance into the endometrial cavity following extensive laparo-

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Figure 3–25 Hysteroscopy depicting normal tubal ostia. Figure 3–27 Hysteroscopic view of a prolapsing myoma protruding through the cervix.

obstructs the tubal orifice, hysteroscopic sterilization can be performed after operative hysteroscopy. Planning ahead will guarantee that appropriate surgical instruments are available and that an expensive sterilization device is not opened if the procedure cannot be completed.

Vaginal Myomectomy Uterine fibroids are a common cause of vaginal bleeding. On occasion, fibroids spontaneously prolapse vaginally or prolapse following a UFE. Encountering a large mass from the cervix is often unanticipated and is another reason that pelvic examination is necessary for all patients with complaints of vaginal bleeding. It is best to schedule the patient for surgery in the outpatient operative center if a prolapsing myoma is detected. A dilated, patulous cervix is encountered with a prolapsing myoma. The fibroid appears vascular and pink or bright red, due to engorgement (Fig. 3–27). On occasion, the prolapsing myoma appears black or blue due to necrosis from a strangulated blood supply (Fig. 3–28). Once the vaginal myomectomy is performed, it may be difficult to close the cervix enough to perform hysteroscopy satisfactorily. Techniques to close the cervix include placing a single-tooth tenaculum on the anterior and posterior lips bilaterally to narrow the opening of the external cervical os or placing a purse-string suture or endo-loop around the cervix. Even when using these techniques, optimal hysteroscopic endometrial visualization, after removal of a myoma vaginally, might not be possible. In these situations, office hysteroscopy performed several weeks after surgery permits visualization of the endometrium and confirms that no additional residual myoma is present. Asymptomatic small, residual leiomyomas might not require additional therapy, but it is important to document whether any remaining fibroids exist. Remaining

Figure 3–26 This patient had abnormal bleeding and desired sterilization with Essure. The patient was evaluated preoperatively and advised to have hysteroscopic myomectomy followed by Essure. This enabled bilateral placement of microinserts and resolution of bleeding.

visualization of both fallopian tubes is paramount for a quick procedure (Fig. 3–25). Inquire about menstrual aberrations if planning for hysteroscopic sterilization. The most common intracavitary lesions in reproductive-age patients with abnormal menstruation are polyps and submucosal fibroids (Fig. 3–26). If a patient requests hysteroscopic sterilization and has irregular menstruation, consider office hysteroscopy to obtain a panoramic view of the endometrium and tubal ostia. Scheduling this advance view will enable you to determine if there is obstruction to the tubal ostia or poor visualization, which might prevent placement of the sterilization device. Office hysteroscopy performed before scheduling confirms lack of tubal obstruction. If a polyp or submucosal fibroid

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Figure 3–28. A large intracavitary leiomyoma with a necrotic tip. Due to its size, hysterectomy rather than hysteroscopic resection was recommended.

Figure 3–29. Patient with three prior cesarean deliveries. Menstrual cycles resumed after breast-feeding, but patient experienced irregular menstruation, postmenstrual staining, and abdominal pain. Hysteroscopy demonstrates a cleft and widening of the lower uterine segment. Operative hysteroscopic resection of the fibrotic tissue, which surrounded the scar, led to resolution of clinical symptoms.

leiomyomas that are symptomatic should undergo operative hysteroscopic myomectomy.

retained blood may be seen, causing bleeding. Retained suture material acts as a foreign body and can contribute to irregular bleeding (Fig. 3–29).

Bleeding after Cesarean Section Approximately one in four babies born today is delivered by cesarean section. A repeat cesarean section occurs in more than half of patients. Increasingly, abnormal menstrual bleeding occurs following a cesarean section. Patients report normal menstruation preceding pregnancy, and after operative delivery they complain of episodic spotting, brown staining, or postcoital bleeding. Medical therapy seldom solves the problem. Office hysteroscopy is uniquely helpful in evaluating menstrual disorders following cesarean section. The lower uterine segment can be rapidly visualized. In fact, the pouch of the cesarean section scar may be visualized as an invagination of endometrium, presence of a hiatus, or diverticula in an anterior isthmus at the site of a previous cesarean delivery scar. Fabres and colleagues22 noted an excellent correlation between TVUS and office hysteroscopy. In all women, TVUS revealed the presence of a diverticulum on the anterior uterine segment at the site of the expected cesarean section. Hysteroscopy revealed a 100% correlation with TVUS in detecting the pouch. Erickson and Monteagudo23,24 evaluated the lower uterine segment with SIS and noted diverticula on the anterior wall at the expected cesarean section. The scar essentially becomes a focus of adenomyosis. Histopathologic findings include widening of the uterine segment (75%), overhang of congested endometrium above the scar (61%), moderate to marked lymphocytic infiltration (65%), residual suture material with foreign body reaction (92%), capillary dilatation (65%), and evidence of free blood suggesting recent hemorrhage within the endometrial stroma. Pockets of

Location of Foreign Bodies Since the early 1990s, more women are using IUDs as a method of contraception. The Paragard IUD is copper and can be worn for 10 years. Mirena, a progesterone-embedded IUD, can be worn for 5 years. The pregnancy failure rates with IUDs are comparable to rates for tubal ligation, occurring in less than 2% of women. The expulsion rate is highest during the first few months of insertion and declines steadily afterward. On occasion the IUD string cannot be palpated by the patient or seen by the physician. When this occurs, it is important to determine if expulsion, migration, or perforation of the IUD into the myometrium has occurred. Curling of the IUD string within the lower uterine segment or endocervix may be all that accounts for the “lost” IUD. Office hysteroscopy can quickly and comfortably establish the location of the IUD and the string. If the hysteroscope has an ancillary port that permits passage of a small forceps, the string can be gently pulled into the ectocervix without removal. The patient benefits from continued IUD use. If the IUD cannot be easily removed, use hysteroscopy to determine its location. Ultrasound can be useful in determining whether the IUD is within the uterine cavity and avoids exposure to x-ray. However, it cannot tell if the IUD is embedded firmly or has migrated into the myometrium. Hysteroscopy can help determine if the

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Indications and Contraindications for Office Hysteroscopy How long it takes a uterine perforation to heal is anyone’s guess. However, consider performing office hysteroscopy to determine if the perforation has closed. It has been my observation that a perforation might not be healed by even 3 to 4 months! If bowel or yellow epiploica are visualized, then the perforation has not healed. If this occurs, then the patient is advised and scheduled for laparoscopy (with suturing of perforation) and concomitant hysteroscopy.

Pregnancy-Related Bleeding Despite the numerous algorithms for evaluating ectopic pregnancy or missed abortion, sometimes it is quite difficult to determine the location of a pregnancy. When a serum human chorionic gonadotropin (hCG) or serum progesterone level falls or plateaus and ultrasound is indeterminate in evaluating the status of the pregnancy, consider office hysteroscopy. A recent study, albeit small, evaluated 15 women whose pregnancy was poorly localized.25 Both endometrial biopsy and hysteroscopy were used to determine if an ectopic pregnancy or missed abortion was seen. In eight patients, an empty cavity was identified at diagnostic hysteroscopy and the endometrial biopsy was negative. In two patients, hysteroscopy was not contributory and the endometrial biopsy was negative. Pregnancy was found in one patient and an IUD with blood in the cavity was found in the other. In three patients who had an early abortion, hysteroscopy and endometrial biopsy demonstrated chorionic villi. Finally, in two patients who had an early abortion, hysteroscopy identified chorionic villi, and endometrial biopsy was not helpful. The sensitivity and specificity of hysteroscopy for the diagnosis of ectopic pregnancy was 100% but the sensitivity of endometrial biopsy was 50% and specificity was 100%. The take-home message from this study was that if pregnancy cannot be correctly localized at ultrasonography, hysteroscopy appears to be better than endometrial biopsy to discriminate between ectopic and early abortion. Hysteroscopy during pregnancy is acceptable, as long as you have determined that the hCG levels are declining and the pregnancy is likely not viable (Fig. 3–31).

Figure 3–30 A 53–year-old woman presented with persistent spotting and leukorrhea for more than 25 years. She had had multiple blind dilation and curettage and antibiotics. This hysteroscopic view demonstrates a foreign body. When removed, it was noted to be Mersilene tape. Previously placed cerclage that was not removed with her last childbirth and migrated into her uterine cavity. Once the tape was removed, all complaints resolved.

arms of the IUD are imbedded in the myometrium. Deep myometrial migration may be difficult to remove in the office due to pain, risk of perforation, or breakage of the IUD string. If office hysteroscopy does not demonstrate the presence of the IUD, then a single radiograph of the kidneys, ureters, and bladder (KUB) will determine if it is present within the peritoneal cavity. Other foreign objects that have been visualized hysteroscopically include migrated cervical cerclage, broken laminaria tents, fragmented IUDs, broken plastic tips of curettes, nonabsorbable suture material, bone fragments from previous pregnancy, and broken ceramic tips from an operative hysteroscope (Fig. 3–30).

Infertility and Recurrent Pregnancy Loss Evaluation of the Uterine Cavity after Perforation

Patients with infertility or recurrent pregnancy loss require an evaluation of the uterine cavity. Intrauterine adhesions or müllerian anomalies are known causes of pregnancy loss. Uterine cavity evaluation with office hysteroscopy offers a direct view of the cavity with immediate results. Patients can view the abnormalities on the monitor and have a visual appreciation of their problem. Although the concept is still controversial, uterine cavity abnormalities such as polyps or myomas may be associated with infertility. The association with pregnancy loss is more accepted. In vitro fertilization requires a normal uterine cavity. Before initiating each cycle, an assessment of the cavity is necessary. Office hysteroscopy and SIS provide similar sensitivity, and personal preference often determines the approach.

One of the most common complications of operative hysteroscopy is uterine perforation. Perforation occurs most often during dilation of the cervix and less often during the resection of intracavitary lesions. When the initial outcome of cervical dilation is perforation, the physician must abandon the procedure because of inability to maintain distention of the uterine cavity and in order to prevent injury to surrounding organs. Alternatively, some gynecologists perform a laparoscopy, suture the perforation, and continue with the operative hysteroscopic procedure under laparoscopic guidance. Most physicians, however, stop the initial procedure and request that the patient return 2 to 3 months later and attempt hysteroscopy again.

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Figure 3–31. Hysteroscopy demonstrating retained products of conception. Previous blind suction curettage after three attempts had failed to remove the residual placental tissue. Ultrasound revealed a 5-cm intracavitary lesions. Operative hysteroscopy with a wire loop resected all of the necrotic decidual tissue and villi, resulting in prompt resolution of symptoms.

Figure 3–32 This patient’s chief complaint was leukorrhea. There were no menstrual disturbances. Hysteroscopy demonstrates an intracavitary polyp.

Additional inaccurate results may be due to the dye used or the interpretation of the results. When results are ambivalent, office hysteroscopy offers a complementary view. Remember that HSG offers visualization of the tubes and can determine patency of the tubes and determine if tubal diverticula or intratubal defects exist.

Evaluation of an Abnormal Hysterosalpingogram Preutthipan and colleagues26 compared the accuracy of HSG with the accuracy of hysteroscopy in women with infertility. Hysteroscopy was the gold standard. A prospective, comparative study included 336 patients undergoing both HSG and diagnostic hysteroscopy. Outcomes evaluated included sensitivity, specificity, PPV and NPV, and accuracy rate of HSG. Among 286 women who had intrauterine abnormalities with HSG, findings were confirmed in only 200 women when hysteroscopy was performed. Hysteroscopy noted an additional four intrauterine lesions in 50 women whose HSG was normal. The most common intrauterine finding of 336 patients on hysteroscopy were intrauterine adhesions (74), followed by endometrial polyps (56) and submucous myoma (26). Statistical analysis revealed that HSG in detecting intrauterine pathology had a sensitivity of 98.0%, specificity of 34.9%, PPV of 69.9%, NPV of 92.0%, accuracy rate of 73.2%, false-positive rate of 30.1%, and false-negative rate of 8.0%. The most common missed diagnosis of HSG was identifying cervical stenosis as severe intrauterine adhesions in 24 patients, endometrial polyps as submucous myoma in 22 out of 50 patients, and submucous myoma as endometrial polyps in 12 out of 72 patients. This study demonstrates the usefulness of hysterosalpingography. However, if a hysterogram demonstrates intrauterine abnormalities, hysteroscopy should be considered to make a definite diagnosis and treatment. These procedures complement to each other. HSG may be associated with both false-positive and falsenegative results due to difficult distention of the uterine cavity, blood, debris, mucus, or air bubbles. Most studies indicate that when an HSG is normal, hysteroscopy will also likely be normal.

Leukorrhea Chronic watery or serosanguineous discharge is irritating to women. Prompt evaluation is needed. Once trichomoniasis is treated or excluded and the patient continues to have leukorrhea, consider evaluation of the endometrium directly with hysteroscopy. Culprits for leukorrhea include endometrial hyperplasia, endometrial cancer, and leiomyomas or endometrial polyps. Visualization of the endometrium can verify that no intrauterine pathology exists. Especially among postmenopausal women, visual inspection of the endometrium is extremely helpful in excluding intrauterine pathology as a cause of leukorrhea. Leukorrhea may be a subtle sign of intrauterine pathology in menopausal women. Astute clinicians inquire annually about the presence of leukorrhea. If the answer is affirmative, then hysteroscopic visualization of the endometrium helps detect intrauterine disease (Fig. 3–32).

Amenorrhea or Leukorrhea Following Uterine Fibroid Embolization UFE has been associated with the development of Asherman syndrome, an obliteration of the endometrial cavity. Amenorrhea occurs in less than 2% of women younger than 40 years and in 2% to 15% of women older than 45 years treated by UFE. The endometrium can become underperfused in the regions overlying an intramural leiomyoma. When this occurs, the endometrium becomes pale, atrophic, and nonviable.

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Figure 3–34 Hysterectomy was performed for a sinus tract developing between the endometrium and myoma. Hysteroscopy demonstrated this sinus tract, too.

Figure 3–33 This patient developed chronic discharge following uterine fibroid embolization. Hysteroscopy demonstrated an intrauterine cavity filled with necrotic debris. The patient underwent hysterectomy for definite treatment.

Evaluation of the Endometrium during Tamoxifen Therapy Tamoxifen is usually considered an estrogen antagonist. It has agonist effects on endometrium, bone mineral density, and lipid metabolism. Thus, tamoxifen can slightly increase the risk of uterine cancer among long-term users. In the National Surgical Adjuvant Breast and Bowel Project (NSABP), tamoxifen 20 mg/ day was compared to a placebo. Results demonstrated a risk of development of uterine cancer of 2.2, which was equivalent to two cases per 1000 women per year. Monitoring women on tamoxifen has been difficult. There is a high false-positive rate when ultrasonography and endometrial biopsy are used. As a screening tool, neither method is advised. Currently, asymptomatic women on tamoxifen do not need any surveillance. If the patient complains of leukorrhea, staining, or bleeding, then direct visualization of the endometrium with hysteroscopy is recommended. A direct inspection and direct biopsy is more accurate than TVUS or biopsy alone. When TVUS alone is used, bizarre endometrial abnormalities are reported. Quite often the endometrium appears ill-defined, not visualized, or thickened. Bizarre changes often occur in the subendometrial layer, including increased sonolucencies representing activation of adenomyotic cysts rather than truly thickened endometrium. To determine the true location of these problems, hysteroscopy is essential and quickly detects the location of the bizarre changes. When viewed hysteroscopically, the endometrium is most often thin, with blebs of subendometrial cysts. These are normal findings and do not require therapy (Figs. 3–35 and 3–36).

Dense adhesions and fibrous tissue have also been noted. There may be a discontinuity in the endometrium in the region overlying the leiomyoma. When this occurs, patients complain of erratic vaginal discharge that can be clear, rusty, or serosanguineous. Some women complain of leukorrhea immediately following UFE. Leukorrhea can also occur weeks, months, or years after UFE. Uterine volume and fibroid size decreases the most within 4 to 6 months after the procedure, but decline in volume can occur up to 1 year following the procedure. It is theorized that the leiomyoma necroses and pockets of cavities develop that connect the endometrium and myometrium. Fluid accumulates within these cavities, leaking into the endometrium episodically. Visual inspection with hysteroscopy demonstrates tunnels from the endometrium into the myometrium. Large denuded regions and areas of discontinuity exist within the endometrium. Treatment can include watchful waiting, hysteroscopic resection of the endometrium, or hysterectomy when the other two treatments fail. Rarely does the patient respond to broad-spectrum antibiotics. Patients with complaints of persistent leukorrhea following UFE benefit from office hysteroscopy. The findings are subtle and often missed if TVUS alone is performed. Sounding the endometrium is paramount. Adhesions can occur after UFE, with the formation of loculations of fluid within the adhesions. Gently probing with a sound disrupts the loculations, resolving the discharge. If this is not effective, then hysteroscopy is helpful. Discharge following UFE can usually be managed expectantly. When expectant management fails, resection of necrotic tissue leads to high patient satisfaction and excellent resolution of the clinical symptoms. Hysterectomy is uncommonly needed for complaints of leukorrhea (Figs. 3–33 and 3–34).

CONTRAINDICATIONS TO OFFICE HYSTEROSCOPY Pelvic Inflammatory Disease Physician inexperience and an extremely reluctant patient are major contraindications to hysteroscopy. Acute pelvic

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31 80

A herpes prodrome or active herpes infection is also an absolute contraindication. Price and colleagues27 describe a case of fulminant hepatic failure and death due to herpes simplex infection after hysteroscopy. This case report detailed the unfortunate sequelae of performing hysteroscopy in a patient with herpes without mucocutaneous lesions. Although this is a rare condition, it reminds us that hysteroscopic procedures should be abandoned if active herpes or a prodromal herpetic episode is suspected. Herpes is a possible cause of postsurgical infection, especially in the setting of high fever, leukopenia, and abnormal liver function. Gynecologists performing hysteroscopy must remain vigilant about asymptomatic herpes when hysteroscopy is performed. Microscopically inspect the vaginal discharge if it appears mucopurulent or malodorous, and obtain cervical cultures. Patients who have trichomoniasis, which is a sexually transmitted disease, might have a higher incidence of other STDs such as gonorrhea or Chlamydia trachomatis. It is far better to postpone the hysteroscopy by 1 week than to cause an acute pelvic infection.

L

0 Figure 3–35 This patient took tamoxifen for 4 years. She had no gynecologic complaints. An ultrasound was ordered for nongynecologic reasons, and a bizarre-appearing endometrial echo was identified.

Vaginal Bleeding Moderate vaginal bleeding is a relative contraindication to office hysteroscopy but with aggressive irrigation of the endometrial cavity, visualization is possible. Rarely does irrigation require more than 200 to 300 mL. This flushes and dilutes the contents of the cavity. In addition to flushing the cavity, reaspirate and discard the bloody contents. The cycle of irrigation, aspiration, and discarding improves visualization. Unfortunately, most small office hysteroscopes do not have a continuous-flow capability. Carbon dioxide can be used in the presence of bleeding; however, bubbles are created, which can lead to more difficulty visualizing the endometrium. Alternating between CO2 and saline irrigation can overcome visualization difficulties.

Other Contraindications

Figure 3–36 Hysteroscopic view of the bizarre changes seen in the patient in Figure 3–35 reveals endometrial blebs, which, when hysteroscopically resected, were due to reactivation of adenomyosis. This is a common finding with prolonged tamoxifen use.

Known intrauterine pregnancy, cervical cancer, severe cervical stenosis, and an unstable patient are contraindications to office hysteroscopy. Especially for patients who are compromised with impaired ventilation, using CO2 could be hazardous, creating acid–base disturbances.

inflammatory disease (PID) is an absolute contraindication to office hysteroscopy. When scheduling a patient for this procedure, inquire about recent history or remote history of PID. If the patient has a known history of tubal obstruction or hydrosalpinx, consider prophylactic antibiotics before and after the procedure. Always visualize the cervix and vaginal secretions before performing office hysteroscopy. Pelvic examination is a must before performing hysteroscopy to determine the size of the uterus or to evaluate for uterine tenderness or adnexal masses and tenderness. If PID is suspected, postpone the procedure until cultures obtained are negative and pelvic tenderness improves.

SUSPECTED OR KNOWN ENDOMETRIAL CANCER Questions have been raised about the safety of diagnostic hysteroscopy preceding surgical treatment of endometrial carcinoma. Several studies have shown that the risk of a positive cytology among patients presenting with endometrial adenocarcinoma was increased after diagnostic hysteroscopy, suggesting a peritoneal dissemination of tumor cells. Yazbeck and colleagues studied this hypothesis on the basis of a systematic review of the scientific data.28 They found five

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Indications and Contraindications for Office Hysteroscopy studies that fulfilled the inclusion criteria and used a fixed model for the meta-analysis. Of a total of 756 studied patients, 79 presented a positive peritoneal cytology. The diagnostic hysteroscopy did not significantly increase the risk of abdominal dissemination of tumor cells. The peritoneal cytology was positive among 38 patients in the group who underwent this intervention versus 41 patients in the control group (odds ratio [OR], 1.64; 95% confidence interval [CI], 0.96-2.80). Thus, no formal evidence is currently available concerning the role of diagnostic hysteroscopy on the frequency of peritoneal dissemination of tumor cells or on the vital prognosis of the patients presenting with endometrial carcinoma. A fluid medium appears to have a higher incidence of dissemination of endometrial cancer cells than does CO2. Although dissemination of cells has been recorded, it is not known whether these cells are viable, leading to persistence and implantation of disease within the peritoneal cavity. There are no long-term randomized outcome studies evaluating women with endometrial cancer who have or have not had hysteroscopy before their surgical procedure. From the data available, there is no reason

to avoid diagnostic hysteroscopy in the initial workup of a patient with possible endometrial cancer.28

SUMMARY In general, hysteroscopy is one of the safest, easiest, and most quickly mastered surgical procedures in gynecology. Office hysteroscopy allows accurate diagnosis of many conditions associated with abnormal bleeding and infertility and improves preoperative evaluation. Hysteroscopy permits full visualization of the endometrial cavity and endocervix and is helpful in diagnosing focal lesions that are missed with endometrial sampling. Rapid visual inspection permits accurate diagnosis of atrophy, endometrial hyperplasia, polyps, fibroids, retained products of conception, and endometrial cancer. There are many indications and few contraindications for office hysteroscopy. Hysteroscopy clarifies equivocal findings on TVUS and SIS. Most importantly, hysteroscopy is extremely valuable in the presurgical evaluation. Complications from hysteroscopy are rare. Incorporating office hysteroscopy into the practice of every gynecologist is a practical and laudable goal.

REFERENCES 1. Neuwirth, RS: Hysteroscopy and gynecology: Past, present and future. J Am Assoc Gynecol Laparosc 2001;8(2):193-198. 2. Dueholm M, Lundorf E, Olesen F: Imaging techniques for evaluation of the uterine cavity and endometrium in premenopausal patients before minimally invasive surgery. Obstet Gynecol Surv 2002; 57(6):388-403. 3. Vilos GA, Abu-Rafea B: New developments in ambulatory hysteroscopic surgery. Best Pract Res Clin Obstet Gynaecol 2005;19(5):727742. 4. Marsh F, Kremer C, Duffy S: Delivering an effective outpatient service in gynaecology: A randomised controlled trial analyzing the cost of outpatient versus daycase hysteroscopy. BJOG 2004;111:243248. 5. Bettocchi S, Selvaggi L: A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc 1997;4:225258. 6. Sagiv R, Sadan O, Boaz M: A new approach to office hysteroscopy compared with traditional hysteroscopy: A randomized controlled trial. Obstet Gynecol 2006;108:387-392. 7. Vercellini P, Vendola N, Ragni G: Abnormal uterine bleeding associated with iron-deficiency anemia: Etiology and role of hysteroscopy. J Reprod Med 1993;38:502-504. 8. Bettocchi S, Ceci O, Nappi L, et al: Operative office hysteroscopy without anesthesia: Analysis of 4863 cases performed with mechanical instruments. J Am Assoc Gynecol Laparosc 2004;11:59-61. 9. Bradley L, Widrich T: State-of-the-art flexible hysteroscopy for office gynecologic evaluation. J Am Assoc Gynecol Laparosc 1995;2(3):263267. 10. Epstein E, Ramirez A, Skook L, et al: Dilation and curettage fails to detect most focal lesions in the uterine cavity in women with postmenopausal bleeding. Acta Obstet Gynecol Scand 2001;80:11311136. 11. Corfman RS: Indications for hysteroscopy. Obstet Gynecol Clin North Am 1988;27:97-99. 12. Grow DR, Iromloo K: Oral contraceptives maintain a very thin endometrium before operative hysteroscopy. Fert Steril 2006;85:204207.

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Maruo T, Laoag-Fernandez JB, Pakarinen P, et al: Effects of the levonorgestrel-releasing intrauterine system on proliferation and apoptosis in the endometrium. Hum Reprod 2001;16:2103-2108. Bakour SH, Khan KS, Gupta JK: The risk of premalignant and malignant pathology in endometrial polyps. Acta Obstet Gynecol Scand 2000;79:317-320. Jansen FW, de Kroon CD, van Dongen H: Diagnostic hysteroscopy and saline infusion sonography: Prediction of intrauterine polyps and myomas. J Minim Invasive Gynecol 2006;13:320-324. Cravello L, Stolla V, Bretelle F: Hysteroscopic resection of endometrial polyps: A study of 195 cases. Eur J Obstet Gynecol Reprod Biol 2000;93:131-134. Bruchim I, Biron-Shental T, Altaras MM, et al: Combination of endometrial thickness and time since menopause in predicting endometrial cancer in women with postmenopausal bleeding. J Clin Ultrasound 2004;32(5):219-224. Fedele L: Transvaginal ultrasonography and hysteroscopy versus hysteroscopy in the diagnosis of uterine submucous myomas. Obstet Gynaecol 1991;77:745-753. Breitkopf D, Frederickson RA, Snyder RR: Detection of benign endometrial masses by endometrial stripe measurement in premenopausal women. Obstet Gynecol 2005;104(1):120-125. Smith-Bindman R, Kerlikowske K, Feldstein VA, et al: Endovaginal ultrasound to exclude endometrial cancer and other endometrial abnormalities. JAMA 1998;280:1510-1517. Rogerson L, Bates J, Weston M, Duffy S: A comparison of outpatient hysteroscopy with saline infusion hysterosonography. BJOG 2002;109:800-804. Fabres C, Aviles G, De La Jara C: The cesarean delivery scar pouch: Clinical implications and diagnostic correlation between transvaginal sonography and hysteroscopy. J Ultrasound Med 2003;22:695700. Erickson SS, Van Voorhis BJ: Intermenstrual bleeding secondary to cesarean scar diverticuli: Report of three cases. Obstet Gynecol 1999;93:802-805. Monteagudo A, Carreno C, Timor-Tritsch E. Saline infusion sonohysterography in nonpregnant women with previous cesarean

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Indications and Contraindications for Office Hysteroscopy delivery: The “niche” in the scar. J Ultraound Med 2001;20:11051115. 25. Gervaise A, de Tayrac R, Fernandez H: Diagnosis of ectopic pregnancy: Endometrial biopsy or diagnostic hysteroscopy. J Gynecol Obstet Biol Reprod (Paris) 2003;32(5):417-419. 26. Preutthipan S, Linasmita V: A prospective comparative study between hysterosalpingography and hysteroscopy in the detection of intrauterine

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pathology in patients with infertility. J Obstet Gynaecol Res 2003;29(1):33-37. Price TM, Harris JB. Fulminant hepatic failure due to herpes simplex after hysteroscopy. Obstet Gynecol 2001;98(5 Pt 2):954-956. Yazbeck C, Dhainaut C, Batallan A, et al: Diagnostic hysteroscopy and risk of peritoneal dissemination of tumor cells. Gynecol Obstet Fertil 2005;33(4):247-252.

Chapter

4

Informed Consent for Hysteroscopy Ruth M. Farrell

sions that reflect these values.6 The quality of care, compliance, and satisfaction are all improved when patients are actively involved in their health care.7-12 For these reasons, physicians should strive to achieve adequate informed consent with their patients before undertaking a medical or surgical intervention. Because of the importance of informed consent in medical practice, it is essential that physicians have the knowledge and skills necessary to achieve it. First, physicians must understand that informed consent is a process of communication rather than a single event. Second, they must understand that there are core components of informed consent and be familiar with what they are and the purpose they serve in patients’ decision-making. These core components include competence or decision-making capacity, disclosure, understanding, and a voluntary authorization.3 Informed consent is only achieved when all of these components have been fulfilled.

Informed consent is one of the most important and misunderstood tenets of the physician–patient relationship. The medical– legal context of clinical practice often skews how physicians conceptualize the definition and function of informed consent. In its truest sense, informed consent is a process of communication whereby a physician can facilitate a patient’s informed decision-making about a medical therapy.1 Instead, informed consent is often viewed as a single event focused on documentation of the indications and risks as presented to a patient in the medical record.2 This one-dimensional notion of informed consent is flawed and leaves the patient vulnerable to misunderstandings about the procedure and its risks and outcome. These misunderstandings, even when minor, can lead to poor quality of medical care and to injury.

BASIC CONCEPTS Individuals have the fundamental right to direct their lives and do so through their decisions, actions, and beliefs.3 This right of self-determination is exemplified when patients must make decisions about accepting or refusing medical treatments and procedures. All health care providers have the obligation to respect and promote this right among their patients.4 This is accomplished by actively involving patients in their medical care so that the end point of therapy reflects their preferences and values. In its ethical function, informed consent is a process of communication between a physician and patient that results in the patient’s ability to make a voluntary decision to proceed with a medical intervention with a good understanding of the nature and risks of the procedure. When adequate informed consent has been achieved, the patient’s right to self-determination has been exercised. Informed consent serves primarily as a vehicle to respect a patient as a person with the right of self-determination.5 From an ethical standpoint, this end is a good in and of itself.3 The ethical practice of medicine is the basis for establishing the trust upon on which the therapeutic relationship is built. On a practical level, following an ethical framework for professional behavior leads to better care for the patient. The process of informed consent emphasizes the role of the patient as the decision-maker rather than the physician or any other third party. Patients benefit when they make decisions on their own behalf because they are the most familiar with their own ideas of health and well-being and can make the best deci-

Competence Competence has many different definitions and criteria depending on the medical or legal context in which it is used. In the clinical setting apart from psychiatry, “competence” is often used interchangeably with “decision-making capacity” and is determined by a clinical judgment rather than a formal assessment.13 Decision-making capacity describes the ability of a patient to understand information material to the situation and the proposed therapy, understand and weigh the risks and benefits of the therapy, and then make a decision regarding this information.3 In general, patients are assumed to have this capacity unless they demonstrate otherwise. If a physician has any reason to believe that a patient does not have full decisionmaking capacity, then a formal psychiatric evaluation should be performed to determine the extent of her abilities.

Disclosure Informed consent entails that pertinent information about the procedure is disclosed to patients before they provide authorization for treatment. Adequate disclosure is one of the most difficult aspects of informed consent to describe because there are no definitive guidelines about how providers can best educate their patients to make a meaningful decision. In the context of modern medicine, disclosure goes beyond the indications, risks, benefits, and alternatives of an intervention. Conversations

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Informed Consent for Hysteroscopy or assist in the procedure. She should also be informed of the extent to which these trainees will be participating and the level of supervision that will be provided by the attending physician.

before surgery must also include information about potential conflicts of interest that the physician might have in performing the procedure and the personnel who will be present or assist with the surgery. During the informed consent process, the physician must disclose sufficient information that allows the patient to make a well-informed decision reflecting her beliefs and values.6 It is essential to frame these risks in a way that lets a patient make a meaningful decision. Merely listing a battery of risks and adverse outcomes does not facilitate patient decision-making. Instead, information must be presented in a way that patients can place the risks and benefits of a procedure within the contexts of their lives and values of health. An open dialogue must exist between the physician and the patient to ensure that the patient obtains as much information and detail as necessary to make a meaningful decision. In terms of hysteroscopy, physicians must be familiar with the risks of the procedure and how these risks vary based on the indication for the procedure and the patient’s medical condition. Further detail about these risks can be found in Chapter 20. Disclosure of information pertinent to the procedure includes discussing the indication for the procedure, the benefits of the procedure, and the risks associated with it. When discussing risks, patients must be made aware of the nature of the risks, the likelihood that those risks will occur, and management of any adverse events.3 Patients should also understand the possible short-term and long-term effects of the procedure, particularly as they pertains to the procedure’s effect on fertility and reproductive function. Change in sexual function, duration of recovery time, and hormonal changes due to surgery are examples of information that are essential to these types of considerations. Patients should also be educated about the risk of procedure failure, including the chance that the procedure might not be able to be executed as planned or that it might not resolve the clinical condition. Finally, the patient must be aware that she does have a choice to accept or decline what is offered and the alternatives to the procedure in case she refuses to proceed. The standard of information disclosure is also applicable when a possible conflict of interest exists.14 This can occur when the use of surgical equipment or performance of a procedure places the physician in the position of weighing personal and professional interests over the interests of the patient. Conflicts of interest may be economic. This can arise when a physician has a vested interest in the successful development and marketing of a new device or technique that could be used during the surgery. Conflicts of interest can also be of a professional nature, such as when the recognition of performing an innovative procedure may be a result of the surgery. Regardless of the source, the patient must be informed about any potential conflicts of interest that the physician might have and incorporate this information into her decision-making. An additional component of disclosure must be included in the discussion when trainees are involved in the surgical procedure. This includes (but might not be limited to) medical students, residents, fellows, and surgical supply vendors. The patient should be informed of the personnel who will participate

Understanding Understanding is an equally important part of the informedconsent process.2 It is not sufficient merely to disclose information about the procedure. Instead, the physician should be confident that the patient understands this information before going ahead with a procedure.1 Medical terminology is often one of the most common barriers to a patient’s understanding. Words such as hysteroscopy, uterine perforation, and hemorrhage may be unfamiliar and confusing to patients. Other clinical factors can obscure understanding, such as illness or medication administration. Patients should be encouraged to ask questions about the performance of the procedure and its risks. Physicians should also ask questions of the patient to assess her understanding of the information that was disclosed. This is an ideal opportunity to clarify any areas of misunderstanding or miscommunication before the procedure is initiated. Patients use this information and their understanding of it to make a voluntary decision for or against treatment. Valid informed consent can only be obtained through the voluntary authorization by a patient.6 Coercion, manipulation, threat of force, harm, or access to treatment are all factors that are incongruous with informed consent. Physicians should be aware of influences that can come from within the physician–patient relationship, family members, or other parties and do their best to ensure that patients make voluntary decisions free of these influences. If a patient is manipulated or coerced into making a decision, then valid informed consent has not been achieved.

Legal Implications Informed consent is primarily an ethical standard of clinical medicine used to protect the interests of the patient. However, informed consent does have an important legal aspect as well. In the legal context, informed consent is the documentation of the process of communication with the patient about the procedure. The rigor of this legal requirement can vary from institution to institution. In some instances, documentation of the informed consent process does not require completion of a standard informed consent form. Instead, this discussion may be documented in a narrative form in the medical record. It is important to keep in mind that both the legal and ethical requirements of informed consent should be met before a surgical procedure is undertaken. Though the legal requirement of documentation is important, it should not take precedence over the process of communication that is necessary for patients to make well-informed decisions about their health care. The dual identity of informed consent as both an ethical process of communication and legal documentation of this discussion can be the source of confusion. This dual nature can mislead providers about the purpose of informed consent and what steps are necessary to achieve it. In many instances,

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Informed Consent for Hysteroscopy knowledge of the patient’s wishes.15 In most cases, this is a family member, such as a spouse or other member of the immediate family. It is also important for gynecologists to be familiar with advance directives that come into play when end-of-life decision-making must take place. This situation is always a possibility when a serious adverse outcome can occur, leaving a patient critically ill. A living will is one method of surrogate decisionmaking in this context.15 This is a legal document in which the patient describes her treatment preferences in the setting of loss of decision-making capacity. The limits of a living will usually pertain to choices about nutrition, hydration, or ventilator support. Do not resuscitate (DNR) orders are another type of advance directive that specifically directs the withholding of lifesaving procedures in the case of cardiopulmonary arrest, such as cardiopulmonary resuscitation and defibrillation. Physicians should initiate discussions about surrogate decision-making and advance directives with their patients before the need arises to rely on such decisions. Preoperative planning is an opportunity for this conversation and is relevant whether the surgery is a minor or major procedure.

physicians believe that documentation requirements take precedence when obtaining informed consent. However, physicians must be aware that the process of communication necessary to facilitate the patient’s decision-making is not substituted by the completion of a legal document. It is important to keep in mind that not all legal documents with a patient’s signature or description of a discussion reflect that an adequate informed consent process has taken place. In these instances, patients might not have been adequately educated about the procedure or understood the ramifications of the risks before signing a document. Other misunderstandings occur when the emphasis of informed consent is placed on documentation rather than communication. Specifically, physicians are led to believe that the purpose of informed consent is to protect them when adverse outcomes occur. This notion of informed consent is erroneous for at least two reasons. First, the practice of informed consent was evolved out of a need to protect the patient’s interests.5 Informed consent was never intended to be a mechanism to protect physicians. The mid-20th century marked a change in medical practice, moving away from notions of paternalism and toward autonomy. The doctrine of informed consent was established to prioritize patients’ autonomous wishes in decisions about their medical care. Second, it is important for physicians to recognize that a signed consent document does not guarantee protection from legal action in the case of an adverse outcome. Legal precedent has clearly demonstrated that physicians can be held accountable for battery and negligence in a court of law even when the patient signed an informed consent document before the surgery.6 Physicians are required to obtain informed consent directly from the patient before beginning a surgical procedure. There are a few exceptions to this standard. Modification of the standards of the informed consent procedure are required when treating incompetent or minor patients or in emergency situations.

Minors Girls and adolescents younger than 18 years are legally designated minors and do not have the authority to provide informed consent for themselves. Surgical procedures cannot be performed on these young patients without the consent of the parent or legal guardian.16 Often, these patients are mature enough to demonstrate the capacity for developing adult decision-making. As a result, the informed consent process poses a particular challenge because it is founded on the notion of a patient’s right to make decisions about her health and medical care. In the case of minors, the process of informed assent is more appropriate and functional than informed consent.17 Informed assent is a mechanism that recognizes and respects the girl’s developing cognitive capacity by facilitating her decision-making in conjunction with parental involvement. Consent to proceed is provided by the child’s parent or guardian. However, the minor patient is encouraged and allowed to participate in the decision-making process to the extent of her developmental capacities. Minor patients should be informed about the procedure by the same standards of disclosure and understanding used for adults. Furthermore, they should be allowed to express their wishes about the procedure and, to the extent of their ability, physicians and parents should respect these opinions. Specific exceptions to the legal standard of parental consent exist but rarely apply for most gynecologic procedures. Legal exemptions, also known as minor treatment statutes, allow minors to access specific reproductive health care, limited to caring for sexually transmitted infections and providing contraception.18 However, this ability to consent for treatment and procedures does not cross over into other areas of their reproductive health care. Minors cannot authorize procedures, such as hysteroscopy, without the consent of a parent or guardian or legal intervention.

INCOMPETENT PATIENTS Incompetence may be a transitory or chronic state. Alzheimer’s disease is an example of permanent incompetence in which the patient will never resume normal decision-making capacity. In contrast, sepsis and renal failure are two examples of when medical conditions can result in reversible incompetence. In either case, when a patient does not have adequate decisionmaking capacity to provide authorization for a procedure, a surrogate decision-maker must be designated.6 Surrogate decision-making has several different forms. In the case of durable power of attorney for health care, a patient designates a specific person to make health care decisions in the setting of loss of decisional capacity. This decision is made while the patient’s ability to make decisions is intact. This surrogate decision-maker is known as a health care proxy or an attorneyin-fact for health care. When the surrogate decision-maker has not been formally established at the time a surgical procedure is indicated, another person is assigned the responsibility to make decisions on behalf of the patient as based upon his or her

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Informed Consent for Hysteroscopy should be based upon what is judged to be in the medical best interest of the patient, and it usually assumes that most people would opt on the side of instituting lifesaving measures. Deferment of informed consent does not release the physician from his or her obligation to fully inform the patient of the intervention taken while she was incapacitated. It is important that the patient be aware of and understand what was performed and the reasons behind the decision. Furthermore, deferment of informed consent for an emergency procedure does not negate the need to obtain informed consent for any future procedures, even if the same procedure is repeated. Once the patient has recovered decision-making capacity or sufficient time is available to discuss the procedure and options, the standards of informed consent should be restored.

Emergency Situations There are very few exceptions to the requirement of obtaining informed consent before proceeding with a surgery. Emergency situations represent the only instance in which informed consent can be deferred before a procedure is initiated.17 Two types of conditions can be present in emergency situations that can preclude discussion and decision-making: there is not sufficient time to obtain informed consent before a procedure must be initiated or the patient is unconscious or is experiencing a temporary loss of decision-making capacity. In these cases, when the patient’s life is at stake and procedures must be done immediately, it is ethically and legally acceptable to proceed with treatment and postpone informed consent until later. This decision to treat

REFERENCES 1.

2. 3.

4.

5. 6.

7.

8.

9.

Sugarman J: Informed consent. In Sugarman J: Twenty Common Problems: Ethics in Primary Care. New York: McGraw-Hill, 2000 pp 234-239. Lidz CW, Appelbaum PS, Meisel A: Two models of implementing informed consent. Arch Intern Med 1988;148:1385-1389. Beauchamp TL, Childress JF: Respect for autonomy. In Beauchamp TL, Childress JF: Principles of Biomedical Ethics, 5th ed. New York: Oxford University Press, 2001 pp 57-112. U.S. Department of Health, Education, and Welfare: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: U.S. Government Printing Office, 1979. Available at http://ohsr.od.nih.gov/guidelines/belmont. html (accessed November 10, 2007). Faden RR, Beauchamp TL: A History and Theory of Informed Consent. New York: Oxford University Press, 1986. Berg JW, Applebaum PS, Lidz CW, Parker LS: The concept and ethical justification of informed consent. In Berg JW, Applebaum PS, Lidz CW, Parker LS: Informed Consent: Legal Theory and Clinical Practice. New York: Oxford University Press, 2004, pp 14-40. Brennan PF, Strombom I: Improving health care by understanding patient preferences: The role of computer technology. J Am Med Inform Assoc 1998;5:257-262. Leape LL, Berwick DM, Bates DW: What practices will most improve patient safety? Evidence-based medicine meets patient safety. JAMA 2002;288:501-507. Parhiscar A, Rosenfeld RM: Can patient satisfaction with decisions predict compliance with surgery? Otolaryngol Head Neck Surg 2002;126:365-370.

10. Rosenberg MJ, Waugh MS, Burnhill MS: Compliance, counseling and satisfaction with oral contraceptives: A prospective evaluation. Fam Plann Perspect 1998;30:89-92. 11. Ruland CM: Improving patient safety through informatics tools for shared decision making and risk communication. Int J Med Inform 2004;73:551-557. 12. Wu HW, Nishimi RY, Page-Lopez C, et al: Improving patient safety through informed consent for patients with limited health literacy. Washington, DC: National Quality Forum, 2005. 13. Sugarman J: Competency and decision-making capacity. In Sugarman J: Twenty Common Problems: Ethics in Primary Care. New York: McGraw-Hill, 2000 pp 225-233. 14. Weinfurt KP, Friedman JY, Dinan MA, et al: Disclosing conflicts of interest in clinical research: Views of institutional review boards, conflict of interest committees, and investigators. J Law Med Ethics 2006;34:581-591. 15. Buchanan AE, Brock DW: The primary ethical framework: Patientcentered principles. In Buchanan AE, Brock DW: Deciding for Others: The ethics of Surrogate Decision-Making. New York: Cambridge University Press, 1990 pp112-16. 16. King NMP: Making Sense of Advance Directives. Washington DC: Georgetown University Press, 1996. 17. Boonstra H, Nash E: Minors and the right to consent to health care. The Guttmacher Report on Public Policy. 2000;3(4):4-8. Available at http://www.guttmacher.org/pubs/tgr/03/4/gr030404.html (accessed November 10, 2007). 18. Committee on Bioethics, American Academy of Pediatrics: Informed consent, parental permission, and assent in pediatric practice. Pediatrics 1995;95:314-317.

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5

Maintenance of Equipment for Hysteroscopy Linda D. Bradley and Sandra Fluharty

The care and maintenance of office hysteroscopic equipment is important for preventing propagation of disease between patients and health care workers. Proper care also prolongs the life of the hysteroscope. Each hysteroscope manufacturer has specific instructions for use that must be carefully followed (Box 5–1). Failure to follow instructions can ruin instruments or cause damage that requires expensive repairs. Each nurse who assists with office hysteroscopy should undergo periodic in-service training and competency evaluation. Policies and procedure manuals should be readily available for reference, if needed. Guidelines have been developed by the Association for Professionals of Infection Control and Epidemiology (APIC) and the Association of Perioperative Registered Nurses (AORN).1 These guidelines should be posted as a step-by-step guide in the sterilization area for handy reference.

CARE AND MAINTENANCE OF INSTRUMENTS Once equipment has been purchased, it is important to refer to the manufacturer’s manual of instruction. When possible, especially in an office or small group practice environment, a brief in-service training given by the vendor is helpful. Practical guidelines, clinical pearls, and a mock in-service test are undertaken. All new nursing staff or allied support staff must have thorough in-service training before handling the sterilization equipment. New nursing staff must have comprehensive in-service training followed by testing that demonstrates competency in maintaining the equipment. This is not a job for a novice. Hysteroscopy equipment lasts a long time when it is cleaned and handled correctly. When the wrong disinfectant is used or the sterilization is performed incorrectly, expensive equipment can be ruined permanently or might need to be rebuilt, which is an expensive proposition. The components of hysteroscopy include equipment that comes into direct contact and indirect contact with the patient. With rigid hysteroscopy the component parts that are in direct contact with the patient include the hysteroscope, telescope, camera, operative sheaths, distention tubing, fiberoptic light cable, vaginal speculum, dilators, and tenaculum. The flexible hysteroscope has a longer working length than the rigid system, but there is still potential contact with the camera and distention tubing. Indirect components of office hysteroscopy include the recorder (compact disk [CD] or digital video disk [DVD]), printer, video monitor, hysteroinsufflator, and light source. The indirect components are low maintenance, but they still require periodic inspection. Especially if CO2 is used, the tank must be inspected regularly to ensure that it is full and functioning. Only a low-pressure hysteroinsufflator should be used with CO2 office hysteroscopy. Hysteroinsufflators work at low pressures ranging from 30 mm Hg to 120 mm Hg. Periodic calibration is important. If diagnostic hysteroscopy is performed in an ambulatory surgical center where laparoscopic insufflators are also available, it is crucial that the surgeon look at the connections from the hysteroscope to the CO2 device and make certain

EQUIPMENT AND SUPPLIES FOR OFFICE HYSTEROSCOPY The equipment needed for office hysteroscopy is not expensive. Each physician will determine the essential items that should be routinely opened and those that should be readily available (Figs. 5–1 and 5–2): ● ● ● ● ● ● ● ● ●

● ● ● ● ●

60 mL syringe Extension tube set Sterile hysteroscope (rigid or flexible) Light cords Camera Monitor Sterile basin Nonsterile gloves Sterile back-table supplies (sterile gloves, procto swabs soaked with chlorhexidine gluconate, biopsy forceps, grasps, scissors, hysteroscopic nipples) Tenaculum Cervical os finder disposable underpad (Chux) Normal saline Low-flow hysteroinsufflator

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Maintenance of Equipment for Hysteroscopy that the connection is to the hysteroinsufflator and not a laparoscopic insufflator. When the procedure is completed, all switches should be turned to the off position. The bulbs are expensive to replace, and this prevents bulb burnout. Turning switches to the off position immediately upon completing the procedure is advisable. Additionally, periodically check the amount of paper in the recorder and check that all connecting cables are properly aligned.

BOX 5–1 Instructions for Using the Steris Processor for the Office Flexible Hysteroscope ● ● ●

●

Be sure that flexible hysteroscope is completely clean by following the instructions for use for the particular hysteroscope. Visually inspect and leak test the flexible hysteroscope to ensure that it is working properly before processing it in the Steris. Position the hysteroscope so that all surfaces will be exposed to the sterilant. Connect the proper quick connect kit to the working or irrigation channel. Remove all light adaptors. The hysteroscope is ready to use immediately after the cycle is completed.

Handling Equipment Hysteroscopic equipment is delicate and must be handled gently. Flexible hysteroscopes must be handled carefully to prevent damage to the fiberoptic bundles. Never force a flexible hysteroscope through an unyielding cervix. Instead, use tapered dilators and then guide the flexible hysteroscope into the cervix under direct visualization. Effortless entry into the uterus is the goal. Never use ring or uterine packing forceps to grasp the end of the flexible hysteroscope (Fig. 5–3). This definitively damages or crushes the distal tip of the flexible hysteroscope, requiring expensive repairs. The flexible hysteroscope should slide effortlessly into the cervix. Both rigid and flexible hysteroscope telescopes should be checked before each use for sharpness of image. Hold the telescope up to the light and inspect for clarity of view, sharpness, and lack of condensation of fluid. The view should be round. If it is another shape, then there is a problem with the telescope that might need repair. The lens should not be blurred, foggy, or dark. If these problems are present, fluid has entered the fiberoptic bundles. If this occurs, properly resterilize the equipment. If it occurs again, then the equipment must be sent for repair. When biopsy or grasping forceps are used, they should easily pass through the operative channel. Do not force equipment

Figure 5–1 A procedure room outfitted with monitors, a comfortable electronic bed, and hysteroscopic equipment.

Figure 5–2 The minimal equipment needed for office flexible hysteroscopy includes a flexible hysteroscope in the Steris container, hysteroinsufflator tubing, 60-mL syringes, sterile speculum, and brochure that explains the office hysteroscopic procedure.

Figure 5–3 The distal tip of the flexible hysteroscope is extremely fragile. Never handle it with ring forceps or uterine packing forceps. The distal hysteroscope should gently be inserted into the cervix atraumatically. Never force the hysteroscope into the cervix.

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Maintenance of Equipment for Hysteroscopy through any sheath. This problem can be caused by misalignment and require service repair from the vendor. Never bend light cables or the working length of the flexible hysteroscope. Light cables should be periodically checked by holding up the light cable and looking for discolored spots or blackened areas. Such spots represent a decline in light capabilities. The light cord should be sent for repair. All component pieces of hysteroscopy are fragile. The handoff of equipment should be orchestrated carefully. Verbalize your sequential actions. For instance, state, “I am going to give you the camera head.” This warning prompts the nurse. The physician should remove the camera and hand it directly to the nurse. Handle the hysteroscope with the eyepiece. Do not bend, crush, or forcefully manipulate the telescope, eyepiece, or telescopic sheath. The nurse should place the telescope and camera in a sturdy container when transporting them to the sterilization area. When handling equipment, the goal is to keep all equipment components separate. Heavier pieces of equipment can damage more fragile and delicate parts. Once the hysteroscope is placed in a secure position, the physician can remove the light cable with a verbal directive. Dropping the hysteroscope to the floor leads to damage and expensive repairs. Finally, the hysteroscope is removed and given to the nurse, who is prepared to receive it. If equipment drops, it should be promptly checked and sent for repairs if it malfunctions.

Figure 5–4 It is imperative to know what hysteroscopes can and cannot go into this autoclave. All nursing personnel should understand the instructions for use of each hysteroscopic device or equipment used in your office.

●

Sterilization Techniques Endoscopes and accessories must be meticulously cleaned before disinfection or sterilization.2 Thorough cleaning removes microorganisms and organic matter that could hamper the effectiveness of the disinfection or sterilization procedure. Once the procedure is complete, each component piece, large and small, should be flushed with water to remove gross tissue and fluid. Saline is not recommended with metallic pieces because it has ionizing properties that can cause rusting and pitting of equipment. Next it should be wiped down with an enzymatic cleaner and water for the manual cleaning. Manually it is cleaned with brushes and soft cloth. After manual cleaning, water used alternately with the enzymatic cleaner completes the cleaning. All small pieces should be cleaned in the decontamination area. It is essential to follow the manufacturer’s guidelines for each hysteroscope. Personnel should wear waterproof clothing, rubber gloves, and an eye shield to protect against the risk of eye or skin irritation. Four essential themes for sterilization emerge3: ●

●

●

The length of time that equipment remains sterilized depends on the manufacturer’s guidelines and method of sterilization.

Ethylene Oxide Gas Sterilization

Ethylene oxide sterilization takes approximately 12 hours to complete. Instruments must be completely dry when using this method. All instruments must be properly aerated following sterilization to remove residual toxic gas. Increasingly, many health care facilities require other methods of sterilization because this method is restricted in some communities (Fig. 5–4). Steam Sterilization

Sterilization using steam is hazardous to telescopes and light cables unless they are wrapped for prevacuum sterilization or are flash sterilized while unwrapped. The prevacuum phase takes approximately 45 minutes and is a multistep process. Flash sterilization is performed at high temperatures and high pressures. Occasionally, a drying phase is added. Equipment must be used immediately after sterilization. Handle the equipment carefully because it is very hot.

Follow the manufacturer’s guidelines and those of regulatory agencies. For instance, ultrasonic cleaning and autoclaving of some component pieces are not allowed by certain manufacturers. Immediately after use, dissemble the equipment for cleaning and reassemble it on the field. Sterilize all moving parts in the open position to ensure proper cleaning.

Steris

Steris systems are increasing in popularity because they rapidly disinfect hysteroscopic equipment. Instruments are immersed in the buffered solution of 35% peracetic acid and then treated in a high-agitation system. The turn-around time is approximately 30 minutes. Instruments must be used immediately after sterilization. The Steris system is a combination of hydrogen

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Maintenance of Equipment for Hysteroscopy

Figure 5–7. The Steris device initiating the cleaning cycle. All nursing personnel who use this equipment should have periodic in-service and refresher courses to minimize breakage.

Figure 5–5 The Steris system quickly sterilizes equipment. Average turnaround time is approximately 30 minutes.

Figure 5–6 The flexible hysteroscope is inserted into the Steris device before initiating the cleansing cycle. Figure 5–8 This portable sterile tray can be transported to the hysteroscopic suite and is ready for use.

peroxide combined with a low-temperature gas plasma system that produces low temperatures (50-104° F-104). Each hysteroscope manufacturer (especially for flexible hysteroscopes) has special precautions and details for use (Figs. 5–5 to 5–8).

SUMMARY Glutaraldehyde 2%

Office hysteroscopy is gaining interest among gynecologists. Once the investment is made in the purchase of the equipment, care and maintenance of the equipment is mandatory to prolong the life of the hysteroscopy unit. Ensuring patient safety and preventing transmission of disease between patients is critical. Review guidelines from your vendor to determine processing methods and safe chemical agents that can be used with your hysteroscope. A periodic in-service review with your nursing team is critical. Several methods are available for disinfecting and cleaning equipment. Follow all guidelines to ensure compliance with Occupational Safety and Health Administration (OSHA) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requirements. Most importantly, the safety of the health care team and patients is the goal.

Some hysteroscopes can be disinfected with glutaraldehyde 2%. This is a chemical germicide that is not corrosive to most hysteroscopes. This disinfectant does not necessarily kill all bacterial endospores, but it is approved by the U.S. Food and Drug Administration (FDA) as effective against all vegetative bacteria, mycobacteria, fungi, and viruses. Instruments must remain submerged for at least 20 minutes in this solution. All lumens must be flushed with this solution to ensure contact and to eliminate air pockets that can prevent contact with the solution. Excellent ventilation is necessary for health care workers to prevent respiratory injury. Glutaraldehyde irritates mucosal membranes including, eyes, nose, and skin. Solution should be kept covered when not in use. Workers must wear protective clothing.

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Maintenance of Equipment for Hysteroscopy REFERENCES 1.

2.

Association of Perioperative Registered Nurses (AORN): Recommended practices for sterilization in the practice setting. In AORN: Standards, Recommended Practices, and Guidelines. Denver: Association or Perioperative Registered Nurses, 2000, pp 267-278. Morrison DM: Disinfection, sterilization, and maintenance of instruments, USA. In van Herendael BJ, Valle R, Bettocchi S (eds): Ambula-

3.

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tory Hysteroscopy. Chipping Norton, UK: Blandon Medical Publishing 2004, pp 166-169. Berter E, Hellman N, Kraft L, et al: Nursing care and maintenance of hysteroscopes. In Baggish MS, Valle RF, Guedj H (eds). Hysteroscopy: Visual Perspective of Uterine Anatomy, Physiology and Pathology. Philadelphia: Lippincott Williams & Wilkins, 2007, pp 187-193.

Chapter

6

Response of the Uterus to Medication: Hysteroscopic Implications Sejal Dharia Patel

D.C. Pantaleoni performed the original hysteroscopy, by using a cystoscope with an internal light and lens to visualize the uterine cavity.1 Since that time, improvements have been made in both the lens quality and light source. However, visualization of the cavity can be challenging. Blood can obscure the visual field. This problem was circumvented by Gauss, who used fluid to wash away the blood and debris.2 Attention to the preoperative and postoperative management of the endometrium has led to an array of effective techniques to assist in decreasing blood loss, decreasing operative time and morbidity, and improving subsequent outcomes. Hysteroscopic evaluation of the uterine cavity requires knowledge of the physiology of the endometrium as well its response to pharmacologic agents. Hysteroscopy is often performed on a patient who is anovulatory or is taking a variety of hormonal agents that alter the endometrium. This chapter reviews the common medications that can affect the endometrium or the uterus.

The Proliferative Phase The endometrium is less than 2 mm thick in the early proliferative phase. It consists of glands and stroma. The epithelium consists of a single layer of columnar cells. Most of the functional layer is shed with each menstrual period. The basal layer is closest to the uterine muscle and serves as the reservoir for regenerating the other layer. Mitotic activity increases from the start of menses, and by day 5 after the onset of menses, regeneration of the epithelium is complete. Then, in response to estrogen, there is glandular hyperplasia and an increase in the height of the glandular epithelial cells and pseudostratification as the endometrium prepares for ovulation.3

The Secretory Phase With ovulation, the endometrium prepares for possible implantation. There is a decrease in mitotic activity in response to progesterone. Progesterone induces decidual changes within the endometrium. The glandular epithelial cells begin to accumulate glycogen-rich vacuoles at their base, and mild secretory activity becomes apparent.4 Under the influence of humoral and local factors, there appear spiral arteries and the increasing coiling of the arteries and glands.4 The microscopic morphology of the endometrium changes almost daily and is easily identifiable by the pathologist. The thickness of the endometrium increases to approximately 6 mm. There is a significant amount of stromal edema. Both features, thick endometrium with edema, can be recognized by hysteroscopy.

PHYSIOLOGY OF THE ENDOMETRIUM The endometrium is one of the most dynamic organs in the body. Physiologically, the endometrial thickness has a wide range. It can respond to an endocrine environment by an increase in thickness in preparation for implantation or by sloughing its lining in preparation for a new cycle. Its dysfunction or anatomic disturbance can result in menorrhagia, and its muscle can allow expulsion of the effluent and yet preserve the integrity of the contents inside. In response to medication, the endometrium can increase or decrease in height at any time during the menstrual cycle and can alter the size of the anatomic pathologies within by an altering its vascularity and proliferation. The response of the endometrium during the menstrual cycle reflects its dynamic nature. Once the dynamic nature of the endometrium is understood, it can be manipulated therapeutically (Fig. 6–1). The endometrium can be classified generally into two layers. The functionalis (subdivided further into spongiosa and compacta) sits adjacent to the luminal epithelium, and the basalis sits adjacent to the myometrium. The functionalis undergoes significant change in response to the menstrual cycle as compared to the basalis.3

Menstruation Before menstruation, the stromal network begins to degrade, with decrease in the secretory products and an infiltration by monocytes and leukocytes.5 There is actually a decrease in the height of the endometrium from the lack of secretory products and a breakdown in the extracellular matrix. With a decrease in serum estrogen and progesterone from decreased function of the corpus luteum, further constriction and coiling of the spiral arterioles occurs. Prostaglandins are secreted, causing contraction of the uterine smooth muscle, ischemia of the spongiosa and compacta, and finally sloughing of endometrial tissue.6,7

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Response of the Uterus to Medication: Hysteroscopic Implications Implantation begins Radial arteries

Gland

Compact layer

Figure 6–1 The endometrium in response to the endogenous hormones during the menstrual cycle. The thinnest endometrial lining occurs immediately after menses.

Spongy layer Basal layer

Menses

Menses

1 Cycle day

13

24

28

Arcuate arteries

Bleeding stops with the increasing influence of estrogen, which causes a prolonged vasoconstriction and fibrin clot formation over denuded endometrial cells. An increase in estrogen levels reinitiates the process of regeneration.4

BOX 6–1 Drugs with an Endometrial Effect Endometrial atrophy under all physiologic conditions ●

Oral contraceptives Estrogen–progestin combination ● Progestins ● Oral, intramuscular, or intrauterine progestins ● Gonadotropin releasing hormone agonists ● Danazol Endometrial effect dependent on estrogen status and length of use

HYSTEROSCOPY AND THE MENSTRUAL CYCLE

●

The changes of the endometrium during the menstrual cycle reflect its response to the hormonal, humoral, and paracrine factors. This response can be manipulated during surgery to allow optimal conditions and outcomes during hysteroscopy. During hysteroscopy, some key factors can facilitate surgery. First is the height of the endometrium. Ablation with rollerball resection can remove 2.5 to 3.0 mm with a single cut, but an ablation usually includes resecting both the endometrium and 2 to 3 mm of the myometrium.8 This means that a satisfactory ablation can be most appropriately performed when the endometrium is quite thin such as in the early proliferative phase, usually days 4 to 8 of the cycle.9 Debris and cells in the uterine cavity can obscure the hysteroscopic view. This is important for both diagnostic and operative hysteroscopies. Debris is increased, with the thicker endometrium found in the late proliferative and luteal phase. The vascularity of the endometrium is also an important factor in the success of a hysteroscopic procedure. Bleeding may be increased during the luteal phase, which can influence operative times, complications, postoperative recovery, and intraoperative visualization. This is especially important for hysteroscopic procedures such as submucous myomectomies.10 The best way to optimize these factors is to schedule all hysteroscopies during the proliferative phase immediately following cessation of menstruation, because the height of the endometrium may be as thin as 2 mm with no debris. However, scheduling may be difficult. Delay in scheduling into the late proliferative phase is not ideal because the endometrial thickness may be increased. In addition, for a patient with irregular menses or oligomenorrhea, predicting the onset of her menses might not be possible. Alternatives to scheduling surgery in the early follicular phase include preopera-

● ● ●

Tamoxifen Clomiphene citrate Letrozole

tive measures to decrease the height and vascularity of the endometrium.

PHARMACOLOGIC INTERVENTION TO DECREASE ENDOMETRIAL THICKNESS Many pharmacologic interventions have been used to decrease the height of the endometrium, including oral contraceptives, progestin (intrauterine, intramuscular, or oral), and gonadotropin agonists (Box 6–1). Certain conditions should be excluded before using these medications, such as bleeding disorders, pregnancy, lactation, and endometrial hyperplasia. Although progestins may be therapeutic, a diagnosis should first be made because 30% of cases of complex endometrial hyperplasia with atypia have concomitant endometrial carcinoma.11

Oral Contraceptives Oral contraceptives typically contain both estrogen and progestogenic components. The estrogenic compound stabilizes the endometrium by maintaining trophic influence on the endometrium and potentially increasing the intracellular progesterone receptors on the endometrium.12 The major influence on the endometrium, however, is the progestin component. The end

50

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Response of the Uterus to Medication: Hysteroscopic Implications ing at the end of 1 year.20 In one study, a comparison of DMPA and placebo revealed a statistically significant increase in fluid deficit at hysteroscopy in the DMPA-treated group compared to placebo. In addition, researchers noted an increase in the thickness of the endometrium as compared to controls during hysteroscopy.18 The variability in the response may be related to the timing of administration. Progestin may be more effective if given in the early follicular phase before estrogen priming as compared to the estrogen-primed endometrium.

effect is a shortened proliferative phase, premature endometrial secretory phase, and then involution and suppression of the endometrium, with small tubular glands and the absence of spiral arterioles.13,14 These effects can lead to a shortened, scanty menses or, in a few cases if taken continuously, amenorrhea.15 The response of the endometrium to progesterone depends on the estrogenic state; however, treatment for longer than 3 months results in endometrial thinning. Initial data suggested patients experienced a decrease of more than 40% in blood loss while taking oral contraceptives.16 However, the response can be quite variable depending on the initial status of the endometrium. In addition, the variability in response may be a result of the level of endogenous estrogen acting on the endometrium, because this estrogenic influence might not be completely suppressed initially. In one study, subjects started oral contraceptives (30 mcg of estradiol) on days 1 to 3 of the cycle and continued taking them for 18 to 20 days. A transvaginal ultrasound revealed a thin endometrial measurement of 4 mm, suggesting that this treatment may be effective for thinning the endometrium before surgery.17 However, the range of resulting endometrial thickness was 2 mm to 8 mm. This variability of response in the endometrium might preclude its routine use.

Oral Progestins

High-dose oral progestins can also be used (Fig. 6–2). Norethindrone 10 mg/day or oral medroxyprogesterone acetate in doses of 5-10 mg three times per day for three weeks has also been successful, but the data are controversial.21,22 In addition, side effects can become problematic as the dose is increased. Side effects include menstrual abnormalities in 25%, headache and abdominal discomfort in 15%, and nervousness and decreased libido in approximately 5% to 10%, which can lead to discontinuation of therapy (Box 6–2).22 A comparison of the gonadotropin-releasing hormone (GnRH) agonist, danazol 200 mg three times daily, and medroxyprogesterone acetate 30 mg/day resulted in minimal difference in endometrial thickness, patient satisfaction, and endometrial histology after therapy suggesting equivalence in therapy.23 In contrast, Romer and colleagues showed minimal benefit using a progestogen before endometrial therapy.24

Progesterone and Progestins Progestin can effectively act to thin the endometrium. Initially, progestin might increase the tortuosity of the glands, increase the secretory capability, and cause pseudostratification.18 However, continued use, especially at higher doses, acts to decrease the number and size of the glands. In addition, vacuolation is diminished, as is its mitotic activity.19

Intrauterine Progestins

The levonorgesterol-releasing intrauterine system (Mirena) is a simple T device with a silicone rubber (Silastic) reservoir of levonorgesterol in the vertical arm. It releases 20 mcg/day over 5 years. Circulating levels peak after 24 hours of insertion.25 The intrauterine device has mainly local progestogenic effects in the uterine cavity. Morphologic changes of the endometrium include stromal pseudodecidualization, glandular atrophy, a leukocytic infiltration, and a decrease in glandular and stromal mitosis.26 Amenorrhea rates approximate 65% at 1 year.25 However, this might not be a practical option secondary to the cost and possible time frame to achieve the desired effect.

Depot Medroxyprogesterone Acetate

An injection of 150 mg depot medroxyprogesterone acetate (DMPA) is usually administered every 3 months. With depot administration, 50% of patients will be amenorrheic after 1 year and 60% to 70% will be amenorrheic after 2 years.20 However, the response is variable depending on the initial status of the endometrium; 10% of patients still suffer from irregular bleed-

Figure 6–2 The endometrium in a patient before high-dose progestin therapy demonstrates increased endometrial thickness (A) and 4 months later showing atrophy (B). (Courtesy of the Division of Reproductive Endocrinology, University of Alabama.)

A

B 51

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Response of the Uterus to Medication: Hysteroscopic Implications required for maximum benefit. Rai and colleagues compared progestins, danazol, and GnRH agonists to placebo and found that danazol induced the greatest degree of atrophy; however, there was no difference in amenorrhea or clinical outcomes with all three therapeutic modalities.23 In a recent trial comparing gestrinone to danazol pretreatment, results suggest a preference for gestrinone related to operative time, infusion volume, and patient satisfaction.30

BOX 6–2 Adverse Effects of Preoperative Agents Oral contraceptives ● ● ● ● ● ●

Bloating Nausea Breast tenderness Mood changes Breakthrough bleeding Venous thromboembolism

Gonadotropin-Releasing Hormone Agonists (GnRH)

Progestins ● ● ● ● ● ●

GnRH agonists bind to a plasma membrane receptor in the pituitary gland, which, if acting in a pulsatile fashion, results in agonist release of gonadotropins through pituitary upregulation of the GnRH receptor.31 However, if GnRH agonists are given continuously, receptor number and responsiveness decreases.32 Clinically, continuous GnRH results in an initial release of FSH and LH over the first 5 to 10 days, with a subsequent decline, resulting in a state of hypoestrogenism. Secretion of LH, estradiol, and progesterone declines. Once the administration is stopped, the agonistic activity characteristic of endogenous pulsatile gradually returns over the next 10 days.33 GnRH agonists have been used for several applications including delaying precocious puberty, inducing ovulation, treating endometriosis, reducing myoma size, and preparing the endometrium for hysteroscopic or open surgery. The depot form can be administered as 3.75 mg every month to 11.25 mg every 3 months.34 Currently GnRH can be administered subcutaneously or intramuscularly daily, monthly, or quarterly or as a daily intranasal form.35,36 Side effects and cost can be a limiting factor. For hysteroscopic surgery, the three advantages to using a GnRH agonist continuously are the increase in the hemoglobin in patients with secondary anemia, the uniform atrophy of the endometrium, and a decrease in the uterine volume and in intrauterine pathologies such as myomas (especially myomas larger than 3 cm or with an intramural portion). This should decrease estimated blood loss, fluid absorption, and operative times.10 It is commonly used for 6 to 12 weeks preoperatively. The beneficial effect has been consistently demonstrated by a number of different studies. Serra and colleagues reported in a multicenter study, after 4 months of GnRH agonist therapy, a decrease of 50% of the volume of the myomas in more than one half of the total myomas within the uterus.37 Friedman and colleagues, in a randomized, prospective, double-blind multicenter study, found a decrease in uterine volume by 36% at 12 weeks, which results in the practice management today of using a GnRH agonist for at least 3 months for pretreatment to decrease the size of intrauterine pathologies.38 For myomas, the decrease in size can be correlated to the histopathologic changes of hyaline degeneration and hydropic degeneration necrosis.39 Romer and colleagues found that before endometrial ablation, the use of GnRH agonist therapy results in an atrophic endometrium with high amenorrhea rates after 2 years.40

Breakthrough bleeding Breast tenderness Nausea Somnolence Constipation Mood disorders

Danazol ● ● ● ● ● ●

Weight gain Muscle cramps Abnormal liver function Acne Hirsutism Irreversible deepening of the voice

Gonadatropin-releasing hormone agonists ● ● ● ● ●

Hot flushes Mood changes Insomnia Urogenital atrophy Accelerated bone loss

Mishell DR Jr: Abnormal uterine bleeding in comprehensive gynecology. In Mishell DR, Stenchever MA, Droegemueller W, Herbst AL (eds): Comprehensive Gynecology, 3rd ed. St Louis: Mosby Year–Book, 1997, pp 1025-1042.

Danazol Danazol is a synthetic hormone derived from ethinyl testosterone, which acts to interrupt the midcycle follicle-stimulating hormone (FSH) and luteinizing hormone (LH) surge. In addition, estradiol levels are decreased, as are sex hormone–binding globulin levels, which results in an increase in circulating free testosterone.22 Side effects from danazol include hot flushes and sweats, androgen-like effects, weight change, and headaches.27 It can be used to achieve endometrial atrophy.28 However, its efficacy has been controversial. Kriplani and colleagues, in their randomized trial compared to placebo, concluded that patients pretreated with danazol had decreased endometrial thickness, decreased fluid deficits, and decreased operative times compared to those not using danazol pretreatment.29 Androgenic side effects can sometimes be problematic, yet according to Erian and colleagues, using a higher dose of danazol (600 mg) resulted in a statistically significant increase in the rate of amenorrhea as compared to the lower dose (200 mg) or placebo.28 Therefore, the higher dose is

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Response of the Uterus to Medication: Hysteroscopic Implications or the effects of leuprolide acetate before misoprostol use.46 Menopausal women might require a higher dose of misoprostol to achieve the desired clinical effect.

Garry and colleagues found that the GnRH agonist was better tolerated and found better improvement in blood loss, fluid deficit, operative time, cavity length, and amenorrhea rates as compared to danazol.41 Campo and colleagues demonstrated that the improvement seen with premedication with an agonist can be matched to performing hysteroscopies during the follicular phase of the cycle. If a hysteroscopic myomectomy is performed during the first few days after menses, similar outcome parameters are achieved as compared to 2 months of pretreatment with a GnRH analogue.42 This was affirmed by Tiufekchieva and colleagues, who looked at two doses of goserelin (Zoladex) 3.6 mg before hysteroscopy. They found a decreased operative time, increased rate of amenorrhea and high patient satisfaction before endometrial ablation as compared to no medical pretreatment, although the study was limited by a small sample size.43 Romer also confirmed these results in a review of improved hysteroscopic view, reduced blood loss, absorption of uterine distending fluid, and high postoperative amenorrhea rates using GnRH agonists.11 For patients with anemia, GnRH analogues produce an amenorrheic state during which iron stores can be replenished and the anemia corrected.42 Another advantage is the decrease in fluid absorption with the use of GnRH analogues.43 This is thought to be in response to suppressed vasopressin levels, which increases the activity of Na+,K+-ATPase levels in the brain and endometrium, protecting women from increased fluid absorption and subsequent hyponatremia. In summary, several drug classes are available to effectively thin the endometrium. Cost and scheduling flexibility are a major determinant of approach. A GnRH agonist is preferred if there is concomitant anemia.

OTHER POTENTIALLY THERAPEUTIC DRUGS Arginine vasopressin is small peptide that is secreted by the posterior pituitary. It acts through two different receptors and has two principal effects: on the cardiovascular system to cause vasoconstriction and on the collecting ducts of the kidney to affect free water absorption. A dilute vasopressin solution injected into the cervical stroma has been demonstrated to reduce blood loss, distention fluid intravasation, and operative time during hysteroscopy. This was affirmed by Phillips and colleagues in a randomized, controlled trial with 0.05 U/mL of a vasopressin solution. They found a 50% reduction in fluid absorption and a 30% reduction in blood loss.47 This decreased absorption during operative hysteroscopy was also seen using 0.2 mg/20 mL by Goldenberg and colleagues.48 The antidiuretic effect of vasopressin could be associated with significant and potentially dangerous complications. Vasopressin causes free water absorption and hyponatremia. If hysteroscopic surgery is performed with an electrolyte-free solution such as glycine and there is significant free water absorption, the use of vasopressin hormone exacerbate the hyponatremia.

POSTOPERATIVE DRUGS WITH ENDOMETRIAL AFFECTS Estrogen and Progestin After resection of intrauterine adhesions, the uterine cavity may be left denuded and susceptible to adhesion reformation. One way to prevent this is with oral or vaginal estrogens for approximately 3 months postoperatively, with the addition of a progestin after 3 months. Although this treatment is often used after adhesiolysis, there is a paucity of data to support its role.

PHARMACOLOGIC AGENTS THAT AFFECT THE CERVIX The thickened endometrium can cause bleeding, poor visualization, and increased operative times; however, the cervix presents its own set of challenges. If the cervix is closed or stenotic, dilation can result in increased operative times and an increased incidence of perforation. Misoprostol has been used as a cervical ripening agent in operative hysteroscopy. Misoprostol is a prostaglandin E1 (PGE1) analogue. The principal side effects are gastrointestinal effects, uterine contractions, and bleeding. Thomas and colleagues, in a double-blind, placebo-controlled trial, demonstrated a benefit over placebo in the ease of cervical dilation.44 This was confirmed by Preutthipan and colleagues in a randomized, controlled trial in a small group of patients, which demonstrated a decreased need for cervical dilation if misoprostol was used; if dilation was required, a decreased operative time overall; and a decreased incidence of cervical tears and uterine perforations.45 This is true for oral or vaginal misoprostol but not with the sublingual forms. In a study by Bisharah and colleagues, sublingual misoprostol was given to women who were pretreated with leuprolide. There was no difference in baseline dilation or time required for dilation. It was unclear whether the lack of effect was due to the route of administration

Antiadhesive Barriers Auto-cross-linked hyaluronic acid gel has been used in a small group of patients with intrauterine adhesions after adhesiolysis. Staging of initial adhesions with a subsequent decrease of adhesion severity on second-look hysteroscopy suggests that auto– cross-linked hyaluronic acid gel might have a role in reducing adhesion formation. However, studies are needed to confirm this.49

Postoperative Endometrial Thinning Agents The use of pharmacologic agents postoperatively has been proposed to maximize amenorrhea rates after endometrial resection or ablation. Erian and colleagues looked at danazol 600 mg daily for 3 months after endometrial resection and found statistically significantly higher amenorrhea rates as compared to placebo.28 GnRH agonists have also been suggested and have been effective preoperatively and postoperatively in providing 85% amenorrhea rates.50 However, preoperative therapy alone as compared to

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Response of the Uterus to Medication: Hysteroscopic Implications both preoperative and postoperative therapy were not significantly different.

Selective Progesterone Receptor Modulators This class of drugs is being investigated for use in women with leiomyomas or endometriosis. A pure progesterone antagonist such as onapristone has a pure proliferative effect on the endometrium. The affect on the endometrium of mixed agonists and antagonists is difficult to predict and depends on many factors such as length of use of the drug. Mifepristone is a progesterone receptor antagonist with some agonist activity. This drug also binds to the glucocorticoid receptor. Blockade of the uterine progesterone receptors causes decidual breakdown. Several studies have demonstrated a decrease in myoma size with the use of mifepristone. Most patients develop amenorrhea with chronic use of mifepristone. However, some patients have developed simple endometrial hyperplasia. Asoprisnil is a mixed agonist–antagonist with different effects on different progesterone-sensitive tissue. The drug induces myoma regression, suppresses endometrial proliferation, and induces amenorrhea.

MEDICATIONS WITH ENDOMETRIAL AFFECTS Many drugs that are used for a variety of disorders can have an effect on the endometrium. These drugs are not used specifically to facilitate hysteroscopy. They are sometimes the cause of the symptoms requiring hysteroscopy. Many of these drugs are referred to as steroid receptor (estrogen or progesterone) modulators because they often do not have a clear agonist or antagonist effect on their receptor.

Aromatase Inhibitors Letrozole, an aromatase inhibitor, has been shown to have similar effects on endometrial morphology and thickness in spontaneous cycles during ovulation induction for 1 month.51 Twelve months of continuous treatment of endometrial hyperplasia results in atrophy, which remained for a follow-up of an additional 10.2 months. However, this study only enrolled 11 women, and more data are needed to evaluate letrozole as a thinning agent on the endometrium.52

Androgen Derivatives In terms of hormone replacement therapy, using an estrogenic– progestogenic agent can result in proliferation and sloughing of the endometrium every cycle. Alternatives include tibolone, a drug widely used for menopause. Tibolone is a 19-nortestosterone derivative with estrogenic, progestational, and androgenic activity. Recent data on tibolone suggest that it alleviates vasomotor symptoms without a proliferative effect on the endometrium.52 (As of March 2008, tibolone has not been FDA approved.)

Selective Estrogen Receptor Modulators Clomiphene citrate, a selective estrogen-receptor modulator (SERM) that acts as an antiestrogen at the level of the endometrium, can have an atrophic effect on the endometrium after 12 months of use.53 Tamoxifen is another SERM commonly used as adjunctive therapy in breast cancer patients. However, it has well-documented effects on the endometrium. Typically, histologically there is hyperplasia of the endometrial stroma without cellular atypia. Usually the glandular epithelium is atrophic. Dilated endometrial glands, in association with endometrial atrophy, have been called cystic glandular atrophy. This might explain thickened sonographic endometrium and curettage results of atrophy. However, there is clearly an increased incidence of endometrial hyperplasia with atypia and cancer with this drug.54 Furthermore, highly vascularized endometrial polyps are often seen in association with tamoxifen. Raloxifene is a SERM that is commonly used for treating menopause-related osteoporosis. It has been shown to have no significant estrogenic stimulation effects.

SUMMARY The endometrium is a dynamic organ, which can respond not only to the endogenous hormones during the menstrual cycle but also to hormonal manipulation through pharmacologic intervention in order to decrease or increase the endometrial contribution. This can help to facilitate hysteroscopic surgery by decreasing operative time, blood loss, and amenorrhea rates after endometrial ablation. In addition, hormonal manipulation with estrogen can preserve the endometrium. Other medications taken by the patient should be elicited, because these can have an effect on the endometrium.

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Schenk LM, Coddington CC: Laproscopy and Hysteroscopy. Obset Gynecol Clin North AM 1999;26:1-22. Gauss CJ: Hysteroskopie. Arch gynaekol 1928;133:18-24. Strauss JF, Lessey BA: Structure, function, evaluation of the female reproductive tract. In Strauss JF, Barbieri RL (eds): Yen and Jaffe’s Reproductive Endocrinology: Physiology, Pathophysiology, and Clinical Management, 5th ed. Philadelphia: WB Saunders, 1999, pp 255-305.

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double-blind study. Aust N Z J Obstet Gynaecol 1998;38:210214. Kriplani A, Manchanda R, Nath, J et al: A randomized trial of danazol pretreatment prior to endometrial resection. Eur J Obstet Gynecol Reprod Biol 2002;103:68-71. Triolo O, De Vivo A, Benedetto V, et al: Gestrinone versus danazol as preoperative treatment for hysteroscopic surgery: A prospective, randomized evaluation. Fertil Steril 2006;85:1027-1031. Vermeiden JPN: GnRH analogues and reproductive medicine. Hum Repro Supp 1996;3:4-5. Shalev E, Leung PC: Gonadotropin-releasing hormone and reproductive medicine. J Obstet Gynaecol 2003;25:98-113. Belchetz PE, Plant TM, Nakai Y, et al: Hypophysial responses to continuous and intermittent delivery of hypothalamic gonadotropinreleasing hormone. Science 1978;202:631-633. TAP Pharmaceutical Products: Lupron prescribing information. PDF available at http://www.tap.com/pi.asp (accessed November 12, 2007). Searle: Synarel nasal spray prescribing information. Available at http:// www.intekom.com/pharm/searle/synarel.html (accessed November 12, 2007). Astra Zeneca: Zoladex (gosrelin) prescribing information. available at http://www.zoladex.net/zoladexBC/9898_18071_10_0_0.aspx?& (accessed November 12, 2007). Serra GB, Panetta V, Colosimo M, et al: Efficacy of leuprolide acetate depot in symptomatic fibroma uteri: The Italian multicentre trial. Clin Ther 1992;14:57-73. Friedman AJ, Hoffman DI , Comite F, et al: Treatment of leiomyomata uteri with leuprolide acetate depot—a double blind, placebo controlled multicentre study. Obstet Gynecol 1991;77:720-725. Deligdisch L, Hirschmann S, Altchek A: Pathologic changes in gonadotropin releasing hormone agonist analogue treated uterine leiomyomata. Fertil Steril 1997;67:837-841. Romer T, Schwesinger G: Hormonal inhibition of endometrium for transcervical endometrial ablation—a prospective study with a 2-year follow-up. Eur J Obstet Gynecol Reprod Biol 1997;74:201-203. Garry R, Khair A, Mooney P, et al: A comparison of goserelin and danazol as endometrial thinning agents prior to endometrial laser ablation. BJOG 1996;103:339-344. Campo S, Campo V, Gambadauro P: Short-term and long-term results of resectoscopic myomectomy with and without pretreatment with GnRH analogs in premenopausal women. Obstet Gynecol Survey 2005;60:795-796. Perino A, Chianchiano N, Petriono M, et al: Role of leuprolide acetate depot in hysteroscopic surgery: A controlled study. Fertil Steril 1993;59:507-510. Thomas JA, Leyland N, Durand N, et al: The use of oral misoprostol as a cervical ripening agent in operative hysteroscopy: A double-blind, placebo-controlled trial. Am J Obstet Gynecol 2002;186:876879. Preutthipan S, Herabutya Y: Vaginal misoprostol for cervical priming before operative hysteroscopy: A randomized controlled trial. Obstet Gynecol 2001;97:640-641. Bisharah M, Al-Fozan H, Tulandi T: A randomized trial of sublingual misoprostol for cervical priming before hysteroscopy. J Am Assoc Gynecol Laparosc 2001;10:390-391. Phillips DR, Nathanson HG, Milim SJ, et al: The effect of dilute vasopressin solution on blood loss during operative hysteroscopy: A randomized controlled trial. Obstet Gynecol 1996;88:761-766. Goldenberg M, Zolti M, Bider D, et al: The effect of intracervical vasopressin on the systemic absorption of glycine during hysteroscopic endometrial ablation. Obstet Gynecol 1996;87:1025-1029. Acunzo G, Guida M, Pellicano M, et al: Effectiveness of auto–crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions

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Response of the Uterus to Medication: Hysteroscopic Implications after hysteroscopic adhesiolysis: A prospective, randomized, controlled study. Hum Reprod 2003;18:1918-1921. 50. Sorensen SS, Colov NP, Vejerslev LO: Pre and postoperative therapy with GnRH agonist for endometrial resection. A prospective randomized study. Acta Obstet Gynecol Scand 1997;76:340-344. 51. Cortinez A, De Carvalho I, Vantman D, et al: Hormonal profile and endometrial morphology in letrozole-controlled ovarian hyperstimulation in ovulatory infertile patients. Fertil Steril 2005;83:110-115.

52. Wender MC, Edelweiss MI, Campos LS, et al; Endometrial assessment in women using tibolone or placebo: 1-year randomized trial and 2-year observational study. Menopause 2004;11:423-429. 53. Dehbashi S, Parsanezhad ME, Alborzi S, et al: Effect of clomiphene citrate on endometrium thickness and echogenic patterns. Int J Gynaecol Obstet 2003;80:49-53. 54. Marchesoni D, Driul L, Fabiani G, et al: Endometrial histologic changes in post-menopausal breast cancer patients using tamoxifen. Intl J Gynaecol Obstet 72001;5:257-262.

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Imaging the Uterus and Uterine Cavity Daniel M. Breitkopf determining the external contours. It is then appropriate to switch to a higher frequency to examine the endometrium in greater detail.

Pelvic imaging is a vital tool in the diagnostic evaluation of most gynecologic disorders. It is hard to imagine a work-up for pelvic pain, abnormal bleeding, or infertility without the use of an imaging study. Sonography and magnetic resonance imaging (MRI) are the most useful imaging techniques available to the clinician for evaluating the uterus. Computed tomography (CT) is limited in evaluating uterine abnormalities and will not be discussed in this chapter. Because this is a text devoted to hysteroscopy, this chapter addresses the use of sonography and MRI in imaging the uterus. The clinical conditions and diagnoses that the hysteroscopist commonly encounters, such as abnormal uterine bleeding (AUB), postmenopausal bleeding, uterine leiomyomas, endometrial polyps, and müllerian anomalies, are covered.

Imaging Tips and Tricks When using the transvaginal probe, it is important to watch the monitor as the probe is initially inserted, because it is easy to miss an important finding. When encountering difficulty in visualizing the uterus or ovaries because of overlying bowel, the nondominant hand may be used to displace the bowel transabdominally while scanning. Ovaries are usually easily identifiable in menstruating women, but they can be very difficult to see in postmenopausal patients. It is helpful to find the ovaries in the transverse plane first, moving from medial to lateral. The ovaries are normally visualized medial and superior to the external iliac artery and vein (Fig. 7–1). In cases where transvaginal imaging is not possible due to patient factors such a patient refusal, imperforate hymen, or patient discomfort, endorectal imaging with the transvaginal probe can be helpful. The probe is inserted into the rectum and directed anteriorly and cephalad, allowing images similar to those obtained with standard transvaginal technique. The images obtained transrectally are often indistinguishable from those acquired transvaginally (Fig. 7–2).

PRINCIPLES OF PELVIC SONOGRAPHY Physics and Instrumentation The ultrasound transducer emits sound waves that are reflected off of the tissue back to the transducer. The reflected sound waves are captured and translated into electrical signals. The intensity of the reflected signal is represented by the relative brightness of the pixel on a gray-scale display. The greater the fraction of sound wave that is reflected back to the transducer, the brighter the image that is displayed. Structures with high levels of calcium or fat, such as dermoid cysts or calcified fibroids, appear bright on the gray-scale image, and muscle tissue and ovarian parenchyma appear darker. It is important to be familiar with the frequencies of the sound waves used in medical ultrasound because selection of a proper frequency influences image resolution and, indirectly, the depth of field visualized. Transducer frequency is inversely proportional to depth of penetration of the ultrasound signal into the body and directly proportional to image resolution. The common transducer frequencies for pelvic imaging range from 3.5 to 7.5 MHz. Transabdominal transducers commonly use 3.5 to 5 MHz, and transvaginal transducers use 5.0 MHz and higher. When obtaining images with an adjustable-frequency transducer, it is important to start at the lowest frequency to be sure that no deep structures are missed. Once the structures of interest are visualized in their entirety, use of higher frequencies allows detailed visualization of the internal contents. Thus, for a uterus with large fibroids, imaging at 3.5 to 5.0 MHz initially is useful for measuring the length and

PRINCIPLES OF MAGNETIC RESONANCE IMAGING Imaging Protocols and Sequences MRI does not use ionizing radiation and appears to be completely without adverse biological effects.1 Radiofrequency radiation is used in the presence of strong magnetic fields, creating cross-sectional images of the body. Motion from hydrogen nuclei within water and lipids in these magnetic fields is then visualized on MRI. Intensity of the signal varies by proton density, T1 and T2 relaxation times, and blood flow. T1 and T2 describe imaging parameters that are defined by the repetition time and the excitation time related to the nuclear response to the radiofrequency pulses. High proton concentrations in tissues and short relaxation times create signals with higher intensity. Tissues with strong signals are displayed as white and weak signals as black. Fat has a strong signal and a short relaxation time, and it thus appears white.2

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Imaging the Uterus and Uterine Cavity [2D] 0.0/7.5cm G58/P80/D14 FA4/6.5MHz TI= 0.1/MI 0.5

R OV SAG

I

2D Distance +D = 21.0mm ×D = 18.6mm

Figure 7–1 Right ovary (R OV) located superior and medial to the external iliac vessels. I, external iliac vein; SAG, sagittal.

+7

Transrectal longitudinal

[2D] 0.0/6.0cm G50/P80/D14 FA4/6.5MHz [C] 1.00KHz G50/F1/FA3 TIs 0.3/MI 0.5

Figure 7–3 T2-weighted magnetic resonance image of a normal uterus in the sagittal plane.

safe; the incidence of mild reactions to IV contrast is less than 3%. Contrast induces T1 shortening, resulting in increased signal intensity. For this reason, IV contrast is useful for determining depth of endometrial cancer invasion and to help differentiate between benign and malignant ovarian tumors.4 Solid or nodular enhancement after gadolinium administration can indicate malignancy within an adnexal mass.5

–7

Figure 7–2 Transrectal image shows an endometrioma after hysterectomy. The bladder is visible superiorly in this sagittal image.

Technique and Normal Examples The endometrium is best imaged by T2-weighted sequences because T1 weighting makes the uterus appear homogenous, with loss of endometrial definition. The uterine zonal anatomy is well seen on T2-weighted images, which is particularly important in examining for endometrial cancer invasion into the myometrium and to diagnose adenomyosis. The normal endometrium has high signal intensity on T2 images, and the junctional zone surrounding the endometrium has low intensity (Fig. 7–3).6 Endometrial thickness as measured by MRI should not be used to exclude endometrial malignancies because these measurements are not supported by sufficient data; use sonographic measurement of the endometrial echo.

Multiple image planes can be evaluated, which are not available as readily in other imaging modalities. Another advantage of MRI over other imaging technologies is the ability to accurately distinguish between fat and blood.3 T1- and T2-weighted images are used to derive images in the axial and sagittal planes. T1-weighted images show fat planes and are useful for visualizing lymph nodes, which are usually surrounded by fat. T1 images with fast spin echo (FSE) imaging and fat saturation are useful to aid in characterizing adnexal masses. T1 demonstrates hemorrhage within organs. T2-weighted images provide excellent soft tissue contrast. T2 sequences are useful for visualizing the endometrium, myometrium, and cystic structures in the ovaries.2

SONOGRAPHIC IMAGES OF THE UTERUS

Using Imaging Contrast

Imaging of the Normal Uterus

Contrast agents for MRI include intraluminal and intravenous varieties. Intravenous contrast agents for MRI include gadolinium (Gd)-DPTA, gadoteriol, Gd-BOPTA, and gadodiamide, all of which are chelates of gadolinium. MRI contrast agents are

The uterus is normally imaged in the sagittal and transverse planes. Length and height are obtained in sagittal planes (Fig. 7–4), and width is obtained in the transverse plane (Fig. 7–5). The myometrium should be uniform in contour and

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UTERUS sagittal

M

[2D] G60 / 96dB FA2 / P100

[Uterus] Uterus L 7.15cm Uterus H 3.29cm

UTERUS sagittal [Uterus] Endo T 0.69cm

Figure 7–4 Measurement of uterine length and height in the sagittal plane.

M

Figure 7–6 Measurement of the endometrial stripe in the sagittal plane, excluding the peripheral echolucent region.

[2D] G60 / 96dB FA2 / P100

UT SAG

Coronal UTERUS

[2D] G60 / 96dB FA2 / P100

[2D] 0.0/4.5d G53/P80 FA4/6.5 TIs 0.1/

[Uterus] Uterus L 7.15cm Uterus H 3.29cm Uterus W 4.32cm Vol. 53.21ml

Figure 7–5 Measurement of uterine width in the transverse or coronal plane. Figure 7–7. Natural sonohysterogram. Fluid is present in the endometrial cavity in this postemenopausal patient with cervical stenosis, clearly outlining the normal-appearing endometrium.

echotexture, and the anterior and posterior aspects of the myometrium should be approximately equal in thickness. The endometrium should be imaged in both sagittal and transverse planes; however, the endometrial thickness should only be measured in the sagittal plane. The thickest portion of the endometrium in the fundus should be measured, not including any peripheral echolucent region (Fig. 7–6). To ensure the accuracy and standardization of the measurement, the endometrium view should be as close to midline or sagittal as possible. The best indicator of a true midline endometrial image is when the endometrial echo can be seen from the fundus to the cervix. Oblique views of the endometrial stripe can lead to overestimating the endometrial thickness.

described in 1981 following the observation of fluid-filled endometrial cavities in postmenopausal women with cervical stenosis (Fig. 7–7). These natural sonohysterograms clearly demonstrated endometrial pathology because masses were outlined by the retained intraluminal fluid. The saline creates contrast to outline the endometrium and any abnormal structures within the cavity. The procedure can be easily learned by those already skilled in transvaginal sonography. The saline is infused via a transcervically inserted catheter. Catheters specifically designed for SHG are available (Fig. 7–8). Many contain a balloon at the tip to help occlude the cervix, preventing egress of saline during the procedure. Nonballoon catheters can be used as well. The nonballoon catheter is inserted to the fundus, and the space occupied by the catheter itself helps to prevent saline egress from the uterus. Using a

Technique and Normal Examples Sonohysterography (SHG; also called saline infusion sonography [SIS]) involves infusion of saline into the endometrial cavity under direct sonographic visualization. The technique was first

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[2D] G58 / 70dB FA1 / P100

A B C D E F

Figure 7–8. Catheters for sonohysterography. A, Foleycath (Wembley Rubber Products; Sepang, Malaysia). B, Hysca hysterosalpinography catheter (GTA International Medical Devices, La Caleta DN, Dominican Republic). C, H/S catheter set (Ackrad Laboratories, Cranford, NJ). D, PBN balloon hysterosalpingography catheter (PBN Medicals, Stenloese, Denmark). E, ZUI-2.0 catheter (Zinnanti Uterine Injection, BEI Medical System International, Gembloux, Belgium). F, Goldstein catheter (Cook, Spencer, Ind). With permission from Dessole S, Farina M, Capobianco G, et al: Determining the best catheter for sonohysterography. Fertil Steril 2001;76:605-609.

+D 0.31cm ×D 0.34cm

Figure 7–9 Measurement of the anterior and posterior endometrial stripes during sonohysterography.

ATL Map 3 170dB/C 4 Persist low 2D opt:gen Fr rate:max

nonballoon catheter can reduce patient discomfort without compromising the diagnostic value of the study. The balloontipped catheter is useful in women with a patulous cervix. It also seems useful in women with submucosal leiomyomas, because the internal os is often slightly dilated. Dessole and colleagues compared six different sonohysterography catheters and found that the Foley catheter was the most difficult to use and the Goldstein catheter was associated with the least patient discomfort.7 No statistically significant differences were seen in the percentage of procedures correctly performed between the catheter types. The transducer should be swept from side to side in the sagittal and transverse planes to visualize the entire cavity. Intracavitary masses should be measured in two orthogonal planes. The endometrium should be measured anteriorly and posteriorly in the sagittal plane, as shown in Figure 7–9. Asymmetry in the endometrium or focal thickening should be noted because these may be signs of endometrial neoplasia (Fig. 7–10). Contraindications to sonohysterography include pelvic infection and known or suspected pregnancy. The endometrial cavity can normally be visualized with infusion of less than 10 mL of saline. The procedure is best performed soon after menses is completed to avoid artifacts from a thick secretory endometrium, although this is often difficult to schedule in the presence of an abnormal menstrual pattern. If the procedure is performed in the presence of active vaginal bleeding, intrauterine blood clots may be mistaken for endometrial polyps or submucous myomas.8

0

1

2

3

4

0.36cm 0.09cm

UT SAG Figure 7–10 Appearance of the asymmetric endometrial stripe during sonohysterography. SAG, sagittal; UT, uterus.

niques. The data for 3D imaging are acquired via manual or automatic 2D scanning though the pelvis. The resulting images can be displayed as 3D-rendered depictions of the structure of interest or as multiplanar images. For gynecologic applications, the multiplanar views are most useful. The 3D image offers the true coronal view of the uterus, which is not routinely available in 2D imaging. The volume rendering of the surface of pelvic organs is not as useful in gynecologic applications compared with obstetrics. In gynecologic applications, the internal structural details are more important than the surface rendering, except in the diagnosis of müllerian anomalies, as discussed later.9 Three-dimensional imaging is useful during sonohysterography. After infusing saline, the 3D images are acquired and the vaginal probe and catheter are removed. The 3D multiplanar display can then be reviewed, scrolling through the alreadyacquired images. This technique minimizes the time the catheter

Three-Dimensional Sonographic Imaging Three-dimensional (3D) sonographic imaging offers some potential advantages over conventional two-dimensional (2D) tech-

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Imaging the Uterus and Uterine Cavity Figure 7–11. Three-dimensional sonohysterogram. The true coronal view (lower left) clearly identifies a polyp, which is not as easily seen on the other two standard orthogonal planes (upper right, upper left).

The European Society of Hysteroscopy has developed a classification scheme for myoma extension into the endometrial cavity (Fig. 7–12). Type 0 myomas are completely within the uterine cavity, type 1 myomas extend less than 50% into the myometrium, and type 2 myomas have more than 50% of their volume in the myometrium. In general, greater extension of the myoma into the myometrium leads to more difficulty in resecting the myoma completely.13 Endovaginal sonography remains the best initial imaging modality for uterine leiomyomas.14 Sonographically, fibroids appear as typically hypoechoic, well circumscribed round masses. Localization is usually straightforward, as seen in Figures 7–13 to 7–15. Assessment of depth of myometrial extension is easily accomplished by sonohysterography. Measurement of myometrial extension is illustrated in Figure 7–16. In cases of multiple large fibroids, sonographic visualization may be limited by shadowing artifact. A large body habitus also can limit sonographic visualization of myomas. MRI may be useful in cases where sonography is nondiagnostic or equivocal.14 Leiomyomas are most easily visualized on T2-weighted MRI images. They have sharp margins with low signal intensity relative to the surrounding myometrium.14 Location of the fibroid relative to the myometrium is usually easily determined by MRI. Figure 7–17 is an MRI image of a submucosal leiomyoma in the sagittal view; Figure 7–18 shows the same myoma in a transverse view. Subserosal fibroids are also easily localized, as seen in Figure 7–19. MRI is also useful in differentiating leiomyomas from other solid adnexal masses. Often, a pedunculated subserosal fibroid can be confused with a solid ovarian mass such as a fibroma. Multiplanar images obtained with MRI can be useful in such cases.

and probe are in the uterus and vagina. Additionally, the 3D images can be reviewed in their entirety at any time after the examination is completed. Benacerraf and colleagues found that transvaginal scanning time was reduced by 50% with use of 3D techniques as compared with standard 2D imaging.10 Sylvestre and colleagues found that 3D SHG was 100% sensitive for intrauterine lesions in a series of 59 patients. Standard 2D SHG performed almost as well as 3D, with a sensitivity of 98%.11 3D sonohysterography provides additional information when compared to standard imaging techniques in a vast majority of cases. The coronal plane was found to be the most useful in determining the relationship of the lesions to the endometrial cavity (Fig. 7–11). The highest value for 3D imaging in gynecology is in evaluating müllerian anomalies. Primarily the value of 3D imaging is in the accurate delineation of the fundal contour of the uterus. When used concomitantly with saline infusion sonohysterography, sonography is likely a better imaging modality for evaluating müllerian anomalies than hysterosalpingography.12 Real-time 3D imaging might offer an advantage in interventional procedures in the pelvis, because needles and catheters could be guided by multiplanar displays.9

IMAGING OF SPECIFIC UTERINE PATHOLOGIES Uterine Fibroids Pelvic imaging in general is helpful in detecting and localizing fibroids. Therapeutic decisions are often based on size and location of these lesions, and thus accurate characterization is important. In particular, for submucosal myomas, the extent of intrauterine extension affects operative approach and success.

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A

B

C

Figure 7–12 European Society of Hysteroscopy classification system for leiomyoma extension into the endometrial cavity. (With permission from Falcone T, Hurd W: Clinical Reproductive Medicine and Surgery. Philadelphia: Mosby, 2007.)

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Imaging the Uterus and Uterine Cavity Pwr 100 Gn C7 / P6 /

0

5

1.07cm 1.80cm 0.66cm

1 anterior SAG uterus

SAG

Figure 7–16. Sonohysterographic image of a type 1 myoma. The calculated depth of extension is 45% [1.07 cm/(1.7 + 0.66) cm].

Figure 7–13 Transvaginal sonographic image of an intramural fibroid. SAG, sagittal.

0 1 2 3 4 5 6 7 8 Figure 7–14

Transvaginal sonographic image of a subserosal fibroid.

Figure 7–17 T2-weighted magnetic resonance image of a submucosal fibroid in the sagittal plane. Pwr 95 Gn C7 / P6 /

Deuholm and colleagues examined 106 consecutive women undergoing hysterectomy with MRI and transvaginal sonography to evaluate the accuracy of myoma detection and mapping.15 The sensitivity and specificity were essentially equivalent for both methods. MRI detected more myomas overall; however, this advantage was only found in women with more than four myomas. Furthermore, the differences between imaging modalities was narrowed if the uterine volume was less than 375 mL. Most patients in whom hysteroscopic resection of fibroids is considered have smaller uteri with fewer fibroids overall. Therefore, sonography remains the imaging test of first choice for mapping of myomas preoperatively. MRI is more useful in patients with larger uteri who may be considering minimally

3 fundal Coronal uterus

Figure 7–15 Transvaginal sonographic image of a submucosal fibroid.

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UT long

[2D] 0.0/12.0cm G50/P80/D14 FA4/6.5MHz TIs 0.1/MI 0.5

2D distance +D = 16.6mm ×D = 37.3mm

Figure 7–20. Transvaginal sonogram of adenomyosis. Note the heterogeneous echotexture of the posterior myometrium without focal masses and the asymmetric thickening of the posterior myometrium. UT long, longitudinal uterus.

Figure 7–18 T2-weighted magnetic resonance image of the submucosal fibroid in Figure 7–16 in the transverse plane. An intramural fibroid is also visible.

two of the 12 benign leiomyomas also had a predominance of high-intensity signals on the T2 images. No consistent, signal characteristic on MRI help to distinguish a leiomyoma from a leiomyomasarcoma.14 Therefore, MRI should not be performed solely for the purpose of evaluating fibroids for potential malignancy.

Adenomyosis Traditionally, adenomyosis is diagnosed by the pathologist on a hysterectomy specimen from a patient with abnormal bleeding or pelvic pain. Noninvasive diagnosis of adenomyosis by transvaginal sonography and MRI is feasible, although not definitive. Sonographic findings indicating adenomyosis include abnormal myometrial echotexture and asymmetrical thickening of the myometrium. Abnormal echotexture is defined as heterogeneity of the myometrium, presence of myometrial cysts, or varied echogenicity.17 In Figure 7–20, evidence for adenomyosis is seen by transvaginal sonography. Reinhold and colleagues evaluated for the presence of adenomyosis in 29 patients by transvaginal sonography, correlating findings with histologic examination. The sensitivity and specificity of sonography for the diagnosis of adenomyosis were 86%. For patients whose diagnosis of adenomyosis is not clear by ultrasound, or if further confidence in the diagnosis is desired before surgery, MRI can be performed. On, MRI, T2 sequences are used to define adenomyosis. The junctional zone between the myometrium and endometrium is particularly important in the MRI evaluation of adenomyosis. Diagnostic criteria include focal or diffuse thickening of the junctional zone or the presence of an ill-defined low-signal-intensity myometrial mass.14 The junctional zone may be measured on MRI. A junctional zone measurement greater than 12 mm is considered positive evidence of adenomyosis, and a value of 8 mm or less excludes the diagnosis.18 Other findings helpful on MRI include high-signalintensity foci within the myometrium, linear striations radiating

Figure 7–19 Subserosal fibroid on a T2-weighted magnetic resonance image of the uterus in the oblique plane. The bladder is displaced anteriorly by the myoma.

invasive therapies such as uterine artery embolization. It is also useful for patients who will undergo laparoscopic or robotic myomectomy. During laparoscopy there is no tactile sensation, and therefore it is imperative to know exactly how many myomas there are and where they are preoperatively. Tanaka and colleagues studied 12 patients with pathologically proven uterine leiomyosarcomas or smooth muscle tumors of uncertain malignant potential by MRI.16 When compared to benign leiomyomas, nine of the 12 nonbenign lesions had more than 50% high-intensity areas on T2-wieghted MRI. However,

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0 1 2 3 4 5 6 Long uterus Figure 7–22 Transvaginal sonohysterogram of an endometrial polyp arising from the posterior wall in sagittal view.

