Transcervical Ablation Research Articles

Radiofrequency Ablation of Uterine Fibroids and Pregnancy Outcomes: An Updated Review of the Literature

Study Objective The purpose of this article is to provide an updated review of pregnancy outcomes after laparoscopic and transcervical radiofrequency ablation of fibroids. Design Literature review using PubMed/Medline. Setting N/A. Patients or Participants Patients were identified from case reports and case series of pregnancies following trials of radiofrequency ablation (RFA) devices for symptomatic uterine fibroids. The pregnancies identified represented large trials of laparoscopic and transcervical ablation from North America, Asia, Europe, and Latin America. Interventions Laparoscopic and transcervical radiofrequency ablation of fibroids. Measurements and Main Results 6 publications met criteria for inclusion, representing 11 clinical trials and 3 reports from real-world settings. 593 patients underwent RFA of fibroids, with 46 total pregnancies identified. The average age of patients was 39 years old and ranged from 27 to 46 years old. The majority of patients had between one and three fibroids ablated, and the size varied from less than 2 centimeters up to 12.5 centimeters. In terms of pregnancy outcomes, among the 46 total pregnancies, there were 4 spontaneous abortions, 7 elective terminations of pregnancy, and 35 term pregnancies with 17 vaginal and 18 cesarean deliveries. The patients who experienced spontaneous abortion were 36 to 38 years old. There was one complication after cesarean delivery presenting as postpartum hemorrhage with resultant expulsion of degenerated myoma with no long-term sequelae. There were no cases of uterine rupture, uterine window, placenta accreta, placental abruption, or fetal growth restriction. Conclusion The majority of patients who had documented pregnancies after radiofrequency ablation of fibroids had full-term deliveries with no maternal or neonatal complications. Given the inherent obstetric risks with myomectomy (e.g., risk of uterine rupture, intrauterine scarring, possible need for cesarean delivery, etc.), these findings add to the growing consensus that radiofrequency fibroid ablation may offer a safe and effective minimally invasive treatment alternative to women seeking uterine-sparing fibroid treatment to preserve fertility. The purpose of this article is to provide an updated review of pregnancy outcomes after laparoscopic and transcervical radiofrequency ablation of fibroids. Literature review using PubMed/Medline. N/A. Patients were identified from case reports and case series of pregnancies following trials of radiofrequency ablation (RFA) devices for symptomatic uterine fibroids. The pregnancies identified represented large trials of laparoscopic and transcervical ablation from North America, Asia, Europe, and Latin America. Laparoscopic and transcervical radiofrequency ablation of fibroids. 6 publications met criteria for inclusion, representing 11 clinical trials and 3 reports from real-world settings. 593 patients underwent RFA of fibroids, with 46 total pregnancies identified. The average age of patients was 39 years old and ranged from 27 to 46 years old. The majority of patients had between one and three fibroids ablated, and the size varied from less than 2 centimeters up to 12.5 centimeters. In terms of pregnancy outcomes, among the 46 total pregnancies, there were 4 spontaneous abortions, 7 elective terminations of pregnancy, and 35 term pregnancies with 17 vaginal and 18 cesarean deliveries. The patients who experienced spontaneous abortion were 36 to 38 years old. There was one complication after cesarean delivery presenting as postpartum hemorrhage with resultant expulsion of degenerated myoma with no long-term sequelae. There were no cases of uterine rupture, uterine window, placenta accreta, placental abruption, or fetal growth restriction. The majority of patients who had documented pregnancies after radiofrequency ablation of fibroids had full-term deliveries with no maternal or neonatal complications. Given the inherent obstetric risks with myomectomy (e.g., risk of uterine rupture, intrauterine scarring, possible need for cesarean delivery, etc.), these findings add to the growing consensus that radiofrequency fibroid ablation may offer a safe and effective minimally invasive treatment alternative to women seeking uterine-sparing fibroid treatment to preserve fertility.

