Indications and options for endometrial ablation

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1 Indications and options for endometrial ablation The Practice Committee of the American Society for Reproductive Medicine American Society for Reproductive Medicine, Birmingham, Alabama Endometrial ablation is an effective therapeutic option for the management of menorrhagia in properly selected patients. Hysteroscopic and non-hysteroscopic techniques offer similar rates of symptom relief and patient satisfaction. (Fertil Steril 2006;86(Suppl 4):S by American Society for Reproductive Medicine.) Endometrial ablation may be considered in premenopausal women for the treatment of menorrhagia. Significant uterine pathology and medical conditions that can cause menorrhagia should be excluded before performing the ablative procedures. Ablative therapy may also be considered when medical treatments fail, are contraindicated, or are poorly tolerated. Endometrial ablation is not indicated in postmenopausal women, in women with endometrial cancer or hyperplasia, or in premenopausal women who wish to preserve their fertility. ENDOMETRIAL THINNING IN PREPARATION FOR ABLATION Endometrial ablation is most effective if performed when the endometrium is relatively thin or atrophic, an objective that can be achieved in 3 ways: [1] scheduling the procedure for the immediate post-menstrual phase when the endometrium generally is 4 mm in thickness (1); [2] preoperative endometrial curettage, which has the advantage of avoiding the delays required for preparatory medical treatment (2); and [3] hormonal therapy aimed at inducing endometrial thinning or atrophy before the ablative procedure. The most common hormonal agents used to attenuate the endometrium include gonadotropin-releasing hormone (GnRH) analogs, danazol, and progestogens. Such preoperative medical treatments offer the additional advantage of improving the anemia that often results from severe menorrhagia. A systematic review of studies that have compared different hormonal therapies for thinning the endometrium concluded that GnRH analogs reliably result in significant endometrial thinning and increase the likelihood that surgery will achieve amenorrhea (3). Down-regulation with a GnRH agonist is effective when used for 30 to 60 days before the ablative procedure. Similar results have been demonstrated with preoperative danazol treatment (600 mg 800 mg daily for days) (3). Few data from randomized trials are available to assess the effectiveness of various progestogens (e.g., oral contraceptives, medroxyprogesterone acetate, and norethindrone acetate) as endometrial thinning agents (3). One trial that compared different progestogens and danazol Educational Bulletin Received September 5, 2006; revised and accepted September 5, Reprints will not be available. found that treatment with progestogen had little or no effect on endometrial thickness (4). Consequently, GnRH analogs and danazol appear to be the treatments most reliably effective for this purpose. TECHNIQUES FOR ENDOMETRIAL ABLATION A variety of methods are currently available for endometrial ablation, and others are under development or investigation. Overall, the techniques for global destruction of the endometrium can be divided into two groups: hysteroscopic procedures and nonhysteroscopic procedures. Hysteroscopic techniques include endometrial ablation with either laser (5), radiofrequency (6) or electrical energy (7), and endometrial resection using an electrosurgical wire-loop electrode (8). The newer nonhysteroscopic procedures employ devices that deliver energy in a global and uniform manner to ablate the endometrium. Hysteroscopic Techniques for Endometrial Ablation The first effective hysteroscopic endometrial ablation was performed using photovaporization with a neodymium-yittrium, aluminum, garnet laser (5). Less expensive techniques using an electrosurgical rollerball instrument (9, 10) or an unmodified resectoscope (11, 12) were described subsequently. The latter technique, often referred to as transcervical resection of the endometrium, typically is followed by ablation using the rollerball electrode. Five randomized controlled trials have compared transcervical resection of the endometrium or other techniques for endometrial ablation with hysterectomy (13 17). A metaanalysis of these trials concluded that hysteroscopic methods for endometrial destruction are highly effective in reducing menstrual