Figure 7–21. T2-weighted magnetic resonance image of adenomyosis. Note the high signal intensity foci in the myometrium and the poorly defined junctional zone. 0 1

from the endometrium, or poorly defined margins of the junctional zone.14 Figure 7–21 demonstrates the presence of highsignal foci of adenomyosis on MRI. Deuholm and colleagues compared the diagnostic accuracy of MRI and sonography in the diagnosis of adenomyosis.19 MRI was 70% sensitive and 86% specific, whereas ultrasound was 66% sensitive and 65% specific. Neither modality was effective in diagnosing adenomyosis in uteri of volumes greater than 400 mL. A paradoxical finding was that the combination of both imaging modalities leads to a higher sensitivity but lower specificity.

2 3 4 5 6 TR

UT

Figure 7–23 Coronal view by sonohysterography of the polyp in the same patient as in Figure 7–23. TR UT, transverse uterus.

Endometrial Polyps Endometrial polyps may be visualized on unenhanced transvaginal sonograms. Polyps appear as smooth, well-defined masses completely encircled by endometrium. Color Doppler may be useful in identifying a single feeding vessel. Cystic spaces are seen within a polyp in 58% to 91% of cases, further aiding in identification.20 Polyps tend to conform to the oblong shape of the endometrial cavity, as opposed to submucosal fibroids, which tend to be more rounded. Submucosal fibroids also often demonstrate heterogeneous echotexture, with posterior shadowing. Submucosal fibroids tend to have a diffuse or peripheral blood flow pattern on Doppler imaging, which is distinctly different from the single feeding vessel seen in polyps. Sonohysterography remains an accurate and definitive method for identifying endometrial polyps. As seen in Figures 7–22 and 7–23, polyps are easily seen with the fluid contrast. The stalks may often be identified, along with the corresponding vessels, by Doppler as seen in Figure 7–24.

Map 3 170dB/C 4 Persist med 2D opt:gen

+11.5

0

Col 79% map 6 WF low PRF 1500 Hz Flow opt:med V

1 2 3

–11.5 cm/s

4 5 6 LG

UT

Figure 7–24 Color Doppler image of the feeding vessel to the polyps (same patient as in Figs. 7–21 and 7–22). LG UT, longitudinal uterus.

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Imaging the Uterus and Uterine Cavity Endometrial Hyperplasia and Carcinoma

UTERUS cor

Diagnosis of endometrial cancer by MRI is difficult because other benign conditions such as polyps, myomas, and hyperplasia might not be distinguishable on imaging alone. On precontrast T1-weighted images, endometrial carcinoma appears isointense with the surrounding endometrium and cannot be reliably seen.21 Use of contrast and dynamic T1-weighted sequences allows better definition of the uterine zonal anatomy, especially the junctional zone between the myometrium and endometrium. MRI is useful in detecting myometrial invasion in patients with known carcinoma and has an accuracy of 86% to 91%.22 Sonographically, endometrial carcinoma and hyperplasia can appear as a thickened irregular endometrium. As with MRI, other conditions can make the endometrial echo appear thickened, such as polyps and endometritis.20 Karlsson and colleagues studied more than 1100 postmenopausal women with bleeding.23 Mean endometrial stripe thickness by transvaginal sonography in patients with endometrial carcinoma was 21.1 mm; with hyperplasia, 12 mm; and with polyps, 12.9 mm. Although a thin stripe of less than 4 mm reliably excluded malignancy, the finding of a thickened endometrial stripe had a specificity of 68%. Distinguishing endometrial cancer or hyperplasia from other conditions is not possible based solely on unenhanced measurements of the endometrial echo. Sonohysterography can demonstrate asymmetric thickening of the endometrium as noted in Figure 7–10. However, no specific cutoff values have been developed to define asymmetry for endometrial stripe measurements during sonohysterography. Inability to distend the endometrial cavity during attempted sonohysterography has been reported as a finding consistent with endometrial carcinoma.20

M

[2D] G50 / 5 FA2 / P

Figure 7–25 A coronal transvaginal sonogram of a bicornuate uterus. cor, coronal.

used during acquisition of images. The fundal configuration can then be determined on fast-spin echo T2-weighted images.

PELVIC IMAGING AND EVALUATION OF ABNORMAL UTERINE BLEEDING Pelvic imaging techniques have gradually become accepted as vital tools in the evaluation of patient with AUB. Traditionally, the evaluation of AUB has included dilation and curettage to exclude malignancy and, more recently, office endometrial aspiration biopsy. Much of AUB is due to anovulatory menstrual cycles, and thus many practitioners choose to start medical therapy immediately.26 When medical therapy is not effective, further evaluation with imaging helps detect endometrial cavity abnormalities such as endometrial polyps and leiomyomas. Although MRI is useful in certain clinical situations as described earlier, it has not been well assessed as an initial step in evaluation of AUB. Sonography remains the imaging test of choice in the work-up of AUB. The effectiveness of sonography in evaluating AUB has been well studied. Saline sonohysterography in particular seems most useful for AUB. De Kroon and colleagues performed a systematic review and meta-analysis of the diagnostic accuracy of sonohysterography in women complaining of AUB.27 The pooled sensitivity and specificity was 95% and 88%, respectively. The success rate for sonohysterography was 93%. The cost effectiveness of transvaginal sonography and sonohysterography was examined in a study by Dijkhuizen and colleagues.26 They examined six strategies for evaluation and treatment of menorrhagia:

Müllerian Anomalies Traditionally, müllerian anomalies were imaged by hysterosalpingography (HSG). HSG characterizes the endometrial cavity contours well; however, the uterine fundal shape is not seen. This limitation is particularly important in the differentiation between a septate and bicornuate uterus. Uterine septa are easily resected hysteroscopically, whereas with bicornuate uteri, reunification is no longer routinely performed. Thus, determining the fundal contour is particularly important in determining therapy. Transvaginal sonography can aid in determining fundal contour. Two-dimensional ultrasound imaging has a pooled accuracy of 90% to 92%.12 Addition of 3D sonography with surface rendering has been reported to have a sensitivity of 93% and a specificity of 100%.24,25 Sonohysterography adds more information about the endometrial cavity contour and should be considered when using sonography for detection of müllerian anomalies (Figs. 7–25 to 7–28). MRI has a reported accuracy of up to 100% in diagnosing müllerian anomalies.12 MRI can provide both fundal and endometrial contours in multiple imaging planes. Surface coils are

● ● ●

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Hormonal treatment with progestins Treatment of all women with balloon ablation Transvaginal sonography followed by hysteroscopy in those with abnormal findings at sonography

Chapter 7

Imaging the Uterus and Uterine Cavity Figure 7–26 The three-dimensional version of this uterus is demonstrated.

Figure 7–27 A sonohysterography was performed, and fluid filled the left side of the uterus. In the threedimensional (3D) images, the true coronal images (lower left) are the most useful. The surface rendering in the lower right of the 3D panels is often not informative in gynecologic imaging.

●

●

●

Transvaginal sonography followed by sonohysterography where indicated, followed by therapeutic hysteroscopy for those with abnormal sonohysterograms Sonohysterography followed by therapeutic hysteroscopy for those with abnormal sonohysterograms Diagnostic hysteroscopy

teroscopy in terms of cost effectiveness. Sonohysterography was recommended as the initial test in the work-up of menorrhagia. Cutoff values for endometrial thickness are not recommended in the work-up of premenopausal patients with abnormal bleeding for several reasons. First, the endometrial thickness varies throughout the menstrual cycle, and thus a thickened stripe might merely be secondary to secretory endometrium. Second, polyps and fibroids may be found even in women with endometrial stripe thicknesses less than 5 mm.28 Based on the aforementioned studies and those of Goldstein and colleagues,29 an algorithm for work-up of AUB is presented in Figure 7–29.

All women with normal endometrial cavities in the last four strategies were treated with balloon ablation. Their analysis demonstrated that sonohysterography and diagnostic hysteroscopy led to the highest success in diagnosis and treatment of menorrhagia. Sonohysterography was superior to diagnostic hys-

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Imaging the Uterus and Uterine Cavity PELVIC IMAGING IN THE EVALUATION OF POSTMENOPAUSAL BLEEDING

HDI

Map 1 DynRg 55 dB Persist med Fr rate med 2D opt:pen

Coronal

Endometrial biopsy is almost universally used in evaluating postmenopausal bleeding, mostly because of the reported effectiveness in excluding endometrial malignancy. Endometrial carcinoma and hyperplasia are the etiologies for up to 20% of postmenopausal bleeding.23 Other etiologies include polyps, fibroids and atrophy. Although carcinoma and hyperplasia are best evaluated by histologic analysis via biopsy, sonography allows a more global assessment of the uterine cavity and myometrium. Medverd and Dubinsky studied a cost-analysis model comparing ultrasoundbased and endometrial biopsy–based algorithms for evaluation of perimenopausal and postmenopausal bleeding.30 When the prevalence of endometrial carcinoma or atypical hyperplasia was less than 31%, the triage scheme with transvaginal sonography as the initial test minimized cost the best. Another study found that sonography-based evaluation was most cost-effective when the prevalence of endometrial carcinoma alone was 15.3%.31 O’Connell and colleagues studied an algorithm for using endometrial biopsy and sonohysterography to evaluate postmenopausal bleeding in 104 women.32 The combination was 94% sensitive and 96% specific with surgical findings, and no cases of endometrial cancer or hyperplasia were misdiagnosed. The Society for Radiologists in Ultrasound conducted an expert consensus conference that concluded that either sonography or endometrial biopsy could be used safely as an initial diagnostic step in the diagnostic evaluation of postmenopausal bleeding. The consensus was that the decision about which test to use should depend on the physician’s assessment of patient risk, the nature of the physician’s practice, the availability of high-quality sonography, and patient preference. Based on the aforementioned data, an algorithm for using sonography in the triage of postmenopausal bleeding is presented in Figure 7–30.

Uterus

Figure 7–28. Sonohysterogram of a bicornuate uterus. Note the fundal contour inferiorly, which suggests a divided fundus.

Premenopausal patient with abnormal uterine bleeding

Anovulatory cycle? Yes*

No

Medical therapy

Fails

SHG

Normal EM cavity

Focal finding

AUB

Hysteroscopy

Figure 7–29 Sonography-based algorithm for evaluation of abnormal uterine bleeding. AUB, abnormal uterine bleeding; EM, endometrial; SHG, sonohysterography. *Endometrial biopsy should be considered before medical therapy in patients at high risk for endometrial hyperplasia or carcinoma, such as in the presence of obesity, diabetes, or hypertension.

Comparison of Ultrasound and Hysteroscopy The relative utility of sonography versus office hysteroscopy for evaluating the endometrial cavity is often debated. Several

Figure 7–30 Sonography-based algorithm for evaluation of postmenopausal bleeding. EM, endometrial; SHG, sonohysterography.

Endometrial biopsy

Endometrial carcinoma or hyperplasia

Insufficient proliferative endometrium polyp

Medical/surgical treatment

SHG

Focal finding

Hysteroscopy

Fails

Atrophy

Hormonal therapy or observation

Normal EM cavity Yes

Persistent bleeding

No

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Imaging the Uterus and Uterine Cavity considerations are relevant in the decision about which test to use, including feasibility, cost, patient acceptability, and diagnostic accuracy. Although no definitive data exist to resolve the debate, several relevant studies provide some basis for comparing hysteroscopy and sonography. With regard to feasibility, the failure rate for saline sonohysterography is reported to be 7%.27 The failure rate for outpatient diagnostic hysteroscopy varies between 4% and 10%.33-35 With regard to pain, some studies indicate that sonohysterography is less painful than hysteroscopy,36 and others have found no difference.37 The accuracy of sonohysterography and outpatient hysteroscopy are similar in detecting endometrial cavity lesions.38 Cost-effectiveness data as presented earlier favor sonohysterography. One study found that sonohys-

terography could replace 84% of outpatient diagnostic hysteroscopies.39 In contrast, Lindhiem and Morales found that sonohysterography helped to clarify confusing hysteroscopic findings, particularly in patients scheduled for operative procedures.40 Hysteroscopy offers the advantage of “see and treat,” in that small polyps can be removed and directed biopsies of suspicious lesions can be obtained immediately in the office setting. Sonohysterography provides information regarding the surrounding myometrium and adnexa, which can help with preoperative planning before resecting myomas. The exact role for both techniques is not yet well defined; however, both sonohysterography and office hysteroscopy are clearly powerful tools for evaluating the endometrial cavity.

REFERENCES 1.

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3. 4.

5. 6. 7. 8.

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Paley MN, Wilkinson ID, van Beek E, Griffiths PD: Magnetic resonance imaging: Basic principles. In Grainger RG, Allison DJ, Adam A, Dixon AK (eds): Grainger & Allison’s Diagnostic Radiology: A Textbook of Medical Imaging. London: Churchill Livingstone, 2001, pp 101-136. Rafal RB: Magnetic resonance imaging: Physical principles and imaging techniques. In: Anderson JC (ed): Gynecologic Imaging. London: Churchill Livingstone, 1999, pp 47-57. Sala EJ, Atri M. Magnetic resonance imaging of benign adnexal disease. Top Magn Reson Imaging 2003;14:305-327. Scheidler J, Reiser MF: MRI of the female and male pelvis: Current and future applications of contrast enhancement. Eur J Radiol 2000;34:220-228. Schneider G, Uder M: Contrast-enhanced magnetic resonance body imaging . Top Magn Reson Imaging 2003;14:403-425. Nalaboff KM, Pellerito JS, Ben Levi E: Imaging the endometrium: Disease and normal variants. Radiographics 2001;21:1409-1424. Dessole S, Farina M, Capobianco G, et al: Determining the best catheter for sonohysterography. Fertil Steril 2001;76:605-609. Breitkopf D, goldstein SR, Seeds JW; ACOG Committee on Gynecologic Practice: ACOG technology assessment in obstetrics and gynecology. Number 3, September 2003. Saline infusion sonohysterography. Obstet Gynecol 102(3):659-662, 2003. Pretorius DH, Borok NN, Coffler MS, Nelson TR: Three-dimensional ultrasound in obstetrics and gynecology. Radiol Clin North Am 2001;39:499-521. Benacerraf BR, Shipp TD, Bromley B: Improving the efficiency of gynecologic sonography with 3-dimensional volumes: A pilot study. J Ultrasound Med 2006;25:165-171. Sylvestre C, Child TJ, Tulandi T, Tan SL: A prospective study to evaluate the efficacy of two- and three-dimensional sonohysterography in women with intrauterine lesions. Fertil Steril 2003;79:1222-1225. Troiano RN, McCarthy SM: Müllerian duct anomalies: Imaging and clinical issues. Radiology 2004;233:19-34. Wamsteker K, Emanuel MH, de Kruif JH: Transcervical hysteroscopic resection of submucous fibroids for abnormal uterine bleeding: Results regarding the degree of intramural extension. Obstet Gynecol 1993;82:736-740. Ascher SM, Jha RC, Reinhold C: Benign myometrial conditions: Leiomyomas and adenomyosis. Top Magn Reson Imaging 2003;14: 281-304. Dueholm M, Lundorf E, Hansen ES, et al: Accuracy of magnetic resonance imaging and transvaginal ultrasonography in the diagnosis, mapping, and measurement of uterine myomas. Am J Obstet Gynecol 2002;186:409-415.

16. Tanaka YO, Nishida M, Tsunoda H, et al: Smooth muscle tumors of uncertain malignant potential and leiomyosarcomas of the uterus: MR findings. J Magn Reson Imaging 2004;20:998-1007. 17. Reinhold C, Atri M, Mehio A, et al: Diffuse uterine adenomyosis: Morphologic criteria and diagnostic accuracy of endovaginal sonography. Radiology 1995;197:609-614. 18. Reinhold C, McCarthy S, Bret PM, et al: Diffuse adenomyosis: Comparison of endovaginal US and MR imaging with histopathologic correlation. Radiology 1996;199:151-158. 19. Dueholm M, Lundorf E, Olesen F: Imaging techniques for evaluation of the uterine cavity and endometrium in premenopausal patients before minimally invasive surgery. Obstet Gynecol Surv 2002;57: 388-403. 20. Laing FC, Brown DL, DiSalvo DN: Gynecologic ultrasound. Radiol Clin North Am 2001;39:523-540. 21. Frei KA, Kinkel K: Staging endometrial cancer: Role of magnetic resonance imaging. J Mag Res Imaging 2001;13:850-855. 22. Kinkel K, Kaji Y, Yu KK, et al: Radiologic staging in patients with endometrial cancer: A meta-analysis. Radiology 1999;212:711718. 23. Karlsson B, Granberg S, Wikland M, et al: Transvaginal ultrasonography of the endometrium in women with postmenopausal bleeding—a Nordic multicenter study. Am J Obstet Gynecol 1995;172:14881494. 24. Raga F, Bonilla-Musoles F, Blanes J, Osborne NG: Congenital müllerian anomalies: Diagnostic accuracy of three-dimensional ultrasound. Fertil Steril 1996;65:523-528. 25. Wu MH, Hsu CC, Huang KE: Detection of congenital müllerian duct anomalies using three-dimensional ultrasound. J Clin Ultrasound 1997;25:487-492. 26. Dijkhuizen FP, Mol BW, Bongers MY, et al: Cost-effectiveness of transvaginal sonography and saline infused sonography in the evaluation of menorrhagia. Int J Gynaecol Obstet 2003;83:45-52. 27. de Kroon CD, de Bock GH, Dieben SW, Jansen FW: Saline contrast hysterosonography in abnormal uterine bleeding: A systematic review and meta-analysis. BJOG 2003;110:938-947. 28. Breitkopf DM, Frederickson RA, Snyder RR: Detection of benign endometrial masses by endometrial stripe measurement in premenopausal women. Obstet Gynecol 2004;104:120-125. 29. Goldstein SR, Zeltser I, Horan CK, et al: Ultrasonography-based triage for perimenopausal patients with abnormal uterine bleeding. Am J Obstet Gynecol 1997;177:102-108. 30. Medverd JR, Dubinsky TJ: Cost analysis model: US versus endometrial biopsy in evaluation of peri- and postmenopausal abnormal vaginal bleeding. Radiology 2002;222:619-627.

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Imaging the Uterus and Uterine Cavity 31. Dijkhuizen FP, Mol BW, Brolmann HA, Heintz AP: Cost-effectiveness of the use of transvaginal sonography in the evaluation of postmenopausal bleeding. Maturitas 2003;45:275-282. 32. O’Connell LP, Fries MH, Zeringue E, Brehm W: Triage of abnormal postmenopausal bleeding: A comparison of endometrial biopsy and transvaginal sonohysterography versus fractional curettage with hysteroscopy. Am J Obstet Gynecol 1998;178:956-961. 33. Clark TJ, Voit D, Gupta JK, et al: Accuracy of hysteroscopy in the diagnosis of endometrial cancer and hyperplasia: A systematic quantitative review. JAMA 2002;288:1610-1621. 34. Sousa R, Silvestre M, Almeida e Sousa L, et al: Transvaginal ultrasonography and hysteroscopy in postmenopausal bleeding: A prospective study. Acta Obstet Gynecol Scand 2001;80:856862. 35. Campo R, Van Belle Y, Rombauts L, et al: Office mini-hysteroscopy. Hum Reprod Update 1999;5:73-81.

36. Widrich T, Bradley LD, Mitchinson AR, Collins RL: Comparison of saline infusion sonography with office hysteroscopy for the evaluation of the endometrium. Am J Obstet Gynecol 1996;174:1327-1334. 37. Cameron ST, Walker J, Chambers S, Critchley H: Comparison of transvaginal ultrasound, saline infusion sonography and hysteroscopy to investigate postmenopausal bleeding and unscheduled bleeding on HRT. Aust N Z J Obstet Gynaecol 2001;41:291-294. 38. Clark TJ: Outpatient hysteroscopy and ultrasonography in the management of endometrial disease. Curr Opin Obstet Gynecol 2004;16:305-311. 39. de Kroon C, Jansen FW, Louwe LA, et al: Technology assessment of saline contrast hysterosonography. Am J Obstet Gynecol 2003;188: 945-949. 40. Lindheim SR, Morales AJ: Comparison of sonohysterography and hysteroscopy: Lessons learned and avoiding pitfalls. J Am Assoc Gynecol Laparosc 2002;9:223-231.

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8

Presurgical Evaluation of the Enlarged Uterus Linda D. Bradley and Brenda Andrews

Current imaging techniques for evaluating the uterus, uterine cavity, and endometrium include TVUS, saline infusion sonography (SIS, also known as sonohysterogram [SHG]), hysteroscopy, and MRI. The potential for intraobserver variation is greatest for TVUS, SIS, and hysteroscopy, and it is least with MRI. The most experienced physicians should perform these procedures to increase the sensitivity of the results. The presurgical evaluation of the enlarged uterus is the goal of this chapter.

Approximately 20% to 80% of women have uterine fibroids. Symptoms of uterine fibroids include menorrhagia, pelvic fullness, pelvic pain, and metrorrhagia.1 Increasingly, patients with symptomatic uterine enlargement seek evaluation and treatment. For some patients, traditional hysterectomy, either by abdominal, laparoscopic, or vaginal approach, alleviates all clinical symptoms. It is highly effective, well accepted, and requested by patients for definitive relief of all fibroid-related symptoms. In these cases, generally an abdominal or transvaginal ultrasound (TVUS) is sufficient to identify the etiology of the pelvic mass before proceeding to hysterectomy (Fig. 8–1). Other women however, seek minimally invasive procedures to alleviate fibroid-related symptoms, despite their reproductive potential. Current alternatives to hysterectomy include abdominal myomectomy, laparoscopic myomectomy, myolysis, uterine fibroid embolization (UFE), magnetic resonance imaging (MRI)focused ultrasound, laparoscopic uterine artery ligation, and endometrial ablation. Endometrial ablation is performed only for women with small (<3 cm) intramural fibroids and those that do not distort the endometrial cavity. A patient who has an enlarged uterus and who desires pregnancy should rarely be counseled for hysterectomy unless malignancy is highly expected. Myomectomy performed by experienced physicians has a less than 3% incidence of conversion to hysterectomy. Referral to a tertiary care center or to physicians with great expertise in myomectomy procedures is advised if high risk of hysterectomy is anticipated during myomectomy for women wishing to retain fertility. Endometrial ablation is contraindicated in women wanting children. Women seeking alternatives to hysterectomy need a thorough presurgical evaluation of the uterus to determine if alternative procedures are warranted, contraindicated, or less likely to be successful. Increasingly, imaging of the uterus is of paramount importance in establishing feasibility of minimally invasive surgery. Specifically size, number, and location of uterine fibroids are important to determine which minimally invasive procedure would be helpful (Fig. 8–2). The gynecologist should not rely only on a written narrative report but, whenever possible, should review actual films and correlate pelvic pathology and clinical history with imaging results.

PREOPERATIVE EVALUATION An exceptional surgeon cannot be judged on manual dexterity and technical skills alone. Knowing the appropriate surgical candidate, understanding the risks of surgery, identifying the procedure that has the best outcomes, recognizing alternative procedures, and knowing outcome of all potential surgical procedures is the true goal of an excellent surgeon. A technically flawless procedure, performed for the wrong indications, or removal of the uterus in a patient desirous of uterine-sparing surgery, or performing surgery with an inadequate workup is problematic. A savvy surgeon must know how to perform a surgical procedure and understand the instrumentation, but performing an excellent preoperative history, physical examination, and appropriate laboratory and imaging evaluation are most important. Remaining patient-centered is critical.

Differential Diagnosis Careful preoperative evaluation should be undertaken to evaluate women with excessive menstrual bleeding. Because intractable, heavy menses may be associated with a number of conditions including pelvic pathology and systemic and hormonal dysfunction, gynecologists must consider all possibilities and in many circumstances recommend medical therapy before scheduling any surgical procedure. The differential diagnosis of menorrhagia can include fibroids, adenomyosis, thrombocytopenia, von Willenbrand disease, hypothyroidism, endometritis, foreign bodies, medications (heparin and coumadin), liver or renal disease, and retained products of conception.

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Presurgical Evaluation of the Enlarged Uterus symptoms is a rare indication for surgery unless it causes pressure on the kidneys with moderate or marked hydronephrosis or compression symptoms on the inferior vena cava (including deep vein thrombosis [DVT] or pulmonary embolism). Rapid growth suggesting sarcomatous change (pain, weight loss, systemic symptoms, and necrosis on MRI of the pelvis) is another indication. Intervention and type of intervention for uterine fibroids depends on: ● ● ● ● ● ● ● ●

Figure 8–1. Large leiomyomas at laparotomy. The patient presented with abdominal enlargement, hydronephrosis, and pelvic pain. Hysterectomy was performed and a 1.2-kg fibroid was removed.

Symptoms Size Location Number Fertility Proximity to menopause Prior surgical history Patient expectations

The era of removing asymptomatic uterine fibroids of larger than 12 weeks’ gestational size is unwarranted. Likewise, adnexa that cannot be palpated, concerns that the fibroid might grow, risk of sarcoma, and possibility of difficult surgery are no longer valid reasons to promote hysterectomy in the asymptomatic patient. Observation, watchful waiting, and reassurance are now the norm.

EVALUATION OF THE UTERINE MASS History and Physical Examination Bimanual examination is the most common initial tool used to diagnose a pelvic mass. It is easy to perform, reproducible, and inexpensive. When combined with the patient’s history, it helps determine the next series of tests (Box 8–1). Understanding the patient’s complaint is essential. Obese patients as well as patients who are unable to relax will require a TVUS or pelvic ultrasound to confirm the etiology of the pelvic mass.

Imaging Transvaginal Ultrasound

TVUS remains the most common imaging modality of the female pelvis. It is quickly performed, widely available, and relatively inexpensive. The size, shape and volume of the uterus changes from puberty to menopause and is well imaged by TVUS. In puberty, the uterine contours are cigar-shaped. During the postpubertal years the uterus is pear shaped and smooth. Maximum normal uterine size in the adult is 9 cm in length, 6 cm in width, and 4 cm in the anteroposterior diameter. During menopause, the uterus atrophies to 6 cm by 2 cm by 2 cm. Endometrial measurements and uterine volume must be correlated with age of the patient, reproductive history, menopausal status, and concurrent medications. Weigel and colleagues2 prospectively evaluated 200 postmenopausal women with endometrial echo of 3 to 10 mm and noted that the echo morphology, with specific reference to

Figure 8–2 The location, size, and number of fibroids are important for determining which minimally invasive surgical options are available.

Pelvic pathology and concomitant systemic disorders can coexist. Is the fibroid or adenomyosis merely present and a passenger? Or is the lesion the culprit? The patient’s history, physical examination, and selective use of laboratory testing and imaging are important.

Uterine Leiomyomas Uterine leiomyomas are the most common benign tumors of the female pelvis. They consist of benign smooth muscle surrounded by a pseudocapsule and extracellular matrix with compressed muscle fibers. When considering therapy, size alone without

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Presurgical Evaluation of the Enlarged Uterus TVUS offers improved image quality over abdominal ultrasound for evaluating the endometrium. In menopausal women with a regular endometrial echo and endometrial echo less than 5 mm, endometrial cancer is effectively excluded, even when hormone replacement therapy is used. Overall diagnostic accuracy of TVUS was quite variable. Sensitivity is 87% (range, 24%-96%) and specificity is 82% (range, 29%-93%), with best outcomes obtained by experts. More missed lesions were detected in premenopausal patients than in postmenopausal patients.3 TVUS can have a high number of equivocal findings, which can require additional studies to characterize the endometrium. Polyps, hyperplasia, and cancer cannot be reliably excluded by TVUS, and endometrial biopsy may be necessary to exclude cancer and hyperplasia. Likewise, hysteroscopy or SIS may be necessary to exclude intracavitary lesions. During TVUS, saline can be injected into the endometrial cavity (SIS) to further delineate submucosal and intracavitary lesions. Saline injected intracervically not only enhances the view of the endometrium and myometrium but also provides an acoustic view that allows three-dimensional investigation of the uterine cavity and ovaries. SIS improves the sensitivity and specificity of TVUS for the detection of endometrial lesions. Studies of SIS reveal overall sensitivity of 94% (range, 83%100%) and specificity of 85% (range, 72%-99%) for detecting endometrial lesions in premenopausal women.4 The endometrium must be imaged in its entirety in all women. Coexisting disease can occur in women with a pelvic mass. For all women who have an enlarged uterus, close attention to the characteristics of the endometrium, endometrial echo, and uterine volume is important. Endometrial findings should be correlated with myometrial disease and adnexal pathology. Ultrasound is used as an adjunct to the pelvic examination and confirms the presence of pelvic or adnexal masses; evaluates size, shape, contour, and characteristics of a pelvic mass; determines the origin of a pelvic mass (uterus or ovary); evaluates involvement of other organs; assesses pelvic tenderness; and looks for ascites, hydronephrosis, and metastatic disease. Leiomyomata should be distinguished from other pelvic masses with increased potential for malignancy, such as ovarian tumors or paraovarian cysts (Figs. 8–3 and 8–4). This is usually easily accomplished with TVUS or abdominal ultrasonography because fibroids appear solid by ultrasound and are usually easily differentiated from adnexal structures. When SIS is incorporated, detection of submucosal fibroids has even greater sensitivity (94%; range, 91%-100%) and specificity (95%; range, 88%100%) than TVUS alone.5 When the uterus is smaller than 12 to 14 weeks gestational size, TVUS is the preferred method of evaluation, compared to abdominal sonography. The transducer is of higher frequency, is closer to the pelvic cavity, and provides better resolution of pelvic masses compared to abdominal ultrasonography. Obese and gaseous patients are more easily imaged with TVUS than with abdominal ultrasound. Using a 5- to 10-MHz transducer, high tissue characterization of the pelvic organs is possible. However, the field of view is limited (usually less than 6 cm from the transducer surface), so that the anticipated size of

BOX 8–1 History and Examination for Enlarged Uterus Menstrual aberrations ● ● ● ● ● ● ●

Menorrhagia Menometrorrhagia Gushing Flooding Clots Severe dysmenorrhea when passing clots Leukorrhea ● Often described as serosanguineous, watery ● Without odor ● Episodic or florid

Bulk symptoms ● ● ● ●

Urinary frequency Urinary urgency Urinary retention Combination of all

Pressure symptoms ● ● ●

Pelvic heaviness Backache Leg ache, lower extremity edema

Pain ● ● ● ●

Constant pain Episodic pain and associated with menses or clotting Pain affected by certain activities or positions Dyspareunia

Reproductive history ● ● ●

Recurrent miscarriages Infertility Premature labor

Cosmetic concerns ● ● ● ● ●

Protuberant abdomen Palpable abdominal mass Inability to lie or sleep on stomach Increased girth Clothing does not fit

Reproductive interests ● ● ●

Completed childbearing Desirous of children Uncertain

homogeneity, thin endometrium, and sonographically depictable central endometrium with symmetry was associated with the absence of pathology, whereas heterogeneity and high echogenicity was associated with pathology. The researchers noted that measurement and morphology were important hallmarks in predicting pathology, and the need to pursue other tests for evaluation. Increased uterine volumes in the menopause must take into account the echomorphology of the endometrium in addition to uterine size.

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HDI

[2D] G45 / FA2 /

[2D] G4 FA2

UT ENDO FIB Endometrioma

Figure 8–3 This patient presented with a pelvic mass and pain. Ultrasound revealed a normal uterus; however, an ovarian mass, likely consistent with an endometrioma, was discovered. UT, uterus.

HDI

RT

Figure 8–5 The endometrium (ENDO) is displaced by this intramural leiomyoma (FIB). The endometrium is completely separated from the leiomyoma.

[2D] G48 / 5 FA2 / P

The most common pelvic mass imaged by TVUS is leiomyoma. Variable histologic changes, including hyaline, calcific, hemorrhagic, and liquefaction necrosis, represent the most frequent degenerative changes seen and are reflected ultrasonographically. Uterine fibroids can undergo vascular compromise, atrophy, fibrotic changes, and degeneration, which create characteristic ultrasonographic patterns. Normally the myometrium is homogeneous; however, discrete fibroids may be hyperechoic if fibrotic changes have occurred. Ultrasound criteria for uterine leiomyomas include uterine enlargement, nodular uterine contour, lack of homogeneity of the myometrium, and focal mass within the myometrium. Most leiomyomas are hypoechoic or heterogeneous compared to normal myometrium, and calcifications cause bright echoes representing calcific deposits with distal acoustic shadowing (Fig. 8–5). Approximately 10% of myomas may have calcification with hemorrhagic changes. Hyalinization of leiomyomas typically appears more hypoechoic than the surrounding myometrium. Degenerating fibroids often appear cystic. If color Doppler imaging is used, marked peripheral and decreased central flow or an avascular core on color Doppler imaging may be noted. With TVUS, despite its high resolution, the endometrium is compressed, and therefore limits the details of endometrial pathology. Specifically, making a diagnosis of endometrial polyps, submucosal fibroids, endometrial folds, and determination of the actual degree of fibroid extension into the uterine cavity is daunting when TVUS is used alone. Among reproductive-age patients, a normal endometrial echo can miss one out of six intracavitary lesions. Therefore, among symptomatic patients, a normal endometrial echo cannot reliably exclude intracavitary lesions. Additionally, the endometrium may be ill defined, not visualized, or not seen in its entirety. When this occurs, additional information is needed. SIS, with the slow injection of

Paraovarian cyst RO

Figure 8–4 This patient’s adnexal fullness was not due to a fibroid but to a paraovarian cyst. RO, right ovary.

pelvic pathology must be anticipated before scheduling the procedure; otherwise the anticipated pelvic mass may not be visible if it is out of the view of the transducer.6 To obtain precise images of the enlarged uterus, it is technically important to include both the fundus and cervical view within the same image. The contiguous endometrial stripe and an empty bladder should be also seen within this view. With newer technology, most transducers have an increased degree of arc of the sector beam area, thus providing a wider field of view, which is necessary when encountering a larger pelvic mass. Sagittal images should measure the uterus at the longest point from the fundus to the cervix. The coronal image obtained at the level of the fundus measures the anteroposterior dimension and width of the uterus.

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Presurgical Evaluation of the Enlarged Uterus sterile saline, which acts as a negative contrast agent, is particularly helpful. Cicinelli and colleagues7 compared the accuracy in detecting submucosal fibroid size and myometrial growth in women scheduled for hysterectomy. All patients underwent TVUS, transabdominal sonohysterography, and hysteroscopy followed by hysterectomy. Physicians were blinded to results. Transabdominal sonohysterography most accurately predicted size and myometrial ingrowth of fibroids. Hysteroscopy was the least accurate in detecting size of the myoma, which may be due to the optical refractive index associated with hysteroscopy. Although transabdominal sonohysterography is rarely used today, whereas SIS more often used, the concept of improved detailed and accurate visualization of the endometrium with ultrasound enhanced with saline is obvious. When SIS results are equivocal, and the physician has greater experience with performing hysteroscopy, especially if hysteroscopic sampling and removal of intracavitary lesions can be performed at the same time.

SIS is especially helpful in evaluating the reproductive-age patient with an enlarged uterus, infertility, or abnormal uterine bleeding. SIS allows more accurate evaluation of the uterus for intracavitary lesions than TVUS and makes it easier to differentiate the causes of increased endometrial thickness, location of uterine fibroids, and depth of myometrial involvement of uterine fibroids. Numerous studies have delineated greater sensitivity in determining the abnormality within the uterine cavity.9 Especially in the infertile patient, intrauterine abnormalities are common. Acquired or congenital anomalies occur in 1 in 700 patients, leading to significant problems with conception,

Saline Infusion Sonography

SIS is extremely valuable in localizing intracavitary lesions. During SIS, saline is infused into the endometrial cavity during TVUS to enhance the view of the endometrium. This constitutes one of the most significant advances in ultrasonography of the past decade. Many terms have been used to describe this technique, among them echohysteroscopy, hydrosonography, sonohysterography, sonohysterogram, and sonoendovaginal ultrasound. Saline infusion sonography was coined at the Cleveland Clinic Foundation in 1996 and is preferred because it defines the technique more precisely.8 Sonohysterogram is commonly used in other centers. SIS can provide a wealth of information about the uterus, location of uterine leiomyomas, and adnexa in patients with abnormal bleeding. It offers an exquisite view of the endomyometrial complex that cannot be obtained with TVUS alone. It differentiates between focal and global processes and improves overall sensitivity for detecting abnormalities of the endometrium (Figs. 8–6 to 8–9). 0

SIS

2 1

Figure 8–7 Figure 8–6.

Corresponding hysteroscopic view of the lesion seen in

SIS TRV

31

0

Gyn 65EV13S 5.0 1 Uterus 2 L ovary 3 R ovary 4 L Fol# 5 R Fol# 6 Cervix 7 Endome

1 2 D1= 34.6mm D2= 10.7mm

L

L 80 Figure 8–8 Unusual saline infusion sonography (SIS) of a 3.5-cm intracavitary lesion with irregular debris extending from a leiomyoma.

Figure 8–6 This is a sagittal view of a 3.1-cm intracavitary lesion, easily visualized with the addition of saline (SIS).

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Figure 8–9 Corresponding hysteroscopic view of the image in Figure 8– 8. The irregular debris extending from the leiomyoma is likely portions of a degenerating leiomyoma.

recurrent miscarriage, implantation failure, or problems with embryo transfer during in vitro fertilization (IVF) procedures. Simply adding saline via an insemination catheter enables a physician to properly diagnose congenital müllerian anomalies or acquired anomalies of the genital tract. SIS permits rapid assessment of the exterior and interior uterus and can differentiate a uterine septum compared to a bicornuate uterus, thickness of the uterine septum, and intrauterine synechiae. Imaging helps in the planning stages of hysteroscopic metroplasty and adhesiolysis. Current indications for SIS include: ●

●

●

●

●

●

Figure 8–10 Saline infusion sonography (SIS) class 1 lesion is equivalent to a purely pedunculated leiomyoma within the uterine cavity. It might have a stalk or might be attached in a broad base to the endometrium.

Abnormal bleeding in premenopausal or postmenopausal patients Evaluation of an endometrium that is thickened, irregular, immeasurable, or poorly defined on conventional TVUS Evaluation of an endometrium that appears irregular on TVUS in women using tamoxifen Differentiating between sessile and pedunculated masses of the endometrium Preoperative evaluation of intracavitary fibroids and determination of the depth of myometrial penetration of uterine fibroids Evaluation of the interstitial area of the fallopian tube

Future applications might include determining if tubal occlusion is achieved by hysteroscopic sterilization methods. We have formulated a rigorous SIS classification of uterine fibroids for the purpose of planning surgery, determining resectability of lesions, and standardizing the comparison of surgical outcomes.10 ●

●

●

Figure 8–11 Saline infusion sonography (SIS) class 1 hysteroscopic view of an intracavitary lesion.

submucosal region to the serosa. These fibroids often appear as a bulge or indentation into the submucosal region when viewed hysteroscopically (Figs. 8–15 to 8–17).

Class 1 fibroids are intracavitary and do not involve the myometrium. The base or stalk is visible with SIS (Figs. 8–10 to 8–12). Class 2 fibroids have a submucosal component involving less than 50% of the myometrium (Figs. 8–13 and 8–14). Class 3 fibroids have an intramural component greater than 50%. They can be transmural and located anywhere from the

For a successful surgical outcome, it is important to preoperatively identify the size, number, location, and depth of intramural extension. Fibroid size and location affect resectability, the number of surgical procedures necessary for complete resection, the duration of surgery, and the potential complications

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+D 0.27cm ×D 0.20cm Figure 8–14 Class 2 saline infusion sonography (SIS) demonstrates a fibroid that involves <50% of the myometrium.

Figure 8–12 Saline infusion sonography (SIS) class 1 lesion seen with an extirpated uterus.

Figure 8–15 Class 3 saline infusion sonography (SIS) sketch is equivalent to a leiomyoma that involves >50% of the myometrium.

cal examination and basic laboratory studies (complete blood count [CBC] and thyroid-stimulating hormone [TSH]) with TVUS unless the clinical history dictates otherwise. In the past, if TVUS was “normal,” no additional testing was performed. However, due to the high false-negative rate of TVUS, SIS, correctly timed, should be considered as a first-line approach in the patient with abnormal uterine bleeding. Physicians can be very confident that a thin endometrium is less likely to harbor malignancy. However, in the reproductive years, there is a wide range of normal of the endometrial echo. Due to ovarian hormonal flucuations, the endometrium ranges from 4 mm to 14 mm between the postmenstrual phase and secretory phase.

Figure 8–13 Saline infusion sonography (SIS) class 2 sketch is equivalent to a leiomyoma that involves <50% of the myometrium.

from fluid overload. An experienced surgeon can successfully resect class 1 or 2 fibroids hysteroscopically. Class 3 fibroids are less amenable to such surgery because perforation is a significant risk. Fluid overload, contracture of the endometrial cavity, and incomplete resection more commonly occur with attempts to remove class 3 fibroids.11 Increasingly, gynecologists are embracing the concept of onestop evaluation for menstrual disorders by combining the physi-

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+D 5.25cm ×D 4.87cm Figure 8–16 Class 3 saline infusion sonography (SIS) view demonstrates a leiomyoma that involves the entire myometrium.

Figure 8–18 Transvaginal ultrasound of a naturally occurring saline infusion sonography (SIS). Fluid accumulation can lead to an enlarged uterine cavity.

If a patient has a normal endometrial echo and SIS is not available, office hysteroscopy should be strongly considered to further evaluate the endometrium. Hysteroscopy can quickly determine if intracavitary pathology exists. Hysteroscopy and SIS are complementary procedures that improve clinical care.

Pathology Intracavitary Fluid Accumulation

An enlarged uterus may be due to accumulation of endometrial fluid. The uterus can distend with several hundred milliliters of fluid that appears as a pelvic mass. Fluid accumulation in menopausal or symptomatic patients warrants further evaluation. Fluid collections may be due to cervical stenosis, hematometra, or pyometria. Additionally, prior irradiation, gynecologic malignancies (including uterine, cervical, tubal, and ovarian cancer), and endometrial hyperplasia contribute to causes of fluid accumulation (Fig. 8–18). Benign conditions including congenital anomalies such as imperforate hymen, vaginal septum, vaginal or cervical atresia, and vaginal agenesis can also be associated with uterine enlargement due to accumulated blood within the uterine cavity (hematometra). When an endometrial ablation fails to treat all of the endometrium, residual endometrium trapped within uterine synechiae may be associated with cyclical pain, tenderness, and uterine enlargement due to a resulting hematometra. All of these etiologies can enlarge the uterus, and appear as a pelvic mass (Figs. 8–19 and 8–20). Patients with a hematometra generally complain of labor-like cramps. Cyclical pain occurs among ovulating women with fluid collection, pelvic pressure, or abdominal pain. Bleeding, if present, is usually scant and erratic. The color of blood is described as rusty, dark brown or even black. Menopausal women often complain of pelvic pressure or a sensation that “feels like my period is going to start.” Entrapped blood or fluid can become infected.

Figure 8–17 Class 3 saline infusion sonography (SIS) extirpative view of a leiomyoma involving the entire myometrium.

The compressible uterine cavity can harbor benign pathology, such as polyps, fibroids, and hyperplasia, in the presence of a normal endometrial echo. When clinically available, SIS should be considered a complementary procedure to TVUS. This is especially true when menstrual bleeding persists in the face of a normal TVUS or does not respond to medical therapy.12 The clinical focus is whether or not intracavitary pathology is present. If TVUS is performed and indeterminate, then SIS should be performed. All women older than 40 years who have a suspicious TVUS examination should undergo SIS. When such evaluation suggests the need for operative intervention instead of medical therapy, the patient can be referred for therapy.

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Figure 8–21 Transvaginal ultrasound with classic changes including myometrial cysts that are seen with adenomyosis. A tender, enlarged, bulky uterus is the classic finding on clinical examination. Figure 8–19 Magnetic resonance imaging view of a hematometra. Presentation was pelvic cramping and occasional spotting.

minimal adhesions, then a normal endometrial cavity is imaged or visualized. Pyometria is most often associated with uterine cancer, pelvic inflammatory disease, or recent uterine instrumentation. Smaller uterine fluid collections generally do not enlarge the uterine cavity, but are most commonly associated with endometritis, recent abortion, UFE, or degenerating fibroids. The sonographic image of endometrial fluid collection includes a centrally cystic, round, hypoechoic, and moderately enlarged uterus. Adenomyosis

Adenomyosis mimics fibroid-related symptoms and can manifest as a pelvic mass. The etiology of adenomyosis is unknown but is thought to represent a breach in the natural barrier between endometrium and myometrium. Histologically, ectopic endometrial glands or nests of endometrium, penetrating at least 2.5 mm beneath the basal level of the endometrium, define adenomyosis. Adenomyosis occurs more often on the posterior uterine wall and involves the inner two thirds of the myometrium. When hemorrhage occurs within the ectopic endometrial glands, small hypoechoic myometrial cysts, described as “Swiss cheese” or “honeycomb” patterns is classic. Although, MRI is the gold standard for diagnosing adenomyosis, on occasion, these classic findings are seen with TVUS. Adenomyosis may be diffuse or focal. With extensive adenomyosis, diffuse uterine enlargement is noted. Hemorrhage in islands of endometrial tissue appears as small myometrial cysts. The posterior myometrium may be thicker compared to the anterior wall and appear more anechoic than normal myometrium. Localized adenomyomas may be difficult to distinguish from leiomyomas. However, they can appear as inhomogeneous, circumscribed regions within the myometrium, without clear borders (Fig. 8–21).

Figure 8–20 Magnetic resonance imaging coronal view of hematometra. Cervical dilation drained approximately 200 mL of brown blood. Symptoms improved and uterine volume decreased.

Febrile patients promptly respond with a decline in temperature with simple dilation and drainage of the hematometra. After the patient becomes afebrile, hysteroscopic inspection of the uterine cavity is essential to complete the evaluation. With simple hematometra, the uterine cavity decreases in size after the blood or fluid is drained. If the cause is cervical stenosis or

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Presurgical Evaluation of the Enlarged Uterus The following constellations of ultrasonographic findings are typical features noted in patients who have adenomyosis13: ●

●

● ● ● ● ●

CANDIDATES FOR HYSTEROSCOPIC MYOMECTOMY

Diffuse abnormal hypoechoic or heterogeneous echotexture of the myometrium Poor definition or nodularity of the junction between endometrium and myometrium Subendometrial echogenic nodules Subendometrial myometrial cysts (1-5 mm) Subendometrial hypoechoic linear striations Enlarged uterus Coexisting leiomyomas

The Case for Presurgical Evaluation Operative hysteroscopic myomectomy in properly selected patients provides immediate and long-term relief of abnormal uterine bleeding, dysmenorrhea, and leukorrhea. Excellent presurgical evaluation and classification of uterine fibroids predicts likelihood of success, intravasation of fluid, likelihood of completing surgery in one operation, complications, and reoccurrence. Hysteroscopic myomectomy has clear advantages over abdominal or laparoscopic approaches, including less morbidity, same-day procedure, shorter hospital stay, and lower costs. Additionally, major complications of operative hysteroscopic myomectomy are infrequent, occurring in 1% to 5% of patients. The most disastrous complication is fluid overload or intravasation, which can cause hyponatremia, cerebral or pulmonary edema, heart failure, and death. This risk can be anticipated by presurgical evaluation, which accurately determines the size of the leiomyoma and depth of myometrial penetration. Emanuel and colleagues15 predicted the two most common risk factors for fluid overload: length of surgical procedure and degree of intramural extension of the uterine fibroid. Until hysteroscopic skills are perfected, limiting hysteroscopic myomectomy to intracavitary lesions smaller than 3 cm is advisable. Transcervical resection by an expert hysteroscopist is advised when the intracavitary fibroid is larger than 4 to 5 cm. Hysteroscopic myomectomy is contraindicated when intracavitary myomas are 6 cm or greater and the distance between the outer limit of the leiomyoma and serosa is less than 5 mm. The larger the intracavitary mass, the more attenuated the myometrium becomes. Thin myometrium is susceptible to perforation. Additional reasons for these recommendations include technical difficulty in distending the uterine cavity, making visualization difficult; copious fibroid chips produced during hysteroscopic myomectomy, leaving little room to navigate with the operative hysteroscope; increased risk of incomplete resection; increased risk of postoperative endometritis due to retained incompletely resected and necrotic leiomyoma; and potential for excessive fluid overload. Mini-laparotomy, hysterotomy, or laparoscopic myomectomy are excellent safe, effective alternatives when intracavitary masses larger than 5 cm are present. These approaches are likely to result in minimal morbidity and complete removal of the leiomyomas with one operation. In the past, hysteroscopic myomectomy was only advised for women with abnormal uterine bleeding and a normal-sized uterus. Emanuel and Polena have clearly demonstrated excellent outcome and low recurrence rates when hysteroscopic myomectomy is performed in patients who have menorrhagia, no other fibroid-related symptoms, and a normal uterine cavity. Patients with a normal uterine cavity with one intracavitary leiomyoma are surgery free more than 90% of time 2 to 5 years from surgery. Women with two or three intracavitary leiomyomas and a normal-sized uterine cavity are free from additional surgery at least 70% of the time 2 to 5 years from surgery.

Leiomyosarcomas

Leiomyosarcomas are uncommon. As a group they make up less than 5% of uterine malignancies and are believed to arise from preexisting leiomyomas. Most leiomyosarcomas occur in women older than 50 years. They generally occur in the fundus and in women with a dominant fibroid approaching 5 to 8 cm. The classic presentation of leiomyosarcoma includes rapid uterine growth (usually of the dominant fibroid), profound menorrhagia, and systemic symptoms (pain, weight loss, and cachexia). Ultrasonographic changes can resemble fibroids or endometrial cancer, with areas of solid and cystic regions. Papadia and colleagues14 reviewed the literature and discovered six cases of reported leiomyosarcomas following UFE. This is equivalent to an incidence of 0.012% (6 cases in 50,000 procedures performed) Although the number of cases is too small to make evidence-based guidelines for treatment, they suggest that patients who fail UFE be offered surgical intervention early to obtain histologic sampling. Among the cases reported, the most common similarities discovered among patients subsequently noted include a dominant fibroid at least 8 cm, menorrhagia as an indication for the UFE, and failure to respond to UFE. Diagnosis was made by subsequent hysterectomy (Fig. 8–22).

Figure 8–22 Leiomyosarcoma noted on gross specimen. Central necrosis is identified.

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Figure 8–24 This fibroid was evaluated preoperatively and revealed a hysteroscopically resectable leiomyoma. Figure 8–23 Preoperative surgical evaluation determined that this 8-cm intracavitary lesion was not hysteroscopically resectable because of its size.

●

●

Emanuel also chronicled the outcome of women with an enlarged uterine cavity 12 to 18 weeks in size and found at least a 60% surgery-free interval up to 5 years from surgery. This information is clinically important in counseling young and perimenopausal women with isolated intracavitary fibroids. A patient who is in late perimenopause or menopause and has single or multiple submucosal fibroids is unlikely to need additional surgery because of her proximity to menopause. During menopause, fibroids rarely reoccur. In summary, hysteroscopic myomectomy is highly effective in treating menstrual disturbances, dysmenorrhea, and leukorrhea in patients with European Society for Hysteroscopy (ESH) type 0 and 1 leiomyomas. Freedom from additional surgical intervention for uterine fibroids is the norm, and hysterectomy is less often needed. Dysmenorrhea is likewise improved, whereas bulk symptoms are not improved with hysteroscopic myomectomy (Figs. 8–23 and 8–24).

Although the ESH hysteroscopic classification system is helpful, it is difficult to determine the depth of penetration of myoma, even when the angle of view is taken into account. Not all leiomyomas are round. Additionally, changes in the angle of view may be affected by uterine distention, and false-negative views of the endometrium can occur. A phenomenon known as the disappearing act can occur with any lesion within the uterine cavity, including endometrial hyperplasia, endometrial polyps, and uterine fibroids. The endometrial cavity is a potential space. Uterine distention, even with low intrauterine pressures, including fluid pumps, gravity, syringe infusion, or hysteroscopic insufflators using CO2, can create a false-negative view. A false-negative view occurs when the pressure pushes lesions into the endometrium and myometrium. Thus distention media can easily change the hysteroscopic classification of a uterine fibroid. If hysteroscopy is used to determine the classification, the view obtained when the uterus is decompressed will be the most accurate. When the angle of view is uncertain and the depth of penetration of the uterine fibroid is uncertain, SIS is particularly helpful. Determination of the depth of the leiomyoma penetration is essential before scheduling surgery, and it correlates well with length of procedure, fluid absorption, complications, and completeness of resection. Complete resection of intracavitary lesions (ESH 0 and ESH I) is customary. Polena and colleagues16 performed hysteroscopic myomectomy in 235 women and had incomplete resection in 5.1% (n = 12). The percentage of hysterectomy-free patients was 98% at 3.3 years. The percentage of patients free from any type of surgery at 3.3 years was 96%. Like most studies, the success rate was 94% (n = 186).

Evaluation with Hysteroscopy Uterine leiomyomas can involve all compartments of the uterine cavity. Fibroids involving the endometrium are called intracavity leiomyomas and can be pedunculated or broad based. Intramural fibroids can abut the endometrial cavity and involve all or most of the myometrium. Intracavitary fibroids are associated with dysmenorrhea, menorrhagia, pelvic cramping, infertility, miscarriage, and leukorrhea. Medical therapy is usually ineffective, and hysteroscopic myomectomy is extremely curative.16 The ESH classification system classifies fibroids into three types: ●

Type 1 (sessile and with an intramural part of less than 50%) and Type 2 (with an intramural part of 50% or more)

Type 0 (pedunculated submucosal fibroids without intramural extension)

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Presurgical Evaluation of the Enlarged Uterus Emanuel and colleagues15 were able to correlate completeness of hysteroscopic myomectomy with ESH classification. All ESH type 0 myomas were resected with one operation. The lesions with more myometrial involvement, ESH 1 and 2 myomas, required several operative hysteroscopic procedures for complete resection. Since the 1990s, numerous hysteroscopic surgeons have demonstrated excellent relief of symptoms and minimal need for repeat surgical intervention in appropriately triaged patients. Complete hysteroscopic resection of leiomyomas decreases the need for hysterectomy and laparoscopic or abdominal myomectomy. Major complications from hysteroscopic myomectomy are rare, occurring in 1% to 5% of procedures. As automated fluid management systems become more available, fluid overload is less common. Other complications, including vaginal hemorrhage and visceral burns, are also uncommon. The most dangerous complication is fluid overload. Excellent preoperative evaluation with hysteroscopy, SIS, or MRI determines size, location, and depth of penetration of uterine fibroids. Larger fibroids larger than 3 cm are associated with increasing fluid deficit, incomplete resection, and longer operative time. Fernandez and colleagues17 reported a 2% (4 of 200) incidence of fluid overload. Cravello and colleagues18 reported 1.5% (3 of 196) and Emanuel and colleagues19 reported 0.4% (1 of 283) cases of metabolic disturbances during hysteroscopic resection. Wegienka and colleagues used TVUS and the alkaline hematin assay to determine uterine fibroid location and blood loss. Contrary to longstanding belief, intramural fibroids as well as submucosal fibroids can be associated with menorrhagia. Certainly submucosal fibroids have a more plausible etiology for aberrations of the menstrual cycle. Intramural fibroids by virtue of prostaglandin mediation, epidermal growth factors, or unknown reasons can also contribute to bleeding. When intramural fibroids abut the endometrium and involve less than 50% of the myometrium, hysteroscopic resection is often curative. Contraindications to operative hysteroscopic myomectomy include leiomyoma larger than 5 cm and distance from the outer edge of the myoma and serosal edge less than 5 mm. SIS is available preoperatively to evaluate the distance between the myoma and the serosal surface. Other minimally invasive procedures, including minilaparotomy and laparoscopic myomectomy, can remove a solitary myoma in one operation rather than multiple operative hysteroscopic resections. ESH type 2 leiomyomas should only be approached by the most experienced hysteroscopic surgeon. Intraoperative ultrasound is helpful in identifying the serosal edge.20 Polena and colleagues16 used preoperative GnRH therapy in women identified by TVUS with intramural fibroids larger than 3.5 cm with deep intramural extension. By decreasing fibroid size, blood flow, and size of uterine vessels, they avoided complications. Complete resection of fibroids weighing more than 15 g was achieved in 4 of 7 patients. Polena’s group had 12 of 235 patients with incomplete resection of fibroids, of which 10 of 12 occurred in women with type 2 leiomyomas. Emanuel’s

group19 reported incomplete resection in 58 of 283 (20.5%), of which 11 patients had no additional symptoms and declined further therapy. Cravello’s group18 had incomplete resection in 39 of 196 (20%), and only offered additional surgery if the patient was symptomatic. Excellent long-term outcomes of avoiding surgery occurs in 60% to 90% of patients. Determining the location and depth of penetration can be evaluated by office hysteroscopy, SIS, and MRI. Practically speaking, the most common methods are hysteroscopy and SIS. Each procedure has benefits and limitations. However, in most cases all methods are complementary in the evaluation. Uterine fibroids are ubiquitous. The location of the fibroid— intracavitary, intramural, or subserosal—determines the patient’s complaints. Subserosal fibroids and exophytic fibroids are associated with symptoms of compression of the bowel, bladder, or ureters. Intramural and intracavity submucosal fibroids are associated with abnormal bleeding and leukorrhea. Theories for abnormal bleeding in women with intracavitary submucosal fibroids are listed in Box 8–2. Typical complaints of women with abnormal bleeding and uterine fibroids are listed in Box 8–3.21 Indications for surgery include menorrhagia, metrorrhagia, intermenstrual bleeding, chronic vaginal discharge, postcoital bleeding, postmenopausal bleeding, dysmenorrhea, recurrent pregnancy loss, infertility, and pelvic pain. The ideal patient for hysteroscopic myomectomy is described in Box 8–4. Women who have multiple intracavitary fibroids on opposing uterine walls and who desire future pregnancy often benefit from a two-stage operative hysteroscopic myomectomy. A planned two-stage operative hysteroscopic myomectomy, with

BOX 8–2 Theories for Abnormal Bleeding in Women with Intracavitary Submucosal Fibroids Vascularization ● Increased vessel number?? ● Decreased vessel function?? Increased endometrial surface area Increased estrogen receptors and growth factors Impeded uterine contractions Uterine contents not expelled efficiently More expandable venules with less efficient clotting

BOX 8–3 Typical Complaints of Women with Abnormal Bleeding and Uterine Fibroids Increased complaints of gushing or flooding Increased reported use of eight or more pads or tampons on heaviest day of menses Bleeding increased with increased leiomyoma size (2.5 -fold increased risk compared to women without leiomyoma) No difference in symptoms when location was accounted for (intramural vs. submucosal)

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Presurgical Evaluation of the Enlarged Uterus BOX 8–4 The Ideal Patient for Hysteroscopic Myomectomy Excellent preoperative surgical evaluation to determine fibroid size, number, and location Single intracavitary fibroid (<3 cm pedunculated and/or involving <50% of the myometrium) No more than 3 or 4 intracavitary fibroids, unless performed by an experienced hysteroscopist Normal blood count and normal electrolytes Uterine size less than 12 to 14 weeks

1 1 Distance: 8.89 cm 1 Min/Max: 31/108 R 2 2 Distance: 8.23 cm 2 Min/Max: 16/121

10cm

Figure 8–26 Magnetic resonance imaging coronal view of myomas >8 cm. Multiple lesions are seen. R, right.

A

10cm

Particularly, for patients seeking minimally invasive surgical procedures such as laparoscopic myomectomy or UFE, the number of suspected fibroids is important in recommending a particular therapeutic intervention, predicting outcome, and determining success of surgery. When inclusion criteria are met for laparoscopic myomectomy (four fibroids <8 cm, size <16 weeks) or leiomyomas that enhance on MRI and are therefore particularly suitable for UFE, increased success rates are the norm. MRI should be considered complementary to abdominal ultrasound or TVUS when results are equivocal.

Figure 8–25 Magnetic resonance imaging sagittal view of a large leiomyoma extending to the umbilicus. A, abdomen.

immediate therapy with estrogen (conjugated estrogen 1.25 mg daily for 30 days, followed by medroxyprosterone 10 mg for 12 days), theoretically can decrease the risk of developing postoperative de novo intrauterine synechiae. Whenever possible, postoperative evaluation of the endometrium with office hysteroscopy or SIS is helpful to determine if postoperative synechiae are present.

Evaluation for Uterine Fibroid Embolization

Especially for patients who desire UFE, MRI facilitates the triage of patients who will most likely benefit from this excellent alternative to hysterectomy. Many academic centers require MRI of the pelvis with and without contrast as an integral component of the work-up of patients desiring UFE. During the consultation with women who are potential candidates for UFE, it is vital to determine if the leiomyomas contribute to symptoms and to determine the anatomic position, size, location, presence of degeneration, presence of a stalk, and vascularity of the leiomyomas. Additionally, pelvic masses mimicking fibroid symptoms such as adenomyosis may be reliably excluded. All of these factors can contribute the outcome, success, failures, or complications of UFE. Similar information helps detect the ease of performing laparoscopic, vaginal, or abdominal hysterectomy.

Evaluation with Magnetic Resonance Imaging MRI of the pelvis reliably characterizes soft tissue masses as well as the size and location of uterine leiomyoma. MRI differentiates leiomyomas from other pelvic masses. Less intraobserver variability exists with MRI than with ultrasound. MRI is useful when a TVUS is equivocal or is unable to differentiate between a pedunculated lesion and adenomyosis, and it can distinguish between a conglomeration of uterine fibroids and individual myomas (Figs. 8–25 and 8–26).

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Presurgical Evaluation of the Enlarged Uterus Predicting Outcome of Embolization

Increasingly, UFE is advised for the treatment of symptomatic uterine fibroids.22 Many institutions use MRI of the pelvis to determine if the patient is a suitable candidate for UFE. Unlike computed tomography (CT) scans, which evaluate only a single tissue parameter x-ray attenuation, MRI does not use ionizing radiation and has excellent soft tissue resolution. When scheduling patients for MRI of the pelvis, contrast is usually requested. The contrast used in MRI of the pelvis is gadolinium, a rareearth heavy metal ion that shortens the T1 and T2 relaxation times and enhances and documents lesions well. For patients with claustrophobia who request open MRIs, the quality of images is lower because of lower field strength and lack of resolution of the high-field-strength tube magnets. MRI analyzes multiple tissue characteristics including hydrogen (proton) density, T1 and T2 relaxation times of tissues, and blood flow within tissue.23 As uterine size increases, abdominal ultrasound is less reliable in detecting differences between the enlarged uterus and adnexal masses. The disparity increases as uterine size increases when ultrasonography is used alone.24 Excellent capacity to differentiate tissue types, adnexal masses, and size is particularly characteristic of MRI imaging.25 Leiomyomas are best visualized with MRI using T2-weighted images, and they have low signal compared to myometrium. MRI can determine the presence of pedunculated leiomyomas and the presence of a stalk attaching the fibroid to the uterine serosa. Especially for women considering UFE, failure rates are increased in women with uterine fibroids larger than 24-week size, exophytic fibroids with stalks smaller than 2 cm, intracavitary leiomyomas, and dominant fibroid larger than 8 to 10 cm.26 When MRI is included as the preprocedure evaluation for UFE, 18% of women are excluded due to concomitant findings.27 Treatment options will be different if adnexal pathology or adenomyosis is detected or if dominant fibroids larger than 8 to 10 cm are present. Leiomyomas usually have a low signal compared to myometrium on both T1-weighted images and T2-weighted images, although the best views are obtained with T2-weighted images. When degeneration occurs, MRI images it as cystic changes with inhomogeneous high internal signals. Leiomyomas are well demarcated from the myometrium, which appears as a low signal. Multiplanar imaging capabilities and enhancement MRI of the pelvis, which analyze MRI signal characteristics, enable physicians to reliably predict leiomyoma response to UFE. Leiomyomas with high signal intensity on T2-weighted images respond better to UFE than leiomyomas with high signal intensity on T1-weighted images. Enhancement corresponds to vascularity. The more vascularity within a leiomyoma, the more response to UFE treatment is observed.28 When UFE fails or symptoms reoccur and a repeat procedure is considered, determining the presence of enhancement is critical in determining whether another procedure would be recommended. Additionally, myomas can undergo cellular degeneration. Using T2-weighted images helps to differentiate degenerated leiomyomas from cellular leiomyomas. Cellular leiomyomas, like vascular leiomyomas, have high T2-weighted image signals

Figure 8–27 Laparotomy view of cystic changes associated with a leiomyoma. When the leiomyoma was opened, a large amount of hemorrhagic fluid was extruded. These fluid-filled cystic changes can also be seen on magnetic resonance imaging.

Figure 8–28 Laparotomy views of fluid-filled cysts and uterine distention. Likely degeneration of leiomyoma was noted histologically.

and enhance after administration of contrast, and they respond favorably to UFE. Fibroids can undergo hyaline, calcific, fluid, and red degeneration (Figs. 8–27 and 8–28). Nondegenerated leiomyomas demonstrate lower signal intensity than the myometrium on T2-weighted images.29 Variable appearances are noted with degeneration, including low signal intensity on T2-weighted images. When MRI detects degeneration within a uterine fibroid, there is less clinical response (reduction in uterine volume) and hence less improvement in abdominal girth, menorrhagia, cosmetic concerns, and bulk symptoms.30 Patients with degeneration should be informed that their bulk symptoms and cosmetic complaints might not be completely relieved by UFE. Thus myomectomy or hysterectomy is confidently recommended.

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Presurgical Evaluation of the Enlarged Uterus increased number of uterine fibroids, pedunculated serosal fibroids, possible adenomyosis, and (in one case) endometrial cancer. The recurrence rate was 17.2% by 30 months. A larger study of 233 patients had repeat intervention in 9.4% of patients, with a mean follow-up of 30 months (range, 34 days to 36 months). The causes of failure were not described.39 When a patient presents with recurrent symptoms or failure of an initial UFE, repeat pelvic MRI with and without contrast of the pelvis is necessary if the patient inquires about the feasibility of a repeat UFE procedure. Information collected— including size, number, and location of fibroids; presence of pedunculated serosal leiomyomas; adenomyosis; and collateral blood flow from ovarian vessels—will help determine whether a repeat embolization is likely to be successful. The technical aspects of embolization need to be clarified. An MRI classification system that is standardized would be helpful in comparing future studies and might be able to identify subgroups of patients prone to success, failure, or recurrence. Tumor perfusion studies are relatively new, and the importance of tumor perfusion is not yet fully understood.40

Complications of UFE are minimized by preprocedural MRI.31 When tubal masses that suggest a tubo-ovarian abscess are detected, UFE should not be performed because of the increased risk of septic complications following the procedure. Patients with suspected hydrosalpinx or tubo-ovarian abscess should receive antibiotics and be scheduled for surgical removal of the infected adnexa and surgical treatment of the uterine fibroid. Morphologic location of leiomyomas is easily calculated with MRI. Intracavitary, intramural, and subserosal fibroids are well delineated with MRI. Lesions occurring on the serosa are classified as exophytic when the diameter of the stalk is 50% narrower than the diameter of the leiomyoma. Pedunculated leiomyomas with a stalk less than 2 cm should not be treated with UFE because of a theoretical concern that the leiomyoma can become detached from the uterus, leading to attachment of other peritoneal structures, infection, excruciating pain, development of intra-abdominal adhesions, chronic peritonitis, prolonged recovery, and surgical intervention.32 Katsumori and colleagues did not find any complications among 12 women undergoing UFE with a stalk larger than 3 cm.33 When endometrial cancer or adnexal pathology is suspected, hysterectomy rather than UFE is recommended.

Findings in Adenomyosis

Adenomyosis may be suspected by clinical symptoms that include pelvic pain, intractable dysmenorrhea, dyspareunia, menorrhagia, abnormal uterine bleeding, or a boggy, tender uterus. Leiomyomas and adenomyosis can coexist, or adenomyosis can occur alone. MRI accurately identifies adenomyosis by detecting a thickening of the junctional zone.41 The junctional zone is usually thicker than 12 mm in women with adenomyosis. Diffuse disease can demonstrate regular or irregular thickening of the junctional zone. Low-signal aberrations represent myometrial hypertrophy. High-signal foci within the myometrium indicate islands of endometrial glands with cystic change and hemorrhage. Leiomyomas are well circumscribed, but adenomyosis has vague, poorly defined margins. Variable clinical outcomes of adenomyosis treated by UFE are reported in the literature. Some authors report minimal improvement, and others have reported 80% to 90% improvement in menorrhagia, dysmenorrhea, and pelvic pain in women who had only adenomyosis that was treated by UFE (Figs. 8–29 and 8–30). Uterine fibroid embolization is an excellent alternative to hysterectomy and myomectomy. Approximately 15,000 procedures are performed annually in the United States, making this one of the fastest-growing alternatives to hysterectomy.42 Shorter hospitalization, less need for general anesthesia (performed under conscious sedation), less hospitalization, less morbidity and mortality, and preservation of the uterus make this a compelling procedure for many women.43 UFE effectively controls menorrhagia, pressure, bulk symptoms, and pain. Menorrhagia improves in 80% to 92% of patients within 3 to 6 months.44,45 Bulk symptoms, pain, and pressure improve within 3 to 6 months in 77% to 96% of patients.46 Patient selection based on symptoms and physical examination are important in making the recommendation for

Technical Findings in Embolization Failures

Many studies have published the benefits and effectiveness of uterine artery embolization (UAE) in improving bulk symptoms, menorrhagia, pain, and other symptoms associated with fibroids.34,35 Although most patients improve, not all patients respond equally well and some have recurrent symptoms. Review of the literature demonstrates 20% repeat intervention within 5 years of UAE. Intervention strategies include repeat embolization, hysterectomy, or myomectomy. The etiology of these failures is uncertain and little studied. MRI can triage patients and help determine if a repeat uterine artery embolization would be beneficial in cases of failure. Yousefi and colleagues36 reviewed factors predisposing to recurrence after treating 25 patients by UAE. These patients had recurrent pressure or bulk symptoms or both (n = 15), recurrent heavy bleeding (n = 12), and pelvic pain or cramping (n = 7). Findings included new fibroid growth and incomplete infarction of tumors after the first embolization. Nine of the 25 (37%) required ovarian artery embolization to occlude aberrant ovarian supply to the uterus. Twenty-one patients were seen a followup, and 19 (90%) had symptom control. MRI imaging in most cases of repeat embolization demonstrated that nearly 50% of the fibroid was infarcted, but even minor residual viable tumor could result in recurrent symptoms. In nearly all cases of incomplete infarction, MRI demonstrated an increase in the extent of viable tissue in incompletely treated tumors between the two embolization procedures. Pelage et al37 demonstrated that symptoms recurred when the tumor was still perfused, regardless of the decline in the size of the fibroid. Marret and colleagues38 described recurrence rates among 81 patients (no MRI described in this paper). Possible causes of failure included increased dominant fibroid size,

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R

R

5cm

5cm

Figure 8–29 Magnetic resonance imaging sagittal view reveals a markedly enlarged uterus with marked thickening of the junctional zone, consistent with adenomyosis. R, right.

Figure 8–30 Magnetic resonance imaging coronal view demonstrates markedly thickened myometrium with numerous myometrial cysts R, right.

UFE. Preoperative MRI of the pelvis with and without contrast accurately detects leiomyomas, characterizes tissue and vascular patterns, and facilitates the triage of the patients who will benefit from UFE or gynecologic intervention. When unanticipated findings are detected by MRI, initial treatment plans may be changed, and other gynecologic surgery recommended. MRI is less operator-dependent, is less subject to interrater variability, and has greater reproducibility than TVUS. MRI is less able to detect endometrial polyps, but it is more accurate than TVUS and hysteroscopy in evaluating exact submucosal myoma ingrowth and size. Size, number, and location of uterine fibroids are better characterized with MRI than with ultrasound. Adenomyosis, a condition that mimics uterine fibroids, causing diffuse enlargement, tenderness, and bulkiness of the uterus, is best diagnosed with MRI. Disadvantages of MRI include higher costs and limited availability. MRI imaging is contraindicated in women with claustrophobia, pacemakers, defibrillators, or metallic foreign bodies.

evaluation with imaging is paramount. As a result, TVUS, SIS, hysteroscopy, and MRI imaging is being used more. Each technology has its benefits and limitations. Most studies consistently demonstrate safety, effectiveness, and high patient satisfaction rates with operative hysteroscopy. Currently, hysteroscopy is underutilized due to lack of training, insufficient hysteroscopic competence, and unfounded fear of operative complications. Certainly the uterine cavity, characterized by its small size, easy access, and notable landmarks, can be conquered. Larger uteri with coexisting intracavitary lesions also respond favorably when well selected. Surgical disasters and complications are minimized by expert preoperative evaluation. Gynecologists can improve outcomes with comprehensive preoperative evaluation with SIS, diagnostic hysteroscopy, and in some cases MRI. Potential patients for laparoscopic myomectomy also require expert visualization, which also relies heavily on ultrasound imaging and on occasion MRI imaging. Many centers performing UFE strongly advise MRI of the pelvis to determine fibroid location and dominant fibroid size and to exclude the presence of adenomyosis. Improving patient outcome, minimizing the abandonment or conversion of a planned surgical procedure, and fewer surprises in the operating room is critical. Imaging paves the way for improved patient outcomes, a laudable goal we all share.

SUMMARY As more clinicians embrace minimally invasive surgical procedures such as operative hysteroscopic myomectomy, laparoscopic myomectomy, and referral for UFE, improved presurgical

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Marshall LM, Spiegelman D, Barbieri RI, et al: Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol 1997;90:967-973. Weigel M, Friese K, Strittmatter HJ et al: Measuring the thickness—Is that all we have to do for sonographic assessment of endometrium in postmenopausal women? Ultrasound Obstet Gynecol 1995;6:97102. Dueholm M, Lundorf E, Olesen F: Imaging techniques for evaluation of the uterine cavity and endometrium in premenopausal patients before minimally invasive surgery. Obstet Gynecol Surv 2002;57(6): 389-403. De Kroon CD, De Brock GH, Gieben SW, et al: Saline contrast hysterosonography in abnormal uterine bleeding: A systematic review and meta-analysis. BJOG 2003;110:938-947. Valenzo MM, Lijoi D, Mistrangelo E, et al: The value of sonohysterography in detecting intracavitary benign abnormalities. Arch Gynecol Obstet 2005;272:265-268. Coleman BG: Transvaginal and transabdominal sonography: Prospective comparison. Radiology 1988:168:639-649. Cicinelli E, Romano F, Anastasio PS, et al: Transabdominal sonohysterography, transvaginal sonography, and hysteroscopy in the evaluation of submucous myomas. Obstet Gynecol 1995;85:42-47. Widrich T, Bradley L, Mitchinson AR, Collins R: Comparison of saline infusion sonography with office hysteroscopy for the evaluation of the endometrium. Am J Obstet Gynecol 1996;174:1327-1334. De Kroon CD, Jansen FW: Saline infusion sonography in women with abnormal uterine bleeding: An update of recent findings. Curr Opin Obstet Gynecol 2006;18:653-657. Bradley LD, Falcone T, Magen AB: Radiographic imaging techniques for the diagnosis of abnormal uterine bleeding. Obstet Gynecol Clin North Am. 2000;27:245-276. Van Dongen H, Emanuel MH, Smeets MJ, et al: Follow-up after incomplete hysteroscopic removal of uterine fibroids. Acta Obstet Gynecol Scand 2006;85:1463-1467. Goldstein SR: Menorrhagia and abnormal bleeding before the menopause. Best Pract Res Clin Obstet Gynaecol 2004;18:5969. Brant WE: Genital tract and bladder ultrasound. In Brant WE, Helms CA (eds): Fundamentals of Diagnostic Radiology. Philadelphia: Lippincott Williams & Wilkins, 2007, pp 954-975. Papadia A, Salom EM, Fulcheri E, et al: Uterine sarcoma occurring in a premenopausal patient after uterine artery embolization: A case report and review of the literature. Gynecol Oncol 2007;104:260263. Emanuel MH, Hart A, Wamsteker K, Lammes F: An analysis of fluid loss during transcervical resection of submucous myomas. Fert Steril 1997;68:881-886. Polena V, Mergui JL, Perrot N, et al: Long-term results of hysteroscopic myomectomy in 235 patients. Eur J Obstet Gynecol Reprod Biol 2007;130:232-237. Fernandez H, Kadoch O, Capella-Allouc S: Hysteroscopic resection of submucous myomas: Long term results. Ann Chir 2001;126(1):5864. Cravello L, D’Ercole C, Azoulay P, et al: The treatment of fibroids hysteroscopically. J Gynecol Obstet Biol Reprod 1995;24:381385. Emanuel M, Wamsteker K, Hart A, et al: Long-term results of hysteroscopic myomectomy for abnormal uterine bleeding. Obstet Gynecol 1999;93:734-738. Coccia ME, Becattini C, Bracco GL, et al: Intraoperative ultrasound guidance for operative hysteroscopy. J Reprod Med 2000;45:413418.

21. Wegienka G, Baird DD, Hertz-Picciotto I, et al: Self-reported heavy bleeding associated with uterine leiomyomata. Obstet Gynecol 2003:101:431-437. 22. The REST Investigators: Uterine-artery embolization versus surgery for symptomatic uterine fibroids. N Engl J Med 2007;356:360-370. 23. Brant WE: Diagnostic imaging methods. In Brant WE, Helms CA (ed): Fundamentals of Diagnostic Radiology. Philadelphia: Lippincott Williams & Wilkins, 2007, pp 3-25. 24. Zawin M, McCarthy S, Scoutt LM, et al: MRI and US evaluation of the pelvis in women with leiomyomas. Magn Reson Imaging 1990;8:371-376. 25. Murase E, Siegelman ES, Outwater EK, et al: Uterine leiomyomas: Histopathologic features, differential diagnosis, and treatment. Radiographics 1999;19:1179-1197. 26. Cura M, Cura A, Bugone AL: Role of magnetic resonance imaging in patient selection for uterine artery embolization. Acta Radiol 2006;47:1105-1114. 27. Omary RA, Vasireddy S, Chrisman HB, et al: The effect of pelvic MR imaging on the diagnosis and treatment of women with presumed symptomatic uterine fibroids. J Vasc Interv Radiol 2002;13:11491153. 28. Broekmans FJ, Heitbrink MA, Hompes PG, et al: Quantitative MRI of uterine leiomyomas during triptorelin treatment: Reproducibility of volume assessment and predictability of treatment response. Magn Reson Imaging 1996;14:1127-1135. 29. Hamlin DJ, Pettersson H, Fitzsimmons J, et al: MR imaging of uterine leiomyomas and their complications. J Comput Assist Tomogr 1985;9:902-907. 30. Burn PR, McCall JM, Chinn RJ et al: Uterine fibroleiomyoma: MR imaging appearances before and after embolizaion of uterine arteries. Radiology 2000;214:729-734. 31. Hovesepian DM, Siskin GP, Bonn J, et al: Quality improvement guidelines for uterine artery embolization for symptomatic leiomyomata. J Vasc Interv Radiol 2004;15:535-541. 32. Spies JB, Spector A, Roth AR, et al: Complications after uterine artery embolization for leiomyomas. Obstet Gynecol 2002;100:873880. 33. Katsumori T, Akazawa K, Mihara T: Uterine artery embolization for pedunculated subserosal fibroids. Am J Roentgenol 2005;184:399402. 34. Worthington-Kirsch R, Popky G, Hutchines F: Uterine arterial embolization for the management of leiomyomas: Quality-of-life assessment and clinical response. Radiology 1998;208:625-629. 35. Spies J, Myers ER, Worthington-Kirsch R, et al; FIBROID Registry Investigators: The FIBROID Registry: Symptom and quality-of-life status 1 year after therapy. Obstet Gynecol 2005;106:13091318. 36. Yousefi S, Czeyda-Pommersheim F, White A: Repeat uterine artery embolization: Indications and technical findings. J Vas Interv Radiol 2006;17:1923-1929. 37. Pelage J, Guaou GN, Jha R et al: Long term imaging outcome after embolization for uterine fibroid tumors. Radiology 2004;230:803809. 38. Marret H, Alonso AM, Cottier JP, et al: Leiomyoma recurrence after uterine embolization. J Vasc Interv Radiol 2003;14:1395-1399. 39. Marret H, Cottier JP, Alonso AM, et al: Predictive factors for fibroids recurrence after uterine artery embolisation. BJOG 2005;112: 461-465. 40. Spies J, Allison S, Sterbis K, et al: Polyvinyl alcohol particles and trisacryl gelatin microspheres for uterine artery embolization for leiomyomas: Results of a randomized comparative study. J Vasc Interv Radiol 2004;15:793-800.

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Presurgical Evaluation of the Enlarged Uterus 41. Tamai K, Togashi K, Ito T, et al: MR imaging findings of adenomyosis: Correlation with histopathologic features and diagnostic pitfalls. Radiographics 2005;25:21-40. 42. Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists: ACOG Committee Opinion: Uterine artery embolization. Obstet Gynecol 2004:103:403404. 43. Goodwin SC, Bonilla SM, Sacks D, et al: Reporting standards for uterine artery embolization for the treatment of uterine leiomyomata. J Vasc Interv Radiol 2001;12:1011-1120.

44. Spies JB, Bruno J, Czeyda-Pommersheim F, et al: Long-term outcome of uterine artery embolization of leiomyomata. Obstet Gynecol 2005;106:933-939. 45. Pron G, Bennett J, Common A, et al: The Ontario Uterine Fibroid Embolization Trial. Part 2. Uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids. Fert Steril 2003;79:120-127. 46. Walker WJ, Pelage JP: Uterine artery embolisation for symptomatic fibroids: Clinical results in 400 women with imaging follow up. BJOG 2002;109:1262-1272.

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9

Abnormal Uterine Bleeding and Hemostatic Disorders Andrea S. Lukes

Hemostasis involves a balance between bleeding and clotting. Surgery is a process that inherently challenges hemostasis. Thus, when surgery is performed on a patient with an underlying bleeding disorder, special considerations are recommended. This chapter provides a brief introduction to hemostasis, a review of underlying bleeding disorders (with emphasis on the most common bleeding disorder, von Willebrand disease), an outline of surgery-related hemorrhagic complications, and a brief outline of perioperative considerations. An overview of a multidisciplinary clinic is presented.

A large fraction of women with vWD report having gynecologic surgery relating to heavy menses. Approximately 25% of women with vWD have undergone a dilation and curettage (D&C) as part of an evaluation of menorrhagia.3,4 As reviewed by James,5 two studies highlight the need for hysterectomy in women with vWD. In one case series, 23% (10 of 44) women with vWD had undergone hysterectomy.6 In a case-control study, 86% (88/102) women with vWD had undergone hysterectomy versus 9% of controls (P < 0.01).7

Platelet Disorders

HEMOSTASIC DISORDERS

Platelet disorders can be divided into problems of function (thrombocytopathies) and number (e.g., idiopathic thrombocytopenia purpura or leukemia). Few studies on platelet function in women have been performed; however, one study, by Philipp and colleagues,8 showed that of 74 women with idiopathic menorrhagia, 33 (45%) had platelet aggregation abnormalities. When there is less aggregation, a platelet plug takes longer to form or forms inadequately, and prolonged bleeding can result. This type of defect can affect bleeding during surgery. Unfortunately there are few evidence-based studies addressing this issue.

The process of hemostasis may be divided into two categories, primary and secondary hemostasis. Primary hemostasis involves the formation of a platelet plug. The initial step of forming this platelet plug involves an interaction of platelets with the protein von Willebrand factor (vWF). A change in the number or function of platelets can affect bleeding. A change in the amount or structure of vWF can also affect bleeding. Secondary hemostasis is the subsequent cascade of events involving circulating coagulation factors (Fig. 9–1). A comprehensive list of primary and secondary hemostasis can be seen in Boxes 9–1 and 9–2.1

PREOPERATIVE EVALUATION FOR UNDERLYING BLEEDING DISORDER

Von Willebrand Disease The most common bleeding disorder in the world is von Willebrand disease (vWD), with a prevalence of approximately 1% to 2% of the population.2 vWD is a family of disorders that involves an absolute deficiency or a qualitative defect in the vWF protein. There are three main types; the most common is a deficiency of a normally structured vWF protein. This mild form (type 1) represents approximately 75% of the total cases. The most severe form (type 3) is the result of a severe deficiency of the vWF protein. Types 1 and 3 involve a disorder in the amount of protein, whereas type 2 involves a qualitative defect in the vWF protein. The vWF protein has two functions: it helps platelets adhere to the site of vascular injury and it helps carry coagulation factor VIII in the blood stream. Although vWD is a family of disorders, the inheritance pattern is usually autosomal dominant, equally affecting males and females.

Given the challenge of hemostasis in uterine surgery and the potential for an unrecognized bleeding disorder in a woman with heavy menses, a careful evaluation should be done before a surgical intervention. A careful history is needed before a woman undergoes a surgical procedure. This should include both a thorough focused family history of bleeding and a personal history of bleeding. As summarized by Kouides and colleagues,9 a personal history for bleeding symptoms includes heavy menses since menarche; history of postpartum hemorrhage, surgeryrelated bleeding, or bleeding associated with dental work; and history at least two other symptoms including bruising greater than 5 cm once or twice a month, epistaxis once or twice a month, frequent gum bleeding, or family history of bleeding symptoms.

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Abnormal Uterine Bleeding and Hemostatic Disorders Intrinsic system Contact activation Factor XII

Factor XIIa

Factor XI

BOX 9–1

Extrinsic system Tissue injury (release of tissue factor)

Disorders of Primary Hemostasis Hereditary disease states

Factor XIa

Factor VII

●

Factor VIIa

● ●

Factor IX

Ca2+

Factor IXa

● ●

Factor VIII, phospholipids

● ●

von Willebrand disease Glanzmann thrombasthenia Bernard-Soulier syndrome Platelet storage pool disease Gray platelet syndrome Wiskott–Aldrich syndrome May–Hegglin anomaly

Iatrogenic disease states

Factor X

Factor Xa + Ca2 Factor Va + Ca2 Phospholipids Prothrombinase complex

● ● ●

Acquired disease states ●

Factor II

Ca2+

Factor IIa (thrombin)

● ● ●

Factor XIII Fibrinogen

Fibrin (soluble)

Post-transfusion purpura Drug-induced immunologic thrombocytopenia (e.g., quinine, heparin, antibiotics) Drug-induced qualitative platelet disorders (e.g., aspirin, NSAIDs)

●

Factor XIIIa

● ●

Fibrin (insoluble)

Autoimmune thrombocytopenia purpura Disseminated intravascular coagulation Systemic amyloidosis Hyperspenism Aplastic anemia Uremia Mechanical platelet destruction from turbulent circulation (e.g., cardiac bypass)

Adapted from Kitchens CS: Surgery and hemostasis. In Kitchens CS, Alving BM, Kessler CM (eds): Consultative Hemostasis and Thrombosis. Philadelphia: WB Saunders, 2002, p 617.

Fibrinopeptide A or B Coagulation Figure 9–1 The pathway of coagulation factors in secondary hemostasis. (From Kohler HP, Grant PJ: Plasminogen-activator inhibitor type 1 and coronary artery disease. N Engl J Med 2000;342(24):1792-1801.)

BOX 9–2 Disorders of Secondary Hemostasis Coagulation factor abnormalities ● Hemophilia A (factor VIII deficiency) ● Hemophilia B (factor IX deficiency) ● Deficiencies in factor II, V, VII, or X ● Acquired inhibitors to specific coagulation factors (e.g., factor VIII or factor V inhibitors) ● Factor XIII deficiency Contact factor abnormalities ● Factor XI deficiency Fibrinogen abnormalities ● Afibrinogenemia ● Hypofibrinogenemia ● Inherited dysfibrinogenemias ● Hyperfibrinolysis Connective tissue disorders ● Ehlers–Danlos syndrome ● Osler–Weber–Rendu syndrome (hereditary hemorrhagic telangiectasia) ● Scurvy (vitamin C deficiency)

Complete Blood Count Basic preoperative laboratory testing includes a complete blood count (CBC). This allows assessment of platelet number and anemia. Thrombocytopenia is defined as a platelet count less than 150,000/μL. Bleeding symptoms associated with low platelets involve the skin or mucous membranes, such as petechiae, ecchymoses, epistaxis, gum bleeding, and menorrhagia. There are accepted criteria for particular platelet counts associated with bleeding. A patient with a platelet count less than 20,000/μL is severely thrombocytopenic and is at risk for lifethreatening bleeding. A patient with a count less than 50,000μL is moderately thrombocytopenic and at risk for bleeding associated with surgery or trauma. A patient with a platelet count less than 100,000μl is mildly thrombocytopenic and usually asymptomatic.10 On average, normal hemoglobin should be between 12 and 18 g/dL. Anemia is defined as less than normal hemoglobin. Common symptoms of anemia include fatigue, weakness, shortness of breath, loss of concentration or confusion, and

From Kitchens CS: Surgery and hemostasis. In Kitchens CS, Alving BM, Kessler CM (eds): Consultative Hemostasis and Thrombosis. Philadelphia: WB Saunders, 2002, p 617.

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Abnormal Uterine Bleeding and Hemostatic Disorders a good indicator of bleeding risk when used alone. The BT can, however, help support a clinical impression. The BT is performed with a commercial device for standardization and reproducibility. The test assesses vessel integrity, vWF activity, and platelet function. Normal values at Duke University are between 3 and 9.5 minutes. It is the only physiologic test of primary hemostasis; however, both its sensitivity and specificity are limited. Other technologies can provide global assessment of primary hemostasis. These instruments are easy to use and provide results in less than an hour. Although there are several technologies for platelet function assays, the one most familiar to me is the PFA-100 platelet function analyzer. This is a test developed by Dade-Behring and evaluated by Ortel and coworkers13 in a group of patients with different clinical settings at Duke University. This test was also evaluated by James and Lukes in a group of women with heavy menstrual bleeding.14 The PFA-100 is a surrogate test of the bleeding time. The result is given as a closure time in seconds. This test has two components. The first component uses a cartridge containing collagen and epinephrine and is broadly sensitive to platelet dysfunction, including that caused by aspirin ingestion and possibly other medications that can inhibit platelet function. The second component uses a cartridge containing collagen and adenosine diphosphate and is generally insensitive to aspirin. A prolonged time for this second component is more suggestive of an underlying bleeding disorder, either platelet dysfunctions or, more commonly, vWD. The platelet function assay, while easy to interpret, has limitations. The results are altered by both common medications and anemia. Evaluation for underlying vWD in a healthy woman who presents with menorrhagia should be considered; however, there is not a clear or evidence-based algorithm for this evaluation. This test is one method for screening,15 but a focused personal and family history is important in this evaluation.9 Ongoing studies by the Centers for Disease Control and Prevention (CDC) and by international investigators will likely help clinicians decide when and how to evaluate women with menorrhagia for underlying bleeding disorders.

dizziness. If the patient is anemic, iron supplementation should be considered before surgery. Either oral or intravenous iron may be given. Depending on the expected blood loss and degree of anemia, a surgeon must consider a type and screen or type and cross.

Tests for Assessing Coagulation The most commonly used tests are the prothrombin time (PT) and the activated partial thromboplastin time (aPTT). Both are standard readily available tests of hemostasis. In general, however, both tests carry a low positive and negative predictive value for an underlying bleeding disorder.11 The PT involves mixing thromboplastin, a mixture of tissue factor and phospholipids, and calcium, which are added to plasma. The time to clot formation is then determined. The clotting time depends on the level of factor VII and of the common pathway factors II, V, and X and fibrinogen. The normal range for PT varies by site and reagents. The PT is a useful screening test of the extrinsic or initiator pathway of coagulation. It is also used to monitor anticoagulation therapy with warfarin (Coumadin). The prothrombin time may be abnormal in patients with liver disease and vitamin K deficiency. The PT is only a screening test of coagulation and does not begin to prolong until one of the PT-based clotting factors decreases to less than about 30% to 40% of normal (exact cutoffs differ between factors and with different PT reagents). With the aPTT, all procoagulant factors except VII and XIII are measured. Normal ranges slightly vary by site. The aPTT prolongs when one of the aPTT-based clotting factors decreases to less than about 30% to 40% of normal (exact cuttoffs differ between factors and with different aPTT reagents), an inhibitor to a specific clotting factor is present, or a nonspecific inhibitor of the intrinsic pathway (heparin or lupus anticoagulant) is present. Although the relationship between bleeding symptoms and factor levels are not linear, it is important that these basic tests be performed. A normal PT or aPTT, however, does not always correspond to normal levels of clotting factors, and even a slight prolongation of the clotting time suggests a factor level of less than about 30% to 40%.

Specialized Laboratory Testing for von Willebrand Disease

Laboratory testing for vWD includes vWF antigen levels, vWF activity levels (ristocetin cofactor), and factor VIII levels. vWF protects factor VIII from proteolytic cleavage. If vWF levels are low, then factor VIII levels may be secondarily low. There is conflicting evidence regarding the timing of laboratory testing relating to the menstrual cycle. Historically, testing for vWD is recommended during the menses. Although evidence is not yet available to guide the timing of testing relating to menses, a clinician should record when testing is done relating to menses. Ongoing studies conducted by the CDC might provide information about this. Because hormones cause fluctuation in vWF levels, historically it was thought that patients should stop using oral contraception before testing for vWD. There is a lack of evidence at

Additional Laboratory Evaluation Consideration of further hematologic testing should be done with on-site laboratory processing and analysis. If laboratory testing is performed off-site, samples may be falsely interpreted due to activation or degradation of the sample due to delays in processing.12 Specific additional testing includes primary hemostasis testing, vWD testing, and platelet aggregation and release testing. Primary Hemostasis Testing

The most common global test for hemostasis is the bleeding time (BT). The BT is common and inexpensive; however, it not

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Abnormal Uterine Bleeding and Hemostatic Disorders to minimize bleeding in patients with underlying bleeding disorders.

present, however, to demonstrate a definite effect of combination oral contraceptives on vWF levels.9 A clinician should tell the laboratory whether a patient is using hormones. It is also important to recognize that blood group influences the interpretation of vWF levels. In general, persons with type O blood have approximately 25% lower vWF and factor VIII levels compared to those with non-O blood types. However, as noted by Kouides and colleagues, because the vWF level may be a continuous inverse variable for bleeding risk, adjustment based on blood type might not be necessary.9

Replacement Strategy In patients with decreased factor levels, replacement is needed. Factor levels should be maintained in a patient as high and as long as indicated. Infusion should occur the morning before surgery and then measured before induction of anesthesia. Hysteroscopy is considered a fairly minor procedure, and thus factor levels may be kept between approximately 30% and 60% for 3 to 4 days. With more invasive surgery, higher concentrations are often required, and continuous infusion of factor concentrates may be needed. One must recognize, however, that if complications arise from hysteroscopy, then more invasive surgery may be needed. Thus, on-site factor availability is recommended. For patients with vWD who undergo surgery, intravenous arginine vasopressin (DDAVP) can prevent excessive bleeding. Known side effects for DDAVP include flushing, tachyphylaxis, and hyponatremia. The surgeon should consider factor VIII concentrates that contain vWF, such as Humate P. Caution is needed in patients with inhibitors who require surgery given that limited treatment is available. In these instances, consultation with a hematologist is important. A review of inhibitor treatment options18 notes that both activated prothrombin complex concentrate and recombinant factor VIIa have been used but that optimal dosages are difficult to calculate because neither can be monitored with a laboratory assay. Surgeons should be familiar with guidelines for surgery in women with underlying bleeding disorders.1 It is important to determine preoperatively the patient’s HIV and hepatitis status and clearly identify the inhibitors. The abnormal hemostatic factor should be assessed as close to the preoperative date as possible. Hemostatic tests should be performed in the preoperative period. The blood bank should be consulted to verify the logistics of supplying appropriate blood products. Avoid platelet-inhibiting medications such as aspirin and nonsteroidal antiinflammatory drugs for 1 to 2 weeks preoperatively. The anesthesiologist should be notified and consulted about the appropriate adjunctive agents that can enhance hemostasis intraoperatively and for administering the correct clotting factor dosage. The patient should be given precautions about potential bleeding complications for up to 2 weeks postoperatively.

Platelet Studies

Platelet aggregation and releases studies should be considered. These tests involve aggregating agents (agonists) that are added to the patient’s platelet-rich plasma to evaluate the ability of her platelets to respond to physiologic stimuli. Several agonists are used, including adenosine diphosphate (ADP), collagen, arachidonic acid, and others. Results may be abnormal if patients have ingested aspirin or aspirin-like medications within the previous 7 to 10 days. These studies help define inherited or acquired qualitative defects in platelets. Other Coagulation Studies

Additional coagulation studies to consider include specific factor levels such as factor XIII, tests for fibrinolysis such as the screening euglobulin lysis test, and more specific fibinolytic defects such as deficiencies of α2-antiplasmin or plasminogen activator inhibitor.9

SURGERY-RELATED HEMORRAGIC COMPLICATIONS Bleeding complications relating to hemostatic disorders relate to the site of bleeding more than the timing of bleeding. In other words, individuals with a defect in primary hemostasis will typically bleed in mucosal or skin surfaces (muco-cutaneous bleeding). Given that both platelets and von Willebrand factors are important for primary hemostasis, when a defect is present there is more bleeding related to invasive surgical procedures and dental work, as well as more bruising, nosebleeds, and heavy menstrual bleeding. In comparison, with defects of secondary homeostasis (e.g., coagulation factor deficiency such as hemophilia) tend to have deep tissue, muscle, or joint bleeding. Surgery involving these deep tissues may also be complicated by bleeding. The blood flow in these areas are mostly low flow with platelets less involved compared to higher flow areas, as seen in muco-cutaneous bleeding. Several reviews of intraoperative and early postoperative bleeding during cardiac bypass point out that 75% to 90% of all such bleeding episodes result from technical issues.16,17 These studies were in patients undergoing cardiac bypass; there is little evidence relating bleeding complications and causes with the gynecologic literature. Careful preoperative evaluation is critical

Role of Multidisciplinary Clinics A multidisciplinary approach that combines the efforts of hematologists, gynecologists, hemophilia nurse specialists, anesthesiologists and others is recommended. This approach helps prepare the patient through educational efforts on what to expect and the surgeon through awareness of available methods (including prophylactic treatments) for controlling potential excessive bleeding. For gynecologists, perioperative management is optimized with input from both hematology and anesthesia.

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Kitchens CS: Surgery and hemostasis. In Kitchens CS, Alving BM, Kessler CM (eds): Consultative Hemostasis and Thrombosis. Philadelphia: WB Saunders, 2002, pp 464-617. Werner EJ, Broxson EH, Tucker EL, et al: Prevalence of von Willebrand disease in children: A multiethnic study. Haemophilia 2000;6:643-648. Kouides PA, Phatak PD, Burkart P, et al: Gynaecological and obstetrical morbidity in women with type I von Willebrand disease: Results of a patient survey. Haemophilia 2000;6:643-648. Kadir RA, Economides DL, Sabin CA, et al: Frequency of inherited bleeding disorders in women with menorrhagia. Lancet 1998;351: 485-489. James AH: More than menorrhagia: A review of the obstetric and gynaecological manifestations of bleeding disorders. Haemophilia 2005;11:295-307. Foster PA: The reproductive health of women with von Willebrand disease unresponsive to DDAVP: Results of an international survey. On behalf of the Subcommittee on von Willebrand Factor of the Scientific and Standardization Committee of the ISTH. Thromb Haemost 1995;74:784-790. Kirtava A, Drews C, Lally C, et al: Medical, reproductive and psychosocial experiences of women diagnosed with von Willebrand’s disease receiving care in haemophilia treatment centres: A case-control study. Haemophilia 2003;9:292-297. Philipp CS, Dilley A, Miller CH, et al: Platelet functional defects in women with unexplained menorrhagia. J Thromb Haemost 2003;1:477-484.

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Kouides PA, Conard J, Peyvandi F, et al: Hemostasis and menstruation: Appropriate investigation for underlying disorders of hemostasis in women with excessive menstrual bleeding. Fertil Steril 2005;84:1345-1351. Goebel RA: Thrombocytopenia. Emerg Med Clin North Am 1993;11:445-464. Fricke W, Kouides P, Kessler C, et al: A multicenter clinical evaluation of the Clot Signature Analyzer. J Thromb Haemost 2004;2:763768. Lipton RA: Misdiagnosis by milk box. Haemophilia 2003;9(2): 235. Ortel TL, James AH, Thames EH, et al: Assessment of primary hemostasis by PFA-100 analysis in a tertiary care center. Thromb Haemost 2000;84:93-97. James AH, Lukes AS, Brancazio LR, et al: Use of a new platelet function analyzer to detect von Willebrand disease in women with menorrhagia. Am J Obstet Gynecol 2004;191:449455. James A, Matchar DB, Myers ER: Testing for von Willebrand disease in women with menorrhagia: A systematic review. Obstet Gynecol 2004;104:381-388. Bevan DH: Cardiac bypass haemostasis: putting blood through the mill. Br J Haematol 1999;104:208-219. Woodman RC, Harker LA: Bleeding complications associated with cardiopulmonary bypass. Blood 1990;76:1680-1697. Mathew P: Current opinion on inhibitor treatment options. Semin Hematol 2006;43(2 Suppl 4):S8-S13.

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Investigation of Abnormal Uterine Bleeding in Premenopausal Women Linda D. Bradley

Abnormal uterine bleeding (AUB) in premenopausal women is common, leading to one third of outpatient visits. The most common culprits leading to the investigation of AUB in the reproductive-age patient include anovulation, polycystic ovary syndrome (PCOS), structural abnormalities (polyps, fibroids, and cancer), foreign bodies, pregnancy-related complications, disorders of hemostasis, trauma, and infection (Figs. 10–1 to 10–3). The investigation by menopausal status is somewhat arbitrary but is practical. There is no clear defining age, but as patients age malignancies become more common, bleeding secondary to pregnancy complications becomes less common, and therefore the order of potential diagnoses becomes different. Subjectively, 30% to 40% of women complain of heavy menses. The most objective way to calculate the amount of menstrual blood loss is the alkaline hematin assay. When the alkaline hematin assay is used, less than 50% of women who complain of menorrhagia actually lose more than 80 mL. Additionally, women who have less education, who are not white, who are single, and who come frim lower socioeconomic groups have the highest complaints of menorrhagia.1 Most reports demonstrate that menorrhagia, by whatever definition is used, effects quality of life for many women. A reduction in work occurs in 7% to 20% of women, which causes loss of days from work. Psychological impairment has also been reported with increased irritability, moodiness, and low energy, and activities of daily living are drastically affected by menstrual dysfunction.2,3 There are few national consensus guidelines, best practice guidelines, or treatment algorithms that provide gynecologists with scrupulous data to make concise decisions for proceeding from minimally invasive to extirpative surgery.4 Most physicians rely on personal treatment algorithms.

levels of estrogen prime the endometrium. Normal secretion of progesterone from the corpus luteum stabilizes the endometrium, decreases vascular fragility, and supports the endometrial stroma. Patients with menorrhagia typically have an imbalance of prostaglandin levels and increased fibrinolytic activity. Emerging new therapies for menorrhagia involve pathways that lower prostaglandin levels or affect the fibrinolytic system. An intact coagulation pathway is important in regulating menstruation. Menstruation disrupts blood vessels, and in the face of normal hemostasis, the injured blood vessels are rapidly repaired. Restoration of the blood vessel integrity requires successful interaction of platelets and clotting factors. Tissue factors and collagen, located within vessels beneath the endometrium, create a nidus at the site of vessel injury to which platelets adhere, creating a platelet plug that halts bleeding. Simultaneously, exposure of tissue factor activates the clotting cascade, the end point of which is the formation of a fibrin net, which stabilizes the platelet plug or evolving clot. von Willebrand factor (vWF) is a large multimeric protein that causes platelets to adhere to sites of blood vessel injury. vWF also protects factor VIII from degradation in the circulation and facilitates fibrin and platelet interactions that result in the formation of a stable clot. When vWF is absent, aberrant, or low, menstrual dysfunction from hemostasis can occur.5 von Willebrand disease (vWD) is increasingly being diagnosed in premenopausal women because of increased physician awareness and ability to screen easily for the disease. The American College of Obstetricians and Gynecologists (ACOG) suggests that the single best screening test for vWD is von Willebrand ristocetin cofactor activity. The platelet function analyzer PFA100 (Dade Behring, Newark, Del) is both sensitive (90%-100%) and specific (88%-95%) in detecting vWD and platelet function disorders.6

MENSTRUATION ABNORMAL UTERINE BLEEDING

A normal menstrual bleed is the final result of a wellorchestrated communication within the hypothalamic– pituitary–adrenal–ovarian axis, leading to a predictable denudation and sloughing of the endometrium. Hemorrhage followed by prompt hemostasis and repair causes stabilization and regrowth of the endometrium. Physiologically, constant low

Abnormal uterine bleeding can usually be classified as either anovulatory bleeding or ovulatory dysfunctional bleeding. Anovulatory AUB is usually due to failure of the corpus luteum to sustain the developing endometrium. Anovulatory bleeding can be episodic or continuous. Patients with anovulatory cycles

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PCOS

Figure 10–3 Classic ultrasonographic image of polycystic ovaries. The multicystic follicles have also been called the string of pearls. Figure 10–1 Vascular leiomyoma manifesting as florid bleeding, anemia, and dysmenorrhea. Hysteroscopic resection resolved all clinical symptoms.

periods. These patients typically have intracavitary lesions including fibroids and polyps, as well as less likely cases of endometrial hyperplasia and endometrial cancer. Patients who ovulate typically have breast discomfort, increased mucoid vaginal discharge at midcycle, premenstrual cramping and bloating, and mood and appetite changes.

