Global Endometrial Ablation - Ob.Gyn. News

.75 FREE CME CREDITSUPPLEMENT TOJune 2012Available at www.obgmanagement.comtheOmniaCMEJOURNALGlobal Endometrial Ablationfor Menorrhagia: The Office OptionThis supplement was submitted by Omnia Education. Selected topics resulted from a process that included a review of needs assessments;quality improvement data; an expert-needs survey, which included medical advisory board input; and peer-reviewed literature.This activity is supported by an independent educational grant from CooperSurgical, Inc.

The Omnia CME JournalGLOBAL ENDOMETRIAL ABLATIONFOR MENORRHAGIA: THE OFFICE OPTIONAUTHORChris Canali, Medical WriterREVIEWERRobert L. Barbieri, MDChief, Department of Obstetrics and GynecologyBrigham and Women's HospitalKate Macy Ladd Professor of Obstetrics, Gynecology,and Reproductive BiologyHarvard Medical SchoolBoston, MALEARNING OBJECTIVESAfter completing this monograph, the participantshould be better able to:⦁ Compare and contrast the risks versus benefits ofcurrent procedures used for endometrial ablation.⦁ Differentiate various methods used for endometrialablation, and their clinical outcomes, to make themost appropriate selection for the patient.⦁ Evaluate current procedures used for endometrialablation from the perspective of their suitability asin-office procedures.⦁ Discuss pain management strategies in reference toendometrial ablation procedures, and implementthose strategies to improve patient outcomes.COURSE DESCRIPTIONIn the United States, an estimated 10 millionnewcases of menorrhagia are reported annually, resultingin an overall prevalence of approximately 20%,and a substantial personal burden of disease. GlobalEndometrial Ablation (GEA) represents a minimallyinvasiveapproach to treating menorrhagia.Join us in this CME activity, which will: (1) examinethe current procedures used for endometrial ablation;(2) compare and contrast methods used for endometrialablation, including the clinical outcomes; (3) evaluatethe suitability of current endometrial ablationtreatments as in-office procedures; and (4) examinestrategies for pain management with endometrialablation procedures.Release Date: May 1, 2012Expiration Date: May 1, 2013Instructions for CreditRead the article and complete the post-test and activity evaluationon page S8. Complete online or fax/mail the completed form asindicated on the form instructions. Your test will be graded. If youreceive a passing score a certificate will be sent via email. If you donot receive a passing score, you will be contacted via email andgiven the opportunity to retake the test.Target AudienceThis course is designed to meet the Continuing Medical Educationneeds of the practicing Obstetrician and Gynecologist, FamilyPhysician, Internist, Nurse Practitioner, and Physician Assistant.AccreditationThe Omnia-Prova Education Collaborative, Inc. (TOPEC) is accreditedby the Accreditation Council for Continuing Medical Education(ACCME) to provide continuing medical education for physicians.Credit DesignationThe Omnia-Prova Education Collaborative, Inc. designates this enduring materialfor a maximum of .75 AMA PRA Category 1 Credit TM . Physicians should claim onlythe credit commensurate with the extent of their participation in the activity.Acknowledgment of Commercial SupportThis activity is supported by an independent educational grant fromCooperSurgical, Inc.Disclosure of Conflicts of InterestTOPEC and Omnia Education assess conflict of interest with its faculty, planners,authors, and reviewers of CME activities. If conflicts of interest are identified foranyone who is in a position to control content, the conflicts are thoroughly vettedand resolved in part by the use of independent reviewers who review contentfor fair balance, scientific objectivity of studies utilized in the activity, and patientcare recommendations. TOPEC and Omnia Education are committed to providingits learners with high quality, unbiased, and state-of-the-art education.FacultyChris Canali has nothing to disclose.Educational Advisory Panel on Global Endometrial AblationLee Philip Shulman, MD, FACOG, FACMG, has disclosed that he is on the speakers’bureau for, is a consultant for, and has received research grants from Bayer, and ison the speakers’ bureaus and is a consultant for Sequanome, Inc. and Teva. He ison the speakers’ bureaus for GlaxoSmithKline, and Merck, and is a consultant forGenzyme Corporation.Stephen M. Cohen, MD, FACOG, has disclosed that he is on the speakers’ bureaufor Bayer and is on the advisory board for Boston Scientific.Steven R. Goldstein, MD, has disclosed that he is the director of Sonosite, Inc., onthe speakers’ bureaus for Amgen and Warner Chilcott, is a consultant for CookObGyn and Philips Ultrasound, and is on the advisory boards for Bayer, NovoNordisk, Pfizer, and Shionogi.Keith Isaacson, MD, has disclosed that he is a consultant for Karl Storz Endoscopy.Robert Rubino, MD, FACOG, has disclosed that he is a consultant for Cooper Surgicaland is a principle investigator for Hologic and Interlace Medical.Robert Zurawin, MD, has disclosed that he is on the speakers' bureau and is aconsultant for Ethicon Women's Health, is a consultant and on the advisory boardfor Conceptus, Inc., and is a consultant for Ethicon EndoSurgery.ReviewerRobert L. Barbieri, MD, has nothing to disclose.PlannersBarry A. Fiedel, PhD, has nothing to disclose.Sean T. Saunders, CCMEP, has nothing to disclose.Erica Spengler has nothing to disclose.Susan Specht, RN, MS, COHN, has nothing to disclose.DisclaimerThe views and opinions expressed in this educational activity are those of thefaculty and do not necessarily represent the views of The Omnia-Prova EducationCollaborative or Omnia Education. This article is not intended to define an exclusivecourse of patient management; the participant should use his/her clinicaljudgment, knowledge, experience and diagnostic skills in applying or adoptingfor professional use any of the information provided herein. Any procedures,medications, or other courses of diagnosis or treatment discussed or suggestedin this activity should not be used by clinicians without evaluation of their patients’conditions and possible contraindications or dangers in use, review of anyapplicable manufacturer’s product information, and comparison with recommendationsof other authorities.

Global Endometrial Ablation forMenorrhagia: The Office OptionIntroductionIn the United States, an estimated 10 million new casesof menorrhagia—also known as abnormal uterinebleeding (AUB) or, more recently, as heavy menstrualbleeding (HMB)—are reported annually, resulting in anoverall prevalence of approximately 20% among Americanwomen. 1,2Over the past decade, management of the more severecases of HMB has been accomplished by ablating the endometriumin the hospital setting. However, as practitionersbecame more proficient in endometrial ablation, and theinstruments used became safer, more efficient, and easierto use, practitioners began to introduce the procedure intothe office setting. Transitioning endometrial ablation froma hospital to an office-based procedure can benefit bothpatient and practitioner as well as substantially reduce thecosts of treatment. 3Participants in the December 3, 2011Educational Advisory Panelon Global Endometrial AblationBoston, MAModerator:Lee Philip Shulman, MD, FACOG, FACMGAnna Ross Lapham Professor in Obstetrics and GynecologyChief, Division of Reproductive GeneticsMedical Director, Graduate Program in Genetic CounselingFeinberg School of Medicine, Northwestern University, Chicago, ILPanel Members:Stephen M. Cohen, MD, FACOGAssociate Professor of Obstetrics and GynecologyAlbany Medical College, Albany, NYAttending Physician, CNY Fertility Center, Albany and Syracuse, NYSteven R. Goldstein, MDProfessor of Obstetrics and GynecologyNYU School of Medicine, New York, NYKeith Isaacson, MDAssociate Professor of Obstetrics and GynecologyHarvard Medical School, Newton, MARobert Rubino, MD, FACOGPresident, Rubino Obstetrics and Gynecology Group, West Orange, NJFaculty, Saint Barnabas Medical Center, Livingston, NJClinical Assistant Professor Obstetrics and GynecologyUMDNJ – New Jersey Medical School, Newark, NJRobert Zurawin, MDAssociate Professor, Director of Minimally Invasive SurgeryDepartment of Obstetrics and GynecologyBaylor College of Medicine, Houston, TXOn December 3, 2011, a panel of experts was convenedin Boston, Massachusetts, with the goal of identifying andaddressing key challenges and opportunities to improvethe care of women in the area of endometrial ablation. Thepanel discussed the latest options for treating HMB thatwere safe, efficacious, and cost-effective for patient andphysician, and had minimal disruption on the patient’slife. This CME activity is based largely on the review anddiscussion of evidence-based data, and the expert opinionsput forth by the panelists. 