Wayne State University School of Medicine, Detroit, Michigan (Dr. Berman).
Advocate Illinois Masonic Medical Center, Chicago, Illinois (Dr. Shashoua).
J Minim Invasive Gynecol. 2020 Mar-Apr;27(3):639-645. doi: 10.1016/j.jmig.2019.06.009. Epub 2019 Jun 23.
To analyze pregnancy delivery and safety outcomes after patient receipt of percutaneous, laparoscopic intra-abdominal ultrasound-guided radiofrequency ablation (Lap-RFA) for symptomatic uterine myomas.
Case series (2010-2017); evidence was obtained from 2 randomized, controlled trials (level I), 6 cohort studies (level II-2), and in commercial settings (level II-3).
Multiple sites in the United States, Canada, Europe, and Latin America (university hospitals, community hospitals, and stand-alone surgery centers). Commercial cases were United States based and followed US Food and Drug Administration clearance of Lap-RFA.
Premenopausal adult women with symptomatic uterine myoma types 1 through 6.
The Lap-RFA procedure was conducted under general anesthesia with laparoscopic and intra-abdominal ultrasound guidance.
Safety unknowns included the safety of a full-term pregnancy for mother and baby, rates of spontaneous abortion, preterm delivery, postpartum hemorrhage, placental abnormalities, intrauterine growth restriction, and vaginal versus cesarean delivery. A total of 28 women (mean age = 35.0 ± 3.4 years) conceived a total of 30 times after Lap-RFA, either as part of a clinical study or in commercial settings. The number of myomas treated per patient ranged from 1 to 7. The diameter of treated myomas ranged from 0.9 to 11.0 cm. Most patients had 1 or 2 myomas, and most myomas were ≤5.5 cm in maximal diameter. The 30 pregnancies resulted in 26 full-term live births (86.7%), all healthy infants, with an equal distribution of vaginal and cesarean deliveries. Four (13.3%) spontaneous abortions occurred. No cases of preterm delivery, uterine rupture, placental abruption, placenta accreta, or intrauterine growth restriction were reported. One event each of placenta previa and postpartum hemorrhage were reported.
Conception and safe, full-term pregnancy are achievable after Lap-RFA of symptomatic myomas. Additional large, rigorous, multivariate prospective studies that adjust for confounders and report pregnancy outcomes after symptomatic myoma treatment are needed.
分析患者接受经皮、腹腔镜腹腔内超声引导射频消融（Lap-RFA）治疗症状性子宫肌瘤后的妊娠分娩和安全性结局。
病例系列研究（2010-2017 年）；证据来自 2 项随机对照试验（I 级）、6 项队列研究（II-2 级）和商业环境（II-3 级）。
美国、加拿大、欧洲和拉丁美洲的多个地点（大学医院、社区医院和独立手术中心）。商业案例基于美国，遵循 Lap-RFA 的美国食品和药物管理局批准。
有症状的子宫肌瘤 1 至 6 型的绝经前成年女性。
Lap-RFA 程序在全身麻醉下进行，结合腹腔镜和腹腔内超声引导。
安全性未知因素包括母婴足月妊娠的安全性、自然流产率、早产率、产后出血率、胎盘异常、宫内生长受限以及阴道分娩与剖宫产率。共有 28 名女性（平均年龄 35.0±3.4 岁）在 Lap-RFA 后总共怀孕了 30 次，要么是作为临床研究的一部分，要么是在商业环境中。每位患者接受治疗的肌瘤数量从 1 到 7 个不等。治疗肌瘤的直径从 0.9 到 11.0 厘米不等。大多数患者有 1 或 2 个肌瘤，大多数肌瘤的最大直径≤5.5 厘米。这 30 次妊娠导致 26 例足月活产（86.7%），均为健康婴儿，阴道分娩和剖宫产分娩各占一半。有 4 例（13.3%）自然流产。无早产、子宫破裂、胎盘早剥、胎盘植入或宫内生长受限病例报告。分别报告了 1 例胎盘前置和产后出血病例。
Lap-RFA 治疗症状性肌瘤后，可以实现妊娠和安全的足月妊娠。需要进行更多大型、严格、多变量的前瞻性研究，以调整混杂因素并报告症状性子宫肌瘤治疗后的妊娠结局。