Definitions Most menstrual cycles occur every 21 to 35 days. Normal menstrual flow lasts 3 to 7 days, with the majority of blood loss occurring within the first 3 days. Normal menstrual flow amounts to 35 mL and consists of effluent debris and blood. Patients with menorrhagia lose more than 80 mL of blood with each menstrual cycle and often develop anemia. In general, most normal menstruating women use five to six pads or tampons per day and do not complain of social embarrassment or inconvenience. Approximately 16 mg of iron is lost with each menstrual cycle, and this rarely results in anemia in women with adequate intake of dietary iron. More than 50% of women who complain of menorrhagia might not actually have heavy menses. Indeed, some patients change their sanitary products more often for hygienic reasons, personal preference, or concern for toxic shock syndrome than for heavy flow. Social obligations, sexual activity, hobbies, work, and travel are not interrupted with normal menstrual function. Menstrual patterns associated with AUB are described in Box 10–1.

Figure 10–2 Long, tapering endometrial polyp extending to the lower uterine cavity.

typically do not experience constitutional premenstrual symptoms. Cycles that vary in length by more than 10 days from one cycle to another are likely anovulatory. Puberty and the perimenopausal years are typically associated with anovulatory menstrual cycles. The immature hypothalamic–pituitary axis does not develop the necessary hormonal feedback to sustain the endometrium. Likewise, the decline of inhibin levels and rise in follicle-stimulating hormone (FSH) levels reflect the loss of follicular activity and competence as the perimenopausal transition occurs. Ovulatory dysfunctional bleeding occurs when ovulatory cycles coexist with the AUB, typically characterized by regular

The Perimenopause: A Time for Change Menstrual aberrations occur at the extremes of the reproductive life cycle. Within the first 1 to 5 years after the onset of menstruation and beginning by the late 30s or 40s, periodic or persistent menstrual dysfunction is typical. Approximately 50% of women by age 45.5 years, 75% of women by age 47.8 years, and 95% by age 50.8 years experience menstrual abnormalities.7

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Investigation of Abnormal Uterine Bleeding in Premenopausal Women Menopause is a retrospective diagnosis. The level of FSH alone cannot make the diagnosis of menopause. Although many clinicians routinely order an FSH level, the results are not sensitive enough or specific enough to dictate therapy. Henrich and colleagues evaluated 576 women between ages 35 and 60 years and found wide and fluctuating levels of FSH and luteinizing hormone (LH) in the reproductive years. Their analysis noted that using an upper limit of FSH of 13 mIU/mL has a sensitivity to determine the probability of reproduction versus menopause of only 67.4% (95% confidence interval [CI], 50.0-81.1) and a specificity of only 88.1% (95% CI, 81.1-92.8). Between perimenopause and menopause, an FSH cutoff of 45 mIU/mL has a sensitivity of 73.6% (95% CI, 60.1-83.7) and a specificity of 70.6% (95% CI, 52.4-84.0).12 Listening to our patients’ menstrual history and reviewing their menstrual diaries and associated physical complaints will more accurately determine onset of menopause. Episodes of oligomenorrhea or menstrual cycles that become 2 to 3 months apart is highly predictive of the final menstruation within 18 to 48 months.13 Many women seek reassurance that changes in menstruation—more frequent menses, erratic menses, longer duration of menses, and variable intervals—is indeed normal. Although abnormal bleeding is normal, it can be a nuisance. Fortunately, medical therapy is effective and appropriate for the majority of patients. Indeed malignancy is rare, but we must rule out organic disease, intrauterine pathology, or endocrine abnormalities when response to medical therapy is less than satisfactory. Many cases of abnormal bleeding are likely due to hormonal fluctuations. Therefore, physicians should emphasize medical therapy or the levonorgestrel IUS. Endometrial ablation should not be the first option for women who are likely experiencing anovulatory cycles. A reasonable trial of medical therapy should be instituted before recommending surgery whenever possible. It is important to use patient-centered outcomes, which influence patient satisfaction, continuation of therapy, or desire to try other therapies. For many patients, the reduction in menstrual blood loss is not the sentinel event. Rather, convenience of therapy, associated costs, outcomes, safety, and side effects are more important determinants of patient satisfaction.

BOX 10–1 Menstrual Patterns Associated with Abnormal Uterine Bleeding Oligomenorrhea: Cycle longer than 35 days Polymenorrhea: Cycle shorter than 21 days Amenorrhea: Absence of menses for 6 months or absence of menstrual periods for 3 normal cycles Menorrhagia: Heavier and increased flow occurring at regular intervals or loss of more than 80 mL of blood Metrorrhagia: Irregular episodes of bleeding Menometrorrhagia: Longer duration of flow occurring at unpredictable intervals Postmenopausal bleeding: Bleeding that occurs more than 12 months after the last menstrual cycle Abnormal uterine bleeding: Excessive, erratic, or irregular bleeding not associated with intrauterine pathology (previously called dysfunctional uterine bleeding)

Although the average age of diagnosis of endometrial cancer is in the sixth decade, 20% to 25% of endometrial cancers are diagnosed in the premenopausal years. Intermittent anovulation during the perimenopause causes recurrent bouts of AUB and associated physical complaints: bloating, cramping, water retention, fatigue, decreased mental clarity, diminished concentration, vaginal dryness, hot flushes, and night sweats. The hormonal milieu is characterized by decreased inhibin levels and variable estradiol levels with normal FSH levels. The decreased inhibin is thought to be the result of an aging granulosa cell–oocyte complex. Despite the multitude of hormonal changes, menstrual cycles can be episodically ovulatory and predictable, followed by episodes of erratic menses. This is especially frustrating for the patient and physician because the pattern of bleeding changes dramatically.8,9 Anovulation is the most common culprit of menstrual dysfunction. Rarely should surgical intervention be the first step in the treatment of perimenopausal abnormal bleeding. Rather, the gynecologist should aggressively treat medically first with hormonal contraceptives, progesterone therapy, or a medicated intrauterine system (levonorgestrel IUS [Mirena]). In addition to anovulatory cycles, reproductive-age patients might also have intrauterine structural abnormalities that contribute to abnormal bleeding. The most conservative approaches to management of abnormal bleeding include watchful waiting, medical therapy, and imaging of the endometrial cavity when medical therapy fails or the patient is markedly anemic. Seltzer and colleagues10 retrospectively followed 500 perimenopausal women and systematically noted the classic categories of bleeding typical for the perimenopause. These included hypomenorrhea (70%), menorrhagia, metrorrhagia or hypermenorrhea (or both) (18%), and sudden cessation of menses (12%). Landgren and colleagues11 evaluated 13 women longitudinally, with multiple hormonal analyses, between 4 and 9 years before menopause and during the year of menopause. They noted that within 30 cycles of final menstruation, the frequency of anovulatory cycles increased, characterized by elevated FSH concentrations. Women with hormonal evidence of ovulatory cycles did not have FSH levels that rose consistently.

DIAGNOSIS Menorrhagia, defined as bleeding in excess of 80 mL, is scientifically defined by a pictorial blood assessment chart (PBAC) score greater than 150. In reality, most physicians do not begin a work-up when the PBAC score is elevated. Rather, the investigation begins when the patient has contacted the physician frequently by phone, has frequent office visits with complaints of irregular or heavy periods, or has anemia. Other complaints include heavier or prolonged menstrual flow, social embarrassment, diminished quality of life, sexual compromise, and alteration in lifestyle. Pain is not a common presenting symptom unless it is associated with passage of large blood clots. Incessant menstrual blood loss can be associated with anemia. Typical complaints of anemia include fatigue, lassitude, unusual

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Investigation of Abnormal Uterine Bleeding in Premenopausal Women food cravings (for ice, starch, or dirt [pica]), pallor, hair loss, and headaches. Severe anemia can cause fainting, congestive heart failure, exercise-induced fatigue, shortness of breath, and inability to perform routine activities. Dysfunctional uterine bleeding is rarely associated with the need for a blood transfusion unless it is a chronic condition. Hemorrhagic shock and death are rare sequelae for AUB.

BOX 10–2 Causes of Menstrual Dysfunction Anatomic causes ● ● ● ● ●

History and Physical Examination

●

Diagnosis has three main requirements. First, a detailed medical history and thorough review of systems must be obtained. Next, a thorough physical examination is necessary. Finally, appropriate laboratory testing is critical.

● ● ● ● ● ●

History

●

Eliciting a detailed clinical history will alert the astute physician to systemic and medical conditions that mimic menstrual dysfunction (Box 10–2). Inherited and acquired disorders of coagulation, liver, and renal diseases often manifest with symptoms of AUB. Important questions that help in formulating a differential diagnosis are listed in Box 10–3. Consider the patient’s risk factors for endometrial cancer. Is she obese? Is she taking unopposed estrogen therapy? Does she have a history of polycystic ovary syndrome? Is she taking tamoxifen? Does she have more than 6 months of irregular menstrual cycles? If the answer is yes to any of these questions, aggressively evaluate the patient for endometrial hyperplasia or endometrial cancer. Be astute and remember that 50% of endometrial cancer cases occur among women with the typical phenotypic profile for endometrial cancer. However, 50% of women do not fit this profile and they must not be forgotten.14

Polyps Fibroids Adenomyosis Cervical (ectropion, cervicitis, eversion) Endometritis (sexually transmitted diseases, tuberculosis, foreign body) Ectopic pregnancy Retained products of conception Sacculation of cesarean scar Endometrial ossification (foreign body) from therapeutic abortion Endometriosis Hyperplasia Malignancy (vulvar, vaginal, cervical, uterine, ovarian, fallopian) Nongenital (bladder, bowel, rectum)

Endocrine causes ● ● ● ● ● ●

Thyroid dysfunction Elevated prolactin Polycystic ovary disease Adrenal dysfunction Hypothalamic or pituitary dysfunction Estrogen-producing tumors

Hematologic causes ● ● ● ● ●

Anemia Coagulopathy von Willenbrand disease Platelet disorders Leukemia

Systemic diseases ● ● ●

Physical Examination

●

The physical examination must be detailed and complete, even in the presence of heavy bleeding. A diagnosis cannot be reached without a pelvic examination. Initially, a thorough inspection of the skin is important, with particular attention to establishing the presence of acanthosis nigricans (seen in women with insulin resistance and anovulation), thyroid enlargement, ecchymosis, or hyperandrogenism (hirsuitism, acne, clitoromegaly, or male pattern baldness). The gynecologic examination must be performed with specific attention to the vulva, vagina, cervix, uterus, adnexa, urethra, bladder, and rectum to exclude pathology. Special attention to the cervix is important to exclude cervical motion tenderness, cervicitis, ectropion, eversion, sexually transmitted ulcerations and infections, prolapsing leiomyomas, or endocervical polyps (Figs. 10–4 and 10–5). Specific attention must be paid to rule out foreign bodies by rotating the speculum to fully visualize the vaginal fornix and to establish that there are no ulcerations or foreign bodies. Particular attention must be made to the bimanual examination. Ask the patient to empty her bladder, then evaluate for uterine tenderness, contour, and size.

● ●

Renal impairment Liver disorders Obesity Anorexia Chronic illness Rapid fluctuations in weight

Medications ● ● ● ● ●

Anticoagulants Steroids Herbal and soy products Antipsychotics Selective serotonin reuptake inhibitors

Miscellaneous ● ● ● ●

Smoking Depression Excessive alcohol intake Sexually transmitted diseases

Laboratory Studies

Use your history and physical examination to guide your choice of appropriate laboratory studies. Pregnancy testing must always be performed in sexually active women. A recently pregnant patient with persistent

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Investigation of Abnormal Uterine Bleeding in Premenopausal Women BOX 10–3 Key Questions in the Work-up of Abnormal Uterine Bleeding When did the bleeding begin? What is the pattern of bleeding (coitus, amount, duration)? Is there a personal or family history of bleeding problems, difficulties with bleeding from minor wounds (tooth extraction), nose bleeds, oral bleeding, intestinal bleeding, ecchymosis, petechiae, hemarthroses, soft tissue hemorrhage, hematuria, purpura, hematomas, easy bleeding after lacerations? New sexual partner? Postcoital bleeding? Intermenstrual bleeding? Associated pain, odor, fever, or discharge? Any change in weight, exercise, hirsuitism, bruising, acne, hair loss, eating disorder? Any trauma? Taking herbal products ( ginseng, ginkgo, soy)? Any new medications (SSRIs, antipsychotics, corticosteroids)? Recent pregnancy, miscarriage, or therapeutic abortion? Recent cesarean section?

Figure 10–5 Flexible hysteroscopic view of a cervical polyp. One in four women with a cervical polyp also has an endometrial polyp.

SSRI, selective serotonin reuptake inhibitor.

Figure 10–4 Cervical ectropion, typical in young women, creates a friable cervix due to columnar epithelium that bleeds spontaneously or during coitus. Treatment can include application of silver nitrate, cryosurgery, or electrocautery to the surface.

Figure 10–6 A 32-year-old woman with a 2-year history of abnormal daily incessant bleeding and foul-smelling discharge after vaginal delivery. Hysteroscopy demonstrates a yellow-necrotic endometrium. Hysteroscopic removal demonstrates an atypical placental site nodule.

vaginal bleeding should have a sensitive β-human chorionic gonadotropin (β-hCG) test to exclude trophoblastic disease. Retained products of conception can be determined by hysteroscopy. A transvaginal ultrasound (TVUS) that demonstrates hyperechoic endometrium or thickened endometrium also raises the suspicion for retained products of conception. This can be confirmed with saline infusion sonography (SIS, also called sonohysterography [SHG]) or hysteroscopy (Fig. 10–6). Blood tests should include a complete blood count (CBC) with platelets and a von Willebrand panel. Thyroid-stimulating

hormone (TSH) should be measured to exclude hypothyroidism or hyperthyroidism. Prolactin should be measured if the patient complains of galactorrhea, oligomenorrhea, or decreased libido. Liver and renal function tests should be performed in women with systemic signs or symptoms of disease. Androgen levels should be measured if there are signs of androgen excess such as hirsutism, acne, or virilization. A Papanicolaou (Pap) smear should be performed. However, a Pap smear is not a diagnostic test. Therefore, a biopsy of any

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Investigation of Abnormal Uterine Bleeding in Premenopausal Women compare treatment of AUB in women who were older than 40 years did not desire fertility. This study showed that a short treatment trial with oral contraceptive pills (OCPs) followed by second-generation endometrial ablation is the most costeffective strategy for treating AUB when a PBAC score less than 100 is the goal. Patient preferences, safety, cost, and physician experience are important factors to consider when reaching decisions.

INTERVENTIONAL INVESTIGATION Endometrial Biopsy

Figure 10–7 Additional views of an atypical placental site nodule that was present in the lower uterine segment and endocervix. Blunt hysteroscopic resection (without cautery) removed this placental remnant with resolution of clinical symptoms.

visible lesion should be performed even if the cytology is negative. Cervical cultures should be taken for sexually transmitted diseases (STDs). An endometrial biopsy should be performed in women older than 35 years and in younger women with risk factors for endometrial hyperplasia or malignancy. Direct visualization of the endometrium is highly recommended. Hysteroscopy or SIS is an office-based, comfortable, and convenient procedure and quickly provides detailed assessment of the endometrial cavity. When coupled with endometrial biopsy, it reliably excludes malignancy and more accurately detects focal intracavitary pathology (Fig. 10–8)

Endometrial biopsy is generally performed in the office with a pipelle instrument. The biopsy is associated with few complications, is performed quickly, and generally is well tolerated by the patient. It has a high sensitivity for detecting endometrial cancer and hyperplasia, but it has a low sensitivity for detecting intracavitary lesions, including polyps and submucosal fibroids.16 Pipelle biopsy is a sensitive method of detecting high-grade and nonendometrioid cancer of the uterus. Lesions encompassing a small surface area and cornual regions are likely to be missed. Additionally, Huang and colleagues16 noted that preoperative pipelle biopsy more often underestimated than overestimated the final grade of endometrial cancer. The biopsy instrument samples only 10% to 25% of the endometrial cavity. Patients with persistent symptoms despite a trial of medical therapy, normal biopsy, and normal TVUS need further evaluation with SIS or hysteroscopy. When hysteroscopy is used alone and the patient has persistent symptoms, TVUS is helpful for excluding intramural fibroids and the rare causes of abnormal bleeding, including ovarian cancer or fallopian tube carcinoma. A meta-analysis of 39 studies reviewing 7914 women (premenopausal and postmenopausal) with endometrial pipelle biopsy noted the following17: ●

GENERAL PRINCIPLES OF INVESTIGATION Despite a thorough history, physical examination, laboratory testing, and imaging of the uterine cavity, an underlying cause of the menstrual disturbance is not pinpointed in more than 50% of cases. In the remainder of cases, pelvic pathology including endocrine disorders, pelvic pathology, and intracavitary lesions are detected. Among the 50% of women who have no identifiable pathology and negative histologic evaluation, medical options are advised. In fact, most surgically conservative physicians often advise watchful waiting, which includes medical management with nonsteroidal antiinflammatory drugs (NSAIDs), hormonal contraception, progesterone therapy, or levonorgestrel IUS insertion. At least 3 months of medical therapy is advised unless the patient declines, refuses, or has contraindications to therapy. This is especially true when the patient is not anemic. When medical management fails, then surgical options can be considered. Wade and colleagues,15 using a decision analytic model, used a third-party payer perspective and 18-month observation to

●

● ●

Pipelle catheter was more sensitive in detecting endometrial cancer and atypical hyperplasia than Vabra biopsy. Detection rate of endometrial cancer was 99.6% in postmenopausal women and 91% in premenopausal women when global disease is present. Atypical hyperplasia detection rate was 88%. Specificity was 98% to 100%.

Hysteroscopically directed biopsies are more likely to uncover focal pathology than a dilation and curettage (D&C) alone (Fig. 10–9). Bettocchi and colleagues found that more than 50% of intrauterine lesions were missed when a D&C was performed alone. These sobering statistics were validated based on 397 women having a blind D&C and then having a hysterectomy within 2 months of the D&C. In these subjects, 159 submucosal or intramural fibroids were missed and 63 endometrial polyps remained in situ. Four cases of complex hyperplasia and five cases of focal endometrial cancer located within the tubal cornua were missed by blind D&C and were detected with the hysterectomy specimen.18 Endometrial biopsy commonly misses intracavitary pathology such as endometrial polyps and fibroids,

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B

A

+D 0.08cm ×D 0.12cm #D 3.30cm *D 1.44cm

C D

E

F

Figure 10–8 A, Transvaginal ultrasound demonstrates an inhomogeneous endometrial echo. Mild thickening of the endometrium is noted. B, Saline infusion sonography of a 3-cm intracavitary leiomyoma arising from the fundus. Visualization is much improved compared to the transvaginal image in A. C, Operative hysteroscopy of the 3-cm intracavitary fibroid noted in B. Excellent correlation with size, location, and number of fibroids is demonstrated with this excellent hysteroscopic view. D, Office flexible hysteroscopy with a lower uterine segment fibroid in the foreground and an endometrial polyp distally. E, Office hysteroscopic view of dense synechiae and a small leiomyoma. F, Transvaginal ultrasound with homogeneous echo (central brightness) shows a fibroid displacing the endometrium.

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G

H

+D 0.80cm

+D 0.92cm

Figure 10–8, cont’d G, Transvaginal ultrasonography depicting an 8-mm heterogeneous endometrial echo. H, Transvaginal ultrasonography depicting a classic trilayer endometrium seen during midcycle.

Figure 10–9. Flexible Karl Storz hysteroscope with ancillary biopsy forceps. Targeted directed biopsies are possible in an office setting.

which are common culprits for menstrual aberrations. These intracavitary lesions rarely respond to hormonal therapy. The pelvic examination and findings dictate the appropriate investigation tools. In women with a bimanual examination indicating the uterus is less than 12 to 14 weeks in size, TVUS has been the gold standard method of imaging in the premenopausal patient. It is minimally invasive and comfortable, and it helps triage patients who might require additional testing. The sensitivity of TVUS is 80% and the specificity is 69% for detecting myomas and polyps and ascertaining endometrial thickness. However, it is difficult to determine if there is any intracavitary pathology (Figs. 10–8F and 10–8G).

A study by Breitkopf19 highlights the limitations of TVUS alone in the reproductive-age patient and strongly advocates, when possible, the additional of saline infusion to improve detection of intracavitary lesions and myometrial abnormalities. Breitkopf evaluated 206 premenopausal women who had a normal endometrial echo and determined that one of six lesions were missed when TVUS was used alone. Saline infusion sonography provided more accurate information regarding the presence of intracavitary pathology. In premenopausal women, TVUS ideally should be scheduled between days 4 and 6 of the menstrual cycle. This is when the endometrium is the thinnest. Endometrial thickness varies between the proliferative phase (4-8 mm) and the secretory phase (8-14 mm).20 TVUS permits rapid assessment of size, position, and presence of uterine fibroids. Not only is the thickness of the endometrium important, but the echotexture of the endometrium is also critical. It is important to determine if the texture is homogeneous of heterogeneous and whether the entire endometrium can be visualized. Adnexal pathology can be assessed and pelvic tenderness can also be assessed during the examination. If the uterus is larger than 12 gestational weeks, then transabdominal scanning is preferred. Transabdominal scanning of an enlarged uterus provides more accurate dimensions, but the interpretation of the endometrial echo may be more difficult. Under these circumstances, additional evaluation of the endometrium may be necessary with hysteroscopy. Hysteroscopy should be strongly considered if a premenopausal patient does not respond to medical therapy as anticipated or if the endometrial echo is thicker than anticipated. There is no place for routine D&C without hysteroscopy in the treatment and evaluation of menstrual disorders. Remember that one sixth of endometrial lesions are missed or are not diagnosed when TVUS is used alone in the premenopausal patient. Increasingly, hysteroscopy or SIS is recommended to further evaluate the endometrium in premenopausal women with

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Investigation of Abnormal Uterine Bleeding in Premenopausal Women abnormal bleeding when the endometrial echo is normal on TVUS. SIS is an excellent companion to traditional TVUS. SIS infuses saline into the endometrial cavity during TVUS to enhance the image (Fig. 10–10). (Many alternative terms have been used to describe this technique: echohysteroscopy, hydrosonography, sonohysterography, sonohysterosalinography, and sonoendovaginal ultrasound. I prefer the term saline infusion sonography because it refers to the more exact definition of the technique.21) SIS allows the clinician to evaluate the uterus for intracavitary lesions more accurately than TVUS. Causes of increased endometrial thickness are clearly differentiated with saline infusion (Fig. 10–11). Current indications for SIS include: ●

●

●

●

●

FIB

Abnormal bleeding in premenopausal or postmenopausal patients An endometrium that is thickened, irregular, immeasurable, or poorly defined on conventional TVUS Irregular-appearing endometrium with TVUS in women using tamoxifen The need to differentiate between sessile and peduculated masses of the endometrium Presurgical evaluation of intracavitary fibroids

A

By distending the endometrium during SIS, the gynecologist can determine if there are focal lesions, multifocal lesions, or a diffuse endometrial process. When focal lesions are present, blind endometrial pipelle biopsies are less accurate. Focal lesions, most of which are polyps, submucosal fibroids, and (less likely) focal hyperplasia, can be scheduled for operative hysteroscopic removal. Operative hysteroscopy in these situations is both diagnostic and therapeutic. When pathologic lesions circumferentially involve the uterine cavity, blind sampling is likely to have a high yield. Leiomyomas are rarely sampled by pipelle biopsy but are commonly encountered. Likewise, polyps are mobile and can move away from a sampling device placed blindly.

+D 1.73cm

B

C

Figure 10–10 Normal saline infusion sonography shows a thin symmetrical endometrium without intracavitary lesions.

Figure 10–11 A, Coronal transvaginal ultrasonography with homogeneous appearance. FIB, fibroid. B, Coronal saline infusion sonography (SIS) view with irregular appearing endometrium. Endometrial biopsy was consistent with endometrial cancer. C, SIS image demonstrating a small fundal endometrial polyp.

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Investigation of Abnormal Uterine Bleeding in Premenopausal Women General Principles of Medical Therapy

MANAGEMENT OF PATIENTS WITH ABNORMAL UTERINE BLEEDING

Abnormal uterine bleeding due to anovulatory cycles is best treated medically, and surgery should be suggested only when medical therapy fails or is contraindicated. Generally, OCPs are the mainstay of therapy. Several medical strategies are also effective in treating this disabling condition. Tailor therapy to the individual patient after reviewing risks, benefits, individual concerns, and contraindications.

The management of AUB is to a certain extent related to its investigation (Fig. 10–12). The pathology report partially determines how to proceed with management. Treatment of an acute uterine bleed is best managed with estrogens, especially intravenous premarin.

Figure 10–12 Algorithm for investigation and management of abnormal uterine bleeding in premenopausal women. FSH, follicle-stimulating hormone; GC, gonococcus; MRI, magnetic resonance imaging; NSAID, nonsteroidal antiinflammatory drug; OC, oral contraceptive; PCOS, polycystic ovary disease; SIS, saline infusion sonography; TSH, thyroid-stimulating hormone; vWD, von Willebrand disease.

Patient presents with abnormal uterine bleeding

Reproductive-age patient

Pregnancy test

Culture chlamydia/GC

Negative

Positive

Stop

Transvaginal ultrasound

<20 y of age

Test for von Willebrand disease and coagulopathies if menses heavy

Positive

>20 y of age

20–34 y of age

Risk factors for endometrial cancer

No

Negative

Treat

≥35 y of age

Yes

Endometrial biopsy

Assess for ovulation

Anovulatory

Ovulatory?

Negative and still bleeds

Further evaluation for thyroid disease (TSH), intracavitary uterine pathology with office hysteroscopy or SIS

OCs, NSAIDs

OCs, progesterone, or other medical therapy

Negative

If no response MRI-pelvis, Endo-biopsy if not done, vWB

Surgery

Negative Negative

Transvaginal ultrasound

Pathology

TSH, prolactin, FSH, (ex PCOS), serum androgen level

Mirena

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Positive

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Investigation of Abnormal Uterine Bleeding in Premenopausal Women Oral Contraceptive Pills

Levonorgesterol Intrauterine System

OCPs clearly have many roles in the treatment of menorrhagia and dysfunctional uterine bleeding. Combined estrogen– progesterone therapy reduces menstrual blood flow, and estrogen raises levels of both factor VIII and vWF. Each woman responds differently; some women cannot take OCPs. Profound menorrhagia rapidly responds to high-dose intravenous conjugated equine estrogen (CEE), promoting rapid regrowth of endometrial tissue, covering denuded endometrium, stabilizing lysosomal membranes, and stimulating proliferation of endometrial ground substance. When bleeding is excessive, incessant, and accompanied by mild anemia, a short-term, higher dose tapered regimen with OCP therapy is effective in treating menorrhagia. It successfully stops heavy menstrual bleeding in the adolescent and the perimenopausal woman. Any low-dose 30 to 35 mcg ethinyl estradiol product can be used in the following manner: one pill every 6 hours for 4 days, then every 8 hours for 3 days, then every 12 hours for 2 days, then once daily. This regimen rapidly stops menstrual bleeding in most patients. Once bleeding has stabilized, a single daily maintenance dose provides regular menstrual cycle and contraception. Low-dose contraception is safe and effective. It can be used in women older than 35 years who do not smoke and do not have history of thromboembolic disease.

Recently introduced, the levonorgesterol intrauterine system (IUS; Mirena) provides another great option for AUB therapy. This new IUS produces a dramatic decline in menstrual blood loss by 65% to 98% within 12 months of use. There is little systemic absorption of progesterone. The device releases 20 mcg of levonorgesterol and causes pseudodecidual changes and amenorrhea. Recently approved in the United States, the levonorgesterol IUS might have a tremendous role for women who additionally need contraception, have menorrhagia and a normal uterus size, and wish to avoid surgery.24

Danazol Danazol, a synthetic androgen, is not a commonly used drug but creates a hypoestrogenic state and decreases menstrual blood loss by 70% to 80%. A less-traditional dosing schedule of 50 to 100 mg daily as well as the conventional 400 to 800 mg daily is helpful. Typical side effects include weight gain, acne, and potential alteration of lipids.22

Gonadotropin-Releasing Hormone Agonists Gonadotrophin-releasing hormone (GnRH) agonists such as leuprolide acetate or nafarelin create a hypoestrogenic, menopauselike condition. Usually within 3 months of therapy, menstruation ceases. Menopausal symptoms, including hot flushes, night sweats, vaginal dryness, bone loss, decreased concentration, insomnia, depression, headaches, and diminished libido, can occur with therapy. Generally compliance is good, despite these symptoms. Osteoporosis is the biggest risk of prolonged therapy; therefore treatment is limited to 6 months, unless estrogen addback or norethindrone is instituted. Norethindrone 5 mg daily is approved by the Food and Drug Administration (FDA) as add-back therapy with the use of a GnRH agonist for endometriosis. This is a great option for the late perimenopausal woman who has significant contraindications for other medical therapy. Halting menses is a relief, and after therapy, many women spontaneously transition into the menopause. Additionally, intermittent GnRH agonist therapy in women with uterine fibroids or women with anovulatory bleeding provides an additional 9 months of symptom control (range, 2 to >25 months) and is appealing to patients and clinicans.23

Nonsteroidal Antiinflammatory Drugs NSAIDs decrease rates of dysmenorrhea and also have significant improvement in clotting and decreasing menstrual blood loss. Vargyas and colleagues evaluated 42 patients with menorrhagia in a placebo crossover trial where patients served as their own control and noted that meclofenamate 100 mg by mouth every 8 hours during menses demonstrated a 50% to 80% reduction in blood loss as measured with the alkaline hematin assay, with proper use.25 Additional improvement in clinical symptoms has also been documented when patients begin NSAIDs 1 or 2 days before menses. It can also be combined with OCPs if needed. Patients with bleeding disorders and platelet abnormalities should avoid all NSAIDs.

Progesterone Therapy Progesterone therapy is effective in women with anovulatory menstrual cycles. It stabilizes disordered and exaggerated proliferative endometrium with stromal dysharmony and promotes cyclic sloughing of the endometrium. Cyclic progesterone is useful in women with contraindications to estrogen therapy (women older than 35 years who smoke and women with a history of deep vein thrombosis, or higher cardiovascular risk factors). Generally, medroxyprogesterone acetate 10 mg for 10 to 14 days each month induces a regular withdrawal bleed in anovulatory women. This does not provide contraception. In patients with ovulatory AUB this regimen is insufficient, and a longer course of treatment is required. Progestins should be given between days 5 and 21 of the menstrual cycle. This decreases the amount of menstrual blood loss, but this regimen is associated with a higher incidence of progesterone side effects including bloating, irritability, fatigue, and premenstrual dysphoria. Long-acting progesterone therapy in the form of depo medroxyprogesterone acetate (DMPA, Depo-Provera) stops menses in the majority of patients. Standard dosing is DMPA 150 mg IM every 3 months. Approximately, 80% to 90% of patients completing 12 months of DMPA will be amenorrheic. Side effects can include weight gain, irregular bleeding, and depression.

Medical Therapy and von Willebrand disease Medical options that successfully treat women with vWD include OCP therapy, desmopressin acetate (DDAVP),

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Investigation of Abnormal Uterine Bleeding in Premenopausal Women antifibrinolytic agents, and plasma-derived concentrates rich in the high-molecular-weight multimers of vWF. Obviously, hysterectomy or surgical therapy should not be the first option; rather, medical therapy is paramount for these women. DDAVP, which is available in concentrated form (1.5 mg/mL; Stimate) can be administered intranasally (2 sprays for the first 2 or 3 days) during menstruation or intravenously before procedures, DDAVP releases stored vWF from within endothelium and reduces bleeding in patients with type 1 vWD, some forms of type 2 vWD, platelet function disorders, and hemophilia carriage.26

Potential New Drugs Tranexamic acid is an antifibrinolytic agent that is currently not available in the United States, but clinical trials are under way to determine safety and effectiveness. Results of studies outside the United States are promising and demonstrate significant decline in menstrual blood loss. Side effects include muscle cramps and nausea occurring in one third of patients.

A

SURGICAL MANAGEMENT Polyps It is rare for women younger than 20 years to develop endometrial polyps. However, many studies demonstrate that 25% to 60% of women evaluated for abnormal bleeding have uterine polyps.27 Metrorrhagia (irregular bleeding) is the most common menstrual abnormality detected. Less-common symptoms include leukorrhea, postcoital staining, prolapse through the cervix, and breakthrough bleeding with OCPs. Larger polyps occur in women using tamoxifen and often cause leukorrhea and irregular menstruation. When polyps are removed completely, menstrual aberrations resolve. Endometrial polyps arise from the endometrium and may be sessile or pedunculated (Figs. 10–13 and 10–14). They vary in size from a few millimeters to several centimeters. Usually single polyps are found, although some patients have multiple polyps. Most polyps are benign; however, some are associated with endometrial hyperplasia with and without atypia or endometrial cancer.28 Some polypoid growths have been found to be malignant mesenchymal uterine tumors.29 Polyps are well imaged with hysteroscopy and SIS. They are not imaged well with TVUS or MRI. Hysteroscopic resection, when complete, is curative and associated with a low reoccurrence rate.

B Figure 10–13 A, Large hemorrhagic polyp. B, Small polyp near the right tubal ostia. Removal demonstrated an endometrial polyp with complex hyperplasia without atypia.

Leiomyomas Uterine fibroids are a common cause of menstrual abnormalities. The mechanism for AUB caused by uterine fibroids is poorly elucidated. Several theories exist regarding the etiology and are listed in Box 10–4.30 Office hysteroscopy with SIS rapidly detects intracavitary lesions (Figs. 10–15 to 10–20). The size, number, and location of leiomyomas is best determined by SIS. Cicinelli and colleagues31

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BOX 10–4 Theories of Uterine Bleeding Caused by Uterine Fibroids Ulceration over the surface of the fibroid Increased surface area of the uterine cavity due to intramural or submucosal fibroids Abnormalities in local venous drainage (congestion and dilation of venous plexus) contributing to venular ectasia Increased vascularity of uterus Variability in prostaglandin production Platelet dysfunction Inhibited uterine contractions decrease expulsion by uterine contractions Impaired endometrial hemostasis Microscopic or macroscopic abnormalities of the uterine vasculature (more expandable venules)

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Figure 10–14 Endometrial polyp arising from the lower uterine segment. Figure 10–16 Leiomyoma with cystic blebs on the distal tip. Resection demonstrated benign leiomyomas.

Figure 10–15 Two opposing leiomyomas, often called kissing lesions.

compared the accuracy of methods for detecting submucosal fibroid size and myometrial growth in women scheduled for hysterectomy. All patients underwent TVUS, transabdominal SHG, and hysteroscopy. Physicians were blinded to results. Transabdominal SHG most accurately predicted size and myometrial ingrowth of fibroids. Hysteroscopy was the least accurate in detecting size of the myoma, which may be due to the optical refractive index associated with hysteroscopy. Complete hysteroscopic resection of leiomyomas is therapeutic and curative.

Endometrial Cancer

Figure 10–17 A patient with profuse menorrhagia had two intracavitary fibroids. Benign leiomyomas were resected.

and it doubles from 2.8 cases per 100,000 in those aged 30 to 34 years to 6.1 cases per 100,000 in those aged 35 to 39. Among women aged 40 to 49 years, the incidence of endometrial carcinoma is 36.5 cases per 100,000. ACOG guidelines recommend endometrial biopsy in women who are older than 35 years and have increased risk for endometrial hyperplasia and endometrial cancer.32 Risk factors include: ●

Incidence of endometrial cancer increases with age. The incidence is 10.2 cases per 100,000 in women aged 10 to 39 years,

● ●

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Figure 10–20 Broad-based leiomyoma arising from the lateral uterine wall.

Figure 10–18 Stalk of a pedunculated leiomyoma arising from the anterior uterine wall.

Figure 10–21. Hysteroscopic view of a friable and fragile endometrium. The uterus was difficult to distend. Endometrial biopsy was consistent with endometrioid uterine cancer.

Figure 10–19 A patient with anovulatory cycles was treated with progestin therapy. Unresponsiveness to progestin therapy led to hysteroscopy, which demonstrated a broad-based myoma arising near the lower uterine segment. Pseudodecidual changes were noted circumferentially.

● ● ● ● ●

weight greater than 90 kg, age older than 45 years, infertility, nulliparity, and family history of colon cancer.33 Although endometrial cancer is less likely than endometrial polyps and fibroids to be a cause of bleeding in the premenopausal woman, maintaining a high index of suspicion is key (Figs. 10–21 to 10–23).

Long history of irregular cycles Unopposed estrogen therapy Tamoxifen use Suspected polycystic ovarian syndrome Strong family history of ovarian, breast, or colon cancer

One study evaluated the risk factors for developing endometrial hyperplasia and endometrial cancer in 1033 premenopausal women with menstrual aberrations. Variables associated with the greatest risk of hyperplasia or malignancy included body

Adenomyosis Adenomyosis is defined as ectopic endometrium within the myometrium. Symptoms include severe dysmenorrhea, menstrual aberrations, dyspareunia, and a boggy, tender uterus on

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A

Figure 10–22 Saline infusion sonography, sagittal view, consistent with bridging and thickened endometrium. The uterus was difficult to distend. Endometrial biopsy was consistent with uterine cancer.

B Figure 10–24 A, Glandlike openings consistent with adenomyosis. B, Glandlike openings with periglandular hyperemia are classic findings consistent with adenomyosis.

Figure 10–23 Coronal view of an endometrial cancer.

bimanual examination. The gold standard diagnosis is usually made by MRI imaging. TVUS might demonstrate myometrial cysts. Hysteroscopy might demonstrate glandlike openings in 10% to 15% of patients. These openings are best imaged right after menses. Blood on occasion may be seen egressing into the openings. They also look like small pits in the uterus, surrounded by hyperemia endometrium. Adenomyosis also can appear as bluish discoloration. Most often adenomyosis occurs in the posterior wall and fundus (Fig. 10–24).

Endometrial Hyperplasia Endometrial hyperplasia occurs throughout the reproductive life cycle. Classically, it is more often suspected among women with obesity, hypertension, diabetes, and a long history of irregular menstruation. When bleeding does not respond to medical

therapy, hysteroscopy can identify classic findings consistent with endometrial hyperplasia (Figs. 10–25 and 10–26). Hyperplastic endometrium can be global or localized. Fragile, thin endometrium with bridging between layers of the endometrium may be seen. With SIS, a mismatch between the thickness of the anterior and posterior endometrium is noticeable (>2-3 mm difference). Directed biopsies are helpful in identifying lesions.

Abnormal Uterine Bleeding after Uterine Fibroid Embolization After uterine fibroid embolization (UFE), a serosanguinous discharge occurs in approximately one third of patients. Usually, the bleeding is self-limited and resolves within 3 to 5 weeks. However, some patients complain of leukorrhea or irregular bleeding following UFE.

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A Figure 10–25 Bridging between the anterior and posterior wall; biopsy was consistent with endometrial hyperplasia.

Most patients who undergo UFE do not have intracavitary pathology. However, it is conceivable that some intracavitary fibroids develop iatrogenically after UFE. Symptoms can include profuse leukorrhea or bleeding. Patients may be evaluated by office hysteroscopy or SIS (Figs. 10–27 to 10–31).

Pregnancy-Related Bleeding In the reproductive age patient, complications of pregnancy must be always considered. Temporally, most pregnancy-related bleeding occurs close to the time of a recent pregnancy.34 However, aberrant bleeding may be seen weeks, months, and even years later. Placental remnants, placental nodules, and trophoblastic disease may be prime culprits accounting for the bleeding. Although termination of pregnancy is now legal, some patients are not always honest when queried about pregnancy. Now that pregnancies can be terminated surgically and medically, the incidence of pregnancy-related complications is on the rise. Several publications35 have described the unique clinical presentation and treatment of bony fragments and retained bone as a culprit of menstrual dysfunction. Many cases are detected due to subinfertility. Retained fetal bone can manifest with irregular menstrual bleeding, dyspareunia, passage of bony tissue, disabling dysmenorrhea, chronic discharge, or pelvic pain. Lewis and colleagues36 measured menstrual loss and prostaglandin E2 (PGE2) levels before and after removal of bony ossification and noted a 50% reduction in menstrual blood loss and prostaglandin levels with removal of fetal bone. Reported cases have occurred usually within 8 weeks of pregnancy termination, but some have occurred as long as 23 years after pregnancy termination.37 The sentinel findings are usually detected by TVUS. Classic ultrasonographic findings include intensely linear bright echogenic focus within the endometrium, which has a similar appear-

B Figure 10–26 A, Focal findings consistent with endometrial hyperplasia. B, Patient taking tamoxifen for 4 years had irregular bleeding. She underwent hysterectomy for irregular menses and endometrial complex hyperplasia without atypia. The hysterectomy specimen demonstrates copious thickened endometrium.

ance to retained IUD, calcified submucosal fibroid, or Asherman syndrome. If a blind D&C is performed, the isolated echogenic foci often persist. However, hysteroscopy guided by a wire loop can bluntly (without cautery) displace endometrium and unroof the bony fragments. Using abdominal ultrasound simultaneously ensures the complete removal of the echogenic plaque. The disappearance of the echogenic plaque is completely noted by abdominal ultrasound. The appearance has been described as looking like a coral reef, with a fan-shaped appearance; thin, calcified, mesh-like bone in the stroma; and white plaques within the endometrium. Histologically, the final diagnosis is often

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Figure 10–29 Close-up view of a necrotic intracavitary leiomyoma following uterine fibroid embolization.

Figure 10–27 Hysteroscopic view of necrotic intracavitary leiomyoma seen after uterine fibroid embolization. Symptoms occurred 6 months after the procedure. No intracavitary lesions were noted on the work-up before magnetic resonance imaging.

5 cm Figure 10–28 An HIV patient underwent uterine fibroid embolization with a known intracavitary leiomyoma. Persistent copious discharge began within 2 months of the procedure and required hysterectomy.

consistent with bony ossification or osseous metaplasia, and the endometrium often has chronic endometritis, plasma cell infiltrate, or lymphocytic infiltrate. Retained foreign bone can predispose to subinfertility by acting like an IUD, increasing prostaglandin production. Bone fragments can prevent implantation by interfering with blastocyst implantation. Although rare, bony ossification should be considered as a cause of irregular bleeding and secondary infertility. Hysteros-

Figure 10–30 Caseous degeneration after uterine fibroid embolization. The endometrium is closely approximated to this necrotic lesion. This close proximity or actual discontinuity of the endometrium overlying the treated myoma may be associated with leukorrhea.

copy ultimately treats this lesion, but TVUS is an important companion in aiding in the diagnosis (echogenic linear calcified lesion) within the endometrium. There are 4000 therapeutic abortions daily in the United States; with increased clinical acumen, this rare but disabling condition should not be missed by a gynecologist. Remember, hysteroscopy and ultrasound are complementary partners in evaluating menstrual disorders. Products of conception can be retained after miscarriage, pregnancy termination, vaginal delivery, and even cesarean section. Daily or intermittent profuse bleeding can occur, accompanied by cramping. Patients do not respond to OCP or

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Figure 10–31 Discontinuity of the endometrium in a patient who underwent uterine fibroid embolization and had continuous leukorrhea.

progesterone therapy. Most patients with suspected retained products of conception are treated by suction D&C. When bleeding does not respond to a blind suction D&C, strongly consider the persistence of retained products of conception. Under these circumstances, office hysteroscopy with saline distension is particularly helpful in elucidating the persistence of retained products of conception. When retained products of conception are discovered, these patients should be scheduled for operative hysteroscopy with wire loop blunt resection. Excellent visualization is the norm, and the wire loop can be used, often without electrical energy, to remove the retained products of conception. Amazingly, even small portions of products of conception can cause abnormal bleeding, and when they are removed, the bleeding resolves.

EMERGENCY HYSTEROSCOPY FOR ACUTE SEVERE UTERINE BLEEDING Patients who present with profound menorrhagia and are hemodynamically unstable should be quickly assessed for the cause of the bleeding. Immediate intervention can be lifesaving until all diagnostic, laboratory, or culture results are available. Once intravenous lines are placed and aggressive fluid resuscitation is begun, a Foley catheter with a 30-mL balloon can be inserted into the uterus to tamponade the bleeding site, stabilizing the patient until the work-up is complete.38 The balloon is inflated until the bleeding decreases and can remain until the patient improves (24-72 hours or even longer). Once the patient is stabilized, the balloon can be deflated slowly over 8 to 12 hours and removed. Some patients experience intense uterine contractions with the inflated balloon, which can require IV narcotics or a patient-controlled anesthesia pump. Emergency hysteroscopy with a high-flow distention pump is highly effective in establishing and treating menorrhagia in criti-

cally ill or unstable patients. Fraser39 noted that the incidence of intracavitary pathology increased as the amount of bleeding increased; 25% of those with a blood loss of less than 60 mL had abnormal findings, compared with 56% of those with moderate menorrhagia (60-120 mL blood loss) and 64% of those with severe menorrhagia (>120 mL blood loss). Despite excessive bleeding, the clots, debris, and endometrial chips that are encountered during hysteroscopy can be easily flushed away or removed, and they aid in establishing a diagnosis and treating the patient concomitantly.40 One study of emergency hysteroscopy for menorrhagia found benign pathology in 40 of 41 women treated. Endometrial cancer was found in one postmenopausal woman. All other women had benign pathology including polyps, fibroids, adenomyosis, and atrophic endometrium. No patients required additional surgical therapy within 1 year of evaluation. Emergency hysteroscopy offers excellent outcomes, improves diagnosis, provides immediate therapy for endometrial pathology, and identifies patients who require further evaluation and treatment.40 Polyps are commonly detected during evaluation of heavy menstruation. Hysteroscopic polypectomy alone has an excellent success rate of 93.7%. When endometrial resection is performed in addition to hysteroscopic polypectomy, the success rate is 98.3%.41 If medical therapy or an intrauterine balloon has not been effective, then direct hysteroscopic evaluation of the endometrium in the operating room is necessary. A fluid management pump coupled with a continuous-flow hysteroresectoscope provides excellent visualization of the uterine cavity. Evacuation of the clots is important and can be accomplished with a suction curette or by using the wire loop to remove large clots under direct view. A dilute solution of vasopressin (20 U vasopressin/ 100 mL normal saline) is injected in 5 mL aliquots circumferentially into the cervical stroma at the 12, 3, 6, and 9 o’clock positions. This decreases fluid absorption and can decrease bleeding. Hysteroscopy under these circumstances can be tedious but very worthwhile, because intracavitary lesions are commonly found. Use the highest intrauterine pressure (100120 mm Hg) to obtain excellent uterine distension. Once the blood has cleared, the intrauterine pressure may be lowered.

SUMMARY The reproductive-age patient can experience menstrual aberrations due to many causes. For many women, hormonal aberrations (anovulatory cycles) are the cause. For others, structural abnormalities and, less often, newly acquired blood dyscrasias are the cause. Abnormal uterine bleeding is usually well categorized after the initial history, physical examination, and laboratory evaluation. Regardless of the patient’s age, AUB requires an aggressive work-up. Medical management is the hallmark unless uterine pathology is suspected. Most patients respond favorably to hormonal contraceptive therapy, NSAIDs, or progesterone treatment. Fortunately, for those patients who cannot tolerate medical therapy, the new levonogesterol IUS is effective in treating

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Investigation of Abnormal Uterine Bleeding in Premenopausal Women abnormal menstruation. When patients fail to respond to medical management, TVUS, hysteroscopy, and SIS are particularly helpful in detecting intracavitary lesions. Incorporating hysteroscopy and SIS into the clinical algorithm, rather than using TVUS alone, increases the sensitivity of identifying intracavitary lesions, which, even when they are small, may be the cause of AUB. Patients with intrauterine polyps and submucosal fibroids have excellent relief of symptoms following operative hysteroscopy.

Women with symptomatic uterine fibroids now have a wide array of options, including medical therapy, myomectomy (abdominal, laparoscopic, hysteroscopic), hysterectomy, or uterine fibroid embolization. Finally, surgical therapy with endometrial ablation offers 90% success in treating menorrhagia and dysfunctional bleeding in women with a normal uterine cavity and negative workup who do not desire children. In this era of many alternative medical and surgical treatments, fortunately, hysterectomy is the last resort for dysfunctional uterine bleeding.

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Cote I, Jacobs P, Cumming DC: Use of health services associated with increased menstrual loss in the United States. Am J Obstet Gynecol 2003;188:343-348. Jones GL, Kennedy SH, Jenkinson C: Health-related quality of life measurement in women with common benign gynecologic conditions: A systematic review. Am J Obstet Gynecol 2002;187:501511. Shaw RW, Brickley MR, Evans L, et al: Perceptions of women on the impact of menorrhagia on their health using multi-attribute utility assessment. BJOG 1998;105:1155-1159. Vilos GA, Lefebvre G, Graves GR: Guidelines for the management of abnormal uterine bleeding. Society of Obstetrics and Gynaecology of Canada (SOGC) Clinical Practice Guidelines. J Obstet Gynaecol Can 2001;23:704-709. Ginsburg D, Wagner D: Structure, biology, and genetics of von Willebrand factor. In Hoffman R (ed): Hematology: Basic Principles and Practice, 3rd ed. New York: Churchill Livingstone, 2000, pp 1937-1945. Favaloro EJ: Utility of the PFA-100 for assessing bleeding disorders and monitoring therapy: A review of analytical variables, benefits and limitations. Haemophilia 2001;7:170-179. Treloar AE: Menstrual cyclicity and the pre-menopause. Maturitas 1981;3:249-264. Santoro N, Adel T, Skurnick JH: Decreased inhibin tone and increased activin A secretion characterize reproductive aging in women. Fertil Steril 1999;71:658-662. Soules MR, Sherman S, Parrott E, et al: Executive summary: Stages of Reproductive Aging Workshop (STRAW), Park City, Utah, July 2001.Menopause 2001;8:402-407. Seltzer VL, Benjamin R, Deutsch S: Perimenopausal bleeding patterns and pathologic findings. J Am Med Womens Assoc 1990;45:132134. Landgren BM, Collins A, Csemiczky G, et al: Menopause transition: Annual changes in serum hormonal patterns over the menstrual cycle in women during a nine-year period prior to menopause. J Clin Endocrinol Metab 2004;89:2763-2769. Henrich JB, Hughes JP, Kaufman SC, et al: Limitations of folliclestimulating hormone in assessing menopause status: Findings from the National Health and Nutrition Examination Survery (NHANES 19992000). Menopause 2006;13:171-177. Santoro N: Doctor, can you order that menopause test? Menopause. 2006;13:158-159. Rose P: Endometrial cancer. N Engl J Med1996;335:640-649. Wade SW, Magee G, Metz L, Broder MS: Cost-effectiveness of treatments for dysfunctional uterine bleeding. J Reprod Med 2006;51:553-562. Huang GS, Gebb JS, Einstein MH, et al: Accuracy of preoperative endometrial sampling for the detection of high-grade endometrial tumors. Am J Obstet Gynecol 2007;196:243-244.

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Dijkhuizen FP, Mol BW, Brolmann HA, Heintz AP: The accuracy of endometrial sampling in the diagnosis of patients with endometrial carcinoma and hyperplasia. Cancer 2000;89:1765-1772. Bettocchi S, Ceci O, Vicino M, et al: Diagnostic approach of dilation and curettage. Fertil Steril 2001;75:803-805. Breitkopf D, Frederickson R, Snyder R: Detection of benign endometrial masses by endometrial stripe measurement in premenopausal women. Obstet gynecol 2004;104:120-125. Goldstein SR, Zeltser I, Horan CK: Ultrasonography-based triage for perimenopausal patients with abnormal uterine bleeding. Am J Obstet Gynecol 1997;177:102-108. Widrich T, Bradley L, Mitchinson AR, Collins R: Comparison of saline infusion sonography with office hysteroscopy for the evaluation of the endometrium. Am J Obstet Gynecol 1996;174:1327-1334. Higham JM, Shaw RW: A comparative study of danazol, a regimen of decreasing doses of danazol and norethindrone in the treatment of objectively proven unexplained menorrhagia. Am J Obstet Gynecol 1993;169:1134-1139. Scialli A, Levi A: Intermittent leuprolide acetate for the nonsurgical management of women with leiomyomata uteri. Fert Steril 2000; 74(3):540-546. Hurskainen R, Teperi J, Rissanen P, et al: Quality of life and costeffectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy, for treatment of menorrhagia: A randomized trial. Lancet 2001;357:273-277. Vargyas JM, Campeau JD, Mishell DR: Treatment of menorrhagia with meclofenamate sodium. Am J Obstet Gynecol 1987;157:944950. Lethagen S: Desmopressin (DDAVP) and hemostasis. Ann Hematol 1994;69:173-180. Shveiky D, Rojansky N, Revel A, et al: Complications of hysteroscopic surgery: “Beyond the learning curve.” J Minim Invasive Gynecol 2007;14:218-222. Savelli L, De Iaco P, Santini D, et al: Histopathologic features and risk factors for benignity, hyperplasia, and cancer in endometrial polyps. Am J Obstet Gynecol 2003;188:927-931. Shushan A, Revel A, Rojansky N: How often are endometrial polyps malignant? Gynecol Obstet Invest 2004;58:212-215. Stewart EA: Uterine fibroids. Lancet 2001;357:293-298. Cicinelli E, Romano F, Anastasio PS, et al: Transabdominal sonohysterography, transvaginal sonography, and hysteroscopy in the evaluation of submucous myomas. Obstet Gynecol 1995;85:4247. American College of Obstetricians and Gynecologists: ACOG Practice Bulletin: Management of anovulatory bleeding. Int J Gynaecol Obstet 2001;72(3):263-271. Farquhar CM, Lethaby MA, Sowter MD: An evaluation of risk factors for endometrial hyperplasia in premenopausal women with abnormal menstrual bleeding. Am J Obstet Gynecol 1999;181:525-529.

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Hakim-Elahi E, Tovell HM, Burnhill MS: Complications of firsttrimester abortions: A report of 170,000 cases. Obstet Gynecol 1990;76:129-135. 35. Elford K, Claman P: Novel treatment of a patient with secondary infertility due to retained fetal bone. Fert Steril 2003;79(4):10281030. 36. Lewis V, Khan-Dawood F, King M, et al: Retention of fetal bone increases menstrual prostaglandins. Obstet Gynecol 1990;75:561-563. 37. Basu M, Mammen C, Owen E: Bony fragments in the uterus: An association with secondary subfertility. Ultrasound Obstet Gynecol 2003;22:402-406.

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March CM: Bleeding problems and treatment. Clin Obstet Gynecol 1998;41:928-939. 39. Fraser IS: Hysteroscopy and laparoscopy in women with menorrhagia. Am J Obstet Gynecol 1990;165:1264-1269. 40. Shalev J, Levi T, Orvieto R, et al: Emergency hysteroscopic treatment of acute severe uterine bleeding. J Obstet Gynecol 2004; 24(2):152-154. 41. Polena V, Mergui JL: Long-term results of hysteroscopic resection of endometrial polyps in 367 patients. Role of associated endometrial resection. Gynecol Obstet Fertil 2005;33:382-385.

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11

Investigation of Abnormal Uterine Bleeding in Postmenopausal Women Linda D. Bradley

Most women spend one third of their lives after the menopause. For most women, the reproductive organs are senescent. Longevity, obesity, endogenous production of estrogen, and hormonal therapy invariably lead to episodes of postmenopausal bleeding (PMB). After years of amenorrhea, the onset of any bleeding leads to physician and patient concern. Even small amounts of bleeding need prompt and thorough evaluation.

ENDOMETRIAL CANCER Endometrial cancer is the most common genital female malignancy.1 In 2005, there were 41,000 cases of endometrial cancer.2 It is the fourth most common cancer in women, ranking behind breast, bowel, and lung cancers. Endometrial cancer is twice as common as ovarian cancer and three times more common than invasive carcinoma of the cervix. Average age of diagnosis is 65 years, and the lifetime risk of diagnosis of endometrial cancer is 2.7%. Endometrial cancer accounts for almost half of all new cases of genital cancer. It usually has an excellent prognosis and is often referred to as the “curable cancer” due to early detection and surgical intervention. Overall 5-year survival of endometrial cancer is 86%, and when the disease is confined within the uterus, survival rates peak at 97% at 5 years. A sobering statistic demonstrates the disparity between white and black patients with endometrial cancer. Although more white women develop endometrial cancer than African American women, African American women have a higher mortality rate than white women. African American women have a later diagnosis, more advanced stage, and a more lethal histologic subtype (serous tumors) of endometrial cancer than white women. The uncorrected survival rate for endometrial cancer is 75%. Moreover, the low death rate from endometrial cancer, which contributes to 23% of all gynecologic cancer deaths, is usually due to early detection coupled with prompt surgery. Currently, fewer than 4,000 women die of endometrial cancer per year. Although the total death rate for endometrial cancer has decreased since 1980s, endometrial cancer is not an indolent

disease. Earlier diagnosis leads to improved survival and better outcomes. Endometrial cancer rates peaked in 1979 and have declined since then. The increased incidence, witnessed in the 1970s, was likely due to unopposed estrogen therapy, which was commonly prescribed by the medical community. Now it is known that women who desire hormone replacement therapy (HRT) should also take a daily progestin or at least 12 days of progesterone with estrogen therapy. Prolonged unopposed estrogen therapy is not indicated in women with an intact uterus or prior endometrial ablation. Most patients with endometrial cancer are symptomatic and present with PMB or a lengthy bout of perimenopausal bleeding. Stage for stage, endometrial cancer is just as lethal as ovarian cancer; however, the tangible hallmark symptoms–namely, PMB, pelvic cramping, or unexplained chronic vaginal discharge–should prompt early investigation. Patients and physicians must not ignore subtle symptoms. With early identification and initiation of treatment, better prognosis is assured. Almost 75% of cases of endometrial cancer occur in women older than 50 years, and less than 5% of cases occur in women younger than 40 years. There are more cases of uterine cancer in the advanced geriatric population (>65 years) than in women between ages 45 and 55.3 In younger women, endometrial cancer is most often associated with obesity, chronic anovulation, long history of abnormal bleeding, and coexisting ovarian malignancy. Clinicians must evaluate abnormal bleeding aggressively in older women, because 95% of endometrial cancers occur in women 40 years and older and because endometrial hyperplasia, the precursor state, can precede the diagnosis.4 Some women are asymptomatic and fortuitously identified by a thickened endometrial echo on transvaginal ultrasound (TVUS) performed for other indications or when the uterus is removed for other indications. When the highest risk factors for endometrial cancer are grouped—diabetes (when due to obesity), nulliparity, age greater than 70 years, and vaginal bleeding—87% of those women have endometrial cancer.5 Ovarian cancer and cervical cancer occur in 3% of women with PMB.6 Fallopian tube carcinoma, a true rarity, must also

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women be considered when persistent vaginal bleeding occurs despite a negative evaluation of the endometrium. These statistics should not be forgotten, especially in the patient who continues to bleed after a negative evaluation of the uterine cavity. Remember to image the adnexa when endometrial evaluation is unremarkable.

POSTMENOPAUSAL BLEEDING PMB is defined as any bleeding that occurs 12 months after the last menstrual period. Noncyclic vaginal bleeding in postmenopausal women receiving HRT warrants evaluation. The average age of menopause has remained steady, occurring in 80% of women by age 51 in and 95% of women by age 55, with virtually all women experiencing cessation of menses by age 58. The highest rate of postmenopausal bleeding occurs within the first year after spontaneous amenorrhea and gradually declines thereafter. This is due to the responsiveness of the endometrium and possibility because a few remaining oocytes precipitate estrogen secretion. A prospective observational population study of 297 postmenopausal women completed 1 year of daily recording of bleeding. Postmenopausal bleeding occurred in 409 per 1000 person-years in the first year immediately after menopause. When more than 3 years elapsed, the rate plummeted to 42 per 1000 person-years.7 Luckily, only 5% to 20% of women with postmenopausal bleeding have endometrial cancer or endometrial hyperplasia.8 Currently, the American Cancer Society guidelines state that there is no proven role of screening asymptomatic women who have an average risk of endometrial cancer.9 Even among symptomatic women taking tamoxifen, no surveillance of the endometrium is advocated. Outpatient evaluation is preferable, when possible, to evaluate PMB. Outpatient evaluation, especially with office hysteroscopy or saline infusion sonography (SIS, also known as sonohysterography [SHG]) is efficient, cost-effective, and well tolerated and has comparable accuracy to inpatient evaluation.

sure that I have not missed a focal lesion?” Karlsson and colleagues reviewed 1168 cases of postmenopausal bleeding with TVUS followed by D&C.11 The study group included 351 women taking HRT, who were between ages 41 and 91 years. Karlsson’s group found that more than 59% of cases of PMB were due to endometrial atrophy; polyps (12%); endometrial hyperplasia (9.8%); endometrial cancer (10%); hormonal effect (7%); hydrometra, pyometra, and hematometra (2%); and cervical cancer (<1%). Consistently, polyps appear as the most common benign structural abnormality in women with postmenopausal bleeding who are evaluated by SIS or hysteroscopy, especially those with breast cancer treated with tamoxifen (Fig. 11–1).12 Tamoxifen has both antiestrogenic and estrogenic effects on the endometrium. The antiestrogenic effects cause atrophy leading to thin, fragile, atrophic endometrium with superficial petechial lesions that bleed easily. Because endometrial cancer is rare, it is most helpful to use less-invasive diagnostic tests that have a high negative predictive value and high sensitivity, thereby reliably excluding cancer, but that can detect intracavitary lesions that can cause bleeding.13

Clinical Symptoms Luckily, most women with endometrial cancer are symptomatic. Sometimes the symptoms are subtle, but clinicians must be astute and question postmenopausal women in detail at annual visits. Unlike ovarian cancer, the silent killer, endometrial cancer patients usually complain of abnormal bleeding, pelvic cramping, or vaginal discharge, albeit in subtle and dismissive ways. Quite often the patient minimizes the amount of bleeding, stating, “I only see a little spot of blood now and then.” As gynecologists, we too are dismissive, because the amount of bleeding seems innocuous. If the patient admits to even a smidgen of blood, gynecologists are obligated to investigate thoroughly. Be persistent. Additional complaints can include abnormal discharge,

Evaluation What modality is best to evaluate women presenting with postmenopausal bleeding? Options include office endometrial biopsy, dilation and curettage (D&C), office hysteroscopy, TVUS, SIS, computed tomography (CT), magnetic resonance imaging (MRI), and three-dimensional (3D) ultrasound. Although 5% to 15% of all gynecologic visits are for the evaluation of postmenopausal bleeding, the correct work-up and triage is still confusing for most clinicians.10 Traditionally, endometrial biopsy was considered the gold standard for the evaluation. If the biopsy was normal, then the clinician and patient were both reassured. The challenge, however, is the two thirds of patients with PMB who have an endometrial biopsy that demonstrates endometrial atrophy or tissue insufficient for diagnosis. When the clinician obtains results of atrophy, the perpetual question or query is, “Am I

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Figure 11–1 A large hemorrhagic polyp in a patient taking tamoxifen.

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women staining, frank blood, and cramping. In fact, 80% of patients with endometrial cancer experience abnormal bleeding, and 10% have leukorrhea. Women should be taught any vaginal bleeding after the menopause needs prompt evaluation. The amount of bleeding is not correlated with the stage of endometrial cancer. Characteristics of bleeding include spotting, mild staining, or frank bright red blood. A subtle but very important clinical caveat is to inquire about abnormal vaginal discharge. The vast majority of women in menopause have vaginal atrophy and annoying vaginal dryness. Vaginal moisture (when not due to urinary incontinence) is unusual. Women subsequently found to have endometrial hyperplasia or endometrial cancer often complain of varying types of discharge from clear to faint pink, serosanguinous, or bright red. Sometimes heavy bleeding and a discharge with associated clotting occur. Pelvic cramping, another subtle complaint, may be due to cervical stenosis or cervical synechiae that prevent egress of blood. Pyometria and hematometra can coexist with postmenopausal bleeding. This may be preceded by uterine cramping or a feeling that “my period feels like it is coming on.” Those with advanced and extrapelvic disease can present with pelvic or uterine cramping, pelvic pressure, back pain, or fever of unknown origin before frank bleeding is noted. The bleeding may be episodic, and length of time ranges from days to months before the patient seeks care. The risk of endometrial cancer increases as the number of years since the last menstrual period elapses. A patient who notes vaginal bleeding more than 10 years since her last menses has a higher risk of uterine cancer than one who recently stopped menstruating. Likewise, women on unopposed estrogen therapy and tamoxifen have a higher incidence of endometrial cancer than women not taking those medications.

Risk Factors Although endometrial cancer accounts for less than 10% of the causes of postmenopausal bleeding, the work-up must be exhaustive before a benign etiology is determined. The survival of patients with endometrial cancer is influenced by stage, grade of disease, and histology. The risk of endometrial cancer increases with each decade of life, such that at age 50, 1% of cases are due to endometrial cancer, and by age 80, 25% of cases of postmenopausal bleeding are due to cancer.14 Risk factors for endometrial cancer include obesity, unopposed estrogen therapy, prolonged tamoxifen use, anovulation, polycystic ovarian syndrome, estrogen-secreting tumors of the ovary, nulliparity, late menopause, and history of complex endometrial hyperplasia with atypia. Medical illnesses associated with endometrial cancer include diabetes, hypertension, arthritis, and hypothyroidism. Obesity is clearly associated with increased risk of endometrial cancer. Women weighing more than 30 pounds over ideal weight have a threefold increased risk of developing endometrial cancer, and those 50 pounds or more over ideal weight have a tenfold increased risk. Other increased risk factors include nulliparity (double), diabetes (threefold), hypertension (1.5-fold), entering menopause after age 52 years

(2.5-fold), and increased bleeding at the time of menopause (fourfold). Patients taking unopposed exogenous estrogen therapy have a four-to 15-times greater risk, and 29% of patients with untreated complex hyperplasia with atypia develop endometrial adenocarcinoma. Newer studies estimate that 17% to 52% of women with endometrial hyperplasia with atypia concurrently have endometrial cancer. Although there are many theories for endometrial cancer, the greatest risk is found in patients in patients taking unopposed estrogen or with higher circulating levels of endogenous estrogen. The TVUS endometrial measurement (endometrial echo or endometrial stripe) is helpful in categorizing patients into a lowrisk or a high-risk group. The exact cutoff measurement chosen is a function of the sensitivity and specificity sought. Most clinicians use a cutoff of 5 mm to define a low-risk patient group, whose combined risk for cancer and atypical hyperplasia ranges from 2% to 3%. The initial goal of ultrasound was not to replace endometrial biopsy but to decrease the number of endometrial biopsies needed.15 Ultrasonographers painstakingly sought to find the magic endometrial echo number, for which the likelihood of missing endometrial cancer would be exceedingly low.16 Stratification of patient risks into low-risk groups include less than 70 years, multiparity, bleeding that occurs within 1 year of menopause, and a no diabetes. In contrast, patients with an endometrial echo of greater than 5 mm have an increased risk of endometrial cancer and atypical hyperplasia approaching 5% or more. Patients with all four risk factors—diabetes, nulliparity, age greater than 70 years, and bleeding that occurs more than 1 year after menopause—have an 80% risk for endometrial cancer or complex hyperplasia. Unfortunately, many articles evaluating the usefulness of the endometrial measurement have included asymptomatic patients, and therefore it is likely that patients presenting with bleeding have a higher detection rate than asymptomatic patients. Remain vigilant in the work-up of your patients with postmenopausal bleeding. TVUS, SIS, and office hysteroscopy are not mutually exclusive studies; they are complementary tools. When the patients’ bleeding persists despite a negative biopsy or normal transvaginal ultrasound, continue to look again with additional technology. If only TVUS and endometrial biopsy were initially used, then consider direct inspection of the endometrium with office hysteroscopy or SIS if bleeding recurs. The interface created by fluid during SIS delineates intraluminal defects well. Likewise, direct visualization of the endometrium with hysteroscopy detects intracavitary pathology.17 Several authors have found that when then initial endometrial biopsy was negative, on follow-up, 20% of women with persistent or episodic vaginal bleeding were ultimately found to have either complex atypical hyperplasia or cancer.18

CLINICAL PEARL ●

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Vigilance and using additional technology is important to minimize missing intracavitary pathology.

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women EVALUATION History and Physical Examination A detailed history and physical examination should be obtained for all patients presenting with postmenopausal bleeding. Query the patient about current or recently discontinued medications. Inspect the vagina, vaginal fornices, vulva, and urethra thoroughly. Urethral prolapse may be the cause of the vaginal bleeding (Fig. 11–2). Genital and vulvar lesions must not be overlooked. Biopsy any palpable or visible lesions. Any vulvar lesion with chronic excoriation should be biopsied liberally. Vaginal atrophy is a common cause of abnormal bleeding. Thin, friable, tissue that bleeds easily spontaneously or with intercourse is common with each advancing decade. When vaginal atrophy is noted, excellent response to oral or topical estrogen therapy is the norm. It can take 8 to 12 weeks of continuous estrogen therapy to notice clinical improvement. Estrogen therapy increases vaginal blood flow, increases glycogen in vaginal cells, changes the pH from alkaline to acidic, increases the amount of lactobacillus, and increases collagen and elastic tissue within the vagina. These changes decrease the friability and fragility of the vaginal epithelium, thereby decreasing the frequency of vaginal bleeding associated with atrophy.

Cervical Cytology The Papanicolaou (Pap) test is not a screening method for endometrial cancer. However, the Pap test must be included in patients with PMB to exclude cervical or endocervical causes of bleeding. Liquid-based Pap smear is warranted for all women with new-onset postmenopausal bleeding, even when the patient has had a Pap test within 3 years. Even though newer cervical cytology guidelines propose less frequent Pap tests in the meno-

Figure 11–2 A 78-year-old woman presented with abnormal bleeding. A large urethral prolapse was detected. After repair and topic estrogen, her symptoms resolved.

pause, remember that there is a bimodal distribution of cervical cancer as well as its indolent endocervical adenocarcinoma counterpart. The mean age of cervical cancer diagnosis is 52 years, with bimodal peaks at age 35 years 39 and again at 60 to 64 years.2 Karlsson’s study of 1168 postmenopausal women11 found a 1% rate of cervical cancer among postmenopausal women studied. Paradoxically, some asymptomatic patients presenting for routine annual examination have endometrial cells detected on Pap. When benign endometrial cells are present on the Pap smear in asymptomatic postmenopausal women, endometrial cancer is rare. More often, atrophy or endometrial polyps are the cause of exfoliated endometrial cells detected on Pap among asymptomatic women. The ideal work-up of such patients is visualization with hysteroscopy or SIS. Although very uncommon, fallopian tube carcinoma must be considered in women with persistent postmenopausal bleeding.19 The mean age of patients with fallopian tube carcinoma is 69 years. Hysteroscopy is most often normal in women with fallopian tube carcinoma; however, a high index of suspicion should be maintained. TVUS is strongly advised for patients with persistent bleeding if hysteroscopy has been the only modality used in the evaluation. Classic findings of fallopian tube carcinoma include adnexal mass, abdominal pain, hydrosalpinx, watery vaginal discharge, and increased pelvic fluid.

ENDOMETRIAL BIOPSY AND TRANSVAGINAL ULTRASOUND Rationale Do we need to rethink the role of endometrial biopsy in evaluating the patient with postmenopausal bleeding? Is endometrial biopsy, when used alone, an outdated modality in evaluating postmenopausal bleeding? Most studies demonstrate the inadequacy of blind endometrial sampling, including D&C, in women with focal lesions.20 A blind endometrial pipelle biopsy is woefully inaccurate in detecting focal pathology. Increasingly, TVUS is proposed as the first-line, minimally invasive tool for evaluating postmenopausal bleeding. Visualization of the entire endometrial echo is imperative in order to determine the health of the endometrium. In general, if TVUS is used alone, an endometrial stripe that is well delineated in its entirety, is homogenous, and has no fluid and no irregularities is unlikely to harbor endometrial cancer when the endometrial echo is less than 5 mm and the patient has minimal risk factors.21 The adnexa should be imaged to rule out adnexal pathology. Using a threshold of less than 5 mm for endometrial echo is the most cost-effective diagnostic strategy for detecting endometrial cancer.22 However, an endometrial echo less than 5 mm can harbor other pathology that causes postmenopausal bleeding. Endometrial atrophy, polyps, endometritis, submucosal fibroids, pyometria, and proliferative and hyperplastic endometrium can be present with an endometrium less than 5 mm. Do not stop the work-up with an endometrial echo of less than

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women 5 mm in a symptomatic patient. Your patient had the initial test because of a complaint: bleeding. Listen to her story and evaluate thoroughly. Certainly the patient is reassured by being told that she does not have cancer. But what does she have that makes her bleed, now and then, or once in a while? A report indicating an endometrial echo less than 5 mm is very unlikely to be malignant, However, when symptoms persist or the amount of bleeding is profuse, reevaluate with direct visualization with hysteroscopy (preferably office based), hysteroscopically directed biopsy, or SIS. When a focal lesion is detected that cannot be completely removed in the office, ambulatory operative hysteroscopic surgery is indicated. Similarly, if a patient with postmenopausal bleeding has a thickened endometrial echo, especially greater than 5 mm, and has endometrial curettings obtained blindly or biopsy that is insufficient, additional evaluation with hysteroscopy or SIS is mandatory (Fig. 11–3). Most of these patients have a focally growing lesion that can be hysteroscopically resected. More than 50% of pathology will be missed using D&C alone. Benign pathology causes bleeding. Polyps and hyperplasia are culprits for bleeding. Less than 2% of polyps contain a malignancy, complex hyperplasia with atypia, or hyperplasia. Malignant changes within polyps can rarely be detected with ultrasound (including Doppler flow) or hysteroscopic visualization alone. Histologic evaluation is mandatory. Even small polyps (<2 cm) can be malignant.23 Utmost care must be taken when removing polyps in order to prevent total thermal damage to the specimen, so that it can be evaluated histologically. Ulceration, hemorrhage, increased surface vascularity, increased endometrial surface area, and progesterone insensitivity are possible causes of the bleeding. Operative hysteroscopy is crucial in all women with postmenopausal bleeding who have a focal lesion. Histologic evaluation of the focal lesion is necessary to make a diagnosis. A polypoid growth can actually be a focal area of hyperplasia, malignancy, or mesenchymal tumor.24

SIS

1 1

A

1 2

3

B

Transvaginal Ultrasonography A thorough review of the literature clearly indicates that in an endometrium that is seen entirely by TVUS and is homogenous, a thickness less than 5 mm likely does not harbor endometrial cancer. However, TVUS alone rarely can determine the presence of focal lesions. Meta-analysis of 35 studies involving 5892 women using an endometrial thickness cutoff found that a 5 mm cutoff had a greater than 92% sensitivity for detecting endometrial disease (polyps, atypical hyperplasia, or cancer) and a 96% sensitivity for detecting endometrial cancer. A postmenopausal woman with a 10% pretest probability of endometrial cancer thus had a 1% probability of cancer if her TVUS had an endometrial echo less than 5 mm.25 Tsuda and colleagues evaluated 600 postmenopausal women and used different endometrial echo cutoff values based on the number of years since menopause. If the patient was less than 5 years in the menopause, the endometrial echo was set at

C Figure 11–3 A 67-year-old woman who was taking hormone replacement therapy presented with postmenopausal bleeding. A “nondiagnostic” endometrium was noted on pipelle biopsy. A, Endometrial echo was 12 mm. B, Saline infusion sonography (SIS) demonstrates three intracavitary lesions. C, the three intracavitary lesions were confirmed at operative hysteroscopy. Polypectomy removed benign endometrial polyps.

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women 4 mm. If she was more than 5 years past menopause, the cutoff was 3 mm. TVUS demonstrated a 97.4% sensitivity, 75.7% specificity, 23.8% positive predictive value, and 99.7% negative predictive value.26 Gull and colleagues followed 394 Scandinavian women followed for 10 years. The subjects initially presented with PMB and had an endometrial echo less than 4 mm; and no cases of endometrial cancer were found by TVUS compared to curettage.16 A Nordic multicenter trial found no cases of endometrial cancer among 1168 women with PMB who had an endometrial echo less than 4 mm and underwent curettage.11 Fleischer and colleagues used TVUS to evaluate 1750 women (without PMB) for a selective estrogen receptor modulator (SERM) study.27 When the endometrial echo was less than 5 mm, the negative predictive value was 99.94% for excluding malignancy (1 cancer in 1750 women) and it was 99.77% for complex hyperplasia (4 in 1750 women). Gull and colleagues, using a 4-mm cutoff found only seven cancers in 1361 women.28 When Epstein and Valentin studied 97 women who had PMB and an endometrial echo less than 5 mm, no endometrial cancers were present.29 The data are very solid for use of TVUS in evaluating postmenopausal bleeding. Literature review supports a conservative approach when the endometrial echo is less than 4 mm in a postmenopausal woman. The risk of missing an endometrial cancer is low. However to rely upon TVUS, the endometrial echo should be fully visualized and should appear homogeneous and without fluid. If the endometrial echo is indistinct, not visualized, or irregular and has a heterogeneous appearance, then additional surveillance with SIS or hysteroscopy is mandatory. Additionally, if bleeding recurs despite a normal TVUS, then a direct view of the endometrium is necessary. Despite a TVUS endometrial echo of less than 4 mm, in patients with persistent bleeding, office hysteroscopy or SIS should be the next tool to evaluate for subtle intracavitary lesions. When the endometrial echo is greater than 4 mm, SIS or hysteroscopy should be performed. The distention of the endometrial cavity permits identification of focal lesions, polyps, fibroids, dyssynchrous endometrium, hyperplasia, and cancer. If a focal lesion is identified, then a targeted endometrial biopsy (with full removal of the lesion) is the most sensitive method of determining the cause of the increased endometrial thickness. If a diffusely thickened endometrium is identified, then a blind aspiration biopsy with a pipelle or electronic suction (Vabra) aspirate provides a sensitive analysis (Fig. 11–4). If endometrial biopsy yields insufficient or inadequate tissue for evaluation, if no endometrial tissue obtained, or if stenosis is encountered, then direct visualization of the endometrium should be performed and directed biopsies taken.

Figure 11–4 A 57-year-old woman presented with postmenopausal bleeding. She was not taking hormone replacement. Examination showed circumferential thickening of the endometrium. Pipelle biopsy confirmed complex endometrial hyperplasia without atypia.

review of 65 articles that evaluated 26,345 women and the role of hysteroscopy determined that a positive hysteroscopy increased the probability of endometrial cancer to 71.8%, whereas a negative result reduced the probability of cancer to 0.6%.30 De Jong and colleagues note that the sensitivity and specificity for the diagnosis of endometrial disease was 78% and 95.8%, respectively. For a positive result, the pretest probability increased from 10.6% to 55.2% and decreased to 2.8% with a negative result. All women having hysteroscopy should also have an endometrial biopsy that provides a tissue diagnosis.30 There is little evidence that there hysteroscopy poses a risk of dissemination of malignant cells and a worsening of the stage of endometrial cancer in women with uterine cancer.31 When this risk is analyzed more critically, it appears that the dissemination of malignant cells with hysteroscopy, whether performed with saline or CO2, is not the critical factor. Rather, poor prognosis is associated with tumor grade, deep myometrial invasion, and disease already present outside of the uterine cavity.32 Hysteroscopy performed in the operating room should be reserved for women who cannot tolerate office evaluation, who present with cervical stenosis, or who have recurrent unexplained bleeding despite previous evaluation. Office hysteroscopy is quick and comfortable, and it accurately details the number and size of lesions within the endometrium.33 Small 3mm flexible hysteroscopes are comfortable when hysteroscopy is performed in an office setting.34

HYSTEROSCOPY Hysteroscopy, preferably office based, is excellent in evaluating the endometrial cavity and endocervix. The false-negative rate of hysteroscopy is 3%. Hysteroscopy is more accurate than TVUS in detecting focal disease and has greater specificity. A

Principles of Hysteroscopy in the Postmenopausal Patient Hysteroscopy is more accurate in detecting intracavitary lesions, such as polyps and fibroids, than blind endometrial biopsy alone.

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women A study of 181 patients reported a sensitivity of 96.6% and a specificity of 100% when hysteroscopy was combined with endometrial biopsy.35 Hysteroscopists sometimes find it difficult to distinguish between proliferative, exaggerated endometrium and endometrial hyperplasia.36 This is why it is critical to also perform endometrial biopsy with hysteroscopy. Theoretically, the specificity and positive predictive value of hysteroscopy in cases of abnormal uterine bleeding is 100%. In practice, however, the false-negative rate is 2% to 4% and is the result of operator error in detecting abnormal endometrial lesions. Evaluation of the endometrium hysteroscopically in postmenopausal women must be regimented, through, and complete. The hysteroscopist should systematically evaluate the endometrial height, surface, and vascular architecture. Uterine distention media can include CO2 or saline. However, both may be complementary and used concurrently. The endometrial thickness is usually less than 5 mm in the postmenopausal woman. The endometrial thickness can be accessed by pressing the tip of the hysteroscope into the endometrium. Without estrogen, there should be no compression or indentation of the endometrium. Under the influence of estrogen, there may be a wave-like surface with pseudopolypoid projections. Whether using CO2 or saline, it is important to distend the endometrium to provide full visualization. Distention of the endometrium can lead to a falsely negative view by compressing subtle intracavitary lesions. Therefore, at the conclusion of the procedure, make it a habit to decrease the intrauterine pressure and reinspect the endometrium closely. In so doing, you will miss fewer subtle lesions. The surface of the endometrium in the menopause is normally pale and can have a porcelain appearance. Pay attention to the presence of glands, gland openings, endometrial texture, vascularized projections, cysts, cystic openings, microcalcifications, and necrosis. Look closely at the endocervix, too. Notice the appearance of the vascular architecture. Normally the blood vessels are rarely seen on the surface of normal atrophic endometrium. Take heed when U-shaped blood vessels are seen, because this is highly associated with endometrial hyperplasia or endometrial cancer. Blood vessels with variable calibers or trajectory endings, or the appearance of hemorrhagic zones, should raise the flag for a malignancy. When atypical blood vessels appear, reinspect them with a lowered intrauterine pressure.

Pathology Results Endometrial cancer begins in the inner glandular lining and has two subtypes.37 Type 1 is more common and is associated with increased estrogen exposure. Risks factors include obesity, nulliparity, polycystic ovary disease, and unopposed estrogen. Type 1 endometrial cancers occur more often in younger women and are less aggressive. Histologic subtypes most often include lower-grade endometrioid adenocarcinomas that account for 75% to 80% of cases. Type 2 cancers occur in older women without estrogen exposure, arise spontaneously, and most often

include histologic subtypes of clear, serous, adenosquamous, and grade 3 adenocarcinomas. Endometrial cancer can arise from atrophic endometrium, from hyperplastic endometrium, or within an endometrial polyp. Ovarian malignancies including granulosa cell or endometrioid tumors can secrete estradiol and increase the risk of endometrial malignancies. Mixed müllerian tumors can arise within an endometrial polyp. Expeditious treatment with hysterectomy is indicated for women with atypical endometrial hyperplasia. Trimble and colleagues prospectively evaluated 289 women who had a diagnosis of atypical endometrial hyperplasia on endometrial biopsy who underwent hysterectomy within 12 weeks of the diagnosis.38 The results were sobering: At hysterectomy, concurrent endometrial cancer was found in 123 specimens (42.6%), and of these, 30.9% had myometrial invasion, including 10.6% in which the invasion was found in the outer 50% of the myometrium. In 18.9% of patients who received a second diagnosis of less than atypical endometrial hyperplasia, 39.1% of patients who received a second diagnosis of atypical endometrial hyperplasia, and 64.3% who received a second diagnosis of carcinoma all had carcinoma in their hysterectomy specimens. Thus 42.6% of patients had endometrial cancer when they underwent hysterectomy. It has been said that atypical endometrial hyperplasia should be treated surgically, and the old dictum of “not cancer, but better out” should be reworded to “likely cancer, and definitely better out.”

Hysteroscopic Findings in Postmenopausal Women Endometrial cancer has myriad appearances. Especially among postmenopausal women, the diagnosis is less likely to be missed. Boring, pale, atrophic, monotonous endometrial architecture best describes the postmenopausal endometrium. When the hysteroscopist detects thickened, irregular endometrium, increased surface vascularity, or friable cells or encounters difficulty distending the endometrium, the chance of endometrial cancer increases. To decrease the chance of artificially creating a negative hysteroscopic view, it is imperative that the intrauterine pressure be decreased (and documented in your office note). In so doing, the true contours of the endometrium can be evaluated. A small-caliber hysteroscope is particularly advantageous in the menopausal woman. Currently available are 3-mm and 5-mm flexible or rigid hysteroscopes manufactured by a variety of companies. Cervical stenosis is more common during menopause compared to the reproductive years. Increasingly, however, misoprostol (Cytotec), when used orally or vaginally 8 to 12 hours before uterine instrumentation, softens the cervix and facilitates cervical dilation. Misoprostol 200 to 400 mcg by mouth 2 days and 8 to 12 hours before hysteroscopy is extremely helpful. Minimal side effects of include bloating, cramping, diarrhea, and occasional bleeding. Atrophy

During menopause, the uterus involutes. The endometrium is pale, thin, and fragile and has a translucent and porcelain

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women appearance. The surface is smooth and dull. An atrophic endometrium might have focal mucus-containing cysts covered by a thin, pale surface. The intrauterine cavity is small, constricted, and narrow, when compared to that of a reproductive patient. Diffuse or isolated petechial hemorrhages are commonly noted when patients complain of postmenopausal bleeding. Landmarks such as the tubal ostia may be less well visualized or, when seen, can appear opaque or covered with a veil of thin, wispy adhesions. Isolated calcifications are often seen. Gland openings or cystic atrophy with openings adjacent to the myometrium are also noted. These gland openings appear translucent blue-gray. Because the endometrium is thin, the underlying muscle bundles of the myometrium and interlacing columns and recesses might produce diverticula. Uterine length when measured is shorter. The endocervix is long, cylindrical, and pale. Cervical stenosis may be encountered. The ratio of the cervical length to fundal length is also different than in the reproductive years. Due to the smaller uterine size and volume, extreme care must be taken with uterine manipulation in to decrease the risk of uterine perforation. Endometrial Polyps

Endometrial polyps are a common cause of postmenopausal bleeding. Polyps vary in size, are usually single, and are usually benign (Fig. 11–5). Polyps respond to estrogen and tamoxifen with growth, but they are less sensitive to progesterone. As polyps grow, they can develop a pedicle and can even protrude into the endocervix or into the vagina. Polyps share the same surface as the surrounding endometrium. They can have a variety of colors ranging from one that resembles the endometrium to red-yellow, and at the distal tip of the polyp an ecchymotic purple-blue color may be seen. In the postmenopausal woman, a pale endometrium covers the

Figure 11–5 Hysterectomy specimen of patient with a large intracavitary polyp filling the majority of the endometrial cavity. The pathology was benign.

polyp, with fragile blood vessels coursing throughout the surface of the polyp. The surface of a polyp in a postmenopausal woman may also contain bluish translucent cysts. Because of the polyp’s mobility, the hysteroscopist can push it away and look under its surface. If saline is used for distention, then the polyp can be seen to float away from endometrium. When CO2 is used, the polyp might appear compressed against the adjacent endometrium. Using the distal tip of the hysteroscope, the gynecologist can indent or compress a polyp. Large endometrial polyps that fill the endometrial cavity can lead the hysteroscopist to a false diagnosis of endometrial hyperplasia. The hysteroscopist views one side of the endometrium and then might view the atrophic opposite wall. Moving the hysteroscope to the lower uterine cavity and evaluating the upper anatomy can lead to fewer incorrect diagnoses. Submucosal Fibroids

Intracavitary fibroids are firm and protrude from the endometrium (Figs. 11–6 to 11–9). They are usually solitary but can be accompanied by additional leiomyomas. In the menopause, the endometrium covering the fibroid is thin. Blood vessels can be seen coursing over the surface of the myoma. On occasion, the endometrium opposite the myoma is ulcerated. When the myoma is palpated with the distal tip of the hysteroscope, resistance is met. Unlike a polyp, the myoma cannot be pushed away from the hysteroscope. Intramural fibroids, which are unlikely sources of bleeding during the menopause, unless the endometrium overlying it becomes markedly atrophic, appear as protuberances from the

Figure 11–6 Vaginal hysterectomy specimen demonstrating a single intracavitary leiomyoma. The patient had persistent postmenopausal bleeding. This procedure was performed without hysteroscopy. The patient had experienced three blind dilation and curettages before her physician performed this procedure.

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Figure 11–7 Fundal pedunculated leiomyoma in patient with postmenopausal bleeding. This was hysteroscopically resected, and her bleeding fully resolved.

Figure 11–9 Operative hysteroscopic view of the lower uterine segment of a patient with a 1-cm leiomyoma; an endometrial polyp can be seen in the foreground.

Endometrial Hyperplasia

Figure 11–8 Hysterectomy specimen of patient with two intracavitary leiomyomas. Most certainly if performed today, hysteroscopic resection would have been performed.

endometrium. The best view of an intramural fibroid appears when it is visualized from the internal os. Hysteroscopy is excellent for determining the number, size, and location and to determine if the patient has an intracavitary fibroid. Merely scraping with a curette is archaic, and in fact scraping can lead to more bleeding when the myoma is merely eroded. A pedunculated fibroid can be hysteroscopically resected completely. Detecting intramural fibroids can spare the patient unnecessary surgical intervention and can exclude other intracavitary lesions that might coexist within the uterine cavity. Most intracavitary leiomyomas are benign. The risk of sarcomatous changes occurs in less than 1% of patients with uterine fibroids.

Making the diagnosis of endometrial hyperplasia in the postmenopausal woman is less difficult than in reproductive-age patients who have a variable appearance of the endometrium due to hormonal fluctuations. Even so, the diagnosis of hyperplasia is the most often missed diagnosis with hysteroscopy compared to SIS.33 The most likely reason for missing the hyperplasia might result from our technique. When distention fluid or CO2 compresses the endometrium, the endometrial projections of hyperplastic tissue are more difficult to discern. Making the diagnosis of endometrial hyperplasia requires close surveillance of the tissue thickness, color, vasculature, and consistency of the endometrium. Hyperplasia can be focal or global (Fig. 11–10). Hyperplastic tissue has no organized structure and is an outgrowth of aberrant tissue, so it is easily friable and tears easily when touched with the hysteroscope. Abnormalappearing endometrium can have focal lesions that include polyps, which may be broad-based or pedunculated. Additional suspicion for hyperplasia includes focal or papillary mucosal projections with or without gland cysts, abnormal vascular network with atypical vessels, and crowded or abnormally spaced gland openings (Figs. 11–11 and 11–12).39 Endometrial hyperplasia cannot be diagnosed with SIS alone during the reproductive years because the ranges of endometrial thickness in hyperplasia and carcinoma overlap. However, during the menopause, endometrium does not change, and an endometrial echo greater than 4 mm raises the suspicion of endometrial abnormalities. A histologic diagnosis based on a hysteroscopically obtained endometrial office biopsy specimen is also required. Most hyperplasias of the endometrium are 0.6 cm to 1.3 cm thick in postmenopausal patients, with a mean thickness of 1 cm. In most endometrial cancers, the thickness is greater than

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Figure 11–12 Complex endometrial hyperplasia without atypia near the lower uterine segment. Directed biopsy was necessary to reach this diagnosis.

Figure 11–10 Focal endometrial complex hyperplasia without atypia near the fundus and anterior wall. The surrounding endometrium is otherwise normal.

times find it difficult to distinguish between proliferative, exaggerated endometrium and endometrial hyperplasia.36 This is why it is critical to also perform endometrial biopsy with hysteroscopy. Theoretically, the specificity and positive predictive value of hysteroscopy in cases of abnormal uterine bleeding, is 100%. In practice, however, the false-negative rate is 2% to 4% and is the result of operator error in detecting abnormal endometrial lesions. Endometrial Cancer

Figure 11–11 Fundal endometrial complex hyperplasia without atypia. Notice the thin bridging tissue surrounded by normal endometrium.

4.7 mm. Most often, hyperplasia occurs diffusely; however, it can be focal or can appear as a broad-based polyp. SIS can also reveal asymmetrical or multifocal areas of endometrial irregularities in endometrial hyperplasia. The endometrial–myometrial interface is intact. Hysteroscopy is more accurate in detecting intracavitary lesions, such as polyps and fibroids, than blind endometrial biopsy alone. A recent study of 181 patients reported a sensitivity of 96.6% and a specificity of 100% when hysteroscopy was combined with endometrial biopsy.35 Hysteroscopists some-

Endometrial cancer requires histologic diagnosis; however, the index of suspicion can be increased when the topography of the endometrium is irregular or has focal lesions. Sugimoto40 have noted a high sensitivity in detecting endometrial cancer when the following features are observed: papillary, polypoid, nodular or mixed endometrial growth demonstrating friable tissue, focal necrosis, and atypical vessels (Fig. 11–13). Guruti and colleagues retrospectively reviewed 25 menopausal patients who had atypical hyperplasia found on endometrial biopsy and treated by hysterectomy.41 The pathologic findings of the uterine specimen were correlated with the diagnosis obtained hysteroscopically. They found that the sensitivity was 84.6%, specificity was 100%, and negative and positive predictive values were 87.5% and 100%, respectively, with hysteroscopy for a diagnosis of infiltrating carcinoma.43 Garuti’s study41 relays an important message about a high false-negative rate when endometrial biopsy demonstrates atypical endometrial hyperplasia yet fails to diagnose infiltrating carcinoma in 44% of patients. Even targeted biopsies did not improve the diagnosis compared to blind tissue collection (Vabra). Why would this happen? Many hysteroscopists realize that the tissue obtained with targeted biopsy is small, and the endometrial stromal tissue or myometrial tissue invaded by cancer may be

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Figure 11–14 Thickening of the endometrium caused difficult uterine distention. Endometrial biopsy was consistent with adenocarcinoma of the endometrium

Figure 11–13 Typical cerebroid thickening of the endometrium. Endometrial biopsy was consistent with endometrioid endometrial cancer.

poorly sampled with small forceps. Failure to diagnose could result from biopsying only the most superficial layers of lesions, with poor sampling of stromal tissue; most operative hysteroscopes have a small 1.5 mm working channel, which uses a 4to 5-F biopsy grasper. Tissue handling of architecturally small samples or friable endometrium can lead to suboptimal tissue given to the pathologist. Finally, friable tissue bleeds easily, and when fluid irrigant is used, the field of view may be distorted, leading to less-accurate directed biopsies. If a symptomatic patient has a highly suspicious hysteroscopic lesion, yet endometrial biopsy is negative for malignancy, strongly consider repeat endometrial sampling with a resection loop electrode (monopolar or bipolar) to obtain excellent tissue samples, improved sampling of the base and deeper layers of the endometrium, and larger specimens, for the most accurate diagnosis. Some patients with endometrial cancer have a very patulous cervix with excessive cervical mucus. This is in stark contrast to cervical stenosis, which is encountered most often. Difficult endometrial distention may be encountered with saline or CO2. Variegated endometrium and diffuse clusters of vascular polypoid lesions are routinely visualized (Fig. 11–14). Leukorrhea, pyometria, and increased amounts of transudate are also hallmarks of coexisting cancer. Focal lesions such as endometrial polyps can also harbor endometrial cancer. Although hysteroscopy cannot stage endometrial cancer, the proximity to the endometrial cavity can be discerned. To avoid a false-negative hysteroscopy, deflate the intrauterine pressure during hysteroscopy.42 High uterine pressures can artificially flatten out lesions and push them into the endometrial cavity or myometrium. Look closely at the architectural landscape. Look at the blood vessels on lesions. Look for variegated colors, hemorrhage, necrosis, and irregularity of lesions. Most benign lesions have smooth borders (Figs. 11–15 and 11–16).

Figure 11–15 This 59-year-old woman was not taking hormone replacement therapy and presented with episodic postmenopausal bleeding. She had an 18-week size uterine fibroid. Friable, polypoid, and thickened endometrium was seen in addition to an intramural leiomyoma. Directed biopsy demonstrated endometrioid cancer.

Early stage endometrial cancer has an excellent prognosis. However, when extension to the cervix occurs, survival rates decrease. Stromal invasion, stage 2 disease, alters the pattern of spread and decreases survival rates to 60% to 70%. With 10% to 20% incidence of endometrial cancer involving the cervix, some gynecologists have attempted to determine hysteroscopically if cervical disease is present. Other techniques used to preoperatively stage endometrial cancer include endocervical curettage, TVUS, and MRI imaging. Lo and colleagues used hysteroscopic inspection of the cervix in 200 consecutive patients with primary endometrial cancer to

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A Figure 11–16 Necrotic friable thickened endometrium consistent with endometrioid endometrial cancer.

determine whether the tumor had spread to the cervix.43 Tumor involvement was noted in 20.5% of patients. Hysteroscopic accuracy was 92.5%, sensitivity was 68.3%, specificity was 98.7%, positive predictive value was 93.3%, and negative predictive value was 92.4% in determining cervical involvement. Grossly inspecting the cervix for malignancy was accurate 93% of the time. Hysteroscopic findings suggesting cervical involvement included exophytic growth, irregular surface contours, and abnormal vasculature. Use of normal saline compared to CO2 improved diagnostic accuracy.

B

Tamoxifen-Induced Changes

Endometrial surveillance of asymptomatic patients taking tamoxifen does not differ from that of women routinely using estrogen replacement therapy. Although most long-term users of tamoxifen have an inactive endometrium, some show increased endometrial thickness during conventional TVUS. Goldstein and colleagues15 advocated SIS to monitor tamoxifen effects because of improved imaging. With traditional TVUS, the endometrial thickness appears highly unusual and heterogeneous and demonstrates centrally located uterine changes. If SIS is not performed, then these unusual features noted with TVUS can easily be overinterpreted. Unlike TVUS, SIS more accurately detects endometrial health and can determine if additional imaging is necessary. SIS can identify the subendometrial sonolucencies to the proximal myometrium. The abnormalities might represent abnormal adenomyomatous-like changes in the proximal myometrium that are microcysts. When viewed microscopically, the junction between the endometrium and myometrium is irregular and nonlinear, whereas in patients not receiving tamoxifen, the junction is linear. Other ultrasonographic TVUS findings observed in patients taking Tamoxifen as compared to control patients consist of increased uterine volume and depth, greater endometrial thickness, increased incidence of endometrial polyps (36% vs. 10%),

Figure 11–17 A, Saline infusion sonography (sagittal view) of a 64-yearold woman with postmenopausal bleeding. Note the very irregular thickened endometrium. Bridging tissue is noted between the anterior and posterior walls. B, The same lesion from the coronal view. Later biopsy results were consistent with cancer.

and increased endometrial atrophy (28% vs. 87%). A slight increase in the incidence of endometrial cancer of 2 to 3 cases per 1000 women has been noted among tamoxifen users (Fig. 11–17).

Summary When symptomatic focal lesions are detected by hysteroscopy, it is imperative that an operative hysteroscopic resection of the lesion be performed. Epstein and colleagues20 describe the sobering statistics when gynecologists perform blind D&C alone in the presence of focal lesions. Remember that endometrial biopsy and D&C is limited for focal, pedunculated, or regions within the uterine cavity that are difficult to access, such as tubal ostia, fundus, or broad-based lesions. A prospective study involving 105 women with postmenopausal bleeding and endometrium greater than 5 mm on TVUS examination underwent diagnostic

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women hysteroscopy, D&C, and hysteroscopic resection of any focally growing lesion still left in the uterine cavity after D&C. Twentyfour women also underwent hysterectomy. If the histologic diagnosis differed between specimens from the same patient, the most relevant diagnosis was considered the final one. In this study,20 80% (84 of 105) of the women had pathology in the uterine cavity, and 98% (82 of 84) of the pathologic lesions manifested a focal growth pattern at hysteroscopy. In 87% of the women with focal lesions in the uterine cavity, the whole or parts of the lesion remained in situ after D&C. D&C missed 58% of polyps (25 of 43), 50% of hyperplasias (5 of 10), 60% of complex atypical hyperplasias (3 of 5), and 11% of endometrial cancers (2 of 19). The agreement between the D&C diagnosis and the final diagnosis was excellent (94%) in women without focally growing lesions at hysteroscopy. It was less than optimal in women with focal lesions. In summary, if there are focal lesions in the uterine cavity, hysteroscopy with endometrial resection is superior to D&C for obtaining a representative endometrial sample in women with postmenopausal bleeding and endometrium greater than 5 mm.20

CLINICAL CONUNDRUMS Cervical Stenosis For the woman who presents with postmenopausal bleeding and who has marked cervical stenosis, evaluation can be challenging. Prior surgical procedures such a laser conization are associated with 0% to 25% risk of cervical stenosis, which increases to 1% to 5% risk after loop excision and 40% after cold-knife cone biopsy.44 Most patients with postmenopausal bleeding do not have endometrial cancer. However, it is imperative that the physician rule out cancer unequivocally in the patient with symptoms. If the patient has had a TVUS and the endometrial echo is greater than 5 mm, then a tissue diagnosis and visualization of the endometrial cavity to determine the presence of a focal or global pathology is of utmost importance. But what can the clinician do in cases of profound cervical stenosis? Traditionally, laminaria tents have been used for cervical dilation. But even the smallest laminaria tent cannot be placed in a markedly stenotic cervix. Oral or vaginal misoprostol is of particular assistance for cervical stenosis. Oral misoprostol 200 to 400 mcg 48 hours and 8 to 12 hours before cervical dilation is associated with increasing cervical softening and enhancing placement of a dilator.45 Patients might have transient cramps, diarrhea, or low-grade fever; however, misoprostol greatly facilitates performance of the procedure. When laminaria tents or misoprostol is not helpful, consider dilation of the cervix under ultrasound guidance. Ultrasound confirms proper placement of the instruments into the uterine cavity. Using transabdominal ultrasound greatly improves the ability to guide an intrauterine catheter or endometrial pipelle biopsy device into the uterine cavity and decreases the likelihood of creating a false tract, perforation, or abandoning the procedure. If this procedure cannot be performed in the office, it can be performed in the operating room under light sedation.46

Alternatively, flexible hysteroscope may be more advantageous when a tortuous uterine cavity is encountered. If a 3-mm flexible hysteroscope can be placed into the cervix, it may be able to be navigated through the endocervix and into the uterine cavity to visualize the endometrium. The use of fluid or CO2 also helps to mechanically dilate the cervix. When marked cervical stenosis is encountered, consider a shallow cone loop electrosurgical excision procedure (LEEP) biopsy to remove the stenotic cervical os. Resorting to this maneuver is very unlikely. Rarely will the gynecologist need to resort to hysterectomy for marked cervical stenosis and postmenopausal bleeding. However, in the presence of an abnormal ultrasound with a nonvisualized endometrium, thickened endometrium, or cervical dysplasia, hysterectomy is a reasonable option for managing cervical stenosis.47 A retrospective study of patients with postmenopausal bleeding and cervical stenosis that precluded further evaluation and was treated by hysterectomy had benign pathology (64%), cervical dysplasia (12%), or uterine cancer (4%).

Hormone Replacement Therapy and Postmenopausal Bleeding Many women use HRT to alleviate vasomotor symptoms, to decrease risk of osteoporosis, and to improve urogenital atrophy. Irregular menstruation was commonly found among 590 women who began cyclic HRT; 38.3% had one or more visits for PMB evaluation, and 12.3% had one or more endometrial biopsies. When combined HRT was used, 41.6% had one or more visits for PMB, and 20.1% had one or more endometrial biopsies.48 In the Women’s Health Initiative study of more than 8000 women randomized to HRT, about 40% of women complained of abnormal bleeding on the combined continuous HRT regimen using conjugated equine estrogen 0.625 mg and medroxyprogesterone acetate 2.5 mg daily.49 Users of estrogen and progesterone HRT have a decreased risk of endometrial cancer than nonusers. Current recommendations include watchful waiting if vaginal bleeding occurs during the first 3 months of HRT. Office hysteroscopy or TVUS can be used to evaluate bleeding if it is persistent. If patients are unwilling to continue therapy because of bleeding, investigation can be initiated earlier. If TVUS only is used and the endometrial echo is less than 5 mm, SIS should be performed next to exclude intracavitary lesions. In the 1960s and 1970s, unopposed estrogen therapy was usually prescribed, but it was later found to increase the risk of endometrial cancer or hyperplasia. We now know that progesterone reduces estrogen-receptor synthesis and increases the conversion of estradiol to the less potent metabolite estrone, and it is a necessary adjunctive therapy for HRT users. Today most women taking HRT use either daily sequential therapy or cyclic therapy. Patients taking cyclic combined estrogen–progesterone therapy should receive a minimum of 12 or 13 days of progestin therapy. Patients who bleed before day 11 of a cyclic progestin regimen should undergo endometrial biopsy. If secretory or pseudodecidual changes are not evident, then additional

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women progestin should be used. Patients using cyclic estrogen– progestin therapy and who experience bleeding should be reassured if their bleeding occurs during the final 12 to 14 days of the progestin regimen or the week following progestin withdrawal. If erratic bleeding occurs, evaluation with office hysteroscopy or TVUS is undertaken. Despite hormonal therapies chosen, approximately 5% to 40% of women initiating HRT experience episodic or prolonged bleeding while taking HRT. In the past, watchful waiting was recommended. Needless worry or discontinuation of hormonal therapy by patients was the rule rather than the exception. The baseline prevalence of endometrial polyps is 20% and the baseline prevalence of submucosal fibroids is 10% to 20%, and for some women, HRT can produce bleeding in women who were previously asymptomatic. Earlier intervention with office

SIS

[2D] G42/105dB FA2/P95

hysteroscopy or SIS demonstrating endometrial atrophy or the presence of intracavitary lesions can allay many fears (Fig. 11–18). If endometrial atrophy is detected, the patient can be reassured that bleeding will likely resolve with continued HRT use. Benign polyps and fibroids might continue to bleed, requiring hysteroscopic resection. Likewise, if a premalignant lesion or occult malignancy detected, prompt treatment with progesterone therapy or hysterectomy must be undertaken.

