7728 Pregnancy Outcomes after Transcervical Fibroid Ablation (TFA) with the Sonata® System

Abstract

<h3>Study Objective</h3> To describe pregnancy outcomes in women who conceived after undergoing transcervical fibroid ablation (TFA) as treatment for symptomatic uterine fibroids. <h3>Design</h3> Retrospective study. <h3>Setting</h3> Hospitals in Europe, the UK, Mexico and the US. <h3>Patients or Participants</h3> Women who reported pregnancies after undergoing TFA with the Sonata® System. <h3>Interventions</h3> TFA was used to ablate fibroids, both under clinical trial protocol and commercial usage. <h3>Measurements and Main Results</h3> To date, there have been 43 pregnancies representing 25 deliveries among 35 women who were treated with TFA. Five women conceived more than once post-ablation, and four conceived through assisted reproductive technology (ART). Outcomes include 10 vaginal deliveries, 15 Cesarean sections, 4 therapeutic abortions, and 8 first-trimester pregnancy losses. Of the 8 miscarriages, four occurred in a patient with a history of recurrent abortion and an immunologic disorder and she subsequently had a delivery at term. Six women are currently pregnant. All 5-minute Apgar scores were >7 and all neonates weighed >2500 gms. Deliveries occurred at ≥37 weeks, except for one delivery at 35 6/7 weeks. There were no uterine ruptures or abnormal placentation and no reports of postpartum hemorrhage. Cesarean sections were performed for standard obstetric indications, including non-reassuring fetal monitoring in a patient with HELLP syndrome, fetal macrosomia, dystocia and patient choice. On average, 1.4 fibroids were ablated per patient, and these included transmural, submucous and intramural myomata up to 7 cm in diameter. <h3>Conclusion</h3> Normal pregnancy outcomes at term have occurred after TFA with the Sonata System, including in women with recurrent abortion and in those undergoing ART.