4Treatment of Heavy MenstrualBleeding: The BeginningsOver the past century, treatment of HMB has made tremendousstrides forward from drug therapy to majorsurgery to minimally invasive procedures that can be performedon an outpatient basis or in the office setting. Intoday’s cost-conscious medical environment, safe and efficacioustreatments that reduce the costs associated withinpatient hospital care are highly desirable.Prior to the introduction of surgical intervention, theprimary treatment of HMB was pharmacotherapy. Indeed,pharmacotherapy is still considered as first-line therapyby clinicians as well as major insurers who require thatthe patient must have failed hormonal treatment or pharmacotherapyor have a contraindication to either of these,before insurers will reimburse for endometrial ablation. 3,5Common pharmacologic approaches include nonsteroidalanti-inflammatory drugs (NSAIDs), oral contraceptives,and tranexamic acid. 6Until the early 1980s, the primary alternative to pharmacotherapywas hysterectomy. Hysterectomy remains anoption for some women with menorrhagia, and approximately15% of women who undergo global endometrialablation (GEA) will eventually undergo a hysterectomy. 7However, panel members broadly agreed that hysterectomy—notGEA—is being offered too frequently as theprimary option, a belief substantiated in a patient surveyperformed by AAGL. 4,8 That survey found that while 98% ofwomen expected their doctors to provide all options, only40% were aware there were minimally invasive optionsthat might enable them to avoid hysterectomy.“It’s interesting. When you look at ACOG guidelines,the big failure rate when you do a hysterectomy...has been that you didn’t try alternative methods.ACOG recommends alternative methods before ahysterectomy.”-CohenAVAILABLE AT WWW.OBGMANAGEMENT.COM Supplement to OBG Management | June 2012 S3

Global Endometrial Ablation for MenorrhagiaThe first surgical attempts at endometrial ablation usingradiofrequency were in the 1930s, but it was not until theintroduction of the shallow-cutting Nd-YAG laser in 1981that modern devices and techniques began to emerge. 6,9These early procedures had many risks (including perforation),and required extensive training, experience, and surgicalskills that put them beyond the capabilities of manyoffice-based gynecologists. 10,11Global Endometrial AblationThe term “GEA” indicates the use of second-generationdevices that began with the thermal balloon endometrialablation system (Gynecare Thermachoice ® ), which wasapproved by the US Food and Drug Administration (FDA)in 1997, and cryoablation (Her Option ® ), which was approvedby the FDA in 2001. 12,13 There are currently 5 devicesapproved for GEA in the United States:DeviceTrade nameThermal balloon Gynecare Thermachoice ®Cryoablation Her Option ®Bipolar radiofrequency NovaSure ®Hydrothermablation (HTA) Hydro ThermAblator ®Microwave endometrial Acculis Microwave Tissueablation (MEA)*Ablation (MTA) SystemGlobal Endometrial Ablation:Is it Ready for the Office?Whether performed in a hospital, ambulatory care center,or office, GEA results have been consistently good.Concerns associated with in-office use of the secondgenerationinstruments have substantially waned. 4“Nothing has shown or given us new information that[GEA] is less effective than we knew it was, and yet fora variety of reasons it has, for many of our colleagues,been put on the back burner.”-ShulmanOutcomes: Successful ablation can be clinically definedas reduction of menorrhagia to normal menstrual bleedingor less; the overall success rate for all GEA devices is>85%, with rates of amenorrhea estimated between 15%and 60%. 14 These results can now be achieved by far morepractitioners than possible with first generation technology.15 Predictors of amenorrhea following GEA include age“There’s never been a head-to-head study of thesedevices randomized to show that one has a higheramenorrhea rate.”-Isaacson*MEA, which delivers fixed-frequency microwave energy to ablate the endometrium,is rarely used in the United States, and is not discussed further in this article.> 45 years, uterine length < 9 cm, and endometrial thickness< 4 mm. 10Patient satisfaction: Overall, patient satisfaction followingGEA is high, whether the procedure results in completeamenorrhea or reduction of menstrual bleeding intoa “normal” pattern of duration and flow. A review of theCochrane Database shows overall patient satisfaction between90% and 95%. 