Nonresectoscopic Endometrial Ablation Research Articles

A 52-mg levonorgestrel-releasing intrauterine system vs bipolar radiofrequency nonresectoscopic endometrial ablation in women with heavy menstrual bleeding: long-term follow-up of a multicenter randomized controlled trial

BACKGROUNDThe symptom of heavy menstrual bleeding has a significant impact on professional, physical and social functioning. In 2021, results from a randomized controlled trial comparing a 52 mg levonorgestrel-releasing intrauterine system and radiofrequency non-resectoscopic endometrial ablation as treatments for women with heavy menstrual bleeding were published. Both treatment strategies were equally effective in treating heavy menstrual bleeding during a two-year follow-up. However, long-term results are also relevant for both patients and health care providers. OBJECTIVEThe aim of this study was to assess long-term differences in reintervention risk and menstrual blood loss in women with the symptom of heavy menstrual bleeding treated according to a strategy starting with a 52 mg levonorgestrel-releasing intrauterine system or radiofrequency non-resectoscopic endometrial ablation. STUDY DESIGNThis study was a long-term follow-up study of a multi-center randomized controlled trial (MIRA trial) in which women were allocated to either a 52 mg levonorgestrel-releasing intrauterine device (n=132) or radiofrequency non-resectoscopic endometrial ablation (n=138). Women from the original trial were contacted to fill out six questionnaires. The primary outcome was reintervention rate after allocated treatment. Secondary outcomes included surgical reintervention rate, menstrual bleeding measured by the Pictorial Blood Loss Assessment Chart, (disease-specific) quality of life, sexual function and patient satisfaction. RESULTSFrom the 270 women that were randomized in the original trial, 196 women (52 mg levonorgestrel-releasing intrauterine system group: n=94; radiofrequency non-resectoscopic endometrial ablation group: n=102) participated in this long-term follow-up study. Mean follow-up duration was 7.4 years (range 6-9 years). The cumulative reintervention rate (including both medical and surgical reinterventions) was 40.0% (34/85) in the 52 mg levonorgestrel-releasing intrauterine system group and 28.7% (27/94) in the radiofrequency non-resectoscopic endometrial ablation group (relative risk: 1.39; 95% confidence interval: 0.92-2.10). The cumulative rate of surgical reinterventions only was significantly higher for patients with a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system compared to radiofrequency non-resectoscopic endometrial ablation (35.3% [30/85] vs. 19.1% [18/94]; relative risk: 1.84; 95% confidence interval: 1.11-3.10). However, hysterectomy rate was similar: 11.8% [10/94] in the 52 mg levonorgestrel-releasing intrauterine system group and 18.1% [17/102] in the radiofrequency non-resectoscopic endometrial ablation group (relative risk: 0.65; 95% confidence interval: 0.32-1.34). Most reinterventions took place during the first 24 months of follow-up. A total of 171 Pictorial Blood Loss Assessment Chart scores showed a median bleeding score of 0.0. No clinically relevant differences were found regarding quality of life, sexual function and patient satisfaction. CONCLUSIONThe overall risk of reintervention after long-term follow-up was not different for women treated according to a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system as compared to a strategy starting with radiofrequency non-resectoscopic endometrial ablation. Yet, women allocated to a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system had a significantly higher risk for surgical reintervention, which was driven by an increase in subsequent endometrial ablation. Both treatment strategies remain effective in lowering menstrual blood loss over the long-term. The results of this long-term follow-up study help physicians to optimize counseling of women suffering from the symptom of heavy menstrual bleeding. Optimized counseling will enable women to make a well-informed choice regarding treatment.

