In which cases should endometrial destruction be performed during an operative hysteroscopy? Clinical practice guidelines from the French College of Gynaecologists and Obstetricians (CNGOF).

OBJECTIVE: To provide guidelines from the French College of Obstetricians and Gynaecologists (CNGOF), based on the best evidence available, concerning the impact of endometrial destruction on bleeding and endometrial cancer risk reduction in patients candidates for operative hysteroscopy. METHODS: Recommendations were made according to AGREE II and the GRADE® (Grading of Recommendations Assessment, Development and Evaluation) systems to determine separately the quality of evidence (QE) and in the level of recommendation. RESULTS: In a retrospective study comparing the incidence of endometrial cancer in 4776 patients with menorrhagia treated with endometrial destruction vs 229 945 patients with a medical treatment. There was a non-significant reduced risk of developing endometrial cancer (HR, 0.45; 95% CI, 0.15-1.40; p = .17). In premenopausal women, five studies compared the incidence of endometrial cancer in patients treated with endometrial ablation/destruction (EA/D) to the incidence of endometrial cancer in a comparable population of women from national registers, all of which show reduced risk of endometrial cancer after endometrectomy. In case of menopausal metrorrhagia, the prevalence of endometrial cancer is 9%, by analogy with the results found in premenopausal patients, the combination of endometrial ablation during operative hysteroscopy seems justified. In a retrospective cohort of 177 non-menopausal patients treated with myomectomy for metrorrhagia and/or menorrhagia, a significantly better control of bleeding at 12 months was found when myomectomy was combined with endometrectomy using roller-ball (OR: 0.18 [95% Cl 0.05-0.63]; p = 0.003). CONCLUSION: In premenopausal women with heavy menstrual bleeding, when an operative hysteroscopy is performed, it is recommended to propose an endometrial ablation/destruction in order to prevent the risk of endometrial cancer, (QE3) and to prevent recurrence of bleeding (QE2). In menopausal women, it is probably recommended to also perform an endometrial ablation/destruction in case of operative hysteroscopy in order to prevent the risk of endometrial cancer (QE1).

A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System.

STUDY OBJECTIVE: To evaluate the safety and effectiveness of the AEGEA Vapor System (Aegea Medical System, Menlo Park, CA) for the treatment of heavy menstrual bleeding (HMB). DESIGN: A prospective, multicenter, single-arm, open-label, clinical trial. Follow-up assessments were conducted at 24 hours; 2 weeks; and 3, 6, and 12 months after the endometrial ablation procedure (Canadian Task Force Classification II-1). SETTING: A private practice and outpatient and hospital settings at 15 sites in the United States, Canada, Mexico, and the Netherlands. PATIENTS: One hundred fifty-five premenopausal women aged 30 to 50years with HMB as determined by a pictorial blood loss assessment score ≥150. Preoperative evaluation included ultrasound, sonohysterography or hysteroscopy, and endometrial biopsy. Screening inclusion allowed treatment of up to 12-cm uterine sound lengths and nonobstructing myomata. INTERVENTIONS: Endometrial ablation (120-second treatment time) was performed under varying anesthesia regimens using the vapor system from September 2014 to May 2015. MEASUREMENTS AND MAIN RESULTS: The primary effectiveness end point was the reduction of menstrual blood loss to a pictorial blood loss assessment score ≤75. Success was judged based on the Food and Drug Administration's objective performance criteria, derived from the success rates of the first 5 global endometrial ablation pivotal clinical trials. The secondary effectiveness end points included quality of life and patient satisfaction as assessed using the Menorrhagia Impact Questionnaire and the Aberdeen Menorrhagia Severity Score as well as the need for surgical or medical intervention to treat abnormal bleeding at any time within the first 12 months after treatment. All adverse events, including device- and procedure-related events, were recorded. At 12 months, the primary effectiveness end point was achieved in 78.7% of subjects exceeding the OPC (p = .0004); 90.8% of subjects were satisfied or very satisfied with the treatment. Ninety-nine percent of subjects showed improvement in quality of life scores with an average decrease in the Menorrhagia Impact Questionnaire score by 8.1, 72% had less dysmenorrhea, and 85% of women whose sex lives were affected by their menses reported improvement in their sex lives. There were no reported serious adverse device effects or any reported serious adverse events that were procedure related. CONCLUSION: The AEGEA Vapor System is a safe, effective, and minimally invasive option for performing in-office endometrial ablation under minimal anesthesia for the purpose of treating women who suffer from HMB.

Endometrial Ablation: Past, Present, and Future Part II.