blood loss in all but 3% to 13% of women (18). The reported incidence of postoperative amenorrhea after endometrial ablation has ranged from 23% to 60%, and 6% to 20% of women have required further surgery for control of their symptoms after 1 to 5 years of follow-up (19). After 2 years of follow-up, women randomized to have hysterectomy were significantly more satisfied with their surgical results than those who had a hysteroscopic ablation (18). However, there was little difference between the two groups in quality of life measures (18). S6 Fertility and Sterility Vol. 86, Suppl 4, November /06/$32.00 Copyright 2006 American Society for Reproductive Medicine, Published by Elsevier Inc. doi: /j.fertnstert

2 In addition to the usual risks and complications of cervical dilation and the application of thermal energy, all hysteroscopic techniques are associated with risk of complications related to fluid management. Therefore, intraoperative fluid deficits must be monitored carefully. Unipolar electrosurgical techniques for endometrial destruction require the use of electrolyte-free solutions to distend the endometrial cavity. Commonly used media include 1.5% glycine, 3% sorbitol, 5% mannitol, and solutions that combine mannitol and sorbitol (20), any of which can be absorbed into the vascular system and result in fluid overload and hyponatremia (21). A bipolar resectoscope and bar electrode (Versapoint ; Gynecare, Somerville, NJ) also are available and allow normal saline to be used as the distention medium, thereby decreasing the risk for hyponatremia (22) but not for fluid overload. The Versapoint device has been approved by the Food and Drug Administration (FDA) for use in the United States. Hydrothermal ablation Hydrothermal ablation (HydroThermAblator ; Boston Scientific, Natick, MA) is a technique that involves the insertion of a single-use, polycarbonate-sheathed 3-mm hysteroscope into the endometrial cavity and the instillation and circulation of heated physiologic saline. Temperature, inflow, and outflow are regulated by a microprocessor. The saline is heated to and maintained at 90 C for 10 minutes (23), resulting in endomyometrial necrosis to a depth of 2 mm to 4mm(24). Saline is infused at a pressure 45 mm Hg, resulting in an intrauterine net pressure between 50 mm and 55 mm Hg that prevents flow through the fallopian tubes. The HydroThermAblator device has been approved by the Nonhysteroscopic Techniques for Endometrial Ablation A variety of nonhysteroscopic techniques for endometrial ablation now offer safety and efficacy that compare favorably with hysteroscopic techniques, while requiring less technical skill and operative time (20). Because these techniques do not require use of a fluid distension medium, the associated complications are eliminated. A number of devices are still under investigation, but several have been approved by the FDA for use in the United States (25 32). Thermal balloon ablation A variety of thermal balloon devices have been developed to provide automated methods for endometrial ablation. The Thermachoice system (J&J Ethicon Gynecare, Sommerville, NJ) was the first such device. The Thermachoice system consists of a handpiece with a catheter and a controller unit. The single-use catheter, with a silicone balloon at its distal end, is inserted into the uterine cavity to the level of the fundus. The technique is not recommended when ultrasonography indicates that the endometrial cavity has a FERTILITY & STERILITY depth 10 cm. After the balloon is filled with sufficient 5% dextrose in water to achieve a stable intrauterine pressure between 160 mm Hg and 180 mm Hg, the controller unit is activated. The controller maintains pressure at 180 mm Hg and temperature at 87 C during a preset 8-minute treatment cycle, resulting in endomyometrial destruction (26, 27). The Thermachoice system has been approved by the FDA for use in the United States. Radiofrequency thermal balloon The radiofrequency thermal balloon device consists of an expandable silastic balloon with 12 electrodes mounted on the surface (28). The device is inserted inside its protective sheath and 10 ml to 15 ml of air are instilled to expand the balloon and bring the electrodes into contact with the endometrial surface. Using radiofrequency energy, the electrodes achieve and maintain a surface temperature of 70 C 75 C during a 4-minute treatment session. The slightly lower temperatures achieved in the cornual regions avoid