Risk of Hysterectomy After Endometrial Ablation: A Systematic Review and Meta-analysis

ABSTRACT A common gynecological problem for approximately 30% of women at reproductive age in European countries is heavy menstrual bleeding (HMB). Although hysterectomy is a highly successful treatment for this benign problem, it also risks serious complications due to its nature as a major operation. Less invasive HMB treatment options include insertion of a levonorgestrel-releasing intrauterine system, medical treatment (such as tranexamic acid and oral contraceptive pill), or endometrial ablation (which aims to destroy endometrial tissue and the superficial myometrium to reduce/stop menstrual bleeding). Endometrial ablation failure may result in the objective outcome of hysterectomy. This meta-analysis and review aimed to assess hysterectomy risk following nonresectoscopic endometrial ablation treatment to improve understanding and HMB patient counseling. Various nonresectoscopic ablation techniques versus their associated hysterectomy rates were investigated, and subgroup analyses were performed. Following a comprehensive and thorough search process of the MEDLINE, CENTRAL, and EMBASE databases, 53 articles ultimately met the inclusion criteria for inclusion in the systematic review. Between 1992 and 2017, in the included studies, 48,071 patients underwent endometrial ablation. A high risk of bias was found in 13 studies (mainly due to selection or reporting bias), whereas 12 studies maintained low risk of bias. However, exclusion of the 13 high-risk studies for a subgroup analysis yielded similar results to the original meta-analysis. Results of the analysis indicated a consistently increasing post–endometrial ablation hysterectomy, with 2% increments annually between 1 and 5 years following the procedure, rising to 4.3% after 1 year and 12.4% after 5 years. In 2 studies, a post–10-year follow-up found a mean hysterectomy rate of 21.3%. Between both various study designs and the different varieties of devices used, no major differences in hysterectomy rates were found, respectively. Limitations of the review include a high risk for heterogeneity found among studies in almost all analyses utilized by this analysis. Publication bias and methodological issues (variation of population size and study type) lent to the heterogeneity. Because of this variation, the authors performed analyses of subgroups with different study designs. In addition, of the 53 studies included, 15 of them included fewer than 50 participants, which was corrected in this analysis via an inverse variance. Overall, the study indicated that hysterectomy risk following endometrial ablation increases from 4.3% at the 1-year mark to 12.4% at the post–5-year mark. Neither differences in nonresectoscopic endometrial ablation techniques nor study design seemed to affect hysterectomy rates. This systematic review's data can be applied to clinical practice and used for counseling patients about hysterectomy risks within 5 years of endometrial ablation.

Risk of Hysterectomy After Endometrial Ablation: A Systematic Review and Meta-analysis.

To assess the risk of hysterectomy after nonresectoscopic endometrial ablation in patients with heavy menstrual bleeding. The EMBASE, MEDLINE, ClinicalTrials.gov and Cochrane databases were searched for eligible articles from inception until June 13, 2022. We used combinations of search terms for endometrial ablation and hysterectomy. Articles included in the review described the incidence of hysterectomy at a specific point in time after ablation with a minimum follow-up duration of 12 months. The literature search yielded a total of 3,022 hits. A total of 53 studies met our inclusion and exclusion criteria, including six retrospective studies, 24 randomized controlled trials, and 23 prospective studies. A total of 48,071 patients underwent endometrial ablation between 1992 and 2017. Follow-up duration varied between 12 and 120 months. Analyses per follow-up moment showed 4.3% hysterectomy rate at 12 months of follow-up (n=29 studies), 11.1% at 18 months (n=1 study), 8.0% at 24 months (n=11 studies), 10.2% at 36 months (n=12 studies), 7.6% at 48 months (n=2 studies), and 12.4% at 60 months (n=6 studies). Two studies reported a mean hysterectomy rate at 10 years after ablation of 21.3%. Minimal clinically relevant differences in hysterectomy rates were observed among the different study designs. Furthermore, we found no significant differences in hysterectomy rate among the different nonresectoscopic endometrial ablation devices. The risk of hysterectomy after endometrial ablation seems to increase from 4.3% after 1 year to 12.4% after 5 years. Clinicians can use the results of this review to counsel patients about the 12% risk of hysterectomy 5 years after endometrial ablation. PROSPERO, CRD42020156281.