OTHER CAUSES OF ABNORMAL VAGINAL BLEEDING The proximity of the urethra to the vagina may make it difficult for patients to determine the source of vaginal bleeding. Most patients assume that the blood originates from the vagina. When persistent bleeding occurs, despite a thorough gynecologic evaluation, urine cytology and bladder imaging should be considered. Common causes of abnormal vaginal bleeding are listed in Box 11–1. The prevalence of bladder tumors was prospectively evaluated in 280 postmenopausal women who underwent TVUS and ultrasound imaging of the bladder. Abnormal findings were confirmed by urologic consultation and cystoscopy. Results demonstrated 3 of 280 subjects had bladder tumors, of which one was malignant. This serves as a reminder to clinicians to also image the bladder when the TVUS is unremarkable.50

BOX 11–1 Common Causes of Abnormal Vaginal Bleeding Foreign bodies Intrauterine devices Trichomonas Medication

⫹D 1.49 cm ⫻D 0.59 cm

A

SIS

[2D] G42/ FA2/

● ● ●

Hormone replacement therapy Unopposed estrogen therapy Tamoxifen therapy

Cancer ● ● ● ● ●

Cervical cancer Ovarian cancer Fallopian tube cancer Bladder tumors Epithelial ovarian cancer and granulosa cell tumors

Anatomy ● ● ● ●

B

●

Figure 11–18 A, Saline infusion sonography (SIS) (sagittal view) demonstrating a small focal lesion. Operative hysteroscopic myomectomy demonstrated a benign endometrial polyp. B, Saline infusion sonography (SIS) (coronal view) demonstrating small focal lesion. Biopsy was consistent with benign endometrial polyp.

Urethral prolapse Cervical lesions Diverticular uterocolonic fistula Genital prolapse Genital atrophy

Therapy ● ● ●

128

Supertherapeutic levels of anticoagulation Radiation therapy Devascularization and obliterative vaginal endarteritis

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women SUMMARY Women are spending one third or more of their lives during the menopause. Therefore, increasing gynecologic complaints, including bleeding and leukorrhea, may be encountered. The use of cervix-softening agents such as misoprostol can help to make hysteroscopy, SIS, and endometrial biopsies more comfortable, decreases the risk of uterine perforation or cervical lacerations, and facilitates cervical dilation. Hysteroscopy, particularly with small-diameter hysteroscopes, provides excellent imaging of the

endocervix and endometrium. When hysteroscopy is not available, TVUS is helpful in the initial triage of patients with abnormal uterine bleeding. When the endometrium is not well visualized with TVUS or when bleeding continues despite normal endometrial parameters, then hysteroscopy or SIS is advisable. The array of clinical tools available to physicians improves the care of women with postmenopausal bleeding. Using these tools decreases the frustration and allays fears of patients while increasing the confidence and the ability of the physician to make an accurate diagnosis.

REFERENCES 1.

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Eitan R, Saenz CC, Venkatraman ES, et al: Pilot study prospectively evaluating the use of the measurement of preoperative sonographic endometrial thickness in postmenopausal patients with endometrial cancer. Menopause 2005;12:27-30. Jemal A, Murray T, Ward E, et al: Cancer statistics, 2005. CA Cancer J Clin 2005;55:10-30. Ozalp S, Tanir HM, Gurer H: Gynecologic problems among elderly women in comparison with women aged between 45-64 years. Eur J Gynaecol Oncol 2006;27(2):179-181. Marchetti M, Vasile C. Chiarelli S: Endometrial cancer :Asymptomatic endometrial findings. Characteristics of postmenopausal endometrial cancer. Eur J Gynaecol Oncol 2005;26(5):479-484. Feldman S, Cook EF, Harlow BL, Berkowitz RS: Predicting endometrial cancer among older women who present with abnormal vaginal bleeding. Gynecol Oncol 1995;56:376-381. Gredmark T, Kvint S, Havel G, et al: Histopathological findings in women with postmenopausal bleeding. Br J Obstet Gynaecol 1995;102: 133-136. Astrup K, Olivarius Nde F. Frequency of spontaneously occurring postmenopausal bleeding in the general population. Acta Obstet Gynecol Scand.2004;83:203-207. Richenberg J, Cooperberg P: Ultrasound of the uterus. In Callen PW (ed): Ultrasonography in Obstetrics and Gynecology, 4th ed. Philadelphia: Saunders, 2000, pp 814-846. Smith RA, Cokkinides V, Eyre HJ: American Cancer Society guidelines for the early detection of cancer, 2005. CA Cancer J Clin 2005;55(1):31-44. Medverd JR, Dubinsky TJ: Cost analysis model: US versus endometrial biopsy in evaluation of peri- and postmenopausal abnormal vaginal bleeding. Radiol 2002;222(3):619-627. Karlsson B, Granberg S, Wikland M, et al: Transvaginal ultrasongraphy of the endometrium in women with postmenopausal bleeding—A Nordic multicenter study. Am J Obstet Gynecol 1995;172:1488-1494. Berliere M, Radikov G, Galant C, et al: Identification of women at high risk of developing endometrial cancer on tamoxifen. Eur J Cancer 2000;36(Suppl 4):S35-S36. Davidson KG, Dubinsky TJ: Ultrasonographic evaluation of the endometrium in post-menopausal vaginal bleeding. Radiol Clin N Am 2003;41:769-780. Okaro E, Bourne T: Sporadic abnormal vaginal bleeding (intermenstrual, postcoital and postmenopausal bleeding). Curr Obstet Gynecol 2002;12:334-340. Goldstein SR, Nachtigall M, Snyder JR, Nachtigall L: Endometrial assessment by vaginal ultrasonography before endometrial sampling in patients with postmenopausal bleeding. Am J Obstet Gynecol 1990;163:119-123. Gull B, Karlsson B, Milsom I, Granberg S: Can ultrasound replace dilation and curettage? A longitudinal evaluation of postmenopausal

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bleeding and transvaginal sonographic measurement of the endometrium as predictors of endometrial cancer. Am J Obstet Gynecol 2003;188:401-408. Epstein E, Ramirez A, Skoog L, et al: Transvaginal sonography, saline contrast sonohysterography and hysteroscopy for the investigation of women with postmenopausal bleeding and endometrium greater than5 mm. Ultrasound Obstet Gynecol 2001;18:157-162. Twu NF, Chen SS: Five-year follow-up of patients with recurrent postmenopausal bleeding. Zhonghua Yi Xue ZaZhi (Taipei) 2000;63:628-633. Jaaback KS, Hirschowitz L: Primary fallopian tube carcinoma—the experience of a UK cancer centre and a review of the literature. J Obstet Gynaecol 2005;25(7):694-702. Epstein E, Ramirez A Skoog L, et al: Dilation and curettage fails to detect most focal lesions in the uterine cavity in women with postmenopausal bleeding. Acta Obstet Gynecol Scand 2001;80: 1131-1136. Moodley M, Roberts C: Clinical pathway for the evaluation of postmenopausal bleeding with an emphasis on endometrial cancer detection. J Obstet Gynaecol. 2004;24(7):736-741. Clark TJ, Barton PM, Coomarasamy A, et al: Investigating postmenopausal bleeding for endometrial cancer: Cost-effectiveness of initial diagnostic strategies. BJOG 2006;113:502-510. Shushan A, Revel A, Rojansky N: How often are endometrial polyps malignant? Gynecol Obstet Invest 2004;58;212-215. Savelli L, De Iaco P, Santini D, et al: Histopathologic features and risk factors for benignity, hyperplasia, and cancer in endometrial polyps. Am J Obstet Gynecol 2003;188:927-931. Smith-Bindman R, Kerlikowske K, Feldstein VA, et al: Endovaginal ultrasound to exclude endometrial cancer and other endometrial abnormalities. JAMA 1998;280:1510-1517. Tsuda H, Kawabata M, Yamamotot K, et al: Prospective study to compare endometrial cytology and transvaginal ultrasonography for identification of endometrial malignancies. Gynecol Oncol 1997;65: 383-386. Fleischer A, Wheeler JE, Lindsay I, et al: An assessment of the value of ultrasonographic screening for endometrial disease in postmenopausal women without symptoms. Am J Obstet Gynecol 2001:184:740744. Gull B, Carlsson SA, Karlsson B et al: Transvaginal ultrasonography of the endometrium in women with postmenopausal bleeding: Is it always necessary to perform an endometrial biopsy? Am J Obstet Gynecol 2000;182:509-515. Epstein E, Valentin L: Rebleeding and endometrial growth in women with postmenopausal bleeding and endometrial thickness <5 mm managed by dilatation and curettage or ultrasound follow-up: A randomized controlled study. Ultrasound Obstet Gynecol 2001;18:499-504.

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Investigation of Abnormal Uterine Bleeding in Postmenopausal Women 30. De Jong P, Doel F, Falconer A: Outpatient diagnostic hysteroscopy. BJOG 1990;97;299-303. 31. Vilos GA, Edris F, Al-Mubarak A, et al: Hysteroscopic surgery does not adversely affect the long-term prognosis of women with endometrial adenocarcinoma. J Minim Invasive Gynecol 2007;14:205-210. 32. Takeshima N, Nishida H, Tabata T, et al: Positive peritoneal cytology in endometrial cancer: Enhancement of other prognostic indicators. Gynecol Oncol 2001;82:470-473. 33. Widrich T, Bradley LD, Mitchinson A, Collins R: Comparison of saline infusion sonography with office hysteroscopy for the evaluation of the endometrium. Am J Obstet Gynecol 1996;174:1327-1334. 34. Shushan A, Protopapas A, Hart R: Diagnostic and therapeutic advantages of hysteroscopic surgery in management of intrauterine lesions in postmenopausal women. J Am Assoc Gynecol Laparosc 2001:8:87-91. 35. Marchetti M, Litta P, Lanza P, et al: The role of hysteroscopy in early diagnosis of endometrial cancer. Eur J Gynaecol Oncol 2002;23(2):151153. 36. Fay TN, Khanem N, Hosking D: Out-patient hysteroscopy in asymptomatic postmenopausal women. Climacteric 1999;2(4):263267. 37. Kurman RJ, Zaino RJ, Norris HJ: Endometrial carcinoma. In Kurman RJ (ed): Blaustein’s Pathology of the Female Genital Tract, 4th ed. New York: Springer-Verlag, 1994, pp 439-486. 38. Trimble CL, Kauderer J, Zaino R, et al: Concurrent endometrial carcinoma women with a biopsy diagnosis of atypical endometrial hyperplasia: A Gynecologic Oncology Group study. Cancer 2006;106:812-819. 39. Garuti G, Sambruni I, Colonnelli M, Luerti M: Accuracy of hysteroscopy in predicting histopathology of endometrium in 1500 women. J AmAssoc Gynecol Laparosc 2001;8:207-213. 40. Sugimoto O: Hysteroscopic diagnosis of endometrial carcinoma. A report of fifty-three cases examined at the women’s clinic of Hyoto University Hospital. Am J Obstet Gynecol 1975;121:105-113.

41. Guruti G, Mirra M, Luerti M: Hysteroscopic view in atypical endometrial hyperplasias : A correlation with pathologic findings on hysterectomy specimens. J Minim Invasive Gynecol 2005;12:247253. 42. Loffer FD: Hysteroscopy with selective endometrial sampling compared with D&C for abnormal uterine bleeding: The value of a negative hysteroscopic view. Obstet Gynecol 1989;73:1620. 43. Lo KWK, Cheung TH, Yim SF: Preoperative hysteroscopic assessment of cervical invasion by endometrial carcinoma: A retrospective study. Gynecol Oncol 2001:82,279-282. 44. Baldauf JJ, Dreyfus M, Ritter J, et al: Risk of cervical stenosis after large loop excision or laser conization. Obstet Gynecol 1996; 88:933-938. 45. Thomas JA, Leyland N, Durand N, et al: The use of oral misoprostol as a cervical ripening agent in operative hysteroscopy: A doubleblind, placebo-controlled trial. Am J Obstet Gynecol 2002;186:876879. 46. Weiderpass E, Adami HO, Baron JA, et al: Risk of endometrial cancer following estrogen replacement with and without progestins. J Natl Cancer Inst 1999;1131-1137. 47. Newman C, Finan M: Hysterectomy in women with cervical stenosis. J Repro Med 2003;48:672-676. 48. Ettinger B, Li DK, Klein R: Unexpected vaginal bleeding and associated gynecologic care in postmenopausal women using hormone replacement therapy: Comparison of cyclic versus continuous combined schedules. Fertil Steril 1998;69:865-869. 49. Writing Group for the Women’s Health Initiative Investigators: Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002;288:321-333. 50. Abdel-Fattah M, Barrington JW, Youssef M, Mac Dermott JP: Prevalence of bladder tumors in women referred with postmenopausal bleeding. Gynecol Oncology 2004;94(1):167-169.

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Evaluation of the Patient for Uterine Fibroid Embolization Linda D. Bradley

Starve a fever? Feed a cold? Can’t remember? Doesn’t matter. It’s folklore not science. But a new procedure that starves (not feeds) uterine fibroids really works. It’s called uterine fibroid embolization and someday, it may spare you a hysterectomy. CCF Toronto Bulletin, 2006

Uterine leiomyoma keep gynecologists busy with office visits, consultations, and surgical procedures. Patients are inundated with myriad medical or surgical options for relief of fibroidrelated symptoms. Until recently, the options for treating fibroids were limited to medical therapy, myomectomy, or hysterectomy. Patients want more options that are organ-sparing, minimally invasive, and associated with short hospitalization. Within the past decade, collegiality and collaboration between gynecologists and interventional radiologists as well as excellent prospective clinical registries that champion excellent outcome, such as the FIBROID (Fibroid Registry for Outcomes Data) registry, have opened new vistas in the treatment of uterine fibroids.1 Uterine fibroid embolization (UFE) is gaining popularity as another option for a select group of patients. UFE is a radiologic procedure that treats the fibroids and related symptoms while preserving the uterus. It does not require general anesthesia. A coordinated effort is recommended, including incorporating a multi-team approach with the interventional radiologist, pain management service, and the gynecologist. As more physicians are exposed to this new option and excellent clinical outcomes reported, its use will increase (Box 12–1).2 Crucial to the success of UFE is the partnership and collaboration between gynecologists and radiologists in the global care of the patient. For interventional radiologists, having excellent technical skills, possessing excellent clinical skills, providing office consultations, demonstrating postprocedural patient involvement, and most importantly having the right to admit patients to the hospital will be rewarded with numerous referrals. The ideal collaborative practice model is one in which the interventional radiologist has admitting privileges and provides feedback to the gynecologist regarding the technical aspects of the procedure. Under these ideal circumstances, the gynecologist will not be required to provide immediate postprocedural hospital management, but will follow the patient during the

months following the procedure. Likewise, the need for gynecologic surgical intervention for complications related to embolization is low. Postprocedural follow-up with the gynecologist 4 to 6 weeks after UFE is customary. This chapter highlights common indications, benefits, risks, and potential complications of UFE. An in-depth review of the recent literature includes results, complication rates, and clinical pearls and tips that increase success rates and outcomes. A proposed protocol is introduced for patient selection, preoperative assessment, and postprocedure follow-up. The use of hysteroscopy to evaluate UFE leukorrhea, irregular bleeding, or evaluation of amenorrhea is addressed.

INTERVENTIONAL RADIOLOGIST: FRIEND OR FOE? Gynecologists serve as primary caregivers for many women in today’s medical environment. In that role, we are often faced with the evaluation of symptomatic pelvic masses, menorrhagia, and irregular vaginal bleeding. The most common anatomic cause of such irregularities is uterine fibroids.3 Evolution of the current medical system and technology has forced us to research less-invasive procedures in all of medicine. One such area has been the search for, and discovery of, a less-invasive treatment for symptomatic uterine fibroids. The treatment of choice for definitive management remains hysterectomy. However, since the 1990s, uterine fibroid embolization (UFE) has emerged as a treatment option for a subset of women. As more physicians are exposed to this new option and patients’ awareness increases, its use will also increase.

Historical Perspective Uterine artery embolization (UAE) historically has been used as a last resort or lifesaving procedure in women experiencing exsanguination due to obstetric and gynecologic conditions.4,5 It was first used in the obstetrics setting in 1979 to successfully treat a patient with severe postpartum hemorrhage who failed standard bilateral hypogastric artery ligation.6 UAE has also been part of conservative management in patients with placenta

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Evaluation of the Patient for Uterine Fibroid Embolization rates.12 Ravina originally recommended prophylactic embolization, with the belief that UFE would decrease blood flow to the uterine arteries and thereby minimize blood loss, intraoperative blood transfusions, or conversion to hysterectomy in women scheduled for abdominal myomectomy. The outcome was unanticipated. Surprisingly, 11 out of 16 patients had resolution of symptoms, three patients had partial resolution, and only two patients later required surgical intervention. After a 20-month follow-up, an overall 20% to 60% reduction in uterine volume occurred. One patient subsequently became pregnant.13 The dramatic results of the French group prompted others to evaluate the benefit of this new minimally invasive procedure for treating fibroids. The success and low complication rate of arterial embolization have generated and encouraged the application of UFE as a nonsurgical alternative to hysterectomy for managing fibroids. As promising results are consistently reported, the use of this procedure has increased and become popular among patients and physicians. To date, more than 150,000 procedures have been performed worldwide. Each year in the United States, approximately 15,000 procedures are performed. Advantages of UFE include preservation of uterine function (menses and fertility), avoidance of a surgical procedure, conscious sedation for anesthesia, short hospital stay, quick return to activities, and low risk of complications. If results are less than satisfactory, myomectomy or hysterectomy remains an option. The development of nonemergent use of UFE for treating uterine fibroids has led to a more circumspect management of this common condition.

BOX 12–1 Advantages of Uterine Fibroid Embolization Avoid major surgery Avoid general anesthesia Early ambulation No scars No hysterectomy Shorter hospital stay Suitable for women with prior myomectomy Minimal blood loss ● ●

Can be performed in high-risk and markedly anemic patients Advantageous in patients who have religious prohibitions against blood transfusion

Effectively treats menorrhagia Treats bulk symptoms and decreases uterine size Suitable for high-risk surgical candidates Potential cost savings Future fertility possible

BOX 12–2 Indications for Uterine Artery Embolization Anticipatory placement in patients at high risk for hemorrhage during delivery or cesarean section51 Severe postpartum hemorrhage Placenta accreta52 Postabortion bleeding Abdominal, cervical, cornual, or ectopic pregnancy Gestational trophoblastic disease Symptomatic leiomyoma Premyomectomy therapy Postabdominal myomectomy hemorrhage Treatment of hemorrhage following radical pelvic cancer surgery Arteriovenous malformations

THE DEMAND FOR ALTERNATIVES TO HYSTERECTOMY

percreta left in situ after delivery.7,8 Its role in gynecology, obstetric emergencies, and other cases of intra-abdominal hemorrhage is well established (Box 12–2). Emergent surgical intervention for postpartum hemorrhage or gynecologic hemorrhagic catastrophes in which hysterectomy or hypogastric artery ligation performed is often hazardous and complicated because of the hemodynamically unstable nature of the patient or comorbid conditions, and can be complicated by ureteral injury, infection, ileus, multiple blood transfusions, and prolonged hospitalization. Additionally, when surgery fails and the patient remains hemodynamically unstable, uterine artery embolization for gynecologic and obstetrical hemorrhage is often effective and lifesaving.9,10 Since the first prophylactic UFE for uterine fibroids in 1995 by Ravina,11 the procedure has gained widespread acceptance as a therapeutic option for symptomatic uterine fibroids. For patients whose only options have been operative intervention with myomectomy or hysterectomy, UFE offers preservation of the uterus, avoidance of major surgery, and low complication

Hysterectomy rates in the United States have declined since the 1980s. However, this procedure, which is performed 600,000 times annually, affects one out of three women by age 60 years, and is commonly recommended for treating fibroids. Approximately 250,000 women have hysterectomy to treat fibroidrelated symptoms. Currently 15, 000 have UFE annually in the United States, compared to 150,000 procedures worldwide, and this low number pales in comparison to the number of hysterectomies performed annually. Fortunately, 90% of hysterectomies are for benign conditions, and fibroids are often the culprit. Increasingly, gynecologists are adding UFE to the options available for treating uterine fibroids. Leiomyomas are the most common benign tumors in the uterus and occur in 30% to 50% of women. Luckily, only 25% to 50% of patients with fibroids experience symptoms. Leiomyosarcoma occurs in less than 1% of patients. Despite the commonness of these tumors, their pathogenesis is not fully understood and the best approach to their management remains controversial, patient centered, and individualized. Debates regarding alternatives to hysterectomy are common and span the gamut from “the uselessness of the uterus when childbearing is completed” preserving the organ with removal of only the parts that do not function properly. Many patients

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Evaluation of the Patient for Uterine Fibroid Embolization request that we only fix what is broken. For some women, childbearing is not the issue. Rather, an organ-sparing procedure, preserving uterine function and menses, is highly desirable. For some women, the psychological loss of the uterus can cause anxiety, depression, decreased libido, or loss of femininity. Certainly more research is necessary to understand the decisionmaking process in women wanting preservation of the uterus compared to those desiring extirpative therapy. Until then, it is prudent to review all options available including risk-to-benefit profile, long-term data, and outcomes of current treatment modalities for uterine fibroids with each patient. Although many patients can be reassured and followed periodically, others require intervention.

CURRENT OPTIONS FOR TREATING UTERINE FIBROIDS The current gamut of surgical treatments include operative hysteroscopic myomectomy, abdominal and laparoscopic myomectomy, cryomyolysis, laparoscopic myolysis, bipolar desiccation of fibroids, temporary transvaginal uterine artery occlusion, laparoscopic uterine artery occlusion, and magnetic resonance imaging (MRI)-focused ultrasound. For patients with minimal symptoms, watchful waiting is also an option. It is paramount to determine whether fibroids are merely present and a passenger or if they are the problem. Current medical alternatives to hysterectomy include intensive medical management with nonsteroidal antiinflammatory drugs (NSAIDs) or hormonal therapy such as contraceptive agents or gonadotropin-releasing hormone (GnRH) agonists. Medical therapy may be used chronically or intermittently. Medical therapy for some women is plagued by resumption of symptoms after therapy is discontinued or by side effects that are not well tolerated. However, a trial of medical therapy is advisable. It is difficult to predict which women will have long-term benefit. Theoretically, women who are closest to menopause would have the greatest benefit from a trial of medical therapy, because cessation of menses is more probable. Recent studies demonstrate excellent clinical results with RU486, an antiprogesterone agent.14 It is very likely that advances in medical therapy, rather than surgical or procedural modalities, in the near future will take a predominant role in treating uterine fibroids. In 2004, Exablate 2000 (InSightec, Tirat Carmel, Israel), an MRI-guided ultrasound, was approved by the FDA as another option in treating uterine fibroids.15,16 Two new radiographic procedures, laparoscopic ultrasound-guided ablation and percutaneous radiofrequency ablation might also soon be used for uterine fibroid embolization.17

mas occur at younger ages, occur more often, and achieve greater size and number in women of Afro-Caribbean ancestry compared to white women (Figs. 12–1 and 12–2). Progressive symptoms include menorrhagia and irregular bleeding with associated anemia and fatigue. Menorrhagia, when incessant, can require blood transfusion.19 Enlargement of leiomyomas can cause frequency and urgency of urination or pelvic pressure and heaviness often collectively called bulk-related symptoms. Other symptoms, including dysmenorrhea, dyspareunia, backache, and chronic discharge or leukorrhea (usually from intracavitary fibroids and fibroids abutting the endometrium) have been reported. Massive leiomyomas may be associated with increased abdominal girth, hydronephrosis, deep vein thrombosis, or even pulmonary emboli (due to venous stasis), and rarely neurologic syndromes (Fig. 12–3). Some patients experience recurrent pregnancy loss or infertility.

Figure 12–1. A massive abdominal enlargement in a 37-year-old patient. Bimanual examination demonstrated a 25-week size uterus.

SYMPTOMS ASSOCIATED WITH LEIOMYOMAS Leiomyomas and abnormal uterine bleeding account for 40% to 50% of all hysterectomies performed in the United States annually. Between 1998 and 2002, there were more than one million hysterectomies and 150,000 myomectomies.18 Leiomyo-

Figure 12–2 Intraoperative findings of large multilobulated uterus with adherent ovary, treated by abdominal hysterectomy and right oophorectomy. The uterus weighed 1.9 kg.

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Evaluation of the Patient for Uterine Fibroid Embolization rather than hospital charges were studied because the authors felt that hospital costs more accurately reflect use of resources including operating room, nursing, radiology, laboratory, and pharmacy than hospital charges do. They found lower hospital costs and greater hospital net income from UFE than from abdominal hysterectomy and abdominal myomectomy, and UFE was more financially favorable to hospitals than traditional gynecologic surgery. The mean professional (physician) reimbursements for UFE, hysterectomy, and myomectomy were $1306, $979, and $1078, respectively. In their analysis, total hospital cost for UFE ($2707) was significantly less than for hysterectomy ($5707) or myomectomy ($5676). More studies (especially studies of laparoscopic surgery) are ongoing to evaluate the cost benefit of UFE compared to surgery.

PRACTICAL ASPECTS OF UTERINE FIBROID EMBOLIZATION

Figure 12–3. Laparotomy of a 2.2-kg uterus. The patient presented with bulk symptoms, hydronephrosis, and atrophic left kidney, likely due to long-standing pressure effects.

Hysterectomy always solves symptoms such as bleeding and bulk-related complaints, but it eliminates fertility and is a major operative procedure. However, hysterectomy has an overall 20% to 40% morbidity risk including blood transfusion, postoperative fever, postoperative vaginal vault hematomas, urinary tract infection, future bowel obstructions, adhesions, nerve entrapment, premature menopause, hernia formation, ileus, deep vein thrombosis, retained ovarian remnant syndrome, pulmonary emboli, keloids, injury to the bowel, bladder, or ureters, and death. Certainly many alternative options are available; however, some patients find them less than satisfactory. Hormonal therapy with GnRH agonists provides temporary treatment, with most fibroids reestablishing normal size and symptomatology within 6 to 12 months following cessation of therapy. Perimenopausal patients treated medically achieve greater relief of symptoms, compared to younger women, due to their proximity to menopause and the natural decline in fibroid-related symptomatology. Myomectomy, whether laparoscopic or abdominal, requires general or regional anesthesia, with their associated surgical risks. Furthermore, myomectomy is associated with a 25% incidence of reoccurrence of fibroids and a 10% to 15% incidence of repeat surgery. Fewer complications, shorter hospital stay, and less blood loss are associated with UFE compared to hysterectomy.20 UFE effectively treats all fibroid-related symptoms: bulk, bleeding, and mass. More variable results are reported regarding change in uterine volume. Cosmetic complaints of an enlarged abdomen may be less well treated than bleeding or bulk symptoms. Most studies also note improved quality of life scores and high patient satisfaction. Excellent long-term relief of clinical symptoms is achieved. Histologically, fibroids treated by UFE can undergo hyaline or coagulative necrosis.21 Goldberg and colleagues compared the hospital costs and reimbursement for abdominal hysterectomy (n = 299), abdominal myomectomy (n = 105), and UFE (n = 136).22 Hospital costs

Gynecologists are well suited to triage candidates for UFE. In fact, gynecologists must be intimately involved in patient referrals for UFE. Preoperative consultation is essential to exclude other factors that mimic fibroid symptoms or require surgical intervention. Patients should have failed medical therapy or wish to avoid other alternatives. UFE can be an excellent option for patients with multiple comorbid factors. Patients with symptomatic intracavitary fibroids remain best treated with hysteroscopic myomectomy rather than UFE because of increased risks of chronic vaginal discharge (watery or serosanguineous), infection, or prolapse of an intracavitary fibroid that subsequently needs hysteroscopic resection. Currently there is no role for UFE in asymptomatic patients. Menopausal women who are asymptomatic do not warrant treatment. Likewise, menopausal women whose fibroids begin to grow or become symptomatic should not undergo UFE. The risk of leiomyosarcoma is greater for menopausal women with these symptoms (Fig. 12–4). Patients who desire fertility are generally not referred for embolization unless surgical conversion from myomectomy to hysterectomy or profound complications from surgery are anticipated.23 Myomectomy is usually suggested when fertility is a priority. However UFE should be discussed when the risk of intraoperative conversion to hysterectomy is high. Although there are anecdotal reports of successful pregnancy outcomes following UFE, there are not enough data to guarantee that fertility and pregnancies would not be compromised.24,25 There are no universal consensus guidelines regarding workup, follow-up, or exclusion criteria. Indications and contraindications are listed in Box 12–3. Cleveland Clinic parameters are discussed next.

Preoperative Outpatient Consultation The preoperative consultation is the most important visit and ideally occurs with a knowledgeable gynecologist who advocates UFE and with an expert interventional radiologist. These

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Evaluation of the Patient for Uterine Fibroid Embolization BOX 12–3 Indications and Contraindications for Uterine Fibroid Embolization Indications ● Symptomatic uterine fibroids have been discovered on bimanual examination and confirmed by ultrasound or MRI ● Patient and physician prefer UFE over other modalities ● Desired improvement in menorrhagia, bulk symptoms, or pelvic pain Absolute contraindications ● Pregnancy ● Exophytic fibroid with stalk <2 cm ● Prolapsing vaginal myomas ● Associated pathology requiring pelvic surgery (complex adnexal mass, symptomatic pelvic prolapse) ● Active pelvic inflammatory disease ● High suspicion for leiomyosarcoma ● Genital malignancy (endometrial cancer, cervical cancer) Relative Contraindications ● Intracavitary leiomyomas ● Desire for future fertility ● Renal Impairment ● Contrast allergy ● Coagulation disorders (must be corrected before procedure) ● Current use of a GnRH agonist ● Dominant fibroid >8-10 cm ● Immunocompromise (must be monitored closely for infection risk) ● Intrauterine device in place

Figure 12–4 A 51-year-old woman presented with profound menorrhagia, anemia, and rapidly enlarging leiomyoma. The patient desired uterine fibroid embolization (UFE); however, preoperative magnetic resonance imaging demonstrated central necrosis, and UFE was not recommended. At hysterectomy, the uterus showed a very abnormal appearing myometrium with numerous cystic changes. Frozen section demonstrated extensive leiomyosarcoma.

consultations are usually performed separately. When the interventional radiologist has admitting privileges, the transition is seamless, including consultation, scheduling, precertification, performance of the procedure, and admission and discharge management. Seven salient questions must be addressed before recommending UFE. ●

● ● ● ●

●

●

Does the patient have fibroids? Could symptoms be related to adenomyosis or other factors? Are the symptoms related to the fibroids? Does she want children? Do the symptoms require treatment? Are there anatomic factors that predispose her to treatment failures or indicate adjunctive evaluation to ensure treatment success? Are there gynecologic or nongynecologic medical conditions that predispose her to risks from UFE or surgery? Are there other reasons that she does not want surgery?

GnRH, gonadotropin-releasing hormone; MRI, magnetic resonance imaging; UFE, uterine fibroid embolization.

●

●

●

●

CLINICAL PEARL ●

●

●

A knowledgeable gynecologist reviews the medical history and gynecologic exam with an emphasis on fibroid-related symptomatology, quality of life concerns, expectations, and desire for pregnancy. Patients interested in pregnancy are not referred for UFE except in extenuating circumstances. It is important to determine if UFE is indicated or if other treatment options should be tried first. The risks and benefits

●

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of UFE must be reviewed. The patient should be given brochures, and website information for additional information. The physician should provide extensive patient education including handouts, technical explanation, and phone contact with another patient who has had the procedure (if desired). Patients should use contraception after the procedure and prescription for the contraceptive should be given if necessary. Discontinue all nonsteroidal antiinflammatory drugs (NSAIDs), vitamin E supplements, aspirin, and herbal products at least 3 weeks before the procedure, thereby reducing the risk of bleeding at the puncture site. If the patient has been using a GnRH agonist, it is stopped and the procedure is not scheduled until the patient has had at least one menstrual cycle. GnRH therapy can result in vascular spasm, making it difficult to catheterize narrowcaliber blood vessels. Unilateral catheterization is associated with the highest risk of failure in relieving symptoms. If an IUD is present, recommend removal before the procedure and placement of another IUD 4 to 6 months after UFE. There is a theoretic increased risk of infection or expulsion as the volume of the uterus decreases.

Chapter 12

Evaluation of the Patient for Uterine Fibroid Embolization If the patient is still a candidate for UFE, then the following laboratory tests are performed:

H 2

Preliminary Testing Laboratory Tests ● ● ● ● ● ●

Complete blood count (CBC) with platelets Prothrombin time Partial thromboplastin time Blood urea nitrogen (BUN) and creatinine Follicle-stimulating hormone (FSH) and estradiol levels Human chorionic gonadotropin (hCG) (urine pregnancy test on day of procedure)

P

A

Additional Tests ● ●

●

Recent normal Pap test Gonorrhea and chlamydia cultures (if clinically indicated). Treat any vaginal infections, including bacterial vaginosis and trichomoniasis before the procedure. Endometrial biopsy (if clinically indicated). ● Women older than 40 years with high risk factors for endometrial hyperplasia or cancer should undergo endometrial sampling. ● Women with noncyclical abnormal bleeding should undergo endometrial biopsy. Perform the endometrial biopsy at least 1 to 2 weeks before UFE, to decrease the risk of infection. ● Patients with endometrial hyperplasia should not be offered UFE.

F

C:00306 W:00681

Figure 12–5 Magnetic resonance imaging T2-weighted images of a 13 cm × 15 cm leiomyoma extending above the umbilicus. This patient was not referred for uterine fibroid embolization because of the large dominant size of this anterior leiomyoma.

H 5

Diagnostic Imaging

MRI of the pelvis should be performed, with and without gadolinium, to confirm the presence of fibroids and to determine dominant fibroid size, number, and location of fibroids. Specify this on your MRI request. Additionally, coexisting adnexal masses and adenomyosis can be diagnosed. MRI is associated with less intraobserver variability compared to ultrasound and provides an excellent means of follow-up. Particularly if the fibroid is above the umbilicus, more accurate measurements are possible with MRI than with ultrasound (Figs. 12–5 and 12–6). If MRI cannot be performed, then pelvic ultrasound should be performed. If ultrasound is equivocal for presence of intracavitary fibroids, then consider office hysteroscopy. MRI is the gold standard for detecting adenomyosis. Adenomyosis and fibroids can coexist. Likewise the degree of adenomyosis (diffuse or local) can be determined by MRI. Increasingly, patients with adenomyosis are being offered UFE therapy with excellent outcomes (Fig. 12–7). Once these records are reviewed and there are no findings that contraindicate UFE therapy, the patient is advised to have a formal consultation with the interventional radiologist. The interventional radiologist obtains informed consent and precertification and schedules the procedure. Whenever possible among fertile patients, the procedure should be scheduled within the first 2 weeks of the menstrual cycle, with a negative

R

L

F

C:00279 W:00619

Figure 12–6 Magnetic resonance imaging T2 coronal view of heterogeneous 13 cm × 15 cm leiomyoma. Bulk symptoms were the predominant complaint. The patient was treated surgically with hysterectomy. Benign uterine fibroids were identified.

pregnancy test on the day of the procedure. This decreases the risk of an unrecognized early or luteal phase pregnancy.

Other Recommendations GnRH agonist therapy should be discontinued at least 6 to 8 weeks before planned UFE. Anecdotally, radiologists have

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BOX 12–4 Medications for Uterine Fibroid Embolization 1 Prophylactic antibiotic therapy ●

Cefazolin 1 g IV piggyback 1 h before procedure

Intraoperative pain control (very important) ● ● ●

A

P

Ketorolac (Toradol) Midazolam (Versed) PCA pump (morphine or fentanyl)

Postoperative pain control ● ● ●

Admission overnight to short stay unit for pain management Ketorolac 30 mg IV q6h Morphine or fentanyl pump

Antiemetics (crucial) ● ●

A

FR

C:00228 W:00530

Ondansetron (Zofran) 8 mg IV immediately before the procedure Ondansetron 8 mg I.V. q8h after the procedure, then as needed

Constipation prophylaxis ● ●

H

●

Docusate (Colace) 100 mg bid Increase fiber: add prunes, raisins, prune juice to daily diet Laxatives as needed

Discharge medications: The cocktail ● ● ● ● ●

Docusate 100 mg PO bid NSAIDS Ketorolac 10 mg PO q6h for 5 days, then Ibuprofen 600-800 mg PO q6-8h Narcotics ● ●

A

●

Oxycodone with acetaminophen (Percocet) 5 mg/325 mg, 1-2 tablets PO q4-6h or Propoxyphene 100 mg with acetaminophen 650 mg (Darvocet N-100) 1-2 tablets PO q4-6h PRN or Hydrocodone 5-10 mg with acetaminophen 500-750 mg (Vicodin) 1-2 tablets PO q4-6h PRN

NSAID, nonsteroidal antiinflammatory drug; PCA, patient-controlled anesthetic.

10 cm

Hospital Considerations B Figure 12–7 A, Magnetic resonance imaging findings demonstrate a normal uterus. The patient complained of menorrhagia and dysmenorrhea. Rather than with uterine fibroid embolization, the patient was treated by endometrial ablation. B, Magnetic resonance imaging findings of diffuse adenomyosis with an ill-defined thickened junctional zone. These are classic features of adenomyosis.

described more difficult catheterization among current GnRH users due to vascular spasm. Additionally, concomitant GnRH therapy can preclude accurate assessment of the clinical response to UFE. However, postprocedure GnRH therapy may be used in patients with profound anemia and incessant menorrhagia to alleviate symptoms until the clinical response of UFE takes effect.

Many regimens have developed to improve patient comfort, minimize prolonged hospitalization, and decrease readmissions. During the initial phase of catheterization, pain is minimal; however once the embolic material has been injected, vascular spasm occurs, and pain is described as a “heart attack” of the pelvis, if the patient has not received adequate pain medication. Prostaglandin levels are elevated, leading to pain, cramping, and nausea and vomiting. Preemptive use of high doses of NSAIDs and narcotics minimize postprocedural pain. With the prophylactic use of the medications listed in Box 12–4, pain relief, delayed discharge, and decreased readmissions have been much improved. Patients should be given instructions to follow after discharge home, including what to watch for and when to call (Box 12–5). Do not discharge the patient if pain, nausea, and vomiting are not well controlled. Do not discharge the patient if she is unable to void after the Foley catheter is removed. Transient com-

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Evaluation of the Patient for Uterine Fibroid Embolization BOX 12–5 Postprocedure Discharge Instructions Take and record temperature every 6-8 hours for 4-5 days Monitor groin puncture site for hematoma formation (order an ultrasound of the groin to rule out pseudoaneursym for groin hematoma if painful lumps occur) Call if temperature is persistently elevated (>100.1° F) Call if there is worsening pain, nausea, or vomiting Call if there is foul-smelling discharge or passage of tissue Call if there is leg pain or shortness of breath Make a follow-up appointment with the gynecologist in 4 weeks, 6 months, and 12 months

plaints after UFE include bloody or serosanguineous discharge, hot flushes, fatigue and lethargy, lower abdominal cramping, and low-grade fever.

PROCEDURE AND TECHNICAL CONSIDERATIONS Embolization Using fluoroscopic guidance, an experienced interventional radiologist performs UFE from a single common femoral artery puncture site, usually on the right. Alternative arterial approaches may be considered when the femoral artery is not accessible. Conscious sedation is used. The operator directs a catheter over the aortoiliac bifurcation into the contralateral (left) internal iliac artery and performs selective arteriography of this vessel. This identifies the major nontarget branches and clarifies the configuration of the origin of the uterine artery. The uterine artery is easily identified angiographically by its characteristic tortuosity and medial course (Fig. 12–8). In the case of uterine fibroids, it is usually markedly hypertrophied and its enlarged terminal branches splay over and penetrate the substance of the fibroid masses (Fig. 12–9). A catheter is advanced deep into the uterine artery. When a secure position is confirmed, embolization may proceed (Fig. 12–10). Most practitioners currently use polyvinyl alcohol (PVA) beads or microspheres, or gelatin-coated trisacryl polymer microspheres, which are available in various size ranges. Particles of 355-500 μm and 500-700 μm diameter are commonly used. The smaller particles tend to cause more rapid tissue necrosis and may be associated with greater postembolization discomfort. Trisacryl plastic spheres (500-900 μm) (Emblospheres, BioSphere Medical, Rockland, Mass.) have become increasingly popular for UFE. Cited advantages include homogeneous particle size, absence of interparticle clumping, and greater penetration into the vascular network feeding the fibroid. The particles are injected under fluoroscopic observation, and they progressively occupy the fibroids’ vascular bed. The catheter then is pulled back into the left internal iliac artery and postembolization angiography is performed to confirm the resultant vascular occlusion. A catheter is then guided into the right uterine artery and an identical process of embolization is

Figure 12–8. A left hypogastric arteriogram. The superior gluteal artery is the large vessel sweeping out horizontally to the patient’s left; the inferior gluteal is the large S-shaped vertical branch, and the uterine artery is the small vertical, slightly redundant branch lateral to the inferior gluteal. The redundancy is a key identifying feature, as well as its hypervascularity in the setting of fibroids. The bones are visible on this injection.

performed. Best results are obtained when both uterine arteries are catheterized. The catheter and vascular sheath are removed. The procedure usually takes 60 to 90 minutes to perform. In 2% of cases, bilateral UFE is not possible. Four possible causes of failure include anatomic variations or arterial spasm that is unresponsive to nitroglycerin or other vasodilators, inability to catheterize one or both uterine arteries, fibroids that receive collateral blood flow from sources other than the uterine artery (ovarian collaterals), and embolic material that clumps and is insufficient to cause ischemia or creates a false appearance of occlusion.26 Inability to perform a bilateral procedure is considered a technical failure. Current Society of Interventional Radiologists (SCIVR) guidelines aim for a technical failure rate of less than 2%.

Recovery Period At institutions where the interventional radiologist has admitting privileges, the patient is managed entirely by the interventional radiology service after the procedure. Otherwise, the gynecologist manages the postprocedural period. More than 95% of patients are discharged within 23 hours after the procedure. Shorter hospitalizations (6 to 8 hours) are being evaluated. Routinely, the gynecologist examines the patient within 4 to 6 weeks after the procedure. Follow-up visits are scheduled every 6 months for 1 year to ensure improvement in clinical symptoms and decrease in uterine size. Acute devascularization and infarction of fibroids occurs immediately after UFE and requires aggressive pain management for most patients (see Box 12–4). Patients are typically

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Aorta

Ext iliac art

Ext iliac art Int iliac art

Ut art

A

C

B

Figure 12–9 A, Arteriogram taken before uterine fibroid embolization. art, artery; Ext, external; Int, internal; Ut, uterine. B, Arteriogram taken of the tangled network of blood vessels surrounding a large leiomyoma (arrows). C, Arteriogram taken after injection of embolic material demonstrating the blush (arrows) and decreased blood flow to the leiomyoma.

admitted overnight to a short-stay unit. A patient-controlled analgesia (PCA) morphine pump and regular doses of ketorolac are administered. The greatest lesson learned is to provide a consistent cocktail of NSAIDs, antiemetics, narcotics, and stool softeners to treat pain and nausea and to prevent constipation. These three culprits can prevent early discharge or lead to early readmission or return to the emergency department. When pain relief is not adequately managed, UFE patients appear more uncomfortable than surgical patients. The patient is placed on bed rest for 4 to 6 hours. The diet is advanced as tolerated. Although the great majority of patients are discharged within 23 hours of the procedure, a small number

require 2 to 4 days of admission for pain management. Patients are discharged home when they can tolerate a normal diet and when discomfort is controlled with oral pain medications. After discharge, the most common complaints are pelvic cramping and several days of a low-grade fever. However, a small minority experience myriad symptoms including prolonged fatigue and lethargy, abdominal pressure, cramping, vaginal bleeding, and vaginal discharge. Most of these symptoms dissipate within 2 to 4 weeks; however, some persist for 8 to 12 weeks following the procedure. The discharge can be profuse, can be serosanguineous or yellow-white, and can contain fibroid remnants.

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Fibroid Catheter

Femoral artery Uterine artery

A

Fibroid

Uterus

Figure 12–11 Approximately 3 weeks after uterine fibroid embolization (UFE) for an 18-cm intracavitary leiomyoma, the patient was referred for complaints of foul-smelling leukorrhea. The sanitary pad was soaking with copious, malodorous discharge. Perineal excoriation was due to the constant need for perineal hygiene.

PVA particles

Uterine artery

Catheter

B Figure 12–10. Schematic representation of uterine fibroid embolization (UFE) procedure. The goal of UFE is to infarct and shrink the uterine fibroid. A, Unilateral or bilateral femoral artery punctures are performed by the interventional radiologist. B, Placement of particles. Choice of particle size is determined by the interventional radiologist. The differential in vascularity between fibroid and normal tissue makes it possible for the numerous occluding agents (polyvinyl acetate, absorbent gelatin sponges [Gelfoam], emblospheres, microspheres, bead blocks, microcoils) to selectively infarct the leiomyoma from a proximal uterine artery catheter. Myometrium is spared.

Most patients’ symptoms improve significantly within 7 to 10 days. The majority of patients resume full activities within 7 to 14 days, although some require 2 to 4 weeks for full recovery. Pron and colleagues’ study of 555 women undergoing UFE found that the mean number of days off activities was 6.50 Abnormal bleeding might respond immediately or take several weeks to stop. Shrinkage of the fibroids appears to be progressive over approximately 6 months, with volume decreasing 30% to 50% as measured on serial MRI examinations or measurement of fundal height.

Telephone contacts are made by the interventional radiologist during the early postembolization period to manage the expected symptoms of low-grade fever and cramping. High fevers, chills, or sweats despite antipyretics, however, are cause for concern and can indicate infection within the infarcted fibroid tissue. Broadspectrum antibiotics are prescribed for low-grade fever. The most common organism cultured in patients with sepsis is Escherichia coli. Lack of prompt defervescence should prompt an office visit for pelvic and abdominal examination, white blood cell count, and possibly MRI or computed tomography (CT) evaluation. Intravenous antibiotic therapy may be indicated. If the fever does not respond to antibiotics, or if drainage includes infected material, hysterectomy may be considered. Fortunately, this circumstance is uncommon. If a patient requires surgical intervention due to sepsis, be extremely proactive in advising hysterectomy. In the face of sepsis, myomectomy should not be attempted. Be aware of postprocedural complaints of chest pain, shortness of breath, or tachypnea. Pulmonary embolism has been observed in patients with uncomplicated procedures days or weeks after the procedure. Patients with shortness of breath should be seen promptly to evaluate for pulmonary embolism and to rule out a deep venous vein thrombosis. A prolapsed fibroid should be suspected when the patient has improved clinically but later develops severe cramping, leukorrhea, bleeding, or vaginal mass. When these symptoms occur, an examination should be performed to exclude transvaginal expulsion of necrotic leiomyomas or pyometria (Figs. 12–11 to 12–14). Very necrotic and friable, prolapsing fibroids may be removed in the office; larger intracavity lesions can require

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Figure 12–14 Using ring forceps, a 15-16 cm necrotic leiomyoma was removed. Intraoperative hysteroscopy demonstrated no residual leiomyoma. Leukorrhea promptly resolved without further sequelae. Figure 12–12. Hygiene pad required for 1 month after onset of leukorrhea. The pad is soaked with serosanguineous fluid caused by a prolapsing myoma. The patient required constant pad use for 1 month until a new referral and consultation were undertaken.

The patient must avoid vaginal intercourse for 2 weeks or until the vaginal discharge resolves. When leukorrhea is persistent or serosanguineous discharge noted, office hysteroscopy is helpful in identifying discontinuity within the endometrium or necrotic prolapsing fibroids (Fig. 12–15C). The gynecologist sees patients who have no complications within 1 month of the procedure. Subsequent office visits are scheduled the first year at 6 months. One year after the procedure, annual visits are scheduled unless new symptoms occur. At each visit, a pelvic examination, including fundal height measurement, should be performed. Patients are asked about resolution of symptoms and their level of satisfaction with the procedure. Most fibroid-related symptoms improve within 4 to 6 months after the procedure. Maximum fibroid shrinkage is obtained by mouth 4 to 6. In 10% of patients, additional fibroid shrinkage occurs up to 12 months after the procedure. Repeat MRI of the pelvis if uterine fibroids continue to grow or if unusual pain occurs. Hysterectomy is recommended for UFE failures (Fig. 12–15B).

ADENOMYOSIS

Figure 12–13 Inspection of the cervix demonstrates a necrotic mass and purulent discharge in the vagina.

hysteroscopic myomectomy. When in doubt, examination under anesthesia and removal of necrotic leiomyoma is preferable. Additionally, hysteroscopic examination under anesthesia permits a more comprehensive view of the endometrial cavity to look for residual lesions or necrotic endometrium. Hysteroscopy is advised after removing a prolapsing fibroid to make sure that no residual fibroid is present that can require hysteroscopic myomectomy (Fig. 12–15). Prolapsed fibroids have occurred up to 7 to 18 months after UFE. Confirmation of pyometria is possible with CT or MRI.

Postprocedure Follow-up Patients with persistent symptoms of bleeding, pain, and fever should be evaluated immediately (Fig. 12–15A).

Adenomyosis is increasingly being diagnosed by MRI in patients initially referred for UFE. Adenomyosis, the ectopic location of endometrium and glands into the myometrium, mimics many fibroid-related symptoms in premenopausal women. The prevalence of adenomyosis ranges from 8% to 31% among premenopausal women. Women with adenomyosis can have incapacitating dysmenorrhea, bulk symptoms, menorrhagia, and a pelvic mass. Why do women with adenomyosis have symptoms? There are several etiologies: increased endometrial surface area, total surface capillaries are increased up to 11.6 times that of controls, and compromise of the myometrium’s contractile function by dysfunctional hypertrophic myometrium.27 Adenomyosis can involve microscopic amounts or large visible nodules termed adenomyomas, which can mimic leiomyomas. MRI with and without contrast is required at most institutions for presurgical evaluation. Many cases of adenomyosis are

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B

A

C

Figure 12–15 A, This patient presented with copious purulent discharge after uterine fibroid embolization (UFE). The discharge was unresponsive to intravenous antibiotics. A necrotic leiomyoma was completely obliterating the endometrial cavity. Hysterectomy was advised due to clinical symptoms. B, This patient presented with persistent pelvic pain after UFE. Pain and fever were unresponsive to antibiotics. Total abdominal hysterectomy and bilateral salpingo-oophorectomy was performed and extensive hyaline degeneration was encountered. The patient succumbed to infection. The patient had connective tissue disease, was being treated with long-term steroids, and did not respond to treatments received in the intensive care unit. C, This patient required hysterectomy for persistent leukorrhea beginning 4 to 6 months after UFE. Hysteroscopy revealed an abdominal sinus tract and discontinuity of the endometrium. Laparoscopic-assisted vaginal hysterectomy was performed; a 3-5 cm area of discontinuity and absence of the endometrium overlying an intramural leiomyoma was found. Chronic discharge resolved after hysterectomy.

detected coincidentally during the workup for leiomyomas. In one study, adenomyosis coexisted with leiomyomas in 35% to 55% of cases.28 Siskin et al29 have reported marked improvement in clinical symptoms of adenomyosis in 12 of 13 patients with adenomyosis and concomitant fibroids. Specifically, they noticed a statistically significant improvement in the SF-36 (short-form, 36-question) questionnaire: improved ability to perform activities of daily life, improved ability to socialize outside the home, increased energy level, diminished pain with intercourse, less pelvic pain, and less cramping. In patients with pure adenomyosis who have been treated by UFE, surprisingly, marked clinical improvement in symptoms were also detected in 25 of 30

patients.30 Pelage and colleagues31 have published the largest long-term series to date of women treated by UFE for adenomyosis. They included 18 women who were treated and followed for 2 years. By year 2, five (56%) of nine women had total resolution of menorrhagia. Eight (44%) of 18 women needed additional therapy, including five women (28%) who had hysterectomy. MRI findings after UFE for the treatment of adenomyosis demonstrate decrease in the size of the junctional zone. The reduction in uterine volume can lead to decrease in surface area and thus bleeding. Endometrial ischemia can also contribute to improvement in bleeding. Lastly, post-MRI findings

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Evaluation of the Patient for Uterine Fibroid Embolization demonstrate changes in areas of adenomyosis with decrease in junctional zone vascularity. Gynecologists must be cognizant of low risks of expulsion of an adenomyoma. In one case report, 5 days after UFE for adenomyosis, a patient presented with cramping, dysuria, and elevated temperature.32 In addition to evidence of focal bladder necrosis (detected by cystoscopy), she also passed a large necrotic intracavity lesion vaginally that represented focal pyoadenomyosis. Eventually, the focal bladder necrosis healed spontaneously, and the patient preserved her uterus without other sequelae.

Table 12–1 Comparison of Outcomes Outcomes

Hysterectomy

Myomectomy Abdominal

UFE

Improved bleeding by month 12

100%

64%

86%-94%

Bulk symptoms improved by month 12

80%-94%

91%

80%-92%

Improved pelvic pain

98%

54%

74%-84%

RESULTS

Mean hospitalization

2.3-7.3 days

2.0-3.6 days

0-3.6 days

Clinical improvements from UFE are very impressive and consistent among centers. Menorrhagia is consistently improved, and menstrual flow declines by 83% to 92%. Bulk symptoms are improved in 78% to 90%. Pron and colleagues evaluated 555 women undergoing the procedure and noted a mean decrease in menstrual flow from 7.4 days to 5.4 days and decrease in pad count for the heaviest days, from 9 to 4 pads used.50 Before the procedure, 30% of patients had menstrual flow exceeding 7 days, and after UFE only 9% had cycles lasting more than 7 days. Improvement also was reflected by marked improvement in quality of life scores. The SCIVR has initiated a national registry (FIBROID) to prospectively tabulate clinical outcomes. Most reports to date have been from individual regional centers, and retrospectively they have reported consistently favorable outcomes. When inclusion and exclusion criteria are followed closely, excellent clinical outcomes are reported. The clinical success rate worldwide is 85%. Wide ranges of uterine sizes and patient symptoms have been treated. Most centers do not exclude patients based on uterine size alone. Even large fundal heights, approaching 28 to 35 weeks, have been treated. An important variable is to determine whether the patient has innumerable fibroids or a dominant fibroid larger than 8 to 10 cm. For each centimeter greater than 8 to 10 cm, the success rate decreases by 10%. A patient with a dominant 15-cm fibroid, for example, has a less than 50% chance that her symptoms will improve. The maximum uterine volume decreases within 4 to 6 months of the procedure. Bulk symptoms and menorrhagia consistently improve even when uterine size does not. For patients who are not concerned about the cosmetic effects of their uterine fibroids, UFE is an excellent alternative. All types of fibroid symptoms (e.g., menorrhagia, bulk-related, and uterine enlargement) have responded to UFE. Patient improvement is greatest in women presenting with menorrhagia alone. The average reduction in size of the uterus is 40% to 60% at 6 months. Long-term follow-up is limited, with only a few centers reporting data for follow-up of 9 to 36 months3 (Table 12–1).

Return to normal activities

33-36 days

36 days

8-14 days

No need for further treatment

100%

90%

87%-99%

PREGNANCY There have been several reports of successful pregnancies and resumption of menses following uterine artery embolization for postpartum hemorrhage, treatment of placentation problems

UFE, uterine fibroid embolization.

(accreta, percreta, or increta), and postcesarean bleeding. These patients are treated with embolization most commonly for hemodynamic instability and massive blood loss.33 The data are sparsely reported and anecdotal regarding pregnancy following UFE for treating uterine fibroids. Proponents of pregnancy after UFE cite positive data of successful pregnancies after uterine artery embolization for postpartum hemorrhage. Future fertility remains largely unstudied. It has been postulated that UFE might affect placenta or fetal growth by decreasing uterine or myometrial vasculature. Ravina, the French gynecologist who first proposed UFE for treating uterine fibroids, provided one of the original case series detailing 12 pregnancies following UFE.11 All of the pregnancies were unplanned, and many patients were older than 40 years. Pron and colleagues evaluated 555 women in a multicenter Canadian trial and noted 24 pregnancies.50 There were 24 pregnancies in 21 patients (some women became pregnant twice). These pregnancies resulted in 18 live births; there were four elective terminations of pregnancy. Complications of pregnancy occurred in three patients, including abnormal placentation with placenta acreta and placenta previa. There were several cases of postpartum hemorrhage that required cesarean hysterectomy. Close surveillance of the placenta and the third stage of labor are advised. Additionally, delivery at a tertiary care site is recommended. Kim and colleagues performed UFE in 94 patients; there were eight pregnancies within the group, including five vaginal deliveries, two elective cesarean sections, and one elective termination of pregnancy.34 There were no complications among the women studied in that group. Women undergoing UFE have demonstrated increased risk of premature ovarian failure (premature menopause), Asherman syndrome, decreased endometrial perfusion, or extrusion of uterine fibroids. The endometrium may be affected by UFE and can contribute to decreased fertility or abnormal placentation (Figs. 12–16 and 12–17A). In fact, several studies have noted increased risk of postpartum hemorrhage, placental abnormalities including placenta accreta and placenta increta, and increased risk of

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Evaluation of the Patient for Uterine Fibroid Embolization BOX 12–7 Postprocedure Complications Postembolization syndrome Ischemic necrosis with prolonged purulent drainage Deep vein thrombosis Pulmonary embolism Nontarget embolization Fibroid regrowth Endometritis or pyometritis Transcervical expulsion of uterine fibroids Premature ovarian failure Sepsis Anorgasmia Death

Figure 12–16 An intramural fibroid (necrotic) extruded from its intramural location after uterine fibroid embolization (UFE). Before UFE, no intracavitary lesions were seen.

BOX 12–6 Procedural Complications Groin hematoma Groin infection Contrast allergy Contrast-related renal failure Arteriovenous malformations Pseudoaneurysm Misembolization of abdominal vessels Radiation exposure

hemorrhage after delivery. It is currently advised that women who become pregnant after UFE use a tertiary care center for their delivery.

COMPLICATIONS Standards related to the care of the patient, technical outcomes, patient selection, and the ability to recognize and treat complications from UFE were tabulated in a recent study.35 Overall, complication rates for UFE are lower than for myomectomy or hysterectomy. Complications related to UFE are divided into two groups: procedure related (Box 12–6) and postprocedure complications. The most common postprocedural complications include postembolization syndrome, fibroid expulsion, and vaginal discharge (Box 12–7). Postembolization syndrome, consisting of the triad of pain, fever, and leukocytosis, occurs within days after UFE. It results in readmission in up to 15% of patients. It is typically the most difficult component of the procedure to manage. In some cases, observation is difficult because patients

are markedly febrile with temperature elevation to 39°C, marked leukocytosis (15,000-30,000/L), and exquisite abdominal pain and tenderness. Nonpurulent vaginal discharge, loss of appetite, nausea and vomiting, and malaise are also noted. Although the rates of admission are low, the incidence of postembolization syndrome can occur in up to 40% of patients and is not considered a major complication unless the patient requires readmission, prolonged recovery, or prolonged hospitalization.36 Temperatures and clinical course must be carefully monitored, because there is a low risk of septicemia associated with UFE. Most febrile symptoms resolve spontaneously or improve rapidly with broad-spectrum antibiotics. Occasionally, hysterectomy has been indicated due to persistent pyrexia. Postprocedural ischemic complications, although rare, have been observed. Complications due to ischemic necrosis are associated with prolonged purulent drainage, endometritis or pyometritis, and transcervical expulsion of uterine fibroids (Figs. 12–17B and C). A large multicenter trial enrolling more than 3000 patients noted a 4.8% rate of readmission within 1 month of discharge.37 Death following UFE is uncommon, but several cases have been reported. One patient was perimenopausal and underwent UFE for a symptomatic 20-week size leiomyoma. Approximately 1 week after the procedure, she developed fever, pain, and disseminated intravascular coagulation followed by an emergent hysterectomy. Intraoperative findings included a foul-smelling uterus and a necrotic submucosal fibroid. Fifteen days following a stormy course, she developed multiorgan failure and died. Another death was reported following a fatal pulmonary embolus in a 61-year-old woman who remained on bed rest following the procedure. It is unclear why this patient was treated with UFE. It is certainly contraindicated for a postmenopausal patient to be treated by UFE for uterine fibroids whether she is symptomatic or not. Hysterectomy is advisable when postmenopausal women develop symptomatic fibroids. Although rare, leiomyosarcomas do occur. Most occur in postmenopausal women, with symptoms that can include weight loss, postmenopausal bleeding, or increased uterine size. Most cases of leiomyosarcomas that have been recorded have occurred

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Evaluation of the Patient for Uterine Fibroid Embolization

A

C

B

Figure 12–17 A, This patient presented 3 months after uterine fibroid embolization (UFE) with persistent discharge. Office hysteroscopy demonstrated pale atrophic anterior endometrium with an intramural fibroid abutting the endometrium. An umbilicated area of necrotic endometrium is seen at the fundus. Endometrial changes are often noted after UFE. B, This patient presented with persistent bleeding and cramping following UFE. Operative hysteroscopy demonstrates a leiomyoma. The small white particles are consistent with the embolic particles used during UFE. C, Due to persistent symptoms, the patient underwent hysterectomy. Small amounts of gelatinous material were consistent with embolic particles used during UFE.

in a dominant fibroid larger than 8 cm. A case study has been reported in a woman treated by UFE who later underwent surgery during which a leiomyosarcoma was found.38 Complications such as skin necrosis of the buttock, claudication, transient gluteal pain, impotence, bladder necrosis, and gait disturbance have been observed in embolization for nongynecologic conditions. The SCIVR reported an anonymous survey report of 4165 procedures, and identified 25 major complications that necessitated a gynecologic surgical procedure within 30 days of UFE. These represent 1 of 167 cases or 6 : 1000 procedures.39

Expulsion of Fibroids

The liberal use of MRI before UFE effectively documents the location of uterine fibroids thus making the theory of expulsion of the myoma more plausible. In general, women with intracavitary fibroids should be treated by hysteroscopic myomectomy rather than UFE.

CLINICAL PEARL ●

●

Generally the necrotic myoma and fibroid tissue is absorbed by the myometrium after UFE. However, due to contraction of the myometrium after UFE, intramural fibroids can protrude into the endometrial cavity, becoming an intracavitary leiomyoma. Transvaginal expulsion, months or years later, has been documented.40 The incidence of fibroid expulsion ranges from 0.5% to 17.7%.41

●

●

●

Consider fibroid expulsion when a patient previously treated by UFE complains of increasing abdominal pain, labor-like cramping, or increasing discharge that may be mucopurulent or serosanguineous. Symptoms promptly resolve after spontaneous expulsion or surgical removal of the necrotic fibroid. If spontaneous expulsion occurs, perform office hysteroscopy to confirm total expulsion of the myoma and to confirm no residual myoma persists. After spontaneous expulsion with residual myoma is documented, watchful waiting is advised. The majority of women have complete resolution of symptoms. Continued

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Evaluation of the Patient for Uterine Fibroid Embolization ●

●

Women expelling a fibroid might also complain of nausea, uterine contractions, fever, vaginal bleeding, and intense dysmenorrhea. Remember to include the pelvic examination when patients present with these complaints.

Vaginal Discharge Approximately 30% of women complain of a mucoid vaginal discharge after UFE. Generally it resolves without further sequelae. However, 4% to 7% of women have a necrotic fibroid, fluid accumulation within the fibroid cavity, and a sinus tract that communicates between the endometrium and myometrium.42 Resolution of the chronic drainage is occurs in 94% of patients within 1 to 3 months. However, symptoms can spontaneously appear months of even years after UFE. Improvement can occur spontaneously or with dilation of the cervix performed in the office. A brief dilation of the cervix can lyse adhesions in the uterine cavity or lower uterine segment. UFE can create adhesions due to decreased endometrial perfusion, a small hematometria or pyometria. Gentle dilation may be all that is needed to resolve the discharge. This should be tried first along with a broadspectrum antibiotic for 7 to 10 days. Consider saline infusion sonography (SIS), which clearly outlines the endometrium and myometrium and helps to determine the resectability and size of the uterine fibroid (Figs. 12–18 and 12–19). If SIS is equivocal, then MRI is recommended. The best treatment involves hysteroscopic resection of the necrotic myoma and resection of the sinus tract and debris.43 Rarely is hysterectomy necessary, except in cases when the residual myoma is large and cannot be resected hysteroscopically.44

Evaluation of Amenorrhea There have been several isolated case reports of premature ovarian failure in women undergoing UFE.45,46 This is an important complication, especially because UFE is most commonly performed in women aged 30 to 40 years. The long-term consequences of premature ovarian failure are well established and include osteoporosis, vasomotor symptoms, cardiovascular disease, and sexual dysfunction. This could have serious sequelae and undermine referral for this procedure if it occurs often. Currently, the reports are sparse and anecdotal. Most studies to date have identified premature ovarian failure in women older than 45 years.47 Amenorrhea is highly age-dependent following UFE. In women younger than 45 years, permanent amenorrhea is noted in 0% to 3%. Women older than 45 years experience permanent cessation of menses in 7% to 15% of cases.48,49,50 The etiology of UFE-induced premature ovarian failure is unclear; however, it may be due to total radiation dose associated with fluoroscopy or with ovarian ischemia due to loss of collateral circulation. It has been estimated that the total amount of radiation received is equivalent to one or two barium enema examinations. Improved radiographic techniques, including shielding or limiting fluoroscopy time, are being studied. Newer imaging units with pulsed fluoroscopic capability might decrease this risk. A few women develop severe Asherman’s syndrome, which obliterates the endometrial cavity. This may be due to the effect of the particles used on the endometrium. If a patient presents with post-UFE amenorrhea lasting more than 3 months, then FSH and estradiol levels should be ordered. If these are normal, then consider office hysteroscopy to determine if endometrial atrophy or Asherman syndrome is present. Typical hysteroscopic appearance of Asherman syndrome includes dense synechiae; fibrous, narrow-caliber endometrium; pale, atrophic-

[2D] G42/105dB FA2/P95

0:49:14

Figure 12–18 Saline infusion sonography coronal view of a large intracavitary leiomyoma present after uterine fibroid embolization. Presenting complaints were leukorrhea and brown vaginal staining.

⫹D 0.08cm ⫻D 0.12cm #D 3.30 cm *D 1.44cm

Figure 12–19 Saline infusion sonography longitudinal view of a large intracavitary leiomyoma present after uterine fibroid embolization. Hysteroscopic myomectomy resolved these complaints.

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Evaluation of the Patient for Uterine Fibroid Embolization appearing endometrium covering an intramural fibroid abutting the endometrium; and absence of endometrial tissue.

Table 12–2 Comparison of Complications

CONCLUSION

Complication

Hysterectomy has been the standard surgical approach for treating symptomatic uterine fibroids and is performed more often in the United States than myomectomy. Although these procedures are still indicated for some patients, uterine fibroid embolization, a less-invasive alternative, is proving highly effective in treating fibroids. To date, we know that embolization of the uterine arteries achieves a decline in uterine blood flow, diminishes the size of the leiomyomas, has a low complication rate and high patient satisfaction. Uterine fibroid embolization is safe and suitable for low-risk and high-risk patients. It is also an excellent alternative for patients with religious prohibitions against blood transfusions and for severely anemic patients needing immediate intervention. In the ideal interdisciplinary approach, the interventional radiologist, as opposed to merely serving as a consultant for lifethreatening ob/gyn disorders, performs UFE for definitive treatment of symptomatic fibroids. Because early reports are promising and patient satisfaction is high, some patients seek minimally invasive procedures for treating uterine fibroids. There is a need for the meticulous collection of long-term data related to safety, effectiveness, relapse rates, complications, pregnancy, impact on fertility, and technical failures. The ideal particle and size best suited for UFE remains to be seen. Additional areas needing further study include recurrence interval, frequency of ancillary procedures, cost analysis, and retreatment for recurrence. Variables affecting outcomes are unknown. Patient age, uterine size, number or location of fibroids, and histopathology can affect outcome. When UFE is not effective, gross pathologic

Hysterectomy (%)

Hemorrhage

1-30

Myomectomy (%) 8-13

UFE (%) 0

Thromboembolism

5

2

0.5

Rehospitalization or reoperation

5-12

3

1-5

Localized infection

10-24

5-31

0-22

Premature ovarian failure

0-20

0

1-15

UFE, uterine fibroid embolization.

findings must be rigorously examined to gain a better understanding of the anatomic location of fibroids. In so doing, we may learn that location, size, and number of fibroids and volume of the uterus play a role in the outcome. Finally, we are not relinquishing our turf to interventional radiologists. Rather, we are providing the most comprehensive care available to our patient. UFE is a safe, well-tolerated procedure that provides excellent relief of fibroid-related symptoms including menorrhagia, bulk symptoms, and dysmenorrhea as well as improving quality of life. The literature consistently demonstrates low complication rates. Less than 3% of patients require gynecologic intervention after UFE (Table 12–2). The most common gynecologic intervention is hysteroscopic myomectomy for removal of necrotic or liquefied myomas that cause a persistent discharge. It is our duty as physicians to ensure that all women who are potential candidates for UFE be given the option.

REFERENCES 1.

2. 3.

4.

5.

6.

7.

Myers ER, Goodwin S, Landow W, et al: Prospective data collection of a new procedure by a specialty society. The FIBROID registry. Obstet Gynecol 2005;106:44-51. ACOG Committee Opinion: Uterine artery embolization. Obstet Gynecol 2004;103:404-407. Goodwin SC, Spies JB, Worthington-Kirsch R, et al: Fibroid registry for outcomes data (FIBROID) registry steering committee and core site investigators. Obstet Gynecol 2008;111:22-33. Salomon LJ, de Tayrac R, Castaigne-Meary V, et al: Fertility and pregnancy outcome following pelvic arterial embolization for severe postpartum haemorrhage. A cohort study. Hum Reprod 2003;18: 849-852. Verspyck E, Resch B, Sergent F, et al: Surgical uterine devascularization for placenta accreta: Immediate and long-term follow-up. Acta Obst Gynecol Scand 2005;84:444-447. Heaston DK, Mineau DE, Brown BJ, Miller FJ: Transcatheter arterial embolization for control of persistent massive puerperal hemorrhage after bilateral surgical hypogastric artery ligation. AJR Am J Roentgenol 1979;133:152-154. Tseng SH, Lin CH, Kwan JI: Experience with conservative strategy of uterine artery embolization in the treatment of placenta percreta in the first trimester of pregnancy. Obstet Gynecol 2006;45(2):150-154.

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Weinstein A, Chandra P, Schiavello H: Conservative management of placenta previa percreta in a Jehovah’s Witness. Obstet Gynecol 2005;105:1247-1250. Oliver JA, Lance JS: Selective embolization to control massive hemorrhage following pelvic surgery. Am J Obstet Gynecol 1979;135:431-432. Vedantham S, Goodwin SC, McLucas B, et al: Uterine artery embolization: An underused method of controlling pelvic hemorrhage. Am J Obstet Gynecol 1997;176:938-948. Ravina JH, Herbreteau D, Ciraru-Vigneron N, et al: Arterial embolization to treat uterine myomata. Lancet 1995;346:671-672. Spies JB, Spector A, Roth AR, et al: Complications of uterine artery embolization for leiomyomata. Obstet Gynecol 2002;100:873-880. Ravina JH, Cirau-Vigneron N, Aymard A, et al: Uterine artery embolisation for fibroid disease: Results of a 6-year study. Minim Invasive Ther Allied Technol 1999;8:441-447. Fiscella K, Eisinger SH, Meldrum O, et al: Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: A randomized controlled trial. Obstet Gynecol 2006;108:1381-1387. Hindley J, Gedroyc WM, Regan L, et al: MRI guidance of focused ultrasound therapy of uterine fibroids: Early results. AJR Am J Roentgenol 2004;183:1713-1719.

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Evaluation of the Patient for Uterine Fibroid Embolization 16. Stewart EA, Rabinovici J, Tempany CM, et al: Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids. Fertil Steril 2006;85:22-29. 17. Pelage JP: Uterine fibroid ablation: The beginning of the end of uterine fibroid embolization? Cardiovasc Intervent Radiol 2006;29:499-501. 18. Becker ER, Spalding J, DuChane J, et al: Inpatient surgical treatment patterns for patients with uterine fibroids in the United States, 19982002. J Nat Med Assoc 2005;97:1336-1342. 19. Wegienka G, Baird DD, Hertz-Picciotto I, et al: Self-reported heavy bleeding associated with uterine leiomyomata. Obstet Gynecol 2003;101:431-437. 20. Pinto I, Chimeno P, Roma A, et al: Uterine fibroids: Uterine artery embolization versus abdominal hysterectomy for treatment. A prospective, randomized, and controlled clinical trial. Radiology 2003;226:425-431. 21. Dundr P, Mara M, Maskova J, et al: Pathological findings of uterine leiomyomas and adenomyosis following uterine artery embolization. Pathol Res Pract 2006;202:721-729. 22. Goldberg J, Bussard A, McNeil J, Diamond J: Cost and reimbursement for three fibroid treatments: Abdominal hysterectomy, abdominal myomectomy, and uterine fibroid embolization. Cardiovasc Intervent Radiol 2007;30:54-58. 23. Marshburn PB, Matthews ML, Hurst BS: Uterine artery embolization as a treatment option for uterine myomas. Obstet Gynecol Clin N Am 2006;33;125-144. 24. Ravina JH, Vigneron NC, Aymard A, et al: Pregnancy after embolization of uterine myoma: Report of 12 cases. Fertil Steril 2000;73:12411243. 25. Goldberg J, Pereira L, Berghella V, et al: Pregnancy outcomes after treatment for fibromyomata: Utereine artery embolization versus laparoscopic myomectomy. Am J Obstet Gynecol 2004;191:18-21. 26. Spies JB: Uterine fibroid embolization for fibroids: Understanding the technical causes of failure. J Vasc Interv Radiol 2003;14:11-14. 27. Ota H: Morphometric evaluation of stromal vascularization in the endometrium in Adenomyosis. Hum Reprod 1998;13:715-719. 28. Ferenczy A: Pathophysiology of adenomyosis. Hum Reprod Update 1998;4:312-322. 29. Siskin GP, Tublin ME, Stainken BF, et al: Uterine artery embolization for the treatment of adenomyosis: Clinical response and evaluation with MR imaging. AJR Am J Roentgenol 2001;177:297-302. 30. Jha RC, Takahama J, Imaoka I, et al: Adenomyosis: MRI of the uterus treated with uterine artery embolization. AJR Am J Roentgenol 2003;181:851-856. 31. Pelage JP, Jacob D, Fazel A, et al: Embolization for symptomatic adenomyosis: Initial experience. Radiology 2005;234:948-953. 32. Huang LY, Cheng YF, Huang CC, et al: Incomplete vaginal expulsion of pyoadenomyoma with sepsis and focal bladder necrosis after uterine artery embolization for symptomatic adenomyosis: Case report. Hum Reprod 2003;18(1):167-171. 33. Stancato-Pasik A, Mitty HA, Richard HM, Eshkar N: Obstetric embolotherapy: Effect on menses and pregnancy. Radiology 1997;204:791-793. 34. Kim MD, Kim NK, Kim HJ, et al: A pregnancy following uterine artery embolization with polyvinyl alcohol particles for patients with uterine

35.

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39. 40.

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fibroid or adenomyosis. Cardiovasc Intervent Radiol 2005;28:611615. Hovsepian DM, Siskin GP, Bonn J, et al: Quality improvement guidelines for uterine artery embolization for symptomatic leiomyomata. Cardiovasc Intervent Radiol 2004;27:307-313. Hovsepian D, Siskin GP, Bonn J, et al: Quality improvement guidelines for uterine fibroid embolization for symptomatic leiomyomata. J Vasc Interv Radiol 2004;15:535-542. Worthington-Kirsch R, Spies JB, Myers ER, et al: The Fibroid Registry for outcomes data (FIBROID) for uterine embolization: Short-term outcomes. Obstet Gynecol 2005;106:52-59. Dover RW, Ferrier AJ, Torode HW: Sarcomas and the conservative management of uterine fibroids: A cause for concern? Aust N Z J Obstet Gynaecol 2000;40;308-312. Society of Interventional Radiologists: UFE survey results: Over 4,000 procedures performed in US to date. SCIVR News 1999;12:7. Marret H, Alonso AM, Cottier JP, et al: Late leiomyoma expulsion after uterine fibroid embolization. J Vasc Interv Radiol 2004;14: 1395-1399. Hehenkamp WF, Volers NA, Montauban Van Swijndregt AD, et al: Myoma expulsion after uterine fibroid embolization: Complication or cure? Am J Obstet Gynecol 2004;191:1713-1715. Walker WJ, Pelage JP: Uterine artery embolisation for symptomatic fibroids: Clinical results in 400 women with imaging follow-up. BJOG 2002;109:1262. Spies JB, Scialli AR, Jha RC, et al: Initial results from uterine fibroid embolization for symptomatic leiomyomata. J Vasc Interv Radiol 1999;10:1149-1157. Walker WJ, Carpenter TT, Kent AS: Persistent vaginal discharge after uterine fibroid embolization for fibroid tumors: Cause of the condition, magnetic resonance imaging appearance, and surgical treatment. Am J Obstet Gynecol 2004;190:1230-1233. Bradley E, Reidy J, Forman R, et al: Transcatheter uterine fibroid embolization to treat large uterine fibroids. BJOG 1998;105: 235-240. Amato P, Roberts AC: Transient ovarian failure: A complication of uterine fibroid embolization. Fertil Steril 2001;75:438-439. Chrisman HB, Smith S, Nemcek AA: The impact of uterine fibroid embolization (UFE) on resumption of menses and ovarian function [abstract]. J. Vasc Interv Radiol 2000;11:172. Stringer NH, Grant T, Park J, et al: Ovarian failure after uterine fibroid embolization for treatment of myomas. J Am Assoc Gynecol Laparosc 2000;7:395-400. Vashisht A, Studd J, Carey A, Burn P: Fatal septicaemia after fibroid embolization. Lancet 1999;354:307-308. Pron G, Bennett J, Common A, et al: The Ontario uterine fibroid embolization trial. Part 2. Uterine fibroid reduction and symptom relief after uterine fibroid embolization for fibroids. Fertil Steril 2003;79(1):120-127. Fuller AJ, Carvalho B, Brummenl C, et al: Epidural anesthesia for elective cesarean delivery with intraoperative arterial occlusion balloon catheter placement. Anesth Analg 2006;102:585-587. Greenberg JA, Miner JD, O’Horo SK: Uterine artery embolization and hysteroscopic resection to treat retained placenta accreta: A case report. J Minim Invasive Gynecol 2006;13:343-344.

Chapter

13

The Role of Hysteroscopy in Infertility Marjan Attaran, Jeffrey M. Goldberg, and Tommaso Falcone

The most common causes of infertility are tubal disease, anovulation, and male factor. Lifestyle causes of infertility are agerelated decrease in fertility, abnormal weight, smoking, and alcohol. Abnormalities of the uterus are a relatively uncommon cause of infertility.1 The basic investigation of infertility has changed little over the last 30 years and consists of evaluation of semen, ovulatory status, and structural abnormalities of the reproductive tract. Hysterosalpingography (HSG) has been part of the basic infertility work-up for decades and continues to be, for most reproductive endocrinologists, the first-line technique for excluding anatomic defects in the uterine cavity and documenting tubal patency. The decision for most infertility specialists to continue to use HSG as a screening procedure is based on its ability to detect tubal disease. However, hysteroscopy has an important role in an infertility practice.

DIAGNOSTIC PROCEDURES HSG is a simple radiographic procedure with an extensive literature validating its usefulness. The HSG not only provides excellent noninvasive information on the patency and shape of the fallopian tube lumen (Fig. 13–1), it also provides information on the uterine cavity. It can detect müllerian anomalies, intrauterine adhesions, diethylstilbestrol (DES)associated changes, submucosal myomas, and endometrial polyps. Several studies have examined the accuracy of the uterine information provided by this modality.2,3 Wang and colleagues2 performed HSG and diagnostic hysteroscopy on 216 women undergoing infertility investigation. The sensitivity of HSG in revealing uterine cavity abnormalities was 80.3%, and the specificity was 70.1%. The false-positive rate was 15.6% and the false-negative rate was 35.4%.2 A study that evaluated only intrauterine pathology demonstrated a sensitivity of 98% but a specificity of only 35% due to difficulties distinguishing between polyps and myomas.4 Thus, HSG fulfills the requirements for a good screening test for revealing abnormalities of the uterine cavity, though any abnormalities found will likely need further evaluation to make a definitive diagnosis.5

The high false-negative rate may be secondary to uterine flexion that was not corrected or too little or too much contrast injection. A thickened endometrium can also hide an abnormality. Although HSG is a relatively safe and inexpensive procedure, patients experience a high degree of discomfort and are exposed to radiation and iodinated contrast. In conjunction with the high false-negative rate, some infertility specialists have suggested that HSG might not be the best modality for evaluation of the uterine cavity. The diagnostic accuracy of office hysteroscopy for evaluation of abnormal uterine bleeding has clearly been established,6 but its precise role in the infertility investigation is not so evident.7,8 Hinckley and colleagues performed office hysteroscopy on 1000 consecutive patients who were scheduled to undergo in vitro fertilization (IVF). Uterine pathology was found in 38% of the patients.9 The majority of the abnormalities were endometrial polyps (32%), followed by submucous myomas (3%) and intrauterine adhesions (3%). Although endometrial polyps have not been established as a clear cause of infertility, there is evidence that pregnancy rates are improved with removal of the polyp.10 Hence, depending on their location, they potentially account for a failed IVF cycle. Nawroth and colleagues examined 375 patients undergoing infertility investigation and found that 10% of patients had intrauterine pathology that could potentially impact infertility treatment.11 One potential advantage of office hysteroscopy is the possibility for immediate therapy. Several studies have documented good patient tolerance in the outpatient or office setting.12,13 Bettocchi14 removed polyps and submucosal fibroids from 501 women during office hysteroscopy without any analgesia or anesthesia using a 5-F Versapoint bipolar unit. Of these patients, 47% to 79% had no discomfort during the procedure.14 Variability in patient discomfort during hysteroscopy may be related to the type of distending medium used. In one study, patients on whom saline was used experienced significantly less uterine cramping and shoulder pain than the group in whom CO2 was used.15 Saline infusion sonohysterogram (SHG, also called saline infusion sonography [SIS]) is another modality used for assessing the uterine cavity in infertile patients.16-18 Ragni and

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The Role of Hysteroscopy in Infertility SIS

S

M

Serosa Figure 13–2 A saline infusion sonogram (SHG) showing a myoma (M) with saline (S) in the uterine cavity.

Figure 13–1 This film demonstrates the features of a technically good study. The speculum is not obscuring anything. The tenaculum on the cervix has straightened the uterus so that it is perpendicular to the x-ray beam. The tip of the cannula remains below the internal os. The right/left marker is in place for orientation. Free spill is seen outlining loops of bowel.

Table 13–1 Diagnostic Accuracy for Polypoid Lesions in the Uterus Method SHG

Sensitivity (%)

Specificity (%)

100

100

PPV (%) 100

NPV (%) 100

TVUS

75

96.5

75

96.5

HSG

50

82.5

28.6

92.2

HSG, hysterosalpingography; NPV, negative-predictive value; PPV, positive-predictive value; SHG, saline infusion sonohysterogram; TVUS, ultrasound. Abstracted from Soares SR, Barbosa dos Reis MM, Camargos AF: Diagnostic accuracy of sonohysterography, transvaginal sonography, and hysterosalpingography in patients with uterine cavity diseases. Fertil Steril 2000;73(2):406-411.

colleagues compared the diagnostic accuracy of SHG to office hysteroscopy.19 Ninety-eight infertile patients first underwent transvaginal ultrasonography (TVUS) followed by SHG followed by office hysteroscopy. The sensitivity of TVUS was 91% and specificity was 83% compared to hysteroscopy, but SHG yielded better results. The sensitivity and specificity for detection of various anomalies (polyps, synechia, malformations, and myomas) were 98% and 94%, respectively, compared to office hysteroscopy. The sensitivity and specificity are even higher when investigating just polypoid lesions of the uterus (Table 13–1).18 Hence SHG provides very accurate information about the uterine cavity. The advantage of SHG compared to hysteroscopy is that it also demonstrates any concomitant pathology in the myometrium and the adnexa. Whereas a small endometrial polyp found at the time of office hysteroscopy may be managed at the time, larger polyps and submucosal fibroids are usually rescheduled

for the operating room. In addition, the information provided by the SHG about a uterine myoma will help determine the type of surgery necessary to address the problem. For example, in Figure 13–2 the myoma is clearly transmural and extends to the serosa. It is immediately apparent that the myoma cannot be resected by hysteroscopy. Patient discomfort is almost nonexistent. In one study of 65 infertile patients undergoing SHG, 21% felt no pain, 55% had slight pain, and 7% considered the pain severe.18 Some have suggested that diagnostic hysteroscopy should be performed in all infertility patients because it can reveal uterine abnormalities not seen on HSG. However, two studies with a combined total of more than 1000 patients with infertility and 100 with recurrent pregnancy loss found no additional benefit to diagnostic hysteroscopy if the HSG was normal.20,21 It seems, therefore, that the SHG should be the procedure of choice for evaluating uterine pathology after a screening HSG. It may also be used instead of HSG when evaluation of the tubes is not necessary, such as in cases of recurrent pregnancy loss or infertility, where tubal status had been previously documented by laparoscopy. Office-based diagnostic hysteroscopy is then reserved for confirmation of equivocal results on SHG and a visual assessment of intrauterine pathology before surgical intervention. It is also useful for evaluating the cervical canal in cases where there is difficulty negotiating the cervical canal with an embryo transfer catheter.

SURGICAL PROCEDURES Although most procedures are still performed in the operating room, some physicians are starting to perform these in an office setting.

Polypectomy The prevalence of endometrial polyps in infertility patients has been estimated at 3% to 5%.1 However, one study diagnosed polyps in 15% of 224 infertility patients and only 3% in 31 fertile

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The Role of Hysteroscopy in Infertility control patients undergoing diagnostic hysteroscopy before tubal ligation reversal.22 Polyps have been hypothesized to reduce fertility through impaired implantation by being an unfavorable nidation site, causing abnormal bleeding, or through the production of human decidua associated protein (hDP 200)23 and glycodelin.24 There are very limited data on the effects of polyps, and polypectomy, on fertility. Two small retrospective studies reported nearly an 80% pregnancy rate after hysteroscopic polypectomy, though other infertility factors and treatments were not excluded.25,26 There was no difference in postoperative pregnancy rates based on polyp size less than or greater than 1 cm.25 The only prospective randomized study compared pregnancy rates with and without polypectomy in infertility patients before treatment with intrauterine insemination. The polypectomy group had a pregnancy rate of 63.4% versus 28.2% for the control group (P < 0.001). There was no difference in the patients’ ages or other infertility diagnoses between the groups. The size of the polyps, from less than 5 mm to more than 2 cm, did not influence the outcome.27 Conversely, IVF outcomes with treated and untreated polyps larger than 2 cm were not different.28 Another IVF study that considered polyps smaller than 2 cm found no difference in pregnancy rates, but the miscarriage rate was higher (27.3 vs. 10.7%, P = 0.08). The miscarriage rate was normalized if polypectomy was performed before embryo transfer.29 Though it is common practice to excise polyps larger than 1 cm, further study is needed to establish whether it is beneficial.30

Myomectomy Myomas occur in 20% to 50% of reproductive-age women but are thought to be the sole cause of infertility in only 1% to 2.4%.31 There is a lack of reliable data on the effect of myomas, and myomectomy, on reproduction. Myomas have been hypothesized to reduce fertility by causing proximal fallopian tube occlusion or dysfunctional uterine contractions, which can impair sperm or ovum transport and nidation. Implantation failure may also be due to vascular compromise, secretion of vasoactive substances, endometrial inflammation, or atrophy or venous ectasia of the endometrium overlying or opposite a myoma.31,32 Further, disordered placentation, reduced uterine compliance, inadequate blood flow, increased uterine irritability, and large myomas distorting the uterine cavity or cervix can predispose to pregnancy complications such as preterm delivery, malpresentation, obstructed labor, and postpartum hemorrhage.32 Pain from red degeneration is also more common during pregnancy.33 There are no prospective studies comparing women attempting conception with or without myomas to help determine the influence of myomas on the fecundity rate and time to conception. Only one prospective study looked at women with unexplained infertility with and without myomas and reported pregnancy rates of 11% versus 25%, respectively, a statistically significant difference. In addition, laparoscopic myomectomy improved the pregnancy rate to 42%.34

Donnez and colleagues reviewed 46 studies reporting pregnancy rates after myomectomy in infertile patients. Most of the studies were small and retrospective and did not consider the woman’s age, duration of infertility, presence of other infertility factors, or the size, number, and location of the myomas. None had an untreated control group. Of those studies, 16 reported on a total of 376 hysteroscopic myomectomies with a mean pregnancy rate of 45%. This was similar to the 49% pregnancy rate in the 1255 patients who underwent myomectomy by laparotomy or laparoscopy.31 Another review article analyzing the results of myomectomy in infertility patients concluded that only myomas distorting the endometrial cavity had lower pregnancy rates (relative risk [RR], 0.3; 95% confidence interval [CI], 0.13-0.70) and implantation rates (RR, 0.28; 95% CI, 0.10-0.72). Removal of those myomas increased the pregnancy rates postoperatively (RR, 1.72; 95% CI, 1.13-2.58). There was no evidence that intramural or subserous myomas cause infertility or that myomectomy enhances fertility in the absence of cavity distortion.35 Additionally, a review of seven IVF studies concurred that myomas distorting the cavity decreased pregnancy rates, but results were inconsistent for intramural myomas not affecting the cavity.31 Hysteroscopic myomectomy should therefore be performed for submucosal myomas. As mentioned, HSG is an excellent screening test for detecting intracavitary defects but not for distinguishing between myomas and polyps. Hysteroscopy can make a definitive diagnosis, but neither these tests nor routine ultrasonography can determine the relative portions of the intracavitary and intramural components. SHG or magnetic resonance imaging (MRI) is needed to make this important determination and hysteroscopic myomectomy should only be considered if at least 50% of the lesion is intracavitary. Between the two tests, the SHG is much more cost-effective. We prefer the continuous-flow resectoscope for performing hysteroscopic myomectomy, though some studies reported that the overall pregnancy rates were no different when hysteroscopic myomectomy was accomplished with scissors, laser, or resectoscope loop.36 The myoma is resected to the level of the normal endometrium using the loop with 60 W-70 W of cutting current. It is common for the intramural component to progressively extrude into the cavity, enabling more of the lesion to be excised. Depending on the size and number of the endometrial defects after removal of the myoma(s), a pediatric Foley catheter balloon may be left in the cavity for 1 week as an adhesion barrier. Patients may also be placed on a regimen of estrogen for 3 weeks followed by a progestin withdrawal to speed regeneration of the endometrium as another effort to reduce postoperative adhesion formation. Data on the effectiveness of both of these measures are lacking. Multiple submucosal myomas increase the risk of adhesions and recurrence.37 Some recommend performing hysteroscopic myomectomy as a two-stage procedure if myomas are on opposing walls.21 Because most studies failed to find an association between infertility and myomas that do not occlude the fallopian tubes or distort the endometrial cavity, infertility as a primary indica-

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The Role of Hysteroscopy in Infertility tion for myomectomy in those cases is rarely appropriate.32 However, some argue that myomectomy should be considered in an effort to reduce the risk of myoma-associated obstetric complications. Qidwai and colleagues reported that women with myomas had statistically increased risks for malpresentation, preterm delivery, placenta previa, severe postpartum hemorrhage, and cesarean delivery compared to women without myomas.38 However, Vergani and colleagues found no significant increase in preterm delivery, premature rupture of membranes, in utero growth retardation, placental abruptio, placenta previa, postpartum hemorrhage, or retained placenta, but cesarean sections were nearly double in women with myomas (23% vs 12%; P < 0.001).39 In addition to the usual surgical risks of infection and organ damage with laparoscopy or laparotomy, myomectomy in particular has a greater risk of excessive blood loss leading to transfusion as well as postoperative adhesion formation. There is also a concern about uterine rupture during pregnancy, for which cesarean delivery is more likely to be recommended.35 Most promising in terms of long-term use for reduction of size and symptoms appears to be the selective progesterone receptor modulators (SPRMs). However, none avoid producing an anovulatory state that inhibits fertility, and none have been shown to enhance fertility following discontinuation. Surgery is the only available treatment if intervention is required for fertility reasons. Medical treatments proposed for myomas, including gonadotropin-releasing hormone (GnRH) analogues, danazol, raloxifene, mifepristone and aromatase inhibitors, have failed to enhance fertility following discontinuation.40 Newer minimally invasive methods of treating myomas, such as myolysis, cryomyolysis and uterine fibroid embolization (UFE), are not recommended for women desiring fertility because there are very limited data on fertility and pregnancy outcomes following these procedures. A compilation of 53 pregnancies after uterine artery embolization (UAE) and 139 after laparoscopic myomectomy noted a statistically significant increase in malpresentation and preterm delivery with UAE. UAE was also associated with higher rates of spontaneous abortion and postpartum hemorrhage, though these differences did not reach statistical significance.41

Lysis of Adhesions Intrauterine adhesions (IUA), or Asherman syndrome, usually occurs after dilation and curettage (D&C) for elective pregnancy termination and for missed and incomplete abortions. The most severe adhesions result from postpartum curettage because it tends to be more aggressive to stop the hemorrhage, and the hypoestrogenism following delivery delays endometrial regeneration. In addition, retained products of conception can induce fibroblast activation and collagen formation. IUA can also develop after routine D&C on the nongravid uterus, so incidental D&C at the time of diagnostic laparoscopy is unwarranted.1 Finally, IUA can result from hysteroscopic or open myomectomy for submucosal myomas or infection such as tuberculosis endometritis or septic abortion.

The diagnosis is suggested when patients have hypo- or amenorrhea, often with premenstrual molimina, following uterine trauma. Biphasic basal body temperature charts, serum progesterone greater than 3 ng/mL, and a failed sequential estrogen– progestin challenge support the diagnosis. Ultrasonography can detect hematometria and measure the endometrial thickness. HSG is the most common method to diagnose IUA and has an excellent correlation with hysteroscopy.21 The menstrual pattern correlates well with the extent of IUA; most patients with amenorrhea have severe IUA and most with normal menses have minimal IUA.21 It is also presumed that the greater the extent of IUA, the greater the incidence of infertility. It is questionable whether minor adhesions affect fertility. 23 Conversely, patients with no adhesions but with a sclerotic atrophic endometrial cavity have the worst prognosis.7 Unfortunately, there is no widely accepted clinically validated classification system, making it difficult to compare study outcomes.1 Increased infertility, intrauterine growth retardation, and intrauterine fetal death may be due to reduced cavity size, deficient endometrium, myometrial fibrosis, and decreased uterine blood flow. The loss of the basalis layer following hysteroscopic adhesiolysis prevents new endometrial regeneration and allows invasion of trophoblast into the myometrium, leading to an increased risk of placenta accreta, increta, and percreta.21 Treatment by operative hysteroscopic adhesiolysis has replaced blind D&C, which is no longer an accepted treatment for IUA. Mild adhesions are easily lysed, but lysis of severe adhesions is the most dangerous hysteroscopic procedure due to lack of anatomic landmarks, resulting in a high risk of uterine perforation. For this reason, the procedure is best performed under the guidance of laparoscopy or transabdominal ultrasonography to help maintain orientation and limit perforation.1,21,37 Access to the tubal ostia is only possible when there is residual endometrium in the uterine cornuae.37 Although there are insufficient data to support the use of uterine splints, such as intrauterine devices (IUDs) or catheter balloons, or high-dose estrogen postoperatively, they are routinely used by most infertility specialists.1,21 The patient should be informed that more than one procedure may be required. About 70% to 90% of patients with hypo- or amenorrhea resume normal menses following hysteroscopic adhesiolysis.1,21 Pregnancy and rates range from 40% to 90% and live birth rates range from 25% to 75%.1,21,32 In general, better success rates were associated with less-severe disease. However, successful pregnancies have been reported even with markedly scarred uteri.42

Septoplasty True incidence of congenital uterine anomalies is unknown. Estimates based on the compilation of several studies are 3% to 4%, with no difference between fertile and infertile populations, and 13% for patients with RPL.43 The septate uterus is the most common and has the worst reproductive outcomes of all the

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The Role of Hysteroscopy in Infertility congenital uterine malformations.44 It accounts for about 35% of all congenital malformations.43 However, estimates in the literature vary widely due to differences in classification systems and methods of diagnosis. HSG and hysteroscopy alone cannot distinguish between septate and bicornuate uteri. Although laparoscopy to visualize the external fundal contour is the gold standard, three-dimensional (3D) ultrasound and MRI have been shown to have nearly 100% sensitivity and specificity, whereas conventional two-dimensional (2D) transvaginal ultrasonography has a sensitivity of 100% and a specificity of 80%.44 The septum does not appear to affect fertility, because the rates of infertility are the same in patients with and without a septum.44,45 About 90% of pregnancies end in spontaneous abortion in patients with a complete septum versus 70% with an incomplete septum.46 The septum might contribute to the high rate of early pregnancy loss due to poor blood supply, deficient estrogen and progesterone receptors, and inadequate endometrial maturation.44 Historically, metroplasty for a septum was performed by laparotomy via the Jones or Tompkins procedure, which involved excising a wedge of the uterine fundus containing the septum or opening the fundus and incising the septum, respectively. These procedures are obsolete, because pregnancy outcomes with hysteroscopic septoplasty are equivalent.47 The advantages of hysteroscopic septoplasty are listed in Box 13–1. The results with scissors, fiberoptic laser, and resectoscope are similar.32,44,48 Scissors carry no risk of thermal injury and allow the use of normal saline but cannot control bleeding and are associated with longer operating times. Lasers provide good hemostasis and can also be used with normal saline but are more expensive and difficult to use. The resectoscope is inexpensive, readily available, and affords good visualization and hemostasis, allowing quicker operative times. Its disadvantages are the need for a larger sheath and the risk of hyponatremia due to nonelectrolytic solutions. However, the short procedure time and avascular septum minimize the risk.44 A bipolar electrode eliminates the risk of hyponatremia with the resectoscope, and short-term results are good.48

BOX 13–1 Advantages of Hysteroscopic Septoplasty No abdominal incision No myometrial incision Outpatient procedure No requirement for cesarean section No reduction in uterine cavity size Less postoperative morbidity Quicker recovery time No surgically induced pelvic adhesions From Goldberg JM, Falcone T: Müllerian anomalies: Reproduction, diagnosis, and treatment. In Gidwani G, Falcone T (eds): Congenital Malformations of the Female Genital Tract: Diagnosis and Managment. Philadelphia: Lippencott Williams & Wilkins, 1999, pp 177-204.

The procedure is terminated when the hysteroscope can move between the cornua with no intervening septum. Also, bleeding indicates that the normal myometrium has been reached. The concern that the cervical portion of a complete septum should not be divided due to an increased risk of cervical incompetence is unsubstantiated. Leaving it intact makes the surgery more difficult and can impede vaginal delivery.44 Laparoscopic or sonographic guidance is used in only the most difficult cases. There is no documented benefit to preoperative hormonal treatment, prophylactic antibiotics, or leaving a uterine stent such as an IUD or balloon catheter.44 A randomized study showed that postoperative estrogen treatment was also unnecessary.49 A summary of 16 retrospective studies reported that 88% of 1062 pregnancies resulted in spontaneously abortion preoperatively versus 14% of 491 pregnancies following hysteroscopic septoplasty. Preterm labor decreased from 9% before septoplasty to 6% after, and term deliveries improved from 3% to 80%.44 There is a consensus that hysteroscopic septoplasty is indicated for patients with two or more spontaneous abortions. However, because hysteroscopic septoplasty is a quick, minimally invasive procedure with negligible risk, preemptive surgical correction is reasonable in patients with only one spontaneous abortion, longstanding unexplained infertility, or age greater than 35 years and before undergoing assisted reproductive technology (ART) or diagnostic laparoscopy.44,50

Diethylstilbestrol DES was used from the 1940s up to 1971 as prophylaxis for spontaneous abortions. It was discontinued when it was found to increase the risk of vaginal clear cell carcinomas in the daughters. DES also induces uterine malformations including hypoplastic cavity, T-shaped cavity, constriction bands, wide lower segment, and irregular borders. Kaufman and colleagues reported that 69% of 267 DES daughters had uterine abnormalities on HSG.51 The most common abnormality was a hypoplastic T-shaped cavity in 31%. The presence of cervicovaginal changes was associated with a fivefold increase in abnormal HSGs. Although fertility was not affected, ectopic pregnancy, spontaneous abortion, and preterm delivery were increased in DESexposed daughters.52 There was an increased incidence of poor pregnancy outcome if the HSG was abnormal, though no specific uterine abnormality was consistently associated with a particular adverse pregnancy outcome.53 Patients who have achieved a term pregnancy have no compromise of their future reproductive performance.54 Two studies performed operative hysteroscopic metroplasty to achieve a more normal appearing endometrial cavity in 23 women with a history of in utero DES exposure.55,56 It cannot be determined if metroplasty of the DES uterus is of any clinical value based on such a small sample size. Also, when assessing the success of any treatment it must be borne in mind that there is a trend toward an increase in duration of each successive

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The Role of Hysteroscopy in Infertility pregnancy even without intervention. Surgery to correct the anatomic abnormalities is not currently recommended.57,58

Tubal Disease Proximal tubal occlusion is a common finding during HSG. Although bilateral proximal tubal occlusion (PTO) usually indicates anatomical pathology, unilateral PTO is often transient due to spasm of the uterotubal ostium, plugging by mucus, debris, or air bubbles. Unilateral PTO is found in 10% to 24% of tubes, but 16% to 80% are patent on repeat HSG or laparoscopy with chromotubation.59 Increasing the hydrostatic pressure establishes patency in a high percentage of patients, 72% in one large series. In one study, rotating the patient so that the side of PTO is down establishes patency in 63%.59 Selective salpingography may be attempted if a repeat HSG at least 1 month later confirms persistent PTO. The repeat HSG is performed with a balloon catheter under intravenous conscious sedation and a 5-F catheter advanced through it and wedged in the cornua under fluoroscopic guidance. Contrast is then injected, establishing patency in one third of the tubes. Tubal cannulation may be attempted in the two thirds that remained occluded during selective salpingography. Hysteroscopic tubal cannulation is also very successful at relieving PTO. This procedure typically uses a Novy cornual cannulation set (Cook, Spencer, Ind). A catheter is introduced into the working channel of an operative hysteroscope. The first is a 5-F catheter and the second catheter is 3 F. The inner catheter has 1-cm markings (Fig. 13–3). The wire guide is introduced through into this catheter. The 5-F catheter is introduced through

Figure 13–3 The transparent curved tip of the outer catheter is seen directed toward the right uterine ostia. The inner catheter is seen with markings.

a port on a 5-mm hysteroscope and is advanced up to the tubal ostia. The inner catheter is then introduced through the 5-F catheter. This catheter has a special adaptor for securing the wire. The wire is positioned at the tip of this catheter and the adaptor is tightened. The tube is cannulated first with the wire guide, and then the inner catheter is brought over it. The wire guide is then removed and indigo carmine dye is injected.

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The Role of Hysteroscopy in Infertility 18. Soares SR, Barbosa dos Reis MM, Camargos AF: Diagnostic accuracy of sonohysterography, transvaginal sonography, and hysterosalpingography in patients with uterine cavity diseases. Fertil Steril 2000;73(2):406-411. 19. Ragni G, Diaferia D, Vegetti W, et al: Effectiveness of sonohysterography in infertile patient work-up: A comparison with transvaginal ultrasonography and hysteroscopy. Gynecol Obstet Invest 2005;59(4): 184-198. 20. Fayez JA, Mutie G, Schneider PJ: The diagnostic value of hysterosalpingography and hysteroscopy in infertility investigation. Am J Obstet Gynecol 1987;156:558-560. 21. March CM: Hysteroscopy and the uterine factor in infertility. In Lobo RA, Mishell DR, Paulson RJ, Shoupe D (eds): Mishell’s Textbook of Infertility, Contraception, and Reproductive Endocrinology, 4th ed. Malden, Mass: Blackwell Science, 1997, pp 580-604. 22. Shokeir TA, Shalan HM, El-Shafei MM: Significance of endometrial polyps detected hysteroscopically in eumenorrheic infertile women. J Obstet Gynaecol Res 2004;30:84-89. 23. Golan A, Halperin R, Herman A, et al: Human decidua-associated protein 200 levels in uterine fluid at hysteroscopy. Gynecol Obstet Invest 1994;38:217-219. 24. Richlin SS, Ramachandran S, Shanti A, et al: Glycodelin levels in uterine flushings and in plasma of patients with leiomyomas and polyps: Implications for implantation. Hum Reprod 2002;17:27422747. 25. Spiewankiewicz B, Stelmachow J, Sawicki W, et al: The effectiveness of hysteroscopic polypectomy in cases of female infertility. Clin Exp Obstet Gynecol 2003;30:23-25. 26. Varasteh NN, Neuwirth RS, Levin B, Keltz MD: Pregnancy rates after hysteroscopic polypectomy and myomectomy in infertile women. Obstet Gynecol 1999;94:168-171. 27. Perez-Medina T, Bajo-Arenas J, Salazar F, et al: Endometrial polyps and their implication in the pregnancy rates of patients undergoing intrauterine insemination: A prospective, randomized study. Hum Reprod 2005;20:1632-1635. 28. Mastrominas M, Pistofidis GA, Dimitropoulos K: Fertility outcome after outpatient hysteroscopic removal of endometrial polyps and submucous fibroids. J Am Assoc Gynecol Laparosc 1996;3: S29. 29. Lass A, Williams G, Abusheikha N, Brinsden P: The effect of endometrial polyps on outcomes of in vitro fertilization (IVF) cycles. J Assist Reprod Genet 1999;16:410-415. 30. Chang AS, Goldstein J, Moley KH, et al: Radiologic and surgical demonstration of uterine polyposis. Fertil Steril 2005;84:17421743. 31. Donnez J, Jadoul P: What are the implications of myomas on fertility? A need for a debate? Hum Reprod 2002;17:1424-1430. 32. Winkel CA: Diagnosis and treatment of uterine pathology. In Carr BR, Blackwell RE (eds): Textbook of Reproductive Medicine, 2nd ed. Stamford, Conn: Appleton & Lange, 1998, pp 583-606. 33. Cooper NP, Okolo S: Fibroids in pregnancy—common but poorly understood. Obstet Gynecol Surv 2005;60:132-138. 34. Bulletti C, Ziegler D, Polli V, Flamigni C: The role of leiomyomas in infertility. J Am Assoc Gynecol Laparosc 1999;6:441-445. 35. Pritts E: Fibroids and infertility: A systematic review of the evidence. Obstet Gynecol Surv 2001;56:483-491. 36. Goldenberg M, Sivan E, Sharabi Z, et al: Reproductive outcome following hysteroscopic management of intrauterine septum and adhesions. Hum Reprod 1995;10:2663-2665. 37. Hucke J, De Bruyne F, Balan P: Hysteroscopy in infertility—diagnosis and treatment including falloposcopy. Contrib Gynecol Obstet 2000;20:13-20.

