PDF(Pubmed)
Abstract：
Background/Objectives: Transcervical fibroid ablation (TFA) is an incisionless method to treat symptomatic uterine fibroids. While safety regarding future pregnancy remains to be established, TFA does not preclude the possibility of pregnancy, and a previous 36-patient case series of post-TFA pregnancies reported normal outcomes. That prior series did not include postmarket cases in the United States, as the Sonata® System was initially cleared and used in Europe. This is a substantive update of known pregnancies with the Sonata System since June 2011, and includes pregnancies in Europe, Mexico, and the US. Methods: TFA was carried out under both clinical trial and postmarket use to treat symptomatic uterine fibroids. All post-TFA pregnancies reported by physicians with their patient\'s consent were included. Results: 89 pregnancies and 55 deliveries have occurred among 72 women treated with the Sonata System. This includes 8 women who conceived more than once after TFA. Completed pregnancies (n = 62 women) include 19 vaginal deliveries, 35 Cesarean sections, 5 therapeutic abortions, 1 ectopic pregnancy, and 1 delivery by an unknown route. Ten pregnancies are ongoing. Mean birthweight was 3276.7 ± 587.3 g. Ten women experienced 18 first-trimester spontaneous abortions (SAbs), with 10 of the 18 SAbs (55.6%) occurring between two patients with a history of recurrent abortion. The SAb rate was 22.8%, inclusive of these two patients, and 10.1% if they were excluded as outliers. There were no instances of uterine rupture, placenta accreta spectrum, or stillbirth. Conclusions: This case series, the largest to date for any hyperthermic ablation modality, suggests that TFA with the Sonata System could be a feasible, safe treatment option regarding eventual pregnancy in women with symptomatic uterine fibroids.
摘要：
背景/目的：经宫颈肌瘤消融术（TFA）是一种无切口治疗有症状子宫肌瘤的方法。虽然未来怀孕的安全性仍有待确定，TFA并不排除怀孕的可能性，先前36例患者的TFA后妊娠病例报告结果正常。之前的系列不包括美国的上市后案例，索纳塔®系统最初在欧洲被清除和使用。这是自2011年6月以来使用奏鸣曲系统的已知怀孕情况的实质性更新，包括欧洲的怀孕情况，墨西哥,和美国。方法：在临床试验和上市后使用TFA治疗有症状的子宫肌瘤。包括医生在患者同意的情况下报告的所有TFA后怀孕。结果：在接受奏鸣曲系统治疗的72名妇女中，有89例怀孕和55例分娩。这包括8名妇女在TFA后怀孕不止一次。完成妊娠（n=62名妇女）包括19例阴道分娩，35剖腹产,5例治疗性流产,1异位妊娠,和1个未知路线的交付。十次怀孕正在进行中。平均出生体重为3276.7±587.3g。10名妇女经历了18次妊娠早期自然流产（SABS），18例SAb中有10例(55.6%)发生在有复发性流产史的两名患者之间。SAb率为22.8%，包括这两个病人，如果将它们排除为异常值，则为10.1%。没有子宫破裂,胎盘植入光谱，或者死产.结论：这个案例系列，迄今为止最大的高温消融模式，这表明索纳塔系统的TFA可能是可行的，关于有症状的子宫肌瘤妇女最终妊娠的安全治疗选择.