8580 Comparison of Anesthetic Usage with Different Endometrial Ablation Devices

<h3>Study Objective</h3> To compare the anesthetic requirements associated with the use of different non-resectoscopic endometrial ablation (NREA) techniques. <h3>Design</h3> Retrospective comparative analysis for five marketed NREA devices using the information reported in their FDA approved instructions for use (IFU). "Physician discretion" directed anesthesia data were compared. <h3>Setting</h3> Office and operating room. <h3>Patients or Participants</h3> The Intent to treat population reported in IFU for the clinical studies conducted in support of FDA Premarket approval of five endometrial ablation devices. <h3>Interventions</h3> Endometrial ablation with the Cerene® Cryotherapy Device, Genesys® HTA Endometrial Ablation System, Mara™ Water Vapor Ablation System, Minerva® Endometrial Ablation System, and NovaSure® Impedance Controlled Endometrial Ablation System. <h3>Conclusion</h3> When comparing endometrial ablation modalities, anesthetic requirements should factor into choosing one technique over another, especially when considering an in-office procedure. Based on these data, cryoablation with Cerene was significantly more likely to be performed without IV medications (97%) demonstrating high tolerability for office use, as compared with hyperthermic endometrial ablation devices.

Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis.

Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis.

Pain Management and Subject Comfort During an Endometrial Ablation Treatment with the Cerene Cryotherapy Device

Study Objective To evaluate the use of medications to manage pain and/or anxiety and the subjects’ level of perioperative pain related to an endometrial ablation treatment with the Cerene Cryotherapy Device (Channel Medsystems, Emeryville, CA). Design A prospective, multi-center, single-arm, open-label, non-randomized study. Setting At 11 academic and private practice settings across North America: 8 sites in the US, 1 site in Mexico, and 2 sites in Canada. Patients or Participants 242 subjects comprise the Intent-to-Treat (ITT) population. Interventions Subjects were treated with the Cerene Device, which delivers a 2.5-minute cryoablation of the endometrium. Analgesia and local anesthesia were administered per investigator discretion. Subjects rated their pain at screening, 5 time points during treatment, and at 3 time points up to 24 hours post-treatment using a numeric rating scale of 0-10. Measurements and Main Results The Cerene treatment was completed with only paracervical block (PCB) in 20 subjects (8.3%), PCB with nonsteroidal anti-inflammatory drugs (NSAIDs) in 48 subjects (19.8%), PCB with oral narcotics and/or anxiolytics in 167 subjects (69%), and IV sedation in 7 subjects (2.9%). No subject received general anesthesia or required airway management. Subjects reported a median pain rating of 2 or less throughout the Cerene treatment. The median pain score was 2 at discharge and 0 at twenty four hours. Conclusion The use of general anesthesia and/or intravenous sedation was markedly less for the Cerene treatment than that reported in clinical studies of other commercially available heat-based non-resectoscopic endometrial ablation devices. The vast majority of subjects tolerated the procedure well with oral NSAIDs, anxiolytics, and/or pain medications. The study demonstrated the natural analgesic effect of cryoablation due to the freezing of pain receptors in the uterus. The Cerene device allows the endometrial ablation treatment of heavy menstrual bleeding to be performed comfortably as an office-based procedure without the support of an anesthesiologist.

Safety and Efficiency in a Canadian Outpatient Gynaecological Surgical Centre.