14“From an efficacy point of view, in good handsthese will all do pretty well, but there are probablysome major differences in terms of ease of [use],anesthesia level needed, and whether you still wantto do it in the hospital or in the office.”-GoldsteinSafety: Global endometrial ablation is generally regardedas a safe procedure; today’s devices have built-in safeguardsto prevent further patient injury in the event of aperforation, leak, or other malfunction. 16 Fewer than 3%of patients undergoing GEA will experience a procedurerelatedinfection, cervical laceration, uterine perforation,or thermal injury to the bladder, bowel, cervix, or vagina. 7As many women with HMB have career and familyobligations, the GEA procedure and recuperation periodbecome much more attractive than hysterectomy with itslong recovery period.Two other concerns are pain and postprocedural scarringof the endometrium. Neither has been evaluated inclass-wide clinical trials, leaving only a few head-to-headtrials and anecdotal reports as bases for judgment. 4 In onetrial (balloon vs radiofrequency) 12 of 412 patients (2.9%)“Misadventure with heat can be a bad thing in theoffice. With cold, the only misadventures I’ve comeacross are just theoretical.”-Rubinorequired hysterectomy because of persistent pelvic pain. 10Periprocedural pain will vary on anesthesia and analgesiaused as well as patient perception. 4The potentials for both complications and pain may beminimized by the approach used for ablation: “thermal”(heat) or “cryo” (freezing). As cryoablation requires noliquid be introduced into the uterus, there is no leakage,“We’ve been talking today about the benefits anddetractions of these procedures and I think the(consensus) is that the freezing is potentially a morecomfortable procedure requiring less analgesia/anesthetic intervention.”-Shulmanespecially at cytotoxic temperatures. In addition, as lowertemperatures contribute to analgesia, analgesic/anestheticrequirements for patients undergoing cryoablation areS4June 2012 | Supplement to OBG Management

markedly less than for thermal-based approaches, oftenlimited to preoperative ibuprofen. 4Uterine scarring after endometrial ablation can obscuresources of bleeding, such as hematometra, postablationtubal sterilization syndrome, retrograde menstruation,and possibly interfere with diagnosing endometrial cancer.17 Again, there is limited data, although anecdotal dataappear to favor cryoablation as the least-scarring option. 4Ensuring SuccessPatient selection for global endometrial ablation: As excessiveuterine bleeding may be the result of a variety of underlyingproblems, such as endometrial cancer, hormoneimbalance, fibroids, coagulopathies, or other causes, theseconditions must be ruled out before considering GEA.In general, contraindications to GEA include pregnancy(or the desire for future pregnancy), cancer or indicationsof a premalignant condition in endometrial tissue, an infectionof the genital or urinary tracts, pelvic inflammatorydisease, or current intrauterine device (IUD). 18“The issue here is for the properly selected woman,endometrial ablation, GEA, needs to be her first linemainstream surgical option. It is not an option ofsecondary or tertiary import.”-ShulmanIn addition, certain patient characteristics (eg, uterineanatomy) may preclude the use of a specific GEA device;patient inclusion and exclusion criteria vary slightlyamong devices. 19Patients with the following conditions/characteristicsmay not be appropriate candidates for office-basedprocedures:⦁ Uncontrolled anxiety⦁ Uncontrolled pain⦁ Moderate to severe systemic diseases (eg, hypertension,arrhythmias, arteriosclerotic vascular disease,severe chronic obstructive pulmonary disease [COPD])⦁ A difficult anatomy which impedes uterine visualization⦁ Patients in generally poor health who may need specialattention or precautionsThe panel stressed that practitioners who administeranesthetics or sedating (narcotic) analgesics must ascertainthe patient will have assistance available following theprocedure, but patients managed with NSAIDs alone arenormally capable of driving or finding another way homethemselves. 4Other factors include:⦁ Optimal location for use (eg, office, clinic, and hospital)○ A patient with concurrent health problems requiringspecial monitoring and resuscitation capabilitiesis better suited to an institutional rather than anoffice setting.