Endometrial ablation (EA) is the most commonly performed surgical procedure for the management of abnormal uterine bleeding unresponsive to medical therapy. In well-selected subjects, EA provides a safe, inexpensive, and convenient alternative to hysterectomy with a rapid return to normal function. The first generation of EA techniques were introduced in 1886 by Professor Sneguireff of Moscow. He was the first to apply super-heated steam to the uterine cavity to vaporize the endometrial basalis. This method-known as atmocausis-was refined by Ludwig Pincus of Danzig in 1895, and he went on to perform over 800 procedures. As the 20th century brought forth other energy sources-electricity, X-ray, radium, and even cryogenics-they were each used, in turn, to accomplish endometrial ablation. In 1981, Dr. Milton Goldrath successfully performed EA by co-locating a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser with a rod-lens hysteroscope to achieve photovaporization of the endometrium. The accomplishment of EA under direct visualization defined the second generation of EA. The challenges and risks of second-generation technology, however, was soon apparent, and though this practice continues today, it appears to be confined to a relatively small number of devoted and highly-skilled sub-specialists. The late 1990s saw increasing interest in safe, affordable, and easily-mastered EA technology. The result was a return to blind technology but modified with a variety of features that brought unprecedented safety to EA, even permitting its selected in-office application. This third generation of EA techniques and devices has propelled the growth of EA in the 21st century. Although much has been accomplished in the quest for safe, affordable, convenient, and easily-mastered EA, the future requires refinement of patient selection criteria, management strategies for late-onset endometrial ablation failures (LOEAFs), as well as minimally invasive methods for reducing them.

Endometrial ablation.

Endometrial ablation (EA) includes a spectrum of procedures performed with or without hysteroscopic direction, designed to destroy the endometrium for the treatment of the symptom of heavy menstrual bleeding (HMB) secondary to a spectrum of causes, but most commonly those that are endometrial in origin (AUB-E) or ovulatory disorders (AUB-O). Resectoscopic endometrial ablation (REA) is often mistakenly referred to as the "first generation" technique, while proprietary devices that do not use the resectoscope (nonresectoscopic EA or NREA) are often misperceived as "second generation" devices. Indeed, the origins of NREA date back to the late 19th century with the use of steam, and the early and mid 20th century, when radiofrequency and cryotherapy based NREA techniques were published - long before the resectoscope was used and reported. The NREA devices have also been mislabeled as "global", a misleading term borrowed from the marketing departments of device manufacturers - there is no device that predictably treats the entire endometrium. Consequently, none can be construed as being "global". Instead, EA is a procedure designed for women as an alternative to hysterectomy, or, perhaps, medical therapy, when future fertility is no longer desired. Women who select EA should anticipate a relatively low risk procedure that will likely reduce their HMB to normal levels or less. This paper will review the spectrum of EA techniques and devices, their clinical outcomes and adverse events, and explore their value compared to hysterectomy and selected medical therapies.

Endometrial resection and global ablation in the normal uterus.

There are various methods that can be used to destroy the endometrium as a treatment for menorrhagia. This chapter reviews the history, rationale, evidence, indications and long-term safety and efficacy of the current techniques. It also discusses endometrial ablation in the context of its clinical utility in comparison with existing alternative treatments.

Hysteroscopic Tissue Removal Systems: A Randomized In Vitro Comparison.

STUDY OBJECTIVE: To compare polyp resection time and myoma resection rate using 2 hysteroscopic tissue removal systems. DESIGN: Prospective randomized in vitro trial (Canadian Task Force classification I). SETTING: Clinical skills laboratory of a non-university teaching hospital. SAMPLES: Polyp surrogate and myoma tissue. INTERVENTIONS: Hysteroscopic tissue removal with the TRUCLEAR system, using the TRUCLEAR INCISOR 2.9 (TI), TRUCLEAR INCISOR Plus (TIP), or TRUCLEAR ULTRA Plus (TUP) device, and the MyoSure system, using the MyoSure Lite (ML), MyoSure Classic (MC), or MyoSure XL (MXL) device. MEASUREMENTS AND MAIN RESULTS: Forty-two fragments of umbilical cord weighing 5 g, as a surrogate for polyps, were randomly allocated to 4 types of devices (TI, TIP, ML, and MC). Three consecutive fragments were removed using a single device. In addition, 18 pieces of myoma tissue were divided into 2 equal parts and randomly allocated to 2 types of devices (TUP and MXL). A new device was used for each fragment. Each type of device was tested at 2 vacuum settings. When removing 1 polyp, the TIP (median time, 2:33 minutes [interquartile range (IQR), 1:32-3:27 minutes]), the MC (median time, 3:15 minutes [IQR, 2:42-3:42 minutes]), and the ML (median time, 3:00 minutes [IQR, 2:16-3:25 minutes]) performed significantly faster than the TI (median time, 14:09 minutes [IQR, 13:44-14:36 minutes]), by 84%, 78%, and 82% respectively (p < .001). The TIP performed 80% faster than the TI (median time, 2:27 minutes [IQR, 1:45-2:46 minutes] vs 10:37 minutes [IQR, 8:38-13:44 minutes]; p < .001) when removing a second polyp. For removal of a third polyp, the TIP performed significantly faster (median time, 2:22 minutes [IQR, 1:32-3:07 minutes]) than the TI (median time, 8:35 minutes [IQR, 7:37-9:03 minutes]) and the ML (median time, 10:02 minutes [IQR, 9:51-10:18 minutes]), by 74% and 78%, respectively (p < .001). The performance of the ML decreased (p < .001) during removal of 3 consecutive tissue samples. For myoma tissue, the estimated mean resection rate of the TUP (2.96 g/min [95% confidence interval (CI), 2.32-3.77 g/min]) was 24% (95% CI 0.2%-52.4%) higher than the mean resection rate of the MXL (2.39 g/min [95% CI 1.87-3.05 g/min]; p = .048). The resection rate of the MXL adjusted for vacuum setting declined by 3% per unit increase in myoma volume (95% CI, -0.6% to -5.7%; p = .02). For the TUP, no linear association was found (0.4%; 95% CI, -2.1% to 3.0%; p = .72). CONCLUSION: In vitro comparison of the removal of surrogate polyps showed that although the larger TIP, MC, and ML devices were significantly faster than the TI for removal of 1 polyp, only the TIP was consistently faster than the TI for consecutive removal of polyps. The performance of the ML decreased significantly during removal of 3 consecutive tissue samples, making it slower than the TIP with a similar window size in the third run. For removal of myoma tissue, the resection rate of the TUP was significantly higher than that of the MXL, and the resection rate of the MXL decreased with increasing myoma volume. In vitro testing can provide useful information on the time and rate of hysteroscopic tissue removal.