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Qidwai GI, Caughey AB, Jacoby AF: Obstetric outcomes in women with sonographically identified uterine leiomyomata. Obstet Gynecol 2006;107:376-382. Vergani P, Ghidini A, Strobelt N, et al: Do uterine leiomyomas influence pregnancy outcome? Am J Perinatol 1994;11:356-358. Olive DL, Lindheim SR, Pritts EA: Non-surgical management of leiomyoma: Impact on fertility. Curr Opin Obstet Gynecol 2004;16: 239-243. Goldberg J, Pereira L, Berghella V, et al: Pregnancy outcomes after treatment for fibromyomata: Uterine artery embolization versus laparoscopic myomectomy. Am J Obstet Gynecol 2004;191:18-21. Carp HJ, Ben-Shlomo I, Mashiach S: What is the minimal uterine cavity needed for a normal pregnancy? An extreme case of Asherman syndrome. Fertil Steril 1992;58:419-421. Grimbizis GF, Camus M, Tarlatzis BC, et al: Clinical implications of uterine malformations and hysteroscopic treatment results. Hum Reprod Update 2001;7:161-174. Homer HA, Li TC, Cooke ID: The septate uterus: A review of management and reproductive outcome. Fertil Steril 2000;73:1-14. Jones HW: Reproductive impairment and the malformed uterus. Fertil Steril 1981;36:137. Heinonen PK: Primary infertility and uterine anomalies. Fertil Steril 1983;40:311. Heinonen PK: Reproductive performance of women with uterine anomalies after abdominal or hysteroscopic metroplasty or no surgical treatment. J Am Assoc Gynecol Laparosc 1997;4:311-317. Zikopoulos KA, Kolibianakis EM, Tournaye H, et al: Hysteroscopic septum resection using the Versapoint system in subfertile women. Reprod Biomed Online 2003;7:365-367. Dabirashrafi H, Mohammad K, Moghadami-Tabrizi N, et al: Is estrogen necessary after hysteroscopic incision of the uterine septum? J Am Assoc Gynecol Laparosc 1996;3:623-625. Colacurci N, De Franciscis P, Fornaro F, et al: The significance of hysteroscopic treatment of congenital uterine malformations. Reprod Biomed Online 2002;4 Suppl 3:52-54. Kaufman RH, Adam E, Binder GL, Gerthoffer E: Upper genital tract changes and pregnancy outcome in offspring exposed in utero to diethylstilbestrol. Am J Obstet Gynecol 1980;137:299-308. Goldberg J, Falcone T: Effect of DES on reproductive function. Fertil Steril 1999;72:1-7. Kaufman RH, Noller K, Adam E, et al: Upper genital tract abnormalities and pregnancy outcome in diethylstilbestrol-exposed progeny. Am J Obstet Gynecol 1984;148:973-984. Veridiano NP, Delke I, Rogers J, Tancer ML: Reproductive performance of DES-exposed female progeny. Obstet Gynecol 1981;58:58-61. Nagel TC, Malo JW: Hysteroscopic metroplasty in the diethylstilbestrolexposed uterus and similar nonfusion anomalies: effects on subsequent reproductive performance; a preliminary report. Fertil Steril1993;59:502-506. Garbin O, Ohl J, Bettahar-Lebugle K, Dellenbach P: Hysteroscopic metroplasty in diethylstilboestrol-exposed and hypoplastic uterus: A report on 24 cases. Hum Reprod 1998;13:2751-2755. Mottla GL, Stillman RJ: Considering the role of assisted reproduction in infertile patients exposed in utero to diethylstilbestrol. Assist Reprod Rev 1992;2:173-183. Goldberg JM, Falcone T: Müllerian anomalies: Reproduction, diagnosis, and treatment. In Gidwani G, Falcone T (eds): Congenital Malformations of the Female Genital Tract: Diagnosis and Managment. Philadelphia: Lippincott Williams & Wilkins, 1999, pp 177-204. Hurd WW, Wyckoff ET, Reynolds DB, et al: Patient rotation and resolution of unilateral cornual obstruction during hysterosalpingography. Obstet Gynecol 2003;101:1275-1278.

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Hysteroscopy for Evaluating and Treating Recurrent Pregnancy Loss Steven F. Palter

Recurrent pregnancy loss (RPL) is classically defined as the loss of three or more consecutive pregnancies before viability (<20 weeks’ gestation or <500 g).1,2 Approximately 2% to 5% of reproductive-age couples attempting conception experience RPL. Many practitioners also differentiate between early (first trimester, <12 weeks’ gestational age) and late (>12 weeks, second and third trimester losses) because they can have different etiologies. Some practitioners also include patients with nonconsecutive losses and begin the evaluation after two or more losses, especially if these are second or third trimester. Unfortunately, studies of RPL often suffer from methodologic flaws including improper or absent control groups, incomplete diagnostic tests, or insufficient power.1,2 Causes of RPL can be broken down into major etiologic groups (Box 14–1). This chapter reviews the structural uterine causes of recurrent pregnancy loss with a focus on the surgical approach to their diagnosis and correction.

CAUSES OF RECURRENT PREGNANCY LOSS The most common cause of pregnancy loss is chromosomal aneuploidy. The majority of these are nondisjunction errors as a result of genetic damage to oocytes. The frequency of these losses increases with maternal age. In addition to these de novo genetic abnormalities of oocytes, in approximately 5% of couples with RPL, one of the parents carries a balanced translocation that puts the carrier at risk of producing gametes with unbalanced translocations.3 The vast majority of these either do not implant or miscarry very early. The exact frequency of the balanced translocation producing unbalanced gametes and recurrent losses depends on the particular translocation. In parents with normal karyotypes, approximately 40% of miscarriages are a result of de novo embryonic aneuploidies.4 The most common of these are monosomies and trisomies of both sex and autosomal chromosomes. The new technique of preimplantation genetic screening (PGS) has promise to reduce this risk. In this technique, the developing embryo undergoes a single blastomere biopsy on day 3 of development. This cell is screened rapidly via fluorescent in situ hybridization (FISH) to test for the additions or deletions of the most common affected

chromosomes (today 9 or 12 are usually tested for). The results allow the transfer of embryos more likely to be genetically normal at the blastocyst stage on day 5 of development. Initial enthusiasm for PGS has been dampened by the discovery of mosaicism in the embryo at this stage of development in some cases. In this situation, selected cells may be abnormal and nonviable while the remainder divide normally, leading to a genetically normal offspring.5-7 Ternamian described a fascinating new technique of performing hysteroscopy to obtain a visual autopsy in cases of pregnancy loss due to unknown causes.8 He performed preevacuation hysteroscopy using a continuous flow 26-F resectoscope with glycine distention and a fluid-control system. The cervix is dilated and a small amniotic membrane window is created at a location away from the placenta and fetus, using a monopolar loop, Next, the amniotic is fluid is exchanged for glycine while the hysteroscopic examination is performed. He reported visual stigmata of chromosomal abnormalities or infection in 7 of 8 cases. The technique proved useful in cases where pathologic evaluations missed these findings or cytogenetic assays failed. The full utility of this technique in conjunction with classic karyotyping is the subject of ongoing studies. Two abnormalities he identified were polydactyly and umbilical torsion with omphalocele, shown in Figures 14–1 and 14–2. A karyotype of both partners is recommended. Other causes of RPL include certain types of thrombophilias, anticardiolipin antibodies, and endocrine disorders. A luteal phase defect is also associated with recurrent pregnancy loss, but it is unclear how to test for it. Uterine abnormalities are a recognized cause of RPL. Imaging of the uterine cavity is an important part of the investigation and can be achieved by hysteroscopy, saline infusion sonohysterogram (SHG, also known as saline infusion sonography [SIS]) or hysterosalpingogram (HSG).

ASHERMAN SYNDROME Asherman syndrome (intrauterine synechiae) was first described by Heinrich Fritsch in 1894 and then further characterized by Asherman in 1948.9 In his classic paper he described the radiologic appearance of the uterine cavity with adhesions seen at

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Hysteroscopy for Evaluating and Treating Recurrent Pregnancy Loss BOX 14–1 Causes of Recurrent Pregnancy Loss Genetic ● ● ● ●

Trisomies Monosomies Abnormalities of ploidy Unbalanced translocation

Hormonal ●

Luteal phase deficiencies Thyroid abnormalities ● Other Immunologic ● Anticardiolipin antibodies ● Lupus anticoagulant ● Other antiphospholipid antibodies ●

Figure 14–1 Hysteroscopic view of fetal demise with polydactyly. (Courtesy of Dr. Artin Termanian, Toronto, Ontario.)

Thrombophilias ● ● ● ●

Protein S and protein C deficiencies Factor II prothrombin abnormalities Factor V Leiden abnormalities MTHFR gene mutations and hyperhomocysteinemia

Metabolic ●

Diabetes

Structural ● ● ● ●

Müllerian anomalies Bicornuate uterus Unicornuate uterus Uterine septum

Intrauterine adhesions ●

Asherman syndrome

Myomas ● ●

Submucosal Intramural

Figure 14–2. Hysteroscopic view of fetal demise with umbilical torsion with omphalocele. (Courtesy of Dr. Artin Termanian, Toronto, Ontario.)

HSG. Although generally considered to be a rare disorder, it may be more common than initially suspected.10 In this study, 40% of women who had a delivery or miscarriage complicated by retained placental fragments for more than 24 hours developed hysteroscopic evidence of adhesions. It has been suggested that Asherman syndrome potentially exists in a milder form in the asymptomatic eumenorrheic infertile woman.11 The clinical features of Asherman syndrome are poorly described. Classically, it is most commonly associated with secondary amenorrhea, especially following postabortion curettage. Many authors have postulated the potential etiologic role of infection.12 Unfortunately, no consensus exists regarding the optimal treatment regimen, and treatment outcomes reported are generally poor.13-19 We performed an international registry study of 297 women with Asherman syndrome to determine the clinical features and treatment outcomes.20 In this study, reproductive outcome was extremely poor and pregnancy losses were extremely common. Before treatment, only 61% of patients were able to achieve a

live-born child. First trimester losses were very commonly reported: 49% of all pregnancies and 42% of patients. Even more ominous, second and third trimester losses were four times more common than would be expected (8.5% of all pregnancies). The vast majority of patient presented with hypomenorrhea or amenorrhea, but infertility and pregnancy losses were also common. We also devised and described a comprehensive diagnostic and treatment algorithm for patients with Asherman syndrome.21 Patients with intrauterine synechiae who presented with complaints of hypomenorrhea or amenorrhea, pelvic pain, or infertility (in any combination) were reviewed. Data were abstracted from operative reports, photos, and postoperative evaluations. The mean age of patients treated was 33.8 years and the median gravity and parity were 2 and 0, respectively. More than one third had previous attempted surgical repair. Patients were queried on antecedent reproductive history, events likely leading to the formation of Asherman syndrome, and patterns of menstrual flow. The causes of the intrauterine scarring are shown in

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Table 14–1 Etiologies of Asherman Syndrome Etiology

IRV UT

Number

Percent

Miscarriage or termination

21

54

Retained products of conception

10

26

4

11

Surgery Cesarean section

3

7

Childhood tuberculosis

1

<1

CN0 16cm DR72 G 50 +1:35:12 21 MI <0.4 Figure 14–4 Intraoperative transabdominal ultrasound guidance of hysteroscopic surgery.

instilled and areas of filling defects in the cavity are recorded for intraoperative guidance. In this step we also look for any evidence of a septum and for fundal areas of endometrium normally proliferating beyond obstructions. Others perform this step as an office hysteroscopic evaluation. Although this gives good information regarding the cavity up to an obstruction, in our experience the finding of a complete obstruction occurs so often that we prefer evaluation by SHG because we can then assess the cavity beyond this obstruction.

Figure 14–3 Sonohysterographic mapping of intrauterine adhesions. Arrows indicate location of lower segment adhesion and small patent upper cavity.

Operative Treatment Technique Table 14–1. All patients with suspected Asherman syndrome underwent preoperative SHG confirmation and surgical correction via hysteroscopy. Patients who had menses underwent at least one ultrasound examination at the time of menses for the evaluation of hematometria, which was not clinically evident in any patient. A subsequent study in a nonhuman primate model of Asherman syndrome suggested that lower segment obstruction to menstrual outflow could cause a secondary reflex downregulation of the global endometrial lining.11

Preoperative Office Evaluation Accurate and thorough preoperative evaluation is crucial to ensure the best operative outcomes. We perform both a complete preoperative two-dimensional (2D) and three-dimensional (3D) coronal plane SHG mapping of intrauterine adhesions as shown in Figure 14–3. During this step we place a 5-F SHG catheter just inside the external cervical os and inflate it just enough to occlude the ostia. We first perform a complete pelvic scan with particular attention to any signs of endometriomas on the ovaries. Next, the uterus is evaluated. We examine for any signs of hematometria and measure the thickness of the endometrial stripe from the fundus to the internal os. Particular attention is paid to any areas of irregularity or discontinuity of the stripe. Next, fluid is slowly

We perform all significant lysis of intrauterine adhesions in the operating room under general anesthesia. Simple localized filmy avascular adhesions have been successfully treated by office hysteroscopy. We use transabdominal ultrasound guidance during these procedures to ensure complete lysis of adhesions.22 To do this, the uterine Foley catheter is clamped and the bladder retrograde filled with saline to provide an acoustic window as shown in Figure 14–4. During the resection procedure we continuously scan in the mid-transverse and mid-sagittal planes. This is correlated with the preoperative map we created at SHG. In this way, the resection can be guided to be exactly in the midline and the creation of a false passage avoided. The dissection can be guided to islands of intact endometrium and also to the lateral limits of the scar. Adhesiolysis is performed using semiflexible micro-scissors without the use of intrauterine energy to minimize the risk of further adhesion formation or devascularization. In some cases a complete obstruction is encountered as you enter the cervical or uterine cavities, as shown in Figure 14–5. Without the use of intraoperative ultrasound guidance, it is very easy to dissect off an axis and create a false passage. Similarly, the lateral limits of dissection might not be visible without ultrasound guidance. Figure 14–6 demonstrates a case where, upon initial insertion of the hysteroscope, it appears that the cavity is nearly com-

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Figure 14–7 Hysteroscopic view of complete obstruction more cephalad. Figure 14–5 Complete adhesion of the cervical canal.

Figure 14–6 Hysteroscopic view of severe Asherman syndrome. The cavity appears completely obliterated, yet ultrasound identifies a patent passage.

Figure 14–8 Hysteroscopic view of open area above the lower segment scar, with bands of adhesions.

pletely obliterated except for a small patent passage and is potentially not repairable. Intraoperative ultrasound confirmed a passage to the fundus with good endometrial lining. However, once this adhesion was resected, a complete obstruction (as judged by hysteroscopy) was encountered, as seen in Figure 14–7. Alternatively, this could have represented the fundus affected by adhesion. Again, ultrasound showed a patent cavity more cephalad. Figure 14–8 shows the open area above this scar with bands of adhesions. Figure 14–9 shows the final patent cavity. Intrauterine Splints

Several methods have been used to reduce the incidence of postoperative adhesion reformation. The most common method is the intrauterine placement of a barrier device. There are no currently FDA-approved devices for this indication. Off-label, the intrauterine device (IUD), Foley catheter, and Cook intrauterine splint (designed for short-term management of hemor-

Figure 14–9 Hysteroscopic view of the final patent cavity.

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Hysteroscopy for Evaluating and Treating Recurrent Pregnancy Loss rhage) have been used. Direct comparisons of the Foley catheter and the IUD have shown superior efficacy with the balloon.23 In 110 cases treated with either method and retrospectively analyzed, 81.4% of the patients using the Foley balloon had restoration of normal menstruation compared with 62.7% in the IUD group. Persistent post-treatment amenorrhea and hypomenorrhea occurred less commonly in the Foley catheter group (18.6%) than in the IUD group (37.3%). The conception rate in the catheter group was 33.9%, also greater than in the IUD group.23 At the completion of the procedure, an 8- to 12-F Foley catheter, with its distal tip cut flush to the balloon, was inflated in the cavity under ultrasound guidance. The latex balloons are better suited for this than are silicone elastic (Silastic) catheters because they allow a larger amount of the tip to be cut off. This allows the balloon to be trimmed to lie flat against the fundus. In cases where there is only cervical scarring, it is not necessary to inflate the balloon to completely fill the upper cavity. Although some have advocated tying off and cutting the tail of the catheter, we prefer to leave it patent to provide easy drainage of any fluid or blood from the uterine cavity. The balloon is inflated to fill and separate the cavity and reduce raw opposing areas of the endometrium from touching. It is inflated under transabdominal ultrasound guidance at the completion of the lysis of adhesions procedure to just fill the cavity with minimization of pressure. The catheter is coiled up and placed inside the vagina, where it is left for 2 weeks. During that time, the patient is placed on a broad-spectrum antibiotics and estrogen to help stimulate endometrial reproliferation.24 She is instructed to take her temperature twice a day and call with any elevation or increasing tenderness as possible signs of infection.

The placement of the balloon is rechecked after 2 to 4 days and again 1 week later because uterine relaxation can allow it to move from optimal placement. Figure 14–10 demonstrates the appearance of a correctly placed balloon on 3D ultrasound after 1 week. We perform this examination via transvaginal ultrasound (TVUS) with instillation of an antiseptic solution. The potential utility of bioabsorbable barriers similar to those used at laparoscopy has been suggested.25-27 Both spray-gel and cross-linked hyaluronic acid have shown potential utility in these pilot studies, with reduction in de novo and reformed adhesions.25-27 Further safety and efficacy studies are required before this approach can be routinely recommended.

Treatment Results The majority of patients we treated had severe intrauterine scarring (European Society for Hysteroscopy [ESH] stage III/IV). We observed three patterns of uterine obstruction: partially patent upper cavity with partial or no obstruction to outflow, cavities with total lower obstruction to outflow, and totally obliterated cavities. We had no uterine perforation using this approach, which eliminated the need for laparoscopic guidance for perforation prevention. No patients had clinical signs of infection or endometritis postoperatively. Fifteen percent of patients required a second lysis of adhesions to treat residual adhesions found at postoperative SHG, all of which were stage I or II. At procedure completion, average cavity patency was 97%. Menstrual bleeding significantly improved, with average days of menstrual flow that increased from 1.8 days preoperatively to 4.7 days postoperatively. Not all patients attempted to conceive, but of those who did, 12 achieved a pregnancy (35% of all patients).

Figure 14–10 Correctly placed balloon on threedimensional ultrasound.

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Hysteroscopy for Evaluating and Treating Recurrent Pregnancy Loss This systematic approach allows an exact diagnosis to be made, including precise preoperative and intraoperative scar localization. This allows better preoperative planning of the surgical procedure. Ultrasound guidance prevented perforation while allowing more aggressive lysis of adhesions. Intraoperative ultrasound guidance allows dissection to progress in the correct plane, eliminates false passages, and identifies limits of dissection. There were no postoperative complications or balloonassociated infections.

comes increases.12,13,28-34 Figure 14–11 shows a patent cavity at the end of a hysteroscopic lysis of adhesions that has good endometrium present on the patient’s left but poor endometrium on her right. Figure 14–12 shows the appearance of a cavity that is patent at the end of a lysis of adhesions where there is no endometrium seen. The prognosis for this pattern is very poor. Tubal ostial patency is crucial for spontaneous pregnancies but can be overcome by in vitro fertilization (IVF) when obstructed. We have found poor rates of continued patency of obstructed ostia even when they are open at the time of surgery.

Classification Systems Several classification systems for Asherman syndrome exist, although all are empirically derived and do not directly correlate with outcomes.12 The two most clinically useful are the ESH system and the American Society for Reproductive Medicine (ASRM) scoring system. The ESH system is based upon the thickness of the adhesive bands, the patency of the tubal ostia, and the amount of the cavity obliterated, as summarized in Box 14–2. Because this is a fertility-based system, a large emphasis is placed on tubal ostial patency. The ASRM system is based on the amount of cavity obliterated, the density of the adhesion, and the menstrual pattern and is summarized in Tables 14–2 and 14–3. None of these completely predict outcomes. We find the most significant predictors are the percentage of the cavity initially obstructed the percentage of the cavity patent at the end of the procedure, the vascularity of the myometrium under the lysed adhesions, and the percentage of the cavity lined by normal endometrium. Others have also observed that the amount of normal endometrium at hysteroscopy predicts outcome. Although successful pregnancies have been reported even with small residual cavities, the risk of adverse obstetric out-

MÜLLERIAN ANOMALIES Müllerian anomalies are structural developmental abnormalities of the female reproductive system. They are classified in accordance with their mechanism of formation into lateral and vertical fusion defects, partial formation, and obstructive and nonobstructive variants of each.35 The ASRM staging system further classifies these abnormalities into hypoplastic/agenesis, unicornuate, didelphus, bicornuate, septate, arcuate, and diethylstilbestrol (DES) related and is summarized in Box 14–3 and Figure 14–13.36

Table 14–3 1989 ASRM Prognostic Classification of Intrauterine Adhesions Stage

Severity

Class 1-4

I

Mild

II

Moderate

5-8

III

Severe

9-12

BOX 14–2 European Society Hysteroscopy Staging I. Thin or filmy adhesions easily lysed with the tip of the scope II. Single firm adhesion not rupturable by the sheath of the hysteroscope. Bilateral tubal ostia are free III. Multiple firm adhesions or obscured single tubal ostia IV. Extensive firm adhesions. Agglutination of the uterine walls. Obscured bilateral tubal ostia

Table 14–2 1989 ASRM Classification of Intrauterine Adhesions Feature

Class 1

Class 2

Class 3

Extent of cavity involved

<1/3

1/3-2/3

>2/3

Type of adhesions

Filmy

Filmy and dense

Dense

Hypomenorrhea

Amenorrhea

Menstrual pattern

Class 0

Normal

ASRM, American Society for Reproductive Medicine.

Figure 14–11 Patent cavity at the end of a hysteroscopic lysis of adhesions. Good endometrium is present on the patient’s left but poor endometrium on her right.

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Hysteroscopy for Evaluating and Treating Recurrent Pregnancy Loss Embryology of the Müllerian Ducts Understanding of these anomalies requires an understanding of normal development. The müllerian or parmesonephric ducts arise as a paired set of tubes in the seventh gestational week. These ducts elongate and then fuse medially from the müllerian tubercle, moving cephalad. This is followed by the disappearance of the separating walls between the fused ducts. In simple terms, failure of fusion leads to the duplication defects, and failure of disappearance of the wall leads to septal defects. In normal development, the unfused cranial portion becomes the

fallopian tubes and the fused lower portion becomes the uterus and proximal vagina. Recent reports have suggested that the fusion wave might proceed from the central portion simultaneously cephalad and caudad, leading to combined proximal and distal abnormalities.37

BOX 14–3 American Society for Reproductive Medicine Classification of Müllerian Anomalies Class Class Class Class Class Class Class

I. Müllerian agenesis or hypoplasia II. Unicornuate uterus III. Didelphus uterus IV. Bicornuate uterus V. Septate uterus VI. Arcuate uterus VII. Diethylstilbestrol (DES)-exposed uterus

Adapted from American Fertility Society: The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, müllerian anomalies and intrauterine adhesions. Fertil Steril 1988;49:944-955

I. Hypoplasis/Agenesis

Vaginal

Cervical

Fundal Tubal

Combined

V. Septate

Complete

Figure 14–12 Hysteroscopic view of patent cavity at the end of a lysis of adhesions; no endometrium is seen.

II. Unicornuate

Communicating

III. Didelphus

Non-communicating IV. Bicornuate

No cavity

No horn

VI. Arcuate

Complete

Partial

VII. DES Drug Related

Partial

Figure 14–13 The American Society for Reproductive Medicine müllerian anomaly staging system. (From American Fertility Society: The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, müllerian anomalies and intrauterine adhesions. Fertil Steril 1988;49:944-955.)

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Hysteroscopy for Evaluating and Treating Recurrent Pregnancy Loss Approximately 1% to 2% of women have congenital abnormalities of the müllerian system.38,39 However, the incidence as diagnosed by ultrasound in women with recurrent pregnancy loss is threefold higher.40

The Septate Uterus The septate uterus is the most common müllerian anomaly, the one associated with the worst reproductive outcome, and the one most amenable to hysteroscopic correction.37,39,40 Uterine septa form from incomplete absorption of the intervening tissue as the two müllerian ducts fuse. High rates of first trimester (25%) and second trimester (6%) losses have been described. Loss rates greater than 50% have been described in other studies. The most common theory is vascular compromise as the fibrous tissue of the septum compromises fetal development.37,39,40 In later gestations, the septum can directly compromise available space for growth, leading to miscarriage, abnormal fetal lie, or preterm birth.

shown in Figure 14–15. The utility of this technique for preoperative planning and guidance is shown with the 3D reconstructed anatomic coronal view in Figure 14–16, which allows precise measurements of the extension and width of the septum. A 3D reconstructed volume rendering is shown in Figure 14–17, which allows visualization of a small central external fundal indentation. Surgical Approach to the Uterine Septum

Hysteroscopic resection has replaced the older metroplasty procedures for the uterine septum.46-55 If the diagnosis of uterine septum is not confirmed by preoperative imaging studies, laparoscopic guidance is suggested. In routine cases we have replaced laparoscopic guidance with transabdominal ultrasound guidance

Preoperative Evaluation of the Septum

It is crucial to make an accurate diagnosis of septate or bicornuate uterus before hysteroscopic repair to avoid inadvertent fundal perforation of the indented central segment of the bicornuate uterus. Hysterosalpingography and hysteroscopy cannot differentiate these two conditions because neither provides a view of the external surface contour of the uterine fundus.41 MRI has been the gold standard method of diagnosis, but it is being replaced by high resolution ultrasound, especially 3D reconstructed coronal views, which provide a similar image.38,41-44 The addition of fluid instillation into the uterine cavity with 3D SHG will likely become the next standard in diagnosis because it is simple, has low cost, and provides excellent visualization of both the internal and external uterine anatomy.45 Figure 14–14 demonstrates the telltale appearance of a duplicated endometrial cavity on 2D transverse ultrasound. This is much more obvious with the addition of fluid during SHG, as

Figure 14–15 Duplicated endometrial cavity on two-dimensional transverse ultrasound sonohysterography.

2

1 3

Figure 14–14 Duplicated endometrial cavity on two-dimensional transverse ultrasound.

Figure 14–16 Three-dimensional reconstructed anatomic coronal view of sonohysterography of uterine septum. 1, thickness of apex; 2, maximal thickness; 3, maximal length of septum.

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Figure 14–18 Hysteroscopic appearance of a wide-based septum.

Figure 14–17 Three-dimensional reconstructed volume rendering of septum showing a small central external fundal indentation.

when necessary.37,56 However, unlike cases of Asherman syndrome, this is rarely if ever required for septa. Various methods have been used to resect the septum including laser, scissors, and wire loop or electrode. I prefer to use cold scissors and avoid electrosurgery to theoretically reduce thermal and cautery damage to the cut edges. Both micro-scissors and rigid sheath scissors can be used. With this method, the septum is incised from the apex upwards while simultaneously working from side to side. The resection is continued cranially until the cavity is flush across the fundal portion and the hysteroscope can be moved from one tubal ostium to the other without hitting residual septal tissue. Studies have shown that small residual septa of less than 1 cm do not adversely affect reproductive outcomes.57 The resection is more accurately described as an incision rather than an excision or resection because no tissue is actually removed. When the procedure is performed correctly the septal tissue retracts and flattens as it is incised. Most septal tissue is fibrous and avascular. Figure 14–18 shows the hysteroscopic appearance of a widebased septum, and Figure 14–19 shows the cavity after it is fully resected with scissors. Several authors have, however, shown that a majority of septa contain myometrial tissue by both histology and MRI evaluation.44,58 In these cases there may be increased bleeding or fluid absorption necessitating the use of electrosurgical hemostasis. In all cases the use of an automated fluid management system to record fluid absorption is recommended. If electrosurgery is used, specialized needle or knife electrodes are recommended. It is not recommended to straighten curved wire loop electrodes because this produces areas of weakness. Utmost care must be taken when incising the septum because this often requires forward movement of the electrode,

Figure 14–19 Uterine cavity after the septum is fully resected.

increasing the risk of inadvertent perforation. Any case of perforation with an activated electrode requires exploration to exclude electrosurgical injury to the bowel. In cases where the septum extends to involve the cervical canal, traditional practice has recommended not fully excising the cervical portion of the septum. The hysteroscope is inserted on one side of the septum, and cautery or scissors is used to incise above the lowermost portion. This approach has been recommended to reduce the risk of subsequent cervical incompetence; however, there is no direct proof of this, and some have fully resected the cervical component without complication.

The Arcuate Uterus The arcuate uterus occurs when there is a mild extension from the uterine fundus caudally. Although some view this as a minimal-extension septum, it is likely a normal variant in many women. In general, the tissue is normal muscular myometrium and not fibrous like a septum. Both normal and adverse reproductive outcomes have been reported.38,41,42 Most of these studies used older methods of diagnosis and suffer from

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Hysteroscopy for Evaluating and Treating Recurrent Pregnancy Loss methodologic limitations. Treatment, when indicated, is performed in the same fashion as for a uterine septum.

LEIOMYOMA Myomas are the most common benign tumor of the female reproductive system and are found by ultrasound in more than 70% of women by age 50 years.59 The classic classification system describes myomas based upon their location within the uterus (submucosal, intramural, and subserosal). Submucosal myomas may be further classified according to the extent to which they impinge upon the uterine cavity. The ESH classification system for submucosal myomas describes myomas based upon the relative amounts of intramural and intracavitary tissue.60,61 A type 0 myoma is wholly contained inside the endometrial cavity and is also referred to as an intracavitary pedunculated myoma. Type I myomas have less than 50% intramural extension and are amenable to hysteroscopic resection. Type II myomas have more than 50% intramural extension and in general are more amenable to transabdominal excision approaches. Hysteroscopic resection of these is more likely to result in incomplete removal, persistence of symptoms or adverse effects on fertility, and regrowth. Hysteroscopy remains the most accurate method of assessing the relative intracavitary versus intramural components of type 0 and I myomas. The assessment via ultrasound or sonohysterography is highly dependent upon scanning in the appropriate perpendicular planes to the uterine axes. What appears to be a type I myoma with less than 50% intramural extension on oblique scanning as shown in Figure 14–20 is actually a type II when viewed in the coronal plane as in Figure 14–21. Figure 14–22 shows the hysteroscopic appearance of this myoma.

myomectomy observed a reduction in the spontaneous abortion rate from 41% before surgery to 19% following myomectomy.62 There are several hypotheses as to potential mechanisms linking fibroids to RPL.63 In cases where they are large or impinging upon the cavity, they might interfere with normal implantation by a purely mechanical mechanism.64 It has also been postulated that in cases of cavity distortion, the blood supply to the endometrium and placenta might be altered. Alteration of local growth factors is another potential mechanism. Finally, it has been suggested that these intracavitary myomas might act similar to an IUD or cause low-grade endometritis. Myomas

1 2

Relationship to Recurrent Pregnancy Loss With fibroids being so common, clearly not all are causes of RPL. Several large retrospective studies have shown improvement in patients with a history of pregnancy loss who underwent myomectomy. One large study of 1941 patients who underwent

Figure 14–20 Sonohysterogram of an apparent type I myoma with <50% intramural extension on oblique scanning.

Figure 14–21 The myoma in Figure 14–20 was actually type II when viewed in the coronal plane.

Figure 14–22 Hysteroscopic view of the myoma in Figure 14–20.

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Hysteroscopy for Evaluating and Treating Recurrent Pregnancy Loss adjacent to the cavity and placental site have also been associated with second and third trimester complications such as an increased risk of bleeding, abruption, and premature rupture of membranes.65,66

Treatment Technique It is generally recommended that myomas that distort the cavity be removed before conception. A type 0 myoma (wholly within the cavity) is most easily resected with either resectoscope or via transection of its pedicle. Because type 0 myomas may be vascular, electrosurgical energy to achieve hemostasis should be available. In general, myomas are primarily resected in an operating room setting. Because fluid absorption can be rapid and unpredictable, an automatic system to monitor fluid balance is recommended, especially when using nonisotonic distention media.67 Some authors have successfully used the 5-F bipolar needle electrodes in saline in the office environment to transect these pedicles. Type I myomas, where a portion grows in the intramural portion of the uterus, are more difficult to resect. These are resected using the electrosurgical resectoscope; unipolar and bipolar versions can be used. Type I myomas are traditionally resected in the operating room environment, and an automatic fluid monitoring system is again recommended.67 Various techniques have been advocated to address the intramural component of the myoma. With partial resection, only the portion that extends beyond the myometrium is resected down to flush with the uterine wall. This surgery is technically simpler; regrowth of the myoma is a significant risk. For RPL, if interruption of normal blood supply to the surface endometrium is a factor, this method will not restore normal anatomy. An alternate technique is to remove the distention media once the myoma is resected flush with the uterine wall. After a short period of waiting, the uterus allowed to contract upon itself. In some cases, the intramural portion herniates into the cavity as it is pushed by myometrial contractions, being now amenable to further resection. A case report suggested that intraoperative injection of prostaglandin F2α increased the expulsion of the intramural portion.68 A dissection technique has also been described.69 Here, an incision is made over the endometrial portion of the myoma, which

is then enucleated as if the surgeon was performing an abdominal myomectomy. Some have advocated this procedure with electrosurgical electrode dissection, and others have performed it with CO2 distention using a pure dissection technique or using a combined resection and grasper technique.70 A hysteroscopic resection device modeled on an arthroscope shaver has been approved for use and also might allow better resection of type I myomas. This device is purely mechanical without electrosurgical current. It morcellates the myoma and mechanically shaves it while simultaneously removing the chips. In both the operating room and office setting, entry of the hysteroscope in cases of cervical stenosis can be aided by the use of oral or transvaginal misoprostol but not by mifepristone.71 Large intramural myomas have traditionally been thought to be a risk for RPL. There are no absolute figures on exact sizeto-risk relationships, and clinical judgment is recommended. The largest meta-analysis of 106 studies concluded that myomas that distort the endometrial cavity have a deleterious effect on fertility.72 Several recent studies have questioned the relationship of small intramural myomas to pregnancy loss or implantation failure.73,74 A large prospective study of more than 400 women found that even small intramural myomas not distorting the cavity had a significant negative effect on pregnancy at IVF (odds ratio, 0.46).73 In terms of overall reproductive outcome at IVF, a retrospective study found that patients who undergo precycle myomectomy have IVF cycle outcomes that are similar to controls with regard to ongoing pregnancy, implantation, and early pregnancy loss. Outcomes were similar for myomas resected via hysteroscopy regardless of intramural components or if resected through laparotomy. It is possible that the amount of normal myometrial tissue between the myoma and the cavity is another significant predictor.

SUMMARY RPL is associated with uterine pathology that can be diagnosed and assessed hysteroscopically in an office setting. Surgical treatment of uterine pathology associated with RPL is usually treated by hysteroscopy. Although the minority of these cases can currently be performed in the office, future refinement in technology has the potential to turn the majority into office-based procedures.

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Christiansen OB: Evidence-based investigations and treatments of recurrent pregnancy loss. Curr Opin Obstet Gynecol 2006;18(3): 304-312. Christiansen OB, Nybo Andersen A-M, Bosch E, et al: Evidence-based investigations and treatments of recurrent pregnancy loss. Fertil Steril 2005;83(4):821-839. De Braekeleer M, Dao T: Cytogenetic studies in couples experiencing repeated pregnancy losses. Hum Reprod 1990;5:519-528. Stephenson M, Awartani K, Robinson W: Cytogenetic analysis of miscarriages from couples with recurrent miscarriage: A case-control study. Hum Reprod 2002;17:446-451. Baart EB, Martini E, van den Berg I, et al: Preimplantation genetic screening reveals a high incidence of aneuploidy and mosaicism in

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embryos from young women undergoing IVF. Hum Reprod 2006;21(1):223-233. Kuliev A, Verlinsky Y: Meiotic and mitotic nondisjunction: Lessons from preimplantation genetic diagnosis. Hum Reprod Update 2004;10(5):401-407. Los FJ, Van Opstal D, van den Berg C: The development of cytogenetically normal, abnormal and mosaic embryos: A theoretical model. Hum Reprod Update 2004;10(1):7994. Ternamian A: Hysteroscopy to understand unexplained pregnancy loss. J Minim Invasive Gynecol 2005;12(5):29-33. Asherman J: Amenorhea traumatica atretica. J Obstet Gynaecol Br Emp 1948;55:23-30.

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Hysteroscopy for Evaluating and Treating Recurrent Pregnancy Loss 10. Westendorp IC, Ankum WM, Mol BW, Vonk J: Prevalence of Asherman’s syndrome after secondary removal of placental remnants or a repeat curettage for incomplete abortion. Hum Reprod 1998: 3347-3350. 11. Palter S, Coad J, Slayden O: Global endometrial dysfunction secondary to scarring of the cervix and lower uterine segment only: A new form of uterine infertility?—Clinical and non-human primate model evidence. J Minim Invasive Gynecol 2006;13:S52. 12. Al-Inany H: Intrauterine adhesions. An update. Acta Obstet Gynecol Scand 2001;80(11):986-993. 13. Capella-Allouc S, Morsad F, Rongieres-Bertrand C, et al: Hysteroscopic treatment of severe Asherman’s syndrome and subsequent fertility. Hum Reprod 1999;14(5):1230-1233. 14. Fernandez H, Al-Najjar F, Chauveaud-Lambling A, et al: Fertility after treatment of Asherman’s syndrome stage 3 and 4. J Minim Invasive Gynecol 2006;13(5):398-402. 15. Ismajovich B, Lidor A, Confino E, David MP: Treatment of minimal and moderate intrauterine adhesions (Asherman’s syndrome). J Reprod Med 1985;30(10):769-772. 16. Katz Z, Ben-Arie A, Lurie S, Manor M, Insler V: Reproductive outcome following hysteroscopic adhesiolysis in Asherman’s syndrome. Int J Fertil Menopausal Stud 1996;41(5):462-465. 17. Klein SM, Garcia CR: Asherman’s syndrome: A critique and current review. Fertil Steril 1973;24(9):722-735. 18. March CM, Israel R: Intrauterine adhesions secondary to elective abortion. Hysteroscopic diagnosis and management. Obstet Gynecol 1976;48(4):422-424. 19. March CM, Israel R, March AD: Hysteroscopic management of intrauterine adhesions. Am J Obstet Gynecol 1978;130(6):653657. 20. Palter SF: Asherman’s syndrome: Etiology, pregnancy loss, and treatment—An international registry. Am AssocGynecol Laparosc 2003;10(3):S6-S7. 21. Palter SF: Highly successful treatment algorithm for Asherman’s syndrome. Fertil Steril 2005;84(Suppl 1):S470. 22. Kohlenberg CF, Pardey J, Ellwood DA: Transabdominal ultrasound as an aid to advanced hysteroscopic surgery. Aust N Z J Obstet Gynaecol 1994;34(4):462-464. 23. Orhue AA, Aziken ME, Igbefoh JO: A comparison of two adjunctive treatments for intrauterine adhesions following lysis. Int J Gynaecol Obstet 2003;82(1):49-56. 24. Palter SF: Development of a highly successful novel comprehensive diagnostic, intraoperative, and postoperative treatment for Asherman’s syndrome. J Minim Invasive Gynecol 2005;12(5):37. 25. Abbott J, Thomson A, Vancaillie T: SprayGel following surgery for Asherman’s syndrome may improve pregnancy outcome. J Obstet Gynaecol 2004;24(6):710-711. 26. Acunzo G, Guida M, Pellicano M, et al: Effectiveness of auto– cross-linked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic adhesiolysis: A prospective, randomized, controlled study. Hum Reprod 2003;18(9):1918-1921. 27. Guida M, Acunzo G, Di Spiezio Sardo A, et al: Effectiveness of autocrosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: A prospective, randomized, controlled study. Hum Reprod 2004;19(6):1461-1464. 28. Carp HJ, Ben-Shlomo I, Mashiach S: What is the minimal uterine cavity needed for a normal pregnancy? An extreme case of Asherman syndrome. Fertil Steril 1992;58(2):419-421. 29. Deaton JL, Maier D, Andreoli J: Spontaneous uterine rupture during pregnancy after treatment of Asherman’s syndrome. Am J Obstet Gynecol 1989;160(5 Pt 1):1053-1054. 30. Dmowski WP, Greenblatt RB: Asherman’s syndrome and risk of placenta accreta. Obstet Gynecol 1969;34(2):288-299.

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Friedman A, DeFazio J, DeCherney A: Severe obstetric complications after aggressive treatment of Asherman syndrome. Obstet Gynecol 1986;67(6):864-867. Georgakopoulos P: Placenta accreta following lysis of uterine synechiae (Asherman’s Syndrome). J Obstet Gynaecol Br Commonw 1974;81(9):730-733. Hulka JF: Uterine rupture after treatment of Asherman’s syndrome. Am J Obstet Gynecol 1990;162(5):1352-1353. Zikopoulos KA, Kolibianakis EM, Platteau P, et al: Live delivery rates in subfertile women with Asherman’s syndrome after hysteroscopic adhesiolysis using the resectoscope or the Versapoint system. Reprod Biomed Online 2004;8(6):720-725. Jones HW Jr: Müllerian anomalies. Hum Reprod 1998;13(4): 789-791. American Fertility Society: The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, müllerian anomalies and intrauterine adhesions. Fertil Steril 1988;49:944-955. Homer HA, Li TC, Cooke ID: The septate uterus: A review of management and reproductive outcome. Fertil Steril 2000;73(1): 1-14. Tulandi T, Arronet GH, McInnes RA: Arcuate and bicornuate uterine anomalies and infertility. Fertil Steril 1980;34(4):362-364. Raga F, Bauset C, Remohi J, et al: Reproductive impact of congenital müllerian anomalies. Hum Reprod 1997;12(10):2277-2281. Salim R, Regan L, Woelfer B, et al: A comparative study of the morphology of congenital uterine anomalies in women with and without a history of recurrent first trimester miscarriage. Hum Reprod 2003;18(1):162-166. Reuter K, Daly D, Cohen S: Septate versus bicornuate uteri: Errors in imaging diagnosis. Radiology 1989;172:749-752. Acien P: Reproductive performance of women with uterine malformations. Hum Reprod 1993;8:122-126. Daya S: Classification of müllerian anomalies. Fertil Steril 1989; 51(3):551-552. Pellerito J, McCarthy S, Doyle M, et al: Diagnosis of uterine anomalies: Relative accuracy of MR imaging, endovaginal sonography, and hysterosalpingography. Radiology 1992;183:795-800. Jurkovic D, Geipel A, Gruboeck K, et al: Three-dimensional ultrasound for the assessment of uterine anatomy and detection of congenital anomalies: A comparison with hysterosalpingography and twodimensional sonography. Ultrasound Obstet Gynecol 1995;5: 233-237. DeCherney AH, Russell JB, Graebe RA, Polan ML: Resectoscopic management of müllerian fusion defects. Fertil Steril 1986;45(5): 726-728. Grimbizis G, Camus M, Clasen K, et al: Hysteroscopic septum resection in patients with recurrent abortions or infertility. Hum Reprod 1998;13(5):1188-1193. Hollett-Caines J, Vilos GA, Abu-Rafea B, Ahmad R: Fertility and pregnancy outcomes following hysteroscopic septum division. J Obstet Gynaecol Can 2006;28(2):156-159. March CM, Israel R: Hysteroscopic management of recurrent abortion caused by septate uterus.[see comment]. Am J Obstet Gynecol 1987;156(4):834-842. McShane PM, Reilly RJ, Schiff I: Pregnancy outcomes following Tompkins metroplasty. Fertil Steril 1983;40(2):190-194. Pace S, Cipriano L, Pace G, et al: Septate uterus: Reproductive outcome after hysteroscopic metroplasty. Clin Exp Obstet Gynecol 2006;33(2):110-112. Porcu G, Cravello L, D’Ercole C, et al: Hysteroscopic metroplasty for septate uterus and repetitive abortions: Reproductive outcome. Eur J Obst Gynecol Reprod Biol 2000;88(1):81-84.

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Hysteroscopy for Evaluating and Treating Recurrent Pregnancy Loss 53. 54.

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Valle RF, Sciarra JJ: Hysteroscopic treatment of the septate uterus. Obstet Gynecol 1986;67(2):253-257. Valli E, Vaquero E, Lazzarin N, Caserta D, Marconi D, Zupi E: Hysteroscopic metroplasty improves gestational outcome in women with recurrent spontaneous abortion. J Am Assoc Gynecol Laparosc 2004;11(2):240-244. Venturoli S, Colombo FM, Vianello F, et al: A study of hysteroscopic metroplasty in 141 women with a septate uterus. Arch Gynecol Obstet 2002;266(3):157-159. Querleu D, Brasme T, Parmentier D: Ultrasound-guided transcervical metroplasty. Fertil Steril 1990;54:995-998. Fedele L, Bianchi S, Marchini M, Mezzopane R, et al: Residual uterine septum of less than 1 cm after hysteroscopic metroplasty does not impair reproductive outcome. Hum Reprod 1996;11(4):727-729. Zreik TG, Troiano R, Ghoussoub, et al: Detection of myometrial tissue in uterine septa. J AM Assoc Gynecol Laparosc 1998;5(2): 155-160. Day Baird D, Dunson DB, Hill MC, et al: High cumulative incidence of uterine leiomyoma in black and white women: Ultrasound evidence. Am J Obstet Gynecol 2003;188(1):100-107. Wamsteker K, Emanuel MH, de Kruif JH: Transcervical hysteroscopic resection of submucous fibroids for abnormal uterine bleeding: Results regarding the degree of intramural extension. Obstet Gynecol 1993;82:736-740. Wamsteker K, de Blok S: Resection of intrauterine fibroids. In Lewis BV, Magos AL (eds): Endometrial Ablation. Edinburgh: Churchill Livingstone, 1993, pp 64-78. Buttram VC, Reiter RC: Uterine leiomyomata: Etiology, symptomatology, and management. Fertil Steril 1981;36(4):433445. Valli F, Zupi E, Marconi D, et al: Hysteroscopic findings in 344 women with recurrent spontaneous abortion. J Am Assoc Gynecol Laparosc 2001;8(3):398-401.

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Farhi J, Ashkenazi J, Feldberg D, et al: Effect of uterine leiomyomata on the results of in-vitro fertilization treatment. Hum Reprod 1995;10(10):2576-2578. Muram D, Gillieson M, Walters JH: Myomas of the uterus in pregnancy: Ultrasonographic follow-up. Am J Obstet Gynecol 1980;138(1):16-19. Rice JP, Kay HH, Mahony BS: The clinical significance of uterine leiomyomas in pregnancy. Am J Obstet Gynecol 1989;160(5 Pt 1):1212-1216. Loffer FD, Bradley LD, Brill AI, et al: Hysteroscopic fluid monitoring guidelines. The Ad Hoc Committee on Hysteroscopic Training Guidelines of the American Associaction of Gynecological Laparoscopists. J Am Assoc Gynecol Laparosc 2000;7(1):167-168. Murakami T, Shimizu T, Katahira A, et al: Intraoperative injection of prostaglandin F2alpha in a patient undergoing hysteroscopic myomectomy. Fertil Steril 2003;79(6):1439-1441. Litta P, Vasile C, Merlin F, et al: A new technique of hysteroscopic myomectomy with enucleation in toto. J Am Assoc Gynecol Laparosc 2003;10(2):263-270. Lin B-L, Akiba Y, Iwata Y: One-step hysteroscopic removal of sinking submucous myoma in two infertile patients. Fertil Steril 2000;74(5): 1035-1038. Preutthipan S, Herabuty Y: A randomized comparison of vaginal misoprostol and dinoprostone for cervical priming in nulliparous women before operative hysteroscopy. Fertil Steril 2006;86(4): 990-994. Donnez J, Jadoul P: What are the implications of myomas on fertility? A need for a debate? Hum Reprod 2002;17(6):1424-1430. Hart R, Khalaf Y, Yeong C-T, et al: A prospective controlled study of the effect of intramural uterine fibroids on the outcome of assisted conception. Hum Reprod 2001;16:2411-2417. Nawroth F, Foth D: IVF outcome and intramural fibroids not compressing the uterine cavity. Hum Reprod 2002;17:2485-2486.

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15

Office Management of Abnormal Uterine Bleeding: Levonorgestrel Intrauterine System Linda Bradley

Increasingly, women request that the least invasive treatment be offered for abnormal bleeding. Some patients request treatment for menstrual dysfunction only, and others also have contraceptive needs. When the work-up has identified a normal uterine cavity and has failed to target any structural abnormality of the uterus, the levonorgestrel intrauterine system (LNG IUS, Mirena) has increasingly become the most prescribed medical therapy. Effectively decreasing menstrual flow and cramping, it also has excellent contraceptive benefits. Unfortunately, American physicians and patients still have major reservations with the use of intrauterine devices (IUDs). Bad news is remembered for a generation and a half of physicians (the Dalkon Shield debacle), and good news takes a decade to eradicate bad news.1 Many health care providers know about the contraceptive efficacy of the LNG IUS, but few know about the significant noncontraceptive benefits. This chapter reviews the merits, benefits, side effects, preinsertion counseling, related costs, and contraindications of the LNG IUS.

IMPLICATIONS FOR CLINICAL PRACTICE The LNG IUS was initially studied in the 1970s. It was approved in Finland in September 1990, and FDA approval was granted in 2000. Approximately 12% of married, reproductive-age women have used an IUD. Overall 106 million women have used an IUD. The highest rates of use are in China and the lowest are in North America. The LNG IUS is now available in the United States and in more than 120 countries and has been used by more than 4 million women. It has a high contraceptive efficacy. The LNG IUS offers a reversible means of contraception with a cumulative gross pregnancy rate of 0.0% to 0.5% for 5 years, or a Pearl index pregnancy rate of 0.0% to 0.2% for 7 years. A multicenter study found that the majority of LNG IUS users were very satisfied with their IUD. Mirena continuation rates at 1 year are reported as 87 per 100 women.2 Preinsertion counseling is critical. High continuation rates for contraceptive use are reported in women who have received extensive preinsertion counseling. Pregnancy rates, including rates of ectopic pregnancy are low. It can be used for 5 years for pregnancy prevention, although data support efficacy up to 7 years.3

The IUD is reversible, works well, provides sexual spontaneity, and is safe; so why do North American women use the IUD so rarely? Outdated data, brief paragraphs written in our textbooks, manuals that continue to overemphasize the side effects, and misinformed lecturers who continue to overstate disadvantages while downplaying advantages.4 Numerous gynecologic benefits have also been reported but are rarely discussed. Lack of access can prevent greater use of the IUD. The most intriguing and unanticipated noncontraceptive benefit of the LNG IUS is related to its effect on the menstrual cycle. Documented benefits include improvements in menstrual bleeding (decreased menstrual blood loss and improved ferritin and hemoglobin levels), decreased dysmenorrhea, low incidence of pelvic inflammatory disease (PID), improved pelvic pain from endometriosis, therapeutic benefit on endometriosis rectovaginal nodules, symptomatic relief of adenomyosis, decreased bleeding in women with intramural fibroids, and excellent treatment of idiopathic menstrual disorders and menorrhagia.5 More studies are under way to evaluate the LNG IUS during postmenopausal hormone replacement therapy in women who cannot tolerate oral or vaginal progesterone.

LEVONORGESTREL DEVICE The LNG IUS is a 32-mm long T-shaped plastic device with a reservoir on the vertical stem. The reservoir contains 52 mg of levonorgestrel mixed with polydimethylsiloxane (Fig. 15–1). After insertion, the LNG IUS liberates 20 mcg of levonorgestrel, a potent 19-nortestosterone derivative progestin, daily and locally to the endometrium through a rate-limiting surface membrane.6 Although there is slight systemic absorption, most of the LNG IUS effects are locally mediated within the endometrium, fallopian tubes, and surrounding myometrium. (Fig. 15–2) Systemic absorption from the LNG IUS is rapid within the first few hours after placement. Within a few weeks, approximately 4% to 13% of the level of progesterone is noted peripherally, compared to the amount usually absorbed with a 150 mcg levonorgestrel tablet ingested orally. Generally, ovulation is not affected, and estrogen levels are within the range seen in normal fertile women, reaching plasma levels of 100 to 200 pg/mL.

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Office Management of Abnormal Uterine Bleeding: Levonorgestrel Intrauterine System BOX 15–1 Contraindications for Mirena Use Suspected pregnancy Postpartum endometritis Infected abortion Uterine size less than 6 cm or greater than 10 cm Fibroids that distort the uterine cavity Suspected pelvic malignancy Untreated cervicitis or vaginitis Active liver disease Liver tumor Hypersensitivity to levonorgestrel

BOX 15–2 Benefits of Mirena Menstrual bleeding decreased by 70% to 97% Decreased dysmenorrhea Amenorrhea Improved anemia Diminished number of days of bleeding Decreased risk for pelvic inflammatory disease Prevention of pregnancy Alternative to endometrial ablation for menstrual dysfunction Alternative to hysterectomy for menstrual dysfunction Progesterone to counteract abnormal perimenopausal bleeding

Figure 15–1 The Mirena intrauterine system.

MECHANISM OF ACTION

Thinning of the lining of the uterus

Inhibition of sperm movement Thickening of the cervical mucus

Figure 15–2 Mechanism of action of the Mirena intrauterine system. (Courtesy of Bayer laboratories, Inc.)

Some women experience hormonal side effects including mild mood changes, premenstrual dysphoria, headache, weight gain, mastalgia, and fatigue. Fortunately, most of these changes abate within 2 to 3 months. Properly counseled patients generally continue with the LNG IUS, understanding that in the long term, resolution of menstrual problems is the norm. The contraindications for use are summarized in Box 15–1.

Contraceptive Benefits The sustained 5-year benefits from the LNG IUS result form a steady, sustained release of levonorgestrel from a ratecontrolling polydimethylsiloxane membrane. Powerful, locally

mediated effects on the endometrium and adjacent tissue attest to its gynecologic benefits. Nilsson and colleagues7 noted that the average amount of levonorgestrel in the endometrium was 391 ng in the LNG IUS group compared with a minimal amount, 1.35 ng, in a comparison group who ingested an oral contraceptive containing 2 mg estradiol valerate and 250 mcg levonorgestrel. This sustained amount of locally mediated tissue concentration contributes to poor sperm transport, inhospitable local endometrial environment, and a hostile environment for blastocyst and implantation. Normally, glycodelin A is not present during an ovulatory cycle. However in patients using the LNG IUS this protein is expressed and prevents sperm–egg binding.8 Additionally, the locally high concentration of progesterone induces a viscous cervical mucus, which inhibits sperm penetration. Finally, the IUD induces a sterile foreign body reaction in the endometrium. Multiple comparison trials have demonstrated the sustained 5year contraceptive efficacy and low pregnancy rates, even among the most fertile of young women (<25 years old).9 The most common requested reason for removing the LNG IUS in contraceptive users is hypomenorrhea. Misinformed patients equate hypomenorrhea or amenorrhea with possible pregnancy and request removal due to fear of pregnancy. The benefits of the LNG IUS are listed in Box 15–2.

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Office Management of Abnormal Uterine Bleeding: Levonorgestrel Intrauterine System Endometrial Effects of Mirena

Menses-Related Anemia

Microscopic and Molecular Findings

Histologically, the most prominent effect on the endometrium in LNG IUS users is antiproliferative. Marked atrophy of the whole functional layer, stromal decidualization, endometrial thinning, glandular atrophy, vascular fragility, atypical endometrial angiogenesis, and inflammation are the hallmark histologic features. Although these effects are most prominently noted with long-term use, histologically these changes can be seen as early as 1 month after insertion. Normal endometrium under the influence of the hypothalamic–pituitary axis produces myriad active compounds (e.g., prostaglandins, estrogen–progesteroneinduced growth factors, and other bioactive peptides). Molecular theories abound for the etiology of endometrial atrophy and fragility.10 Ultrasonographic Findings

Zalel and colleagues11 evaluated 36 women clinically and sonographically and reported on the time required for the progesterone effects of the LNG IUS to be manifested. They studied the Doppler flow of the cervical and spiral branches of the uterine artery and the endometrial echo during the first 2 months of use and then 4 to 6 months later. Initially the rate of intermenstrual bleeding was 44% during the first 2 months but was only 8% after 4 to 6 months. Amenorrhea rate was 5% after 2 months of use and 66% after 4 to 6 months following insertion. Doppler flow studies demonstrated a change in the cervical branch of the uterine artery and a significant reduction in the subendometrial flow in the spiral artery. There was also a significant reduction in the endometrial echo after 4 months of use. The progesterone effects are demonstrated sonographically by the third month of use. This information can help with patient counseling and hopefully contribute in decreasing the discontinuation rate due to the initial menstrual disturbances.

Effects on Menstruation Bleeding Patterns

The most troublesome complaint from patients initially is erratic bleeding. Patients must be counseled that irregular, unpredictable, and unscheduled bleeding is very common and should be expected the first 4 to 6 months after LNG IUS insertion. Thereafter, the duration and amount of bleeding significantly decreases. Initial breakthrough bleeding is thought to be due to down-regulation of prostaglandin dehydrogenase (a progesterone-dependent enzyme), the estrogen receptor, and two subtypes of the progesterone receptor.12 Hidalgo and colleagues13 extensively tabulated the menstrual diaries of 256 women over 2 years. Menstrual diaries were summarized as follows: 44% reported amenorrhea at 6 months and 50% were amenorrheic at 12 and 24 months after insertion. At 6 months, 25% of women had spotting, and this decreased to 8% at 18 months and 11% at 24 months. In another randomized multicenter trial, 17% of LNG IUS users were amenorrheic at 12 months and 30% at 2 years.14

Among all cultures, menorrhagia is the most common cause of iron-deficiency anemia in reproductive-age women. Contraceptive studies were the first to elucidate the improvement in serum ferritin and hemoglobin levels among LNG IUS users. After 1 year of LNG IUS use, blood hemoglobin levels increased by 1.8 to 1.9 g/L among LNG IUS users and decreased by 0.9 to 1.2 g/L among copper IUD users. Additionally, serum ferritin, an indirect marker for iron-deficiency anemia was increased among LNG IUS users.15 Faundes and colleagues conducted a landmark study in the Dominican Republic.15 Subjects were low-income women and had a high prevalence of anemia. In the study population, 30% had low hematocrit and 43% had low ferritin. Women were followed for 41 months. One group of women used the LNG IUS and the control group used a copper IUD or Lippes loop. After 41 months, 26% of users of the Lippes loop, 22% of copper IUD users, and only 2% of LNG IUS users were anemic. Furthermore, serum ferritin levels remained low in 70% of Lippes loop users, 55% of copper IUD users, and only 14% of LNG IUS users. The researchers rightly concluded that clinical anemia with depletion of iron stores was lower among the LNG IUS users. Improved hemoglobin increases vigor, energy, and quality of life for most women. Correcting anemia is one essential goal of treating patients with menorrhagia; this is easily and quickly accomplished by using the LNG IUS. Disorders of Hemostasis

Bleeding disorders are more common than most gynecologists realize. Without suspecting these disorders, we unnecessarily create havoc in our patients’ lives. Unnecessary medical therapies are often tried for these patients. Worse yet, unnecessary surgical therapies are often recommended or performed.16 Women with inherited bleeding disorders consistently have lower quality-of-life scores during menstruation than do control groups with normal coagulation profiles, especially when flooding and clots occur with menstruation.17 Studies demonstrate that 1% to 13% of women without pelvic pathology who are seen in a general gynecology clinic have an inherited blood dyscrasia. In a survey of 99 patients with type 1 von Willebrand disease attending four hemophilia centers in the United States, 78% reported their periods to be quite heavy, 71% required medical attention, and 15% ultimately required a hysterectomy.18 Kingman and colleagues19 first reported the benefits of using the LNG IUS in women with inherited bleeding disorders as well as the tolerability in women who had failed prior medical therapy. He reported 8.6% of such women underwent hysterectomy due to profound menorrhagia (average age, 38 years) and many suffered from a surgical morbidity including vault hematoma or secondary hemorrhage. Patients with an inherited bleeding disorder must be scrupulously identified before major surgery, postoperative supportive measures must be undertaken, and a high index of suspicion for postoperative bleeding must be maintained.

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Office Management of Abnormal Uterine Bleeding: Levonorgestrel Intrauterine System Detailed evaluation and follow-up by Kingman’s group show the superiority of LNG IUS placement for the treatment of menorrhagia in women with bleeding disorders. Sixteen women identified from the database in their hemophilia center were followed for 9 months. In addition, their center had a large Ashkenazi Jewish population and hence a relatively large population of women with factor XI deficiency. These women had no pelvic pathology identified by transvaginal ultrasound and had failed medical therapy (oral contraceptives, nasal DDAVP, or tranexamic acid). All had documented menorrhagia using the pictorial bleeding assessment chart (PBAC) as described by Higham.20 Scores higher than 100 were consistent with menorrhagia. The scores ranged from 98 to 386, with a median score of 213. All women before insertion of the LNG IUS had at least one day a month when their life was severely affected by their bleeding, and 37.5% had at least three days per month affected by their menses. The LNG IUS was placed during menses and patients were followed for 9 months. Kingman demonstrated that irregular spotting was seen in all women after placement. The length of spotting ranged from 30 to 90 days (mean, 42 days). Amenorrhea was noted in 9 of 16 women. The remaining PBAC scores ranged from 24 to 75 (median, 47; P = 0.0001). All 16 women reported at 3 and 9 months that their periods were much better. All hemoglobin concentrations were better, and no one had hemoglobin less than 11 g/dL. At 9 months, no woman had any days of the month when her period significantly affected her quality of life, and none reported any side effects. Thus, women with an inherited bleeding disorder should be counseled and offered the LNG IUS as a first-line option to control menstrual bleeding as long as there are no contraindications. Insertion of the LNG IUS is quicker than, more cost-effective than, and as effective as an ablation. Additionally, it most often solves the complaint of heavy bleeding.

COUNSELING CONSIDERATIONS Most randomized trials consistently report excellent outcomes. Consultation is the key to having patients consider the LNG IUS for the treatment of heavy bleeding. What strategies can we employ to encourage increased and ongoing use of the device? First, understand the numbers. Have a strategy. Use the statistics to bolster your counseling efforts. Stay in contact with your patient. Dedicate a nurse, use patient brochures and video educational programs, and offer return visits to discuss patient concerns. Unless a complication (not merely a nuisance) is noted, encourage your patient to try a little “tincture of time” to get through the first 4 to 6 months of LNG IUS use. Generally, after the first few months, minor side effects improve dramatically. Most studies reveal that 20% of LNG IUS users request that it be removed due to increased blood loss and abnormal uterine bleeding. Initially, the first few months, approximately 30% of users experience prolonged bleeding lasting for more than 8 days or experience erratic or heavy bleeding.21 The initial increase in

number of days of bleeding and increased flow will be disconcerting to the woman who initially presented for pure menorrhagia and now suffers from menometrorrhagia. Ask her how she would feel about this if it were to occur before you place the device. Ask her if she would be willing to endure a 4 to 6 month change in her bleeding to likely have 5 years worth of improved menstrual flow.

TREATMENT OF MENORRHAGIA What the Data Show Tang and colleagues22 evaluated 10 Chinese women in a small, open, and nonrandomized study who had the LNG IUS placed for menorrhagia. By 6 months, 95% of patients had a reduction in menstrual blood loss. Importantly, this study also demonstrated the importance of excluding intrauterine pathology before LNG IUS placement, because two patients had spontaneous expulsion of the device. Both of these patients were found to have submucosal fibroids. Mirena has also been compared to medical therapy in several trials. Irvine and colleagues23 randomized 44 women to the LNG IUS or medical therapy with oral progesterone (norethisterone 5 mg tid) on cycle days 5 to 26. Each arm had 22 women. Only 36 women completed the trial. Most withdrawals were from the oral progesterone arm due to ineffective treatment or adverse side effects. Although both therapies reduced the amount of menstrual bleeding, the LNG IUS was better tolerated, was better accepted, and had more satisfied patients. Another medical trial compared the LNG IUS with a prostaglandin inhibitor (flurbiprofen) and tranexamic acid. All therapies decreased menstrual bleeding; however, the LNG IUS had the highest level of improvement in menstrual blood loss and was the only treatment that decreased bleeding to less than 80 mL per cycle. After four menstrual cycles, the reduction in mean blood loss was 20.7% ± 9.9% with flurbiprofen, 44.4% ± 8.3% with tranexamic acid, and 81.6% ± 4.5% in LNG IUS users.24 Invasive therapies including endometrial ablation and hysterectomy have been compared to the LNG IUS for treatment of abnormal uterine bleeding. Crosagnini and colleagues,25 Kittelsen and Istre,26 and Romer27 compared the LNG IUS with transcervical resection of the endometrium for menorrhagia. Both treatment groups demonstrated reduced bleeding and improved hemoglobin and iron levels. Quality-of-life scores were equally improved among treatment groups. Only LNG IUS treatment preserves future fertility and is reversible. Reid and colleagues28 recently compared the efficacy and tolerability of the LNG IUS with mefenamic acid in the management of objective idiopathic menorrhagia. Twenty-five women were randomized to receive the LNG IUS and 26 women took mefenamic acid for six cycles. After six cycles, the median menstrual blood loss was 5 mL in the LNG IUS group and 100 mL in the mefenamic acid group (P < 0.001). The mean PBAC score was 25 in the LNG IUS group (representing a 95% reduction in mean blood loss by 6 months) and 159 in the

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Office Management of Abnormal Uterine Bleeding: Levonorgestrel Intrauterine System mefenamic acid group. The LNG IUS produced greater reductions in all parameters than mefenamic acid. In a study by Llahteenmaki and colleagues,29 women who were on a waiting list for hysterectomy for treatment of menorrhagia were offered the LNG IUS placement. The waiting list was 1 to 2 years. Once surgery became available, they could opt to proceed with surgery or continue with the LNG IUS. After 6 months, 64.3% of women in the LNG IUS group had canceled surgery, compared to 14.3% of controls. By 12 months, 47% of the LNG IUS users continued with the IUD and 53% requested surgery. A longer 4- to 5-year study of 50 women who had the LNG IUS inserted noted that 50% continued to use the device and 67% avoided additional surgery after a mean follow-up of 54 months.30 Among women who had the device spontaneously expelled or removed, the older the patient was, the more likely she avoided additional surgery. Most women were extremely or very satisfied with relief of symptoms. In 2004, Hurskainen and colleagues31 reported their 5-year findings of 236 Finnish women who were randomly assigned to the LNG IUS or hysterectomy. Initially, quality-of-life scores were low among both study groups compared to the control population. After 5 years, both groups reported improvement in scores. Specifically, there was no difference between quality of life, anxiety, and depression scores between study groups. After 5 years, 42% of women using the LNG IUS underwent hysterectomy. Cost analysis for the LNG IUS users (direct and indirect) remained significantly lower than in the hysterectomy group. Satisfaction with treatment was equal in both groups (94% and 93%). Of the women who continued using the LNG IUS, 75% reported amenorrhea or oligomenorrhea, and 19% had irregular bleeding. Of the women who had the LNG IUS removed, causes included intermenstrual bleeding, heavy bleeding, and hormonal symptoms.

Quality of Life Hurskainen and colleagues,32 reported results of a randomized trial on the quality of life and cost effectiveness of hysterectomy versus the LNG IUS in the treatment of menorrhagia. Women were randomized to the LNG IUS (n = 119) or hysterectomy (n = 117). Menstrual blood loss, health-related qualityof-life questionnaire scores (SF 36), and total costs were calculated. Anxiety, depression, and sexuality-related factors were tabulated. At 12 months, 68% of women continued to use the LNG IUS. Mean blood loss was 13 mL and 69% had minimal spotting or amenorrhea. Twenty percent had undergone hysterectomy. Among the women randomized to hysterectomy, 91% had the procedure, 4% canceled their operation, and five women were lost to follow-up. Quality of life scores and psychological well-being improved significantly in both groups. The only difference between groups was less pain noted in the hysterectomy group. Overall costs were three times higher in the hysterectomy group (US$4222) than in the LNG IUS group (US$1530). This trial demonstrated that the LNG IUS is a cost-effective

alternative to hysterectomy in the treatment of menorrhagia during the first year of treatment, with improved quality of life scores noted. Bourdrez and colleagues33 asked 144 women with dysfunctional uterine bleeding to discuss their rationale and preference for LNG IUS placement, endometrial ablation, or hysterectomy for treatment of menorrhagia. Statistical analysis demonstrated that the women who chose hysterectomy wanted a definitive solution to their problem. Patients choosing the LNG IUS or endometrial ablation desired minimal intervention with or without a short hospital stay. These latter two groups were inclined to take a risk of 50% likelihood of treatment failure to avoid a hysterectomy. Of patients who opted for hysterectomy, 60% stated that they would have preferred a noninvasive treatment if the success rate of this type of treatment were greater than 80%. It is important to consider patient preference for treatment. In a randomized, controlled trial, Kennedy and colleagues34 evaluated the effects of information on treatment choices, with and without a structured preference interview. The control group received no information, another group received information, and one group received information plus a structured interview. Just providing women with information did not change the hysterectomy rate. What mattered was the structured interview that answered that patient’s questions, clarified personal values, and elicited preferences. The personal connection (structured interview and time for questions) was the salient factor in decreasing the hysterectomy rate. A personalized message promoting LNG IUS use is associated with patients more willing to try this unique alternative to treat their bleeding and most importantly to sustain continued use.

COSTS The LNG IUS has been compared to hysterectomy and endometrial ablation in relation to costs. Recent cost considerations and quality-of-life scores have been tabulated. Almost 60% of women avoid hysterectomy and are willing to continue therapy. Bayer the manufacturer of Mirena, recently tabulated cost of the Mirena device to be approximately US$450 to US$490. The cost of office insertion of the device on average is $100 to $200. Many insurance companies do pay for device and insertion fee. For patients whose IUD coverage is nonexistent, Bayer offers a direct patient purchase program that spreads payment over several months for cash-paying patients. Some insurance companies do not cover the cost of contraception and therefore for some segments of the population coverage is unattainable. Some Title X clinics can obtain discounted IUDs through the manufacturer. Finally patients and health care providers can access http://www.archfoundation. com for information about the Access and Resources in Contraceptive Health (ARCH) Foundation, which can also provide IUDs free or at markedly reduced cost to low-income women who do not have insurance coverage.

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BOX 15–3

Evidence-based care for the well woman and gynecologic patient is rapidly evolving. In particular, alternatives to hysterectomy and management of abnormal uterine bleeding has always created challenges for gynecologists. Within the last decade, it has undergone radical reassessment due to the many novel methods, allegedly minimally invasive, that are available for therapy, and patients and physicians are therefore often confused about what is really supported by data. The LNG IUS heralds a novel approach to treatment for abnormal uterine bleeding that is evidence based. The LNG IUS is the most effective pharmacologic treatment of menorrhagia. In the 1980s, approximately 60% of women who complained of heavy bleeding had a hysterectomy within 5 years. Now, even with the advent of endometrial ablation and operative hysteroscopy, half of such women have a hysterectomy within 2 years. Hopefully, broad acceptance of the LNG IUS will change these sobering statistics. This local progesterone intrauterine therapy offers myriad advantages: unparalleled contraceptive efficacy, marked reduc-

Future Potential Benefits of Mirena Symptomatic relief of adenomyosis symptoms35 Treatment of endometriosis-related symptoms36 Treatment for myoma-associated bleeding and dysmenorrhea37 Menopausal progestin source for hormone therapy38 Potential treatment for endometrial hyperplasia39 Protective role for endometrium in tamoxifen patients?40

tion in menstrual blood loss, improvement in dysmenorrhea, and promising therapy for endometriosis and adenomyosis. The indications for the use of the LNG IUS will continue to broaden and will have an impact on treatment of other disorders (Box 15–3). Every astute gynecologist should consider including the LNG IUS in armamentarium for treating abnormal uterine bleeding. In so doing, the number of endometrial ablations and hysterectomies are likely to diminish. Our patients deserve this option.

REFERENCES 1.

Darney PD: Time to pardon the UD? N Engl J Med 2001;345: 608-610. 2. Luukkainen T, Allonen H, Haukkamaa M, et al: Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study. Contraception 1987;36:169-179. 3. Dubuisson JB, Magnier E: The Mirena Study Group: Acceptability of the levonorgestrel-releasing intrauterine system after discontinuation of previous contraception: Results of a French clinical study of women aged 35-45 years. Contraception 2002;66:121-128. 4. Espey E, Ogburn T: Perpetuating negative attitudes about the intrauterine device : textbooks lag behind the evidence. Contraception 2002;65:389-395. 5. Jensen JT, Speroff L: Contraceptive and therapeutic effects of the levonorgestrel intrauterine system : An overview. Obstet Gynecol Surv 2005;60(9):604-612. 6. Andersson JK, Rybo G: Levonorgestrel-releasing intrauterine device in the treatment of menorrhagia. BJOG 1990;97:690-694. 7. Nilsson CG, Haukkamaa, Vierola H, et al: Tissue concentrations of levonorgestrel in women using a levonorgestrel-releasing IUD. Clin Endocrinol (Oxf) 1982;16:529-536. 8. Mandelin E, Loistinen H, Koistinen R, et al: Levonorgestrel-releasing intrauterine device-wearing women express contraceptive glycodelin A in endometrium during midcycle: Another contraceptive mechanism? Hum Reprod 1997;12:2671-2675. 9. Andersson K, Odlind V, Rybo G: Levonorgestrel-releasing and copperreleasing (NovaT) IUDs during five years of use: A randomized comparative trial. Contraception 1994;49:56-72. 10. Maruo T, Laoag-Fernandez JB, Pakarinen P, et al: Effects of the levonorgestrel-releasing intrauterine system on proliferation and apoptosis in the endometrium. Hum Reprod 2001;16:2103-2108. 11. Zalel Y, Gamzu R, Shulman R, et al: The progestative effect of the levonorgestrel-releasing intrauterine system—when does it manifest? Contraception 2003;67:473-476. 12. Critchley HO, Wang H, Kelly RW, et al: Progestin receptor isoforms and prostaglandin dehydrogenase in the endometrium of women using a levonorgestrel-releasing intrauterine system. Hum Reprod 1998;13:1210-1217.

13. Hidalgo M, Bahamondes L, Perrotti M, et al: Bleeding patterns and clinical performance of the levonorgestrel-releasing intrauterine system (Mirena) up to two years. Contraception 2002;65:129-132. 14. Sivin I, Stern J: Health during prolonged use of levonorgestrel 20 μg/d and the copper T Cu 380AG intrauterine contraceptive devices: A multicenter study. International Committee for Contraception Research (ICCR). Fertil Steril 1994;61:70-77. 15. Faundes A, Alvarez F, Brache V, et al: Trel IUD in the prevention and treatment of iron deficiency anemia during fertility regulation. Int J Gynecol Obstet 1988;26:429-433. 16. Kouides PA: Obstetric and gynaecological aspects of von Willebrand disease. Balliere’s Best Pract Clin Haematol 2001;14(2):381399. 17. Kadir RA, Sabin CA, Pollard D, et al: Quality of life during menstruation in patients with inherited bleeding disorders. Haemophilia 1998;4(6):836-841. 18. Kouides PA: Females with von Willebrand disease: 72 years as the silent majority. Haemophilia 1998;4(4):63-65. 19. Kingman CEC, Kadir RA, Lee CA, et al: The use of levonorgestrelreleasing intrauterine system for treatment of menorrhagia in women with inherited bleeding disorders. BJOG 2004;111:14251428. 20. Higham JM, O’Brien PMS, Shaw RW: Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990;97:734– 739. 21. Luukkainen T, Toivonen J: Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties. Contraception 1995;52: 269-276. 22. Tang GW, Loa SS: Levonorgestrel intrauterine device in the treatment of menorrhagia in Chinese women: Efficacy versus acceptability. Contraception 1995;51:231-235. 23. Irvine GA, Campbell Brown MB, Lumsden MA, et al: Randomized comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia. BJOG 1998;105:592-598. 24. Milsom I, Andersson K, Andersch B: A comparison of flurbiprofen, tranexamic acid and a levonorgestrel-releasing intrauterine contraceptive

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25.

26.

27.

28.

29.

30.

31.

32.

device in the treatment of idiopathic menorrhagia. Am J Obstet Gynecol 1991;164:879-883. Crosignani PG, Vercellini P, Mosconi P, et al: Levonorgestrel-releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding. Obstet Gynecol 1997;90:257-263. Kittelsen N, Istre OA: A randomized study comparing levonorgestrel intrauterine system (LNG IUS) and transcervical resection of the endometrium (TCRE) in the treatment of menorrhagia: Preliminary results. Gynaecol Endoscopy 1998;7:61-65. Romer T: Prospective comparison study of levonorgestrel IUD versus roller-ball endometrial ablation in the management of refractory recurrent hypermenorrhea. Eur J Obstet Gynecol Reprod Biol 2000;90:27-29. Reid PC, Virtanen-Kari S, Randomised comparative trial of the levonorgestrel intrauterine system and mefenamic acid for the treatment of idiopathic menorrhagia: A multiple analysis using total menstrual fluid loss, menstrual blood loss and pictorial blood loss assessment charts. BJOG 2005;112:1121-1125. Llahteenmaki P, Haukkamaa M, Puolakka J, et al: Open randomized study of use of levonorgestrel-releasing system as alternative to hysterectomy. BMJ 1998;105:595-598. Nagrani R, Bowen-Simpkins P, Barrington JW. Can the levonorgestrel intrauterine system replace surgical treatment for the management of menorrhagia? BJOG 2002;109:345-347. Hurskainen R, Teperi J, Rissanen P, et al: Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: Randomized trial 5-year follow-up. JAMA 2004;291:1456-1463. Hurskainen R, Teperi J, Rissanen P, et al: Quality of life and costeffectiveness of levonorgestrel-releasing intrauterine system versus

33.

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hysterectomy for treatment of menorrhagia: A randomized trial. Lancet 2001;367:273-277. Bourdrez P, Bongers MY, Mol BWJ: Treatment of dysfunctional uterine bleeding: Patient preferences for endometrial ablation, a levonorgestrel-releasing intrauterine device, or hysterectomy. Fert Steril 2004;82(1): 160-166. Kennedy ADM, Sculpher MJ, Coulter A: Effects of decision aids for menorrhagia on treatment choices, health outcomes, and costs. A randomized controlled trial. JAMA 2002;288:2701-2708. Fedele L, Portuese A, Bianchi S, et al: Treatment of adenomyosisassociated menorrhagia with a levonorgestrel-releasing intrauterine device. Fert Steril 1997;68:426-429. Vercellini P, Frontino G, De Giorgi O, et al: Comparison of a levonorgestrel-releasing intrauterine device versus expectant management after conservative surgery for symptomatic endometriosis: a pilot study. Fert Steril 2003;80:305-309. Grigorieva V, Chen-Mok, Tarasova M, et al: Use of a levonorgestrelreleasing intrauterine system to treat bleeding related to uterine leiomyomas. Fert Steril 2003;79:1194-1198. Varila E, Wahlstrom T, Rauramo I: A 5-year follow-up study on the use of a levonorgestrel intrauterine system in women receiving hormone replacement therapy. Fert Steril 2001;76:969-973. Vereide AB, Arnes M, Straume B, et al: Nuclear morophometric changes and therapy monitoring in patients with endometrial hyperplasia: A study comparing effects of intrauterine levonorgestrel and systemic medroxyprogesterone. Gynecol Oncol 2003;91: 526-533. Gardner FJE, Konje JC, Abrams KR, et al: Endometrial protection from tamoxifen-stimulated changes by a levonorgestrel-releasing intrauterine system: A randomized controlled study. Lancet 2000;356:1711-1717.

Chapter

16

Analgesia and Anesthesia for Office Hysteroscopy and Hysteroscopic Procedures Teresa E. Dews

Analgesia and anesthesia for office-based procedures is a relatively new field in the specialty of anesthesiology. As more physicians perform invasive procedures in the office or an ambulatory surgery center (ASC), the need for anesthesia services for these procedures has increased. Some physicians are comfortable with administering sedative medications alone or in combination with providing local anesthetic infiltration or local anesthetic nerve blocks. There are several considerations if one wishes to add this service for patient safety, comfort, and satisfaction. This chapter is an overview of anesthesia considerations for office-based anesthesia and analgesia for physicians performing hysteroscopy.

SURGICAL ASPECTS THAT AFFECT ANESTHESIA PLANNING Hysteroscopy Hysteroscopy may be performed under local, regional, or general anesthesia. The choice of anesthesia depends on several factors, including the procedure, the facility, the surgeon’s experience and preferences, the hysteroscopy equipment, the availability of anesthesia providers, and patient factors (e.g., medical status, patient preferences). Additionally, the duration of the procedure and anticipated recovery time and discharge planning help determine the best anesthetic technique.

Facility Hysteroscopy is now performed in a variety of settings. Diagnostic hysteroscopy performed in an office setting is possible with the smaller-diameter flexible hysteroscopes, which obviate the need for dilating the cervix. Generally, patients tolerate the procedure well without anesthesia, and the rate for adequate access and visualization is high.1 Topical or local anesthetic injections do not improve success of the procedure, patient comfort, or patient satisfaction.1-4 Operative hysteroscopy is associated with more patient discomfort. This may be particularly true if larger-diameter rigid

scopes and instrumentation are used. Therefore the venue for this procedure is often a hospital surgical suite, ambulatory surgery center, or specifically designated procedure room in the office setting. This diversity of infrastructure allows a wider range of options for monitoring, analgesia, and anesthesia.

Surgeon Preferences Based on the planned procedure and experience with the technical aspects of performing hysteroscopy, the surgeon may have a preference for the type of anesthesia offered to the patient. It is important to communicate any special surgical considerations to the anesthesiology consultant. This will allow a patient-centered dialogue regarding the optimal care plan. It is also important to be open to recommendations from the anesthesiology consultant, who might have additional perspectives regarding the case, based on an airway examination and the patient’s medical condition.

Surgical Procedure Technical aspects of the procedure as well as potential complications influence the choice of anesthesia. Sources of pain and discomfort from the procedure include patient anxiety, procedure positioning, cervical dilation, and the diameter of the hysteroscope or sheath. Endometrial biopsy can induce moderate pain and cramping. Intrauterine media or carbon dioxide insufflation can cause shoulder pain and abdominal cramping from uterine contractions. Additionally, one should remain vigilant regarding potential complications in the preoperative period. The overall complication rate for hysteroscopy is low but can include fluid overload from distension media, hemorrhage, uterine perforation, gas embolism, and cervical lacerations.5 Some patients have a vasovagal response to cervical dilation.

Patient Factors Patient factors include the medical history of the patient, the patient’s previous experience with anesthesia, and patient

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Analgesia and Anesthesia for Office Hysteroscopy and Hysteroscopic Procedures preferences (e.g., refusing regional anesthesia). The diagnoses that require the procedure and any comorbidity can directly affect the planning for anesthesia and monitoring. For example, a patient who has a history of ischemic heart disease and is being evaluated for menorrhagia might have chronic anemia, with the concomitant concern of oxygen delivery. Another example is a patient treated with chronic pain medications. Standard levels of anesthesia might be inadequate for her, or she might have a higher anxiety level.6 She might need higher levels of anesthesia,7 leading to an increased risk for overmedication, oversedation, respiratory depression, and to the need for airway support or resuscitation.

BOX 16–1 Planning for Anesthesia for Hysteroscopy When to consult anesthesia ● ● ● ●

Preoperative preparation ●

● ●

GENERAL CONSIDERATIONS FOR ANESTHESIA

● ●

Anesthesia is medication-induced loss of sensitivity to pain for medical reasons. The medication can affect all of the body, such as in general anesthesia, or a part of the body, which occurs with local or regional anesthesia. There are several ways of accomplishing the goal of anesthesia. Medications administered systemically via intravenous or pulmonary routes produce a range of anxiolysis, sedation, and general anesthesia. Medications, usually local anesthetics, may be applied topically, infiltrated locally, or administered near nerves, nerve bundles, or nerve plexi (nerve blocks). Spinal and epidural anesthesia are common techniques used by anesthesiologists to render the pelvic area and lower extremities insensate. Anesthesia should encompass the entire perioperative period. For simplicity, one may divide management of anesthesia into overlapping sections, such as the preoperative assessment and preparation, intraoperative management, and postoperative care and follow-up (Boxes 16–1 and 16–2)

●

● ● ●

● ● ● ●

●

● ●

It is important to assess the patient’s past and present medical history to allow appropriate planning for monitoring during the procedure, choice of the route of anesthesia, and appropriate medications. Routinely, the medical history is obtained before surgery. However, important information regarding experience with previous exposure to anesthesia, allergies to anesthetic agents, or a personal or family history of difficulty with anesthesia may be overlooked. Patients who have had anesthesia in the past might report no concerns or difficulty. However, some patients indicate previous sensitivity, which will require less than recommended doses of anesthetic agents. Alternatively, a history of tolerance to anesthetic medications leads to judicious titration of anesthetic agents as tolerated within appropriate safety margins. Some patients have a genetic predisposition for altered metabolism of medications or interac-

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Recovery Monitoring Anlagesics Treat PONV with antiemetics

Criteria for discharge ●

Anesthesia History

Personnel dedicated to patient monitoring and medication administration Monitoring for airway obstruction, oxygenation, and ventilation Assessment of adequate anesthesia and analgesia Vigilance in patient positioning and protection Sedation levels monitored closely

Postoperative management ●

●

It is important to assess the medical status of each patient in addition to the surgical considerations.

Appropriate emergency medications and equipment are available, including reversal agents (naloxone and flumanzenil), bag and mask for positive pressure ventilation, suction BLS or ACLS training and certification History and focused physical examination with airway evaluation Instructions to the patient NPO guidelines (see Box 16–2) and driver status Information about the anesthesia options ● Discussion of risks, benefits, and options for anesthesia and sedation ● Supportive brochure Appropriate monitoring equipment Noninvasive BP, pulse oximetry, ECG, O2 nasal cannula with capnography Dedicated trained personnel to monitor the patient and to record vital signs and medications administered

Intraoperative management ●

●

PREOPERATIVE ASSESSMENT

History of difficulty with anesthesia. Suspected or known difficult airway Failed outpatient hysteroscopy Patient preference

● ● ●

Normal mentation Eating without PONV Drinking without PONV Safe ambulation Able to void Responsible driver

Postdischarge management ● ● ● ●

Watch for persistent cognitive impairment after sedatives for 24 hours Written instructions for patient regarding expectations, (medications, diet, activity), and emergency contact numbers Follow-up evaluation Telephone survey

ACLS, advanced cardiac life support; BLS, basic life support; BP, blood pressure; ECG, electrocardiogram; PONV, postoperrative nausea and vomiting.

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Analgesia and Anesthesia for Office Hysteroscopy and Hysteroscopic Procedures BOX 16–2

BOX 16–3

Summary of American Society of Anesthesiologists Preprocedure Fasting Guidelines

Some Factors that May Be Associated with Difficult Airway Management

Not less than 2 hours before the procedure

History

●

●

Clear liquids: water, fruit juices without pulp, carbonated beverages, clear tea, black coffee

● ●

Not less than 4 hours before the procedure ●

●

Breast milk

Physical examination

Not less than 6 hours before the procedure ● ● ●

Previous problems with anesthesia or sedation Stridor, snoring, or sleep apnea Advanced rheumatoid arthritis Chromosomal abnormality (e.g., trisomy 21)

●

Infant formula Nonhuman milk* Light meal (toast and clear liquids)†

Habitus Significant obesity (especially involving the neck and facial structures) Head and neck ● Short neck ● Limited neck extension ● Decreased hyoid–mental distance (<3 cm in an adult) ● Neck mass ● Cervical spine disease or trauma ● Tracheal deviation ● Dysmorphic facial features (e.g., Pierre Robin syndrome) Mouth ● Small opening (<3 cm in an adult) ● No teeth ● Protruding incisors ● Loose or capped teeth ● Dental appliances ● High, arched palate ● Macroglossia ● Tonsillar hypertrophy ● Nonvisible uvula Jaw ● Micrognathia ● Retrognathia ● Trismus ● Significant malocclusion ●

●

Note: These recommendations apply to healthy patients of all ages who are undergoing elective procedures. They are not intended for women in labor. Following the guidelines does not guarantee that complete gastric emptying has occurred. *Because nonhuman milk is similar to solids in gastric emptying time, the amount ingested must be considered when determining an appropriate fasting period. † Meals that include fried or fatty foods or meat can prolong gastric emptying time. Both the amount and type of foods ingested must be considered when determining an appropriate fasting period. Adapted from American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-anesthesiologists: Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002;96:1004-1017.

●

tion with chronic medications (cytochrome P450 inducers or competitive inhibitors). Other causes of tolerance include chronic treatment with medications such as opioids or benzodiazepines that are similar to common anesthetic agents. Care should be exercised in patients who report failures of regional techniques such as epidurals, because they might have anatomic variations that lead to unreliability of the technique.

●

The Difficult Airway Administration of any medication by any route can cause unconsciousness as a planned event (deep sedation) or as a side effect or complication (oversedation or total spinal anesthesia). Therefore one must be prepared to appropriately manage the patient’s airway. Managing the airway means oxygenating and adequately ventilating the patient. Inability to manage the airway in an unconscious patient who is not spontaneously breathing is a major cause of morbidity and mortality in anesthesia.8,9 The difficult airway is defined as the inability to secure and adequately ventilate the unconscious patient. This may be anticipated in some cases, and there is much attention in the anesthetic literature to identifying patients with potentially difficult airways.10-12 The patient who presents with an unexpected difficult airway is still a source of significant morbidity in anesthesia.13,14 Therefore, a history of a difficult airway should be specifically and directly elicited from every patient. If the patient has a history or a physical examination consistent with a potentially difficult airway, then a consultation with an anesthesiology specialist is required before considering sedation or anesthesia for procedures15 (Box 16–3).

Adapted from American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-anesthesiologists: Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002;96:1004-1017.

Allergy to Anesthesia Allergic reactions occur during anesthesia and may be related to specific anesthetic agents (e.g., muscle relaxants) or other medications (e.g., antibiotics) and substances (e.g., latex) that the patient is exposed to during the perioperative period. It is important to obtain details of the administration, reaction, and treatment if information is available. Patients who report an allergy to local anesthetics are often reporting acute toxicity to inadvertent intravascular injection of the local anesthetic or to epinephrine-containing mixtures.16 This should be differentiated from anaphylaxis or anaphylactoid reactions. Allergy testing, such as the radioallergosorbent test (RAST) and skin testing, can be used to confirm the diagnosis in episodes of anaphylaxis and to differentiate these from anaphylactoid reactions.17 Even when there are no reports of

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Analgesia and Anesthesia for Office Hysteroscopy and Hysteroscopic Procedures anaphylaxis with anesthesia inhalation agents, immune-mediated hepatic toxicity can occur.18

Medical History In general, patients presenting for elective procedures should have stable medical histories and be optimized for all chronic conditions. Common chronic medical conditions that affect anesthetic planning include diabetes, cardiovascular disease, pulmonary disease, hiatal hernia or gastroesophageal reflux disease, and renal or hepatic impairment. Additionally, antiplatlet therapy or anticoagulant therapy determines anesthetic technique. Specifically, patients must have normal coagulation and platelet function to receive epidural and spinal anesthetic injections. Coagulation derangement is a relative contraindication to most other nerve blocks or injections. Diabetes Mellitus

A history of diabetes mellitus requires assessment of the patient’s overall diabetic control. Comorbidities related to the diabetes, such as vasculopathy of the cardiac, cerebrovascular, and renal systems, should be evaluated. Monitoring the patient’s current glycemic medication regimen with clear instructions regarding fasting status (see Box 16–2), timing of medications such as insulin, and timing of the surgical procedure will decrease the potential for hyperglycemia or hypoglycemia during the perioperative period. Diabetes is often associated with multisystem abnormalities including autonomic dysfunction,19 which can lead to more hemodynamic instability during anesthesia than is seen in nondiabetic patients. The patient’s glycemic control should be optimized before hysteroscopy. If this is done, then blood glucose may be monitored every 2 hours and insulin may be administered as needed using a sliding scale.

features and dentition are inspected. Any anatomic abnormality such as morbid obesity, history of severe facial trauma, or decreased mouth opening is cause for concern. The distance from the mental to the cricroid is often measured to anticipate difficult visualization during laryngoscopic examination. Laboratory studies are based only on the physical status of the patient. Routine laboratory studies have not been shown to predict patient outcome in minimally invasive surgical procedures in symptomatic patients.21

INTRAOPERATIVE MANAGEMENT Choice of Anesthesia Hysteroscopy may be performed with intravenous sedation, local anesthesia, regional anesthesia, or general anesthesia (Box 16–4). Small-diameter flexible hysteroscopes do not require cervical dilation for placement, and patients typically tolerate hysteroscopy well with no additional medication or oral anxiolytics administered before the procedure. This has greatly facilitated the transition to office-based hysteroscopy. However, some patients require more sedation to tolerate the procedure.

Intravenous Sedation IV sedation may be used alone or in combination with local or regional anesthesia. Information regarding IV sedation for

Cardiovascular Disease

Cardiovascular disease is prevalent in industrialized societies. Medications should be optimized before elective surgical procedures. Certain anesthetic agents or procedures can lead to symptomatic hypotension and therefore possibly to decreased cardiac perfusion. Appropriate monitoring, and in some cases dedicated monitoring personnel, is needed. Chronic Obstructive Pulmonary Disease and Tobacco

Patients with lung diseases are at increased risk for perioperative pulmonary complications due to hypoxemia and decreased ciliary clearing of mucus in patients undergoing general anesthesia. Unfortunately, brief periods of abstinence from smoking do not consistently decrease complications.20 Local or regional anesthesia is recommended, if appropriate, for patients with severe chronic obstructive pulmonary disease.

Physical Examination The physical examination of the patient undergoing anesthesia is problem focused and based on the patient’s history. Additional attention is given to the airway. The patient’s facial

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BOX 16–4 Cardiovascular Function Minimal sedation (anxiolysis) is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected. Moderate sedation/analgesia (conscious sedation) is a drug-induced depression of consciousness during which the patient responds purposefully* to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Deep sedation/analgesia is a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully* following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients might require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. General anesthesia is a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper than initially intended. Persons administering conscious sedation should be able to rescue patients who enter a state of deep sedation or analgesia. Persons administering deep sedation or analgesia should be able to rescue patients who enter a state of general anesthesia. *Reflex withdrawal from a painful stimulus is not considered a purposeful response. Adapted from American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-anesthesiologists: Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002;96:1004-1017.

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Analgesia and Anesthesia for Office Hysteroscopy and Hysteroscopic Procedures

Table 16–1 Depth of Sedation*

hysteroscopy is limited; however, moderate and deep sedation have been effective in other outpatient surgical procedures.22 Guidelines are available to assist the nonanesthesiologist who chooses to administer moderate sedation.15 The guidelines highlight the importance of perioperative care and safe administration of sedatives and analgesics. Sedation is a continuum from the awake and alert status through a gradation to complete unresponsiveness (general anesthesia). (Table 16–1) The guidelines do not specifically address small doses of medications that are used for mild sedation or anxiolysis because of their minimal risk for morbidity. The ideal medication for IV sedation has immediate onset, is well tolerated, and has predictable levels of titration. This medication has no perturbation of respiratory or cardiovascular parameters and no toxicity. Awakening and recovery are rapid, and there is no postprocedure hangover effect or postoperative nausea and vomiting. Unfortunately, the ideal medication does not yet exist. However, several medications, used judiciously, can provide an excellent patient experience during the procedure and the perioperative period. Midazolam is a benzodiazepine that is commonly used for anxiolysis. It provides excellent amnesia and decreases the overall anesthesia requirements of other agents as well. The most common route of administration is IV, and it is well tolerated. The typical adult dose is 1 to 2 mg IV (0.5-1 mg in the elderly) with onset of 1 to 5 minutes and duration of 30 to 60 minutes. Diazepam is an effective oral anxiolytic, and 5 to 10 mg may be administered the previous evening and 60 to 90 minutes before the procedure in very anxious patients. Oversedation associated with benzodiazepines can be reversed with flumazenil, which is a competitive antagonist at the benzodiazepine receptor. Flumazenil 0.1 to 0.2 mg can be administered every 1 to 2 minutes to effect up to 5 mg total. Large doses can precipitate withdrawal.23

with midazolam, although this has not been formally evaluated in this patient population. Hasen22 compared midazolam and fentanyl moderate sedation to proprofol infusion deep sedation in aesthetic plastic surgery procedures with comparable patient satisfaction between the two groups. The patients in the proprofol group had less intraoperative recall but more postoperative nausea and vomiting. Fentanyl is usually administered intravenously, although other routes of administration (transbuccal, sublingual, intranasal) are available. Intravenous fentanyl has the advantage of rapid onset and excellent analgesia. It can be associated with pruritus and postoperative nausea and vomiting. Slow titration of up to 1-2 mcg/kg may be administered for sedation and analgesia. Respiratory depression is a concern, particularly when fentanyl is administered with other sedative agents. Respiratory depression and oversedation may be reversed with a competitive antagonist, naloxone.24 Propofol

Propofol is an alkylphenol hypnotic agent that has a rapid onset of action (90-100 sec) and short duration of action. It is one of the most widely used IV anesthetic agents because it is easy to titrate the level of sedation by intermittent bolus injections or continuous infusion. Average patient emergence is 5 to 10 minutes after a bolus dose, and patients awake with a sense of well-being. The injection itself is initially painful, but the pain can be decreased by adding lidocaine to the solution. Respiratory depression and apnea do occur and are associated with the dose and rapidity of injection. Episodes of prolonged apnea (>30 sec) can occur, and the incidence is increased when other sedatives are administered. The possibility of transition from moderate sedation to general anesthesia with propofol may be rapid, and only personnel trained and experienced in airway management should use this agent.23

Nerve Blocks

Opioids

Fentanyl is a potent synthetic opioid that may be appropriate to consider for painful aspects of hysteroscopy or in combination

Several studies have shown no difference in flexible hysteroscopy for various nerve block techniques. The techniques

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Analgesia and Anesthesia for Office Hysteroscopy and Hysteroscopic Procedures (paracervical block, intracervical local anesthetic block, and topical application) were noted to be uncomfortable for the patient and did not improve patient experience with the procedure or patient satisfaction.1-4 Additionally, there is no difference in the rate of successful procedure visualization.1-4 This is not surprising, because paracervical blocks have not consistently facilitated analgesia for cervical dilation and tenaculum placement in patients undergoing therapeutic abortions.25

General Anesthesia versus Monitored Anesthesia Care The American Society of Anesthesiologists practice guidelines for sedation define general anesthesia as a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.15

Regional Anesthesia Spinal or epidural anesthesia techniques involve placing local anesthetics in the neural axis. The epidural approach involves accessing the potential space between the ligamentum flavum and the dura. It is technically more difficult, but it offers the advantage of placing a catheter to administer additional medications if the surgical procedure is prolonged. Spinal anesthesia offers a more consistent endpoint (aspiration of cerebrospinal fluid) due to the need to penetrate the dura. Spinal anesthesia therefore requires very low doses of anesthetic, and the onset is fast. Adjunctive medications such as opioid and α-adrenergic agonists are also used to increase analgesia with variable success and side effects.26,27 Spinal, epidural, or combined spinal–epidural techniques are reasonable options for patients who cannot undergo hysteroscopy without anesthesia or who are scheduled for operative hysteroscopy procedures. Goldenberg and collegues compared epidural to general anesthesia in patients undergoing hysteroscopic endometrial resection. The only difference they found was increased absorption of the glycine distention fluid in the epidural group.28 Danelli and colleagues found that patient satisfaction may be higher with general anesthesia using shortacting intravenous agents rather than spinal anesthesia.29 For other outpatient procedures, spinal, epidural, and general anesthesia can be equally effective and satisfactory for patients.29 Spinal anesthesia may be associated with increased recovery time due to prolonged motor or sensory block.29 General anesthesia has been generally well tolerated, but there are variable reports of increased incidence of postoperative nausea and vomiting, which can delay recovery. Postoperative nausea and vomiting are also associated with spinal anesthesia when opioids are administered intraspinally.26,30

Due to current hysteroscopy equipment and techniques, general anesthesia is not required in most procedures. When general anesthesia is chosen, ultrashort-acting intravenous agents, inhalation agents, and mask or laryngeal mask airways are associated with excellent patient satisfaction.29,32 Monitored anesthesia care is defined as physician monitoring and administration of medications in patients undergoing procedures with or without local anesthesia. The same standard of care for the patient is rendered as with administration of anesthesia techniques. Patient safety and comfort continue to be the priority, and the use of less medication allows more rapid recovery, decreased drug costs, and potentially decreased recovery time.

SUMMARY Hysteroscopy is well tolerated as an outpatient procedure, and because of improvements in equipment, most patients need no anesthesia. For patients who request or require anesthesia for the procedure, anxiolysis with midazolam and analgesia with fentanyl intravenously offers excellent onset of action and low risk of oversedation, airway obstruction, or cardiopulmonary compromise. In experienced hands, additional anesthetic agents for moderate sedation or general anesthesia are available and can facilitate more challenging cases. Local anesthetic blocks and local infiltration do not appear to improve analgesia or patient satisfaction compared to placebo. In selected cases and venues, regional anesthesia is comparable to general anesthesia but may be associated with longer recovery time.

REFERENCES 1.

2. 3.

4.

Kremer C, Barik S, Duffy S, et al: Flexible outpatient hysteroscopy without anaesthesia: A safe, successful and well-tolerated procedure. BJOG 1998;105:672-676. Vercellini P, Colombe A, Mauro F, et al: Paracervical anesthesia for outpatient hysteroscopy. Fertil Steril 1994;62:1083-1085. Broadbent JAM, Hill NCW, Molnar BG, et al: Randomized, placebocontrolled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy. BJOG 1992;99:777-780. Wong AY, Wong K, Tang LC, et al: Stepwise pain score analysis of local lignocaine on outpatient hysteroscopy: A randomized, double blind, placebo-controlled trial. Fertil Steril 2000;73:12341237.

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5.

6.

7.

8.

Batra N, Khunda A, O’Donovan, PJ: Hysteroscopic myomectomy. Obstet Gynecol Clin North Am 2004;31(3):669685. Gupta JK, Clark TJ, More S: Patient anxiety and experiences associated with an outpatient “one-stop” “see and treat” hysteroscopy clinic. Surg Endosc 2004;18(7):1099-1104. Hong JY, Jee YS, Luthardt FW: Comparison of conscious sedation for oocyte retrieval between low-anxiety and high-anxiety patients. J Clin Anesth 2005;17(7):549-553. Caplan RA, Posner KL, Ward RJ, et al: Adverse respiratory events in anesthesia: A closed claims analysis. Anesthesology 1990;72:828833.

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Analgesia and Anesthesia for Office Hysteroscopy and Hysteroscopic Procedures 9. 10. 11.

12.

13.

14. 15.

16. 17.

18. 19.

20.

21.

Peterson GN, Domino KB, Caplan RA: Management of the difficult airway: A closed claims analysis. Anesthesiology 2005;103(1):33-39. Rose DK, Cohen MM: The airway: Problems and predictions in 18,500 patients. Can J Anaesth 1994;41:372-383. El-Ganzouri AR, Mc Carthy RJ, Tuman KJ, et al: Preoperative airway assessment: Predictive value of a multivariate risk index. Anesth Analg 1996;82:1197-1204. Williamson JA, Webb RK, Szekely S, et al: Difficult intubation: An analysis of 2000 incident reports. Anaesth Intens Care 1993;21:602-607. Combes X, Le Roux B, Suen P, et al: Unanticipated difficult airway in anesthetized patients: Prospective validation of a management algorithm. Anesthesiology 2004;100(5):146-150. Langeron O, Masso E, Huraux C, et al: Prediction of difficult mask ventilation. Anesthesiology 2000;92(5):1229-1236. American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-anesthesiologists: Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology 2002;96:1004-1017. Fisher MM, Bowey CJ: Alleged allergy to local anaesthetics. Anaesth Intensive Care 1997;25:611-614. Mertes PM, Laxenaire MC, Alla F: Anaphylactic and anaphylactoid reactions occurring during anesthesia in France in 1999-2000. Anesthesiology 2003;99(3):536-545. Hepner DL, Castells MC: Anaphylaxis during the preoperative period. Anesth Analg 2003;97(5):1381-1395. Bugess LG, Ebert TJ, Asiddao C: Increased intraoperative cardiovascular morbidity in diabetics with autonomic neuropathy. Anesthesiology 1989;70(40):591-597. Arozullah AM, Conde MV, Lawrence VA: Preoperative evaluation for postoperative pulmonary complications. Med Clin North Am 2003;87(1):153-173. Schein OD, Katz J, Bass EB, et al: The value of routine preoperative medical testing before cataract surgery. Study of medical testing for cataract surgery. N Engl J Med 2000;342(3):168-175.