⦁ Personnel needed (eg, anesthesiologist, pulmonologist,etc)⦁ Analgesia/anesthetic requirements⦁ Options/facilities available⦁ Patient wishesIn-Office Global Endometrial AblationPerforming GEA in the office setting has several advantagesover the hospital or ambulatory setting for both patientand practitioner 4,20,21 :⦁ Physician benefits○ No travel○ Complete control○ Ease of scheduling○ Cost-effective (ie, better reimbursement and feweror no ancillary personnel)⦁ Patient benefits○ Familiarity with staff and setting◾ Less intimidating○ Privacy○ Individualized attention○ Less risk○ Streamlined procedure (eg, no preadmissions, etc)○ Possibly lower copay (or lower cost for uninsured)○ Less interruption of routineThere are several regulatory agencies governing inofficesurgeries with oversight including professional aswell as federal, state, and possibly local regulations. Practitionersconsidering in-office surgery should becomefamiliar with the regulation involved. 19,22Physical Office Needs: Creating the physical operatingarea in an office requires minimal space and equipment.Provisions must be made for equipment needed for visualization,anesthesia, patient monitoring, and equipmentsterilization. Resuscitation equipment must be available foremergencies. 19Although all GEA devices are basically similar, the HerOption ® cryoablation system is the only system specificallydesigned for use in the office setting. 19,23 All systems, however,can be used successfully in either the office, hospital,or clinic.By the time you bring the patient into the room,whether it’s in your office or in the operating room,and then you do (everything) that you’re goingto do with them - and then do the device - thedifference between 90 seconds and 8 minutes and10 minutes is insignificant.-ZurawinMany practitioners believe much of a system’s desirabilitylies in the actual time required to use the instrument todo the actual ablation. Working times for the various systemsrange from 90 seconds to almost 15 minutes, statisticsthat were considered irrelevant by the panel as the timesaved during the procedure may be lost to prep time ortime needed for analgesia to become effective. 4AVAILABLE AT WWW.OBGMANAGEMENT.COM Supplement to OBG Management | June 2012 S5

Global Endometrial Ablation for MenorrhagiaGEA Systems at a Glance *Gynecare Thermachoice ®20Gynecare Thermachoice ® consists of a hot liquid-filled balloonthat ablates endometrial tissue with thermal energy. Asterile fluid is heated to ~83ºC in a silicone balloon that requiresdirect contact with the endometrium for 7 to 9 minutes.Advantage(s): It has a small-diameter, flexible catheterthat requires minimal dilation; it is easily used and easilytaught. Gynecare Thermachoice ® performed in the officesetting had success rates equal to procedures performed inthe hospital setting.Drawback(s): The inflation pressure (160 to 180 mm Hg) iscapable of causing pain to the patient for the duration ofthe procedure.The procedure requires a 3-minute pretreatment suctioncurettage, and analgesia is usually provided with aparacervical block and keterolac, and possibly narcotics.Exclusions include abnormally shaped uteri caused bymyomas, polyps or submucous fibroids; anatomic or pathologicconditions in which weakness of the myometriumcould exist, including classical cesarean sections or transmuralmyomectomy. Other exclusions are a uterine cavity>10 cm or previous ectopic abdominal pregnancy (EAP).In US trials to 1 year, major safety issues included cramping(mild, 34.3%; moderate, 47.8%; severe, 9.7%), nausea/vomiting (23.9%), and vaginal discharge (74.6%). 24Her Option ®20Her Option ® is a cryoablation system consisting of a cryoprobeinserted through the cervix into the uterus. An iceball forms around the probe as the temperature drops to–90ºC, permanently destroying the endometrial tissue(–20ºC is cytotoxic). The procedure is monitored by ultrasoundto help prevent potential injury to adjacent organsshould the cryo zone extend beyond the serosal surface ofthe uterus; it has the lowest pain score of all devices.Advantage(s): Cryoablation is considered very safe; patientsare able to leave unassisted following the procedure,the result of minimal, non-narcotic analgesia, and coldtemperatures add to analgesic effect. Designed specificallyfor office use, Her Option ® is considered by many as theeasiest system to learn.Drawback(s): The required use of ultrasound guidancemay be considered a drawback to those not proficient inusing ultrasound.It is recommended that patients should be pretreatedwith leuprolide acetate. Although in rare cases a paracervicalblock may be used, preoperative NSAIDs are generallyadequate for analgesia.