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.

Efficacy of a novel educational curriculum using a simulation laboratory on resident performance of hysteroscopic sterilization.

OBJECTIVE: To assess whether a novel educational curriculum using a simulation teaching laboratory improves resident knowledge, comfort with, and surgical performance of hysteroscopic sterilization. DESIGN: An educational prospective, pretest/posttest study. SETTING: The Montefiore Institute of Minimally Invasive Surgery Laboratory. PATIENT(S)/SUBJECT(S): Thirty-four OB/GYN residents in an academic medical center. INTERVENTION(S): Hysteroscopic sterilization simulation laboratory and a brief didactic lecture. MAIN OUTCOME MEASURE(S): Differences in scores on validated skill assessment tools: Task specific checklist, Global Rating Scale (GRS), pass fail assessment, and a multiple-choice examination to evaluate knowledge and attitude. RESULT(S): In the entire cohort improvements were observed on all evaluation tools after the simulation laboratory, with 31% points (SD+/-11.5, 95% confidence interval [CI] 27.3-35.3) higher score on the written evaluation; 63% points (SD+/-15.7, 95% CI 57.8-68.8) higher score on the task specific checklist; and 54% points (SD+/-13.6, 95% CI 48.8-58.3) higher score on the GRS. Higher PGY status was correlated with better pretest performance, but was not statistically significant in posttest scores. Residents reported an improvement in comfort performing the procedure after the laboratory. CONCLUSION(S): Simulation laboratory teaching significantly improved resident knowledge, comfort level, and technical skill performance of hysteroscopic sterilization.

A summary of reported pregnancies after hysteroscopic sterilization.

The purpose of this article is to describe 64 unintended pregnancies reported by patients who had undergone hysteroscopic sterilization and to provide recommendations for avoiding post-procedure pregnancies. Sixty-four pregnancies out of an estimated 50,000 procedures were reported to the device manufacturer from 1997 through December 2005. Most occurred in patients without appropriate follow-up. Other causes included misread hysterosalpingograms, undetected preprocedure pregnancies, and failure to follow product-labeling guidelines. The risk of pregnancy with hysteroscopic sterilization may be reduced by educating patients about the necessity of follow-up, ensuring that patients use effective contraception before and after placement, following the instructions for use, and adhering to the hysterosalpingography protocol.

Prospective analysis of office-based hysteroscopic sterilization.

STUDY OBJECTIVES: To evaluate the efficacy of performing the Essure hysteroscopic sterilization in an office-based setting. DESIGN: Prospective, longitudinal analysis (Canadian Task Force classification II-3). SETTING: University out-patient office. PATIENTS: All patients undergoing permanent sterilization in our outpatient office who opted for hysteroscopic sterilization were included. INTERVENTIONS: Hysteroscopic placement of the Essure device in an office-based setting with only non-steroidal antiinflammatory drugs and paracervical block. MEASUREMENTS AND MAIN RESULTS: Multiple data points were collected on each patient including demographic data, specific procedural information, and 12-week hysterosalpingogram data. Most of our patients were Hispanic and had an average body mass index of 30.3. Average time to perform the procedure was 12.4 minutes, with the steepest improvement in the first 13 cases. Bilateral placement of the device was successful in 98 (96%) of 102 patients. Of these patients 92 have 12-week hysterosalpingography results (6 patients were lost to follow-up), with 90 (98%) showing bilateral tubal occlusion. There were no intraprocedural or postprocedural complications. CONCLUSION: In our institution and in our experience, office-hysteroscopic placement of the Essure device is a feasible and effective approach for permanent sterilization.

Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost analysis.

STUDY OBJECTIVE: To evaluate the actual cost difference in performing Essure hysteroscopic sterilization in the office compared with ambulatory surgery using laparoscopic sterilization in the operating room. DESIGN: Cost-comparison analysis (Canadian Task Force classification III). SETTING: University hospital and affiliated outpatient office. INTERVENTIONS: Hysteroscopic placement of Essure device in an office setting and laparoscopic tubal ligation for permanent sterilization. MEASUREMENTS AND MAIN RESULTS: The various costs associated with the two procedures at our institution were compiled, and a direct cost comparison was made. We used actual institutional costs of the procedures, not billing or reimbursement. We found laparoscopic tubal ligations to cost 3449 dollars compared with hysteroscopic placement of the Essure device that costs 1374 dollars yielding a 2075 dollars difference between the procedures. CONCLUSION: In our institution and in our experience, office-hysteroscopic placement of the Essure device is a more cost-effective method than laparoscopic tubal ligation.