Case Series of Reproductive Outcomes after Laparoscopic Radiofrequency Ablation of Symptomatic Myomas

Abstract

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. Design: 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). Setting: 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. Patients: Premenopausal adult women with symptomatic uterine myoma types 1 through 6. Interventions: The Lap-RFA procedure was conducted under general anesthesia with laparoscopic and intra-abdominal ultrasound guidance. Measurements and Main Results: 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. Conclusion: 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.

Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice

“…The largest case series reported 30 pregnancies in 28 women who had undergone RFA of leiomyoma in clinical trials or post-market practice settings 22 , Among these pregnancies, 26 (86.7%) delivered at term with healthy infants; 50% by cesarean section and 50% by vaginal delivery.…”

“…Confidence in performing the procedure was also high with 100% of gynecologists reporting that they felt somewhat or very confident in performing the procedure after 4 cases. On a scale from 0 to 10, the mean difficulty rating by gynecologists after the first case was 6 (SD 2.35) and decreased each case to a nadir of 4.25 (SD 2 22). after four cases.Postoperative recovery was, on average, less than two weeks(Figure 4).…”

The current and future state of surgery in reproductive endocrinology

“…This technique is not FDA approved for women desiring fertility. However, early studies indicate it is well tolerated during pregnancy [26 ▪ ]. As more evidence accrues, radiofrequency ablation will become more mainstream.…”

Management of Symptomatic Uterine Leiomyomas

“…In a case-series of 30 pregnancies after laparoscopic RFA, there were 26 full-term live births and four pregnancy losses (64). Although in this small case series there were no cases of preterm delivery, uterine rupture, placental abruption, placenta accreta, or intrauterine growth restriction (64), sample size precludes any definitive conclusions about risk or incidence of pregnancy complications.…”