Endometrial ablation: first- vs. second-generation techniques.

INTRODUCTION: Endometrial ablation is a procedure that surgically destroys (ablates) the lining of the uterus (endometrium). The goal of endometrial ablation is to reduce menstrual flow. In some women, menstrual flow may stop completely. In some cases, endometrial ablation may be an alternative to hysterectomy. There are several techniques used to perform endometrial ablation, including electrical or electrocautery ablation, in which an electric current travels through a wire loop or rollerball is applied to the endometrial lining to cauterize the tissue; hydrothermal ablation, in which heated fluid is pumped into the uterus and destroys the endometrial lining via high temperatures; balloon therapy ablation, in which a balloon at the end of a catheter is inserted into the uterus and filled with fluid, which is then heated to the point that the endometrial tissues are eroded away; radiofrequency ablation in which a triangular mesh electrode is expanded to fill the uterine cavity, at which point the electrode delivers an electrical current and destroys the endometrial lining; cryoablation (freezing), in which a probe uses extremely low temperatures to freeze and destroy the endometrial tissues; and microwave ablation, in which microwave energy is delivered through a slender probe inserted into the uterus and destroys the endometrial lining. EVIDENCE ACQUISITION: The purpose of this systematic review was to evaluate the feasibility, safety, and efficacy of endometrial ablation performed with first- and second-generation techniques. A literature search in PubMed from January 2000 to September 2015 was performed using the keywords endometrial ablation, menorrhagia, and heavy menstrual bleeding. Results were restricted to systematic reviews, randomized control trials (RCT)/controlled clinical trials, and observational studies written in English from January 2000 to September 2015. EVIDENCE SYNTHESIS: There is no evidence that either broad category is more effective than the other in reducing HMB, and there is no evidence that rates of satisfaction differ significantly. CONCLUSIONS: The overall results of the presented studies suggest that endometrial ablation is an effective therapy for menorrhagia in women with bleeding disorders.

New technologies and innovations in hysteroscopy.

Ambulatory services, with the performance of diagnostic and operative hysteroscopy as an outpatient or office procedure, are providing much of the stimulus for the development of devices that will offer women a better hysteroscopy experience. For the many women who are readily able to tolerate outpatient hysteroscopy, it offers significant advantages, as they can receive safe, efficient and effective assessment and treatment of abnormal uterine bleeding, with avoidance of the disadvantages of general anaesthesia and hospital admission. In addition, provision of such services is cost effective. Whilst the focus for the development of new devices has been the improvement of ambulatory hysteroscopy services, new instrumentation may be beneficial for hysteroscopy procedures in any setting. For ambulatory services, important goals are to reduce pain and the duration of procedures, and to enable the ready delivery of both diagnostic and therapeutic outpatient hysteroscopy. This article discusses innovations for both diagnosis and treatment. Much of the information available about these new devices has been obtained from the manufacturers or from published abstracts submitted for presentation at international meetings that have not been peer-reviewed. Some of the reported studies have been randomised controlled trials, others the results of early investigations.

Design and Preclinical Validation of the Composite-Type Optical Fiberscope for Minimally Invasive Procedures of Intrauterine Disease.

STUDY OBJECTIVE: Because of the rapid growth of minimally invasive surgical procedures, we developed an ultrathin fiberscopic imaging system for laser surgery that could be an important instrument for clinical use in an office setting. METHODS AND MAIN RESULTS: A new device, consisting of a custom 1.1-mm diameter flexible fiberscope and ytterbium laser-supported ablation system (composite-type optical fiberscope), has been developed to achieve accurate laser irradiation for minimally invasive procedures of intrauterine disease. This system was validated ex vivo with successful laser ablation under observation. This study provides the design, characterization, performance, and preclinical validation of an optimized composite-type optical fiberscope system. The validation of this fiberscope for endometrial ablation was performed in 12 hysterectomy samples. The irradiated spot diameter and depth were (mean ± SD) 2.80 ± 0.28 mm and 1.53 ± 0.58 mm, respectively, in the range of 185 to 400 J. The effects of the laser on endometrial tissue depended strongly on the combined effects of the output power density and duration of irradiation. The new device makes it possible to perform accurate ablation, because our technology concentrated on combining the 2 subsystems into a single prototype capable of simultaneously observing both the endometrial lesion and the laser spot on a monitor. CONCLUSIONS: In conclusion, the feasibility and performance of the composite-type fiberscope system were demonstrated in preclinical studies.