Three-Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata

Objective: This article reports on 3-year clinical outcomes of the Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA) pivotal trial of transcervical fibroid ablation (TFA) in women with symptomatic uterine myomata.Materials and Methods: The SONATA, prospective, controlled, multicenter interventional trial enrolled 147 premenopausal women with symptomatic uterine fibroids who underwent uterus-preserving, sonography-guided TFA with the Sonata® System (Gynesonics, Inc., Redwood City, CA, USA). Clinical outcomes were assessed over 3 years and included surgical reinterventions, Symptom Severity Score (SSS), and Health-Related Quality of Life (HRQoL) subscales of the Uterine Fibroid Symptom and Quality-of-Life Questionnaire, EuroQol 5-Dimension (EQ-5D) questionnaire, Overall Treatment Effect, treatment satisfaction, physical activity, work impairment, pregnancy outcomes, and adverse events.Results: The 3-year rates of surgical reintervention for heavy menstrual bleeding calculated by the binomial and Kaplan–Meier methods were 9.2% and 8.2%, respectively. Compared to baseline, mean SSS decreased from 55 ± 19 to 22 ± 21, HRQoL increased from 40 ± 21 to 83 ± 23, and EQ-5D increased from 0.72 ± 0.21 to 0.88 ± 0.16 (all p < 0.001). Treatment benefit on the SSS, HRQoL, and EQ-5Q exceeded the minimal clinically important difference at every follow-up visit over 3 years. At 3 years, 94% of the subjects reported treatment satisfaction, 88% reported reduced fibroid symptoms, work absenteeism due to fibroid symptoms decreased from 2.9% to 1.4%, and impairment due to fibroids decreased from 51% to 12% for work, and 58% to 14% for physical activity (all p < 0.001). No late complications occurred.Conclusions: Women treated with sonography-guided TFA in the SONATA pivotal trial experienced significant and durable reduction of fibroid-related symptoms, with low surgical reintervention rates over 3 years of follow-up.

The Inspire Comparative Cost Study: One-Year Medical Resource Utilization, and Payer Cost Analysis Associated with Hysterectomy and Myomectomy Compared to Sonography-Guided Transcervical Ablation for the Treatment Of Uterine Fibroids

Study Objective The INSPIRE study compared health care resource utilization (HCRU) and payor costs associated with transcervical radiofrequency (RF) ablation, hysterectomy, and myomectomy. Design Data for transcervical RF ablation were derived from a prospective, multicenter, single-arm clinical trial (the SONATA trial); data for hysterectomy and myomectomy arms were derived from the Truven Health MarketScan Commercial Claims Database. Setting 6 clinical sites in the US. Patients or Participants Premenopausal women between the ages of 25 and 50 with heavy menstrual bleeding secondary to fibroids treated prospectively with transcervical RF ablation; matched hysterectomy and myomectomy procedures of interest for uterine fibroids were identified using appropriate diagnostic and procedural codes. Interventions Ultrasound-guided transcervical, intrauterine radiofrequency ablation using the Sonata system® performed on up to 10 fibroids per subject; hysterectomy and myomectomy (for the comparative payor data arms). Measurements and Main Results Mean total payor cost for treatment with the Sonata system and 12-month associated postoperative HCRU ($8,941) were significantly lower than that for hysterectomy ($24,156) or myomectomy ($22,784). Furthermore, the mean payor cost for the 12-month postoperative HCRU associated with Sonata ($143) was significantly lower than that associated with hysterectomy ($699) or myomectomy ($1,444). Finally, Sonata patients had significantly lower costs associated with complications, prescription medication, and radiology studies than either hysterectomy or myomectomy patients. Conclusion Transcervical RF ablation using the Sonata system is a lower-cost alternative to hysterectomy and myomectomy for the treatment of symptomatic uterine fibroids.