This study sought to describe safety and efficiency outcomes for patients undergoing procedures at the Women's Health Centre, an outpatient gynaecological surgical centre in Saskatoon, SK. A retrospective chart review of surgical outpatient health records was conducted for the period of July 2014 to June 2015. Data were abstracted using a standardized data form for patient admissions during the study period. Primary outcomes of interest included procedure time, lead time (registration to discharge), complication rates, readmission rates, and reoperation rates. Descriptive statistics were calculated using Microsoft Excel and were summarized using frequencies and percentages. The Kruskal-Wallis test was performed for lead time and procedural time by using IBM SPSS Statistics 24 software (IBM, Armonk, NY). During the study period, 1720 patients were seen by 21 providers. The mean number of patients seen per month was 144. The main services provided include hysteroscopic sterilization, non-resectoscopic endometrial ablation, loop electrosurgical excision procedure, hysteroscopy, and therapeutic abortion. Pain management was administered by local anaesthetic and/or conscious sedation. The mean procedure time was 10 ± 6 minutes, whereas the lead time was 171 ± 43 minutes. Immediate complications occurred in 3.9% of patients, the most common being vaginal bleeding (1.3%). The long-term complication rate was 5.1%, with the most common complication being reoperation in the main operating room, at 2.9%. Currently, many gynaecological procedures in Canada occur in a formal operating theatre setting. Our study demonstrates the safety and efficiency of an alternate setting where gynaecological procedures are performed on an outpatient basis by using local anaesthetic and conscious sedation.

Cost-effectiveness of treatments for heavy menstrual bleeding

Heavy menstrual bleeding affects up to one third of women in the United States, resulting in a reduced quality of life and significant cost to the health care system. Multiple treatment options exist, offering different potential for symptom control at highly variable initial costs, but the relative value of these treatment options is unknown. The objective of the study was to evaluate the relative cost-effectiveness of 4 treatment options for heavy menstrual bleeding: hysterectomy, resectoscopic endometrial ablation, nonresectoscopic endometrial ablation, and the levonorgestrel-releasing intrauterine system. We formulated a decision tree evaluating private payer costs and quality-adjusted life years over a 5 year time horizon for premenopausal women with heavy menstrual bleeding and no suspected malignancy. For each treatment option, we used probabilities derived from literature review to estimate frequencies of minor complications, major complications, and treatment failure resulting in the need for additional treatments. Treatments were compared in terms of total average costs, quality-adjusted life years, and incremental cost-effectiveness ratios. Probabilistic sensitivity analysis was conducted to understand the range of possible outcomes if model inputs were varied. The levonorgestrel-releasing intrauterine system had superior quality-of-life outcomes to hysterectomy with lower costs. In a probabilistic sensitivity analysis, levonorgestrel-releasing intrauterine system was cost-effective compared with hysterectomy in the majority of scenarios (90%). Both resectoscopic and nonresectoscopic endometrial ablation were associated with reduced costs compared with hysterectomy but resulted in a lower average quality of life. According to standard willingness-to-pay thresholds, resectoscopic endometrial ablation was considered cost effective compared with hysterectomy in 44% of scenarios, and nonresectoscopic endometrial ablation was considered cost effective compared with hysterectomy in 53% of scenarios. Comparing all trade-offs associated with 4 possible treatments of heavy menstrual bleeding, the levonorgestrel-releasing intrauterine system was superior to both hysterectomy and endometrial ablation in terms of cost and quality of life. Hysterectomy is associated with a superior quality of life and fewer complications than either type of ablation but at a higher cost. For women who are unwilling or unable to choose the levonorgestrel-releasing intrauterine system as a first-course treatment for heavy menstrual bleeding, consideration of cost, procedure-specific complications, and patient preferences can guide the decision between hysterectomy and ablation.

Endometrial Ablation: Normal Imaging Appearance and Delayed Complications.

Nonresectoscopic endometrial ablation techniques are being used as an alternative first-line management for menorrhagia. With these techniques, patients are at risk of developing delayed complications including painful obstructed menses, such as central hematometra and cornual hematometra, and postablation tubal sterilization syndrome. Pregnancy and the detection of endometrial cancer after ablation pose challenges in management. Radiologists should recognize the normal imaging findings in patients who have undergone endometrial ablation, be aware of the causes of treatment failure, and accurately identify delayed complications associated with these procedures.

Endometrial ablation in the management of abnormal uterine bleeding.

Abstract 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.

Late-onset endometrial ablation failure--etiology, treatment, and prevention.