Endometrial ablation in the management of abnormal uterine bleeding.

BACKGROUND: Abnormal uterine bleeding (AUB) is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for the problem during their reproductive years. OBJECTIVE: To provide current evidence-based guidelines on the techniques and technologies used in endometrial ablation (EA), a minimally invasive technique for the management of AUB of benign origin. METHODS: Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of both location in Canada and type of practice, as well as subspecialty expertise and general background in gynaecology. The committee reviewed all available evidence in the English medical literature, including published guidelines, and evaluated surgical and patient outcomes for the various EA techniques. Recommendations were established by consensus. EVIDENCE: Published literature was retrieved through searches of MEDLINE and The Cochrane Library in 2013 and 2014 using appropriate controlled vocabulary and key words (endometrial ablation, hysteroscopy, menorrhagia, heavy menstrual bleeding, AUB, hysterectomy). RESULTS were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English from January 2000 to November 2014. Searches were updated on a regular basis and incorporated in the guideline to December 2014. Grey (unpublished) literature was identifies through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES: The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). RESULTS: This document reviews the evidence regarding the available techniques and technologies for EA, preoperative and postoperative care, operative set-up, anaesthesia, and practical considerations for practice. BENEFITS, HARMS, AND COSTS: Implementation of the guideline recommendations will improve the provision of EA as an effective treatment of AUB. Following these recommendations would allow the surgical procedure to be performed safely and maximize success for patients. CONCLUSIONS: EA is a safe and effective minimally invasive option for the treatment of AUB of benign etiology. Summary Statements 1. Endometrial ablation is a safe and effective minimally invasive surgical procedure that has become a well-established alternative to medical treatment or hysterectomy to treat abnormal uterine bleeding in select cases. (I) 2. Endometrial preparation can be used to facilitate resectoscopic endometrial ablation (EA) and can be considered for some non-resectoscopic techniques. For resectoscopic EA, preoperative endometrial thinning results in higher short-term amenorrhea rates, decreased irrigant fluid absorption, and shorter operative time than no treatment. (I) 3. Non-resectoscopic techniques are technically easier to perform than resectoscopic techniques, have shorter operative times, and allow the use of local rather than general anaesthesia. However, both techniques have comparable patient satisfaction and reduction of heavy menstrual bleeding. (I) 4. Both resectoscopic and non-resectoscopic endometrial ablation (EA) have low complication rates. Uterine perforation, fluid overload, hematometra, and cervical lacerations are more common with resectoscopic EA; perioperative nausea/vomiting, uterine cramping, and pain are more common with non-resectoscopic EA. (I) 5. All non-resectoscopic endometrial ablation devices available in Canada have demonstrated effectiveness in decreasing menstrual flow and result in high patient satisfaction. The choice of which device to use depends primarily on surgical judgement and the availability of resources. (I) 6. The use of local anaesthetic and blocks, oral analgesia, and conscious sedation allows for the provision of non-resectoscopic EA in lower resource-intense environments including regulated non-hospital settings. (II-2) 7. Low-risk patients with satisfactory pain tolerance are good candidates to undergo endometrial ablation in settings outside the operating room or in free-standing surgical centres. (II-2) 8. Both resectoscopic and non-resectoscopic endometrial ablation are relatively safe procedures with low complication rates. The complications perforation with potential injury to contiguous structures, hemorrhage, and infection. (II-2) 9. Combined hysteroscopic sterilization and endometrial ablation can be safe and efficacious while favouring a minimally invasive approach. (II-2) Recommendations 1. Preoperative assessment should be comprehensive to rule out any contraindication to endometrial ablation. (II-2A) 2. Patients should be counselled about the need for permanent contraception following endometrial ablation. (II-2B) 3. Recommended evaluations for abnormal uterine bleeding, including but not limited to endometrial sampling and an assessment of the uterine cavity, are necessary components of the preoperative assessment. (II-2B) 4. Clinicians should be vigilant for complications unique to resectoscopic endometrial ablation such as those related to fluid distention media and electrosurgical injuries. (III-A) 5. For resectoscopic endometrial ablation, a strict protocol should be followed for fluid monitoring and management to minimize the risk of complications of distension medium overload. (III-A) 6. If uterine perforation is suspected to have occurred during cervical dilatation or with the resectoscope (without electrosurgery), the procedure should be abandoned and the patient should be closely monitored for signs of intraperitoneal hemorrhage or visceral injury. If the perforation occurs with electrosurgery or if the mechanism of perforation is uncertain, abdominal exploration is warranted to obtain hemostasis and rule out visceral injury. (III-B) 7. With resectoscopic endometrial ablation, if uterine perforation has been ruled out acute hemorrhage may be managed by using intrauterine Foley balloon tamponade, injecting intracervical vasopressors, or administering rectal misoprostol. (III-B) 8. If repeat endometrial ablation (EA) is considered following non-resectoscopic or resectoscopic EA, it should be performed by a hysteroscopic surgeon with direct visualization of the cavity. Patients should be counselled about the increased risk of complications with repeat EA. (II-2A) 9. If significant intracavitary pathology is present, resectoscopic endometrial ablation combined with hysteroscopic myomectomy or polypectomy should be considered in a non-fertility sparing setting. (II-3A).