1630 12-Month Outcomes of the Us Patient Cohort in the Sonata Pivotal IDE Trial of Transcervical Ablation of Uterine Fibroids

Study Objective The SONATA trial was performed in the United States (US) and Mexico to examine the safety and effectiveness of transcervical radiofrequency ablation in the treatment of symptomatic uterine fibroids. This is an analysis of 12-month clinical outcomes in the US cohort. Design Prospective, longitudinal, multicenter, single-arm trial. Setting 21 clinical sites in the US. Patients or Participants Premenopausal women between the ages of 25 and 50 with heavy menstrual bleeding secondary to fibroids. Interventions Transcervical, intrauterine radiofrequency ablation was performed on ≤10 uterine fibroids from 1 to 5 cm in diameter with the Sonata® system. Twelve-month co-primary endpoints were reduction in menstrual bleeding and rate of surgical reintervention. Symptom severity, quality of life, satisfaction, safety, and fibroid volume reduction were also evaluated. Measurements and Main Results 125 patients were enrolled/treated in the US. Both IDE trial co-primary endpoints were achieved, as 65.3% of patients reported ≥50% reduction in menstrual bleeding and 99.2% of patients were free from surgical reintervention. Symptom improvement was noted by 97.4% of patients and 98.3% were satisfied. Ninety-five percent of patients reported reduced menstrual bleeding at 12 months, and 86.8% noted >20% reduction. Significant mean improvements at 12 months were realized in both symptom severity and health-related quality of life (33.8 points and 45.8 points, respectively). Mean maximal fibroid volume reduction per patient was 63.8%. There were no device related adverse events. Mean length of stay was 2.5 hours and 50% of patients returned to normal activity within 1 day. Conclusion This analysis of US patients in the SONATA pivotal IDE trial demonstrates results consistent with those in the full cohort. Treatment with the Sonata system significantly reduced fibroid symptoms with a low surgical reintervention rate through 12 months. These results support the efficacy and safety of Sonata as a first-line treatment for women affected by symptomatic uterine fibroids.

12-month outcomes of the US patient cohort in the SONATA pivotal IDE trial of transcervical ablation of uterine fibroids.

ObjectiveThe prospective SONATA pivotal Investigational Device Exemption (IDE) trial was performed in the United States (US) and Mexico to examine the safety and effectiveness of transcervical fibroid ablation (TFA) in the treatment of symptomatic uterine fibroids. This is an analysis of 12-month clinical outcomes in the US cohort.MethodsTFA with the Sonata® System was performed on women with symptomatic uterine fibroids. The 12-month co-primary endpoints were reduction in menstrual blood loss and freedom from surgical reintervention. Symptom severity, quality of life, patient satisfaction, safety, and reductions in uterine and fibroid volumes were also evaluated.ResultsOne hundred twenty-five patients were enrolled and treated in the US. Both co-primary endpoints were achieved in this US-based cohort, as 65.3% of patients reported ≥50% reduction in menstrual bleeding and 99.2% of patients were free from surgical reintervention. Symptom improvement was noted by 97.4% of patients and 98.3% were satisfied. Ninety-five percent of patients reported reduced menstrual bleeding at 12 months, and 86.8% noted >20% reduction. Significant mean improvements at 12 months were realized in both symptom severity and health-related quality of life (33.8 points and 45.8 points, respectively; all P<0.0001). Mean maximal fibroid volume reduction per patient was 63.8%. There was a 0% incidence of device related adverse events. Mean length of stay was 2.5 hrs and 50% of patients returned to normal activity within 1 day.ConclusionThis analysis of US patients in the SONATA pivotal IDE trial demonstrates results consistent with those in the full cohort. TFA with Sonata significantly reduced fibroid symptoms with a low surgical reintervention rate through 12 months. These results support the efficacy and safety of the Sonata system as a first-line treatment for women affected by symptomatic uterine fibroids.

Insights from outside BJOG

Insights from outside BJOG

486 - Early Clinical Outcomes of the Sonata® Pivotal IDE Trial: Sonography-Guided Transcervical Ablation of Uterine Fibroids

Study Objective: To establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.

Early Results of the SONATA Study: Sonography-Guided Transcervical Ablation of Uterine Fibroids

Early Results of the SONATA Study: Sonography-Guided Transcervical Ablation of Uterine Fibroids

The SONATA Study: Sonography-Guided Transcervical Ablation of Uterine Fibroids.

The SONATA Study: Sonography-Guided Transcervical Ablation of Uterine Fibroids.