Leyland Nicholas, Harris Micah
Department of Obstetrics and Gynaecology, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, L8S 4K1, Canada.
AEGEA Medical, Menlo Park, CA, 94025, USA.
Int J Womens Health. 2021 Feb 10;13:169-176. doi: 10.2147/IJWH.S279864. eCollection 2021.
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).
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.
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%.
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.
报告一项关键试验的36个月随访结果，该试验评估了AEGEA水蒸气系统治疗因子宫内膜疾病或子宫肌瘤（AUB - E和AUB - L）导致的异常子宫出血继发的月经过多（HMB）的安全性和有效性。
在美国、加拿大、墨西哥和荷兰的14个地点进行的一项前瞻性、多中心、单臂临床试验。纳入标准包括图像失血评估（PBLAC，海厄姆）评分≥150分，并允许治疗国际妇产科联合会（FIGO）分类为2 - 6型、直径达4厘米、子宫腔长度达12厘米（子宫探子测量）、已植入依舒佳林避孕装置和/或既往有剖宫产史的子宫肌瘤患者。在子宫内膜消融术后每年进行随访评估，直至36个月。对125/155名女性评估了以下结果：妇科不良事件、月经流量的定性评估、使用月经过多影响问卷（MIQ）评估生活质量、患者满意度以及针对AUB的医疗或手术再次干预情况。
2014年9月至2015年5月招募了155名年龄在30至50岁的绝经前女性。在办公室、手术中心和手术室，在不同的麻醉/镇静方案下进行了水蒸气子宫内膜消融术。在12至36个月的随访期间发生了6起与手术相关的不良事件，其中1起被认为严重（宫腔镜成功处理积血）。72%的患者报告闭经或月经流量少。生活质量（MIQ）平均评分从基线时的14.7提高到6.4。93%的患者报告“满意”或“非常满意”。6.5%的患者因任何指征进行了消融术后子宫切除术，出血再次干预的总发生率为7.1%。
水蒸气子宫内膜消融术治疗HMB 36个月后的结果与在所有评估亚组中12个月和24个月的随访结果一致。AEGEA水蒸气系统增加了因异常子宫出血（AUB - E、-L）导致的月经过多（HMB）且适合有效且可接受治疗的患者群体。ClinicalTrials.gov标识符：NCT01979861，于2013年11月8日注册。