extrauterine injury. As of January, 2006, the radiofrequency balloon device was not approved by the FDA for use in the United States. Three-dimensional bipolar ablation The three-dimensional bipolar ablation device (Nova- Sure ; Cytyc Corp., Marlborough, MA) consists of a gold-plated, mesh electrode that conforms to the endometrial cavity. The device is inserted into the uterine cavity and deployed from its protective sheath. Suction is created by the system generator, drawing the endometrium into contact with the expanded mesh electrode. The generator delivers power up to 180 W at 500 khz in a bipolar mode that ablates the endometrium to a uniform depth. Once activated, the suction device removes moisture and debris to achieve tissue dessication to a depth of 4.0 mm to 4.5 mm in the uterine body and 2.2 mm to 2.9 mm in the cornual regions of the uterus. The programmed treatment cycle ( seconds depending on endometrial thickness) ends when the preset target impedance is attained (28). The NovaSure device has been approved by the Microwave endometrial ablation The microwave endometrial ablation system (Microsulis ; Waterloo, UK) employs microwave energy to ablate the endometrium (28, 29). The dielectric constant of endometrial tissue is such that a microwave frequency of 9.2 GHz results in tissue dessication to a depth of 6 mm. The device is inserted into the uterine cavity through an 8-mm applicator to the level of the fundus. Once the device is activated, microwave energy achieves a temperature of 95 C, and the probe is moved laterally to assure contact with the cornual regions. The mean treatment time is approximately 2 minutes and is determined by the size of the endometrial cavity and endometrial thickness. The Microsulis device has been approved by the S7

3 TABLE 1 Outcomes following endometrial destruction procedures. Technique Treatment time (min) Follow-up Amenorrhea (%) Patient satisfaction (%) Transcervical resection (25) months Rollerball (25) months Hydrothermal ablation (25) 10 2 months Thermal balloon ablation (25) 8 12 months Radiofrequency balloon (25) 4 12 months Three-D bipolar ablation (25) months Microwave ablation (25) 2 12 months Laser interstitial ablation (30) 5 12 months Cryoablation (25) months ASRM Practice Committee. Endometrial ablation. Fertil Steril Laser interstitial hyperthermy The endometrial laser intrauterine thermal therapy device (GyneLase ; Lumenis, Santa Clara, CA) employs neodymiumyittrium, aluminum, garnet laser energy to achieve endometrial destruction (30). The device houses a triple-laser fiber instrument. After insertion into the uterine cavity, the sliding handpiece is activated to deploy lateral fibers into the cornual regions. The deployed device thus assumes a triangular configuration that conforms to the endometrial cavity and delivers 5 to 7 W per fiber for an interval of approximately 5 minutes. As the laser light diffuses throughout the cavity, absorbed light is converted to heat, resulting in endometrial coagulation. As of January 2006, the GyneLase device was not approved by the Cryoablation Cryosurgical techniques for endometrial destruction were first described about 30 years ago (31) but then met with only limited success. The uterine cryoablation therapy system (HerOption ; American Medical Systems, Minnetonka, MN) consists of a 5.5-mm cryoprobe that is inserted into the uterine cavity (32). Transabdominal sonography is used to confirm proper placement of the probe and to follow the growth of the ice ball that forms during the treatment cycle. Once activated, the system circulates a mixed fluid through the probe to achieve intrauterine temperatures between 90 C and 110 C. The device is directed into the cornual regions, each of which is treated individually. The HerOption device has been approved by the FDA for use in the United States. COMPARISON OF RESULTS WITH HYSTEROSCOPIC AND NONHYSTEROSCOPIC TECHNIQUES FOR ENDOMETRIAL DESTRUCTION There is no single prospective study in which all methods have been compared, but numerous trials have compared the newer nonhysteroscopic endometrial ablation techniques with established hysteroscopic methods. The available data indicate that nonhysteroscopic techniques are an appropriate clinical choice. Because they may be performed under local anesthesia and sedation, nonhysteroscopic methods offer a considerable advantage over hysteroscopic techniques and should be considered in all cases where general anesthetic may