Contexte : Les saignements utérins anormaux (SUA) sont directement à l'origine d'un fardeau de santé considérable que doivent porter les femmes, leur famille et la société en général. Jusqu'à 30 % des femmes chercheront à obtenir l'aide d'un médecin pour contrer ce problème au cours de leurs années de fertilité. Objectif : Fournir des lignes directrices factuelles à jour quant aux techniques et aux technologies utilisées aux fins de l'ablation de l'endomètre (AE), soit une intervention à effraction minimale permettant la prise en charge des SUA d'origine bénigne. Méthodes : Les membres du comité sur la directive clinique ont été sélectionnés en fonction de leurs spécialisations respectives en vue de représenter une gamme d'expériences pratiques et universitaires : le milieu de pratique au Canada, le type de pratique, la sous-spécialité et les antécédents généraux en gynécologie ont donc été pris en considération. Le comité a analysé les données pertinentes issues de la littérature médicale anglophone (y compris les lignes directrices publiées), en plus d'évaluer les issues chirurgicales et les issues qu'ont connues les patientes à la suite de l'utilisation de diverses techniques d'AE. Les recommandations ont été formulées par consensus. Données : La littérature publiée a été récupérée par l'intermédiaire de recherches menées dans MEDLINE et The Cochrane Library en 2013 et en 2014 au moyen d'un vocabulaire contrôlé et de mots clés appropriés (p. ex. « endometrial ablation ¼, « hysteroscopy ¼, « menorrhagia ¼, « heavy menstrual bleeding ¼, « AUB ¼, « hysterectomy ¼). Les résultats ont été restreints aux analyses systématiques, aux études observationnelles et aux essais comparatifs randomisés / essais cliniques comparatifs publiés en anglais entre janvier 2000 et novembre 2014. Les recherches ont été mises à jour de façon régulière et intégrées à la directive clinique jusqu'en décembre 2014. La littérature grise (non publiée) a été identifiée par l'intermédiaire de recherches menées dans les sites Web d'organismes s'intéressant à l'évaluation des technologies dans le domaine de la santé et d'organismes connexes, dans des collections de directives cliniques, dans des registres d'essais cliniques et auprès de sociétés de spécialité médicale nationales et internationales. Valeurs : La qualité des résultats a été évaluée au moyen des critères décrits dans le rapport du Groupe d'étude canadien sur les soins de santé préventifs (Tableau). Résultats : Le présent document passe en revue les données quant aux techniques et aux technologies disponibles en ce qui concerne l'AE, les soins préopératoires et postopératoires, le milieu d'intervention, l'anesthésie et les facteurs pratiques à prendre en considération. Avantages, désavantages et coûts : La mise en œuvre des recommandations de la présente directive clinique entraînera une amélioration de l'offre de l'AE à titre de traitement efficace contre les SUA. Le respect de ces recommandations permettrait l'exécution de l'intervention chirurgicale en cause de façon sûre et en maximiserait la réussite pour les patientes. Conclusions : L'AE est une option à effraction minimale sûre et efficace pour la prise en charge des SUA d'étiologie bénigne. Déclarations sommaires 1. L'ablation de l'endomètre est une intervention chirurgicale à effraction minimale sûre et efficace qui en est venue à constituer, dans certains cas, une solution de rechange bien établie au traitement médical ou à l'hystérectomie pour la prise en charge des saignements utérins anormaux. (I) 2. Une préparation de l'endomètre peut être mise en œuvre pour en faciliter l'ablation résectoscopique et peut également être envisagée dans le cas de certaines techniques non résectoscopiques. Lorsque l'on a recours à l'ablation résectoscopique de l'endomètre, l'amincissement préopératoire de ce dernier donne lieu à une hausse des taux d'aménorrhée à court terme, à une atténuation de l'absorption du liquide de distension et à une réduction de la durée opératoire, par comparaison avec l'absence de traitement. (I) 3. Les techniques non résectoscopiques sont techniquement plus faciles à utiliser que les techniques résectoscopiques, nécessitent des temps opératoires plus courts et permettent l'utilisation d'une anesthésie locale (plutôt que d'avoir recours à une anesthésie générale). Toutefois, ces deux techniques comptent des taux comparables de satisfaction des patientes et d'atténuation des saignements menstruels abondants. (I) 4. Les techniques résectoscopiques