*Data sources include manufacturer's Web sites and www.accessdata.fda.gov.Patients with anatomic or pathologic weakness of themyometrium may not be suitable candidates for cryoablation,including classical cesarean sections or transmuralmyomectomy, intramural myomas >2 cm, intrauterinepolyps, pedunculated fibroids, and septate uterus; anatomythat impedes ultrasound visualization may also not besuitable for cryoablation.In US trials to 1 year, the major adverse reactions wereuterine cramping or other abdominal or pelvic pain/cramping(4% each); vaginal infection (4%); hot flashes (2%); urinarytract infection (UTI; 1%); and nausea/vomiting (1%). 25NovaSure ®20NovaSure ® utilizes bipolar radiofrequency; energy fromalternating current ablates endometrial tissue using anintrauterine probe consisting of an electrode array ofstretchable gold-plated fabric. This fabric conforms tothe endometrial surface and steam and moisture are suctionedas the endometrial tissue is desiccated.Actual ablation is completed in 90 seconds, and thissystem is well suited for use in the hospital or ambulatorysurgical center settings.Advantage(s): Treatment is not cycle-dependent.Drawback(s): The NovaSure ® system is more complex thanother systems, requiring the keying of data into the controller.No pretreatment is required, and analgesia requirementsrange from NSAIDs to oral narcotics and paracervical block.NovaSure ® should not be used on a patient with an abnormal/obstructeduterine cavity, septate or bicornulateuterus, pedunculated submucosal leiomayomata, or polyps>2 cm. Previous uterine surgery and poor uterine wallintegrity are also contraindications.In a 12-month follow-up of clinical trials, pelvic pain/cramping and vaginal infections were each reported by2.9% of patients; UTI, pelvic inflammatory disease (PID),and endometritis (1.1% each); and hematometra andhemorrhage (0.6% each). 26Hydro ThermAblator ®20Hydro ThermAblator ® is a circulating hot-water system;saline is introduced through a hysteroscope and circulatedfor ~10 minutes to destroy endometrial tissue. The GenesysHTA system is a newer version with a smaller console andsimplified set-up.Advantage(s): These systems feature an automatic shut-offif there is unacceptable use or loss of fluid.Drawback(s): This treatment approach requires extensivecervical dilation, often resulting in pain; the hot solutionmay result in vaginal burning.The procedure can be monitored by visualization of theuterine cavity. Abnormally-shaped cavities can be success-S6June 2012 | Supplement to OBG Management

fully treated, as well as small fibroids.Pretreatment with leuprolide acetate is recommended,analgesia is normally achieved with ketorolac, an anxiolytic(lorazapam), or oral narcotics.This method of GEA should not be used for menorrhagiaresulting from intramural fibroids >4 cm, or in cases ofuterine anatomic abnormality, previous EAP, or patientswho have undergone classic cesarean section.In the 1-year follow-up to clinical trials, uterine crampingwas the most common adverse event (14%); followedby vaginal infections (3%); nausea and vomiting (2% each);and hematometra, abdominal pain, and UTI (1% each). 27GEA: Overall ContraindicationsAs noted above, each system has unique characteristicsthat may prove problematic. In addition, there are classwidecontraindications for global endometrial ablation:⦁ Pregnancy or desire to become pregnant⦁ A patient with a known or suspected endometrial carcinoma(uterine cancer) or premalignant change of the endometrium,such as unresolved adenomatous hyperplasia⦁ A patient with an active genital infection or UTI at thetime of the procedure (eg, cervicitis, vaginitis, endometritis,salpingitis, or cystitis)⦁ A patient with active PID⦁ A patient with an IUD currently in placeFinancial AspectsAlthough office-based procedures such as GEA are extremelyattractive to many patients, any practitioner whois considering offering office-based procedures must considerthe move very carefully as it means a financial investmentand, to a lesser extent, a change in practice patterns.It is important to consider possible increases in malpracticeinsurance and the physician’s payer mix. 16,23Billing and ReimbursementGEA has three primary current procedural terminologycodes for billing. These are: 58353, GEA without hysteroscopy;58356, cryoablation with ultrasound; and 58563,hysteroscopy and GEA. All codes can be used for office orinstitutional procedures. 