22.

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25. 26. 27.

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Hasen KV, Samartzis D, Casas LA, et al: An outcome study comparing intravenous sedation with midazolam/fentanyl (conscious sedation) versus propofol infusion (deep sedation) for aesthetic surgery. Plast Reconstr Surg 2003;112(6):1683-1689. Reves JG, Glass PSA, Lubarsky DA, McEvoy MD: Intravenous nonopioid anesthetics. In Miller RD: Miller’s Anesthesia, 6th ed. Philadelphia: Churchill Livingstone, 2004, pp 317-378. Fukuda, K: Intravenous nonopioid anesthetics. In Miller RD: Miller’s Anesthesia, 6th ed. Philadelphia: Churchill Livingstone, 2004, pp 379-437. Keder LM: Best practices in surgical abortion. Am J Obstet Gynecol 2003;189(2):418-422. Nguyen H, Garber JE, Hassanbusch SJ: Spinal analgesics. Anesthesiol Clin North America 2003;21(4):805-816. Borgeat A, Ekatodramis G, Schenker CA: Postoperative nausea and vomiting in regional anesthesia: A review. Anesthesiology 2003;98(2):530-547. Goldenberg M, Cohen SB, Etchin A, et al: A randomized prospective comparative study of general versus epidural anesthesia for transcervical hysteroscopic endometrial resection. Am J Obstet Gynecol 2001;184(3):273-276. Danelli G, Berti M, Casati A, et al: Spinal block or total intravenous anaesthesia with propofol and remifentanil for gynecological outpatient procedures. Eur J Anaesthesiol 2002;19(8):594-599. Mulroy MF, Larkin KL, Hodgson PS, et al: A comparison of spinal, epidural, and general anesthesia for outpatient knee arthroscopy. Anesth Analg 2000;91(4):860-864. Liu SS, Strodtbeck WM, Richman JM, et al: A comparison of regional versus general anesthesia for ambulatory anesthesia: A meta-analysis of randomized controlled trials. Anesth Analg 2005;101(6):16341642. Fredman B, Zohar E, Philipov A: The induction, maintenance, and recovery characteristics of spinal versus general anesthesia in elderly patients. J Clin Anesth 1998;10(8):623-630.

Chapter

17

Hysteroscopic Sterilization Linda D. Bradley

Hysteroscopic sterilization is likely the last gynecologic frontier conquered by gynecologists as a minimally invasive surgical procedure. Myriad attempts have been made to perform hysteroscopic sterilization during the past 150 years, including, mechanical, thermal, cryosurgery, and chemical occlusion. In 2002, after excellent results from several clinical trials,1 the FDA approved the microinsert sterilization device ( Essure System, Conceptus, San Carlos, Calif), a hysteroscopic technique that provides a permanent method of female contraception. Data from Conceptus indicate that more than 50,000 procedures have been performed worldwide. Five-year data show that the procedure is 99.74% effective when strict adherence to procedural and postprocedural protocols are followed.2 The method is incisionless, office-based, and cost-effective, the recover is quick, and pregnancy rates are low.3

HISTORY OF STERILIZATION The history of sterilization took a circuitous route. In the early 20th century, sterilization was performed via the abdominal route using a ligation or crushing technique. Notable methods included Pomeroy’s resection of tubes via laparotomy, culdoscopy (vaginal), or colpotomy.4 These were favored over the laparoscopic approach, which initially was technically difficult and cumbersome. It was not until the early 1970s that laparoscopic fulguration was employed. Initially, monopolar current was used, but it led to many tragic complications from bowel burns, peritonitis, and death. Fewer complications were observed when laparoscopic bipolar cautery of the fallopian tubes was employed. Pioneers tried hysteroscopic electrocoagulation of the tubal ostia in the 1970s, but this was short-lived due to high tubal patency rates, tubal fistulas, high pregnancy rates, and frequent complications including tubal perforation, bowel burns, and death. Hysteroscopic cryocoagulation of the tubal ostia was attempted, but lack of long-term follow up derailed its implementation. Worldwide, more than 10 million sterilizations have been performed since the 1980s. Time really changes procedures. In the 1970s less than 1% of sterilizations were performed laparoscopically. By the late 1970s, 55% of all interval sterilizations and 89% of all hospital-based outpatient tubal sterilizations were performed laparoscopically.5

In general, laparoscopic sterilization is safe, effective, and easily learned. However, it is not without serious complications including unintended major surgery, transfusion, injury to major organs (bowel, bladder, and major vessels), febrile morbidity, and life-threatening events. Each year, four deaths per 100,000 procedures are directly related to laparoscopic sterilization. Rehospitalization rates of 2% following laparoscopic sterilization have been reported. The 10-year cumulative pregnancy rates for laparoscopic sterilization vary between 3 and 5 per 1000. With hysteroscopic sterilization, fewer complications are anticipated (Table 17–1).

CLINICAL TRIALS Before U.S. Food and Drug administration (FDA) approval in 2002, there were four phases of rigorous clinical testing with the microinsert sterilization device. Phase IA involved 99 subjects in a perihysterectomy study. This was a single-arm, prospective, nonrandomized, noncontrolled, multicenter international study to test the placement feasibility of various microinsert designs and design iterations. Patients undergoing planned hysterectomy were recruited to evaluate the feasibility of microinsert placement, to evaluate placement techniques and delivery systems and to assess accurate tubal occlusion immediately after microinsert placement. Outcomes of the perihysterectomy study were crucial because the preliminary results revealed safety and ease of placement of microinserts, the ability of the device to be anchored to the fallopian tube, and the ability of the device to fill the space of the fallopian tube for occlusion. These initial studies were conducted in the United States, Europe, and Mexico. The Phase IB prehysterectomy study then followed and involved 63 subjects.6 Patients enrolled in this phase of the clinical trial used the device for 1 day to 7 months before undergoing a planned hysterectomy. The device was in place for 10 to 12 weeks on average. Within 72 hours before the planned hysterectomy patients underwent a hysterosalpingogram (HSG) to determine tubal occlusion. Following hysterectomy, the uterus was x-rayed and the location of the microinsert evaluated. After hysterectomy, the uterus was opened and the tubes were removed and histologically evaluated. Women also recorded any side effects noted from using the device.

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Table 17–1 Comparison of Hysteroscopic Sterilization to Laparoscopic Sterilization Feature

Hysteroscopic

Laparoscopic

Anesthetic

Local, general, regional

General

Incision

None

2 incisions, 5-10 mm

Complications

Theoretically fewer

1%-3.5%

Successful completion rate with one procedure

>90%

Theoretically 100%

Postoperative pain

Minimal

Mild to moderate

Postprocedure confirmation testing needed

3-month HSG

None

Contraceptive failure rate

<1%

1.6% to 1.8% per 10 years

Likely or usually less than laparoscopy

Likely more than hysteroscopy

Cost

Table 17–2 Summary of Micro-Insert Placement Study Results Feature

Phase II Study

Pivotal Trial

Patients who underwent a placement procedure

227

518

Bilateral placement rate, first attempt

86%

86%

Bilateral placement rate, second attempt

88%

90%

Average hysteroscopy time

18 minutes

13 minutes

Average procedure time

—

35 minutes

Effectiveness rate after 4 y of follow-up

99.80%

99.9%

Patient satisfaction with the Essure procedure at all visits up to 3 y of follow-up

>97% good to excellent

92% somewhat satisfied to very satisfied

HSG, hysterosalpingogram.

Key outcomes from this trial included data related to histologic findings supporting the theory that tubal occlusion with polyethelene terephthalate (PET) fibers was localized to the microinsert. Feedback on the safety and comfort of placement in an awake patient and limited data on the safety and comfort of device placement were also reviewed. There were no adverse clinical sequelae. These studies were conducted in the United States and Mexico. Conceptus conducted two clinical trials (phase II and the pivotal study) to demonstrate the safety and effectiveness of the microinsert device system in providing permanent contraception. All patients were between ages 21 and 45 years. All patients had had at least one live birth, had regular cyclic menses, and were willing to use alternative contraception for the first 3 months following microinsert device placement. During both of these studies, after undergoing HSG at 3 months that demonstrated tubal occlusion, patients relied upon the microinsert device as a means of contraception. The phase II study provides the preliminary safety and effectiveness data needed to move to the pivotal FDA trial.7 The phase II study recruited 227 women who desired sterilization. Safety and effectiveness data were accrued. Four objectives of the phase II trial included effectiveness of the microinsert device to prevent pregnancy, safety of the placement procedure, the participant’s tolerance of and recovery from the procedure, and long-term safety and stability of the microinserts. After 3 months, if the HSG demonstrated tubal occlusion, patients relied upon the microinsert device as a permanent means of contraception. Women were followed for 5 years. None of the women in the phase II study became pregnant while relying on the final version of the microinsert. A summary of the phase II study is seen in Table 17–2. The FDA pivotal trial included women desiring permanent sterilization. It was a prospective, multicenter, single-arm, nonrandomized international study of women seeking permanent

contraception. This pivotal safety and effectiveness trial was begun in 2000, and recruitment concluded in 2001. The pivotal trial enrolled 518 women. These patients have now been followed for more than 7 years. The primary endpoints of the pivotal trial were pregnancy (after HSG confirmation of occlusion), safety of the placement procedure, and safety of longterm use. Secondary endpoints included participant satisfaction with the device placement procedure, participant satisfaction with device wearing, bilateral device placement rate, and data for development of clinical patient profile for appropriate microinsert device candidates. Table 17-2 shows the results of the pivotal trial. The pivotal trial initially enrolled 518 patients, but placement was attempted in only 507 (98.8%). In 11 patients, the tubal ostia were not well seen because of polyps or thickened endometrium or because tubal ostia were not visualized. Bilateral placement occurred in 446 (86%) after the first procedure and in 464 of the 518(90%) after a second procedure. The additional 18 women had placement at a later time. Of the 54 women for whom bilateral placement was never achieved, 11 did not undergo a placement attempt. Two patients were found to have a unicornuate uterus. Of patients who never achieved bilateral placement and who underwent follow-up HSG, 15 of 18 (83%)were found to have proximal tubal occlusion. In summary, of the 464 patients having bilateral placement, 449 (97%) were able to rely on the microinsert device for contraception. Patients who were unable to rely on the microinsert for contraception included cases associated with expulsion, perforation or unsatisfactory placement, or they were lost to followup (Table 17–3). There were no expulsions of properly placed devices. Average procedure time was 35 minutes. Patients spent approximately 44 minutes in the recovery room. Only 80 minutes were spent between start of procedure and discharge home. Most patients returned to normal function 1 day following placement and patient satisfaction was high. In a first-year follow-up, the failure rate was 0%.

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Table 17–3 Combined Outcome of Micro-Insert Placement Phase II and Pivotal Trial Outcome

Phase II (n = 227)

Pivotal (n = 518)

Number

Percent

Number

Percent

Bilateral placement after one procedure

196/227

86%

446/518*

86%

Bilateral placement after two procedures

200/227

88%

464/518*

90%

Reliance rate† among women with bilateral placement

194/200

97%

449/464

97%

Note: The placement rates presented here are based on data from the clinical trials. Data on the placement rates in the clinical setting are being gathered in a postapproval study. As updated data regarding placement rates are included in the product labeling, they will also be posted on the Conceptus website: http://www.essuremd.com/. *Of the 54 women for whom bilateral placement was never achieved, 11 did not undergo a placement attempt because the tubal ostia could not be visualized. Two women were found to have a unicornuate uterus (both of whom received unilateral placement). Of women who never achieved bilateral placement and who also underwent a follow-up hysterosalpingogram (HSG), 15 of 18 (83%) were found to have proximal tubal occlusion. † The reliance rate is the number of women who were able to rely on the micro-insert for birth control (i.e., the 3-month HSG indicated correct location and bilateral occlusion) divided by the number of women with successful bilateral micro-insert placement. Three of the 449 in the pivotal study decided to rely on the micro-insert without the recommended 3-month HSG visit.

Figure 17–1 Flexibility of the Essure microinsert device.

A

During the pivotal trial, there were four luteal-phase pregnancies. None of the four women became pregnant while relying on the microinsert device. Three pregnancies were voluntarily terminated, and one ended with a spontaneous abortion. Following the abortion, each patient was able to rely on the microinsert device, and none of these women subsequently became pregnant while relying on it.

COMPONENTS OF THE MICROINSERT DEVICE SYSTEM The Essure third generation (ESS305) microinsert permanent kit consists of a disposable package with two microinsert devices, one insert per disposable delivery catheter, and one disposable introducer. The essential component is the microinsert. The microinsert is soft, flexible, and form-fitting (Fig. 17–1). It consists of an expanding microcoil with a flexible stainless steel inner coil, and an outer coil made of nickel–titanium alloy and PET fibers wound around the inner coil. A local, occlusive, and fibrotic reaction occurs within the proximal tubal ostia. The microinsert is 4 cm long and 0.8 mm in diameter in the wounddown configuration. After deployment and release, the outer coil expands to 1.5 to 2.0 mm and anchors the microinsert in the fallopian tube (Fig. 17–2). A disposable single-use ergonomic handle contains the delivery wire, release catheter, and catheter that contains the microinsert device (Fig. 17–3). The deployment of the microinsert is effortless and controlled by a button–thumbwheel combination on the handle that places the microinsert within the fallopian tube. The DryFlow introducer protects the fragile microinsert

B C D Figure 17–2 A, Micro-coil neutral position. B, Micro-coil released. C, Outer coil released. D, Device separated from catheter. The expanding micro-coil is made with a flexible stainless steel inner coil, and the outer coil is made of nickel–titanium alloy and polyethylene terephthalate fibers (PET) wound around the inner coil.

before placement and prevents fluid leakage during microinsert placement. Once the microinsert is released, the trailing coils are easily visualized hysteroscopically at the tubal ostia and can be seen radiographically. Patients with a nickel allergy (documented by skin testing) should avoid using the microinsert device. Because the proximal uterotubal junction is blocked, this procedure is absolutely irreversible. PET is well known to the surgical community and has been used in aneurysm coils and prosthetic arterial grafts since the 1990s.

MECHANISM OF ACTION OF MICROINSERTS Tubal occlusion with microinsert device occurs by two mechanisms: mechanical obstruction and tissue ingrowth. The PET fibers elicit an intense fibroblastic ingrowth with foreign body and giant cell reactions that culminate in tubal occlusion.2 The PET fiber mesh and the microinsert act as scaffolding into which

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A

C

B

D

Figure 17–3 A, The ergonomic handle contains the delivery wire, release catheter, and catheter that contains the embossed symbols on the Essure microinsert handle. Each kit contains two delivery systems. B, Completely assembled system with the DryFlowTM valve. C, represents the enhanced visual markers of the black marker at the tubal ostia. D, represents the gold band that should be visualized at the tubal ostia.

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A

E Figure 17–3, cont’d E, represents the trailing coils after placement.

B

the tissue grows, further anchoring the microinsert within the fallopian tube and occluding the tubal lumen, resulting in permanent sterilization. This benign tissue response is quick, peaks within the first 2 to 4 weeks after device placement, and is complete by 3 months in the majority of patients. The device is anchored to the tube by a brisk histologic response including appearance of fibroblasts, plasma cells, foreign body cells, and macrophages (Fig. 17–4). This cascade of events creates a fibrotic occlusive response localized to the device, leading to retention of the device and pregnancy prevention. The fallopian tube distal to the microinsert is normal.

PREOPERATIVE CONSIDERATIONS The most important requirement for hysteroscopic sterilization is visualization of the tubal ostia. Scheduling during the early proliferative phase or medical preparation of the endometrium is paramount to achieve clarity of view. Some physicians prescribe continuous low-dose oral contraceptive pills (OCPs) (avoiding placebo) or begin progesterone (norethindrone 5 mg or medroxyprogesterone 10 mg) on day 5 of menses and continue until surgery can be scheduled. Both methods prevent menstruation, induce endometrial atrophy and thinning, avoid unnecessarily fluffy endometrium, and facilitate ease of surgical scheduling. Although routine use of saline infusion sonography (SIS, also known as sonohysterography [SHG]) or hysteroscopy is not advocated, it should be strongly considered preoperatively in patients with menstrual aberrations who desire microinsert sterilization. Approximately one third of women with menstrual disorders have intracavitary pathology, including endometrial polyps or submucosal fibroids. If an intracavitary lesion obstructs the view of the tubal ostia, hysteroscopic sterilization may be technically difficult to perform. Hysteroscopic removal of the polyp or fibroid may be required before placement of the device (Fig. 17–5). Avoid surprises in the operating room.

C Figure 17–4 Schematic diagram demonstrating proximal Essure placement (A), trailing coils (B), and fibroblastic tubal ingrowth (C), leading to occlusion.

Figure 17–5 Operative hysteroscopic view of long tapering endometrial polyp almost obscuring the tubal ostia.

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BOX 17-1

Although sterilization takes only a few moments, there can be a lifetime of regret for women who reach their decision for permanent sterilization too quickly, without fully informed consent, or who find their life circumstances in disarray.8 Patients do change their minds about sterilization. Regret after sterilization (up to 20%) is greatest in women who are younger than 30 years, who have fewer than two children, and whose relationship with a partner dissolves. In women older than 30 years, regret rates are lower, approaching less than 6%. The lowest regret rates occur in women older than 40 years. Pregnancy rates are favorable with microsurgical reversal of laparoscopic sterilization, achieving approximately 80% success in younger patients.9 Currently, the success of tubal reanastomosis in women treated with the microinsert device is unknown. However, it is more probable that microsurgical reanastomosis after microinsert placement is not technically feasible due to marked cornua fibrosis and the presence of the intrauterine coils, which could affect an ongoing pregnancy. Practitioners should carefully and methodically document informed consent for the microinsert device, especially noting the permanent and irreversible nature of this device. Patients should be advised that initial clinical trials demonstrated a 14% failure to achieve bilateral placement of the device with the first attempt during the first surgical procedure. Patients must be reminded to use a backup method for contraception until the 3-month confirmatory HSG is performed. Future electrosurgery should be avoided near the tubal cornua and proximal fallopian tubes during laparoscopy or open surgery. Risk of ectopic pregnancy is increased, as it is with incisional methods of contraception. Patients who might need endometrial ablation in the future should only be treated with balloon endometrial ablation (Thermachoice) after documenting tubal occlusion at the 3-month post-HSG hysteroscopy until more clinical studies are completed.

Indications and Contraindications for Hysteroscopic Sterilization Indications ● ● ●

Patient is fully informed and comfortable with permanent, nonreversible method of contraception Time for effective counseling by physician Physician experienced in hysteroscopy

Contraindications ● ● ● ●

● ● ● ● ● ● ● ●

Suspected pregnancy Desire for future pregnancy Uncertain about desire to end fertility Only one microinsert can be placed (including patients with apparent contralateral proximal tubal occlusion and patients with a suspected unicornuate uterus) History of previous tubal surgery, including tubal ligation, tubal pregnancy, tuboplasty History of hydrosalpinx Severe intrauterine adhesions preventing access to tubal ostia Laterally placed fallopian tubes Active or recent upper or lower pelvic infection Known hypersensitivity to nickel confirmed by skin test Interval of less than 6 weeks following delivery, miscarriage, or pregnancy termination Allergy to hysterosalpingogram contrast media

BOX 17-2 Complications from Hysteroscopic Sterilization Uterine perforation Tubal perforation Device breakage Band detachment (occurs when the platinum band of the outer coil of the microinsert breaks off during placement) Incorrect placement Expulsion of the device Fluid overload Vasovagal reaction

Potential Candidates Any patient who desires permanent sterilization should be considered for hysteroscopic sterilization unless there are absolute contraindications. Indications and contraindications are listed in Box 17–1. The rare but devastating bowel and vascular complications that are associated with laparoscopy are generally avoidable with the hysteroscopic approach (Box 17–2). On average, 90% of patients achieve bilateral occlusion with the first attempt. Most patients can rely on hysteroscopic sterilization as a means of contraception by 3 months after the procedure. Many high-risk patients who need permanent sterilization are good candidates for hysteroscopic sterilization. High-risk patients include those with cardiac disease, morbid obesity, thrombophilias, previous extensive bowel and abdominal procedures, colostomies, severe restrictive lung disease, immune suppression, and renal transplant. All of these situations pose challenges to the laparoscopic surgeon, and sterilization should be more

easily and safely performed hysteroscopically, with fewer theoretical risks when compared to laparoscopic approaches.

PROCEDURAL GUIDELINES An operative hysteroscope with a 5-mm operating channel is needed to deploy the microinsert device. Most physicians prefer a 12- to 30-degree angled lens hysteroscope for hysteroscopic sterilization. This angle of view provides excellent visualization of the proximal tubal ostia. The hysteroscope (not the camera) can be rotated to more easily view the tubal ostia when needed. Uterine distention is maintained with warmed saline 3-L solution infused with a pressure pump, with pressures ranging between 80 and 100 mm Hg. It is best to schedule and perform the procedure on postmenstrual days 4 to 9. Steps for performing the procedure are listed in Box 17–3. Hysteroscopic placement of the device is initiated in the low-profile position, where the outer coil is tightly opposed to

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Hysteroscopic Sterilization BOX 17-3

BOX 17-4

Essential Steps in Performing the Microinsert Device Hysteroscopic Sterilization Procedure

Proper Placement of the Microinsert Device Ways to increase bilateral microinsert device placement rates

Obtain informed consent Make sure the patient does not have a nickel allergy Schedule during early proliferative phase (days 4-9 of cycle) Use warmed saline to distend the endometrium Consider pressure bags vs. pump Visualize both tubal ostia Attempt to place the more difficult microinsert device first Insert the microinsert hysteroscopically to the proximal section of the lumen Use the light post on the hysteroscope to guide the direction of placement of the microinsert ● Point the light post in the direction of the tubal ostia you wish to treat ● Turn the light post in the opposite direction for easy view of the other tubal ostia Once the tubal ostia is identified, roll the Essure thumbwheel back to a hard stop Stop and check positioning and look for the gold (“notch”) band outside of the tubal ostia with the green catheter in view Press the button on the sleek purple handle Finally, roll the thumbwheel back to a hard stop After correct placement withdraw the outer delivery catheter to expose the device; the microinsert expands into the proximal segment Document placement and number of protruding coils in the operative note Schedule the patient for postprocedure HSG 3 months after placement to confirm tubal blockage (in the future, confirmation may be provided by conventional or 3D HSG, with or without contrast media to determine correct placement of device) 10,11 Remind the patient that a reliable method of contraception is needed until the HSG confirms tubal occlusion bilaterally

● ● ● ●

● ● ● ●

Patient selection Physician training Work quickly once the tubal ostia are visualized Proper timing ● Early proliferative phase ● Depot medroxyprogesterone acetate (Depo-Provera), progestin, or oral contraceptive pills should be used until the procedure is scheduled ● Avoid performing during menses Turn off inflow during any down time during hysteroscopy Infuse warmed saline during placement and use pressure bag to improve uterine distention Pretreatment with nonsteroidal antiinflammatory drugs to decrease uterotubal spasm Consider glucagon 0.2 mg IV (wait 10-15 min) if tubal spasm occurs

Potential causes of placement failure ● ● ● ● ● ● ● ●

Note: When performing microinsert device in the office or without anesthesia, some physicians have placed the hysteroscope without use of a vaginal speculum. HSG, hysterosalpingogram; 3D, three-dimensional.

the inner coil, maintained by a release wire. Once the tubal ostia are visualized, placement of the device spans the uterotubal junction and occludes the intramural portion of the tube. A single-handed control mechanism guides the release of the guidewire, and then the outer coil unwinds rapidly and expands into the tubal lumen, anchoring the device in place.10 The actual placement takes just a few moments. The tubal ostia are visualized and the microinsert device is deployed, releasing the hydrophilic outer cannula. The microinsert is released by retraction of the inner catheter, allowing the microinsert outer coil to expand. The number of trailing coils should be documented in the operative report. Currently, Conceptus recommends a strict protocol before performing hysteroscopic sterilization. The gynecologist who has had experience in laparoscopy and hysteroscopy and experience in working in a three-dimensional (3D) field projected onto a two-dimensional (2D) screen will embrace this technology quickly. Credentialing for this procedure occurs in the following manner: didactic lectures, practicing with hands-on simulator, observing a live case, and performing the procedure with a proctor. Anecdotally, most physicians feel comfortable in performing this procedure after 4 to 6 placements.

Tubal spasm Undiagnosed tubal adhesions or synechiae Tubal polyps Prior surgical procedure (D&C, myomectomy causing narrowed tubal ostia) Unicornuate uterus Intracavitary lesion blocking tubal ostia (fibroids, polyps, fluffy endometrium) Profound bleeding Device malfunction

The learning curve for hysteroscopic sterilization has been rapid for most gynecologists who have performed operative hysteroscopy. Rosen identified several factors that affected outcomes.15 When cases were separated into those performed in the follicular phase and those performed inn the luteal phase, the average time for follicular phase placement was 9.3 minutes versus 16.6 minutes during the luteal phase. Placement during the luteal phase can be more problematic: Edematous tissue hinders visualization, fluffy endometrium is more often encountered, and false tracks may be created. Surgical time is reduced with increased experience and successful placement increased by improving visibility with proper cycle timing (Box 17–4).13 Increasingly, microinsert placement is being performed in an office setting with minimal anesthesia. Several reports of anesthesia with only a paracervical block reveal excellent patient acceptance and tolerability. Do not consider general anesthesia a failure. Patients have the option to choose method that they want. Interventional radiologists have also performed microinsert device under fluoroscopic control with an 87.5% success rate.14

DOCUMENTATION OF TUBAL OCCLUSION Three months after microinsert device placement, an HSG must be performed. The purpose of the HSG is to determine correct placement of the microinsert and occlusion of the fallopian

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Hysteroscopic Sterilization Radiographic View Approximate length of outer coil Approximate length of inner coil Distal end of inner coil Distal end of outer coil Proximal end of inner coil (hidden by outer coil) Expanded outer coil (sometimes visible) End of outer coil Photographic View (platinum band) Figure 17–6 Radiographic view (top) and photographic view (bottom) of Essure microinserts.

Figure 17–8. Document image when a small amount of hysterosalpingogram contrast has been infused. This image documents an adequate cervical seal. Confirm the uterine silhouette. If the uterus is not seen, realign the patient or the fluoroscope beam.

Figure 17–7 Scout film obtained before contrast injection showing presence of both microinserts. The lie and curvature of microinsert are seen.

tubes. When tubal occlusion is demonstrated, the patient may rely upon the microinsert device as her permanent means of contraception. Gynecologists or radiologists may perform the HSG. For gynecologists who perform their own HSGs, the radiographic interpretation and location on HSG is very different from that seen with hysteroscopy. A correctly placed microinsert may appear more distal on HSG than noted hysteroscopically (Figs. 17–6 to 17–16). The most important outcome to document is tubal occlusion. Additionally the proximal end of the microinsert placement must span the uterotubal junction at the uterine cornua. Guidelines for interpretation and performance of the HSG include: ●

●

●

●

Documentation of excellent delineation of the uterine silhouette and cornual filling Fluoroscopy beam directed to obtain an anteroposterior projection as close to the uterus as possible An excellent cervical seal to prevent leakage of contrast material Speculum removed before fluoroscopy and downward traction maintained on the cervix with the tenaculum to obtain the best images

Figure 17–9. Document image when the uterus is almost opacified. The proximal microinserts might not be fully occluded. ●

Six still radiographs, at minimum, taken to assess microinsert location and tubal occlusion

If the 3-month postinsertion HSG does not demonstrate tubal occlusion, follow the clinical algorithm in Figure 17–17.

Pregnancy Data No method of contraception is 100% effective at preventing pregnancy except for abstinence or hysterectomy. During the preoperative consultation, when obtaining informed consent,

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Hysteroscopic Sterilization and when postoperative instructions are provided, it is extremely important to document the need for continued use of contraception until the 3-month postprocedure HSG demonstrates tubal occlusion. In the phase II and III clinical trials in which the final version of the microinsert device was used, there were no reported pregnancies among study patients in 7532 woman-months of use. Although the results are not officially published, Conceptus is aware of 64 pregnancies in more than 50,000 procedures performed since widespread adoption of this technology. Analysis of these pregnancies find a similar theme: Most pregnancies were luteal phase and undetected at the time of device place-

Figure 17–10. Document image when complete opacification of uterus is obtained. The proximal component of the microinsert is likely to be obscured. Do not overdistend the uterine cavity.

ment or the physician failed to document tubal occlusion by HSG at 3 months. One possible early pregnancy may have been ectopic and was treated expectantly with methotrexate. Currently, the calculated 5-year success rate approaches 99% and compares favorably to other methods.

COSTS The cost of hysteroscopic sterilization compares favorably to that of laparoscopic sterilization. Performed without general anesthesia and without operating room and facility charges, the procedure less expensive than traditional operative sterilization

Figure 17–12 This view demonstrates excellent and satisfactory placement of bilateral microinserts.

B

A

Figure 17–11 Obtain magnified views of the right (A) and left (B) cornua at maximum distension. This confirms proximal placement of the microinserts into the uterine cornua.

195

Figure 17–13 No microinsert is noted on the patient’s left. This is likely the result of a complete expulsion of the microinsert from the left tube. This patient cannot rely upon Essure for contraception.

Figure 17–15 Complete expulsion of the microinsert into the peritoneal cavity. This patient cannot rely upon this method for contraception.

Figure 17–14 Expulsion of the microinsert into the uterine cavity on the patient’s left. This patient cannot rely upon Essure for contraception.

Figure 17–16 Placement of the microinsert is too distal on the patient’s right. The inner coil is more than 30 mm into the tube for the contrast filling the cornu. Figure 17–17 Algorithm for 3-month hysterosalpingogram follow-up after hysteroscopic sterilization (Essure).

Three-month follow-up

Satisfactory microinsert + bilateral tubal location

Satisfactory location but tubal patency beyond

Expulsion or peritoneal distal placement

Patient may rely on Essure alone.

Patient must continue alternative contraception for 3 additional months and repeat HSG at 6 months from original placement. If tubes are still patent, patient must rely on another method.

Patient cannot rely upon Essure.

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Hysteroscopic Sterilization procedures. For the busy physician, the ability to perform microinsert device in the office is particularly appealing. The procedure offers less down time, flexibility in procedure scheduling, less time spent traveling to a surgical center or hospital, less paperwork, and no need to wait for room turnovers in the operating theater. Closed health care systems have evaluated all of the inherent variables and costs of performing microinsert device procedure including 3-month HSG, failed procedures, and disposable equipment and concluded that there were significant savings to the health care system when hysteroscopic sterilization was performed as compared to laparoscopic sterilization.15

OFFICE-BASED APPROACH During the clinical trials 92% of the procedures were performed under local anesthesia, with or without intravenous sedation. High patient satisfaction was achieved, and long-term comfort with wearing the device was 99% at 18 months. Momentum is gaining for performing this procedure in the office. Ubeda and colleagues16 reported than 81 of 85 women underwent microinsert device placement without any anesthesia, with 96% reporting good to excellent rating. As hysteroscopic sterilization moves from the operating room to the office, it is likely that the costs will decrease. Levie and colleagues17 evaluated the costs between laparoscopic sterilization and office microinsert device sterilization. They found that the cost of the microinsert device was $1374 versus $2075 for laparoscopic tubal ligation. In the United States, coding and insurance dictate reimbursement. Depending on the location where hysteroscopic sterilization is performed, the amount reimbursed to the physician is variable. The total relative value units payable to the physician for the new CPT code 58565 (hysteroscopy, surgical, with bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants) is 12.12 if performed in a facility and 57.91 if performed in the office. The office code helps physicians to achieve reimbursement of overhead expenses when the procedure is performed in the office. Patient acceptance for hysteroscopic sterilization has been excellent. The lack of incisions, the speed of the procedure, and the possibility of the sterilization being performed in the office and with minimal anesthesia are appealing to patients. In the clinical trial, more than 50% of patients were treated under local anesthesia without intravenous sedation. Patient satisfaction and tolerance of the procedure was rated as good to excellent in 88% of cases. Only 4% of patients rated their pain as severe. At the time of discharge, 79% of patients had no pain and did not take pain medication.

ENDOMETRIAL ABLATION WITH THE MICROINSERT DEVICE IN PLACE New product labeling for microinsert device was mandated by the FDA in 2006 and states that balloon endometrial ablation and microinsert device hysteroscopic sterilization should not be performed on the same day. Outcomes and interpretations of

the 3-month microinsert device confirmation HSG led to these new recommendations and product labeling. Initially, Valle and colleagues18 eloquently demonstrated that the performance of endometrial ablation and microinsert device in a one-step approach is safe and effective. To assess safety of concomitant procedures, thermocouplers were placed along the fallopian tubes and uterine walls in women who immediately underwent hysterectomy after microinsert device placement; these were studied and found to be safe when performed together. The thermocouplers detected no lateral thermal damage to the microinserts and no rupture of the Thermachoice balloon. Histologic stains did not demonstrate tissue necrosis or thermal damage to the fallopian tubes. The marriage between microinsert device and balloon endometrial ablation was initially sanctioned and required FDA postapproval follow-up studies. The postapproval FDA studies revealed problems with concomitant endometrial ablation and hysteroscopic sterilization. After review of HSG films of women undergoing concomitant microinsert device sterilization and balloon endometrial ablation, the FDA required product relabeling in 2006. Data presented in the postapproval FDA study of microinsert device and balloon endometrial ablation performed concomitantly found marked deficiencies in the interpretation of HSGs. Intrauterine synechiae were found in 10 of 30 women who underwent HSG 3 months after balloon endometrial ablation and microinsert device placement. Of these 10, five had HSGs that were uninterruptible and prevented physicians from assessing tubal patency due to dense synechiae. These five women failed to satisfy the FDA requirements of having an interpretable HSG at the 3-month visit, and therefore another method of contraception was necessary. The test of tubal occlusion and hence success of microinsert sterilization requires that an effective low-pressure HSG be performed and interpretable. The 3-month HSG is the gold standard to prove occlusion. If it is not performed or cannot be interpreted, then the patient cannot be informed that she can rely on hysteroscopic sterilization for contraception. Ablation and hysteroscopic sterilization can be performed at different intervals but currently only with balloon technology. However, hysteroscopic sterilization with the microinsert device must be performed first. After 3 months, tubal occlusion must be confirmed with low-pressure HSG. Once occlusion is confirmed, balloon endometrial ablation can be scheduled for the treatment of menstrual dysfunction. No electrosurgical procedures should be performed within the uterine cavity after microinsert device placement. This implies that rollerball, microwave, and radiofrequency (Novasure) endometrial ablation should never be performed after the coils are placed. Additionally, there is no FDA approval for concomitant cryosurgery ablation or hydrothermal ablation during simultaneous microinsert device placement. While not approved by the FDA, two additional ablation technologies have used endometrial ablation and microinsert device hysteroscopic sterilization. Novasure (Cytec Corp.,Palo Alto, Calif) and HydroThermAblator (Boston Scientific, Natick, Mass) have published feasibility studies with microinsert device placement. 19 In some cases, the ablation was performed first

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Hysteroscopic Sterilization and the fallopian tubes were cannulated following ablation. Although these procedures were technically possible, theoretically the same risk related to poor interpretation of the HSG at the 3-month interval is conceivable. If intrauterine synechiae prevent or interfere with performance or interpretation of an effective HSG at 3 months following microinsert device placement, then the patient by FDA guidelines cannot rely on microinsert device as a means of contraception. Additionally, there are no well-designed safety studies regarding damage to microinserts or transmission of heat or lowered temperature from the coils to surrounding pelvic organs when other global endometrial ablation technologies are used. If concomitant hysteroscopic sterilization and endometrial ablation are performed, the patient must be informed of the off-label use of such combined technologies. At this time, concomitant ablation with microinsert device is not advised.

PROGESTERONE INTRAUTERINE CONTRACEPTION DEVICE For patients who need both contraception and control of menstrual dysfunction, the levonorgestrel intrauterine system (IUS; Mirena) is strongly encouraged (see Chapter 15). Microinsert device sterilization alone will not treat menstrual dysfunction. Most patients using the levonorgestrel IUS benefit from marked reduction in menstrual flow, an excellent method contraception, and low complication rates. Intrauterine devices initially were approved for contraception. Earlier devices, in the 1960s and 1970s, were fraught with complications including pelvic inflammatory disease (PID), tubo-ovarian abscess, and death. However, the levonorgestrel IUS has minimal complications compared to older IUD devices. Recently introduced, the levonorgestrel IUS provides contraception for 5 years but heralds another new option for therapy for abnormal uterine bleeding. The levonorgestrel IUS should be considered as an option for women with heavy menses who wish to avoid endometrial ablation or anesthesia or have the most minimally invasive treatment for abnormal bleeding. A systemic review touted an impressive 74% to 97% reduction in menstrual bleeding and blood loss within 6 to 12 months of use.20 Initially there may be an increase in number of days of bleeding or spotting for the first 2 to 4 months until amenorrhea

or hypomenorrhea occurs. There is little systemic absorption of progesterone. When compared to current medical therapies available for abnormal uterine bleeding, the New Zealand Guidelines Group reported a 94% reduction in mean blood loss.21 Surgical ablation with endometrial resection was recently compared to the levonorgestrel IUS. Endometrial ablation resulted in a the most reduction in blood loss when compared to the levonorgestrel IUS. The continuation rates for using the levonorgestrel IUS was high at 3 years after placement.22 A 5-year follow-up randomized trial23 compared hysterectomy to levonorgestrel IUS insertion and reported that 58% of women who continued with the IUS were satisfied, continued users, and that health related costs, both direct and indirect, were substantially lower. The device, imbedded with 20 mcg of levonorgestrel, causes pseudodecidual changes and hypomenorrhea or amenorrhea. This device now offers a minimally invasive alternative to surgery for women who might or might not need contraception and have menorrhagia, normal uterine size, and a desire to avoid surgery.24 Patients with abnormal uterine bleeding that has not been fully evaluated or women who are not in a monogamous relationship need special consideration.

SUMMARY Transcervical sterilization with microinsert device is the newest and most effective hysteroscopic procedure to prevent pregnancy. Mechanical obstruction and tissue ingrowth provides a highly successful means of permanent sterilization. Excellent hysteroscopic skills, proper microinsert training, and confirmatory occlusion demonstrated at the 3-month postprocedure HSG are critical to achieving excellent patient outcomes and avoidance of pregnancy. Benefits of hysteroscopic sterilization are obvious. It can be performed under local anesthesia in the office or ambulatory setting and it has high procedural tolerance and excellent patient satisfaction. Microinsert device insertion by hysteroscopy is a relatively quick procedure with rapid resumption of work and other activities. It is cost-effective and offers a minimally invasive procedure to many patients who have absolute or relative contraindications to a laparoscopic approach. Potential cost savings are realized.

REFERENCES 1.

2. 3.

4. 5.

Kerin JF, Carignan CS, Cher D: The safety and effectiveness of a new hysteroscopic method for permanent birth control: Results of the first Essure PBC clinical study. Aust N Z J Obstet Gynaecol 2001;41:364-370. Cooper JM, Carignan CS, Cher D: Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol 2003;102:5-64. Ubeda A, Labastida R, Dexeus S: Essure: A new device for hysteroscopic tubal sterilization in an outpatient setting. Fert Steril 2004;2: 196-189. Wortman J: Tubal sterilization—review of methods. Popul Rep C 1976;(7):73-96. Peterson HB, Greenspan JR, DeStefano F, et al: The impact of laparoscopy on tubal sterilization in United States hospitals,

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6.

7.

8.

9.

1970 and 1975 to 1978. Am J Obstet Gynecol 1981;140:811814. Valle RF, Carignan M, Wright T: Tissue response to the STOP microcoil transcervical permanent contraceptive device: Results from a prehysterectomy study. Fert Steril 2001;76:974-980. Kerin J, Cooper J, Price M, et al: Hysteroscopic sterilization using a microinsert device: Results of a multicenter phase II study. Hum Reprod 2003;18:1223-1230. Hills SD, Marchbanks PA, Taylor LR, Peterson HB: Post-sterilization regret: Findings from the United States Collaborative Review of Sterilization. Obstet Gynecol 1999;93:889-895. Hanafi MM: Factors affecting the pregnancy rate after microsurgical reversal of tubal ligation. Fert Steril 2003;80:434-440.

Chapter 17

Hysteroscopic Sterilization 10. 11.

12.

13.

14.

15.

16.

17.

Abbott J: Transcervical sterilization. Best Pract Res Clin Obstet Gynaecol 2005;19(5):743-756. Kerin JF, Levy BS: Ultrasound: An effective method for localization of the echogenic Essure sterilization microinsert: Correlation with radiologic evaluations. J Minim Invasive Gynecol 2005;12: 50-54. Thiel JA, Suchet IB, Lortie K: Confirmation of Essure microinsert tubal coil placement with conventional and volume-contrast imaging three-dimensional ultrasound. Fertil Steril 2005;84:504-508. Rosen DMB: Learning curve for hysteroscopic sterilization: Lesson from the first 80 cases. Aust N Z J Obstet Gynaecol 2004;44:62-64. McSwain H, Shaw C, Hall LD: Placement of the Essure permanent birth control device with fluoroscopic guidance: A novel method for tubal sterilization. J Vasc Interv Radiol 2005;16:1007-1012. Levie MD, Chudnoff SG: Office hysteroscopic sterilization compared with laparoscopic sterilization: A critical cost analysis. J Min Invasive Gynecol 2005;12:318-322. Ubeda A, Labastida R, Dexeus S: Essure: A new device for hysteroscopic tubal sterilization in an outpatient setting. Fert Steril 2004;82: 196-199. Levie MD, Chudnoff SG. Office hysteroscopic sterilization compared with laparoscopic sterilization: A critical cost analysis. J Minim Invas Gynecol 2005;12:318-322.

18.

19.

20.

21.

22.

23.

24.

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Valle RF, Valdez J, Wright TC: Concomitant Essure tubal sterilization and Thermachoice endometrial ablation: Feasibility and safety. Fert Steril 2006;86(1):152-158. Sabbah R, Howell T: Clinical results on feasibility and compatability of the Essure sterilization immediately following Novasure endometrial ablation. J Minim Invasive Gynecol 2005;12: S27. Stewart A, Cummins C, Gold L, et al: The effectiveness of the levonorgestretl-releasing intrauterine system in menorrhagia: A systematic review. BJOG 2001;108:74-86. National Health Committee: Guidelines for the management of heavy menstrual bleeding. New Zealand Guidelines Group. Available at http://www.nzgg.org.nz/guidelines/dsp_guideline_popup.cfm?guideli neCatID=26&guidelineID=32 (accessed November 11, 1007). Rauramo I, Elo I, Istre O: Long-term treatment of menorrhagia with levonorgestrel intrauterine system versus endometrial resection. Obstet Gynecol 2004;104:1314-1321. Hurskainen R, Teperi J, Rissanen P, et al: Clinical outcomes and costs with the levonorgestrel-releasing intrauterine system or hysterectomy for treatment of menorrhagia: Randomized trial 5-year follow up. JAMA 2004;291:1456-1463. Hurskainen R, Teperi J, Rissanen P, et al: Quality of life and costeffectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy, for treatment of menorrhagia: A randomized trial. Lancet 2001;357:273-277.

Chapter

18

Endometrial Ablation Linda D. Bradley

More than 10 million premenopausal women suffer from excessively heavy menses. Menorrhagia most commonly affects women between ages 35 and 55 years and requires an exhaustive and thorough history, physical examination, laboratory evaluation, and hysteroscopic or ultrasonographic evaluation. Abnormal uterine bleeding (AUB) causes social embarrassment, sexual dysfunction, loss of work, and decreased quality of life. The prevalence of abnormal bleeding is 22% among healthy women. Menorrhagia is defined as more than 80 mL blood loss during menses. In reality, it is not practical to measure blood loss, so a woman’s perception of heavy bleeding is the key to referral for evaluation and treatment. When evaluating women for abnormal bleeding, physicians must exclude problems with pregnancy, iatrogenic causes, genital tract pathology, and hormonal imbalances. Most cases of dysfunctional bleeding occur at the extremes of life. More than 20% of cases occur in patients younger than 20 years, and more than 50% occur in patients older than 45 years. Rates of hysterectomy are highest for women between ages 40 and 44 years. When evaluating women for abnormal bleeding, an adequate trial of medical therapy should be undertaken. If medical therapy fails and the patient has a normal-size uterus, then endometrial ablation can be considered in women certain that they do not want children and do not wish to use a progesterone IUD. In general, endometrial ablation provides excellent improvement in bleeding. Thirteen percent to 55% of patients become amenorrheic, 65% to 70% become hypomenorrheic and 5% to 19% fail therapy immediately. Improvement in premenstrual symptoms and dysmenorrhea has also been described. Approximately 6% to 20% of patients treated by endometrial ablation require a subsequent surgical procedure within 5 years of surgery.

GENERAL CONCEPTS OF ENDOMETRIAL ABLATION The endometrium has a tremendous power of regeneration and renewal. Endometrial ablation injures the basalis layer of the endometrium so that menstrual flow is reduced or eliminated. Hysteroscopic and nonhysteroscopic methods offer similar relief of symptoms and excellent patient satisfaction in properly selected patients.

When compared to hysterectomy, endometrial ablation has fewer complications. Advantages of endometrial ablation include decreased risk of surgical trauma, decreased risks of postoperative complications, less need for general anesthesia, direct cost savings to insurance companies (due to less need for inpatient surgical service), and decreased indirect costs because women can return to work and other activities sooner. First-generation endometrial ablation technology includes Nd : YAG (neodymium : yttrium–aluminum–garnet) laser ablation, rollerball ablation, transcervical resection of the endometrium (TCRE), or a combination of TCRE and rollerball ablation (Fig. 18–1). These first-generation technologies are performed under hysteroscopic guidance and produce thermal fullthickness injury to the basalis layer. DeCherney and Polan performed the first TCRE with a urologic loop electrode.1 Rollerball ablation was first performed in 1988 and became more popular than TCRE because of fewer complications, less risk of perforation, decreased risk of fluid overload, and ease of use. Rollerball endometrial ablation remains the gold standard to which new global ablation technology is compared. The first-generation devices are controlled by hysteroscopy, require astute fluid monitoring, and depend on operator skill for success, all of which are relative drawbacks. This form of endometrial ablation requires uterine distention, and gynecologists must be highly knowledgeable about fluid management and adhere to strict fluid guidelines to ensure patient safety. Surgeon experience, number of cases, and years of training are key factors in reducing complications from hysteroscopic endometrial ablation methods. In the United Kingdom, the MISTLETOE (Minimally Invasive Surgical Techniques—Laser, EndoThermal or Endoresection.) study systematically reviewed clinical outcome of 80% of hysteroscopic ablation procedures and found that complications were more common in the first 100 cases performed by a surgeon.2 After 100 cases, complication rates decrease dramatically. The MISTLETOE study also demonstrated that both endometrial rollerball ablation and TCRE had similar patient satisfaction scores and improvement in bleeding. However, TCRE was associated with higher complication rates compared to rollerball techniques. The lengthy training required for rollerball ablation led device companies to develop faster and more user-friendly automated systems. Despite newer developments in global endometrial

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Endometrial Ablation Figure 18–1 A, An operative hysteroscope can be used to perform transcervical resection of the endometrium or rollerball ablation. B, Rollerbar (top left and bottom left), rollerbarrel (top right and middle left), rollerball (middle right), and wire loop (bottom right) may be used to remove the basalis layer of the endometrium.

A

B

ablation, it is imperative that surgeons retain their hysteroscopic operative skills. When a global device malfunctions or does not deploy or when the uterine cavity is too large to accommodate a global ablation device, the surgeon equipped with hysteroscopic ablation skills can complete the surgical procedure. Currently, most rollerball or TCRE procedures are performed in an ambulatory surgery center, whereas global endometrial ablation can be performed with minimal sedation and paracervical block in the office. Global ablation can also be performed in an ambulatory surgical center as well as the traditional operating suite. Procedures performed in an office or ambulatory surgical center are always less expensive than those performed in the traditional operating room, even when less-expensive devices are used. Costs are scrutinized by insurance companies, hospitals, and patients. One advantage of endometrial ablation with rollerball or TCRE is that the single-use cost of a disposable electrode is less expensive than a disposable global product.

Thermachoice (Thermal balloon)

HTA system (Heated free fluid)

HTA system (Heated free fluid)

Her Option (Cryotherapy)

GLOBAL ENDOMETRIAL ABLATION TECHNOLOGIES Since December 1997, the U.S. Food and Drug Administration (FDA) has approved five devices for endometrial ablation: ThermaChoice uterine balloon therapy (UBT), Her Option uterine cryoablation, Hydro ThermAblator, NovaSure, and Microsulis microwave endometrial ablation (MEA) (Fig. 18–2). These systems are automated or semiautomated. The most comparable studies in the literature are those conducted during the FDA approval process, providing the best comparison of these devices. During an FDA trial, definitions, end points, complications, and outcomes are standardized. Complications are adjudicated by an outside safety and data committee. Most published studies are manufacturer-funded trials, which have inherent bias. All five global ablation trials required documentation of menorrhagia using the premenstrual blood loss activity chart (PBLAC). Menstrual blood loss exceeding 80 mL is defined as menorrhagia. The PBLAC score takes into account the number of menstrual pads and tampons used as well as amount of satura-

MEA (Microwave)

Non-FDA Approved: Diode laser, phototherapy Figure 18–2 Global endometrial devices.

tion. A score greater than 100 is correlated with a menstrual blood loss of at least 80 mL. In the clinical trials, inclusion criteria usually required a PBLAC score of 150 to 185. Success was defined as a PBLAC score of 75 or less after treatment, which represents a return to normal menses or less. An additional end point in the clinical trial was the rate of amenorrhea. By definition, improvement was clinically defined as reduction in bleeding to normal flow or less. The FDA trial was randomized with a 2 : 1 comparison between global technology and

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Endometrial Ablation rollerball endometrial ablation. A data and safety monitoring committee closely monitored side effects and complications. Additional parameters for patient selection are listed in Table 18–1.

Patient Selection The ideal patient for endometrial ablation is one who has completed childbearing, has a normal uterine cavity, has no intracavitary uterine pathology, has small intramural fibroids (<3 cm), has failed or medical therapy (or medical therapy is contraindicated), and is willing to accept cyclical hypomenorrhea or eumenorrhea as a final outcome. Menorrhagia must have a benign cause and there must be no obstructive intracavitary pathology. This is best determined by hysteroscopy or saline infusion sonography (SIS, also known as sonohysterography [SHG]) (Figs. 18–3 and 18–4). The uterine cavity must be anatomically normal, as determined by SIS or hysteroscopy (Fig. 18–5). Beware of myometrial thinning less than 10 mm, absence of myometrium covering a cesarean section scar, or marked attenuation of a uterine scar (Fig. 18–6). Endometrial ablation should not be performed concomitantly with microinsert device (Essure) sterilization. All ablation candidates must use a reliable method of contraception. Once menopause ensues, patients desiring hormone replacement therapy (HRT) must also use progesterone in combination with estrogen. Strictly speaking, patients scheduled for endometrial ablation should have documentation that they have been offered medical therapy or the levonorgestrel intrauterine system (IUS;

Mirena) and declined it or tried and failed it before endometrial ablation was recommended (Box 18–1).3

Preparation for Endometrial Ablation A thin and atrophic endometrium improves visualization when a hysteroscopic technique is used. Late proliferative and postovulatory endometrium is thickened and lush, with a velvety

SIS

+D 2.01cm xD 1.28cm Figure 18–3 Saline infusion sonography (SIS) demonstrates a retroverted uterus with a fundal leiomyoma measuring 2.0 × 1.2 cm.

Table 18–1 Patient Selection Criteria for Global Endometrial Ablation Devices Global Ablation Device

ThermaChoice (n = 137)

Her Option (n = 193)

HTA (n = 187)

NovaSure (n = 175)

MEA (n = 215)

Protocol Differences and Exclusion Criteria Maximum sound length (cm)

10

10

10.5

10

14

Inclusion of polyps

No

No

No

Yes (<2 cm)

Yes

Inclusion of submucosal fibroids

No

No

No

Yes (<2 cm)

Yes (<3 cm)

Inclusion of distorted cavities

No

No

No

No

Yes

Congenital malformations

No

No

No

No

Yes

Endometrial pretreatment

D&C

Lupron 3.75 mg

Lupron 7.5 mg

None

Lupron 3.75 mg

Gynecologic History Age (years)

40.4 (±4.8)

41.2 (±5.1)

40.7 (±5.2)

39.7 (±5.5)

40.5 (±4.6)

BMI

29.1 (±7.8)

29.3 (±8.4)

29.0 (±7.4)

27.6 (±6.3)

27.94 (±7.1)

Number of Pregnancies

ND

2.5 (±1.2)

ND

2.7 (±1.3)

ND

Number of term deliveries

ND

2.4 (±1.2)

ND

2.2 (±1.1)

ND

Baseline diary score

552.5 (±712.2)

Uterine sounding length (cm)

8.5 (±1.3)

570 (±441) 8.0 (±1.1)

596.55 (±787.6) 8.3 (±1.3)

BMI, body mass index; D&C, dilation and curettage; HTA, Hydro ThermAblator; MEA, Microsulis Microwave Endometrial Ablation; ND, no data; From Bradley LD: Global endometrial ablation in the presence of fibroids. Cleveland Clinic continuing medical education, February, 2004.

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562 (±381) 8.8 (±0.8)

451.8 (±356.6) 8.09 (±1.0)

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Endometrial Ablation

SIS SIS

+D 0.51cm

+D 1.74cm

Figure 18–6. Saline infusion sonography (SIS) of a patient who has had three cesarean sections. A thin lower uterine segment with attenuation is noted. The myometrium overlying this lesion is only 5 mm. Caution is necessary when considering endometrial ablation with global technology in patients with attenuated lower uterine segments.

Figure 18–4. Coronal view of a 2-cm leiomyoma. This patient is not a candidate for a global endometrial ablation because of the intracavitary lesion. The lesion should be removed before ablation is performed. SIS, saline infusion sonography.

Figure 18–5. Normal hysteroscopic view of the endometrium and endocervix. This is an ideal patient for global endometrial ablation. Ideally, all conservative methods should be tried, failed, or declined before proceeding with endometrial ablation in a patient not desiring pregnancy.

architecture that rapidly becomes edematous when exposed to a fluid environment. Hysteroscopic surgical procedures performed under these circumstances are frustrating and time consuming. The rollerball or wire loop becomes coated with endometrial debris, requiring multiple insertions and removals for cleaning. Failure rates may be higher if only thickened late proliferative or secretory endometrium is coagulated, rather than the endometrial basalis layer. To facilitate the procedure and possibly improve clinical outcomes, many physicians prefer performing the procedure when the endometrium is thin and atrophic.

The FDA trial of all of the currently approved global endometrial ablation devices, except for NovaSure, required endometrial thinning by medication, usually a GnRH agonist or suction dilation and curettage (D&C) (mechanical preparation). ThermaChoice ablation was preceded by a 3-minute suction D&C. Microwave endometrial ablation and hysteroscopic thermal ablation (HTA) required pretreatment with leuprolide (Depo Lupron) 3.75 mg 1 month before treatment. Her Option (Cryogen) was preceded by leuprolide 7.5 mg intramuscularly 1 month before surgery. Ablation with NovaSure was permitted at any time during the menstrual cycle and did not require mechanical endometrial thinning, GnRH analogues, or medical preparation. As more physicians have gained experience in performing endometrial ablation, protocols for achieving endometrial thinning have emerged. Three methods of endometrial preparation have been advocated. The most inexpensive is scheduling the patient immediately after menstruation when the endometrium is thin. If endometrial ablation is performed on postmenstrual day 4 to 7, the endometrium is consistently thinner than 10 mm when measured ultrasonographically. Performing an intraoperative suction curettage removes the superficial endometrium, permitting ablation closest to the basalis layer. A D&C can be considered with all global technology except for microwave endometrial ablation, because the instruction guide prohibits any mechanical scraping on the day of the procedure. Hormonal medical preparations that promote endometrial atrophy include GnRH agonists, danazol, progestogens and or oral contraceptive pills (OCPs). Pretreatment endometrial thinning increases the likelihood that surgery will achieve satisfactory results and resolution of anemia.4

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Endometrial Ablation BOX 18–1 Deciding if Endometrial Ablation is Appropriate ●

General criteria ●

●

● ●

No desire for childbearing. Patients must be told that that endometrial ablation is not a method of contraception, however, and must take precautions to prevent pregnancy or consider sterilization. Documented diagnosis of menorrhagia for benign causes without obstructive intracavitary pathology. This is best determined by hysteroscopy or saline infusion sonography (see Figs. 18–3 and 18–4). Menorrhagia affecting quality of life: socially disruptive, associated with anemia, or prevents normal lifestyle. Patient expectation of clinical outcome.

● ● ● ● ●

Inclusion considerations ● ● ● ● ● ●

●

Documented diagnosis of menorrhagia due to benign disease Failed or declined medical therapy for menorrhagia, or medical therapy is contraindicated Completed childbearing Anatomically normal uterine cavity as determined by SIS or hysteroscopy (see Fig. 18–5) Uterine cavity length 6-12 cm Normal Pap test within previous 12 months

●

Abnormalities that increase the complication rate ●

● ● ● ● ● ● ●

Desire for future pregnancy Premalignant changes in the genital tract Intrauterine devices in place Congenital uterine abnormalities (septum or bicornuate uterus) Active genital or urinary tract infections at the time of the procedure Expectation of or demand for amenorrhea Anatomic weakness of myometrium (previous classic incision cesarean sections or transmural myomectomy) Active pelvic inflammatory disease or active or prodromal herpes infection

●

Precautions on the day of surgery ● ● ●

Other considerations ●

Determine if the patient has had A uterine surgical procedure ● Transmural myomectomy ● Classic cesarean section ● Recent uterine perforation ● More than one lower uterine segment cesarean section, which can thin the lower uterus Beware of myometrial thinning <10 mm, absence of myometrium covering a cesarean section scar, or marked attenuation of uterine scar (see Fig. 18–6) ●

Exclusion considerations ●

Endometrial biopsy in women >40 years or in women <40 years with risk factors for endometrial hyperplasia (longstanding anovulatory cycles, unopposed estrogen therapy) Consider endometrial biopsy to rule out chronic endometritis as the cause of bleeding Exclude bleeding diathesis (von Willenbrand disease) with an excellent history and limited von Willenbrand diagnostic panel Consider thyroid-stimulating hormone levels Perform a sexually transmitted disease culture; specifically inquire if the patient has history of herpes Endometrial ablation is contraindicated in menopause Be suspicious of women with disabling dysmenorrhea (they may have adenomyosis, which can increase the risk of failure and continued postoperative pain) Uterine size should be <12 weeks and uterine cavity 10-14 cm in length (depending upon device used)

●

Quality of life appears to be more important to women than amenorrhea rates

Document a negative pregnancy test Remind the patient that reliable contraception is necessary Remind the patient of realistic expectations of outcomes The patient must be willing to accept eumenorrhea or hypomenorrhea as a final outcome of endometrial ablation

Pap, Papanicolaou; SIS, saline infusion sonography.

The only GnRH agonist currently officially approved by the FDA for prethinning the uterine endometrium before endometrial ablation or resection is goserelin acetate (Zoladex). Goserelin product information recommends use 4 or 8 weeks before treatment to produce endometrial thinning. In practice, leuprolide is used off label for thinning the endometrium in preparation for endometrial ablation. It is best to administer the first dose of the GnRH agonist at the onset of menstruation. A second injection may be required for the patient with anemia or to allow flexible surgical scheduling. Treatments that seem to demonstrate the most reliable thinning of the endometrium include danazol 400 to 800 mg daily for 15 to 30 days before the procedure or a GnRH agonist used for 30 to 60 days before surgery, causing down-regulation, amenorrhea, and consistent endometrial atrophy. When progestogens used continuously were compared to danazol, there was little to no effect on the endometrium.5 Little data exist from randomized trials to assess the effectiveness of OCPs, medroxyprogesterone acetate (MPA), or nor-

ethindrone acetate as methods of thinning the endometrium before endometrial ablation. Anecdotally, some physicians have noted more edematous endometrium when progesterone is used continuously rather than cyclically to induce menstruation. When hysteroscopic endometrial ablation is performed with fluid distention, there may be less fluid absorption when a GnRH analogue is used. The only drug therapy that reliably results in improved amenorrhea when used before endometrial ablation is GnRH therapy.6 Although the FDA trials commonly employed endometrial thinning before ablation therapy, many gynecologists are abandoning medical therapy in favor of scheduling in the early proliferative endometrial phase. Scheduling is used because it is less expensive, has fewer drug-related side effects, and is preferred by patients. Several studies have demonstrated a minimal to variable impact of prethinning on endometrial ablation outcomes.7,8 It is not known if adjuvant suppression results in durable and sustained amenorrhea rates. GnRH therapy has the highest additional costs compared to medical therapy such as danazol.

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Endometrial Ablation TECHNIQUES FOR ENDOMETRIAL ABLATION The success of any ablation technique depends on complete treatment of the entire uterine cavity and both cornua and avoidance of the endocervix. Endometrial ablation techniques are divided into two groups: hysteroscopic procedures and nonhysteroscopic procedures. Hysteroscopic procedures are performed with laser,9 radiofrequency (RF),10 or electrical energy.11 Newer methods destroy the endometrium globally and do not require hysteroscopic expertise (except for HTA). In theory, global methods of endometrial ablation require less skill and less training and have outcomes similar to those of hysteroscopic methods of endometrial ablation. Additionally, there is less risk of perforation and less fluid absorption, and the procedure is quicker and can usually be performed in the office. Five randomized trials compared hysterectomy to transcervical resection of the endometrium and other methods of endometrial ablation.12-16 Amenorrhea resulted in 23% to 60% of women, blood loss was reduced in 87% to 97%, and additional surgery to control menstrual bleeding within 1 to 5 years of surgery was needed in 6% to 20%. There was little difference in the quality-of-life scores between women who had hysterectomy who had endometrial ablation,17 yet women randomized to hysterectomy were significantly more satisfied with their results than women who had undergone endometrial ablation.18 Patients undergoing endometrial ablation compared to hysterectomy had fewer complications related to sepsis, blood loss, urinary retention, hemorrhage, blood transfusion, vault hematoma, and wound hematoma. Women who had ablation had fewer postoperative anesthesia complications than women who had hysterectomy. Fluid overload and uterine perforation rates were higher in patients undergoing endometrial ablation. Women having endometrial ablation in their late 40s have a higher degree of patient satisfaction and less chance of requiring repeat procedure or hysterectomy compared to younger women.19,20 The Lethaby study17 also noted that within 4 years after endometrial ablation, women were more likely to require further surgery for heavy bleeding than women undergoing hysterectomy (odds ratio [OR], 9.84; 95% confidence interval [CI], 4.92-19.67). If costs are considered between hysterectomy and endometrial ablation, ablation is less expensive; however, over time the cost discrepancy narrows because of cost of repeat treatment. Although there are no studies to compare the age of the patient and subsequent costs, it seems intuitive that the older patient (especially late 40s) is less likely to require future interventions related to menstrual dysfunction than is a woman in her 30s. Menopause has a salutary benefit on menstruation. Hysteroscopic methods (rollerball ablation or endometrial resection) are performed less often in the office due to more inherent risks, including perforation, fluid overload, and need for an automated fluid pump system (Figs. 18–7 to 18–9). Intrauterine synechiae can also make the procedure more difficult to perform in the office (Fig. 18–10). When hysteroscopic techniques are used in the ambulatory care setting, physicians

Figure 18–7 The proximal handle of a Karl Storz operative hysteroscope.

Figure 18–8 An Olympus rollerball attachment.

Figure 18–9 An Olympus roller barrel used for transcervical ablation of the endometrium.

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Endometrial Ablation BOX 18–2 SIS

Choosing the Right Patient for Office-Based Ablation Psychosocial considerations ● ● ● ●

What has been the patient’s previous experience been with other office procedures? What is her understanding of the procedure? What are her expectations? What is her pain tolerance?

Medical considerations ● ● ● ● ●

+D 0.31cm

● ●

Figure 18–10 Saline infusion sonography (SIS) demonstrating intrauterine synechiae.

must be cognizant of risks from paracervical blocks, cervical dilation, application of thermal energy, and risks associated with fluid overload.

OFFICE-BASED ENDOMETRIAL ABLATION Rationale Stiff competition for new patients, improved revenue, quick procedures, excellent outcomes, and advent of smaller endometrial ablation devices are the most common reasons given by gynecologists to perform global ablation in the office. New current procedural terminology (CPT) codes also permit excellent reimbursement. Endometrial ablation performed in the office allows more efficient use of the physician’s time. Delays in the operating room, travel costs, and competing for operating room space is minimized by performing ablation in the office. Patients feel more comfortable when procedures are performed in familiar surroundings. Additional factors to consider include the ability to discharge home within several hours after the procedure, the need for opiate rescue, and the ability to have a recovery area after the procedure. All manufacturers in the FDA trial reported that their devices can be used under conscious sedation, local and paracervical block, or general anesthesia. Preoperative use of nonsteroidal antiinflammatory drugs (NSAIDs) and belladonna and opium (B&O) suppositories also improves patient comfort. The literature indicates variable outcome in performing, completing, or abandoning the procedure when general anesthesia is not used. Clark and colleagues21 noted that 94% of ThermaChoice surgical procedures were completed with local anesthesia. Postoperative opiate pain relief was required in 27% of patients, and 4% of patients required an overnight stay. ThermaChoice ablation performed without intravenous sedation or local anesthesia was evaluated in 27 patients. Marsh and colleagues22 noted that 24 of 27 women (89%) tolerated the

Highly anxious Asthma Diabetes mellitus Morbid obesity Heart disease Not generally cooperative History of vasovagal reaction with other procedures

procedure without IV sedation or local anesthesia. Most patients were discharged home within 3 hours. The use of NSAIDs and paracervical blocks and the potential presence of a certified registered nurse anesthetist (CRNA) can facilitate endometrial ablation in the office. Choosing the right patient for office endometrial ablation requires astute clinical skills. Judging the patients’ reaction to a bimanual examination, endometrial biopsy, SIS, or hysteroscopy may be instructive in deciding whether she can cooperate with an office endometrial ablation procedure.

General Concepts Endometrial ablation most commonly is an outpatient procedure and is increasingly performed in the office. Pathology findings in patients who fail the procedure indicate a greater degree of adenomyosis, intracavitary lesions such as polyps or fibroids, or large (>4 cm) intramural fibroids. Success of the procedure is improved by excellent preoperative evaluation. Realistic outcomes of endometrial ablation must be explained to the patient. The patient should not be told that amenorrhea is the goal; she should be told that endometrial ablation is meant to decrease the amount of bleeding to normal flow or less. Amenorrhea should be considered a bonus and should not be promised to the patient. Criteria for patient selection are shown in Box 18–2. Successful office endometrial ablation requires a coordinated team approach. Another trained member of your office staff should be available to monitor clinical symptoms, pulse oximeter, and blood pressure and to give moral support. Reversal agents should be available if using midazolam and fentanyl. Atropine is extremely helpful in cases of a vasovagal reaction. Operator training, equipment, and essential supplies for conscious sedation are shown in Box 18–3.

Paracervical Block Endometrial ablation in highly selected patients may be performed in the office. When minimal dilation, short procedure

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Endometrial Ablation BOX 18–3 Operator Training, Equipment, and Supplies Needed for Conscious Sedation Working knowledge of the emergency cart ● ● ●

Where is it located? What is in it? Supplies within date?

Oxygen tank ● ● ●

Does it work? Nasal cannula Back-up tank available

Figure 18–11 The ThermaChoice controller and 5.5-mm distensible balloon device.

Suction canister available. Suction must meet operating room standards Self-inflating hand resuscitator bag capable of administering at least 90% oxygen as a means to deliver positive pressure ventilation Enough anesthesia for the intended procedure, enough supplies and equipment for the duration of the intended anesthesia Adequate monitoring equipment to include pulse oximeter Atropine Excellent illumination of the patient, the anesthesia machine, and monitoring equipment Enough space to handle extra personnel, equipment, and resuscitative equipment if needed for a dramatic resuscitation effort Emergency cart with defibrillator and emergency drugs for cardiopulmonary resuscitation Each location should meet all applicable building and safety codes Periodic emergency practice drills are advised

●

●

●

●

times, and minimal perioperative instrument manipulation are observed, successful completion is the norm. When evaluating the office-based procedure, one should consider that pain associated with endometrial ablation can have three sources: cervical dilation, uterine distention, and tissue destruction. Misoprostol (Cytotec) has been noted to facilitate cervical dilation by making the cervix more patulous. Misoprostol administered orally or vaginally 200 to 400 mcg 8 to 12 hours before ablation facilitates cervical dilation and decreases the risk of cervical laceration. Each gynecologist who desires to perform office endometrial ablation must develop anesthetic algorithms and paracervical block techniques that provide the most comfort for their patient population. For patient safety, when narcotics or antianxiety medications are given, the patient must have someone immediately available to drive her home after the procedure.

CLINICAL PEARL ●

●

●

Preoperative use of NSAIDs 12-24 hours before endometrial ablation. NSAIDs decrease levels of prostaglandin and improve cramps, nausea, and vomiting. A narcotic is administered 1 to 2 hours before the procedure. Typical medications that may be used include hydrocodone with acetaminophen (Vicodin), tramadol, ketorolac (Toradol), and oxycodone with acetaminophen (Percocet). Preoperative anxiolytics administered 30 to 60 minutes before the procedure to decrease anxiety.

●

●

Preoperative antimetics and antimetics to use at home can reduce vomiting (ondansetron [Zofran], compazine, phenergan) Local anesthetic nerve block with proper injection, dose, and amount. Generally, a deep nerve block in addition to a superficial nerve block provides excellent pain relief. Wait at least 5 to 10 minutes before proceeding (depending on the drug used). IV sedation may be provided in a well-equipped office with appropriate support personnel. Postoperative pain management that begins immediately after the procedure minimizes rebound pain, nausea, and cramping. Patients should be instructed to use the cocktail of pain medications at home preemptively for 24 to 36 hours to maximize pain relief. The medication should be taken as directed (not prn) to prevent rebound pain. An excellent nursing support staff provides a liberal dose of vocal-local. Music, guided imagery, headphones, aromatherapy, and a heating pad to the lower abdomen are other comfort measures that may be considered. For some patients, a supportive friend or spouse is helpful. Postoperative phone call 24 hours after the procedure to determine patient satisfaction and level of pain, and to answer questions.

Balloon Ablation The ThermaChoice UBT system was the forerunner of the second-generation endometrial ablation technology (Fig. 18–11). It is the first global endometrial ablation technology and received FDA approval in 1997. ThermaChoice has the longest and most robust clinical data regarding outcomes of any second-generation technology.23 More than 560,000 women have been treated with balloon ablation. It does not require hysteroscopic experience or uterine distention. The ThermaChoice III device is individually packaged, with a uterine balloon system that consists of a 16-cm long by 4.5mm diameter catheter with a silicon balloon catheter at its distal end, which houses an internal propeller heating unit. The inter-

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Endometrial Ablation nal propeller circulates the fluid to ensure even temperature distribution throughout the balloon. A separate controller unit monitors temperature, uterine pressure, and duration and contains an alarm. Generally, intrauterine pressure is maintained at 160 to 180 mm Hg for 8 minutes. A preheat cycle of variable length (depending upon amount of fluid infused), but usually 30 seconds to 4 minutes, heats the fluid to 87° C. Once 87° C is achieved, the treatment lasts for 8 minutes, followed by an automatic cooldown phase and removal of the device. D5W is used to fill the balloon to a maximum of 35 mL. The amount of fluid required depends upon uterine volume, sounding length, and uterine pliability. Safety features incorporated into the device abort the procedure if the pressure reaches 210 mm Hg or if the pressure is less than 145 mm Hg after the device is activated. If the temperature inside the balloon exceeds 95° C (203° F) for 2 seconds or falls below 75° C (167° F) for 15 seconds or is unable to reach 87° C (188° F) within 4 minutes of preheating, the controller automatically terminates the procedure. Once the treatment is completed, the balloon is deflated, removed, and discarded. The physician can continuously monitor temperature, treatment time, and intrauterine pressure. In the FDA trial, a 3-minute suction curettage was used before performing ablation with the balloon ablation device. ThermaChoice I, introduced in 1997, was the initial model and is no longer available for clinical use. Initially, the device was made with a latex balloon and lacked an internal impeller. Since its inception, the device has undergone two improvements. The current balloon is called ThermaChoice III and was introduced in 2004. Enhancements include changing from latex to silicon, deeper thermal injury, and the ability to treat the lower uterine segment and cornua more thoroughly. An internal propeller was added, which evenly distributes fluid during treatment. These modifications have been made since the FDA trial. The ThermaChoice III device is vastly different than ThermaChoice I, with notable clinical differences in patient outcome. ThermaChoice III results now demonstrate improved amenorrhea rates (32.6% vs. 14%), decreased premenstrual syndrome (PMS) symptoms, and decreased rates of dysmenorrhea, as well as less need for pain medications during menses.24 Individual case series demonstrate higher amenorrhea rates with the ThermaChoice III technology compared to the initial device. The catheter diameter is 4.5 mm, the smallest of all current devices. This minimizes the need for cervical dilation and theoretically minimizes the risk of cervical laceration and uterine perforation. The FDA randomized trial had strict clinical inclusion guidelines including symmetrical uterine cavity without intracavitary pathology (polyps, submucosal fibroids) and no congenital anomalies. Treatment was not offered if the endometrial cavity was deeper than 10 cm, See Box 18–4 regarding balloon ablation system selected inclusion and exclusion criteria in the FDA clinical trial.25 The endometrium was pretreated with mechanical curettage or medical suppression. Knowledge of the intrauterine cavity

BOX 18–4 Clinical Trial Selection Criteria for the ThermaChoice UTB System Inclusion Criteria ● ● ● ● ●

Premenopausal woman >30 years of age in good general health PBAC menstrual diary score ≥150 for at least one menstrual cycle Excessive uterine bleeding ≥3 months and failed traditional medical therapy Normal Pap smear and benign endometrial pathology within 6 months of procedure Uterine sound measurement 6.0-10.0 cm

Exclusion Criteria ● ● ● ● ●

Submucosal fibroids, polyps, septate uterus, clotting defects, or bleeding disorders Previous EA procedure or previous uterine surgeries resulting in thinning of uterine musculature Classic cesarean section Active PID or STD Pregnancy or desire to become pregnant

Pretreatment ● ●

A 3-minute suction curettage was performed immediately before EA Drugs such as danocrine or GnRH agonists were not used but may be administered.

EA, endometrial ablation; GnRH, gonadotropin-releasing hormone; Pap, Papanicolaou; PBAC, pictorial blood assessment chart; PID, pelvic inflammatory disease; STD, sexually transmitted disease. From Bradley LD: Global endometrial ablation in the presence of fibroids. Cleveland Clinic continuing medical education, February 2004.

length is important in determining the appropriateness of scheduling a balloon ablation. Most patients require an office endometrial biopsy before scheduling. Document uterine cavity length with the pipelle biopsy instrument during the office evaluation. This information can be used when scheduling patients for ablation. If the endometrial cavity sounds to more than 10 cm, balloon ablation might not be feasible. The controller heating unit effectively heats 35 mL D5W within 4 minutes. If the uterine cavity requires more than 35 mL of fluid to achieve a pressure of 160 to 180 mm Hg, then the device might not work, because it might take longer than 4 minutes to reach 87° C to activate the device. The FDA has approved a maximum volume of 35 mL D5W during ablation with ThermaChoice III. Various types of anesthesia have been described with this technology, including general anesthesia, local paracervical block with intravenous sedation, and regional anesthesia.

Cryoablation (Her Option) The second global endometrial ablation technology approved by the FDA in April 2001 was the Her Option Uterine Cryoblation Therapy System (American Medical Systems, Minnetonka, Minn).26 This technology uses a cryoprobe and a proprietary compressed-gas mixture that freezes the endometrium to −100° C to −120° C (Figs. 18–12 and 18–13). An iceball forms around the probe, which causes endometrial cell death through freezing. During the course of freezing, an elliptical freeze zone

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Serosa

Bladder

Endometrial Lining

Longitudinal View Figure 18–14. Ultrasound imaging of the uterus before placement of Her Option. Transabdominal ultrasound with a full bladder is required with Her Option ablation. The bladder, serosa, and endometrial lining can be seen in this view. The yellow curved line indicates the serosa.

Figure 18–12 The Her Option console contains a proprietary compressed-gas mixture that freezes the endometrium to −100° C ± 20° C.

Serosa

Bladder

Probe tip

Transverse view Figure 18–15 The tip of the probe present in the center of this transverse view. The yellow curved line indicates the serosa.

Figure 18–13 The Cryoprobe (left) has a 4.5-mm outer diameter and a disposable sheath (right) that fits over the control unit.

is produced and reproduced several times within the endometrial cavity. It creates the largest depth of necrosis (9-12 mm) compared to other second-generation devices. The unit consists of a console cryoprobe, which measures 4.5 mm outer diameter and disposable sheath that fits over the control unit. FDA guidelines require continuous transabdominal ultrasound guidance to monitor the progression of the ice ball created during the procedure (Figs. 18–14 to 18–17).

Cervical dilation is minimal, requiring only 5 to 6 mm to insert the probe. Once the probe is placed into the uterine cavity, continuous transabdominal ultrasound images confirm placement of the device within the uterine cavity. Initially, the cryoablation unit is activated and initiates a 3- to 5-minute prefreezing cycle that heats the tissue to 37° C. The device is flushed with saline to clear air, and ablation begins. Once the iceball approaches the uterine serosa, the procedure is stopped. In the FDA trial, patients were pretreated with a single dose of leuprolide acetate (3.75 mg intramuscularly). The FDA trial used a total of two freezes. The first freeze was for 4 minutes at one cornu, followed by a short heat cycle that disengaged the

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Endometrial Ablation BOX 18–5 Clinical Trial Selection Criteria for the Her-Option Uterine Cryoblation Therapy System Inclusion Criteria

Serosa

● ● ● ●

Leading edge of cryozone

●

Probe tip

● ● ●

Premenopausal woman 30-50 years of age in good general health History of excessive bleeding for ≥3 months Previously failed, did not tolerate, or refused medical therapy or D&C PBAC daily score >150 recorded for one menstrual cycle Excessive uterine bleeding with a minimum PBAC score of ≥150 Uterine cavity sound measurement <10 cm Uterine volumetric measurement <300 mL Patient does not desire to maintain fertility

Exclusion Criteria ●

Transverse view

● ●

Figure 18–16 The Cryoprobe is now activated. The temperature drops precipitously to −100° C. The leading edge of the cryozone (shorter yellow curved line) can be seen in this view. The longer yellow curved line indicates the serosa.

● ● ● ● ● ● ●

Clotting defects or bleeding disorders Active PID Abnormal Pap smear within the previous year Gynecologic malignancy within the past 5 years Intramural myomas >2 cm in diameter Intrauterine polyps or pedunculated fibroids Septate uterus Previous EA procedure or previous uterine surgeries causing thinning of the uterine musculature Pregnancy Malignant pathology or hyperplasia within the previous 6 months

Pretreatment ●

Bladder Serosa RT

Leading edge of cryozone

The endometrial cavity must be thinned by administering a GnRH agonist 21-28 days before the procedure, or performing suction curettage immediately before the procedure.

D&C, dilation and curettage; EA, endometrial ablation; GnRH, gonadotropin-releasing hormone; Pap, Papanicolaou; PBAC, pictorial blood assessment chart; PID, pelvic inflammatory disease. From Bradley LD: Global endometrial ablation in the presence of fibroids. Cleveland Clinic continuing medical education, February 2004.

LT

Probe tip

Hysteroscopic Thermal Ablation Transverse view

Figure 18–17 In the transverse view, a larger leading edge of the cryozone can be seen (shorter yellow curved line). The leading edge of the cryozone should be monitored throughout the course of the treatment. The longer yellow curved line indicates the serosa. LT, left; RT, right.

probe from adherent endometrium, followed by a 6-minute freeze at the opposite cornu. In clinical practice, the total number of freeze cycles may include an additional freeze in the lower uterine cavity. Ultrasound monitors the progression of the ice ball and provides clinical guidance throughout the procedure. The unit automatically terminates after each 10-minute treatment. Total treatment time is usually 15 to 20 minutes. See Box 18–5 for selected inclusion and exclusion criteria regarding Her Option in the FDA clinical trial.

Also approved in April 2001, the HydroThermAblator (Boston Scientific, Natick, Mass) is a software-controlled, hysteroscopic thermal ablation system composed of an operational unit, a heated canister, a saline bag mounted to an IV pole, and a sterile procedure set (Figs. 18–18 to 18–20). The device is a single-use, 7.8-mm polycarbonate-sheath coupled with a 3-mm rigid hysteroscope that circulates heated saline into the endometrium with constant visualization. It uses a small, rigid 3-mm hysteroscope, which is introduced into the insulating sheath and provides visualization throughout the procedure. A 3-L saline bag is elevated to 115 cm above the uterus, creating hydrostatic pressure that maintains intrauterine pressure between 50 and 55 mm Hg, which is below the threshold for opening the fallopian tubes and provides a measure of safety, preventing tubal spillage. A tenaculum placed tightly on the cervix prevents leakage. During the priming phase, room-temperature saline circulates within the system and uterus for 2 minutes. During the active treatment phase, the heating element is activated. It takes

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Figure 18–18 A schematic view of the hysteroscopic thermal ablation system being inserted into the lower uterine segment. Free-floating saline heated to 90° C circulates for 10 minutes, treating the intrauterine cavity.

Figure 18–20. The complete hysteroscopic thermal ablation unit. This unit holds a 3-L bag of saline. Hydrostatic pressure maintains intrauterine pressure between 50 and 55 mm Hg. This unit is self-contained.

Figure 18–19 The hysteroscopic thermal ablation probe with the insulated tubing that distributes heated saline. This sheath is 7.8 mm and is made of polycarbonate.

approximately 3 minutes to heat the fluid to 90° C. When the saline temperature reaches 80° C, the 10-minute treatment cycle is initiated, continually increasing the temperature to 90° C. After the treatment is completed, a cooldown period starts. After 1 minute, the post-treatment flush phase is completed and the device is withdrawn. The fluid is infused and returns to the unit via a peristaltic pump in a closed-loop system.27 Low pressure minimizes the risks of cervical, vulvar,

and vaginal burns. Depth of endomyometrial necrosis ranges from 3 mm to 4 mm.28 Safety features of the HTA, unlike other second-generation devices, include continuous hysteroscopic monitoring before, during, and after therapy. Occasionally, the turbulence created by the circulating saline compromises the hysteroscopic view. The amount of fluid circulating is continuously monitored, and any egress of fluid of more than 10 mL triggers an automatic shut-off, audible alarms, and cessation of the procedure. During the clinical trial, patients were pretreated with leuprolide acetate 3.75 mg intramuscularly. They had normal uterine cavities (no polyps or intracavitary leiomyoma) and sounding length of less than 10.5 cm. Although several retrospective studies29,30 describe clinical outcomes of women with intracavitary pathology, uterine septum, or other congenital anomalies, additional prospective trials are needed to determine efficacy of HTA in the presence of intracavitary pathology. In the FDA trial, cervical ulcerations were noted in 13% of patients, and they resolved within 1 month without additional therapy.31 Box 18–6 gives selected inclusion and exclusion criteria regarding the HTA System in the FDA clinical trial.

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Endometrial Ablation BOX 18–6 Clinical Trial Selection Criteria for the HydroThermAblator System Inclusion criteria ● ● ● ●

Excessive uterine bleeding with a minimum PBAC score of ≥150 Endometrial cavity measuring ≤10.5 cm Age ≥30 years Previously failed, did not tolerate, or refused medical therapy

Exclusion criteria ● ● ● ● ● ● ● ● ● ●

Age >50 years Active PID Clotting defects, bleeding disorders, or anticoagulant treatments Abnormal Pap smear with evidence of dysplasia Malignant pathology or simple hyperplasia Gynecologic malignancy in past 5 years Submucosal myomas or polyps Intramural fibroids >4 cm on ultrasound contributing to menorrhagia Uterine anatomic anomaly Previous EA procedure or classic cesarean section

Figure 18–21. The NovaSure controller and disposable mesh electrode. The mesh electrode conforms to the endometrial cavity. The control contains a CO2 canister, desiccant, and power cord. The uterine cavity length and width are key-entered into the radiofrequency controller.

Pretreatment ● ● ●

Subjects received a 7.5-mg dose of leuprolide acetate administered 3 weeks before ablation. Other ablation trials used smaller 3.75-mg doses. Treatment took place on days 19-27 after injection.

EA, endometrial ablation; Pap, Papanicolaou; PBAC, pictorial blood assessment chart; PID, pelvic inflammatory disease. From Bradley LD: Global endometrial ablation in the presence of fibroids. Cleveland Clinic continuing medical education, February 2004.

NovaSure Radiofrequency Ablation The NovaSure RF ablation system (NovaSure, Cytec Corp, Marlborough, MA) received FDA approval in September 2001. The RF ablation system consists of the disposable RF device, which is gold-plated mesh electrode that conforms to the endometrial cavity (Fig. 18–21). It has a controller, CO2 canister, desiccant, and foot switch and power cord. The device delivers RF energy to treat the interior surface of the uterine cavity. The system continuously monitors the tissue impedance (resistance) to the flow of electrical current and stops the procedure when impedance of 50 Ω is achieved. The disposable device is inserted transcervically into the uterine cavity. The uterine cavity length (measured during sounding) and width (measured by the device) are entered into the RF controller to automatically calculate the power level required to treat the uterine cavity of the given size. By pressing the foot switch, the cavity integrity assessment cycle starts. When that cycle finishes, the ablation cycle is initiated by pressing the foot switch again. The generator delivers power up to 180 W at 500 kHz in a bipolar mode that ablates the endometrium uniformly. The actual RF treatment time averages approximately 90 seconds, with a range from 40 to 120 seconds depending upon endome-

trial thickness and when the preset target impedance is reached.32 Neither concomitant hysteroscopic visualization nor endometrial pretreatment is required. During the brief treatment cycle, the suction device removes debris and moisture, so that treatment desiccation to a depth of 4.0 mm to 4.5 mm is achieved in the uterine body and 2.2 mm to 2.9 mm is achieved in the cornual regions. Less coagulation occurs in the cornua and lower uterine segment, with deeper necrosis to the endometrial cavity. The automatic cavity integrity assessment system determines whether there is a defect or uterine perforation, and the device position feedback feature detects the inadvertent insertion of the device into a false passage. Advantages of the RF device include the shortest endometrial treatment time compared to other devices and, unlike other devices, the FDA pivotal trials were performed during any day of the menstrual cycle and were conducted without endometrial pretreatment with leuprolide or D&C.33 Box 18–7 lists the RF system selected inclusion and exclusion criteria in the FDA clinical trial.

Microwave Endometrial Ablation Methodology

Microsulis MEA is the latest ablation device to gain FDA approval (2003). The novel characteristics of microwave energy and the technique employed to deliver that energy by direct heating of tissue with thermal propagation of heat has made MEA one of the most versatile thermal ablation options. It is a software-controlled device that ablates the endometrium using

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BOX 18–8

Clinical Trial Selection Criteria for the NovaSure System

Clinical Trial Selection Criteria for the Microsulis Microwave Endometrial Ablation System

Inclusion Criteria ● ● ● ●

Inclusion criteria

Refractory menorrhagia with no definable organic cause Age 25-50 years Uterine sound measurement 6.0-10.0 cm A minimum PBAC score ≥150 for 3 months before study enrollment or PBAC score ≥150 for 1 month for women who had at least 3 prior months of documented failed medical therapy and medical therapy refused or contraindicated

● ● ●

●

Exclusion Criteria ● ● ● ● ● ● ● ● ●

● ● ● ● ●

Bacteremia, sepsis, or other active systemic infection Active or recurrent PID or active STD Documented coagulopathies Symptomatic endometriosis Prior uterine surgery that interrupts the integrity of the uterine wall Using medication that could thin the myometrial muscle Pregnant or desire to preserve fertility or get pregnant Using hormonal birth control therapy or unwilling to use nonhormonal birth control after ablation Abnormal or obstructed uterine cavity as confirmed by hysteroscopy, SIS, or HSG. Specifically septate or bicornuate uterus, pedunculated submucosal leiomyomas, or other such as polyps (>2 cm) likely to cause menorrhagia Using an IUD Endometrial hyperplasia confirmed by histology Suspected or confirmed uterine malignancy in past 5 years Cervical dysplasia Elevated FSH level consistent with ovarian failure

● ● ● ● ● ●

Exclusion criteria ● ● ● ● ● ●

●

Pretreatment ● ●

Excessive bleeding, with a documented PBAC score ≥185 Patients failed, were unable to tolerate, or refused medical therapy (required 1 month [1 cycle] documentation) If presented to the study without documentation of failed medical treatment, the patient was then required to record 3 months (3 cycles), with a PBAC average of ≥185 Age ≥30 years and premenopausal at enrollment as determined by FSH measurement ≤30 IU/mL Appropriate candidate for general or local anesthesia Not pregnant and has no desire to conceive at any time Agreement not to use hormonal contraception or any other intervention for bleeding during the study Benign endometrium on preoperative endometrial sampling Uterine sounding ≤14 cm Uterine fibroids ≤3 cm that did not obstruct the endometrial cavity

●

No pretreatment needed May be performed at any time during the menstrual cycle.

● ● ●

FSH, follicle-stimulating hormone; HSG, hysterosalpingogram; IUD, intrauterine device; PBAC, pictorial blood assessment chart; PID, pelvic inflammatory disease; SIS, saline infusion sonography; STD, sexually transmitted disease. From Bradley LD: Global endometrial ablation in the presence of fibroids. Cleveland Clinic continuing medical education, February 2004.

● ● ●

Menopausal women as indicated by elevated FSH level >30 IU/mL Presence of submucosal fibroids that obstructed treatment access to any part of the endometrial cavity (as determined by hysteroscopy) Uterus sounded <6 cm Previous endometrial ablative surgery Previous classic cesarean section Any portion of uterine wall <8 mm in thickness as determined by pelvic ultrasound in both the transverse and sagittal views, measuring the distance between the uterine cavity and uterine serosa Presence of IUD Pregnant or still desire to conceive Presence of atypical endometrial hyperplasia (adenomatous) or endometrial carcinoma on preoperative endometrial sampling Active endometritis History of gynecologic malignancy within past 5 years Active PID Known clotting defects or bleeding disorders Untreated or unevaluated cervical dysplasia

Pretreatment ●

microwave energy at a fixed frequency of 9.2 GHz to destroy the endometrium (Fig. 18–22). MEA is recognized by physicians as the only thermal endometrial ablation technology to demonstrate effectiveness in patients whose uterine cavities are distorted by fibroids and patients with larger uterine cavities (up to 14 cm), thus treating the widest array of patients. The rigorous FDA trial included patients with known uterine fibroids up to 3 cm that did not prevent placement of the microwave probe and larger endometrial depths (up to 14 cm) compared with other trials in which the endometrium had to be no deeper than 10 cm. Superior and durable results in both amenorrhea and patient satisfaction were maintained when compared to all similar trials in both the normal and irregular cavity. Advantages of this system include brief treatment time of 2 to 5 minutes and the highest level of amenorrhea in the intent-to-treat group compared with other ablation systems. Box 18–8 lists selected inclu-

Endometrium was thinned preoperatively with goserelin or danazol 4 to 5 weeks before ablation.

FSH, follicle-stimulating hormone; HSG, hysterosalpingogram; IUD, intrauterine device; PBAC, pictorial blood assessment chart; PID, pelvic inflammatory disease; SIS, saline infusion sonography. From Bradley LD: Global endometrial ablation in the presence of fibroids. Cleveland Clinic continuing medical education, February 2004.

sion and exclusion regarding the Microsulis Microwave Endometrial Ablation System in the FDA clinical trial. The MEA device consists of a disposable transcervical singleuse applicator (FemWave, Microsulis Americas, Waltham, MA) that is connected to an ergonomic handle designed specifically for a sweeping technique (Figs. 18–23 to 18–27). Microwave energy is provided to the handheld device from the controller system when the foot pedal is depressed. The controller contains a viewing screening for real-time temperature monitoring.

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Endometrial Ablation Figure 18–22. The complete Microsulis Microwave Endometrial Ablation System (MEA) global ablation device. This device can treat larger uterine cavities that are distorted by uterine fibroids.

Figure 18–23 The disposable transcervical Femwave device.

Figure 18–24. A schematic view of a treatment cycle that is guided by observing the monitor. Treatment ideally should be between 70 and 80° C. The movements necessary for microwave endometrial ablation are shown.

GUIDANCE THROUGHOUT TREATMENT Consistencies across best techniques: • Complete fundal treatment • Treatment of each cornu • Continuous sweeping of corpus adapting to irregularities • Continued treatment in lower segment

90 80 70 60 50 40 30 20 10

2

2 Cornua

3

1

0

1 Fundus

4

1

2

3 Corpus

3

4

5

6

4 Lower segment

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Figure 18–25 The first component of the procedure includes sweeping the fundus.

Figure 18–27 The probe is moved in a to-and-fro manner to treat the posterior and lateral walls. Microwave energy uses a noncontact method, ensuring adequate treatment of the endometrial cavity.

limitations with the spray-paint effect surrounding the treated areas. Recommended Preoperative and Intraoperative Protocols

Figure 18–26 After fundal sweeping, each cornu is treated.

MEA technique uses localized therapeutic ablation that is controlled by the surgeon. Constant feedback is achieved by observing the temperature rise gate, which provides real-time temperature monitoring from the thermocouple at the tip of the applicator. This allows the gynecologist to treat each area of the cavity until therapeutic levels are reached, individualizing treatments based on anatomic findings. This technology had the highest rate of amenorrhea in all patient populations and cavity variations studied in the FDA clinical trial. A unique feature of microwave energy is that when tissue is not in direct contact with the applicatory, the microwave energy fills the gap to penetrate tissue to depths slightly less than 3 mm, yet still produces the direct conductive heating effect. This is what I describe as the spray-paint effect. This phenomenon adequately treats the tubal ostia, one region quite difficult to reach with other technologies. Distortions caused by fibroids can lead to indirect tissue contact. However, MEA overcomes these

Preoperative evaluation of the uterine cavity with transvaginal ultrasound (TVUS) is required before performing microwave endometrial ablation. TVUS screening is particularly important to determine myometrial thickness and, in particular, to evaluate the lower uterine segment in patients with prior cesarean section. Microwave ablation treats to a depth of 5 to 6 mm. Myometrial thickness should be more than 10 mm when performing endometrial ablation. If myometrial thickness is less than 10 mm, microwave endometrial ablation is contraindicated. Myometrium that is thin (<10 mm) and attenuated should not be treated with microwave technology. Myometrial thickness is measured from the endometrium to the serosa in the sagittal and coronal planes (Fig. 18–28). On the day of the surgical procedure, hysteroscopy is required after dilation of the cervix to exclude uterine perforation or cervical lacerations. Delineation of all uterine landmarks, including tubal ostia, is advisable. The endometrial cavity should not be curetted before the procedure. An additional safety mechanism prevents initiation of treatment if the applicator insertion length is greater than the original sound or if an abnormal rise is detected that is associated with possible placement of the applicator in a perforation or initiation of the treatment before the applicator is inserted into the uterine cavity. These guidelines for preoperative and intraoperative evaluation are different from those for other global technology. Once the cervix is dilated, the 8.5-mm Femwave probe is inserted to the level of the mid-fundus. Sweeping is performed across the fundus. The temperature is constantly displayed as it rises from the initial body tissue temperature to the therapeutic level (treatment band) of 70° to 80° C. Tissue ablation is occur-

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Endometrial Ablation ring at all times during the rise to this level; however, the desired 5 to 6 mm of destruction needed to destroy the basal layer is not attained until the 70° C point. Once the entire fundus has been treated to the 70° C level, each cornu is confirmed to have been completely treated during the fundal sweeping by directing the applicator to each cornu for up to 5 seconds. The applicator is then gradually withdrawn through the cavity with continued sweeping motions, simultaneously monitoring the temperature, keeping it in the treatment band. The physician methodically and strategically maintains the temperature in the treatment band. Microwave Outcomes in the Presence of Fibroids

Microwave endometrial ablation was the only study that used a uterine size deeper than 10 cm and included uterine cavities with fibroids that did not distort the uterine cavity (up to 3 cm). The amenorrhea rate for the patients with uterine fibroids was

61.3%, compared to 38.5% in the rollerball arm. Patients with a body mass index (BMI) of 30 or more were successfully treated.

COMPARATIVE RESULTS WITH DIFFERENT DEVICES In general, results discussed in this chapter pertain to individual company-sponsored clinical trials that were reviewed by the FDA. There are no single prospective studies in which all global methods have been studied. Generally, single centers or individual physicians report outcomes. The global devices, when compared to nonhysteroscopic methods, appear safe, with excellent patient outcomes in the appropriately triaged patient. In the FDA trial, only microwave technology was studied with uterine fibroids that distorted the endometrial cavity. In the intent-to-treat group, sustained and high levels of amenorrhea were noted. Table 18–2 shows the treatment times of all global technology. Table 18–3 lists study success rates and amenorrhea rates of patients treated with global technology compared to rollerball. Table 18–4 shows 12-month FDA outcome data from postoperative observations of all five methods. Figure 18–29 shows the study success rates of the intent-to-treat population treated with global endometrial ablation.

SUMMARY

+D 0.58cm Figure 18–28 Preoperative evaluation is essential before scheduling the patient for microwave endometrial ablation. A transvaginal ultrasound must be performed and the myometrial measurement must be >10 mm in both the sagittal and coronal views. This is done to decrease risk of injury to the bowel or bladder.

Global ablation technology effectively manages menorrhagia. All devices demonstrate excellent outcomes, high patient satisfaction, and low complication rates (Table 18–5). With the proper infrastructure, excellent ancillary support staff, and ability to safely resuscitate a patient, global ablation can be performed in the office. Global technology is easier to master compared to first-generation rollerball ablation. Perceived ease of use by gynecologists and ancillary nursing support, costs of disposables, size of equipment, total treatment time, total time to set up and deploy the technology, pretreatment of the endometrium, size of the uterine cavity, and ease of performing the procedure with local anesthesia and sedation guide the choice of technique. Future research should determine patient acceptability, rates of abandonment of the procedure, and frequency with which patients would choose outpatient therapy.

Table 18–2 Treatment Features for All Global Devices Feature

ThermaChoice (n = 137)

Her Option (n = 193)

HTA (n = 187)

NovaSure (n = 175)

MEA (n = 215)

Average treatment time

8 min

ND

10 min

1.4 min

3.45 min

Average procedure time

27.4 min

No Data

26.4 min

4.2 min

ND

Local anesthesia*

39%

54%

45%

73%

62%

*With or without intravenous sedation. HTA, Hydro ThermAblator; MEA, Microsulis Microwave Endometrial Ablation; ND, no data. From Bradley LD: Global endometrial ablation in the presence of fibroids. Cleveland Clinic continuing medical education, February, 2004.

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% of patients with PBLAC <75

Endometrial Ablation 100

82 83

78 74

80

76 68

67

74 77

73

60 40 20 0 MEA

NovaSure

HTA

Cryogen

Thermachoice

Thermal Technology/Rollerball Figure 18–29 Graph showing the study success rates of the intent-to-treat population.

Table 18–3 Key Measures from Pivotal Trials for FDA Approval*

Subjects Treated Technology ThermaChoice

Thermal (%) 1†

REA (%)

Study Success (PBLAC <75)

Amenorrhea Rates (PBLAC <0)

Thermal (%)

Thermal % (%)

REA (%)

REA (%)

134

126

75

77

14

25

Cryogen2

193

86

67

73

22

47

3

187

89

68

76

35

47

NovaSure4

175

90

78

74

36

32

5

215

107

87

83

55

46

HTA

MEA

PBLAC, premenstrual blood loss activity chart; REA, rollerblade electroablation. *Thermal ablation summary of safety and effectiveness data, study success and amenorrhea rates, 12-month results from multicenter trials, intent-to-treat results as defined by the FDA. † Adjusted for the intent-to-treat population, which was the evaluable population. 1 Gynecare ThermaChoice Uterine Balloon Therapy, Summary of Safety and Effectiveness Data, PMA P970021, Dec. 12 1997. Deputy Director, Office of Device Evaluation, Center for Devices and Radiological Health, Department of Health and Human Services. 2 Cryogen Her Option Uterine Cryoablation Therapy System, Summary of Safety and Effectiveness Data, PMA P000032, April 20, 2001. Deputy Director, Office of Device Evaluation, Center for Devices and Radiological Health, Department of Health and Human Services. 3

BEI Medical Systems Hydro ThermAblator Endometrial Ablation System, Summary of Safety and Effectiveness Data, PMA P000040, April 20, 2001. Deputy Director, Office of Device Evaluation, Center for Devices and Radiological Health, Department of Health and Human Services.

4

NovaSure Impedance Controlled Endometrial Ablation System, Summary of Safety and Effectiveness Data, PMA P010013, September 28, 2001. Deputy Director, Office of Device Evaluation, Center for Devices and Radiological Health, Department of Health and Human Services. 5 Microsulis Microwave Endometrial Ablation (MEA) System, Summary of Safety and Effectiveness Data, PMA P020031, Amendment filing, July 14, 2003. Deputy Director, Office of Device Evaluation, Center for Devices and Radiological Health, Department of Health and Human Services. From Bradley LD: Global endometrial ablation in the presence of fibroids. Cleveland Clinic continuing medical education, February 2004.

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Table 18–4 Twelve-Month FDA Outcome Data from Postoperative Observations Global Ablation Device

ThermaChoice (n = 137)

Her Option (n = 93) (%)

HTA (n = 187) (%)

NovaSure (n = 175) (%)

MEA (n = 216) (%)

23

32

3.4

72

7

23

0.6

5

Cramping and Pain First 24 h

ND

24 h-2 wk

91.8%*

2 wk-1 y

ND

18

15

2.9

8.8

First 24 h

ND

2

22

1.7

Nausea, 22.6 vomiting, 13.4

24 h-2 wk

23.9%*

1

18

0.6

1.4

2 wk-1 y

ND

1

0

0

1.4

Nausea and Vomiting

Other Observations Amenorrhea at 1 y†

80

67

68

78

87

Study success†

80‡

67

68

78

87

Patient satisfaction

96

86

ND

92

96

*Data reported for both first 24 h and 24 h-2 wk intervals. † Intent-to-treat group. ‡ Data reported on evaluable patients. FDA, U.S. Food and Drug Administration; HTA, Hydro ThermAblator; MEA, Microsulis Microwave Endometrial Ablation; ND, no data. From Bradley LD: Global endometrial ablation in the presence of fibroids. Cleveland Clinic continuing medical education, February 2004.

Table 18–5 Comparison of Nonresectoscopic Endometrial Ablation Devices Trade Name

Energy or Delivery System

ThermaChoice†

Balloon

Device Outside Diameter (mm)

Pretreatment

Maximum Uterine Sounded Length (cm)

5.5

Mechanical or medical

10

Submucus Myomas Allowed?

Myoma Size

Myoma Type*

Yes‡

<3 cm

II

Typical Treatment Time (min) 8.0

Amenorrhea Rate (%)

14

Her Option

Cryogenic

4.5

Medical

10

No

N/A

N/A

10

22

HTA

Heated fluid (free)

7.8

Medical

11

Yes§

Not known

Not known

14

35

NovaSure

RF (bipolar)

7.2

None

10

Yes‡

<2 cm

MEA

Microwave

8.0

Medical

14

Yes

<3 cm

II, selected I

1.5

36

2.5

55

HTA, hysteroscopic thermal ablation; MEA, microwave endometrial ablation; RF, radiofrequency alternating current. *Type 0 myomas are entirely intracavitary, on a stalk; type I are sessile but have 50% or more of their maximum circumference within the endometrial cavity; type II myomas have less than 50% of their maximum circumference within the endometrial cavity. † ThermaChoice procedure was performed with ThermaChoice I device. This is no longer commercially available. ThermaChoice III now notes amenorrhea rates approximately 30%. ‡ Myomas 2 cm or less were allowed, but no data are available regarding clinical outcomes at this time. § There are insufficient data to determine the type and dimension of myomas treatable with HTA.

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Endometrial Ablation REFERENCES 1.

2.

3.

4.

5.

6.

7.

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11. 12.

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14.

15.