et non résectoscopiques d'ablation de l'endomètre comptent toutes de faibles taux de complication. La perforation utérine, la surcharge liquidienne, l'hématomètre et les lacérations cervicales sont plus courantes dans le cas de l'AE résectoscopique; les crampes utérines, la douleur et les nausées / vomissements périopératoires sont plus courants dans le cas de l'AE non résectoscopique. (I) 5. L'efficacité de tous les dispositifs d'ablation non résectoscopique de l'endomètre disponibles au Canada a été démontrée en ce qui concerne l'atténuation du flux menstruel; de plus, ils mènent tous à des taux élevés de satisfaction des patientes. Le choix du dispositif à utiliser dépend principalement de l'opinion du chirurgien et de la disponibilité des ressources. (I) 6. L'utilisation d'anesthésiques et de blocs locaux, d'une analgésie orale et d'une sédation consciente permet la tenue d'une ablation non résectoscopique de l'endomètre au sein de milieux nécessitant des ressources moindres, y compris dans des milieux non hospitaliers réglementés. (II-2) 7. Les patientes n'étant exposées qu'à de faibles risques et présentant une tolérance satisfaisante à la douleur sont de bonnes candidates pour ce qui est de la tenue d'une ablation endométriale dans un milieu autre qu'en salle d'opération ou dans un centre chirurgical autonome. (II-2) 8. Les techniques d'ablation de l'endomètre tant résectoscopiques que non résectoscopiques sont relativement sûres et ne comptent que de faibles taux de complication. Parmi les complications les plus graves, on trouve la perforation (s'accompagnant de lésions potentielles aux structures adjacentes), l'hémorragie et l'infection. (II-2) 9. La tenue concomitante d'une stérilisation hystéroscopique et d'une ablation endométriale peut être sûre et efficace tout en favorisant une approche à effraction minimale. (II-2) Recommandations 1. L'évaluation préopératoire devrait être exhaustive, de façon à pouvoir écarter toute contre-indication à l'ablation de l'endomètre. (II-2A) 2. Les patientes devraient être avisées de la nécessité d'une contraception permanente à la suite de l'ablation de l'endomètre. (II-2B) 3. Les évaluations recommandées en présence de saignements utérins anormaux (dont, entre autres, le prélèvement endométrial et l'évaluation de la cavité utérine) sont des composantes nécessaires de l'évaluation préopératoire. (II-2B) 4. Les cliniciens devraient demeurer à l'affût des complications propres à l'ablation résectoscopique de l'endomètre, comme celles qui sont associées au produit de distension et aux lésions électrochirurgicales. (III-A) 5. Dans le cas de l'ablation résectoscopique de l'endomètre, un protocole strict devrait être respecté pour ce qui est de la surveillance liquidienne et de la prise en charge, et ce, afin de minimiser le risque de voir se manifester des complications associées à la surcharge de produit de distension. (III-A) 6. Lorsque l'on soupçonne qu'une perforation utérine s'est manifestée au cours de la dilatation cervicale ou dans le cadre de l'utilisation du résectoscope (sans électrochirurgie), l'intervention devrait être abandonnée et la patiente devrait faire l'objet d'une surveillance étroite de façon à ce que l'on puisse demeurer à l'affût des signes d'hémorragie intrapéritonéale ou de lésion viscérale. Lorsque la perforation se manifeste dans le cadre d'une électrochirurgie ou lorsque le mécanisme de la perforation demeure incertain, la tenue d'une exploration abdominale est justifiée pour assurer l'hémostase et écarter la présence de lésions viscérales. (III-B) 7. Dans le cas de l'AE résectoscopique, lorsque la présence d'une perforation utérine a été écartée, l'hémorragie aiguë pourrait être prise en charge au moyen d'un tamponnement intra-utérin par sonde de Foley, d'une injection intracervicale de vasopresseurs ou de l'administration de misoprostol par voie rectale. (III-B) 8. Lorsqu'une nouvelle ablation de l'endomètre est envisagée à la suite d'une intervention non résectoscopique ou résectoscopique, elle devrait être menée par un chirurgien hystéroscopique sous visualisation directe de la cavité. Les patientes devraient bénéficier de services de counseling au sujet des risques de complications qui sont associés à la tenue d'une nouvelle ablation de l'endomètre. (II-2A) 9. En présence d'une pathologie intracavitaire considérable, la tenue concomitante d'une ablation résectoscopique de l'endomètre et d'une myomectomie / polypectomie hystéroscopique devrait être envisagée. (II-3A).