be associated with particular risk. Moveover, nonhysteroscopic techniques are technically easier and quicker to perform. Although long-term follow-up comparisons of the various techniques for endometrial ablation are not yet available, nonhysteroscopic techniques appear to achieve results and patient satisfaction similar to those observed with hysteroscopic methods of endometrial ablation (Table 1) (25). COMPLICATIONS Complications associated with hysteroscopic techniques of endometrial ablation involve primarily those resulting from unrecognized uterine perforation and injury to adjacent structures or from fluid and electrolyte disturbances relating to excessive absorption of distension media. Severe fluid overload can result in fatal hyponatremia and pulmonary edema (33). Complications relating to distension media occur in approximately 4% of hysteroscopic procedures and vary with the type of medium employed (34). The use of continuous fluid monitoring systems has been demonstrated effective for reducing the incidence of such complications (35). The complications associated with nonhysteroscopic endometrial ablation techniques are essentially limited to those resulting from unrecognized uterine perforation and subsequent injury to adjacent organs or structures. Because experience with these newer techniques is still somewhat limited, the true incidence of associated complications is not yet entirely clear. Concern has arisen that endometrial cancer might develop in isolated islands of viable endometrium after an ablation procedure; at least eight cases of endometrial cancer after S8 ASRM Practice Committee Endometrial ablation Vol. 86, Suppl 4, November 2006

4 endometrial ablation have been reported (36). Consequently, it seems prudent to recommend that endometrial ablation not be performed in women with chronic anovulation. Pregnancies after endometrial ablation also have been reported (37). Potential complications include spontaneous abortion, intrauterine growth restriction, preterm labor, premature rupture of membranes, abnormal placentation, and intrauterine fetal death (37). SUMMARY AND CONCLUSIONS Endometrial ablation is an effective therapeutic option for the management of menorrhagia. Hysteroscopic and nonhysteroscopic techniques for endometrial ablation offer similar rates of symptom relief and patient satisfaction. Later definitive surgery may be required in 6% to 20% of women after endometrial ablation. Women who undergo hysterectomy after a failed endometrial ablation report significantly more satisfaction after 2 years of follow-up. Endometrial ablation generally is more effective when the endometrium is relatively thin. Ideally, hysteroscopic methods for endometrial ablation should be performed using a fluid monitoring system to reduce the risks of complications relating to fluid overload and electrolyte imbalance. Nonhysteroscopic methods for endometrial ablation require less technical skill and operating time. Acknowledgments: This report was developed under the direction of the Practice Committee of the American Society for Reproductive Medicine as a service to its members and other practicing clinicians. While this document reflects appropriate management of a problem encountered in the practice of reproductive medicine, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment. Other plans of management may be appropriate, taking into account the needs of the individual patient, available resources, and institutional or clinical practice limitations. The Practice Committee of the American Society for Reproductive Medicine and the Board of Directors of the American Society for Reproductive Medicine have approved this report. REFERENCES 1. Weingold AB. Gross and microscopic anatomy. In: Kase NG, Weingold AB, Gershenson PM, eds. Principles and Practice of Clinical Gynecology, 2nd edition. New York: Churchill Livingston, 1990: Shawki O, Peters A, Abraham-Hebert S. Hysteroscopic endometrial destruction, optimum method for preoperative endometrial preparation: a prospective, randomized, multicenter evaluation. JSLS 2002; 6: Sowter MC, Lethaby A, Singla AA. Pre-operative endometrial thinning agents before endometrial destruction for heavy menstrual bleeding. Cochrane Database Syst Rev 2002;(3):CD Rich AD, Manyonda IT, Patel R, Amias AG. 