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DeCherney A, Polan M: Hysteroscopic management of intrauterine lesions and intractable uterine bleeding. Ostet Gnyecol 1983; 61: 392-397. Overton C, Hargreaves J, Maresh M: A national survey of the complications of endometrial destruction for menstrual disorders: The MISTLETOE study. Minimally Invasive Surgical Techniques—Laser, EndoThermal or Endoresection. BJOG 1997;104:1351-1359. The Practice Committee of the American Society for Reproductive Medicine: Indications and options for endometrial ablation. Fert Steril 2006;86(Suppl 4):S6-S10. Shawki O, Peters A, Abraham-Hebert S: Hysteroscopic endometrial destruction, optimum method for preoperative endometrial preparation: A prospective, randomized, multicenter evaluation. JSLS 2002;6:23-27. Rich AD, Manyonda IT, Patel R, et al: A comparison of the efficacy of danazol, norethisterone, cyproterone acetate and medroxyprogesterone acetate in endometrial thinning prior to ablation: A pilot study. Gynaecol Endosc 1995;4:59-61. Sowter MC, Singla AA, Lethaby A: Pre-operative endometrial thinning agents before hysteroscopic surgery for heavy menstrual bleeding. Cochrane Database Syst Rev 2000;(3):CD001124. Elgarib AEH, Nooh A: ThermaChoice endometrial balloon ablation: A possible alternative to hysterectomy. J Obstet Gynecol 2006; 26(7):669-672. Lissak A, Fruchter O, Mashiach S, et al: Immediate versus delayed treatment of peri-menopausal bleeding due to benign causes by balloon thermal ablation. J Am Assoc Gynecol Laparosc 1999;6:145-150. Goldrath MH, Ruller TA, Segal S: Laser photovaporization of endometrium for the treatment of menorrhagia. Am J Obstet Gynecol 1981;140:14-19. Phipps JH, Lewis BV, Roberts T: Experimental and clinical studies with radiofrequency-induced thermal endometrial ablation for functional menorrhagia. Obstet Gynecol 1990;76:876-881. Vancaillie TG: Electrocoagulation of the endometrium with the ballend resectoscope. Obstet Gynecol 1989;74:425-427. Dwyer N, Hutton J, Stirrat GM: Randomised controlled trial comparing endometrial resection with abdominal hysterectomy for the surgical treatment of menorrhagia. BJOG 1993;100:237-243. Gannon MJ, Holt EM, Fairbank J, et al: A randomized trial comparing endometrial resection and abdominal hysterectomy for the treatment of menorrhagia. BMJ 1991;303:1362-1364. Crosignani PG, Vercellini P, Apolone G, et al: Endometrial resection versus vaginal hysterectomy for menorrhagia : Long-term clinical and quality-of-life outcomes. Am J Obstet Gynecol 1997;177:95101. O’Connor H, Broadbent JA, Magos AL, McPherson K: Medical Research Council randomized trial of endometrial resection versus hysterectomy in management of menorrhagia. Lancet 1997;349: 897-901. Pinion SB, Parkin DE, Abramovich DR, et al: Randomised trial of hysterectomy, endometrial laser ablation, and transcervical endometrial resection for dysfunctional uterine bleeding. BMJ 1994;309:979-983. Lethaby A, Shepperd S, Cooke I, et al: Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database Syst Rev 1999;(2):CD000329.

18. Abbott JA, Garry R: The surgical management of menorrhagia. Hum Reprod 2002;8:68-78. 19. Pooley AS, Ewen SP, Sutton CJ: Does transcervical resection of the endometrium for menorrhagia really avoid hysterectomy? Life table analysis of a large series. J Am Assoc Gynecol Laparosc 1998;5:229-235. 20. Seidman DS, Bitman G, Mashiach S, et al: The effect of increasing age on the outcome of hysteroscopic endometrial resection for management of dysfunctional uterine bleeding. J Am Assoc Gynecol Laparosc 2000;7:115-119. 21. Clark TJ, Gupta JK: Outpatient thermal balloon ablation of the endometrium. Fertil Steril 2004;82:1395-1401. 22. Marsh F, Thewlis J, Duffy S: ThermaChoice endometrial ablation in the outpatient setting, without local anesthesia or intravenous sedation: A prospective cohort study. Fertil Steril 2005;83:715720. 23. Loffer FD, Grainger D: Five-year follow-up of patients participating in a randomized trial of uterine balloon therapy versus rollerball ablation for treatment of menorrhagia. J Am Assoc Gynecol Laprosc 2002;9(4):429-435. 24. Leal JG, Pena A, Donovan A, et al: Clinical evaluation of Gynecare ThermaChoice III uterine balloon therapy system (ThermaChoice 3) for menorrhagia. Presented at 35th Annual Global Conference of the American Association of Gynecologic Laparoscopists, Las Vegas, Nevada. November 22, 2006. 25. Bradley LD: Global endometrial ablation in the presence of fibroids. Cleveland Clinic Foundation continuing medical education activity, February 2004. 26. Center for Devices and Radiologic Health: Summary of safety and effectiveness data: Her Option Uterine Cryoablation Therapy System, Cryogen, Inc. Available at http://www.fda.gov/cdrh/pdf/P000032b. pdf (accessed November 12, 2007). 27. Morgan H, Advincula AP: Global endometrial ablation: A modern day solution to an age-old problem. Int J Gynecol Obst 2006;94:156-166. 28. Richart RM, das Dores GB, Nicolau SM, et al: Histologic studies of the effects of circulating hot saline on the uterus before hysterectomy. J Am Assoc Gynecol Laparosc 1999;6:269-273. 29. Glasser MH, Zimmerman JD: The HydroThermAblator system for management of menorrhagia in women with submucous myomas: 12-20 month follow-up. J Am Assoc Gynecol Laparosc 2003;10: 521-527. 30. Rosenbaum SP, Fried M, Munro MG: Endometrial hydrothermablation: A comparison of short-term clinical effectiveness in patients with normal endometrial cavities and those with intracavitary pathology. J Minim Invasive Gynecol 2005;12:144-149. 31. Corson SL: A multicenter evaluation of endometrial ablation by Hydro ThermAblator and rollerball for treatment of menorrhagiagia. J Am Assoc Gynecol Laparosc 2001;8:359-367. 32. Cooper JM, Erickson ML: Global endometrial ablation technologies. Obstet Gynecol Clin North Am 2000;27:385-396. 33. Center for Devices and Radiologic Health: Summary of safety and effectiveness data: NovaSure Impedance Controlled Endometrial Ablation System, Novacept, Inc. Available at http://www.fda.gov/ cdrh/pdf/P010013b.pdf (accessed November 12, 2007).

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19

Hysteroscopic Resection of Myomas and Polyps Linda D. Bradley

In 1860, Pantaleoni performed the first operative hysteroscopy when he cauterized a bleeding polyp in a postmenopausal woman. A century later, modifications of the urologic resectoscope provided gynecologists a new visually directed method to resect intrauterine polyps and submucosal fibroids, to treat synechiae, and to obtain targeted biopsies (Fig. 19–1). The first operative hysteroscopic polypectomy and myomectomy were performed by Neuwirth in 1976, using ovum forceps and electrosurgery.1 Gynecologists are slowly embracing operative hysteroscopy to treat myriad intrauterine conditions. The development of a continuous flow resectoscope permitted distention of the uterine cavity with fluid and removal of blood and debris. Since the 1990s, improvements in optics, video recording, and intrauterine distention systems, as well as scrutiny of types and amounts of fluid used during operative hysteroscopy have improved the safety of hysteroscopic surgery. Preoperative pain management, cervical dilating agents, paracervical blocks, and smaller-diameter hysteroscopes have increased the number of procedures performed in the office or under minimal sedation. Physician awareness of the benefits of operative hysteroscopy and excellent outcomes has increased its use. Patient demand for minimally invasive surgery has also been influential. Monopolar instrumentation, bipolar equipment, and hysteroscopic morcellators that remove uterine debris (fibroid chips or polyp pieces) are now available. Hysteroscopic morcellators are the newest devices available to gynecologists. These two new modifications in the hysteroscope increase the speed of the procedure, remove intrauterine debris, and improve intraoperative visualization. The desire of many women to retain the uterus and return to normal activities quickly prompted development of lessinvasive technologies for treating uterine fibroids. Operative hysteroscopy fulfills those goals in appropriately triaged patients who have intracavitary lesions amenable to hysteroscopic intervention.

GENERAL PRINCIPLES Performing operative hysteroscopic myomectomy requires six essential components:

●

●

● ●

● ●

Determining indications and contraindications for hysteroscopic surgery Excellent preoperative evaluation of uterine fibroids, including a detailed knowledge of the number, size, location, and depth of myometrial involvement of the uterine fibroid (Fig. 19–2) Superb eye–hand coordination Detailed understanding of fluid management and fluid management systems Astute surgical skills and intraoperative judgment Judgment and common sense regarding when to abandon the hysteroscopic approach

PATIENT SELECTION AND COUNSELING The desire of many women to retain their uterus and return to normal activities quickly prompted the development of lessinvasive technologies for treating symptomatic fibroids. Fibroids are associated with abnormal uterine bleeding, bulk symptoms, and infertility. Choosing the right procedure requires a marriage between the symptoms and the procedure most likely to eradicate them. Patients with bulk symptoms and cosmetic complaints such as a protuberant abdomen will not improve with operative hysteroscopy. Profound menorrhagia due to submucosal fibroids or intramural fibroids that are hysteroscopically resectable and removed completely is associated with excellent success rates and high patient satisfaction. However, the patient must have realistic expectations of what can be done by hysteroscopy. Some myomas cannot be treated by hysteroscopy (Fig. 19–3). Contraindications to hysteroscopic myomectomy are listed in Box 19–1.

Symptoms Associated With Submucosal Leiomyomas Among symptomatic women with uterine fibroids, menstrual disturbances are the most common complaint leading women to see their gynecologist. Aberrations include menorrhagia, metrorrhagia, menometrorrhagia, dysmenorrhea, and leukorrhea. The patient typically experiences menses that are predictable but excessively heavy with associated flooding, gushing, clotting,

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Hysteroscopic Resection of Myomas and Polyps BOX 19–2 Why Submucosal Fibroids Bleed Ulceration over the surface of the fibroid Increased surface area of the uterine cavity due to intramural or submucosal fibroids Abnormalities in local venous drainage (congestion and dilation of venous plexus) contributing to venous ectasia Increased vascularity of the uterus Variability in prostaglandin production Platelet dysfunction Normal uterine contractions are inhibited and decreased expulsion of uterine contents occurs Impaired endometrial hemostasis Micro- or macroscopic abnormalities of the uterine vasculature (more expandable venules) Local vasoactive growth factors and molecular mediators that regulate vessel function Defects of arterioles, veins, and extracellular matrix surrounding myomas

Figure 19–1 Completely assembled Karl Storz 31-F operative hysteroscope.

BOX 19–1 Contraindications for Hysteroscopic Myomectomy No preoperative evaluation Lack of surgical skill for advanced procedures Lack of understanding of fluid management systems Acute pelvic inflammatory disease or prodromal herpes infection Purely transmural fibroid Poor intrauterine distention of the uterus Poor intraoperative visualization

increased sanitary product use, more days of menstrual bleeding, and dysmenorrhea.2 Evidence suggests that bleeding worsens as fibroid size increases. Personal, medical, and financial factors may be adversely affected due to symptomatic fibroids. Social embarrassment, inability to work, alteration of lifestyle, and avoidance of sexual activity finally lead many women to seek care. Iron-deficiency anemia, pica (especially ice and starch cravings), and fatigue are common with prolonged menstrual disturbances. Shortness of breath, dizziness, and tachycardia are also associated with profound anemia. Blood transfusions are occasionally required. Some patients complain of intermittent or chronic watery vaginal discharge and postcoital bleeding interspersed with irregular menstruation. The mechanism for abnormal uterine bleeding is poorly elucidated. There are many theories for the etiology of abnormal uterine bleeding secondary to submucosal fibroids (Box 19–2 and Figs. 19–4 and 19–5).3,4

Submucosal Fibroids Amenable to Hysteroscopic Resection The most conservative surgical approach for abnormal bleeding in women with intracavitary fibroids is hysteroscopic myomectomy. High success rates (>90%) are predictable when the patient has been properly selected and the surgeon has adequate

operative hysteroscopic surgical skills. Complications of operative hysteroscopic myomectomy are low, ranging from 1% to 5%. Patients with larger myomas (>3 cm) should be informed that a two-step procedure may be necessary. As the fibroid diameter increases, the volume of resected tissue increases exponentially. The larger fibroid requires more surgical time and increased use of distention media and carries an increased risk of fluid overload. Thus it is imperative that a surgeon has the best preoperative assessment of the volume of tissue needing resection. A planned two-stage procedure is not a surgical failure or mishap, but it is crucial in preventing fluid overload when maximum fluid deficit has been reached. When fibroids larger than 3 cm are approached hysteroscopically, duration of surgery increases. Longer surgical times result not only from the size of the fibroid but also, more importantly, management of the fibroid chips, need to remove the operative hysteroscope to evacuate chips, decreased visualization encountered due to these factors, and more fluid absorption, which can preclude completion of surgery and lengthen surgical times. How can gynecologists consistently obtain high success rates when performing operative hysteroscopic myomectomy? First by identifying factors that are associated with recurrence including larger uterine volumes (>10-12 gestational weeks), more than two submucosal fibroids, and depth of myometrial involvement. Second by improving intraoperative surgical tactics and strategies that maximize complete enucleation of leiomyomas.

HYSTEROSCOPIC CLASSIFICATION OF UTERINE MYOMAS Wamsteker and colleagues5 pioneered the concept of classification of uterine fibroids according to the level of myometrial penetration. This classification was determined at a consensus meeting and denoted as the European Society of Hysteroscopists (ESH) classification of uterine fibroids. Definitions of hysteroscopic fibroid location are as follows (see Fig. 19–2):

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A

C Figure 19–2 European Society of Hysteroscopic Classification system aims to objectively determine size, location, and the degree of intramural involvement of a fibroid.

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Figure 19–5 Hysteroscopic view of a variegated-appearing leiomyoma.

Figure 19–3 Hysterectomy specimen demonstrating 6-7 cm intracavitary pedunculated myoma manifesting with profound anemia, leukorrhea, and cramping. This was not a hysteroscopically resectable lesion.

Figure 19–4 Hysteroscopic view of a hemorrhagic tip of a submucosal leiomyoma.

●

●

●

Type 0: Pedunculated submucosal fibroid without intramural extension Type 1 : Sessile submucosal fibroid with less than 50% intramural extension Type 2: Sessile submucosal fibroid with greater than 50% intramural extension

This classification helps compare studies and outcomes of women treated hysteroscopically, but it has limitations. The most important determinant requires a subjective calculation of the angle of view, which determines the degree of intramural extension as it indents the endometrium. The angle of view is determined by the hysteroscopist. The angle of view is affected by the intrauterine distention medium. The uterine cavity is a

distensible organ. When fluid or CO 2 is used, intrauterine pressure increases, and subtle endometrial lesions may be flattened and actually disappear. Likewise, increased intrauterine pressure can push the fibroids into the myometrium. This can create a negative hysteroscopic view or compromise the true classification of the fibroid. This has been referred to as the disappearing act, and should remind us that excellent distention of the uterine cavity is required, but at the end of the procedure, the uterine pressure must be lowered and the uterine cavity must be reinspected to determine the angle of view and to ensure that subtle intracavitary lesions are not missed. Because determining the depth of penetration is so vital, what are the best tools to determine this? Figure 19–6 shows examples of different depth of penetration of myomas that must be determined preoperatively so as to make an appropriate management decision. Hysteroscopic myomectomy is extremely helpful when a pedunculated myoma is identified (Fig. 19–7). However, when the tip of the iceberg, or just the rounded protuberant surface of the fibroid, is identified, it is difficult to determine hysteroscopically the degree of myometrial involvement (Fig. 19–8). In these cases, consider a saline infusion sonohysterogram (SIS, also known as sonohysterography [SHG]), a complementary companion to hysteroscopy, to more objectively identify the degree of myometrial involvement.6 With SIS, the distance between the serosal edge and the myoma can be fully determined (Figs. 19–9 and 19–10). Magnetic resonance imaging (MRI) is accurate in determining the degree of myometrial penetration, but it is expensive compared to SIS (Fig. 19–11).

PREOPERATIVE CONSIDERATIONS When compared to open myomectomy and laparoscopic myomectomy, hysteroscopic myomectomies are associated with fewer complications and excellent success rates.7 Nonetheless, thorough informed consent is imperative. Patients must understand the low risk of complications including fluid overload, twostaged procedure, hemorrhage, and uterine perforation. Consent

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A

C

B

Figure 19–6 A, Hysterectomy specimen demonstrating two intracavitary fibroids that were amenable to hysteroscopic resection. B, Hysterectomy specimen demonstrating a type 1 leiomyoma, which involves less than 50% of the myometrium. C, Hysterectomy specimen demonstrating a type 2 leiomyoma, which involves more than 50% of the myometrium.

Figure 19–7 Hysteroscopic view of a type 0 leiomyoma filling the endometrial cavity.

and documentation for laparoscopy, laparotomy, and hysterectomy must be obtained, even though the absolute risks of complications and conversion to more extensive procedures is low. Most operative hysteroscopes are 7 to 10 F. The most common complications of operative hysteroscopy are uterine perforation or cervical lacerations. Pratt or Hegar dilators are used for cervical dilation. Often the most difficult part of performing operative hysteroscopy is dilating the cervix. Although the incidence of perforation is low, ranging from 0.8% to 1.2% in more than 24,000 hysteroscopic procedures analyzed,8,9 if perforation occurs, the planned procedure cannot be completed and must be rescheduled. Preoperative placement of laminaria tents or administration of oral or vaginal misoprostol is strongly encouraged. Both methods effectively ease cervical dilation, decrease the risk of cervical tears, decrease the risk of using undue force to dilate the cervix, and hence decrease the risk of uterine perforation. Ease of cervical dilation is markedly improved. Oral or vaginal misoprostol (200-400 mcg) given 8 to 12 hours before surgery, softens and creates a patulous cervix,

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A

Figure 19–8 Hysteroscopic view of a type 1 leiomyoma that abuts the endometrial cavity.

reduces the force needed to perform cervical dilation, decreases cervical complications, and reduces operative time in comparison with placebo controls in both premenopausal and menopausal women.10,11 Although misoprostol has several bothersome side effects, such as lower abdominal pain, diarrhea, and slight vaginal bleeding, few if any side effects prevent its use. Uterine cramping occurs with misoprostol use. Anecdotally, some intracavitary fibroids prolapse into the cervix or vagina with misoprostol use, facilitating surgery. All patients undergoing operative hysteroscopy benefit from misoprostol, but consider prescribing preoperative misoprostol for patients who are at greatest risk for cervical stenosis and uterine perforation: menopausal or nulliparous women, those who are taking GnRH therapy, and those with prior cone biopsy, LEEP procedure, or cesarean section. These latter patients are prescribed oral misoprostol 200-400 mcg to take 2 days before and 8 to 12 hours before operative hysteroscopy, with tremendous improvement in the ability to dilate the cervix. Likewise, laminaria tents inserted 12 to 24 hours before surgery also facilitate cervical dilation, but this requires an extra office visit and cannot be used in women with shellfish allergy. Especially among women with a pinpoint cervical os, laminaria tents cannot be inserted. When removing a laminaria tent, inspect its length to determine that no piece has become detached. A randomized trial comparing misoprostol and laminaria tents showed that both were equally effective for cervical priming before operative hysteroscopy.12 The advantage of misoprostol however, is that it can be taken orally or vaginally in the privacy of the patient’s home and does not require an additional office visit.

B

+D 2.17cm

Figure 19–9. Saline infusion sonohysterogram. Class 1 leiomyoma sagittal view (A) and coronal view (B). The fibroid is purely intracavitary.

+D 5.25cm +D 4.86cm Figure 19–10. Saline infusion sonohysterogram. Class 3 transmural leiomyoma.

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R

MF 1.00

A

10cm

8927931 Figure 19–11 Magnetic resonance image of a transmural leiomyoma that impinges on the uterine cavity. This fibroid is not hysteroscopically resectable.

ELECTROSURGERY PRINCIPLES Currently, four operative hysteroscope systems are available to the gynecologic surgeon. The oldest system uses monopolar technology. The bipolar system followed several years later. The newest operative hysteroscopy systems use morcellators for removing intracavitary lesions.13 Monopolar systems use glycine 1.5%, sorbitol 3%, or mannitol 5% solution during operative hysteroscopic resection procedures. Bipolar technology uses isotonic and isonatremic normal saline or lactated Ringer as the distention media. Both systems perform operative hysteroscopic procedures well; each has its own inherent risk factors that must be understood. Understanding the brief principles of electrosurgery minimizes surgical risks to patients. To remove tissue, energy must be transferred and conducted. The basic principle of monopolar electricity is that energy follows the path of least resistance or impedance. High-frequency alternating current cuts and coagulates tissue. The current passes through the tissue and dissipates within the tissue. Cellular destruction occurs from thermal damage. Two electrodes are needed to complete the electrical circuit. With monopolar energy, the active electrode may consist of a loop, ball, needle, or flat blade, and the instrument makes contact with the tissue (Figs. 19–12 and 19–13). The return electrode is often referred to as the patient return electrode and is larger. In essence, the electrical energy passes from the active electrode through the patient’s body and back to the return electrode. Current density is high at the active electrode and

B Figure 19–12. Monopolar electrodes made by Olympus. A, Monopolar roller ball. B, Monopolar loop.

low at the return electrode. High voltages (<9000 V) causes deep tissue necrosis with deep thermal margins. Fluids used with monopolar equipment (glycine, sorbitol, or mannitol) are nonelectrolytic and may be associated with water intoxication and hyponatremia. Unrecognized hyponatremia is serious and associated with cerebral edema, seizures, coma, and death. A coaxial bipolar operative electrode (Versapoint, Gynecare, Somerville, NJ) was introduced in 1997, requires saline as the distention medium, and was invented with the aim of preventing hyponatremia and complications associated with fluid overload using a hypotonic fluid. It consists of a high-frequency electrosurgical generator and myriad coaxial bipolar electrodes that can cut, desiccate, and vaporize tissue. Three electrode tips that fit through a 5-F, 36-cm long operating channel include the Twizzle tip, which cuts, and a ball electrode, which coagulates (see Fig. 19–13). A 2.5-mm wire loop electrode is also available that can be used with a 27-F continuous flow resectoscope. The two electrodes within the wire loop deliver precise tissue cutting. When

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Figure 19–14 Correct placement of legs in Allen stirrups. The patient is wearing pneumatic compression stockings.

A

B Figure 19–13. Monopolar electrodes made by Olympus. A, Electrode. B, Roller bar.

used in the vaporizing mode, the generator creates a steam bubble that, when in contact with the tissue, immediately vaporizes cellular water and effectively vaporizes tissue. When the wire loop makes contact with the tissue, an orange halo is seen and precisely delineates the tissue that is being resected. For larger amounts of tissue that need bulk desiccation, consider using the 4-mm vaporizing electrode to quickly desiccate tissue. Completing the procedure with the wire loop provides tissue sampling for pathology. Bipolar electrosurgical systems do not require dispersive return electrodes and do not generate stray currents, thus minimizing the risk of electrical burns. Bipolar systems only work in a saline environment. Although saline is theoretically inherently safer, it is not without risk. The maximum absorption of normal saline during operative hysteroscopy should be 2500 mL. In patients with renal failure, history of heart failure, or congestive heart failure, a lower threshold should be used. Likewise, prompt diuresis with furosemide (Lasix) should be considered when symptoms of fluid overload are present. One death has been

Figure 19–15 The back table contains the necessary equipment for dilators, heavy weighted speculum, fluids, and usual collection of materials used during dilation of the cervix and placement of the operative hysteroscope.

reported with saline, so fluid precautions are still paramount in monitoring patients.14

HYSTEROSCOPIC RESECTION TECHNIQUES To proceed with surgery, the patient must be positioned correctly with her legs in Allen stirrups or candy cane stirrups. Generally, compression stockings are advised when the surgical procedure is longer than 30 to 60 minutes (Fig. 19–14). The hysteroscope must be connected properly to perform the surgery without difficulty (Figs. 19–15 and 19–16). Several methods are available to remove fibroids, including hysteroscopic scissors, laser energy, and knife electrode. Most commonly the loop electrode is used exclusively for hysteroscopic myomectomy owing to its versatility and ease of use. The wire loop electrode is used as a morcellating device to shave away a broad-based myoma or to sever a stalk at its base.

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B

A

C D

E

F

Figure 19–16. Sequential assembly of the Karl Storz operative hysteroscope. A, The parts of the hysteroscope before assembly. B, Insertion of wire loop. C, Placing the loop into the operative sheath. D, Attaching the inner sheath. E, Final hysteroscopic unit together. F, The assembled hysteroscope. Always make sure that the inflow port and outflow port are correctly attached to the fluid used. Inappropriate connections will prevent distention of the uterus.

The operative hysteroscope should be advanced in a clear view and without undue force. Visualization of landmarks is critical throughout the procedure. The endocervix, lower uterine segment, and tubal ostia should be visualized at the onset of the procedure. Attempt to reconstruct the location of the fibroid in a three-dimensional (3D) plane. Once the submucosal fibroid or focal intrauterine pathology identified, the wire loop electrode is placed beyond the most cephalad portion of the fibroid and advanced in clear view toward the surgeon (Fig. 19–17). Once the loop is placed behind the myoma, the entire hysteroscope can be moved toward the surgeon. Alternatively, the loop alone, through its spring mechanism on the handpiece, can be engaged in a to-and-fro action. A combination of these movements may also be used. The electrical wattage generally used with monopolar current is 60 to 80 W cutting current and produces excellent cutting of tissue. Fibrous or calcified fibroids are more difficult to cut and can require

cutting currents between 80 and 100 W to successfully remove leiomyoma. The wire loop should easily pass through the tissue. Adjust power settings to prevent tissue from sticking to the wire loop. Bipolar technology uses the default setting for excellent cutting and hemostasis. As the wire loop is drawn toward the surgeon, small crescentshaped chips or fragments of leiomyoma are produced. Placing the tip of the operative hysteroscope close to the myoma provides a clear and unencumbered view and minimizes stray pieces of tissue that obstruct the surgical view (Fig. 19–18). Fibroid chips can remain free until they interfere with visualization; then they should be removed with polyp forceps, suction curettage, Corson graspers, or the wire loop itself (Fig. 19–19). Alternatively, the inner sheath of the resectoscope can be removed to allow the pieces to traverse the larger channel. Avoid operating when the field of view is limited. Although the process is cumbersome and time consuming, it is better to remove fibroid

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A Figure 19–17 Correct placement of the Gynecare bipolar operative hysteroscope loop. The leiomyoma should always be approached from behind the leiomyoma and brought forward.

pieces intermittently to prevent complications that can occur from poor visualization. As the leiomyoma is cut, the edges of the fibroid fall inward as the middle is resected (Fig. 19–20). The leiomyoma is shaved until it is flush with the endometrium (Fig. 19–21). The whorled fibrous appearance of the leiomyoma is clearly different from the fascicles of soft underlying myometrium. Attempt full enucleation of the myoma from its pseudocapsule by identifying myometrial landmarks. The wire loop electrode, when strategically placed behind the myoma, can be lifted from the capsule for full removal (Fig. 19–22). Mechanical enucleation with the inactive electrode and deflating of the uterine cavity allow the myoma to be delivered into the cavity and resected there rather than within the myometrium.15 Myometrial sinuses are readily identified once the capsule is reached. Once the myometrium is breached, increased bleeding may also be noted. Smaller bleeders can be coagulated if necessary. Intravascular absorption of fluid is increased when the myometrial sinuses are breached. For fibroids located more deeply within the myometrium, the surgical caveat is to work quickly and expeditiously, monitoring intravascular absorption of fluid frequently. Wire loop resection is most often used for hysteroscopic myomectomy. However, additional modalities may be considered with larger myomas (>3 cm). These myomas can be debulked initially by using a bulk vaporization electrode (Vaportrode) or bipolar vaporizing electrode or by dividing them into quadrants and retrieving the pieces by avulsion techniques. Vaportrode electrodes have a grooved or spiked barrel shape, with a number of edges that function like an array of narrowcaliber electrodes, each with of which can vaporize adjacent tissue. Large volumes of tissue are rapidly desiccated and vaporized, eliminating accumulation of tissue fragments. To achieve this result, the power requirements are several times higher. For

B

C Figure 19–18 A-C, Free-floating fibroid chips obtained by meticulous hysteroscopic resection of tissue. A large aggregate weighing 79 g was removed.

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Hysteroscopic Resection of Myomas and Polyps example, with a Valleylab Force FX electrode, settings of 120 to 220 W are necessary. This technique should be avoided at the cornua and isthmus regions to reduce the risk of perforation, with subsequent bowel burns and injuries. When higher power settings are used, two dispersive pads should be placed for grounding the patient so as to decrease the risk of skin burns.16 The technique of dividing the larger circular myoma into four quadrants is appealing to some surgeons. Use a 90-degree wire loop and reshape the electrode so that it is straight. The electrode can then divide the myoma into 4 to 6 segments, facilitating blunt removal with grasping instruments. Care must be taken if this blind technique is employed so as to minimize the risk of uterine perforation. Bipolar technology enables surgeons to diagnose and treat various kinds of benign intrauterine pathology including myomas

Figure 19–19 Fibroid chips can be manually removed with polyp forceps or Corson graspers.

A Figure 19–20

and polyps using bipolar energy in a safe saline environment. Several innovative electrode designs, including ball, twizzle, and spring configurations deliver bipolar energy through 5-F instrument channels to vaporize, cut, and desiccate tissue. Surgical strategies and caveats similar to those discussed for monopolar technology apply when the bipolar technique is used.

EMERGING TECHNOLOGY Hysteroscopes One of the most frustrating aspects of performing operative hysteroscopic myomectomy is the production of numerous

Figure 19–21 The fibroid should be shaved until it is flushed with the endometrial cavity. Periodic uterine decompression is performed to facilitate complete removal.

B

A, Fibroid being shaved from the endometrial cavity. B, Small pieces of fibroid floating within the uterine cavity.

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B

A

Figure 19–22 A, The wire loop can be placed behind the leiomyoma to facilitate complete enucleation. B, The myometrial fasicles look clearly different from the whorled appearance of the uterine fibroid.

crescent-shaped chips. Ultimately these chips float within the endometrium and can obstruct the view. Chips traditionally are removed piecemeal with polyp forceps, Corson graspers, suction curettage, or the wire loop. These efforts increase the time of surgery and risk of perforation, cervical lacerations, and infection because instruments are removed and reinserted frequently. Two devices are available that theoretically increase visualization during operative hysteroscopic procedures. The Hysteroscopic Morcellator System (Smith & Nephew, Andover, MA) uses normal saline as a distention medium and does not use any electrical energy.17 It consists of a morcellator, fluid-monitoring system, and hysteroscope (Fig. 19–23). This system is similar to an arthroscopic surgery blade. The components include a 9-mm hysteroscope and a morcellator that is 35 cm long, which is inserted into the working channel of the hysteroscope. A powerful motor controlled by a foot pedal begins the rotation and mechanically suctions and cuts the tissue that is pulled into the inner tube (Fig. 19–24). No electrical energy is generated with this system. It is faster than traditional resection, and it morcellates myomas and polyps and removes them from the operative site without producing fibroid fragments, so that the hysteroscopic view is stellar. The Chip E-Vac operative hysteroscope (Richard Wolf, Vernon Hill, Illinios) uses monopolar energy, with glycine 1.5% or Sorbitol as the distending media. Modifications in the near future will make it a bipolar system using saline as the distending medium (Fig. 19–25). The Chip-E-Vac system is similar to traditional operative hysteroscopic resection except that tissue fragments are vacuumed or suctioned into a channel within the operative hysteroscope, removing them from the field of view most of the time. With the Chip E-Vac system, tissue can be cut and desiccated, unlike with the Smith & Nephew. Future modifications will permit bipolar cauterization with saline as the distention medium.

Both of these modifications of the operative hysteroscope make operative hysteroscopy less frustrating, especially for the novice. Even for experienced hysteroscopists, these new systems offer a pleasant alternative and should be considered if challenging cases are anticipated.

Fluid Distention and Fluid Monitoring The endometrial cavity is a potential space, and fluid pumps (preferably) or gravity-flow systems distend the endometrium and improve visualization. Fluid-pump systems can be regulated to increase intrauterine pressure between 30 and 120 mm Hg. The higher intrauterine pressure produced by fluid pumps can create an artificial or negative hysteroscopic view by pushing lesions into the endometrium or myometrium and preventing detection of subtle pathology. Intermittently, the intrauterine pressure should be decreased to help enucleate the uterine fibroid. Some fluid systems have a pulsatile mechanism that helps massage the fibroid from its base. Alternatively, episodic decompression manually can be accomplished by varying the intrauterine pressure or removing the hysteroscope periodically. By decreasing the intrauterine pressure, the fibroid bulges into the endometrial cavity, facilitating its complete removal in a piecemeal fashion. Although there have been no reported complications of fluid overload with diagnostic hysteroscopy, the incidence ranges from 0.2% to 11%.8 Factors that increase risk of fluid intravasation include length of surgery, cervical lacerations, depth of resected myometrium, increased intrauterine pressure, and vascularity of tissue. Fluid-monitoring systems with audible alerts that can be preset are essential to ensure the safety of the patient.18 If an automated fluid pump is not available, then input and output should be manually calculated for every 1000 mL used, or the

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B D A

C

E Figure 19–23. Components of the Smith & Nephew hysteroscopic morcellator. This device is used with saline distention media. A, Components of the system; B, morcellator tip for polyps; C, morcellator tip for fibroids; D, handheld piece; E, inner sheaths

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ADJUVANT MODALITIES Carboprost

the myoma is difficult to delineate. Fibroids with a deep intramural location pose more surgical challenges. Carbosprost (Hemabate, Upjohn, Kalamazoo, Mich) is the methyl analogue of prostaglandin F2α. In one study it was helpful with removal of fibroids. The FDA has approved its use for intractable postpartum hemorrhage due to atony. Indman recently described the off-label use of carboprost in 10 women to facilitate hysteroscopic myomectomy.19 Carboprost led to contraction of the myometrium and extrusion of

Despite excellent preoperative evaluation, some myomas are technically difficult to remove or the pseudocapsule surrounding

Figure 19–24 Schematic hysteroscopic myomectomy performed with the Smith & Nephew hysteroscopic morcellator.

A

Figure 19–26 Automated fluid pumps are recommended for operative hysteroscopic procedures. They provide instantaneous visual and audible feedback and can minimize fluid overload when used correctly.

B

Figure 19–25. Components of the Richard Wolf Chip-E-Vac system. A, Complete Chip E-Vac system; B, individual components of operative system. This system permits hysteroscopic resection with electrical energy and removal of the chips with each resection, minimizing floating chips within the endometrial cavity.

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Hysteroscopic Resection of Myomas and Polyps the usefulness of intraoperative ultrasound guidance during hysteroscopic resection.

Paracervical Blocks and Dilute Vasopressin Routinely, a paracervical block with 0.25% bupivacaine is injected (10 mL each at the 12, 3, 6, and 9 o’clock positions) to manage postoperative dysmenorrhea. A dilute pitressin solution (20 mL vasopressin mixed in 100 mL normal saline) injected circumferentially in 5 mL aliquots into the cervical stroma at the 12, 3, 6, and 9 o’clock positions of the cervix and facilitates operative hysteroscopic myomectomy. Vasopressin has the beneficial advantage of decreasing intrauterine absorption of glycine (or other fluids) by vasoconstriction, decreasing bleeding, and increasing intrauterine contractions. Intrastromal injections also soften the cervix.21 Repeat injections of the dilute vasopressin solution can be administered every 45 to 60 minutes as needed. Close monitoring of blood pressure, heart rate, and electrocardiogram is necessary while administering dilute vasopressin. This use of vasopressin is off label, and the patient should be informed during the consent process.

RESULTS

Figure 19–27 As essential as fluid pumps is correct draping of the patient to collect all fluid. Fluid that pools on the floor cannot be accounted for and prevents accurate assessment of inflow and outflow.

the unresectable intramural component into the endometrium, facilitating complete hysteroscopic resection. Side effects include transient fever, nausea, diarrhea, and vomiting. Additionally, due to strong uterine contractions, visualization was hampered and increased intrauterine pressures were required to manipulate the resectoscope in some cases. Care must be taken to prevent contamination of stool into the operative site if carboprost is used. Future studies are warranted to determine the benefits and limitations of carboprost during hysteroscopic myomectomy.

Intraoperative Ultrasound Coccia and colleagues20 described the benefits of intraoperative ultrasound guidance during operative hysteroscopy in treating fibroids and removing uterine septa. Prospective evaluation of 81 patients involved an experienced ultrasonographer who mapped the limits of treatment. Patients were compared to historical controls that had been similarly treated with laparoscopic monitoring. Satisfactory outcomes included relief of menorrhagia, complete resection of fibroids (including full resection of intramural fibroids), and thorough metroplasty of uterine septa. Ultrasound guidance made it possible to extend the resection beyond the limit conventionally defined by hysteroscopy, and none of the patients in the ultrasound group required reintervention. Among controls, a second operation was necessary in four cases. Investigators concluded that a wider resection (10-15 mm from the external surface of the uterus) was achieved using ultrasound guidance. Future studies are needed to determine

Making comparisons between studies of hysteroscopic myomectomies is confounded by lack of uniformity in describing menopausal age, type of myoma treated, length of follow-up, bleeding outcomes, reoperation data, pregnancy rates, and complications. As aptly stated by Myers and colleagues, “a systemic review of the literature on medical and surgical management of uterine leiomyomata concluded that available evidence is of poor quality, so that patients, clinicians, and policymakers do not have the data needed to make informed decisions.”22 Against this backdrop, the following conclusions from multiple case studies are drawn. Emanuel and colleagues23 noted that almost all ESH type 0 myomas could be removed with one surgical procedure. When uterine fibroids, even type 0, weighed more than 15 g, the chance increased that multiple procedures were needed for complete removal. The degree of intramural extension did affect the number of procedures required to achieve complete resection; ESH type 0, type I, and type II submucosal fibroids required 1.04, 1.42, and 1.72 procedures per patient, respectively, to achieve complete resection. Emmanuel and colleagues23 also concluded that women with a normal uterine volume and one or no submucosal fibroids avoided additional surgery 90% of the time by 5 years following surgery. This information is very valuable in providing informed consent regarding the likelihood for additional surgery. Particularly for late perimenopausal women undergoing operative hysteroscopic myomectomy, the chances of avoiding hysterectomy and additional surgery is particularly appealing. Thus operative hysteroscopic myomectomy can be confidently advised for a woman with an enlarged uterus whose main complaint is menstrual aberrations (without bulk symptoms, pressure, or cosmetic complaints). Such a patient can be advised that her bleeding problems are likely to subside with hysteroscopic intervention only. The late perimenopausal patient is especially likely

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Hysteroscopic Resection of Myomas and Polyps to transition to the menopause with residual intramural and subserosal fibroids shrinking, and therefore she should avoid additional intervention. Growth of fibroids during the menopause is unlikely. Likewise, Emmanuel and colleagues23 discovered that 64% of women with uterine sizes larger than 12 gestational weeks and with more than three submucosal fibroids who underwent hysteroscopic myomectomies avoided additional surgery by year 5. These numbers are sobering, yet when coupled with a woman’s age and proximity to menopause, they may be more encouraging than for a woman age 35 years in the same clinical situation. Wamsteker and colleagues noted that of patients having incomplete resection, 50% required additional surgery within 2 years. Fibroids that penetrated deeper than 50% into the myometrium more often required a two-stage procedure.5 Polena and colleagues evaluated long-term results of hysteroscopic myomectomy in 235 patients.24 Complete resection was achieved among patients with ESH type 0 and I myomas. In Polena’s study 5.1% (n = 12) had incomplete resection and underwent repeat procedures, of which 10 were type II myomas. The other incomplete failures occurred in two patients with type I myomas, but those were very large (20 and 26 g of tissue resected). Complication rates were greater among women with multiple intracavitary leiomyomas. Polena’s group also performed postoperative hysteroscopy 1 to 2 months after surgery.24 No intrauterine synechiae were noted in patients treated with a one-step operative hysteroscopic myomectomy procedure. The mean follow-up was 40 months (range, 18-66 months), and hysterectomy was avoided in 98% of patients. Ideally, complete hysteroscopic resection of the entire leiomyoma is the goal of operative intervention. On occasion however, fluid overload, bleeding, anesthesia complications, technical issues, and poor visualization can hamper safe resection, requiring that the procedure be aborted. What happens when full resection is not completed? Van Dongen and colleagues25 studied this dilemma and concluded that incomplete resection does not always require subsequent surgery. During the study period, 528 patients were treated, of whom 17.2% had incomplete resection. Type II leiomyomas were more commonly associated with incomplete resection due to fluid overload. Women desiring pregnancy or IVF (n = 37) were immediately retreated and not considered a part of the study, leaving 41 (7.8%) patients who were monitored. It is possible that spontaneous regression or expulsion of residual myoma occurs. Surgery-free percentages were 70% at 1 year, 54% at 2 years, and 44% at 3 years. Nineteen patients (50%) required subsequent surgery for recurrent symptoms within 8 months (range, 2-77 months). Size of the leiomyoma was also an influential variable in predicting incomplete removal. A hazard ratio of 1.76/cm increase in diameter increased the likelihood of incomplete resection. For some women, especially for whom pregnancy and infertility issues are not a concern, a wait-and-see policy is warranted. Spontaneous regression, onset of menopause, and sloughing of residual fibroids might account for lack of additional surgical

intervention. Evaluation with SIS is strongly advised if recurrent hysteroscopic surgical intervention is planned. With SIS, an objective measurement of the degree of residual myoma, size, and location can be ascertained. This information, coupled with surgeon skill, can determine whether repeat hysteroscopic myomectomy or hysterectomy is warranted. Vercellini and colleagues26 evaluated 101 women with menorrhagia treated by hysteroscopic myomectomy. The mean follow-up was 41 months; myomas recurred in 27 subjects, and 20 women had recurrent symptomatic menorrhagia. Derman and colleagues,27 during a 10-year follow-up, noted that 16% of women required additional surgical intervention. In addition to excellent outcomes of operative hysteroscopic myomectomy in alleviating menstrual bleeding complaints, many patients note improvement in menstrual cramps. Dysmenorrhea is often a companion with menorrhagia. Once heavy bleeding is ameliorated, cramps improve too. Leukorrhea also improves following hysteroscopic myomectomy.

ENDOMETRIAL POLYPS Incidence Endometrial polyps are benign growths found within the uterine cavity. They consist of variable amounts of stroma, glands, and blood vessels that are covered by epithelium. They protrude from any region within the uterine cavity, tubal ostia, or endocervix (Figs. 19–28 and 19–29). Usually they are asymptomatic and remain undetectable for decades. In women without symptoms, they are often found coincidentally when pelvic ultrasound is performed for unrelated problems.28 However, in women investigated for abnormal uterine bleeding, polyps may be found in 10% to 33% (or more) of patients.29 Among premenopausal women with abnormal bleeding, polyps were observed more often in symptomatic women (32.5% vs. 10%) compared to asymptomatic women, intracavitary myomas (12% vs. 1%), and intramural fibroids (58% vs. 13%).30 Resection of polyps is associated with excellent clinical response. Especially among reproductive-age patients, resection might not alleviate menstrual abnormalities, because anovulatory cycles, adenomyosis, or intramural fibroids might coexist.31,32 Patients treated with hysteroscopic polypectomy who continue to bleed should have ultrasound evaluation (if not performed before surgery) to exclude intramural fibroids and adenomyosis. These patients may benefit from levonorgestrel intrauterine system (IUS; Mirena) placement. Some physicians consider endometrial ablation as an adjunct to improve outcomes of hysteroscopic polypectomy in reproductive-age patients who have completed childbearing.

Symptoms Symptoms most often related to uterine polyps include abnormal bleeding, postcoital staining, chronic vaginal discharge, dysmenorrhea, and infertility. Generally, bleeding due to polyps may be characterized by increased clotting, intermenstrual or premenstrual spotting, or heavier menstrual flow. Women using

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A

B

Figure 19–28. Hysteroscopic views of benign endometrial polyps.

Although cancer is rarely found within an endometrial polyp, removal because of abnormal bleeding is imperative to treat menstrual dysfunction and to reliably exclude premalignant or malignant disease. When totally asymptomatic polyps are detected, there is little justification for operative intervention. Quite often these polyps are suspected by routine TVUS and can be followed with repeat ultrasound 3 to 4 months later to determine whether the polyp (endometrial echo) has increased. Conservative management is usually all that is needed.

Hysteroscopic Polypectomy

Figure 19–29 Hysteroscopic view of an endometrial polyp with complex endometrial hyperplasia.

tamoxifen therapy have a higher incidence of endometrial polyps. Additionally, one fourth of women with endocervical polyps have an intrauterine endometrial polyp.

Malignancy Luckily, 99% of polyps removed by operative hysteroscopy are benign.33 In symptomatic women, however, operative hysteroscopic removal is imperative to evaluate histology associated with the endometrial polyps. Endometrial cancer and hyperplasia rarely occur within an endometrial polyp. In fact, only 1% of endometrial polyps have a coexisting malignancy. Endometrial polyps can coexist with other lesions including endometrial hyperplasia and submucosal fibroids. Approximately 15% to 20% of intracavitary leiomyomas coexist with polyps.

The principles of performing hysteroscopic polypectomy are similar to those for performing hysteroscopic myomectomy. Direct visualization at all times, proper orientation, retrieval of all tissue fragments, and close attention to fluid deficits improves the outcome and safety of the procedure. Endometrial polyps originate from the endometrium and therefore do not invade into the myometrium. Hysteroscopic resection is limited to the endometrial cavity. The myometrium does not need to be entered to remove the polyp. Deflation of the uterine cavity by lowering the intrauterine pressure is essential to detect polyps. They are generally smaller than fibroids, and their surface mimics that of the endometrium. Hence, high intrauterine pressures can artificially flatten polyps and prevent full visualization. Close inspection of the endocervical region should always be a goal to prevent missing a lesion. Although polyps rarely involve endometrial hyperplasia or malignancy, it is essential that the wire loop not burn or thermally destroy the submitted tissue. The pathologist must have a specimen that can be interpreted. Submit all small pieces that are removed for histologic evaluation. Polyps can be sessile, broad-based, or elongated and extending from a stalk. Care should be taken to remove the entire polyp to resolve any menstrual disturbances caused by the endometrial polyp.

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Hysteroscopic Resection of Myomas and Polyps Gebauer and colleagues34 evaluated the role of hysteroscopy in detecting and extracting endometrial polyps in 83 postmenopausal women with postmenopausal bleeding (n = 40) or sonographically thickened endometrium (n = 37) or both (n = 6). Initially the hysteroscopic surgeon surveyed the endometrium and independently recorded results. The second surgical team performed curettage and used Randall polyp forceps. Afterward, control hysteroscopy was performed by the initial hysteroscopist, and if an intracavitary lesion was detected, operative hysteroscopic resectoscopy was performed. Endometrial polyps were detected in 51 of 81 patients. Endometrial polyps were found by curettage in 22 cases (sensitivity, 43%) When the Randall polyp forceps were used immediately after curettage, endometrial polyps were detected in another 23 patients. Thus in 45 of 51 patients (sensitivity, 88%) endometrial polyps were detected by curettage and Randall forceps. The second-look hysteroscopy detected small remnants of polyps (polyp or stalk) in 22 patients and entire polyps in eight patients. Complete extraction of polyps was possible in only four patients (8%) by curettage alone. Using Randall forceps increased the number of patients with complete extraction to 8 (41%). Polyp extraction was less complete with polyp forceps or curettage when the endometrial echo was greater than 10 mm. Thinner endometrial echo was associated with an increased incidence of complete extraction with blind operative procedures. The most complete removal of polyps occurs when operative hysteroscopy and wire loop resection are performed simultaneously. Cravello and colleagues reported a series of 65 patients who underwent hysteroscopic polypectomy. Only 6.7% of their patients required additional surgical intervention.35 Preutthipan and Herabutya36 (n = 145), reported a 90% success rate for repeat surgery, when hysteroscopic polypectomy was performed.

POSTOPERATIVE COUNSELING Most operative hysteroscopic procedures are performed as day surgery. Smaller polyps and fibroids may be removed in the

office setting. When a paracervical block, nonsteroidal antiinflammatory drugs (NSAIDs), and occasionally a mild narcotic are used, most patients have very little pain following operative hysteroscopy. Patients typically can expect a mild serosanguineous discharge for 1 to 4 weeks. Mild cramping should be relieved with NSAIDs. Patients with persistent pain and discharge must be promptly evaluated for endometritis or hematometria, because persistent or escalating pain is not the norm following operative hysteroscopy. Most patients typically resume work and other activities within 24 to 48 hours. Sexual activity may resume when the discharge ceases. Patients having incomplete resection might notice a longer episode of spotting and vaginal discharge. Patients who have fever, malaise, or worsening pain or who require escalating pain medication should be seen in the office. Avoid telephone triage and treatment. Evaluate the patient for possible visceral injuries of the bowel or bladder, endometritis, pyometria, or hematometria. Bimanual examination, transvaginal ultrasound, and complete blood cell count are an important component of the work-up if postoperative complications are suspected. Flat plate radiography of the abdomen detects free air if a perforated bowel is suspected. Sometimes computed tomography (CT) scan of the pelvis and abdomen is indicated if hematometria or a perforated bowel or bladder is suspected. Management of hysteroscopic complications are discussed in Chapter 20.

SUMMARY Operative hysteroscopic myomectomy and polypectomy has many advantages. Most often it can be performed as same-day surgery using local anesthesia and sedation. Recuperation is short, and relief of symptoms is excellent. Operative hysteroscopic myomectomy and polypectomy are essential surgical procedures that improve menstrual disorders, improve pregnancy outcomes, and treat postmenopausal bleeding. The presurgical evaluation is critical to decrease complications and improve the success of the procedure. Patients benefit from this minimally invasive procedure and avoid additional surgical intervention most of the time.

REFERENCES 1. 2.

3.

4.

5.

Neuwirth RS, Amin HK: Excision of submucous fibroids with hysteroscopic control. Am J Obstet Gynecol 1976;126:95-99. Wegienka G, Baird DD, Hertz-Picciotto I, et al: Self-reported heavy bleeding associated with uterine leiomyomata. Obstet Gynecol 2003;101(3):431-437. Stewart EA, Nowak RA: Leiomyoma-related bleeding: A classic hypothesis updated for the molecular era. Hum Reprod Update 1996;2:295-306. Hickey M, Fraser IS: Clinical implications of disturbances of uterine vascular morphology and function. Baillieres Best Pract Res Clin Obstet Gynaecol 2000;14:937-951. Wamsteker K, Emanuel MH, Kruif JH: Transcervical hysteroscopic resection of submucous fibroid for abnormal uterine bleeding: Results regarding the degree of intramural extension. Obstet Gynecol 1993;82:736-740.

Dueholm M, Lundorf E, Olesen F: Imaging techniques for evaluation of the uterine cavity and endometrium in premenopausal patients before minimally invasive surgery. Obstet Gynecol Survey 2002;57(6):389-400. 7. Hart R, Molnar BG, Magos A: Long-term follow-up of hysteroscopic myomectomy assessed by survival analysis. BJOG 1999;106: 700-705. 8. Jansen FW, Vredevoogd CB, van Ulzen K, et al: Complications of hysteroscopy: A prospective, multicenter study. Obstet Gynecol 2000;96:266-270. 9. Agostini A, Cravello L, Bretelle F: Risk of uterine perforation during hysteroscopic surgery. J Am Assoc Gynecol Laparosc 2002;9:264-267. 10. Preutthipan S, Herabutya Y: Vaginal misoprostol for cervical priming before operative hysteroscopy: A randomized controlled trial. Obstet Gynecol 2000;96:890-894.

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Hysteroscopic Resection of Myomas and Polyps 11. Thomas JA, Leyland N, Durand N, Windrim RD: The use of oral misoprostol as a cervical ripening agent in operative hysteroscopy: A double-blind, placebo-controlled trial. Am J Obstet Gynecol 2002;186:876-879. 12. Darwish AM, Ahmad AM, Mohammad AM: Cervical priming prior to operative hysteroscopy: A randomized comparison of laminaria versus misoprostol. Hum Reprod 2004;19:2391-2394. 13. Vilos GA, Abu-Rafea B: New developments in ambulatory hysteroscopic surgery. Best Pract Res Clin Obstet Gynaecol 2005;19(5):727-742. 14. Vilos GA: Intrauterine surgery using a new coaxial bipolar electrode in normal saline solution (Versapoint): A pilot study. Fertil Steril 1999;72:740-743. 15. Falcone T, Gustilo-Ashby AM: Minimally invasive surgery for mass lesions. Clin Obstet Gynecol 2005;48(2):353-360. 16. Munro MG: Capacitive coupling: A comparison of measurements in four uterine resectoscopes. J Am Assoc Gynecol Laparosc 2004;11:379-387. 17. Emanuel M, Wamsteker K: The intrauterine morcellator: A new hysteroscopic technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol 2005;12:62-66. 18. Loffer FD, Bradley LD, Brill A, et al: Hysteroscopic fluid monitoring guidelines. J Am Assoc Gynecol Laparosc 2000;7:438-440. 19. Indman PD: Use of carbosprost to facilitate hysteroscopic resection of submucous myomas. J Am Assoc Gynecol Laparosc 2004; 11(1):68-72. 20. Coccia ME, Becattini C, Bracco GL, et al: Intraoperative ultrasound guidance for operative hysteroscopy. J Reprod Med 2000;45:413-418. 21. Phillips DR, Nathanson HG, Milim SJ, et al: The effect of dilute vasopressin solution on blood loss during operative hysteroscopy: A randomized controlled trial. Obstet Gynecol 1996;88:761-766. 22. Myers ER, Barber MD, Gustilo-Ashby T, et al: Management of uterine leiomyomata: What do we really know? Obstet Gynecol 2002;100:8-17. 23. Emanuel MH, Wamsteker K, Hart AA, et al: Long term results of hysteroscopic myomectomy for abnormal uterine bleeding. Obstet Gynecol 1999;93(5 Pt 1):743-748.

24. Polena V, Mergui JL, Perrot N, et al: Long-term results of hysteroscopic myomectomy in 235 patients. Eur J Obstet Gynecol 2007;130:232-237. 25. Van Dongen H, Emanuel M, Smees M, et al: Follow-up incomplete hysteroscopic removal of uterine fibroids. Acta Obstet Gynecol Scan 2006;85(12):1463-1467. 26. Vercellini P, Zaina B, Yaylayan L, et al: Hysteroscopic myomectomy: Long-term effects on menstrual pattern and fertility. Obstet Gynecol 1999;94:341-347. 27. Derman SG, Rehnstrom J, Neuwirth RS: The long-term effectiveness of hysteroscopic treatment of menorrhagia and leiomyomas. Obstet Gynecol 1991;77:591-594. 28. Ryan GL, Syrop CH, Voorhis BJ, et al: Role, epidemiology, and natural history of benign uterine mass lesions. Clin Obstet Gynecol 2005;48:312-324. 29. Anastasiadis PG, Koutlaki NG, Skaphida PG, et al: Endometrial polyps: Prevalence, detection, and malignant potential in women with abnormal uterine bleeding. Eur J Gynaecol Oncol. 2000;21:180-183. 30. Clevenger-Hoeft M, Syrop C, Stovall DW, van Voorhis BJ: Sonohysterography in premenopausal women with and without abnormal bleeding. Obstet Gynecol 1999;94:516-520. 31. Nagele F, Mane S, Chandrasekaran P, et al: How successful is hysteroscopic polypectomy? Gynaecol Endosc 1996;5:137-140. 32. Henriquez D, Van Dongen H, Wolterbeek R, et al: Polypectomy in premenopausal women with abnormal uterine bleeding: Effectiveness of hysteroscopic removal. J Minim Invasive Gynecol 2007;14:59-63. 33. Ben-Arie A, Goldchmit C, Laviv Y, et al: The malignant potential of endometrial polyps. Eur J Obstet Gynecol Reprod Biol 2004; 115:206-210. 34. Gebauer G, Hafner A, Siebzehnrubl E, Lang N: Role of hysteroscopy in detection and extraction of endometrial polyps: Results of a prospective study. Am J Obstet Gynecol 2001;184:59-63. 35. Cravello L, D’Ercole C, Roge P, et al: Hysteroscopic treatment of endometrial polyps. Gynaecol Endosc 1995;4:201-205. 36. Preutthipan S, Herabutya Y: Hysteroscopic polypectomy in 240 premenopausal and postmenopausal women. Fert Steril 2005;83: 705-709.

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20

Complications of Hysteroscopic Surgery Jonathan Emery and Tommaso Falcone

Recent advances in technology have allowed even general gynecologists to begin to perform advanced hysteroscopic surgery. With newer procedures such as global endometrial ablation, an increasing number of gynecologic surgeons are using hysteroscopy as an alternative to more invasive procedures. However, some gynecologists are still reluctant to incorporate these techniques into their surgical armamentarium due to fears of complications. It is true that as more hysteroscopic procedures are performed, more complications may arise; however, prevention of and recognition of these complications is of vital importance for the gynecologic surgeon. This chapter reviews the most common complications of diagnostic and operative hysteroscopy as well as appropriate treatment and follow-up. Techniques aimed at prevention of these unfortunate events are also discussed.

The common peroneal nerve goes around the head of the fibula and is easily compressed. The patient presents with foot drop with inability to dorsiflex the foot. Physical therapy is usually successful in treating this nerve disorder. Attention to the lateral aspect of the leg during positioning prevents most of these injuries. The femoral nerve crosses into the leg under the inguinal ligament. If the patient’s legs are hyperflexed or hyperextended, the femoral nerve may be compressed. The patient presents with weakness in the quadriceps muscles. The knee jerk response is attenuated or absent. There is also numbness over the medial and anterior thigh. Electromyography is helpful in delineating the extent of involvement. Physical therapy is all that is required for most patients.

PREVALENCE Since the 1990s, hysteroscopy has been increasingly used to evaluate and treat dysfunctional uterine bleeding, evaluation of infertility, and assessment of postmenopausal bleeding. Despite its minimally invasive nature, there are risks associated with hysteroscopy. Estimates for the frequency of complications during and after hysteroscopic surgery vary from 0.22% to 4.44%1,2 depending upon type of operative procedure, with more extensive procedures (endometrial ablation, resection of submucosal leiomyoma, or septum adhesiolysis) having higher associated rates of complications (Table 20–1). Hysteroscopic surgical complications can be classified as intraoperative and postoperative, with differences between early and late postoperative events.

INTRAOPERATIVE COMPLICATIONS The types of intraoperative complications include positioning, direct traumatic events, mechanical events, hemorrhage, distention medium complications, air embolism, and electrosurgical and laser complications.

Patient Positioning Proper patient positioning can generally prevent most of the nerve injuries that are seen. The most usually affected nerves are the common peroneal nerve and the femoral nerve.

Mechanical Complications Hysteroscopic surgery begins with mechanical dilation of the cervix in order to allow passage of the hysteroscope into the uterine cavity. Difficulty with this initial cervical dilation can lead to cervical lacerations, creation of a false uterine passage, and perforation of the uterus. Specific risk factors include nulliparity, prior cervical treatment for cervical dysplasia (cryosurgery, cone biopsy, laser or electrosurgical excision, and multiple cesarian sections), and postmenopausal or estrogen-deficient status. One author has suggested that patients treated with gonadotropin-releasing hormone (GnRH) agonists are also at risk for increased cervical resistance.7 Lacerations of the cervix can lead to increased bleeding during the hysteroscopy, with subsequent poor operative field visualization and increased fluid absorption. Creation of a false passage can lead to increased risk of perforation with injury to bladder, bowel, or vascular structures if the false passage is not quickly recognized. If the hysteroscope is used to visualize the introduction of the instrument through the cervical canal, then the proper view depends on the angle of view of the lens. A 0-degree lens gives a panoramic view of the cervical canal. However a 30-degree lens should be introduced with a view that shows part of the cervical canal. If a panoramic view is obtained during insertion, the hysteroscope is going in the wrong direction and can impale the cervical canal.

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Complications of Hysteroscopic Surgery Hemorrhage

Table 20–1 Overall Complications of Hysteroscopic Surgery Study

Year

Country

Complication Rate

Number

Operative or Diagnostic

Aydeniz1

1999

Germany

0.22%

21,676

Operative

Jansen4

1997

Netherlands

0.28%

13,600

Propst5

2000

US

2.7%

Hulka3

1995

US*

Overton2

1997

UK

6

1995

Scotland

Scottish

Both

925

Operative

2.97%

14,707

Operative

4.44%

10,696

Operative

978

Operative

12%

*From a survey conducted by the American Association of Gynecologic Laparoscopists. UK, United Kingdom; US, United States.

Uterine perforation can occur with insertion of cervical dilators or at the time of insertion of the hysteroscope. This risk is increased in postmenopausal women, women who have undergone prior uterine surgery (cesarean section, myomectomy), patients with severe anteflexion or retroflexion of the uterus,8 and those with endometrial adenocarcinoma. The overall incidence of perforation ranges from 0.12%1 to 1.4%.2,3 Operative hysteroscopes usually require dilation of the cervix to a number 8 to 10 Hegar dilator,9 which also increases risk. Use of thermal or electrosurgical energy during operative hysteroscopy can also increase the risk of perforation, especially if the operator uses the energy while the electrical instrument is not fully visualized. Signs of perforation include loss of uterine distention, increased distention medium imbalance, or frank visualization of other pelvic or abdominal viscera. Management of uterine perforation injury should begin as soon as the injury is found or possibly even suspected. Rapid completion of diagnostic hysteroscopic visualization is recommended, but cessation of operative procedures within the endometrial cavity is advised. Simple fundal perforations can be managed expectantly if there is minimal bleeding, and suturing is rarely needed. Anterior, posterior, or lateral perforations should warrant consideration for further assessment with laparoscopy, laparotomy, or cystoscopy. Certainly, if surgical energy was being used when the perforation occurred, this should require abdominal and pelvic exploration at once for visceral organ injury, especially of the large and small bowel, ureters, and pelvic vasculature. Diminishing the risk of cervical and uterine trauma can be accomplished by preoperative use of laminaria or misoprostol. Laminaria can be inserted the day before surgery but may not be used in woman with a shellfish allergy or with significant cervical stenosis. Use of both vaginal10 and oral11,12 misoprostol (200-400 mcg), when given up to 9 to 24 hours before the procedure, has been shown to decrease need for cervical dilation and decrease cervical resistance at the time of dilation. Side effects are few and can include vaginal spotting or bleeding and lower abdominal cramping.

Intraoperative and immediate postoperative bleeding are common problems that occur with hysteroscopic surgery. Surveys have shown hemorrhage occurs in 2.2% to 2.4% of hysteroscopic cases.2,3 Most frustrating is when intraoperative bleeding forces a procedure to be terminated before it is completed. Bleeding may be from cervical trauma but more commonly occurs in operative surgery with resection of myomas or septa and in endometrial ablation.13 Intrauterine distention pressure generally keeps smaller venous bleeding to a minimum, but larger arterial vessels, especially when associated with submucosal leiomyomas, can cause problematic bleeding and poor visualization. Loffer8 and Cooper13 described the use of 40 W of coagulating current with a wire loop or rollerball at the base of the open vessel to control such bleeding. Intrauterine distention pressure should be lessened just before completing operative or diagnostic hysteroscopy so as to visualize the entire endometrial cavity and check for bleeding. Minimal bleeding with a postoperative bloody efflux may be tolerated, but more significant bleeding can be controlled with insertion of a Foley catheter into the uterus or vasopressin (20 U in 100 mL normal saline) injected deep into the cervix in 5 mL aliquots in 4 quadrants. If these measures fail, rectal misoprostol or uterine packing may be needed. If bleeding continues, uterine artery embolization or possibly hysterectomy must be considered.13

Distention Media Complications Low-Viscosity Solutions

Of all of the complications of hysteroscopic surgery, those involving distention media have been more commonly associated with severe morbidity and mortality. The choice and proper use of the distention medium is critical for a safe hysteroscopic procedure. Estimated rates of distention media complications are 0.2% to 1.1%.4,8 Most of these complications are due to absorption and intravasation of fluid, mainly during operative hysteroscopic procedures for resection of endometrium, myometrium, or leiomyomas. Typically, operative hysteroscopy transects and disrupts the fine network of blood vessels within the surgical field of the uterine cavity. As intrauterine pressure is maintained to lyse, resect, or ablate the tissue, the distention fluid enters these vessels and eventually accumulates in the systemic circulation. With prolonged surgery, large volumes of distention medium are absorbed and the distention fluid deficit grows. Lack of awareness of this imbalance can lead to a myriad of symptoms depending on the medium used. In general, distention media are mainly hypotonic, lowviscosity fluids that can be used during operative procedures using monopolar energy. These include glycine 1.5%, sorbitol 2.7% with mannitol 0.54%, and mannitol 5%. Bipolar energy requires isotonic solutions such as normal saline or Ringer lactate, and these fluids are generally preferred for diagnostic hysteroscopic procedures due to ease of use and general availability.

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Complications of Hysteroscopic Surgery Dextran 70 is used less often because of its high viscosity and improvements in fluid management systems. Excessive absorption of hypotonic, electrolyte-free solutions can cause severe and symptomatic hyponatremia. This resultant hyponatremia can be either hypotonic (such as with glycine 1.5% or sorbitol 3.3%) or isotonic (with mannitol 5%).14 Symptoms of hyponatremia are predominantly manifested through the central nervous system and includes headache, nausea, vomiting, and agitation13 with accompanying muscle cramps, restlessness, and lethargy, and with decreased reflexes becoming more apparent if the decrease in serum sodium is large or rapid,14 as can occur during hysteroscopic surgery. Serum sodium levels greater than 120 to 125 mmol/L generally do not cause significant symptoms, but further decreases in sodium levels can lead to impaired response to noxious stimuli and hypoventilation.15 This cycle continues as hyponatremia worsens. With falling serum sodium concentrations there is a rise in the hypotonic solutes from the distention media (specifically glycine and sorbitol) and a decline in serum osmolality (Table 20–2). Permanent brain injury can result as serum hypo-osmolality develops with subsequent movement of free water across the blood–brain barrier and into the cerebral tissue, with resultant cerebral edema. At this point, hypo-osmolality fuels the increase in neurologic sequalae: bradycardia, hypertension, and seizures followed by respiratory arrest, coma, hypotension, and cardiovascular collapse. Brain stem herniation and death may also occur if recognition of and response to the condition is delayed. It appears that women of reproductive age are especially at risk for these severe neurologic symptoms due to an effect of estrogen on the brain’s ability to cellularly dissipate the cerebral edema.16 In addition to the effects of hyponatremia, the solute glycine also is metabolized cellularly in the liver and kidney to ammonia and glycolic acid. This transient hyperammonemia also contributes to neurologic symptoms and can cause azotemia and a residual intravascular water load as the glycine metabolites are excreted by the kidney.17 A peculiar side effect of glycine is a transient blindness.

Table 20–2 Hysteroscopic Media: Osmolality and Sodium Concentrations Medium

Osmolality (mOsm/kg H2O)

Sodium Concentration (mEq/L)

Normal (0.9%) saline

308

154

Serum

290

135-145

Mannitol 5%

280

Ringer latate

273

Glycine 1.5%

200

—

Sorbitol 3%/mannitol 0.5%

178

—

— 130

Adapted from Cooper JM, Brady RM: Intraoperative and early postoperative complications of operative hysteroscopy. Obstet Gynecol Clin North Am 2000;27:347-366.

Because mannitol is isotonic there is less risk of severe serum hypo-osmolality, but this medium also carries the risk of hyponatremia. Mannitol also acts as an osmotic diuretic, which some have suggested can reduce risk of water overload and hyponatremia.18 Use of isotonic media such as normal saline and Ringer lactate can also lead to significant fluid intravasation, but their sodium content and serum osmolality prevent development of hyponatremia and hypo-osmolality (see Table 20-2). Massive intravascular shifts can lead to fluid overload with resultant pulmonary edema and congestive heart failure.9,19 Recognition and treatment of hysteroscopic fluid complications requires attention from the surgeon, anesthesia team, and operating room staff. Risk factors for increased absorption of fluid include prolonged operating time, excessive intrauterine fluid pressure, operative hysteroscopic procedures such as endometrial ablation, myoma, septa resections or lysis of intrauterine adhesions such as with Asherman syndrome. Operative procedures that last longer than 60 to 90 minutes increase fluid absorption. This can be especially true if the surgeon discovers a submucosal myoma has a larger intramural component than was anticipated or if there is poor visualization from bleeding vessels within the myoma. Also, continued interruptions in the procedure to clear myoma chips from the operative field with resumption of distention are all common causes of extended surgical time. Although there is no definite time requirement, patients should be informed preoperatively that difficult and prolonged cases might need to be completed in more than one step. It is better to return to the operating room to complete a difficult case rather than to struggle over a long time and increase risk of fluid absorption and other potential complications. Excessive intrauterine pressure is a likely cause of increased fluid absorption. In general, the lowest pressure necessary to achieve an unobstructed view of the uterine cavity should be used. Typically this can be achieved with infusion pressures of 60 to 75 mm Hg and intrauterine pressures of approximately 10 to 15 mm Hg less.8,20 The risk of fluid absorption and subsequent overload increases when mean infusion pressure is greater than the mean arterial pressure.21 Appropriate infusion can be accomplished using an infusion pump. A decline in serum sodium levels is first recognized soon after an imbalance of distention fluid intake greater than output is noted. Intraoperative fluid measurement systems are imperative in operative hysteroscopic surgical cases because these systems allow rapid assessment of the rate of fluid loss and for early warning of excessive fluid intravasation by using real-time totals.22 If mechanical monitoring is not available, there must be one member of the operating room team whose job it is to accurately measure distention fluid intake, output, and deficit and report these levels frequently to the surgeon. Communication between the surgeon, operating room personnel, and the anesthesiologist is imperative. Although hyponatremia is less likely to occur with diagnostic hysteroscopic procedures, attention to fluid inflow and outflow should be monitored by staff in the operating room or office procedure room.

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Complications of Hysteroscopic Surgery When intraoperative fluid deficits approach 750 mL, expeditious completion of the procedure is recommended. Several authors have recommended that once the fluid deficit reaches 1500 mL of a hypotonic solution, the procedure should be terminated.13,22,23 Others have suggested a fluid deficit of 1000 to 2000 mL.24,25 Aside from fluid deficits, serum sodium concentrations can be used to guide surgery. Once the serum sodium declines to 129 mmol/L or less, the procedure should be abandoned. As the case is concluding, the anesthesia team should be notified, serum electrolytes should be quickly measured, a Foley catheter should be placed for postoperative urine measurement, and furosemide 20 mg IV should be given. Furosemide will induce a hypotonic diuresis. Patients who have decreased serum sodium levels need close monitoring postoperatively. Indman has suggested that patients with a serum sodium less than 120 mmol/L should be considered for treatment and monitoring in a critical care setting.23 Treatment of hyponatremia is supportive and should be focused on decreasing fluid overload and restoring serum sodium, although there is no definitive agreement on optimal treatment of symptomatic hyponatremia.14 Serum potassium and calcium should also be assessed. Oxygen administration is important and intubation and hyperventilation may be required in order to reduce cerebral edema. In addition to furosemide to clear the excess free water, hypertonic saline may be given judiciously. In general, hypertonic saline is not needed if there are no neurologic or cardiac abnormalities. The goal is to raise the serum sodium level by 1 mmol/L per hour. A too-rapid correction of the low sodium has been implicated in causing central pontine myelinolysis.18,25 Hypertonic saline is generally not needed when hyponatremia is iso-osmolar, as is common with mannitol infusions. Mannitol acts as its own diuretic, which helps to reverse the declining sodium. When using isotonic electrolyte solutions as distention media, fluid deficits of up to 2500 mL can be tolerated as the risk of hyponatremia and hypo-osmolality are reduced. Fluid overload with pulmonary edema and congestive heart failure can still occur, and they respond well to fluid restriction, diuretic administration, and oxygen supplementation. Regional anesthesia, either spinal or epidural, with minimal sedation has been advocated because it allows earlier detection of neurologic sequelae associated with fluid overload of hypotonic solutions. In women with cardiovascular disease undergoing significant operative procedures such as endometrial ablation or myoma resection, endotracheal intubation and central venous pressure monitoring is recommended.25 High-Viscosity Solutions

Less frequently used today is dextran 70, a high-viscosity solution of 32% dextran 70 in D10W. Although this fluid allows a clear intrauterine picture, it can be difficult to use because it requires significant pressure to infuse and damages hysteroscopic equipment if it is allowed to crystallize. Rare but significant complications from use of dextran 70 include anaphylactic reactions, coagulopathy, and fluid overload.

Anaphylaxis is rare, with an incidence of 1 in 10,000,26 and is postulated to occur secondary to prior sensitization from sugar beets or a cross-reactivity with bacterial antigens (pneumococci, streptococci, or salmonella).18 Treatment is supportive with epinephrine, diphenhydramine, and steroids if needed as well as intravenous fluids and ventilatory support. Coagulopathic changes are also associated with dextran use due to the antithrombotic effect of this branched polysaccharide. It is theorized that there is decreased platelet adhesiveness and alterations in the fibrin clot that render it less stable. It also decreases several clotting factors (fibrinogen and factors V, VII, IX, and VIII [vWF type C]).18 Fluid overload with dextran is the most common complication. Fluid overload can occur with much smaller volumes than for the low-viscosity media. Leake and colleagues reported on two patients in whom noncardiogenic pulmonary edema developed with infusion volumes of approximately 350 mL and 600 mL, respectively.27 Lukascko reported that 100 mL of dextran absorbed intravascularly can expand the plasma volume by 860 mL.28 The high molecular weight polysaccharides are not excreted by the kidney because they exert oncotic pressure in the intravascular space without renal excretion; therefore, diuretics have less effect clearing the fluid overload.13 Thus, dextran causes increased intravascular plasma oncotic pressure, with resultant intravascular volume overload, as opposed to the water intoxication seen with a distending medium such as glycine.18 Prevention intraoperatively involves the use small quantities of fluid, expeditious surgical technique, and continuous pulse oximetry. Treatment of dextran associated fluid overload includes adequate oxygenation and ventilatory support if needed. Diuretics are less useful. Gas Media

Carbon dioxide is used almost exclusively for distention during diagnostic hysteroscopy. It is clean, easy to use, and well tolerated.29 No other gas is safe to use for this purpose because the CO2 is rapidly absorbed into the blood and then released during respiration. This inert gas is used for distention and delivered at a maximum flow of 100 mL/min and a maximum pressure of 100 mm Hg. Embolization of small amounts of CO2 is not dangerous,8 and it has been shown that just over 50% of hysteroscopies have some amount of CO2 embolized.30 The risk of subclinical CO2 embolic events was studied in more than 3900 diagnostic hysteroscopies using CO2. The incidence was found to be 0.51%.31 Embolism of carbon dioxide has been reported as a significant consequence when performing hysteroscopic surgery with the neodymium : yttrium–aluminum–garnet (Nd : YAG) laser.8 The risk of intravasation markedly increases when using CO2 as a coolant along the laser fiber. Risk is lessened by using carbon dioxide only for diagnostic procedures, using insufflators designed for hysteroscopy, and keeping flow rates and pressures in recommended ranges.22 The surgeon and operating room personnel must make every attempt to expunge all room air from the insufflation tubing because this will decrease the risk of gas embolism from room air.

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Air embolism during hysteroscopic surgery is an uncommon but potentially fatal complication that requires an understanding of its pathophysiology, recognition, management, and prevention. During hysteroscopic surgery, room air that accumulates within the uterine cavity can be compressed into the small venous blood vessels that are disrupted within the endometrium and, infrequently, in the cervix. The increased intrauterine pressure can allow this ambient air to be displaced into venous channels, which eventually enters the vena cava and ultimately the right heart. This air can enter the uterine cavity in a number of ways: as unpurged air in the tubing with the distention medium, during cervical dilation, and with repeated removal and replacement of the hysteroscope in the uterus intraoperatively. The entry of air into the circulation is increased if the uterus is located above the level of the heart, as occurs in the Trendelenberg position. In this situation, diastole creates a negative intravenous pressure, facilitating air advancement into venous channels. It is therefore prudent to avoid the Trendelenberg position during hysteroscopy, especially if an operative procedure is planned.

intravenous bolus of saline should be given and nitrous oxide discontinued if it is used. If the patient’s condition continues to worsen, she should be placed in the left lateral decubitus position in steep Trendelenberg in order to keep the air in the right heart and prevent it from passing into the pulmonary vessel bed. Removal of air from the right atrium can be attempted by placement (and aspiration from) a central venous catheter. Cardiac massage and pericardial thumps can help to break up larger air bubbles.33 Steps can be taken to decrease the likelihood of air embolism. Some have suggested that pretreatment of the uterus with GnRH analogues can decrease the capacity of the intrauterine venous channels.24 Preoperative removal of air from insufflation tubing, avoidance of the Trendelenberg position, decreasing operative time, using standard infusion pressures, and avoiding repeated advances of the hysteroscope into the uterus all decrease risk of air embolism. Continuous end-tidal CO2 volume should be continuously monitored by anesthesia personnel. An alternative to nitrous oxide should be used because nitrous oxide can increase the size of bubbles in the blood stream. Most importantly, never ignore a drop in end-tidal CO2.

Pathophysiology

Energy-Related Complications

Air Embolism

Once the air enters the right heart, it accumulates within the atrium and ventricle. This compromises the pump function of the heart, occludes the right outflow tract, and dramatically decreases pulmonary blood . . flow. Physiologically, this creates a ventilation/perfusion ( V/Q) mismatch with a resulting increase in pulmonary. dead space and development of a right-to-left . shunt. This V/Q mismatch causes a decrease in end-tidal CO2. Subsequent to this, pulmonary blood flow decreases, cardiac output declines, and blood pressure and arterial oxygen saturation decrease.32 Resulting tachycardia, cardiac arrythmias, and tachypnea develop, and changes in the patient’s electrocardiogram are noted. Cardiovascular collapse is imminent at this point. Intraoperatively, the anesthesia personnel note a sudden decrease in end-tidal CO2 and a decrease in oxygen saturation. Development of a heart murmur is also noted as air enters the heart. This begins as a systolic murmur, which develops into the classic mill-wheel murmur if a large amount of air accumulates in the right heart. There is also an increase in central venous . . pressure. Arterial blood gas reveals hypoxemia from the V/Q mismatch. Under regional or local anesthetic, patients might note chest pain and difficulty breathing or a sense of breathlessness and a change in consciousness. These patients develop a respiratory alkalosis from tachypnea as well. Understanding the mechanism of development of air embolism as well as the signs and symptoms of air accumulation in the heart help in establishing immediate and effective treatment to avoid complete cardiovascular collapse.

Use of electrosurgical and laser energy during operative hysteroscopy is increasing in popularity as operative procedures for relief of menorrhagia, resection of septa and submucosal myomas, and release of intrauterine adhesions are being performed more often. Complications arising from use of operative energy are mainly focused on thermal injury, commonly to the pelvic viscera. These surgical events might not be recognized at the time of the procedure and might have delayed effects of peritonitis, bowel obstruction, fistula formation, sepsis, and even death. Use of surgical energy in the setting of unrecognized uterine perforation causes the most devastating of injuries, but complications can arise in the absence of a perforation. The thermal effects of monopolar electrical energy have to do with the dispersion of unrecognized energy transfer; the stray current from the monopolar electrode can cause tissue damage outside of the view of the hysteroscope,13 although the mechanism for this occurrence in hysteroscopy is not well understood. Use of monopolar energy in hysteroscopic resection can lead to increased risk of injury outside the uterine cavity if the myometrium is too thin (as occurs in the cornua or along a prior cesarean section scar) or to increasingly undermined and destroyed tissue by continued resection with a loop. Because of this, many surgeons believe use of the rollerball or rollerbarrel decreases risk of injury due to less myometrial penetration than the loop, though complications have been reported with endometrial rollerball ablation using monopolar energy.2,34

Treatment and Prevention

Prevention

Once air embolism is suspected, 100% oxygen should be administered and the anesthesia team should immediately alert the surgeon, who should discontinue the procedure at once.25 An

Prevention of electrosurgical complications can be accomplished by using sound judgment in the preoperative, intraoperative, and postoperative periods. Before surgery, an awareness of uterine

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Complications of Hysteroscopic Surgery position is important: Severe anteflexion or retroflexion of the uterus can lead to difficulty in maneuvering the loop or rollerball, with increased myometrial penetration inadvertently. Women with a history of one of more cesarean sections are at risk for thinning of the myometrium adjacent to the scar; this is especially important in women who underwent a classic rather than lower uterine segment cesarean. Preoperative assessment of myometrial thickness, uterine myoma position, and other uterine parameters can undertaken with ultrasonography or magnetic resonance imaging (MRI). During surgery, the most important technique is that the tip of the energized instrument (loop, wire, ball, laser) must be in direct view during activation of energy. Loffer has ascertained that risk of perforation and damage to the pelvic viscera is most common when the activated electrode or laser is advanced away from the operator because depth of penetration of the instrument and its energy are difficult to estimate.8 Therefore, energy should be activated while withdrawing the activated electrode toward the hysteroscope in plain view. In some surgical procedures, such as treatment of a uterine septum, the electrode is necessarily advanced when the energy is activated. In some cases, intraoperative ultrasonography or laparoscopy can assist the surgeon with increased surveillance of the uterus and viscera, with the goal of preventing complications, although these can occur despite the additional surveillance. Diagnosis and Management

If perforation is suspected intraoperatively or in the immediate postoperative period in a case involving surgical energy, it is imperative that an assessment be undertaken to exclude the possibility of thermal injury to pelvic viscera. Some authors advise exploratory laparotomy for full-length assessment of the small bowel to detect any serosal blanching, duskiness, or frank laceration or perforation because it is extremely difficult for all but the most experienced endoscopic surgeons to evaluate all of the bowel laparoscopically. Postoperatively, any patient with persistent nausea, vomiting, fever, or increasing abdominal pain after operative electrical hysteroscopy warrants a full physical examination and laboratory and imaging assessment. Delay in diagnosis and treatment of these serious complications can result from unrecognized and untreated visceral injuries, leading to sepsis and death. Bipolar and Laser Energy

Recent advances in technology have allowed use of bipolar energy with hysteroscopic surgery. These systems use a small active electrode located at the tip or end of the operative instrument (e.g., ball, spring, paddle) with a return electrode located on the shaft and separated by a ceramic insert. This allows isotonic electrolyte solutions to be used as distention media as well as the small loop involved with bipolar energy with less risk of inadvertent spread of energy and subsequent damage to other viscera. The risk of energy-related injuries still, exists especially if perforation occurs. Use of the Nd : YAG laser is decreasing because it is awkward to use (articulating arms, difficulty with fibers), it is expensive,

and newer technologies are superior. Use of the laser with CO2 as a coolant increases the risk of air and gas embolism. Also, definitive techniques and movement of the laser tip decrease risk of deep tissue penetration and subsequent injury during operative hysteroscopy.

POSTOPERATIVE COMPLICATIONS Although expeditious recognition and management of intraoperative complications is of tantamount importance, the gynecologic surgeon should not conclude that her or his job is over upon leaving the operating theater. Hysteroscopic surgery has several late complications that can occur hours to days after surgery, even extending to years after the original surgery has been completed. Correct diagnosis and ultimate treatment of these outcomes requires attention to patient complaints. Postoperative complications can be classified as those of infectious etiology, hematometra, pregnancy-related complications following endometrial ablation, post–tubal sterilization syndrome, and postablation endometrial adenocarcinoma (Box 20–1).

Infection Infection after surgery can take the form of endomyometritis, cystitis, and rare cases of parametritis. Postoperative uterine infection following hysteroscopic surgery usually manifests within several days to several weeks of the procedure. The incidence of posthysteroscopic endomyometritis is between 0.01%1 and 1.6%35 and is more commonly associated with prolonged operative hysteroscopic procedures, especially when the surgical instruments are passed into the uterine cavity repeatedly. Other risk factors for infection include lack of aseptic technique and extensive tissue destruction in utero such as with lysis of adhesions or endometrial resection. McCausland reported increased risk of postoperative tuboovarian abscess after operative hysteroscopy in patients with documented history of pelvic inflammatory disease who did not receive preoperative antibiotic prophylaxis.36 Preoperative antibiotics should be used in patients with known cardiac valvular disease or artificial joints. The value of perioperative antibiotics in diagnostic hysteroscopy and uncomplicated operative hysteroscopy has not been established in the absence of the abovementioned criteria. Avoidance of postoperative infections can be improved by appropriate evaluation and perioperative management. Known or active genital tract infections are a contraindication to hysteroscopic surgery. Although this seems obvious for infections

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BOX 20-1 Late Postoperative Complications Infection Hematometra Pregnancy-related complications Post–tubal sterilization syndrome Postablation endometrial adenocarcinoma

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Complications of Hysteroscopic Surgery with Neisseria gonorrheae or Chlamydia trachomatis, an oftenforgotten pathogen is the herpes simplex virus. A case of fulminant hepatic failure and death following hysteroscopy in a patient with herpes simplex has been reported.37 Appropriate preoperative screening for a history of herpetic infections should be undertaken, and any suggestion of prodromal or active herpes infection should be cause for rescheduling the procedure until the infection has cleared. Avoidance of repeated entry through the cervix and crucial attention to proper aseptic technique help to decrease the incidence of postoperative endomyometritis. A long operative hysteroscopic procedure that causes increased endometrial or myometrial tissue destruction as well as multiple tissue fragments or chips that do not get flushed out of the uterine cavity can increase the risk of infection after surgery. Postoperative patient complaints of lower abdominal pain, fever, or foul-smelling vaginal discharge should prompt investigation for an infectious source within the pelvis. Suprapubic or adnexal tenderness on abdominal examination or a pelvic examination that reveals a boggy, tender uterus or adnexa, especially in the face of a fever or leukocytosis with a left shift, should alert the clinician to a diagnosis of endomyometritis. Further investigation may include an endometrial biopsy. If increased white blood cells are seen, then the diagnosis is confirmed (plasma cells denote a chronic infection). Cooper has advocated that women with a postoperative endometritis should receive a pelvic ultrasound to rule out abscess as well as an abdominal series to check for free air in the peritoneal cavity if there was no concomitant laparoscopy.13 Treatment consists of broadspectrum antibiotics. Hospitalization is usually reserved for patients with proven or suspected abscess.

Pregnancy-Related Complications Pregnancy-related complications following hysteroscopic surgery, specifically hysteroscopic ablation or resection, are uncommon. Pregnancy after these cases is an unplanned event. The incidence of pregnancy following endometrial ablation is estimated between 0.7% and 1.6%,38,39 and pregnancy after endometrial ablation has been reported up to 12 years after hysteroscopic surgery.40 The main concern with these pregnancies is that the endometrium has been denuded and scarred by the prior ablation, with subsequent attachment of the placenta onto this less-hospitable tissue layer. Therefore, difficulties arising with pregnancy after endometrial destruction are commonly associated with problems of placentation, similar to pregnancies in women with Asherman syndrome. Obvious early complications include spontaneous abortions both early (<12 weeks’ gestation) and late (>16 weeks’ gestation). For pregnancies that progress to fetal viability, common obstetric complications include intrauterine growth restriction, placental accreta, increta, or percreta, placental abruption, uterine rupture, and postpartum hemorrhage.41 One review reported that of postablation pregnancies that progressed beyond 24 weeks’ gestation, 50% delivered prematurely.42 Prevention of pregnancy after endometrial ablation is the obvious way to avoid

these subsequent unwanted obstetric outcomes. Women should be counseled preoperatively about risks of subsequent pregnancy and should be offered sterilization (if appropriate, as a combination procedure) either hysteroscopically or laparoscopically, or the male partner may choose to be sterilized. Alternatively, temporary and reversible methods of contraception should be offered and subsequent care of these patients postoperatively in the long-term should annually address this need to prevent future pregnancies. In addition to endometrial ablation, pregnancy complications can occur after other hysteroscopic procedures such as resection of uterine septa or submucosal leiomyoma or lysis of intrauterine adhesions. In these cases, pregnancy is not an unwanted event and therefore the physician should be vigilant because the complications discussed can occur. Uterine perforation during operative hysteroscopy has been shown to be a cause of future pregnancy complications, though one author has noted that this risk factor is usually a secondary factor when another risk factor such as use of electrosurgery is also present.43 Uterine rupture can occur during labor or without labor. The most common procedure associated with uterine rupture is a hysteroscopic metroplasty.43 Use of electrosurgery, especially with monopolar energy, can cause extensive tissue damage beyond the surgeon’s field of view during the operative procedure, thus weakening the myometrium and rendering the uterus susceptible to rupture during pregnancy and labor. Prevention of hysteroscopic complications, specifically perforation and use of surgical energy, should be followed as outlined earlier to prevent these problems. Also, in women who have undergone extensive hysteroscopic resections or adhesiolysis, vigilance by the obstetrician is paramount, especially once viability is established. Consideration of elective cesarean section after confirmation of fetal lung maturity (if remote from term) may be considered in these patients.

Chronic Pain Hematometra

It has been estimated that postoperative hematometra occurs in 1% to 2 % of all women undergoing endometrial resection or ablation.44 In general, this complication should be considered if a woman presents from 2 to 15 months postoperatively with cyclic, midline, cramping pain; there is likely also amenorrhea. Residual, often loculated islands of endometrial glands and stroma may be walled off within the scarred uterine lining after endometrial ablation, which leads to collection of blood within the uterine cavity. Diagnosis is usually made by ultrasound, but examination might also show cervical stenosis. Treatment may consist of simple cervical dilation but can at times require operative hysteroscopy with resection of adhesions. Avoidance of endometrial resection of the lower uterine segment and cervix can help prevent this infrequent complication. Postablation Tubal Sterilization Syndrome

First described by Townsend and colleagues in 1993,45 postablation tubal sterilization syndrome (PTSS) is similar to hemato-

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Complications of Hysteroscopic Surgery metra but occurs when pockets of isolated endometrium are left within the hard-to-resect uterine cornua. These areas produce cyclic retrograde menstruation into an occluded fallopian tube with resultant dilatation, swelling, and pain.42 The incidence of PTSS is difficult to assess but is estimated to be as high as 10%.46,47 Patients undergoing endometrial ablation are counseled in regard to the need for continued contraception, and therefore some undergo tubal sterilization either before or concomitantly with endometrial ablation. Women who have undergone previous tubal ligation by most any method are at risk for the syndrome. Typically, the patient presents from 2 to 12 months after endometrial resection with cyclic, at times severe, cramping lower abdominal pain, which may be unilateral or bilateral. This is often associated with a light menstrual flow in patients who have not achieved postoperative amenorrhea. Radiologic evaluation might demonstrate fluid in the uterus and occasionally within the tube. MRI has been shown to have specific radiologic criteria for the diagnosis of corneal hematometra that support the diagnosis of PTSS.48 The gold standard for diagnosis is laparoscopy where a dilated proximal fallopian tube is seen. In Townsend’s original description, the tube may be swollen to twice its normal size, and obvious hematosalpinx may be present.45 Treatment is surgical: Salpingectomy is curative. Bilateral salpingectomy is recommended, and in some cases hysterectomy may be preferred. Hysteroscopic resection or ablation of any remaining visible endometrium should also be undertaken. Mall and colleagues49 showed that a previous tubal ligation was a risk factor for having a hysterectomy following endometrial ablation due mainly to new-onset pelvic pain associated with PTSS. Conservative treatment with nonsteroidal antiinflammatory medications and hormonal manipulation (progestin or oral contraceptives) may be given as first-line treatment in patients with a clinical or radiologic diagnosis of PTSS, but curative surgery should be considered in patients who fail these measures. Preventing PTSS remains difficult. At the time of hysteroscopic endometrial ablation, attempts should be made to ablate the cornua sufficiently. This must be done with care because perforation by vigorous attempts to remove this tissue is more likely in this region. Pretreatment of these patients with GnRH analogues has also been suggested to thin the endometrium to facilitate a more complete ablation.42 In regard to tubal sterilization, the tubes should be ligated, banded, or clipped as close to the cornua as possible in women who undergo concomitant ablation with sterilization. There is a small risk of endosalpingioblastosis, however, with possible increased risk of uteroperitoneal fistula and risk of ectopic pregnancy,50 although this seems more a theoretical than actual risk.

Endometrial Cancer Following Endometrial Ablation or Resection Another complication of hysteroscopic endometrial resection or ablation that can occur years after the initial surgery is uterine endometrial cancer. Operative resection or ablation with resec-

toscope, rollerball, or laser rarely removes or destroys the entire endometrial surface. Therefore, the persistence of viable, functioning endometrial glands and stroma within the uterine cavity can allow development of endometrial cancer, most commonly adenocarcinoma. This is to be differentiated from malignancy diagnosed at the time of endometrial resection from tissue obtained during the operative hysteroscopy.52,53 Women who develop a significant increase in menstrual bleeding after ablation require a thorough and complete evaluation. Radiographic evaluation with ultrasound or MRI is often of limited value, and the main goal of the evaluation is to obtain tissue for pathologic evaluation to exclude malignancy. Pipelle biopsy, aspiration biopsy, curettage, or hysteroscopy may be used to diagnose this problem. Gimpelson contends that patients should be evaluated with hysteroscopy and directed biopsies so as not to miss scarred or adherent portions of the uterine cavity.54 Use of laminaria or misoprostol before intrauterine evaluation may be helpful, especially in postmenopausal women. Inability to gain access to the endometrial cavity or to obtain tissue for pathologic evaluation should prompt consideration of definitive diagnosis with hysterectomy. Prevention of postablation malignancy is primarily a function of patient selection and involves a complete preoperative evaluation. This includes careful assessment of the endometrium before the ablation with an office endometrial biopsy, curettage specimen, or hysteroscopically directed biopsy confirming endometrium without cytologic atypia, hyperplasia, or frank carcinoma. Many case reports are available of patients who underwent endometrial ablation after endometrial tissue sampling showed endometrial hyperplasia.55,56,57,58 The hyperplasia may have been treated before the ablation. These authors also comment on the fact that many of these patients are also burdened with comorbid conditions such as diabetes, hypertension, and obesity. Often because of these conditions, patients refuse or are refused (due to comorbidities) for hysterectomy and thus are offered endometrial resection or ablation. Subsequent development of adenocarcinoma then necessitates hysterectomy. Gimpelson has proposed that endometrial hyperplasia be considered a contraindication to endometrial ablation until further studies can assess the impact of endometrial ablation on these patients.54 Patients in whom endometrial hyperplasia is diagnosed at the time of endometrial ablation, by biopsy or curettage, require close treatment and surveillance. Treatment with progestins in patients without cytologic atypia is mandated as well as follow-up tissue sampling to confirm the resolution of these cellular changes. Radiology evaluation is less helpful because ultrasonography might not show a thickened endometrium in a scarred postablation uterus and saline infusion sonography might also be misleading for the same reason. Patients, especially those who are postmenopausal, should be instructed to report any abnormal bleeding, which must be investigated. If persistence of hyperplasia is found or if adequate endometrial sampling cannot be undertaken or patients are not compliant with postablation monitoring, then consideration for definitive treatment with hysterectomy is advisable.

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Complications of Hysteroscopic Surgery SUMMARY Gynecologic surgeons will continue to work to advance the use of hysteroscopy, and thus the likelihood of complications associated with these surgeries will continue to be present. However,

with appropriate patient selection and preoperative evaluation, intraoperative communication, and attention to detail as well as postsurgical awareness and follow-up, many of these events can be managed quickly with little harm to the patient and can, in some cases, be avoided.

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21. Garry R, Hasham F, Kokri MS, et al: The effect of pressure on fluid absorption during endometrial ablation. J Gynecol Surg 1992;8:1-10. 22. Loffer FD, Bradley LD, Brill AI, et al: Hysteroscopic fluid monitoring guidelines. J Am Assoc Gynecol Laparosc 2000:16-17. 23. Indman PD, Brooks PG, Cooper JM, et al: Complications of fluid overload from resectoscopic surgery. J Am Assoc Gunecol Laparosc 1998;5:63-67. 24. Isaacson KB: Complications of hysteroscopy. Obstet Gynecol Clin North Am 1999;26:39-51. 25. Murdoch JAC, Gan TJ: Anesthesia for hysteroscopy. Anesthsiol Clin North Am 2001;19:125-140. 26. Ahmed N, Falcone T, Tulandi T, et al: Anaphylactic reaction because of intrauterine 32% dextran-70 instillation. Fertil Steril 1991;55: 1014-1016. 27. Leake JF, Murphy AA, Zacur HA: Noncardiogenic pulmonary edema: A complication of operative hysteroscopy. Fertil Steril 1987;48: 497-499. 28. Lukascko P: Noncardiogenic pulmonary edema secondary to intrauterine instillation of 32% dextran 70 (letter). Fertil Steril 1985;44:560-561. 29. Bradley LD, Widrich T: Flexible hysteroscopy: A state-of-the-art procedure for gynecologic evaluation. J Am Assoc Gynecol Laparosc 1995;2:263-267. 30. Rythen-Alder E, Brundin J, Notini-Gundmarsson A, et al: Detection of carbon dioxide embolism during hysteroscopy. Gynaecol Endosc 1992;1:207-210. 31. Bradner P, Neis KJ, Ehmer C: The etiology, frequency, and prevention of gas embolism during CO2 hysteroscopy. J Am Assoc Gynecol Laparosc 1999;6:421-428. 32. Corson SL, Brooks PG, Soderstrom RM: Gynecologic endoscopic gas embolism. Fertil Steril 1996;65:529-533. 33. Behnia R, Holley HS, Milad M: Successful early intervention in air embolism during hysteroscopy. J Clin Anesth 1997;9:248-250. 34. Kivnick S, Kante MK: Bowel injury from rollerball ablation of the endometrium. Obstet Gynecol 1992;79:833-835. 35. MacDonald R, Phipps J, Singer A: Endometrial ablation: A safe procedure. Gynaecol Endosc 1992;1:7-9. 36. McCausland VM, Fields GA, McCausland AM, et al: Tubal ovarian abscesses after operative hysteroscopy. J Reprod Med 1993;38: 198-200. 37. Price TM, Harris JB: Fulminant hepatic failure due to herpes simplex after hysteroscopy. Obstet Gynecol 2001;98:954-956. 38. Pugh CP, Crane JM, Hogan TG: Successful intrauterine pregnancy after endometrial ablation. J Am Assoc Gynecol Laparosc 2000;7: 391-394. 39. McLucas B: Pregnancy after endometrial ablation: A case report. J Reprod Med 1995;40:237-239. 40. Pinette M, Katz W, Drouin M, et al: Successful planned pregnancy following endometrial ablation with the YAG laser. Am J Obstet Gynecol 2001;185:242-243. 41. Cooper JM, Brady RM: Late complications of operative hysteroscopy. Obstet Gynecol Clin North Am 2000;27:367-374. 42. Lo JSY, Pickersgill A: Pregnancy after endometrial ablation: English literature review and case report. J Minim Invasive Gynecol 2006;13:88-91.

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Complications of Hysteroscopic Surgery 43. Sentilhes L, Sergent F, Roman H, et al: Late complications of operative hysteroscopy: Predicting patients at risk of uterine rupture during subsequent pregnancy. Eur J Obstet Gynecol Reprod Biol 2004;120: 134-138. 44. Hill D, Maher P, Wood C, et al: Complications of operative hysteroscopy. Gynaecol Endosc 1992;1:185-189. 45. Townsend DE, McClausland V, McClausland A, et al: Post-ablation tubal sterilization syndrome. Obstet Gynecol 1993;82:422424. 46. McClausland AM, McClausland VM: Frequency of symptomatic corneal hematometra and postablation tubal sterilization syndrome after total rollerball endometrial ablation: A 10-year follow-up. Am J Obstet Gynecol 2002;186:1274-1283. 47. Bae IK, Pagedas AC, Perkins HE, et al: Post-tubal sterilization syndrome. J Am Assoc Gynecol Laparosc 1996;3:435-438. 48. Turnbull L, Browsley SJ, Horsman A: Magnetic resonance imaging of the uterus after endometrial resection. Br J Obstet Gynaecol 1997;104:934-938. 49. Mall A, Shirk G, Van Voorhis BJ: Previous tubal ligation is a risk factor for hysterectomy after rollerball endometrial ablation. Obstet Gynecol 2002;100:659-664. 50. McClausland AM: Endosalpingiosis (endosalpingioblastosis) following laparoscopic tubal coagulation as an etiologic factor of ectopic pregnancy. Am J Obstet Gynecol 1982;143:12-24.

51.

52.

53.

54.

55. 56.

57.

58.

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Dwyer NA: Early endometrial carcinoma: An incidental finding after endometrial resection (case report). Br J Obstet Gynaecol 1993;98:733-734. Vilos GA, Harding PG, Sugimoto AG, et al: Hysteroscopic endomyometrial resection of three uterine sarcomas. J Am assoc Gynecol Laparosc 2001;8:545-551. Hansen UD, Lund CO: Finding of an unsuspected endometrial stromal sarcoma by hysteroscopic endometrial resection. Gynaecol Endosc 1998;7:279-280. Gimpelson RJ: Not so benign endometrial hyperplasia: Endometrial cancer after endometrial ablation. J Am Assoc Gynecol Laparosc 1997;4:507-511. Baggish MS, Ringgenberg E, Sze EHM: Adenocarcinoma of the corpus uteri following endometrial ablation. J Gynecol Surg 1995;11:91-94. Horowitz IR, Copas PR, Aaronoff M, et al: Endometrial adenocarcinoma following endometrial ablation for postmenopausal bleeding. Gynecol Oncol 1995;56:460-463. Copperman AB, DeCherney AH, Olive DL: A case of endometrial cancer following endometrial ablation for dysfunctional uterine bleeding. Obstet Gynecol 1993;82:640-642. Ramey JW, Koonings PP, Given FT, et al: The process of carcinogenesis for endometrial adenocarcinoma could be short: Development of a malignancy after endometrial ablation. Am J Obstet Gynecol 1994;170:1370-1371.

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Assessing Hysteroscopic Skills: A Practical Approach Amy VanBlaricom

In these times of ever-progressing medical and surgical technology, it is important to think about not only innovation and advancement but also education, credentialing, and assessment of knowledge and skills related to new surgical technology. That is, how do we disseminate new technologies to surgeons and ensure competency in them while maintaining patient safety? Previous generations of surgeons learned techniques via the see one, do one, teach one approach. This type of learning occurred in the operating room setting, where faculty surgeons performed a surgery with an apprentice surgeon who gradually took on greater responsibility over time. This style of training dates back to Halsted’s original (1889) concept of graduated responsibility.1 Since its inception, a host of problems with this type of training have emerged. The ethics of teaching junior surgeons and allowing them to make mistakes on live patients has been questioned in hospital and patient rights initiatives for improved patient safety. Difficulties inherent in the surgery, including patient factors such as age, weight, and other medical conditions that increase the technical difficulty of the case or that carry with them a need to complete the surgery in a timely fashion, affect how much an apprentice surgeon can do in a given surgical case. This style of training has been shown to result in variable acquisition of skills because attending surgeons have different preferences in techniques and apprentices have different comfort levels with the surgery itself.

NEW TECHNOLOGIES Surgical technology has been advancing with astounding speed since the 1990s. We have seen several generations of innovative minimally invasive approaches to surgeries that historically had been performed by laparotomy. In some cases, newer endoscopic approaches are replacing tried and true laparotomy. In many situations, faculty who are perceived as good surgeons are finding themselves uncomfortable with new technologies due to inadequate experience with them. The current generation of apprentice surgeons is thus finding itself with fewer and fewer opportunities to actually perform critical components of the surgery because the supervising physician is not comfortable turning that over to them. This is occurring in a time when new

options for minimally invasive approaches to surgery are appearing every day. For all of these reasons it has become important to develop new ways to teach surgical techniques: The resident in training needs to learn the basics followed by options in approach, and the experienced practicing surgeon wants to learn new ways to go about the same surgery. It is also necessary to develop ways to assess surgical competency for a new surgeon graduating from a residency program or for a practicing surgeon acquiring new credentials.

ACQUIRING SURGICAL SKILLS The road to surgical expertise has several stages. Fitts and Posner described in the 1960s a three-stage theory of motor skill acquisition (Table 21–1).2 The cognitive phase is characterized by learning basic steps of a technique. In this phase, direct demonstration and feedback is given. Learners then move to integration, when they can perform the mechanics of a technique with more fluidity and less direct instruction. With practice, learners can gradually move into the automation phase, where they do not have to think about every step of the procedure, can act in a continuous, adaptive way, and can think about other aspects of the procedure while performing the technique. Most physicians in practice work in the automation phase, but they only reach this phase with experience and practice. A significant depth and breadth of experience is required for surgical privileges and is even being considered for standardization in national board examinations, and it is now important to determine innovative ways to teach and assess surgical skill. Ways to allow structured, deliberate practice outside of the operating room as well as assessment of technique away from live patients have been documented in the literature.

Objective Assessment of Surgical Skill The traditional apprenticeship method of teaching a surgical skill was accompanied by an assessment method that was flawed. In most instances, evaluation of the learner was subjective and was offered by the teacher after the fact. This type of evaluation is subject to significant recall bias and is impossible to standardize.

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Table 21–1 The Fitts–Posner Three-Stage Theory of Motor Skills Acquisition Stage

Goal

Activity

Performance

Cognition

Understand the task

Demonstration Explanation

Inconsistent Distinct steps

Integration

Comprehend and perform

Deliberate practice Feedback

More fluid

Automation

Task performance is speedy, precise, and efficient

Performance is automatic, requires little cognitive input

Continuous, fluid, adaptive

Adapted from Fitts PM, Posner MI: Human Performance. Belmont, Calif: Brooks/Cole, 1967.

The halo affect potentially altered the assessment if the teacher liked the apprentice personally. Different faculty have different standards for grading, so that one might inflate grades while another rates more fairly for the same trainee. Cumulative subjective assessment has been demonstrated to have poor reliability and validity.3 Without structured criteria, such evaluations often conflict. Trainees do not always have the same opportunities in the live patient setting because of varying time constraints, patient factors, and faculty sense of urgency to complete the case. There are ethical arguments against using live patients to allow inexperienced surgeons to make mistakes, even if the mistakes are immediately corrected. For all of these reasons, more objective measures of assessing surgical skill outside of the live operating room setting have been sought. Any tools being developed for objectively assessing skills must demonstrate reliability and validity. Validity is the extent to which an assessment tool measures what it intends to measure. In surgical skills training, we often use construct validity as a proxy measure, which is the ability of the assessment tool to differentiate between levels of experience. Reliability is the consistence of the assessment instrument or the extent to which results on a test will be replicated each time the test is given. Good assessment tools also have excellent interrater reliability, which is the consistency of the assessment when the examiners are blinded to level of experience of the examinee.4 Why consider objective assessment of surgical skill? In residency training, the Accreditation Council for Graduate Medical Education (ACGME) has moved toward a competency-based assessment and documentation of competency in patient care, including surgical technique, at the time of graduation from residency. There is increasing national concern over patient safety and medical errors, and teaching environments are particularly scrutinized as teachers work with inexperienced surgeons. With constantly developing new technologies in surgical approach, even the more seasoned surgeons are finding themselves uncomfortable and inexperienced with new techniques. For all of these reasons it has become important to move toward more creative, objective and standardizable ways to teach and assess surgical competency.