3SummaryGEA offers women with HMB an important option thatis effective, often permanent, and a minimal interruptioninto the patient’s life. Practitioners who bring GEA intothe office setting add another important quality—privacy.However, in addition to the benefits in-office GEA bringsto the patient, in-office GEA has many advantages for thepractitioner as well.Probably the most important decision to be made is thechoice of system. As all units have data that show similarsafety and efficacy, experts recommend a system that is easyto operate and causes the least pain for the patient. 4 Carefulreview of the literature, FDA-approved product material,participation in available workshops sponsored throughthe American Congress of Obstetricians and Gynecologists(ACOG) and AAGL, and discussions with colleagues whouse each of the systems will aid in the final decision.References1. Centers for Disease Control and Prevention. Blood disorders in women: heavymenstrual bleeding. CDC Web site. http://www.cdc.gov/ncbddd/blooddisorders/women/menorrhagia.html. Accessed February 2, 2012.2. Centers for Disease Control and Prevention. Blood disorders in women: research.CDC Web site. http://www.cdc.gov/ncbddd/blooddisorders/women/research.html. Accessed February 2, 2012.3. ARBenefits. Health plan coverage policy: endometrial ablation. Document:ARB0145. Endometrial ablation. http://portal.arbenefits.org/coveragePolicies/ARB0145_EndometrialAblation.pdf. Accessed February 9, 2012.4. Omnia Education. Global Endometrial Ablation Education Advisory Panel. Boston,MA. December 3, 20115. Shulman LP. Slide presentation for Global Endometrial Ablation Education AdvisoryPanel. Boston, MA. December 3, 2011.6. Pickett SD. Endometrial ablation. Medscape Web site. http://emedicine.medscape.com/article/1618893-overview#a1. Accessed February 2, 2012.7. Middleton LJ, Champaneria R, Daniels JP, et al. Hysterectomy, endometrialdestruction, and levonorgestrel releasing intrauterine system (Mirena) for heavymenstrual bleeding: systematic review and meta-analysis of data from individualpatients. BMJ. 2010;341:c3929.8. American Association of Gynecologic Laparoscopists. Press release: AAGL studyfinds women still in the dark about minimally invasive treatments for pelvichealth disorders. AAGL Web site. http://www.aagl.org/files/AAGLSurveyPressRelease%20FINAL%207.9.08.pdf. Accessed February 9, 2012.9. Surgical Laser Technologies. The SLT Nd:YAG Contact Laser in ENT-Head andNeck Surgery. Surgical Laser Technologies: Montgomeryville, PA; 1994.http://www.uhssurgicalservices.com/documents/_surgical/NDYag%20brochure.pdf Accessed February 2, 2012.10. El-Nashar SA, Hopkins MR, Creedon DJ, et al. Prediction of treatment outcomesafter global endometrial ablation [published correction appears in Obstet Gynecol.2009;115(3):663]. Obstet Gynecol. 2009;113(1):97–106.11. Biscette S, Shepherd J, Pasic RP. Global endometrial ablation. Surg Technol Int.2010;20:208-213.12. U.S. Food and Drug Administration. Access Data: Pre Market Approval: thermalballoon endometrial ablation. FDA Web site. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=1328. Accessed February 2, 2012.13. U.S. Food and Drug Administration. Access Data: Pre Market Approval: thermal(cryosurgical) endometrial ablation device. FDA Web site. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=15733. Accessed February 2, 2012.14. Stovall DW. Alternatives to hysterectomy: focus on global endometrial ablation,uterine fibroid embolization, and magnetic resonance-guided focused ultrasound.Menopause. 2011;18(4):437-444.15. Carter JF. Endometrial ablation: more choices, more options. Female Patient.2005;30(12):35-40.16. Sharp HT, Jardine G. Global endometrial ablation injuries in 186 patients andassociated risk factors. J Minim Invasive Gynecol. 2005;12(suppl):S8. Abstract 18.17. McCausland AM, McCausland VM. Long-term complications of endometrialablation: cause, diagnosis, treatment, and prevention. J Minim Invasive Gynecol.2007;14(4):399-406.18. National Guidelines Clearinghouse. Endometrial ablation. American College ofObstetricians and Gynecologists (ACOG). AHRQ Web site. http://www.guidelines.gov/content.aspx?id=10918. Accessed February 9, 2012.19. Fothergill RE. Endometrial ablation in the office setting. Obstet Gynecol Clin NorthAm. 2008;35(2):313-330.20. Sanfilippo JS, ed. Options in Endometrial Ablation. Dowden Health Media; 2005.http://www.obgmanagement.com/mededlibr/PDFs/1205Suppl_EA.pdf. AccessedFebruary 2, 2012.21. Roy KH, Mattox JH. Endometrial ablation for perimenopausal menorrhagia. MenopauseManag. 