Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective, Multicenter Pivotal Clinical Trial
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STUDY OBJECTIVE: To report 36-month follow-up of a pivotal trial that evaluated the safety and effectiveness of the AEGEA Water Vapor System for the treatment of heavy menstrual bleeding (HMB) secondary to Abnormal Uterine Bleeding due to Endometrial disorders or Leiomyomata (AUB-E and AUB-L). METHODS: A prospective, multicenter, single-arm clinical trial at 14 sites in the US, Canada, Mexico, and the Netherlands. Inclusion criteria included a Pictorial Blood Loss Assessment (PBLAC, Higham) score ≥150 and allowed treatment of subjects with leiomyomata classified by the International Federation of Gynecology and Obstetrics (FIGO) Types 2-6 up to 4 cm in diameter, a uterine cavity up to 12 cm in length (uterine sound), Essure® contraceptive inserts and/or prior cesarean section. Follow-up assessments were conducted annually up to 36 months after endometrial ablation. The following outcomes were evaluated for 125/155 women: gynecological adverse events, qualitative assessment of menstrual flow, quality of life using the Menorrhagia Impact Questionnaire (MIQ), patient satisfaction, and medical or surgical reintervention for AUB. RESULTS: One hundred and fifty-five premenopausal women aged 30 to 50 years were enrolled from September 2014 through May 2015. Water vapor endometrial ablation was performed under varying anesthesia/sedation regimens in offices, surgical centers and operating rooms. There were 6 procedure-related adverse events that occurred between 12- and 36-month follow-up, 1 of which was deemed serious (hematometra managed successfully hysteroscopically). Seventy-two percent reported amenorrhea or light menstrual flow. The mean quality of life (MIQ) score improved from 14.7 at baseline to 6.4. Ninety-three percent reported "Satisfied" or "Very Satisfied." Post-ablation hysterectomy for any indication was performed in 6.5% of patients, and the total rate of re-intervention for bleeding was 7.1%. CONCLUSION: Outcomes 36-months after water vapor endometrial ablation for HMB are consistent with 12- and 24-month follow-up results in all subgroups evaluated. The AEGEA Water Vapor System increases the population of patients amenable to efficacious and acceptable treatment of Heavy Menstrual Bleeding (HMB) due to Abnormal Uterine Bleeding (AUB-E,-L). CinicalTrials.gov NCT01979861 registered November 8, 2013.