This review summarizes the history and demographics of nonresectoscopic endometrial ablation and global endometrial ablation procedures as well as the presentation, etiology, risk factors, treatment options, and prevention of late-onset endometrial ablation failures.

Nonresectoscopic Endometrial Ablation in High-Risk Surgical Patients: A Cohort Study

Study ObjectiveTo evaluate the use of nonresectoscopic endometrial ablation in women with high anesthetic and surgical risk compared with low-risk women based on the American Society of Anesthesia (ASA) physical status stratification. DesignThis is a cohort study of women who were classified as high-risk (HR) or low-risk (LR) cohorts based on ASA physical status stratification. The ASA classification includes 6 grades: ASAP1, a normal healthy person; ASAP2, mild systemic disease; ASAP3, severe systemic disease; ASAP4, severe systemic disease that is a constant threat to life; ASAP5, a critically ill patient who is not expected to survive without the operation; and ASAP6, declared brain-dead patient whose organs are being removed for donor purposes. Baseline characteristics including comorbidities were obtained. Outcome measures included amenorrhea, treatment failure, and operative complications. The time to treatment failure was compared using Kaplan-Meier analysis. Risk adjustments were performed using regression models. SettingAcademic medical center in the Upper Midwest. PatientsSeven-hundred eleven women underwent nonresectoscopic endometrial ablation at our institution between January 1998 and December 2005. InterventionsBipolar radiofrequency was used in 448 women and thermal balloon ablation in 263 women. Measurements and Main ResultsThe HR cohort had a higher proportion of women with cardiac disease (27.1% vs 6.7%, p < .001) and more women with nongynecologic cancer (12.3% vs 2.9%, Fisher exact test, p < .001). Nonetheless, endometrial ablation had comparable efficacy in both the HR and LR cohorts with 5-year failure rates of 11.7% and 14.8% (p = .659), respectively. Amenorrhea rates were also similar in both cohorts (29.7% vs 27.2%, p = .645). After adjusting for known confounders including age, parity, dysmenorrhea, previous tubal ligation, uterine length, and the type of the procedure, the calculated hazard ratio for failure in the HR cohort was 0.80 (95% confidence interval; 0.31–1.74, p = .607), and the adjusted odds ratio for amenorrhea was 1.27 (95% confidence interval, 0.71–2.20; p = .411). Complications were rare in both groups. The mortality rate in the HR cohort was significantly higher compared with the LR cohort (7.9% vs <1%, p < .001), but this was not related to the ablation procedures. ConclusionFor women who are high anesthetic and surgical risks because of serious underlying comorbidities, nonresectoscopic endometrial ablation can provide minimally invasive, safe, and effective therapy for menorrhagia.

Endometrial Ablation: Where Have We Been? Where Are We Going?

Endometrial ablation (EA) is targeted destruction of the endothelial surface of the uterine cavity. The procedure was originally designed as a less invasive alternative to hysterectomy for the symptom of heavy menstrual bleeding unrelated to structural pathology of the uterus, that was not responsive to medical therapy. More recently it has become apparent that the procedure can be performed in the presence of submucous leiomyomas, providing they meet a number of size and location criteria. The first EA serie as published in Germany in the 1930s, but the procedure did not attract much attention until the latter part of the 20th century. Currently, EA can be performed under endoscopic direction with the neodymium:yttrium alumnum garnet laser, with a radiofrequency resectoscope, or with an expanding array of nonresectoscopic EA systems. It is apparent that most but not all of the complications associated with resectoscopic endometrial ablation are eliminated with nonresectoscopic endometrial ablation, but serious morbidity has been reported with all of the newer systems to date. Success and patient satisfaction seem to be enduring in the majority of well-selected patients treated in clinical trials, but repeat surgery, usually hysterectomy, is performed in 25% to 40% by 5 years after surgery. Increased efficiencies should be realized if the procedure could be moved to an office setting.

Complications associated with non-resectoscopic endometrial ablation: The utility of the MAUDE database

Complications associated with non-resectoscopic endometrial ablation: The utility of the MAUDE database