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: Goldrath MH, Fuller TA, Segal S. Laser photovaporization of endometrium for the treatment of menorrhagia. Am J Obstet Gynecol 1981;140:14 9. FERTILITY & STERILITY 6. Phipps JH, Lewis BV, Prior MV, Roberts T. Experimental and clinical studies with radiofrequency-induced thermal endometrial ablation for functional menorrhagia. Obstet Gynecol 1990;76: Brooks PG, Serden SP. Endometrial ablation in women with abnormal uterine bleeding aged fifty and over. J Reprod Med 1992;37: Rutherford AJ, Glass MR, Wells M. Patient selection for hysteroscopic endometrial resection. Br J Obstet Gynaecol 1991;98: Vancaillie TG. Electrocoagulation of the endometrium with the ballend resectoscope. Obstet Gynecol 1989;74: Lin BL, Miyamoto N, Tomomatsu M. The development of a new hysteroscopic resectoscope and its clinical applications on transcervical resection and endometrial ablation. Jpn J Gynecol Obstet Endosc 1988; 4: DeCherney A, Polan ML. 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Medical Research Council randomised trial of endometrial resection versus hysterectomy in management of menorrhagia. Lancet 1997;349: Pinion SB, Parkin DE, Abramovich DR, Naji A, Alexander DA, Russell IT, et al. Randomised trial of hysterectomy, endometrial laser ablation, and transcervical endometrial resection for dysfunctional uterine bleeding. BMJ 1994;309: Lethaby A, Shepperd S, Cooke I, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database Syst Rev 1999;(2):CD Abbott JA, Garry R. The surgical management of menorrhagia. Hum Reprod 2002;8: Munro MG. Abnormal uterine bleeding: surgical management Part III. J Am Assoc Gynecol Laparosc 2001;8: Istre O, Skajaa K, Schjoensby AP, Forman A. Changes in serum electrolytes after transcervical resection of endometrium and submucous fibroids with use of glycine 1.5% for uterine irrigation. Obstet Gynecol 1992;80: Loffer FD. Preliminary experience with the VersaPoint bipolar resectoscope using a vaporizing electrode in a saline distending medium. J Am Assoc Gynecol Laparosc 2000;7: Weisberg M, Goldrath MH, Berman J, Greenstein A, Krotec JW, Fronio L. Hysteroscopic endometrial ablation using free heated saline for the treatment of menorrhagia. J Am Assoc Gynecol Laparosc 2000;7: Richart RM, das Dores GB, Nicolau SM, Focchi GR, Cordeiro VC. Histologic studies of the effects of circulating hot saline on the uterus before hysterectomy. J Am Assoc Gynecol Laparosc 1999;6: Lethaby A, Hickey M, Garry R. Endometrial destruction techniques for heavy menstrual bleeding. Cochrane Database Syst Rev 2005;(4): CD Meyer WR, Walsh BW, Grainger DA, Peacock LM, Loffer FD, Steege JF. Thermal balloon and rollerball ablation to treat menorrhagia: a multicenter comparison. Obstet Gynecol 1998;92: Grainger DA, Tjaden BL, Rowland C, Meyer WR. 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5 center, prospective, randomized, clinical trial. J Am Assoc Gynecol Laparosc 2000;7: Cooper JM, Erickson ML. Global endometrial ablation technologies. Obstet Gynecol Clin North Am 2000;27: Cooper KG, Bain C, Lawrie L, Parkin DE. A randomised comparison of microwave endometrial ablation with transcervical resection of the endometrium; follow up at a minimum of five years. BJOG 2005;112: Donnez J, Polet R, Rabinovitz R, Ak M, Squifflet J, Nisolle M. Endometrial laser intrauterine thermotherapy: the first series of 100 patients observed for 1 year. Fertil Steril 2000;74: Droegemueller W, Makowski E, Macsalka R. Destruction of the endometrium by cryosurgery. Am J Obstet Gynecol 1971;110: Center for Devices and Radiological Health. HerOption Uterine Cryoablation Therapy System P PMA Panel Report, December 12, Arieff AI. Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest 1999;115: Bassil S, Nisolle M, Donnez J. Complications of hysteroscopic surgery in gynecology. In: Donnex J, Nisolle M, eds. An atlas of laser operative laparoscopy and hysteroscopy. New York: The Parthenon Publishing Group, 1994: Cooper JM, Brady RM. Intraoperative and early postoperative complications of operative hysteroscopy. Obstet Gynecol Clin North Am 2000;27: Valle RF, Baggish MS. Endometrial carcinoma after endometrial ablation: high- risk factors predicting its occurrence. Am J Obstet Gynecol 1998;179: Roy KH, Mattox JH. Advances in endometrial ablation. Obstet Gynecol Surv 2002;57: S10 ASRM Practice Committee Endometrial ablation Vol. 86, Suppl 4, November 2006

Endometrial Ablation. Description

Endometrial Ablation. Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Endometrial Ablation Page: 1 of 10 Last Review Status/Date: December 2012 Endometrial Ablation