Long-term patient satisfaction with thermal balloon ablation for abnormal uterine bleeding.

BACKGROUND AND OBJECTIVE: Thermal balloon ablation is a minimally invasive surgical technique that can be used to treat abnormal uterine bleeding/heavy menstrual bleeding (AUB/HMB). Most published studies to date provide information on short-term patient satisfaction and outcomes. The purpose of this study was to determine long-term patient satisfaction after thermal balloon endometrial ablation 7 to 10 years postoperatively in a population previously surveyed at the Penn State Milton S. Hershey Medical Center at 1 to 5 years postoperatively. METHODS: Two-hundred fourteen patients were identified who underwent thermal balloon ablation at our institution between January 1, 2001 and December 31, 2004. These patients were mailed a 2-page survey asking for information on demographics, patient satisfaction, postoperative bleeding patterns, and the need for subsequent surgery. Satisfaction rates, amenorrhea rates, and the rates of women who required hysterectomy were calculated as percentages. RESULTS: Ninety-seven patients returned completed surveys. The survey response rate was 62%, excluding 57 surveys that were returned as undeliverable. The follow-up interval was 93 to 129 months. Eighty-seven percent of respondents were satisfied with the results of their procedure compared with 88% in the original study. Subsequent hysterectomy was required in 21.6% of women after 7 to 10 years compared with 9% after the 1- to 5-year follow-up period. Of the 76 women who did not undergo hysterectomy, 58% reported amenorrhea and 35.5% reported minimal to light bleeding. CONCLUSION: This study demonstrates a consistently high patient satisfaction rate with thermal balloon ablation at our institution at 7 to 11 years postoperatively compared with 1 to 5 years postoperatively. The hysterectomy rate, however, was 2.4 times greater in the long-term follow-up period.

Analysis of the safety and reliability of a hydrothermal ablation system: a multicenter, prospective postmarket study.

OBJECTIVE: To obtain information on practitioner experience in the use of the Genesys HydroThermAblator (HTA) System under normal clinical conditions through documentation of the system's acute safety features, in terms of burn rates, and its technical reliability. STUDY DESIGN: This was a prospective, observational, multicenter, postmarket interventional clinical trial with outcome measures of acute (within 21 days post-procedure) safety, serious adverse device effects, and technical malfunctions in a population of premenopausal women > or = 18 years of age. RESULTS: A total of 992 women (mean age, 41.7 +/- 6.8 years; range, 22-65 years) were enrolled in 18 clinical sites throughout the United States. The Genesys HTA System provided low burn rates in the intent-to-treat (n = 992 [0.4%] [95% CI 0.1-1.0%]) and evaluable (n = 931 [0.2%] [95% CI 0.1-0.8%]) subject populations. Only 1 burn was clinically significant and was defined as a serious adverse device effect (1/992 [0.10%] [95% CI 0.0-0.6%]). Fifty-three (5.1%) technical malfunctions occurred in 44 procedures, and 27 (27/44 [61.4%]) patients completed their procedures after 31 (31/ 53 [58.5%]) technical problems were addressed and resolved. CONCLUSION: The Genesys HTA System delivers a safe and reliable treatment option for premenopausal women with heavy menstrual bleeding.

Minimally invasive endometrial ablation device complications and use outside of the manufacturers' instructions.

OBJECTIVE: To review the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience database for reports describing serious adverse events and adverse events reports describing use outside of the manufacturers' labeled instructions for the five FDA-approved minimally invasive endometrial ablation devices. METHODS: We queried the Manufacturer and User Facility Device Experience database for reports of device malfunction, patient injury, or death reported for each device from January 1, 2005 to December 31, 2011. We reviewed U.S. reports individually for annotations of patient injury or death and tabulated the reports by type of injury and device. We identified nine categories of serious injury (death, sepsis or bacteremia, intra-abdominal abscess, uterine rupture, thermal bowel injury, mechanical bowel injury, transmural uterine thermal injury, urologic injury, and lower genital tract or skin burns) and noted all reports citing device use outside of the manufacturers' labeled instructions. We also identified reports of hysterectomy or bowel resection attributable to an adverse event. RESULTS: Serious adverse events, including bowel injury (n=128), sepsis or bacteremia (n=47), intra-abdominal abscess (n=18), urologic injury (n=2), and uterine rupture (n=1) were reported. Death was also reported (n=4). Eight percent (66 of 829) of serious adverse events reports cited use outside of the manufacturers' labeled instructions, as did 7.3% (6 of 82) of reports citing need for hysterectomy and 8.7% (9 of 103) of reports of bowel resection. CONCLUSION: The findings from the Manufacturer and User Facility Device Experience database highlight the potential risk of serious complications related to endometrial ablation and underscore the importance of training in correct device use and familiarity with the manufacturer's labeled instructions. LEVEL OF EVIDENCE: III.

Tranexamic acid: a potential adjunct to resectoscopic endometrial ablation.

Abnormal uterine bleeding (AUB) is a substantial cause of ill health in women worldwide. In this study, our aim was to evaluate the effectiveness of endometrial ablation using a modified urologic resectoscope along with tranexamic acid in AUB. Sixty patients were enrolled in this study. All patients underwent resectoscopic surgery. Patients were randomly divided into two groups. Group 1 (n = 30) received 500 mg of tranexamic acid. Group 2 (n = 30) served as the control group and underwent surgery without the administration of tranexamic acid. Total pictorial blood loss assessment chart (PBAC) scores were significantly lower postoperatively (152.14 ± 9.65 versus 6.6 ± 0.90; P < 0.001). When stratified by the administration of tranexamic acid, the number of patients with a postoperative day 1 PBAC score ≤15 was higher in the tranexamic group (19 versus 13), whereas the number of patients with a post operative day 1 PBAC score >15 was lower in the tranexamic group (11 versus 17), but the differences were not statistically significant (P > 0.05). AUB is a complex disease that may need repeated treatments. In expert hands, the treatment rate of resectoscopic surgery seems acceptable. However, some patients may require additional interventions, like repeated surgery, hysterectomy, or a drug therapy in the long run. Introduction of tranexamic acid as a potential adjunct to rollerball endometrial ablation may present an interesting option that requires additional well-designed studies before firm conclusions can be made.