Objective assessment first was mentioned in the general surgery literature in 1993 and was related to resident training.3 Since this first and landmark paper establishing the importance of and basic approach to objective structured assessment of technical skills (OSATS), the concept has spread to the obstetrics and gynecology literature, confirming its effectiveness and applicability to what we do.5-10 The data demonstrate that OSATS improves upon inherent inconsistencies with previous evaluation techniques. There is also a growing body of literature demonstrating that training on virtual reality models actually translates to better performance in the operating room.11,12 To perform an OSATS, learners are evaluated with a global assessment form for basic technique and a task-specific checklist. Global assessment looks at basic technique such as proper tissue handling and appropriate use of assistants. The taskspecific checklist should include all of the steps of a procedure that are deemed critical to its competent completion. One exciting aspect of OSATS is that it can be developed for any level of learner: a medical student’s baseline fine motor skill, a resident’s ability to perform a hysteroscopic resection of a polyp, or a faculty surgeon’s ability to perform a complex hysteroscopy from start to finish for credentialing. One taskspecific checklist has been developed and validated for hysteroscopy, and a previously validated global assessment form was again validated for a hysteroscopy OSATS (Figs. 21–1 and 21–2).3,10

Many Faces of Objective Structured Assessment What exactly is an OSATS? In developing an OSATS, first one must determine the specific task to perform, such as assembling an operative hysteroscope or performing a resection task. The task must be standardized so that all those being assessed perform the same task. The task must be rated objectively by standardized criteria developed before the task is performed (global assessment and task-specific checklist). Very importantly, a learner must be allowed to operate completely independently during the OSATS without interference, feedback, or guidance by the evaluator. One of the more important components of OSATS is the ability of the surgeon being evaluated to make all decisions regarding the task, forcing the surgeon to plan, choose instruments, and troubleshoot complications. In this way, one can assess not only the surgeon’s technical skill but also his or her judgment and ability to navigate complications. Although it is important to refrain from teaching or giving feedback during the OSATS, the major advantage of an OSATS in surgical education is the ability to give constructive feedback afterward to allow improvement. In this manner, OSATS can be used repeatedly to perform many instances of a given task and learn from each until competency is attained. In this way, OSATS can be developed for the basic junior surgeon learning primary surgical technique (e.g., tying knots) or for a more seasoned surgeon who wants to gain more experience, comfort, and competency with new techniques (e.g., complex laparoscopy, hysteroscopy).

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Figure 21–1 Global rating scale for hysteroscopy.

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Figure 21–2 Task-specific checklist for testing competence in hysteroscopy.

Assessment tools such as OSATS can be used for standalone testing, such as for credentialing purposes or for establishing baseline knowledge (is this second-year resident where she should be?). OSATS can also be used as a pretest and posttest to test the effectiveness of an intervention such as an educational curriculum. Testing can also be done repeatedly over time to determine if learners are advancing in their skill the way they should be.

PROGRAMS FOR SURGICAL SKILLS EDUCATION For any surgical skills program to be successful, it must contain the following elements: ●

Reliable, valid assessment tools for global and task-specific assessment

● ●

Effective, feasible educational curricula Models, trainers, or simulators to teach and perform assessments on

Many educational curricula have been developed with an OSATS as a pretest and posttest to determine the effectiveness of the curriculum. Concepts important to a curriculum include effectiveness, feasibility, and expense. Effectiveness is indicated by student performance: Learners should perform better after the training as evidenced by improved assessment score, shortened surgical time, and so on. The curriculum is feasible if it is applicable to the specific situation, is portable, and is easy to implement and if evaluators can be easily trained in its implementation. Expense is an important feature because programs that are overly cumbersome or costly will not be fully implemented and thus will never reach their true potential even if they work.10,13,14

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Competency-Based Learning and Assessment for All

Nonmedical fields, such as the airline industry, have invested tremendous resources in technology-based simulation that allows full scale rehearsal of all aspects of a given practice while minimizing or even eliminating the risks of such practice. We in medicine are behind but catching up in this area. In particular, the technology for minimally invasive gynecologic procedures such as hysteroscopy has been developed and is being refined. Taking teaching and assessment of surgical skills out of the operating room has been demonstrated to be effective. However, the human patient bleeds and responds to surgical errors in a lifelike, appropriately stressful way, and it becomes important to replace the lifelike effect in an assessment. That is, if a learner perforates a human uterus in the process of an operative hysteroscopy, a cascade of events follows that allow the learner to make judgments and interventions to complete the procedure. To mimic this level of experiential learning outside of the human body, lifelike models must exist. Fortunately, endoscopic procedures such as hysteroscopy lend themselves well to simulators and models. In addition, evidence that skills learned and practiced on a model can be transferred to the operating room is even stronger for endoscopic surgery than for open procedures.15,16 In these studies, skills practiced on box trainers and simulators transferred to complex operative laparoscopy tasks such as suturing. A host of such models and computerized simulators have been developed for teaching and assessing skill in hysteroscopy (Figs. 21–3 and 21–4). With advances in computerized simulation of surgical skills training, what has been done related to hysteroscopy? The current technology in computerized endoscopy simulation allows visual cues when collision has occurred, such as uterine perforation. However, haptic technology, or the tactile characteristics of simulated organs, has not reached the same level. This realistic force feedback, which is felt in the instruments the learner handles, is incompletely developed and therefore limits the level of skill acquisition and assessment that can be achieved with computerized simulation in hysteroscopy. This tactile feedback varies significantly in computerized simulation from what an expert surgeon would expect in real-time surgery and thus limits use of such technology in educating anyone but less-experienced surgeons.17 In particular, use of computerized hysteroscopic simulation technology to teach and assess an experienced hysteroscopist, such as for certification purposes, is limited. Until better haptic technology is developed, teaching and assessment of response to consequences of such complications is inadequate. Additionally, to be able to simulate real-time hysteroscopy, computerized interfaces need to be perfected that behave like actual human tissue and mimic the dynamic nature of a surgery in process. Examples include simulation of air bubbles, media complications, bleeding, and floating endometrial debris. Full-scale simulation of hysteroscopy must involve proper patient selection for the procedure, media options, fluid management, and familiarity with instrumentation.

There has been a movement toward competency-based learning and assessment at the level of residency training, which places surgical skill assessment via simulators and models prominently in the ACGME toolbox. The ACGME Toolbox of Assessment Methods suggests best methods for evaluating patient care, medical knowledge, practice-based learning and improvement, and professionalism competencies.18 The toolbox contains an entire section describing the usefulness of simulation and models in training new physicians. Currently, minimum performance standards are determined by residency programs for a given procedure such that a graduating resident is certified as competent to perform each at graduation. To that end, surgical skills curricula are popping up in surgical and in obstetrics and gynecology residencies either as a standalone rotation or built into the curriculum throughout training.19 This concept of competency-based assessment has translated to the postresidency arena as well. Surgical associations such as the American Association of Gynecologic Laparos-

A

B Figure 21–3 A, B, Dr. VanBlaricom directing a resident through hysteroscopy OSATS on an inatimate model. Model from Simulation Inc, Bristol, UK.

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A Figure 21–4

B A, B, Hysteroscopy virtual reality trainer (Immerson Medical, San Jose, Calif).

copists (AAGL) publish guidelines for training in endoscopic procedures and specifically in hysteroscopy.20 The fluid-management guidelines published by the AAGL have been adopted by the American College of Obstetricians and Gynecologists (ACOG) Committee on Gynecologic Practice.21 These guidelines are suggested as minimal requirements, with the burden of achieving competency falling on the surgeons and the burden for satisfying surgical competency falling on the institution from which the surgeon requests privileges. At this point there is much to be done to determine minimal criteria for competence that can be standardized to every surgeon in every institution. The movement toward competence-based assessment rather than case lists or documented experience is sure as these traditional methods of documentation provide evidence of experience only and not competence. Many hospitals are developing their own simulation centers to allow physi-

cians to practice new techniques and achieve competence, however that is defined at the institution, in them. The evidence supporting the importance of surgical training and assessment outside of the operating room is overwhelming. Currently this is most used in medical and graduate medical training across North America. However, there is a movement to incorporate this type of training into credentialing and recertification of physicians in practice, and therefore OSATS is being integrated into faculty development programs. Now attention must be paid to establishing applicable standards for technique in order to implement a competence-based system for certification of practicing physicians. A minimum performance standard needs to be established for hysteroscopic skills. This will require significant involvement from surgeons, hospitals, and educators and needs to be developed within the framework of available technology for assessment of such skill.

REFERENCES 1. 2. 3. 4. 5.

6.

7.

Carter BN: The fruition of Halsted’s concept of surgical training. Surgery 1952;32:518-527. Fitts PM, Posner MI: Human performance. Belmont, Calif: Brooks/ Cole, 1967. Reznick RK: Teaching and testing technical skills. Am J Surg 1993;165:358-361. Reznick RK, MacRae H: Teaching surgical skills—changes in the wind. N Engl J Med 2006;355:2664-2669. Goff BA, Lentz GM, Lee D, et al: Development of an objective structured assessment of technical skills for obstetrics and gynecology residents. Obstet Gynecol 2000;96:146150. Goff BA, Lentz GM, Lee D, Mandel LS: Formal teaching of surgical skills in an obstetric–gynecologic residency. Obstet Gynecol 1999;93:785-790. Coleman RL, Muller CY: Effects of a laboratory based skills curriculum on laparoscopic proficiency: A randomized trial. Am J Obstet Gynecol 2002;186(4):836-842.

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9. 10.

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Cundiff GW: Analysis of the effectiveness of an endoscopy education program in improving residents’ laparoscopic skills. Obstet Gynecol 1997;90(5):854-859. Mandel LP, Lentz GM, Goff BA: Teaching and evaluating surgical skills. Obstet Gynecol 2000;95:783-785. VanBlaricom AL, Goff BA, Chinn M, et al: A new curriculum for hysteroscopy training as demonstrated by an objective structured assessment of technical skills (OSATS). Am J Obstet Gynecol 2005;193:1856-1865. Seymour NE, Gallagher AG, Roman SA, et al: Virtual reality training improves operating room performance: Results of a randomized, double blinded study. Ann Surg 2002;236:458-463. Grantcharov TP, Kristiansen VB, Bendix J, et al: Randomized clinical trial of virtual reality simulation for laparoscopic skills training. Br J Surg 2004;91:146-150. Ault G, Reznick R, Macrae H, Leadbetter W, et al: Exporting a technical skills evaluation technology to other sites. Am J Surg 2001;182:254-256.

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Assessing Hysteroscopic Skills: A Practical Approach 14. Goff BA, Mandel L, Lentz G, et al: Assessment of resident surgical skills: Is testing feasible? Am J Obstet Gynecol 2005;192(4):13311338. 15. Fried GM, Feldman LS, Vassiliou MC, et al: Proving the value of simulation in laparoscopic surgery. Ann Surg 2004;240:518-528. 16. Scott DJ, Bergen PC, Rege RV, et al: Laparoscopic training on bench models: Better and more cost effective than operating room experience? J Am Coll Surg 2000;191:272-283. 17. Seymour NE, Rotnes JS: Challenges to the development of complex virtual reality surgical simulations. Surg Endosc 2006;20:1774-1777. 18. ACGME Outcomes Project: Toolbox of assessment methods, version 1.1. PDF available at http://www.acgme.org/outcome/assess/toolbox. pdf (accessed November 15, 2007).

19. Horvath KD, Mann GN, Pelligrini C: EVATS: A proactive solution to improve surgical education and maintain flexibility in the new training era. Curr Surg 2006;63(2):151-154. 20. Loffer FD, Bradley LD, Brill AI, et al: Hysteroscopic training guidelines from the ad hoc committee on hysteroscopic training guidelines of the American Association of Gynecologic Laparoscopists. J Am Assoc Gynecol Lap 2000;7(1):165-168. 21. American College of Obstetricians and Gynecologists: ACOG technology assessment in obstetrics and gynecology, number 4, August 2005: hysteroscopy. Obstet Gynecol 2005;106:439-442.

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Credentialing in Hysteroscopic Surgery Andrew I. Brill

The accelerated and still unabated incorporation of endoscopic surgical techniques into virtually every facet of the gynecologic surgical armamentarium remains an unparalleled phenomenon in the history of gynecologic surgery. Propagated by a myriad of prevailing trends including patient self-advocacy, growing medical consumerism, the instant message of visual media, direct advertising to consumers by industry, access to information via the World Wide Web, and the popular notion that less is simply better, the demand for minimally invasive alternatives is increasing rapidly. This cascade has the realistic potential to push some gynecologists to perform procedures that they are not appropriately trained in, which risks greater costs and higher morbidity. Indubitably, we are morally and ethically bound to protect patients from the results of poor surgical training and judgment.

BACKGROUND AND RATIONALE Credentialing and monitoring deservedly continue to be the active concern of authoritarian agencies outside of medicine, including malpractice insurance companies, government health agencies, third-party payers, hospital boards, and physician associations.1-11 Without question, if our profession is not willing to undertake the necessary steps to ensure the training and credentialing of ourselves, outside authority will be forced to unilaterally devise and implement such systems. The reflex to regulate from inadequate credentialing is exemplified by the early experience of laparoscopic cholecystectomy in the state of New York.12 After the report of at least seven deaths and 185 serious injuries between August 1990 and June 1992, the state health department asked hospital trustees to methodically spell out procedure, process, and assessment and to clearly outline a credentialing process. Subsequent guidelines specified that “surgeons must perform at least 15 laparoscopies under supervision” before a hospital could issue privileges allowing them to perform a laparoscopic cholecystectomy independently. Shortly thereafter, laparoscopic-assisted hysterectomy was also incorporated into these guidelines. Ideally, endoscopic surgical training should be part of every obstetrics and gynecology residency training program. Unfortunately for the majority of residents, the challenge of attaining

competence in diagnostic and operative hysteroscopy by graduation is formidable and is stunted by the widely acknowledged crisis in surgical education within our specialty. To date, few academic programs offer an organized or formalized curriculum in endoscopic surgery.13-15 They have yet to develop expertise within their curriculum or faculty, and many graduates have or will receive little or no training in hysteroscopic surgery. Faced with the gradual disintegration of surgical training in our residency programs, the evolution is complex and largely attributable to the restriction of work hours,16 the curricular shift toward more primary care, the lack of controlled randomized trials to compel the adoption of these techniques by academics, the disappearance of experienced mentors, insufficient funding for proper equipment, little to no accountability for competency in these procedures by the residency accreditation or board certification process, and the over-differentiation of our specialty, resulting in the veritable creation of part-time surgeons. A recent study assessing the objective outcome of hysteroscopy training reported that only one of six second-year residents and three of six fourth-year residents could assemble a resectoscope, and only one of the 12 was able to correctly name the types of media used for operative hysteroscopy.15 It comes as no surprise that many graduates are forced to achieve their skills in hysteroscopic surgery by attending weekend postgraduate programs that provide didactics and laboratory models of variable quality. For most practicing gynecologists, having missed any formal training in endoscopic surgery during their residency, these programs are the only option for acquiring these new surgical skill sets. Because this type of training offers no time for clinical proctoring and guided technical advancement, complications are more apt to occur following these courses. Adding fuel to the fire, the evolution of nonhysteroscopic devices to perform endometrial ablation and the recent introduction of the medicated intrauterine device (levonorgestrel intrauterine system [Mirena]) have radically diminished the number of patients heretofore considered candidates for hysteroscopic surgery. Although it remains the gold standard for diagnosing intracavitary uterine masses, diagnostic hysteroscopy has been demoted by the adoption of sonohysteroscopy (SHG, also called saline infusion sonography [SIS]) as a validated surrogate and even less invasive option. Moreover, for many

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Credentialing in Hysteroscopic Surgery physicians who have achieved competence in hysteroscopic surgery, adoption may be limited by the realization that these procedures are economically punitive when compared to moreinvasive traditional alternatives. Similarly, the transition of hysteroscopic services from the hospital or surgical center to the office setting can be truncated by the inequities imposed by a relative value system used by third-party payers for services in a nonhospital setting. Although complications are an accepted risk of any surgery, evidence of a surgeon’s training and skill in a technique will minimize his or her liability in the event of a malpractice suit. Faced with the potential for allegations of corporate disregard, risk managers are ringing the alarm of rising exposure if their surgeons are perceived to have been inadequately trained, credentialed, or monitored. Fundamentally, the formal documentation of suitable skills and experience are essential for the medicolegal protection of the patient, institution, operating room personnel, and surgeon. The fear that implementation of a formal and consistent credentialing process could increase the risk of litigation is unfounded. Rather, hospitals and hospital staff are more likely to be found liable when logical qualitycontrol measures have not been properly instituted. Simply put, structured credentialing should be enforced by institutions who grant surgery privileges.

VOCABULARY OF CREDENTIALING It is the fiduciary responsibility of the institution to implement minimum standards. Granting privileges is the sole authority of the governing body of an institution and is normally delineated in the medical staff bylaws.17,18 Surgical privileges are those functions and procedures granted a physician that allow him or her to perform such activity during the course of caring for patients within a given institution. The granting of privileges is typically based on the surgeon’s training, experience, and demonstrated competence. Competence is generally regarded as the minimum level of knowledge and skill acceptable in regard to a specific procedure. The process of credentialing confers the right or authority to perform a procedure. Granting of privileges can vary according to the relative risk or newness of the procedure. In the case of operative hysteroscopy, special credentials or privileges may be necessary when a technology has been introduced subsequent to residency training. Extension of privileges under these circumstances is customarily granted based on documented education, demonstrated experience, and supervision by a qualified physician. The American College of Obstetricians and Gynecologists (ACOG) suggests that good standing in the department, documented education and personal experience in the specified procedure, and documentation by supervision all be required to attain privileges for each new operative procedure. Certification provides a certificate stating that the surgeon has completed a course of study and has met specific standards of some official body, which then attest to the surgeon’s ability to practice a certain procedure in a specific area of the profession. The credentialing effort must be a cooperative effort

between the physician and hospital, whereby the surgeon plans the educational experience, fulfills the requirements, and presents appropriate evidence to justify his or her request for the official recognition to perform certain clinical procedures. These goals are entrusted to the department chairperson. Properly exercised, such decisions are made with the help of a jury of peers using criteria that should be rational, justifiable, objective, and fair; their recommendation is subsequently forwarded to the governing board. Whereas the governing board bears the ultimate responsibility for the quality of medical care, the medical staff remains responsible for self-governance. Because technical competence and knowledge can change, they are subject to periodic reevaluation. Institutions are expected to establish objective standards of evaluation and periodic review to document continuing competence in procedures or services rendered by the surgeon.

MODELS FOR CREDENTIALING With the caveat that gynecologic surgeons should restrict their activities to equipment for which they are qualified and procedures for which they are credentialed, ACOG has recommended that to be credentialed in operative hysteroscopy, the applicant must be in good standing with the department, have extensive experience using the hysteroscope for diagnostic procedures, have documented resident education and experience or must have completed a course approved for American Medical Association (AMA) category I credits in operative hysteroscopy, and be adequately supervised by a qualified physician to attain privileges in operative hysteroscopic procedures. The Society of Reproductive Surgeons (SRS) is more unambiguous, recommending the granting of privileges on a graduated scheme related to levels of surgical complexity, starting with baseline qualifications and graduating to more difficult procedures with preceptorship and training. In this system, at least five and preferably 10 procedures must be overseen and acceptably completed before privileges are granted at each skill level. Responding to the rapid influx of requests by gynecologists to attain privileging in endoscopic surgery, the Society of Obstetricians and Gynecologists of Canada (SOGC) issued a policy statement to provide a common framework of reference for all Canadian institutions credentialing in endoscopic surgery. Using a stratified system based on the level of technical complexity, these guidelines mandate a series of steps in training and competence. The surgeon must be able to perform diagnostic before operative hysteroscopy. The surgeon must attend an accredited course designed for the level of surgery to be performed, and the course must include comprehensive didactics, a minimum of 10 hours of hands-on laboratory experience (of which 6 hours must be spent working with tissue or animal models, or both), and review of video recordings for demonstration purposes. The surgeon must then undergo an orderly process of preceptorship, including observation, initially as first assistant to an experienced surgeon and then incrementally assume the role of primary surgeon under the guise of the preceptor. The preceptor can then recommend to the department head that procedural

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Credentialing in Hysteroscopic Surgery privileges be granted. Whenever an experienced preceptor is not available, it is recommended that two experienced gynecologist having performed hysteroscopy for more than 3 years be given temporary privileges. This team must then operate on at least 10 advanced cases before each one may operate alone. The need for grandfathering is acknowledged and recommended for individual surgeons with many years of experience performing these procedures and having shown leadership in their respective hospitals or communities in diagnostic and operative hysteroscopy. The Society of Gastrointestinal Surgeons (SAGES) also recommends systematic observation of surgeons applying for privileges in gastrointestinal laparoscopic and/or thoracoscopic surgery. Evaluation criteria include knowledge of instrumentation and equipment, aptitude in their use, suitability of patient selection, precision of dissection, safety, time taken to complete the procedure, and successful completion.

ANATOMY OF CREDENTIALING This revolution of endoscopic surgery has created the urgent need for our profession to formally respond by instituting measures that appropriately serve to ensure the quality of care. Despite the absence of reports that definitively validate the effectiveness of credentialing programs, common sense and good will dictate that surgical outcomes are best ensured by the institution of appropriate training, credentialing, and periodic monitoring of physicians who perform endoscopic techniques. The traditional method of “see one, do one, teach one” is now unacceptable. Rather, the new axiom must read “practice on a model, watch videos, observe in the operating room, and perform with feedback, evaluation, and validated capability.” In response to the perceived need to improve the quality of education and thereby enhance the quality of medical care, in 1997 the Accreditation Council of Graduate Medical Education (ACGME) recently endorsed the concept of competency as the new paradigm of medical education and certification. Surgical competence requires a mixture of knowledge, technical skills, decision-making skills, communication skills, and leadership skills. Acquisition and refinement of basic technical skills are of central importance and the first step in the process of learning surgical competence. Outcome depends not only on the competence of the surgeon but also on his or her ability to lead and coordinate the teams of allied personnel involved in patient care. Rather than simply establishing the potential to educate, this new system is focused on establishing whether graduates are in fact being educated. Ultimately, this system is designed to provide physicians with an organic framework that can be used to improve their surgical skills and promote the responsible acquisition of new surgical techniques throughout the span of their professional careers. The assignment of operative privileges by a hospital or other operating facility should culminate an orderly process of appropriate surgical training, certification, and credentialing after the essential knowledge and surgical skills are acquired and documented. In every situation, the granting of privileges should

follow an orderly pattern that always requires progress from lower-level to upper-level procedures. Preferably, this process can be designed after the aforementioned logistical core for contemporary residency training. A practitioner acquires the necessary knowledge and skills by following a stepwise approach, including didactics that serve to provide theoretical issues and mental knowledge of central principles and patient care, a second phase of hands-on laboratory training with in vivo as well as in vitro models, including simulators to provide surrogates of increasing reality for modeling, a third phase of observation of videos and a specific procedure or set of procedures to provide focused inspection of new techniques, a fourth phase of preceptorship, and then a fifth phase of tutorial where the physician performs the procedures under the supervision of a preceptor. Understandably, finding a preceptor may be difficult given the onus to affirm competence of a colleague. Nevertheless, the preceptor should be unbiased and have demonstrated expertise in diagnostic and operative hysteroscopy and should be instructed to allow the trainee to progressively do more of the surgery. The trainee must assume responsibility for preoperative patient selection and preparation as well as postoperative management. Documentation of skill and competence must not be issued, for the benefit of all involved, until the trainee readily shows the supervising surgeon satisfactory and independent hysteroscopic skills that correspond to the skill level required. On the other hand, a surgeon who has extensive experience before application for privileges may be observed by a preceptor for several cases without prior observation or acting as first assistant. In the unusual circumstance when a preceptor is unable to endorse the candidate for the requested level of complexity, reassessment of the application should take place and recommendations made. There should always be a reasonable mechanism for appeal by any surgeon to whom privileging is denied. Published guidelines for hysteroscopic training by the American Association of Gynecologic Laparoscopists (AAGL) reiterate all of these steps and recommend the completion of a comprehensive continuing medical education (CME) program that includes a didactic portion with a minimum of 6 hours and hands-on laboratory training of at least 4 hours. It further recommends that the didactic portion should initially include diagnostic and operative hysteroscopy, and must adequately address uterine anatomy, options of distention media, management of distention media, energy sources, instrumentation, surgical indications and techniques for the entire spectrum of hysteroscopic procedures, and prevention and management of hysteroscopic complications. The hands-on laboratory training should include training and experience in the particular instrumentation as well as simulated surgical procedures for which the surgeon will be seeking privileges. As a matter of policy, the surgeon should not assume that teaching alone suffices to develop a specific skill set. Rather, the knowledge and skills attained require resolute practice to reach a level of suitable expertise with a particular technique. Regardless of a particular credentialing system, all guidelines must be implemented in a uniform and indiscriminate fashion across the entire enterprise to obviate otherwise foreseeable medicolegal

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Credentialing in Hysteroscopic Surgery to complete case lists with pertinent patient demographics along with procedure, diagnosis, and complications. Using this information, a committee appointed by the department chair, including senior surgical leadership, may be asked to recommend privileges for these levels of surgical complexity. Whereas grandfathering is an unavoidable reality at the outset of credentialing, at a certain point all members of the department who desire more advanced privileges should be uniformly subject to additional credentialing requirements including preceptorship.

BOX 22-1 Surgical Skills by Levels of Relative Difficulty Level I ● ● ● ● ●

Lysis of minor adhesions Removal of simple endometrial polyp Removal of pedunculated myoma <3 cm Removal of IUD Transcervical sterilization

Level II ● ● ●

MAINTAINING COMPETENCY

Removal of submucosal myoma <3 cm, type 0 or I Lysis of moderate adhesions Endometrial rollerball ablation

Level III ● ● ● ● ●

Endometrial resection Removal of submucosal myoma type II Removal of submucosal myoma >3 cm Division of intrauterine septum Lysis of severe intrauterine adhesions

IUD, intrauterine device.

conflicts and the risk of antitrust claims. Rather than being procedure-specific, credentialing is most efficiently managed by separating surgical skills by levels of relative difficulty (Box 22–1). Using this system, level I skills are customarily obtained during residency training, whereas more advanced skills are typically attained after graduation. If competence in hysteroscopic surgery was acquired in residency, the certification of this surgical expertise and skill becomes the responsibility of the program director, and granting of surgical privileges can then follow according to the routine of the institution’s credentialing guidelines. On the other hand, certification of surgeons who acquire training after residency must be closely tied to the assignment of operating privileges by a hospital or other operative facility. Some surgeons may be actively performing hysteroscopic procedures during the initiation of any formalized departmental credentialing process. In these circumstances, surgeons with broad experience in more advanced procedures who request grandfathering can be asked

It is the fiduciary responsibility of the parent institution to establish sustained competence before renewing privileges for a particular surgical procedure. Ideally, competence in a particular surgical procedure must be maintained by its continual performance. Given the uniqueness of each surgeon’s capabilities and experience, any requirements that periodically mandate a certain number of cases at a certain level of complexity or of a particular procedure are arbitrary and remain without objective validation. Nevertheless, the cyclical review and documentation of competency by institutions providing these services is mandated by the Joint Commission on Accreditation of Health Care Organizations (JCAHO). The Society of Reproductive Surgeons has recommended that surgeons annually compile case lists including any complications to demonstrate unbroken competence in specific procedures with a tolerable rate of adverse events. Given the significant overlap of skill sets and competencies among different hysteroscopic procedures within a given level of technical complexity, recredentialing is more apt to be less onerous and contentious by credentialing according to level of difficulty rather than procedure. On the other hand, even the frequent performance of hysteroscopic myomectomy does not necessarily affirm a similar level of competence at performing hysteroscopic adhesiolysis of severe intrauterine adhesions. To date, there is no validated model or consensus regarding the best methodology to carry out the periodic renewal of surgical privileges. Regardless of the absence of established norms and the inevitable inconsistencies borne by logical variants of this process, an equitable and executable system must be established for renewing surgical privileges at least biannually.

REFERENCES 1.

2.

3.

4.

American College of Obstetricians and Gynecologists: Guidelines for Women’s Health Care, 2nd ed. Washington, DC: American College of Obstetricians and Gynecologists, 2002, pp 31-39. Loffer FD, Bradley LD, Brill AI, et al: Hysteroscopic training guidelines. The ad hoc committee on hysteroscopic training guidelines of the American Association of Gynecologic Laparoscopists. J Am Assoc Gynecol Laparosc 2000;7(1):165. Society of Obstetricians and Gynaecologists of Canada: Guidelines for training in operative endoscopy in the specialty of obstetrics and gynecology. Policy Statement No. 18. Ottawa: Society of Obstetricians and Gynaecologists of Canada, 1993. American College of Obstetricians and Gynecologists: Credentialing guidelines for operative hysteroscopy. ACOG committee Opinion

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5.

6.

7.

107. Washington, DC: American College of Obstetricians and Gynecologists, 1992. American College of Obstetricians and Gynecologists: Credentialing guidelines for new operative procedures. ACOG committee Opinion 142. Washington, DC: American College of Obstetricians and Gynecologists, 1994. American College of Obstetricians and Gynecologists: AAFP–ACOG joint statement on cooperative practice and hospital privileges. ACOG statement of policy. Washington, DC: American College of Obstetricians and Gynecologists, 2001. American College of Obstetricians and Gynecologists: Guidelines for Implementing Collaborative Practice. Washington, DC: American College of Obstetricians and Gynecologists, 1995.

Chapter 22

Credentialing in Hysteroscopic Surgery 8.

American Medical Association: Licensing and Credentialing: What Every Physician Needs to Know. Chicago: American Medical Association, 1999. 9. Joint Commission on Accreditation of Healthcare Organizations: 1995 Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, Ill: Joint Commission on Accreditation of Healthcare Organizations, 1994. 10. Bashook PG, Miller SH, Parboosingh J, Horowitz SD (eds): Credentialing Physician Specialists: A World Perspective. Evanston, Ill: American Board of Medical Specialties, 2000. 11. Society of American Gastrointestinal Endoscopic Surgeons: Granting of privileges for laparoscopic general surgery. Am J Surg 1991;161:324-326. 12. Altman LK: Surgical injuries from new operation lead New York to demand improved training. New York Times, June 14, 1992, section 1, p 1.

13. Milad M, Kim R, Cohen B: Resident training and endoscopic hospital privileging. Curr Opin Obste Gynecol 2001;19:431-436. 14. Julian TM, Rogers RM Jr: Changing the way we train gynecologic surgeons. Obstet Gynecol Clin North Am 2006;33(2):237-246. 15. VanBlaricom AL, Goff BA, Chinn M, et al: A new curriculum for hysteroscopy training as demonstrated by an objective structured assessment of technical skills (OSATS). Am J Obstet Gynecol 2005;193(5):1856-1865. 16. Blanchard MH, Amini SB, Frank TM: Impact of work hour restrictions on resident case experience in an obstetrics and gynecology residency program. Am J Obstet Gynecol 2004;191(5):1746-1751. 17. Milad MP, Miller D, Shaw S: Comprehensive gynecologic endoscopic hospital privileging program. Implementation and assessment. J Reprod Med 2000;45(5):365-370. 18. Keye WR: Hitting a moving target: Credentialing the endoscopic surgeon. Fertil Steril 1994;62(6):1115-1117.

263

Index Note: Pages followed by b indicate boxes; f, figures; t, tables.

A Abdominal myomectomy, 71, 133, 151-152 Ablative therapy. See Endometrial ablation. Abnormal uterine bleeding, 20-21, 21b, 22f adenomyosis and, 25 anovulatory, 21, 95-96, 97 as surgical contraindication, 36 cervical stenosis and, 127 complications of, 220 definition of, 97b dilation and curettage for, 20-23. See also Dilation and curettage. emergency management of, 112 endometrial ablation for, 199-217. See also Endometrial ablation. endometrial biopsy in, 25, 118-119, 120 endometrial cancer and, 25 endometrial echo in, 118-120, 119f endometrial hyperplasia and, 25 endometrial polyps and, 13f, 23-24, 106, 116, 119, 119f, 122, 122f, 234-235 endometrial thickness and, 67 estrogen and, 23 fibroids and, 24-25, 31, 82, 106-107, 106b, 107f, 108f, 122-123, 122f, 123f, 133, 219-220 imaging studies in, 66-67, 68f in adenomyosis, 108-109 in endometrial atrophy, 23, 23f, 121-122 in endometrial cancer in older women, 115-116 in younger women, 107-108, 108f, 109f in endometrial hyperplasia, 109, 110f, 123-124, 124f in fallopian tube cancer, 115-116 in hemostatic disorders, 89-92, 95, 105-106, 173-174. See also Von Willebrand disease. in pregnancy, 110-112 in urethral prolapse, 118 in vaginal atrophy, 118 intrauterine devices and, 23 irrigation for, 36 levonorgestrel intrauterine system for, 23, 51, 105, 171-176 mechanisms of, 220, 220b, 222f medical therapy for, 20 menstrual, 82, 82b, 89-92, 97b. See also Menorrhagia. ovulatory, 96 perimenopausal, 96-97 causes of, 68 postmenopausal, 68, 68f, 97b, 116-129 causes of, 68, 128, 128b

Abnormal uterine bleeding (Continued) definition of, 116 endometrial biopsy for, 118-119, 120, 123, 124-125 evaluation of, 116, 118 follow-up in, 117 hormone replacement therapy and, 127128 hysteroscopy in, 120-127 in fallopian tube cancer, 118 incidence and prevalence of, 116 magnetic resonance imaging in, 66-67 Pap smear for, 118 saline infusion sonography in, 68, 69f, 120, 126 transvaginal ultrasonography in, 68, 68f, 117, 118-120, 119f urinary tract disorders and, 128, 128b postoperative, 30 after cesarean section, 32, 32f after uterine fibroid embolization, 109-110, 111f pregnancy-related, 33, 34f premenopasual, 95-113 anovulatory, 95-96 diagnosis of, 97-103 drug therapy for, 100, 104-106, 104f fibroids and, 106-107, 107f, 108f history in, 98, 99b imaging in, 99, 99f-103f laboratory studies in, 98-100 management of, 97, 104-113, 104f ovulatory, 96 perimenopause and, 96-97 physical examination in, 98 polyps and, 106, 106f, 107f surgery for, 104f, 106-113 watchful waiting in, 100 prevalence of, 20 progesterone and, 23 quality of life and, 220 retained products of conception and, 30, 33, 110-112 Abortion. See Pregnancy loss. Accreditation Council for Graduate Medical Education (ACGME), 250 competency paradigm of, 259 Toolbox of Assessment Methods of, 250 Acetaminophen, for uterine fibroid embolization, 137b Adenocervical polyps, 13f Adenomyosis, 25, 28f, 79-80, 108-109, 109f, 141-143 bleeding in, 108-109 imaging of, 64-65, 64f, 65f, 79-80, 79f, 85-86, 86f, 141-142 prevalence of, 141 signs and symptoms of, 141 tamoxifen-related, 35, 36f uterine fibroid embolization for, 136, 141-143 vs. fibroids, 141

265

Adhesiolysis, 152 in Asherman syndrome, 159-162 pregnancy after, 161, 162, 245 Adhesions, 14f, 34-35, 146-147, 152 after uterine fibroid embolization, 146 classification of, 162, 162b imaging of, 205f in Asherman syndrome, 35, 157-158. See also Asherman syndrome. infertility and, 149 lysis of. See Adhesiolysis. prevention of, 53, 151, 160-161 Advance directives, 41 African Americans endometrial cancer in, 115 fibroids in, 133 Air embolism, 243 Airway, difficult, in anesthesia, 181, 181b Allergic reactions to anesthesia, 181-182 to dextran 70, 242 Amenorrhea, 34-35, 97b. See also Menstruation, abnormal. after uterine fibroid embolization, 146-147 levonorgestrel intrauterine device and, 173-176 American Association of Gynecologic Laparoscopists (AAGL), 259 American College of Obstetricians and Gynecologists (ACOG), credentialing by, 258 American Society of Reproductive Medicine scoring system, for Asherman syndrome, 162, 162t Ammonia, elevated serum, 241 Analgesia. See also Anesthesia. deep, 182b, 183t for endometrial ablation, 206 moderate, 182b, 183t postprocedure, for uterine fibroid embolization, 137, 137b, 138-139 preprocedure, administration of, 9 Anaphylaxis, dextran-related, 242 Anemia hemoglobin count in, 90 menorrhagia and, 97-98, 173 menstruation and, 96, 97-98, 173 signs and symptoms of, 90-91, 97-98 uterine bleeding and, 90-92 Anesthesia, 179-184 administration of, 9, 182-183 allergic reactions in, 181-182 conscious sedation in, 182b, 183t deep sedation/analgesia in, 182b, 183t definition of, 180 diazepam in, 183 difficult airway in, 181, 181b discharge criteria for, 180b fasting guidelines for, 181b flumazenil in, 183 for endometrial ablation, 205-206 general, 182b, 183t

Index Anesthesia (Continued) in cardiovascular disease, 182 in chronic obstructive pulmonary disease, 182 in diabetes mellitus, 182 in hysteroscopic myomectomy, 233 in smokers, 182 intraoperative management of, 180b, 182-184 methods of, 182-184 selection of, 182 midazolam in, 183 minimal sedation in, 182b, 183t moderate sedation in, 182b, 183t monitored care in, 184 nerve blocks in, 183-184 operative setting and, 179 opioids in, 183 patient factors in, 179-180 postdischarge management of, 180b postoperative management of, 180b preoperative assessment for, 180-182, 180b anesthesia history in, 180-181 laboratory studies in, 182 medical history in, 182 physical examination in, 182 propofol in, 183 regional, 184 routes of administration in, 180 sedation in depth of, 182, 182b, 183t intravenous, 182-183, 183t surgeon preferences and, 179 type of procedure and, 179 Aneuploidy, pregnancy loss and, 157 Anovulatory bleeding, 21, 95-96, 97. See also Abnormal uterine bleeding. Antiadhesive barriers, 53 Antibiotics, 17 for uterine fibroid embolization, 137b Antiemetics for endometrial ablation, 206 for uterine fibroid embolization, 137b, 139 Antiestrogen agents, endometrial effects of, 54 Anxiolytics for endometrial ablation, 206 in anesthesia, 182b, 183t. See also Anesthesia. Arcuate uterus, 163b, 163f, 165-166. See also Müllerian anomalies. Arginine vasopressin. See Desmopressin. Aromatase inhibitors, endometrial effects of, 54 Asherman syndrome, 34-35, 146-147, 152 causes of, 159b classification of, 162, 162b diagnosis of, 158-159, 159f, 160f hysteroscopic adhesiolysis in, 159-162 infertility in, 158, 162 outcomes in, 161-162 pregnancy in, 161, 162 preoperative evaluation in, 159 recurrent pregnancy loss in, 157-162 staging of, 162, 162b Asoprisnil, endometrial effects of, 54 Assisted reproduction. See also Infertility; Pregnancy. after myomectomy, 167 preimplantation genetic screening in, 157 Atrophy. See Endometrial atrophy. Attorney-in-fact for health care, 41 Autopsy, preevacuation hysteroscopic, 157, 158f

B Ball electrode, 4 Balloon catheters. See also Balloon tamponade. for saline infusion sonography, 59-60, 60f Balloon endometrial ablation, 200, 200f, 206-207. See also Endometrial ablation. patient selection for, 207b sterilization and, 191, 195-197 technique of, 206-207 ThermaChoice device for, 200, 200f, 206-207, 207b, 215, 215t-217t, 216f Balloon tamponade for adhesion prevention, 151, 160-161 in Asherman syndrome, 160-161 postmyomectomy, 151 for uterine bleeding, 112 Benzodiazepines, for anesthesia, 183 Bicornuate uterus, 66, 66f, 68f, 163b, 163f. See also Müllerian anomalies. Biopsy. See Endometrial biopsy. Biopsy forceps, 4f, 102f proper handling of, 44-45 Bipolar electrodes, 3-4, 4f, 225-226, 229, 244 injury from, 244 Bladder tumors, bleeding from, 128, 128b Bleeding, uterine. See Uterine bleeding. Bleeding disorders, 89-92. See also Hemostatic disorders. Bleeding time, 91 Blend waveform, 4 Blood groups, von Willebrand factor and, 92 Brain injury, intraoperative, 241 Bupivacaine, in hysteroscopic myomectomy, 233 Burns, 243-244

C Cancer bladder, bleeding in, 128, 128b cervical, 115 endometrial. See Endometrial cancer. fallopian tube, 115-116, 118 hematologic, uterine bleeding in, 89-92 ovarian, 115 Cannulation, tubal, 154, 154f Carbon dioxide embolism, 242 Carbon dioxide–based uterine distention. See Uterine distention, gas. Carboprost, for hysteroscopic myomectomy, 232-233 Cardiovascular disease, anesthesia in, 182 Catheters balloon. See also Balloon tamponade. for saline infusion sonography, 59-60, 60f Foley for adhesion prevention, 151, 160-161 for postoperative bleeding, 240 Cefazolin, for uterine fibroid embolization, 137b Cerclage tape, retained, 33, 33f Cerebral edema, in hyponatremia, 242 Certification, 258-260 Cervical cancer, 115 Cervical dilation, 12 after uterine fibroid embolization, 146 complications of, 239-240

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Cervical dilation (Continued) for stenosis, 12, 53, 121, 127 in endometrial ablation, 206 in hysteroscopic myomectomy, 223-224 laminaria tents for, 127, 223, 224, 240 misoprostol for, 53, 121, 127, 206, 223-224, 240 ultrasound-guided, 127 Cervical stenosis, 12 bleeding and, 127 dilation methods for, 12, 53, 121, 127. See also Cervical dilation. fluid accumulation in, 78-79 Cervical trauma, iatrogenic, 241 Cesarean section bleeding after, 32, 32f myometrial thinning after, thermal injury and, 244 retained products of conception in, 15f, 30, 30f Chip E-Vac hysteroscope, 230, 232f Chromosomal aneuploidy, pregnancy loss and, 157 Chronic obstructive pulmonary disease, anesthesia in, 182 Cigarette smoking, anesthesia and, 182 Clomiphene citrate, endometrial effects of, 54 Coagulation, physiology of, 89, 90f Coagulation cascade, 89, 90f Coagulation disorders, 89-92. See also Hemostatic disorders. Coagulation factors, preoperative use of, 92 Coagulation tests, 91-92 Common peroneal nerve compression, 239 Complete blood count, 90-91 Complications, 239-246 intraoperative, 239-244 air embolism, 243 brain injury, 241 cervical trauma, 239-240 energy-related, 243-244 gas embolism, 242 hemorrhage, 240 hyperammonemia, 241 hyponatremia, 241-242, 241t hypo-osmolality, 241-242, 241t mechanical, 239-240 nerve compression, 239 positioning-related, 239 uterine perforation, 17, 33, 240, 243, 244 pregnancy after, 245 postoperative, 244-246 chronic pain, 245-246 endometrial cancer, 246 hematometra, 245 hemorrhage, 92, 240 infection, 244-245 postablation tubal sterilization syndrome, 245-246 pregnancy-related, 245 prevalence of, 244 Compression stockings, 226, 226f Congenital anomalies genetic screening for, 157 müllerian, 152-154, 162-166. See also Müllerian anomalies. Congenital uterine anomalies. See Müllerian anomalies. Conjugated equine estrogen, intravenous, for menorrhagia, 105 Conscious sedation, 182b, 183t. See also Anesthesia. Consent. See Informed consent.

Index Constipation, after uterine fibroid embolization, 137b, 139 Continuing medical education programs, 259-260 Continuous-flow technique in flexible hysteroscopy, 2f, 3 in rigid hysteroscopy, 2f, 3 instrumentation for, 2f, 3, 11 Contraception. See also Oral contraceptives; Sterilization. backup, after sterilization, 191, 193 Contraindications, 35-36 Contrast agents, for magnetic resonance imaging, 58 Cook intrauterine splint, for adhesion prevention, 160-161 Corson graspers, 227, 229f Cramps in endometrial cancer, 117 menstrual, after hysteroscopic myomectomy, 234 Credentialing, 257-260 competency and, 259-260 for hysteroscopic sterilization, 192 historical perspective on, 257 legal aspects of, 258 maintaining competency and, 260 models for, 258-259 preceptors and, 259 rationale for, 257-258 surgical privileges, 257-260 vocabulary of, 258 Cryoablation, 200, 200f, 207-209, 208f, 209b, 209f, 215, 215t-217t, 216f. See also Endometrial ablation. Curettage. See also Dilation and curettage. suction, for endometrial thinning, 202 Cystic glandular atrophy, tamoxifen-related, 54

D Danazol adverse effects of, 52 for menorrhagia, 105 postoperative use of, 53-54 preoperative use of, 23, 52, 203 David, Charles, 49 D&C. See Dilation and curettage. DDAVP. See Desmopressin. Deep sedation/analgesia, 182b, 183t. See also Anesthesia. Depo-Provera. See Medroxyprogesterone acetate. DES. See Diethylstilbestrol (DES). Desiccation waveform, 4 Desmopressin for emergency hysteroscopy, 112 for hysteroscopic myomectomy, 233 for postoperative bleeding, 240 for von Willebrand disease, 92, 106 operative indications for, 53 Dextran, for uterine distention. See also Uterine distention. adverse effects of, 242 Diabetes mellitus anesthesia in, 182 endometrial cancer and, 117 Diazepam, for anesthesia, 183 Didelphus uterus, 163b, 163f. See also Müllerian anomalies.

Diethylstilbestrol (DES) infertility and, 153-154 müllerian anomalies and, 153-154, 163b, 163f Difficult airway, in anesthesia, 181 Digital distal tip sensors, 17 Digital flexible hysteroscopes, 17 Dilation, cervical. See Cervical dilation. Dilation and curettage, 20-23 Asherman syndrome and, 34-35, 146-147, 152 blind, limitations of, 21-22, 102 for retained products of conception, 112. See also Retained products of conception. indications for, 20 medical therapy prior to, 20 Disappearing phenomenon, 16f, 81, 222 Discharge. See Vaginal discharge. Discharge instructions, 17 Disclosure, informed consent and, 39-40 Disinfection, 45-46 Distal tip digital sensors, 17 DMPA. See Medroxyprogesterone acetate. Do not resuscitate (DNR) orders, 41 Documentation, 17 credentialing and, 257-260 of informed consent, 40-41 Draping, in hysteroscopic myomectomy, 232, 233f Durable power of attorney for health care, 41 Dysfunctional uterine bleeding. See Abnormal uterine bleeding. Dysmenorrhea. See Menstruation, abnormal.

E Echohysteroscopy. See Saline infusion sonography. Ectopic pregnancy, 33, 191, 194 Edema, cerebral, in hyponatremia, 242 Education and training. See Credentialing; Surgical skills. Electrodes bipolar, 3-4, 4f, 225-226, 229, 244 injury from, 244 5-F, 3-4, 4f Force FX, 229 injury from, 243-244 loop for endometrial ablation, 199, 200f, 204, 204f for myomectomy, 225-228, 226f-228f miniaturized, 3-4, 4f monopolar, 225, 225f, 226f patient return, 225, 225f rollerball for endometrial ablation, 199, 200f, 204, 204f for myomectomy, 225, 225f rollerbar for endometrial ablation, 199, 200f for myomectomy, 225, 226f spring, 4 twizzle, 4, 5, 225, 229 Vaportrode, 228-229 Electrosurgery. See also Electrodes. energy-related complications in, 243-244 in endometrial ablation, 199, 200f, 204, 204f in myomectomy, 167, 225-226 bipolar electrodes for, 225-226, 229 monopolar electrodes for, 225, 225f, 226f

267

Embolism air, 243 carbon dioxide, 242 gas, 242 pulmonary, 140 Embolization, uterine fibroid. See Uterine fibroid embolization. Emergency management informed consent for, 42 of abnormal uterine bleeding, 112 End-of-life issues, 41 Endometrial ablation, 71, 199-217 advantages of, 199 anesthesia for, 215t balloon, 200, 200f, 206-207 patient selection for, 207b sterilization and, 191, 195-197 technique of, 206-207 ThermaChoice device for, 200, 200f, 206-207 cervical dilation for, 206. See also Cervical dilation. clinical pearls for, 206 clinical trials of, 199, 200 complications of, 200, 204 contraindications to, 71, 201, 201t, 203b, 207b, 209b, 211b, 212b, 246 cryotherapy for, 200, 200f, 207-209, 208f, 209b, 209f, 215, 215t-217t, 216f development of, 199 devices for, 199-200, 200f, 200t electrosurgery in, 199, 200f, 204, 204f. See also Electrodes; Electrosurgery. thermal injury from, 243-244 endometrial cancer after, 246 endometrial hyperplasia and, 246 endometrial thinning for, 202-203 first-generation techniques in, 199 global (office-based), 199-203, 200f-202f, 201t, 204, 205-215 advantages of, 205 anesthesia for, 205-206 goals of, 205 patient counseling for, 205 patient selection for, 205b, 207b, 209b, 211b, 212b results of, 215, 215t-217t, 216f team approach in, 205 techniques for, 206-215 vs. hysteroscopy, 204 hysteroscopic, 204-205, 204f thermal, 209-210, 210f, 211b, 215, 215t217t, 216f imaging studies for, 201-202, 201f, 202f indications for, 71, 201, 201t, 203b, 207b, 209b, 211b, 212b instrumentation for, 200, 200f, 204-205, 204f comparative analysis of, 215, 215t-217t, 216f laparoscopic ultrasound-guided, 133 laser, 199 methods of, 206-215 microwave, 200, 200f, 211-215, 212b, 213f-215f overview of, 199-200 pain management in, 206 patient selection for, 201, 201t, 203b, 205b, 207b, 209b, 211b, 212b percutaneous radiofrequency, 133 postoperative care in, 206 pregnancy after, 245 preoperative care in, 206

Index Endometrial ablation (Continued) preoperative evaluation for, 201-202, 201f, 202f preparation for, 201-203 procedure time in, 215t radiofrequency, 200, 200f, 211, 211f, 212b, 215t-217t, 216f results of, 199, 204, 215, 215t-217t, 216f rollerball, 199, 200f, 204, 204f sterilization and, 191, 196-197 technique of, 204-215 thermal, 200, 200f, 209-210, 210f, 211b, 215, 215t-217t, 216f timing of, 202, 203 training in, 199-200 transcervical resection in, 199 vs. hysterectomy, 71, 199, 204 vs. levonorgestrel intrauterine system, 174, 175, 197 wire loop for, 199, 200f, 204, 204f Endometrial atrophy, 14f, 23, 23f. See also Endometrial thickness. after cesarean section, thermal injury and, 244 cystic glandular, tamoxifen and, 54 drugs causing, 23, 50, 50b, 116 preoperative use of, 23, 50-53, 52b hysteroscopic findings in, 121-122 intrauterine devices and, 23, 51 tamoxifen and, 116 Endometrial biopsy, 100-103, 102f, 103f, 116, 118-120 for postmenopausal bleeding, 116, 118-119, 120, 123, 124-125 for uterine fibroid embolization, 136 forceps for, 4f, 44-45, 102f grasp technique for, 4-5 imaging studies and, 100-103, 101f-103f indications for, 25, 118-119, 120 instrumentation for, 4-5, 4f, 19-20, 20f technique of, 4-5 Endometrial cancer, 15f, 25, 28f age and, 97 as contraindication, 36-37 biopsy for, 116, 118-120. See also Endometrial biopsy. bleeding in, 107-108, 108f, 109f, 117. See also Abnormal uterine bleeding. diagnosis of, 116, 124-126 endometrial echo in, 118-120 endometrial hyperplasia and, 117, 121, 123-125 endometrial thickness in, 25, 117, 119, 125f hysteroscopic findings in, 124-126, 125f, 126f hysteroscopic tumor dissemination in, 37 imaging of, 64, 66, 118-120 in older women, 115-116 in polyps, 119, 235 in younger women, 107-108, 108f, 109f, 115 incidence and prevalence of, 115 magnetic resonance imaging in, 64 pathology of, 121 postoperative, 246 racial differences in, 115 risk factors for, 98, 115, 117 saline infusion sonography in, 28 screening for, 116 signs and symptoms of, 115, 116-117 staging of, 125-126 subtypes of, 121 survival in, 115, 125 time since menopause and, 25 transvaginal ultrasonography in, 25-28 ultrasonography for, 118-120

Endometrial echo, 118-120, 119f Endometrial fibroids. See Fibroids. Endometrial fluid accumulation, preoperative evaluation of, 78-79, 78f, 79f Endometrial hyperplasia, 15f, 25 bleeding in, 109, 110f, 123-124, 124f endometrial ablation and, 246 endometrial cancer and, 117, 121, 123-125, 246 hysterectomy for, 121 hysteroscopic findings in, 123-124, 124f imaging of, 66 Endometrial monitoring, for tamoxifen, 35, 36f Endometrial polyps, 13f, 23-24, 234-236 abnormal bleeding and, 106, 106f, 107f, 112 bleeding and, 116 definition of, 234 imaging of, 65, 65f, 235f incidence of, 234 infertility and, 149-154 malignant changes in, 119, 235 overview of, 234 resection of, 119, 234-236 complications of, 236 emergency, 112 for infertility, 149, 150-151 forceps in, 229 postoperative counseling in, 236 prior to sterilization, 190, 190f results of, 236 technique of, 5, 235-236 signs and symptoms of, 234-235 tamoxifen-related, 54 ultrasonography of, 119, 119f vs. fibroids, 65 Endometrial stripe endometrial cancer risk and, 117, 118 sonographic measurement of, 59, 59f, 66 Endometrial thickness. See also Endometrial atrophy. abnormal uterine bleeding and, 67 after cesarean section, thermal injury and, 244 endometrial cancer and, 25, 117, 119, 125f estrogen and, 23, 49, 50f hysteroscopy technique and, 50 normal variation in, 23, 49, 50f, 77-78 postmenopausal, 121 progesterone and, 23, 49, 50f reduction of. See Endometrial thinning. sonographic measurement of, 58-59, 59f, 60, 66, 67 tamoxifen and, 110f, 116, 126, 126f timing of hysteroscopy and, 10, 50 Endometrial thinning, 23, 50-53, 52b, 202-203 adverse effects of, 52b atrophic. See Endometrial atrophy. intraoperative, 202 pharmacologic agents for, 23, 50-53, 202-203 postoperative, 53-54 preoperative, 23, 50-53, 82 in endometrial ablation, 202-203 suction curettage for, 202 Endometrioma, ultrasonography of, 58 Endometriosis, selective progesterone receptor modulators for, 54 Endometrium. See also under Uterine; Uterus. layers of, 49, 50f levonorgestrel effects on, 173-174 menstrual-cycle changes in, 23, 49-50, 50f physiology of, 49-50 transcervical resection of, 199, 200f. See also Endometrial ablation.

268

Endometrium basalis, 49, 50f Endometrium compacta, 49, 50f Endometrium functionalis, 49, 50f Endometrium spongiosa, 49, 50f Endorectal ultrasonography, 57, 58f. See also Ultrasonography. Epidural anesthesia, 184. See also Anesthesia. Equipment and supplies, 43-46, 44f. See also Hysteroscopes. care and maintenance of, 43-46 direct vs. indirect, 43 for flexible hysteroscopy, 3, 7-18 for rigid hysteroscopy, 1-3, 2f, 4f sterilization of, 45-46, 45f types of, 43 Essure microinsert device, 189-197, 189f. See also Hysteroscopic sterilization. Estradiol, for menorrhagia, 105 Estrogen endometrial cancer and, 117 endometrial thickness and, 23, 49, 50-51, 50f for abnormal uterine bleeding, 100, 105 for adhesion prevention, 151 for menorrhagia, 105 in hormone replacement therapy, 127-128. See also Hormone replacement therapy. in two-stage myomectomy, 83 intravenous conjugated equine, 105 postoperative use of, 53-54, 151 preoperative use of, 50-51, 203 Estrogen replacement therapy, bleeding and, 127-128 Ethical issues, informed consent, 40-41 Ethinyl estradiol, for menorrhagia, 105 Ethylene oxide gas sterilization, 45 European Society Hysteroscopy Staging system, for Asherman syndrome, 162, 162b Exablate 2000, for fibroids, 133

F Factor replacement, preoperative, 92 Fallopian tube cancer of, 115-116, 118 imaging of, 149-150, 149f, 150f. See also Hysterosalpingography. obstruction of, 34, 154 occlusion of. See Hysteroscopic sterilization. False-negative results, 16, 16f, 81 Femoral nerve compression, 239 Femwave ablation device, 212, 213f Fertility. See Infertility; Pregnancy. Fever, after uterine fibroid embolization, 140 Fibroids, 13f, 14f, 15f, 24-25, 24f, 25f, 82 bleeding and, 24-25, 24f, 31, 82, 82b, 106-107, 106b, 107f, 108f, 122-123, 122f, 123f, 133 classification of, 24, 26f-27f, 76, 76f-78f, 81-82, 166, 166f, 219-222, 221f degeneration of, 84, 84f depth of penetration of, 61, 62f, 222, 223f disappearing, 16f, 81, 222 expulsion of, 144, 145-146, 145f extension into endometrial cavity, 61, 62f, 222, 223f gross pathology of, 72f, 84f, 222f, 223f

Index Fibroids (Continued) hysteroscopic findings in, 122-123, 122f, 123f imaging of, 61-64, 63f, 64f, 83-86, 83f, 86f, 101f-102f, 136, 136f, 137f, 151 preoperative, 72-78, 222, 223f-225f incomplete resection of, 30, 30f infertility and, 33, 149-154 intracavitary, 81, 122, 122f, 123f intramural, 81, 122-123 kissing, 14f, 107f location of, 63-64, 82, 220-222, 221f clinical manifestations and, 82, 82b preoperative mapping of, 63-64, 82 menorrhagia and, 82 necrotic, 140-141, 141f-143f, 144 pedunculated, 123, 222, 223f pregnancy outcome and, 33, 152 preoperative evaluation of, 63-64, 71-86, 72-78 prolapsed, 31-32, 31f, 32f after embolization, 140-141, 140f, 141f racial differences in, 133 recurrent pregnancy loss and, 166-167 saline infusion sonography of, 28, 29f selective progesterone receptor modulators for, 54, 152 signs and symptoms of, 82, 82b, 133-134, 219-220 submucosal, 24-25, 24f treatment of, 72, 132-133, 134, 167 ablative, 133 pharmacologic, 54, 133, 134, 152 prostaglandin F2α in, 167 surgical, 71, 133, 151-152, 167, 219-234. See also Hysterectomy; Hysteroscopic myomectomy; Myomectomy. alternatives to, 71, 132-133 uterine fibroid embolization for, 131-147. See also Uterine fibroid embolization. vascular, 14f vs. endometrial polyps, 65 vs. leiomyosarcoma, MRI differentiation of, 64 watchful waiting for, 72, 234 Fitts-Posner motor skills acquisition theory, 249, 250t 5-F bipolar electrodes, 3-4, 4f Flexible hysteroscopes. See also Hysteroscopes. assembly of, 227f care and maintenance of, 43-46 components of, 43 insertion of, 11, 12, 44 proper handling of, 44, 45f sterilization of, 45-46, 45f Flexible hysteroscopy, 3, 7-20. See also Office hysteroscopy. advantages of, 7, 19 complications of, 17 documentation of, 17 duration of, 12 false-negative results in, 16, 16f for biopsy, 19-20, 20f future directions for, 17 instrumentation for, 3, 7-9, 8f-12f menstrual cycle phase and, 10, 10f overview of, 7 patient positioning for, 11 patient preparation for, 9 postprocedure instructions for, 17 predictive value of, 12-16

Flexible hysteroscopy (Continued) scheduling of, menstrual cycle and, 10, 50 scope handling in, 12, 12f scope introduction in, 11-12, 44 scope location in, 12 technique of, 10-12 uterine distention in, 8, 43-44. See also Uterine distention. vaginoscopic (no-touch) approach in, 11, 16, 20 visualization in, 12-16, 13f-15f vs. rigid hysteroscopy, 7 Fluid accumulation, 78-79, 78f, 79f Fluid deficit, in uterine distention, 241-242 Fluid distention. See Uterine distention, liquid. Fluid overload, in uterine distention, 80, 82, 230, 242 Fluid pumps, 230-232, 232f Fluid-monitoring systems, 230-232, 232f, 233f Flumazenil, for anesthesia, 183 Flurbiprofen, vs. levonorgestrel intrauterine system, 174 Foley catheter for adhesion prevention, 151, 160-161 for postoperative bleeding, 240 Follicle-stimulating hormone, in menopause, 97 Foot drop, 239 Force FX electrode, 229 Forceps biopsy, 4f, 102f grasping, 4f, 227, 229f proper handling of, 44-45 polyp, 229 proper handling of, 44-45 Foreign bodies, 32-33, 33f

G Gadolinium, in magnetic resonance imaging, 58 Gas embolism, 242 Gas-based uterine distention. See Uterine distention, gas. General anesthesia, 182b, 183t. See also Anesthesia. Genetic screening, preimplantation, 157 Genital herpes, as contraindication, 36 Gestational trophoblastic disease, bleeding in, 110-112 Global endometrial ablation, 199-200, 205-215. See also Endometrial ablation. Glutaraldehyde 2% disinfection, 46 Glycine, for uterine distention, 240, 241, 241t adverse effects of, 241 Gonadotropin-releasing hormone agonists adverse effects of, 52b for abnormal uterine bleeding, 105 postoperative use of, 53-54, 82 preoperative use of, 23, 52-53, 202-203 uterine fibroid embolization and, 135, 136-137 Goserelin. See also Gonadotropin-releasing hormone agonists. preoperative use of, 53 in endometrial ablation, 23, 52-53, 203 Grasp biopsy technique, 4, 4f Grasping forceps, 4f, 227, 229f proper handling of, 44-45

269

Gynecologic history, 10 Gyrus ACMI Invisio hysteroscope, 17, 18f

H Health care proxy, 41 Heart disease, anesthesia in, 182 Hematometra, 78-79, 79f, 245 Hemoglobin decreased. See Anemia. normal values for, 90 Hemorrhage. See Uterine bleeding. Hemostasis, 89, 90f assessment of, 91-92 Hemostatic disorders, 89-92, 105-106. See also Von Willebrand disease. diagnosis of, 89-92 factor replacement in, 92 multidisciplinary approach in, 92 primary, 89, 90b secondary, 89, 90b, 90f signs and symptoms of, 89 surgery in, 92 uterine bleeding in, 89-92 Her Option Uterine Cryoablation Therapy System, 200, 200f, 207-209, 208f, 209, 209b, 215, 215t-217t, 216f. See also Endometrial ablation. Herpes simplex virus infection, as contraindication, 36 History, gynecologic, 10 Hormone replacement therapy, bleeding and, 127-128 Hyaluronic acid gel, for adhesion prevention, 53 Hydrocodone, for uterine fibroid embolization, 137b HydroThermAblator, 200, 200f, 209-210, 210f, 211b, 215, 215t-217t, 216f. See also Endometrial ablation. Hyperammonemia, 241 Hypersensitivity to anesthesia, 181-182 to dextran 70, 242 Hypertonic saline, for hyponatremia, 242 Hyperventilation, for hyponatremic cerebral edema, 242 Hypoammonemia, in uterine distention, 241 Hyponatremia, in uterine distention, 241-242, 241t Hypo-osmolality, in uterine distention, 241-242, 241t Hysterectomy after failed uterine fibroid embolization, 141, 142f alternatives to, 71, 132-133 complications of, 134, 147t contraindications to, 71 costs of, 134 for chronic leukorrhea, 35, 35f for endometrial hyperplasia, 121 in von Willebrand’s disease, 89 indications for, 71 utilization rates for, 133 vs. endometrial ablation, 199, 204 vs. levonorgestrel intrauterine system, 174, 175, 197 vs. myomectomy, 71 vs. uterine fibroid embolization, 132-133

Index Hysteroinsufflators, 43-44, 44f Hysterosalpingography, 34 for fallopian tube occlusion, 154 for infertility, 149, 150f, 150t, 151 for müllerian anomalies, 66, 66f-68f in sterilization documentation, 192-193, 193f-195f Hysteroscopes assembly of, 227f care and maintenance of, 43-46 flexible, 3, 7-9, 8f-12f, 19-20, 20f, 43. See also Flexible hysteroscopy. future developments in, 17 scope improvements for, 17 for myomectomy, 227f, 229-230, 231f, 232f for sterilization, 191 image sharpness and, 44 irrigation-suction devices for, 2f, 3 morcellating, 230, 231f, 232f proper handling of, 44, 44f rigid, 1-3, 2f, 43. See also Rigid hysteroscopy. small-diameter, 1-3, 2f sterilization of, 45-46, 45f vacuum, 230, 232f Hysteroscopic adhesiolysis, 152 in Asherman syndrome, 159-162 pregnancy after, 161, 162, 245 Hysteroscopic autopsy, preevacuation, 157, 158f Hysteroscopic metroplasty, 152-153, 153t, 164165, 165f for DES-related anomalies, 153-154 for septate uterus, 152-153, 153t, 164-165, 165f pregnancy after, 245 Hysteroscopic morcellators, 230, 231f, 232f Hysteroscopic myomectomy, 31-32, 31f, 167, 219-234 advantages of, 80 after embolization, 140-141 alternatives to, 80 anesthesia for, 233 angle of view in, 16f, 81, 222 bipolar electrodes for, 225-226 carboprost for, 232-233 cervical dilation in, 223-224 chip removal in, 227-228, 228f, 229f, 230 completeness of, 82 complications of, 80, 82, 147t, 152, 220, 239246. See also Complications. contraindications to, 80, 219, 220b, 222f disappearing act in, 16f, 81, 222 draping for, 232, 233f duration of, 220 dysmenorrhea improvement after, 234 electrosurgery in, 167, 225-226, 225f, 226f thermal injury from, 243-244 endometrial cancer after, 246 equipment for, 225-226, 225f-227f, 229-233, 229f-233f essential components of, 219 fibroid chips in, 227-228, 228f, 229f fluid distention in, 230-232, 232f, 233f for infertility, 149, 151-152 for larger fibroids, 220, 228, 233, 234 for necrotic fibroids, 140-141, 141f-143f, 144 for prolapsed fibroids, 140-141 goals of, 234 historical perspective on, 219 hysteroscopes in, 227f, 229-230, 231f, 232f hysteroscopic morcellator in, 230, 231f incomplete resection in, 30, 30f, 234

Hysteroscopic myomectomy (Continued) indications for, 72, 80-81 intraoperative prostaglandin F2α injection in, 167 lesion size and, 80 monopolar electrodes for, 225, 225f, 226f overview of, 219 paracervical block in, 233 patient counseling for, 219-220, 222-223 patient positioning for, 226, 226f patient selection for, 80-83, 83b, 219-220 postoperative evaluation in, 30 preconception, 166-167 pregnancy after, 167, 245 preoperative considerations in, 222-224 preoperative evaluation for, 80-83, 222-224. See also Preoperative evaluation. fibroid classification in, 81-83 repeat, 234 results of, 220, 233-234 shaving device in, 167 technique of, 5, 167, 226-229, 226f-230f two-stage, 82-83, 220, 234 ultrasonography in, 233 vaginal, 31-32 vasopressin for, 233 vs. hysterectomy, 71 Hysteroscopic polypectomy, 234-236 complications of, 236 emergency, 112 for infertility, 149, 150-151 postoperative counseling in, 236 prior to sterilization, 190, 190f results of, 236 technique of, 5, 235-236 Hysteroscopic septoplasty, 152-153, 153t, 164165, 165f pregnancy after, 245 Hysteroscopic sterilization, 30-31, 31f, 45-46, 45f, 187-197 age and, 191 backup contraception after, 191, 193 clinical trials for, 187-189, 188t, 189t complications of, 191, 191b contraindications to, 191, 191b costs of, 194-196 credentialing for, 192 documentation of, 192-193, 193f-195f ectopic pregnancy and, 191, 194 effectiveness of, 193-194 endometrial ablation and, 191, 196-197 failure of, 191, 193-194 follow-up for, 192-193, 195f historical perspective on, 187 hysterosalpingography after, 192-193, 193f-195f imaging in postoperative, 192-193, 193f-195f preoperative, 190, 190f indications for, 191, 191b instrumentation for, 191-192 microinsert device for, 189-190, 189f components of, 189-190, 189f mechanism of action of, 190 placement of, 190, 191-192, 192b office-based, 196 patient counseling for, 191 patient satisfaction with, 196 patient selection for, 191, 191b preoperative considerations in, 190-191 regret after, 191 reimbursement for, 196 reversal of, 191

270

Hysteroscopic sterilization (Continued) technique of, 191-192, 192b timing of, 192 training in, 192 tubal ostia visualization in, 190, 190f Hysteroscopic tubal cannulation, 154, 154f Hysteroscopy. See Flexible hysteroscopy; Office hysteroscopy; Rigid hysteroscopy. Hysterotomy, vs. hysteroscopic myomectomy, 80

I Ibuprofen for uterine fibroid embolization, 137b preprocedure administration of, 9 Idiopathic thrombocytopenic purpura, uterine bleeding in, 89 Imaging studies, 57-69. See also specific indications. endometrial biopsy and, 100-103, 101f-103f hysterosalpingography in, 34, 149, 150f, 150t, 151 in Asherman syndrome, 158-159, 159f, 160f in infertility, 149-150, 150f, 150t in postmenopausal bleeding, 68, 68f in sterilization documentation, 192-193, 193f-195f in uterine fibroid embolization, 136, 136f, 137f magnetic resonance imaging, 57-58. See also Magnetic resonance imaging. of abnormal uterine bleeding, 66-67 of adenomyosis, 64-65, 64f, 65f, 79-80, 79f of bicornuate uterus, 66, 66f, 68f of fibroids, 61-64, 63f, 64f, 72-78, 101f-102f, 222, 223f-225f preoperative, 72-78 of müllerian anomalies, 61, 66 of polyps, 65, 65f, 235f of pyometra, 79 sonographic, 57-69. See also Saline infusion sonography; Ultrasonography. In vitro fertilization. See also Infertility; Pregnancy. after myomectomy, 167 preimplantation genetic screening in, 157 Incompetence, 41-42. See also Informed consent. Indications, 19-35 abnormal hysterosalpingogram, 34 abnormal uterine bleeding, 20-21, 21b, 22f adenomyosis, 25, 28f amenorrhea, 34-35 diagnostic, 20 endometrial atrophy, 23, 23f equivocal ultrasound results, 25-28 foreign bodies, 32-33, 33f infertility, 33 intrauterine device localization, 23, 32-33 leukorrhea, 34-35, 34f overview of, 19-20 postoperative evaluation, 30 pregnancy-related bleeding, 33, 34f preoperative planning, 22-23, 28-29 recurrent pregnancy loss, 33 retained products of conception, 30, 33, 34f sterilization, 30-31, 31f submucosal fibroids, 24-25, 24f surgical, 20 uterine perforation, 33

Index Infections, postoperative, 244-245 after uterine fibroid embolization, 140 Infertility, 33. See also Pregnancy. adhesions and, 152 after adhesiolysis, 161, 162 after uterine fibroid embolization, 134, 143-144 DES exposure and, 153-154 diagnosis of, 149-150 hysterosalpingography in, 34, 149, 150f, 150t, 151 magnetic resonance imaging in, 151 saline infusion sonography in, 149-150, 150t transvaginal ultrasonography in, 150, 150f, 150t in Asherman syndrome, 158 müllerian anomalies and, 152-153, 164-165 postablation tubal sterilization syndrome and, 245-246 treatment of hysteroscopic adhesiolysis in, 152 hysteroscopic myomectomy in, 149, 151-152 laparoscopic myomectomy in, 151 pharmacologic, 152 septoplasty in, 152-153 Informed consent, 10, 39-42 communication and, 41 competence and, 39 deferment of, 42 definition of, 39 disclosure and, 39-40 documentation of, 40-41 ethical aspects of, 40-41 in emergencies, 42 informed assent and, 41 legal aspects of, 40-41 medical terminology and, 40 of minors, 41 of surrogate, 41 understanding and, 40 Instrumentation. See also Hysteroscopes. care and maintenance of, 43-46 for flexible hysteroscopy, 3, 7-18 for rigid hysteroscopy, 1-3, 2f, 4f Intracavitary fibroids, 81, 122, 122f, 123f. See also Fibroids. Intramural fibroids, 81, 122-123. See also Fibroids. Intrauterine adhesions. See Adhesions. Intrauterine device(s) for adhesion prevention, 160-161 for sterilization, 187-197. See also Hysteroscopic sterilization. levonorgestrel-releasing. See Levonorgestrel intrauterine system. uterine fibroid embolization and, 135 visualization of, 23, 23f, 32-33 Intrauterine pressure in fibroid visualization, 25 in uterine distention, 241. See also Uterine distention. air embolism and, 243 gas embolism and, 242 Intrauterine splint, for adhesion prevention, 160-161 Intrauterine synechiae. See Adhesions. Intravasation, in myomectomy, 80 Invisio Digital Flexible Hysteroscope, 17, 18f Iron loss. See also Anemia. from menstruation, 96

Irrigation, for vaginal bleeding, 36 Irrigation-suction device, 2f, 3

J Joint Commission on Accreditation of Healthcare Organizations (JCAHO), 260

K Karl Storz flexible hysteroscopes, 8, 9f, 20f, 102f assembly of, 227f Ketorolac, for uterine fibroid embolization, 137b Kissing leiomyomas, 14f, 107f

L Laminaria tents, 127, 223, 224, 240 Laparoscopic myomectomy, 80, 133 for infertility, 151-152 Laparoscopic sterilization, 187, 188t reversal of, 191 Laparoscopic ultrasound-guided ablation, 133. See also Endometrial ablation. Laser therapy carbon dioxide embolism in, 242 CO2 coolant in, air/gas embolism and, 242, 243, 244 energy-related complications in, 243-244 for endometrial ablation, 199 Nd:YAG, disadvantages of, 242, 244 Laxatives, for uterine fibroid embolization, 137b, 139 Legal issues advance directives, 41 credentialing, 258 informed consent, 40-41 liability, 258 surrogate decision-making, 41 Leiomyomas. See Fibroids. Leiomyosarcoma, 80, 80f. See also Endometrial cancer. gross pathology of, 135f postembolization, 144-145 uterine fibroid embolization and, 134, 135f vs. leiomyoma, magnetic resonance imaging differentiation of, 64 Letrozole, endometrial effects of, 54 Leukemia, uterine bleeding in, 89-92 Leukorrhea, 34-35, 34f. See also Vaginal discharge. after uterine fibroid embolization, 34-35, 35f, 140, 140f-142f, 141, 146, 146f hysterectomy for, 35, 35f Leuprolide for abnormal uterine bleeding, 105 for preoperative endometrial thinning, 23, 5253, 202-203 Levonorgestrel intrauterine system, 105, 171-176, 197 advantages of, 172b, 174-175, 176, 176b adverse effects of, 172, 175

271

Levonorgestrel intrauterine system (Continued) contraceptive benefits of, 172 contraindications to, 172b costs of, 175-176 efficacy of, 174-175 endometrial effects of, 23, 51, 173 for abnormal uterine bleeding, 105 historical perspective on, 171 mechanism of action of, 171-172, 172f menstrual effects of, 173-174 noncontraceptive uses of, 171 overview of, 171 patient counseling for, 174, 175 patient satisfaction with, 171, 174, 175 quality of life and, 175 resistance to use of, 171 vs. endometrial ablation, 174, 175, 197 vs. flurbiprofen, 174 vs. hysterectomy, 174, 175, 197 vs. medical therapy, 174 vs. mefenamic acid, 174-175 vs. oral progesterone, 174 vs. tranexamic acid, 174 Liability, credentialing and, 258 Light cables, handling of, 45 Light-emitting diodes, 17 Liquid-based uterine distention. See Uterine distention, liquid. Living will, 41 Loop electrodes for endometrial ablation, 199, 200f, 204, 204f for myomectomy, 225-228, 226f-228f Lung disease, anesthesia in, 182 Luteinizing hormone, in menopause, 97

M Magnetic resonance imaging, 19, 57-58 advantages of, 58 contrast agents for, 58 imaging protocols and sequences in, 57-58 in preoperative evaluation, 72-78, 83-86, 83f, 86f in uterine fibroid embolization, 83-86, 83f, 86f, 136, 136f, 137f of abnormal uterine bleeding, 66-67 of adenomyosis, 64-65, 65f, 79, 79f, 85-86, 86f, 136, 141-142 of endometrial cancer, 66 of endometrial hyperplasia, 66 of endometrial polyps, 65 of fibroids, 61-64, 63f, 64f, 83-86, 83f, 86f, 136, 136f, 137f, 151, 222f, 225f of müllerian anomalies, 66 of normal uterus, 58, 58f physics of, 57-58 principles of, 57-58 T1/T2-weighted images in, 57-58 technique of, 58 Malpractice, credentialing and, 258 Mannitol, for uterine distention, 240, 241, 241t Meclofenolate, for menorrhagia, 105 Medroxyprogesterone acetate adverse effects of, 52b bleeding and, 127-128 endometrial thinning and, 23, 51 for abnormal uterine bleeding, 105 for sterilization, 190

Index Medroxyprogesterone acetate (Continued) in hormone replacement therapy, 127-128. See also Hormone replacement therapy. in two-stage myomectomy, 83 postoperative use of, 53-54 preoperative use of, 50-51, 203 Mefenamic acid preprocedure administration of, 9 vs. levonorgestrel intrauterine system, 174 Menometrorrhagia, 97b. See also Abnormal uterine bleeding; Menorrhagia. Menopause age at, 116 diagnosis of, 97 endometrial cancer and, 25 hormone replacement therapy in, bleeding and, 127-128, 128f Menorrhagia, 95-113, 97b. See also Abnormal uterine bleeding; Menstruation, abnormal. anemia due to, 97-98, 173 anovulatory, 95-96 complications of, 220 danazol for, 104-105 definition of, 97, 199 diagnosis of, 97-103 differential diagnosis of, 71-72 fibroids and, 82, 82b, 133, 219-220 history in, 98, 99b imaging in, 99, 99f-103f in hemostatic disorders, 89-92, 173-174 in von Willebrand disease, 95 laboratory studies in, 98-100 management of, 97, 104-113, 104f, 171-176 emergency, 112 endometrial ablation in, 199-217. See also Endometrial ablation. levonorgestrel intrauterine system in, 23, 51, 105, 171-176 pharmacologic, 100, 104-106, 104f surgical, 104f, 106-113 ovulatory, 96 perimenopause and, 96-97 physical examination in, 98 quality of life and, 220 watchful waiting in, 100 Menstrual bleeding abnormal, 95-113, 97b, 98b. See also Abnormal uterine bleeding; Menorrhagia. anovulatory, 21, 95-96, 97 in hemostatic disorders, 89-92, 173-174 levonorgestrel and, 173-176 normal, 96 volume of, 96 Menstrual cramps, after hysteroscopic myomectomy, 234 Menstrual cycle endometrial changes during, 49-50, 50f hysteroscopy during, 50 proliferative phase of, 49, 50f secretory phase of, 49, 50f timing of, 96 Menstrual history, 98 Menstruation abnormal, 95-113. See also Abnormal uterine bleeding, premenopausal; Menorrhagia. after hysteroscopic myomectomy, 234 causes of, 98b fibroids and, 106-107, 106b, 107f, 108f in adenomyosis, 108-109 in endometrial cancer, 107-108, 108f, 109f in endometrial hyperplasia, 109, 110f

Menstruation (Continued) management of, 97, 103-106 polyps and, 106, 106f, 107f prevalence of, 95, 96 after uterine fibroid embolization, 146-147 anemia and, 96, 97-98, 173 endometrial thickness and, 23, 49, 50f iron loss from, 96 levonorgestrel intrauterine system and, 173-176 normal, 95 pad/tampon use in, 96 perimenopausal changes in, 96-97 procedure scheduling and, 10, 50 regulation of, 95 Metroplasty for DES-related anomalies, 153-154 for septate uterus, 152-153, 153t, 164-165, 165f Metrorrhagia, 97b Microinsert device, for sterilization, 189-197, 189f. See also Hysteroscopic sterilization. Microsulis ablation device, 200, 200f, 211-215, 213f, 215t-217t, 216f Microwave ablation, 200, 200f, 211-215, 212b, 213f-215f. See also Endometrial ablation. fibroids and, 215 instrumentation for, 200, 200f, 213f patient selection for, 212b preoperative evaluation in, 214, 215f results of, 215, 215t-217t, 216f spray-paint effect in, 214 technique of, 213-215, 213f, 214f Midazolam, for anesthesia, 183 Mifepristone endometrial effects of, 54 for fibroids, 133 Miniaturized electrodes, 3-4, 4f Minihysteroscopes. See also Hysteroscopes. flexible, 3 rigid, 1-3, 2f Mini-laparotomy, vs. hysteroscopic myomectomy, 80 Minimal sedation (anxiolysis), 182b, 183t. See also Anesthesia. Minors, consent of, 41 Mirena. See Levonorgestrel intrauterine system. Mirena system, endometrial atrophy and, 23, 51 Miscarriage. See Pregnancy loss. Misoprostol, for cervical dilation, 53, 121, 206, 223-224, 240 Missed abortion, 15f, 30, 30f, 33, 34f Moderate sedation/analgesia, 182b, 183t, 206. See also Anesthesia. Molar pregnancy, bleeding in, 110-112 Monitored anesthesia care, 184 Monosomy, pregnancy loss and, 157 Morcellators, 230, 231f, 232f Müllerian agenesis, 163f Müllerian anomalies, 162-166 classification of, 162, 163t definition of, 162 diethylstilbestrol-related, 153-154, 163b, 163f embryology of, 163-164 hysteroscopic metroplasty for, 152-154, 164-165 imaging of, 61, 66 saline infusion sonography in, 66, 66f-68f, 76 incidence of, 164 infertility and, 152 septate uterus, 66, 152-153, 163b, 164-165, 164f, 165f staging of, 162, 163b

272

Müllerian ducts, development of, 163-164 Müllerian hypoplasia, 163f Myomas. See Fibroids. Myomectomy abdominal, 71, 133, 151-152 effectiveness of, 134 for infertility, 151-152 historical perspective on, 219 hysteroscopic. See Hysteroscopic myomectomy. laparoscopic, 80, 133, 151-152 preoperative evaluation for, 71-80. See also Preoperative evaluation. recurrence after, 134 vaginal, 31-32 Myometrial thickness, sonographic measurement of, 61 Myometrium, fibroid extension into, 61, 62f, 222, 223f

N Nafarelin, for abnormal uterine bleeding, 105 Narcotics. See also Analgesia. for uterine fibroid embolization, 137b, 139 Natural saline infusion sonography, 59, 59f, 78, 78f. See also Saline infusion sonography. Nd:YAG laser therapy. See also Laser therapy. carbon dioxide embolism in, 242 disadvantages of, 243 Necrotic fibroids, 140-141, 141f-143f, 144 Nerve blocks, 183-184 in endometrial ablation, 205-206 in hysteroscopic myomectomy, 233 Nerve compression, intraoperative, 239 Nonsteroidal antiinflammatory drugs for abnormal uterine bleeding, 105 for uterine fibroid embolization, 137b, 139 preprocedure administration of, 9 Norethindrone adverse effects of, 52b for abnormal uterine bleeding, 105 for endometrial thinning postoperative use of, 53-54 preoperative use of, 51 for sterilization, 190 No-touch technique, 20 for flexible hysteroscopy, 11, 16-17, 20 for rigid hysteroscopy, 1 NovaSure ablation device, 200, 200f, 211, 211f, 212b, 215, 215t-217t, 216f. See also Endometrial ablation. Nulliparity, endometrial cancer and, 117

O Obesity, endometrial cancer and, 117 Objective structured assessment of technical skills (OSATS), 250-252, 251f, 252f Office Continuous Flow Operative Hysteroscope, 2-3 Office hysteroscopy advantages of, 7, 19-20 anesthesia for, 179-184 cervical dilation for, 53, 121

Index Office hysteroscopy (Continued) complications of, 239-246. See also Complications. contraindications to, 35-36 credentialing for, 257-260 ease of performance of, 20 emergency, 112 equipment and supplies for, 1-18, 43-46, 44f. See also Hysteroscopes. failure rate for, 69 false-negative results of, 16, 16f, 81 flexible, 3, 7-20. See also Flexible hysteroscopy. instrumentation for, 3 historical perspective on, 3, 49 indications for, 19-35. See also Indications. rigid, 1-5. See also Rigid hysteroscopy. instrumentation for, 1-3, 2f, 4f scheduling of, menstrual cycle and, 10, 50 see-and-treat, 3 surgical skills for, 249-254. See also Surgical skills. underutilization of, 86 Office-based endometrial ablation, 199-200, 205215. See also Endometrial ablation, global (office-based). Oligomenorrhea, 97b Olympus flexible hysteroscopes, 8, 8f, 9f Olympus rollerball, 199, 204f, 225, 225f Olympus wire loop, 204f Onapristone, endometrial effects of, 54 Ondansetron, for uterine fibroid embolization, 137b Operative privileges, 257-260. See also Credentialing. Opiates. See also Analgesia. for uterine fibroid embolization, 137b, 139 Oral contraceptives adverse effects of, 52 endometrial thinning and, 23, 50-51, 203 for abnormal uterine bleeding, 100, 104-105 for menorrhagia, 104-105 for sterilization, 190 postoperative use of, 53 preoperative use of, 50-51, 203 von Willebrand factor and, 91-92 Osteoporosis, gonadotropin-releasing hormone agonists and, 105 Ovarian cancer, 115 Ovarian failure. See also Amenorrhea. after uterine fibroid embolization, 146-147 Ovaries, ultrasonography of, 57, 58f Oxycodone, for uterine fibroid embolization, 137b Oxygen administration for air embolism, 243 for hyponatremic cerebral edema, 242

P Pain, 1. See also Analgesia; Anesthesia. after uterine fibroid embolization, 137, 137b, 138-139 chronic postoperative, 245-246 in endometrial ablation, 206 in saline infusion sonography, 69 minimization of, 1 shoulder, in gas distention, 11

Pap smear, 99-100 in abnormal uterine bleeding, 118 Paracervical block in endometrial ablation, 205-206 in hysteroscopic myomectomy, 233 Parental consent, 41 Partial thromboplastin time, 91 Patient instructions, postprocedure, 17 Patient positioning, 11 air embolism and, 243 nerve compression due to, 239 Pedunculated fibroids, 123, 222, 223f. See also Fibroids. Pelvic cramping in endometrial cancer, 117 menstrual cramps, after hysteroscopic myomectomy, 234 Pelvic imaging. See Imaging studies. Pelvic inflammatory disease, as contraindication, 35-36 Pelvic sonography. See Ultrasonography. Pelvic viscera, thermal injury of, 243-244 Percutaneous radiofrequency ablation, 133. See also Endometrial ablation. Perimenopausal bleeding, 96-97. See also Abnormal uterine bleeding. causes of, 68 Peroneal nerve compression, 239 PFA-100 platelet function analyzer, 91, 95 Pitressin, in hysteroscopic myomectomy, 233 Placenta abnormalities of, after uterine fibroid embolization, 143-144 retained, 15f, 30, 30f, 33, 34f, 90, 110-112 bleeding and, 110-112 diagnosis of, 99, 110-111 Placental site nodules, 30, 30f, 99 bleeding and, 110 Platelet aggregation and release studies, 92 Platelet count, 90 Platelet disorders, uterine bleeding in, 89-92 Platelet function assays, 91, 95 Polymenorrhea, 97b. See also Menstruation, abnormal. Polyps adenocervical, 13f endometrial. See Endometrial polyps; Hysteroscopic polypectomy. Positioning. See Patient positioning. Postablation tubal sterilization syndrome, 245-246 Postembolization syndrome, 144 Postmenopausal bleeding causes of, 68 definition of, 97b imaging studies in, 68, 68f Postoperative evaluation, 30 Postoperative hemorrhage, 92, 240 Preceptors, 259 Pregnancy. See also Infertility. after adhesiolysis, 161, 162, 245 after endometrial ablation, 245 after hysteroscopic surgery, 245 after metroplasty/septoplasty, 153, 245 after sterilization, 191, 194 assisted reproduction in. See also Infertility. after myomectomy, 167 preimplantation genetic screening in, 157 bleeding in, 33, 34f, 110-112 cesarean section in. See Cesarean section. ectopic, 33, 191, 194 in DES daughters, 153-154

273

Pregnancy (Continued) molar, 110-112 postoperative complications of, 245 uterine rupture in, 245 Pregnancy loss, 33 bleeding in, 30, 33, 110-112 fibroids and, 33, 152 recurrent, 33, 157-167 Asherman syndrome and, 157-162 causes of, 157, 158b chromosomal aneuploidy and, 157 definition of, 157 diethylstilbestrol for infertility after, 153-154 müllerian anomalies and, 153-154, 163b, 163f fibroids and, 166-167 hysteroscopic autopsy in, 157, 158f müllerian anomalies and, 153-154, 162-164 prevalence of, 157, 158b retained products of conception and, 15f, 30, 30f, 33, 34f, 110-112 bleeding and, 30, 33, 110-112 diagnosis of, 99, 110-111 septate uterus and, 153, 162-164, 163b, 163f Preimplantation genetic screening, 157 Preoperative evaluation, 71-86. See also specific procedures. differential diagnosis in, 71-72 for fibroid embolization, 83-85 for hysteroscopic myomectomy, 80-83, 83b history in, 72, 73b hysteroscopic classification in, 81-83 imaging in, 72-78, 83-86, 83f, 86f of adenomyosis, 79-80 of fibroids, 63-64, 72-78 of fluid accumulation, 78-79 of leiomyosarcoma, 80 pathology in, 78-80 physical examination in, 72, 73b Preoperative mapping, of fibroids, 63-64 Preoperative planning, 22-23 Privileges, surgical, 258-260 Progesterone endometrial thickness and, 23, 49, 51 for abnormal uterine bleeding, 100, 105 for sterilization, 190 in hormone replacement therapy, 127-128. See also Hormone replacement therapy. oral, vs. levonorgestrel intrauterine system, 174 postoperative use of, 53-54 preoperative use of, 51, 203 Progestins adverse effects of, 52 endometrial thickness and, 23, 50-51 in hormone replacement therapy, 127-128. See also Hormone replacement therapy. intrauterine. See Levonorgestrel intrauterine system. postoperative use of, 53-54 preoperative use of, 51, 203 Prolapsed fibroids, 31-32, 31f, 32f after embolization, 140-141, 140f, 141f Propofol, for anesthesia, 183 Propoxyphene, for uterine fibroid embolization, 137b Prostaglandin F2α, for fibroids, 167 Prothrombin time, 91 Pulmonary disease, anesthesia in, 182

Index Pulmonary embolism, after uterine fibroid embolization, 140 Pumps, in fluid distention, 230-232, 232f Pyometra, 79 after uterine fibroid embolization, 140-141

R Racial differences in endometrial cancer, 115 in fibroids, 133 Radiofrequency ablation, 211, 211f, 212b Raloxifene, endometrial effects of, 54 Recurrent pregnancy loss. See Pregnancy loss, recurrent. Regional anesthesia, 184. See also Anesthesia. Relaxation methods, 10-11 Reproductive history, 10 Respiratory disorders, anesthesia in, 182 Retained products of conception, 15f, 30, 30f, 33, 34f, 99, 110-112 bleeding and, 110-112 diagnosis of, 99, 110-111 Rigid hysteroscopes care and maintenance of, 43-46 components of, 43 proper handling of, 44, 44f sterilization of, 45-46, 45f Rigid hysteroscopy, 1-5. See also Office hysteroscopy. advantages of, 1-2 disadvantages of, 7 for biopsy, 4-5 for myomectomy, 5 for polypectomy, 5 instrumentation for, 1-3, 2f lens angle for, 1, 2f scope introduction in, 1 scope location in, 1, 2f uterine distention in, 2f, 3-4. See also Uterine distention. vaginoscopic (no-touch) approach in, 1 vs. flexible hysteroscopy, 7 Ringer lactate, for uterine distention, 241, 241t Rollerballs for endometrial ablation, 199, 200f, 204, 204f for myomectomy, 225, 225f Rollerbars for endometrial ablation, 199, 200f for myomectomy, 225, 226f

S Saline infusion, for hyponatremia, 242 Saline infusion sonography, 19, 59-60, 59f, 60f. See also Ultrasonography. advantages of, 69, 75-76 contraindications to, 60 cost effectiveness of, 69, 204 diagnostic accuracy of, 73 disadvantages of, 69 endometrial biopsy and, 101-103, 103f failure rate for, 69

Saline infusion sonography (Continued) in abnormal uterine bleeding, 66-67, 68f, 77-78, 99, 99f, 222, 223f postmenopausal, 68, 69f, 120, 126 premenopausal, 102-103, 103f in endometrial thickness measurement, 60, 65, 65f in infertility, 149-150, 150t in sterilization, 190, 190f indications for, 76, 103 natural, 59, 59f, 78, 78f of endometrial cancer, 66 of endometrial polyps, 24, 65, 65f of fibroids, 24-25, 222, 223f of leiomyomas, 28, 29f of müllerian anomalies, 66, 66f-68f, 76 of retained products of conception, 99 of tamoxifen-induced changes, 126, 126f pain in, 69 preoperative, 73, 75-78, 76f, 77f technique of, 59-60 three-dimensional imaging in, 60-61, 61f timing of, 60 transvaginal ultrasonography and, 27-28, 77, 78, 103 vs. hysteroscopy, 68-69 Saline irrigation, for vaginal bleeding, 36 Saline-based uterine distention. See Uterine distention, liquid. Scheduling, menstrual cycle and, 10, 50 Scissors, 4f Screening for endometrial cancer, 116 preimplantation genetic, 157 Sedation. See also Anesthesia. depth of, 182, 182b, 183t See-and-treat hysteroscopy, 3 Selective estrogen receptor modulators (SERMs), 54 Selective progesterone receptor modulators (SPRMs), 54, 152 Sensors, digital distal tip, 17 Sepsis, after uterine fibroid embolization, 140 Septate uterus, 152-153, 163b, 164-165, 164f, 165f. See also Müllerian anomalies. imaging of, 66, 164, 164f, 165f Septoplasty, 152-153, 153t, 164-165, 165f Sex hormones. See also specific hormones. in menopause, 97 Shoulder pain, in gas distention, 11 Simulation training, 253, 253f, 254f Small intestine, thermal injury of, 243-244 Smith & Nephew hysteroscopic morcellator, 230, 231f Smoking, anesthesia and, 182 Society of Gastrointestinal Surgeons (SAGEs), credentialing by, 258 Society of Obstetricians and Gynecologists of Canada (SOGC), credentialing by, 258 Society of Reproductive Surgeons (SRS), credentialing by, 258 Sodium deficiency, in uterine distention, 241-242, 241t Sonohysterography. See Saline infusion sonography. Sorbitol, for uterine distention, 240, 241, 241t Spinal anesthesia, 184. See also Anesthesia. Splint, intrauterine, for adhesion prevention, 160-161 Spray-paint effect, in microwave ablation, 214 Spring electrode, 4 Steam sterilization, 45

274

Stenosis, cervical. See Cervical stenosis. Sterilization of equipment and supplies, 45-46, 45f surgical historical perspective on, 187 hysteroscopic, 187-197. See also Hysteroscopic sterilization. laparoscopic, 187, 188t, 191 postablation tubal sterilization syndrome and, 245-246 reversal of, 191 Steris systems, 45-46, 46f Steroid receptor modulators, 54, 154 Stool softeners, for uterine fibroid embolization, 137b, 139 Submucosal fibroids, 24-25, 24f, 82. See also Fibroids. Suction curettage, for endometrial thinning, 202 Suction-irrigation devices, 2f, 3 Surgery in hemostatic disorders, 92 preoperative hysteroscopy for, 22-23, 28-29 Surgical privileges, 258-260 Surgical skills acquisition of, 249 competency-based learning in, 254 educational programs for, 252-254, 259-260 for endometrial ablation, 199-200 for hysteroscopic sterilization, 192 guidelines for, 259-260 preceptors in, 259 simulation training in, 253, 253f, 254f stages of, 249, 250t assessment of competency-based, 254 objective structured, 249-252, 251f-252f credentialing for, 257-260. See also Credentialing. levels of, 260b maintenance of, 260 new technologies and, 249 performance standards for, 254 Surrogate decision-making, 41 Synechiae. See Adhesions.

T Tamoxifen adenomyosis and, 35, 36f endometrial cancer and, 117 endometrial effects of, 54, 110f, 116, 126, 126f endometrial monitoring for, 35, 36f, 126 Tamponade. See Balloon tamponade. Tape, cerclage, retained, 33, 33f ThermaChoice uterine balloon therapy, 200, 200f, 206-207, 207b, 215, 215t-217t, 216f. See also Balloon endometrial ablation. Thermal ablation, hysteroscopic, 200, 200f, 209210, 210f, 211b, 215, 215t-217t, 216f. See also Endometrial ablation. Thermal injuries, 243-244 Three-dimensional ultrasonography, 60-61, 61f, 66 Thrombocytopenia platelet count in, 90 uterine bleeding in, 89-92 Tibolone, endometrial effects of, 54 Tobacco use, anesthesia and, 182 Toolbox of Assessment Methods (ACGME), 250

Index Training. See Surgical skills. Tranexamic acid for menorrhagia, 106 vs. levonorgestrel intrauterine system, 174 Transcervical resection of endometrium, 199 Transvaginal ultrasonography. See Ultrasonography. Trendelenburg position. See also Patient positioning. air embolism and, 243 Trichomoniasis, as contraindication, 36 Trisomy, pregnancy loss and, 157 Trophoblastic disease, bleeding in, 110-112 Tubal cannulation, 154, 154f Tubal obstruction, hysterosalpingography for, 154 Tubal occlusion. See Sterilization. Tumor dissemination, hysteroscopic, 37 Twizzle electrode, 4, 5, 225, 229

U Ultrasonography, 57-69 abdominal, vs. transvaginal, 73 endometrial biopsy and, 100-103, 101f-103f endorectal, 57 hysteroscopic follow-up for, 25-28 in abnormal uterine bleeding, 66-67 postmenopausal, 68, 68f, 117, 118-120, 119f premenopausal, 100, 101f-103f, 102-103 in adenomyosis, 64-65, 64f, 79, 79f in Asherman syndrome, 158-159, 159f in cervical dilation, 127 in endometrial cancer, 66, 118-120 for risk assessment, 117 in hysteroscopic myomectomy, 233 in infertility, 150, 150f, 150t instrumentation for, 57 of bicornuate uterus, 66, 66f, 68f of endometrial hyperplasia, 66 of endometrial polyps, 65, 65f, 119, 119f of fibroids, 61-64, 63f, 64f, 101f-102f preoperative, 72-78 of müllerian anomalies, 66, 66f-68f of normal uterus, 58-59, 59f of ovaries, 57, 58f of pyometra, 79 of tamoxifen-induced changes, 126, 126f physics of, 57 preoperative, 72-78 saline infusion, 19, 59-60, 59f, 60f. See also Saline infusion sonography. three-dimensional, 60-61, 61f tips and tricks for, 57 transvaginal diagnostic accuracy of, 73 endometrial echo in, 118-120, 119f limitations of, 25-28, 28f, 74-75 preoperative, 72-75, 74f saline infusion sonography and, 27-28, 77, 78, 103 vs. hysteroscopy, 68-69 Umbilical fibroid embolization, complications of, 147t Unicornuate uterus, 163b, 163f. See also Müllerian anomalies. Urinary tract disorders, bleeding in, 128, 128b Uterine artery embolization. See Uterine fibroid embolization.

Uterine atrophy. See Endometrial atrophy. Uterine balloon therapy, 200, 200f, 206-207, 207b, 215, 215t-217t, 216f. See also Balloon endometrial ablation. Uterine bleeding abnormal. See Abnormal uterine bleeding. anovulatory, 21 as contraindication, 36 in bleeding disorders, 89-92, 90b intraoperative, 240 menstrual. See Menstrual bleeding; Menstruation. normal, 23 postoperative, 92, 240 Uterine cramping in endometrial cancer, 117 menstrual, after hysteroscopic myomectomy, 234 Uterine distention bleeding and, 240 complications of, 240-243 gas, 242 carbon dioxide embolism in, 242 complications of, 242 equipment for, 43-44, 44f hysteroinsufflators for, 43-44 in flexible hysteroscopy, 11 in rigid hysteroscopy, 3 vs. liquid distention, 3, 11 in flexible hysteroscopy, 8, 11, 11f in myomectomy, 230-231, 232f, 233f in rigid hysteroscopy, 2f, 3 infusion/intrauterine pressure in, 241 air embolism and, 243 liquid, 3, 11, 11f bipolar electrodes and, 3-4 complications of, 240-242, 241t fluid deficit in, 240, 241-242 fluid monitoring in, 230-232, 232f, 233f, 241-242 fluid overload in, 80, 82, 230, 242 fluid pumps for, 230-232, 232f high-viscosity solutions for, 242 hyponatremia in, 241 in myomectomy, 80, 82, 230-232, 232f, 233f low-viscosity solutions for, 240-242 vs. gas distention, 3, 11 Uterine enlargement fibroids and, 72-78. See also Fibroids. fluid accumulation and, 78-79, 78f, 79f preoperative evaluation of, 72-86 Uterine fibroid embolization, 85, 131-147 advantages of, 85, 132, 132b, 134 amenorrhea after, 146-147 Asherman syndrome after, 34-35 beads/microspheres for, 138 bleeding after, 109-110, 111f clinical pearls for, 135 complications of, 85, 144-147, 144b contraindications to, 135b, 144 costs of, 134 discharge instructions for, 137-138, 138b drug therapy for, 137-138, 137b endometrial ablation for, 133 failure of, 85, 138 fertility after, 134, 143-144, 152 fibroid expulsion after, 144, 145-146, 145f follow-up in, 142 for adenomyosis, 136, 141-143 gonadotropin-releasing hormone agonists and, 135, 136-137

275

Uterine fibroid embolization (Continued) historical perspective on, 131-132 in postmenopausal patients, 144 increasing use of, 132 indications for, 132b, 135b infection after, 140 ischemic necrosis after, 144, 145f leiomyosarcoma risk and, 134, 135f, 144-145 leukorrhea/vaginal discharge after, 34-35, 35f, 140, 140f-142f, 141, 146, 146f mortality in, 142f, 144 ovarian failure and, 146-147 overview of, 131 pain management in, 137, 137b, 138-139 patient education for, 134-135 patient selection for, 134, 144 postembolization syndrome and, 144 postprocedure management in, 138-141 pregnancy after, 142f, 143-144, 152, 245 preoperative evaluation for, 83-85, 134-137 endometrial biopsy in, 136 imaging studies in, 136, 136f, 137f laboratory tests in, 136 patient consultation in, 134-135 prolapsed fibroids in, 140-141, 140f, 141f pulmonary embolism after, 140 results of, 143, 143t technique of, 138, 139f, 140f timing of, 136 vs. hysterectomy, 132-133 Uterine fibroids. See Fibroids. Uterine perforation, 17, 33, 240 energy-related complications and, 243, 244 pregnancy after, 245 Uterine rupture, in pregnancy, 245 Uterus. See also under Endometrial; Endometrium. age-related changes in, 72 arcuate, 163b, 163f, 165-166 bicornuate, 66, 66f, 68f, 163b, 163f congenital anomalies of. See Müllerian anomalies. DES-related anomalies of, 153-154, 163b, 163f didelphus, 163b, 163f imaging of. See Imaging studies. septate, 66, 152-153, 153t, 163b, 164-165, 164f, 165f. See also Septate uterus. thermal injuries of, 243-244 unicornuate, 163b, 163f

V Vacuum hysteroscope, 230, 232f Vagina, hysteroscopic examination of, 19 Vaginal atrophy, abnormal uterine bleeding and, 118 Vaginal bleeding. See Uterine bleeding. Vaginal discharge, 34, 34f. See also Leukorrhea. after polypectomy, 236 after uterine fibroid embolization, 34-35, 35f, 139, 140, 140f-142f, 141, 146, 146f hysterectomy for, 35, 35f in endometrial cancer, 117 postmenopausal, 117 postprocedure, 17 Vaginal distention, 1. See also Uterine distention. Vaginal myomectomy, 31-32

Index Vaginoscopic approach, 20 for flexible hysteroscopy, 11, 16-17 for rigid hysteroscopy, 1 Vapor cut waveform, 4 Vaportrode electrode, 228-229 Vasopressin for emergency hysteroscopy, 112 for hysteroscopic myomectomy, 233 for postoperative bleeding, 240 for von Willebrand disease, 92, 106 operative indications for, 53 Venous thrombosis, after uterine fibroid embolization, 140

Versapoint Bipolar Electrosurgical System, 3-4 Virtual reality training, 253-254, 254f Volume levels. See under Fluid. Von Willebrand disease, 89 diagnosis of, 91-92, 95 screening for, 95 surgery in, 92 treatment of, 105-106 Von Willebrand factor, 89 blood groups and, 92 in menstrual bleeding, 95 oral contraceptives and, 91-92 tests for, 91-92, 95

276

Von Willebrand ristocetin cofactor activity, 95

W Waveforms, 4 Wire loop for endometrial ablation, 199, 200f, 204, 204f for myomectomy, 225-228, 226f-228f