2003;12(5):13-17.22. Anderson TL. Endometrial ablation in the office. Slide presentation at: VanderbiltUniversity Medical Center; November 14, 2007; Nashville, TN.23. Miller L. Understand menorrhagia: treatment with office-based systems. SurgTechnologist. 2010. http://www.ast.org/publications/Journal%20Archive/2010/3_March_2010/CE.pdf. Accessed February 2, 2012.24. Meyer WR, Walsh BW, Grainger DA, Peacock LM, Loffer FD, Steege JF. Thermalballoon and rollerball ablation to treat menorrhagia: a multicenter comparison.Obstet Gynecol. 1998;92(1):98-103.25. Townsend DE, Dulbea AJ, Wilkes MM; Endometrial Cryoablation Study Group.Durability of treatment effects after endometrial cryoablation versus rollerballelectroablation for abnormal uterine bleeding: two-year results of a multicenterrandomized trial. Am J Obst Gynecol. 2003;188(3):699-701.26. Cooper J, Gimpelson R, Laberge P, et al. A randomized, multicenter trial of safetyand efficacy of the NovaSure system in the treatment of menorrhagia. J Am AssocGynecol Laparosc. 2002;9(4):418-428.27. Goldrath MH, Barrionuevo M, Husain M. Endometrial ablation by hysteroscopicinstillation of hot saline solution. J Am Assoc Gynecol Laparosc. 1997;4(2):235-240.AVAILABLE AT WWW.OBGMANAGEMENT.COM Supplement to OBG Management | June 2012 S7

Review Questions1) Which of the following statements is true concerning thecharacteristics of cryoablation and heat therapy?a. Cryoablation provides superior safety and efficacy than heat therapy.b. Heat therapy provides superior safety and efficacy than cryoablation.c. There are major safety and efficacy differences in outcomesbetween the two.d. There are no major safety and efficacy differences in outcomesbetween the two.2) An IUD or IUS system may remain in place duringglobal endometrial ablation to provide post-procedurecontraception.a. Trueb. False3) Reimbursement for global endometrial ablation requiresa diagnosis of:a. Dysmenorrheab. Abnormal uterine bleedingc. Menorrhagiad. Any of the above4) Which of the following is not a contraindication for globalendometrial ablation?a. Pregnancyb. A history of preeclampsiac. Urinary tract infectiond. Pelvic inflammatory disease5) Global endometrial ablation may be a first-line therapy forits menorrhagia indication(s).a. Trueb. False6) Based on this presentation, what two new patient carestrategies do you plan to use that you have not usedbefore?7) What challenges or barriers might you face as you work toimplement these strategies?Activity EvaluationAnswer each question using a scale of 1 to 5 (5=Strongly Agree, 3=Agree, and 1=Strongly Disagree):1) The article met the stated objectives. 5 4 3 2 12) The article is relevant to my current clinical practice needs. 5 4 3 2 13) Disclosure of faculty relationships with commercial organizations was made available to me before the article.◯ True ◯ False4) The commercial supporter was acknowledged in print. ◯ True ◯ False5) The article was balanced and free of commercial bias. ◯ True ◯ False6) If trade names were used, all product trade names were discussed. ◯ True ◯ False7) Any off-label drug use, and/or investigational drug use not yet approved by the FDA was disclosed before or during theactivity. ◯ True ◯ False8) If you answered “false” to any of the above questions, please provide details below.________________________________________________________________________________________________________________________________________________________________________________________________________________________Your certificate for continuing education credit will be issued using the following information (Please print clearly):Today’s dateNameDegree ◯ MD ◯ DO ◯ Resident ◯ NP ◯ OtherSpecialtyNo. of providersPreferred mailing address ◯ Home ◯ BusinessAddressCity State ZipHome phoneMobile phoneOffice phoneOffice faxEmail*Time spent on this activitySignatureMaximum of 0.75 AMA PRA Category 1 Credit.*Your CME certificate will be sent via email.Detach and return completed post-test andactivity evaluation form to:Omnia Education, ATTN: OMJ500 Office Center Drive, Ste 300Fort Washington, PA 19034Fax: 215-358-0556Release Date: May 1, 2012Expiration Date: May 1, 2013Printed in the USA © May 2012. The Omnia-ProvaEducation Collaborative, Inc.Omnia Education500 Office Center Drive, Suite 300Fort Washington, PA 19034Check out our upcoming activities and online CME!www.OmniaEducation.comOr call: 800-889-4944S8June 2012 | Supplement to OBG Management