Global endometrial ablation.

Abnormal uterine bleeding (AUB) is a significant health problem for many women. Surgical treatment of AUB often follows failed attempts with first-line medical therapy. Hysterectomy, while being a definitive treatment, is a major surgical procedure with potential for significant complications and economic costs. Endometrial ablation was developed as an alternative to hysterectomy. The first-generation endometrial ablation devices required extensive training and experience to be performed effectively and safely. As a result, newer ablative devices were developed addressing the need for less technical knowledge and improved safety. Since 1997, the United States FDA has approved 5 global endometrial ablation devices for treatment of AUB attributable to benign causes. This review will focus on the technical aspects of these second- generation devices and their applications for treatment of AUB.

A cost-utility analysis of microwave endometrial ablation versus thermal balloon endometrial ablation.

OBJECTIVE: To evaluate the cost-effectiveness of microwave endometrial ablation (MEA) and thermal balloon endometrial ablation (TBALL) for heavy menstrual bleeding. METHODS: A cost-utility analysis performed alongside a pragmatic RCT in a single hospital within Scotland on women undergoing MEA and TBALL. Resource use data collected from all 314 trial participants were combined with study specific and published unit cost data to estimate a cost per patient. Quality-adjusted life-years (QALYs) were based on EQ-5D responses at baseline, 2 weeks, 6 and 12 months. The incremental cost per QALY of TBALL versus MEA was calculated and bootstrapping was performed to determine the likelihood that a treatment would be cost-effective at different threshold values for society's willingness to pay for a QALY. RESULTS: The mean cost of TBALL (10 years equipment life, 100 uses annually) of reusable equipment was pound181 (95% confidence interval [CI] pound70-434) greater than MEA. There were no statistically significant differences between the total nonhealth costs and health benefits of the two arms. On average, MEA provided more QALYs after adjusting for baseline EQ-5D score (0.017; 95% CI 0.017-0.051). In terms of mean incremental cost per QALY, MEA was, on average, dominant (less costly and at least as effective) and there was over a 90% chance that MEA would be considered cost-effective at a pound20,000 threshold of a cost per QALY. CONCLUSIONS: MEA is likely to be more cost-effective than TBALL at 1 year. Further longer-term follow-up is, however, needed.

[Outpatient treatment of menorrhagia]. / Behandling af menoragi i ambulant regi.

INTRODUCTION: Abnormal menstrual bleeding, menorrhagia, is a common problem in premenopausal women. Thermal balloon ablation can be done with Thermablate. It is simple to use and can be done quickly in an outpatient setting. MATERIAL AND METHODS: We have performed 116 treatments with Thermablate and followed the patients during a six month period. The treatment was primarily performed in paracervical block to outpatients. RESULTS: Few problems were observed. The general satisfaction was good, 76% was very or fairly satisfied. More than 80% reported reduced bleeding, but only 7% became amenorrheic. CONCLUSION: Thermablate is suitable in treatment of menorrhagia and can be done in paracervical block to outpatients. It is a simple treatment with few complications. Few became amenorrheic, the majority of patients experienced reduced bleeding and were satisfied.

Practical tips for office hysteroscopy and second-generation "global" endometrial ablation.

Hysteroscopy and endometrial ablation using the second-generation devices are safe, generally well tolerated, and effective when performed in the medical office as opposed to the ambulatory surgery center or hospital operating room. Not only does this benefit the patient and physician in terms of convenience and cost savings, and the overall economic benefit to the health care system is great. The availability of modern hysteroscopic and video equipment, the advent of second-generation "global"endometrial ablation devices, and use of minimal sedation combined with effective local anesthesia have made office procedures possible. Several states have enacted specific regulations and requirements for office based surgery. It is incumbent on the physician to be aware of which local regulations are applicable and the level of procedure he or she is willing to perform before embarking on an office-based surgery program. The AAGL ListServ discussion forum provides members with an invaluable source of clinical opinion about patient care issues in minimally invasive gynecology. These opinions come from experts around the world representing both academic centers and clinical practice who respond to questions or issues posed by colleagues. This review discusses each of the second-generation endometrial ablation devices in detail and some of the more pertinent issues related to office hysteroscopy and global endometrial ablation that were posted on the ListServ. Rollerball and transcervical resection of the endometrium are not discussed because the overwhelming majority of these procedures are performed in the operating room and there is little potential for their becoming office procedures. Practical clinical tips based on the evidence in the literature are discussed.

Vaginal myoma expulsion after NovaSure endometrial ablation.

A 46-year old multiparous woman visited a 1-stop clinic for abnormal uterine bleeding. There was a small submucosal type 2 myoma of 2 cm in her normal sized uterus. We treated her using Novasure endometrial ablation. One year later the patient suffered from sudden excessive vaginal bleeding and collapse. A myoma of 4 cm was being expelled from the uterus.