Long-Term Clinical Outcomes of Transcervical Radiofrequency Ablation of Uterine Fibroids: The VITALITY Study

Abstract

Abstract Objective: The aim of this research was to learn the long-term (> 5 years) clinical outcomes of transcervical radiofrequency ablation of uterine fibroids. Materials and Methods: For this retrospective, single-arm, long-term data-collection study, 23 women with heavy menstrual bleeding secondary to fibroids were treated with transcervical radiofrequency ablation guided by integrated intrauterine sonography (using the Sonata® System, Gynesonics, Redwood City, CA). This study was within the 12-month Fibroid Ablation Study-EU clinical trial in Mexico. Symptoms were assessed using the Uterine Fibroid Symptom and Quality-of-Life s Symptom Severity Score (SSS) and Health-Related Quality of Life (HRQoL) subscales. Patients were queried regarding pregnancy and surgical reinterventions. Results: Seventeen women (73.9%) provided long-term follow-up information, with a mean of 64.4 months ±4.5 months (range: 57–73 months). From baseline, mean SSS decreased significantly from 64.9\u2009±\u200916.9 to 27.6\u2009±\u200936.1, and mean HRQoL improved significantly from 27.2\u2009±\u200922.4 to 76.0\u2009±\u200932.6 (p\u2009=\u20090.002, and p\u2009=\u20090.0001, respectively). There were no surgical reinterventions through the first 3.5 years post-treatment. There was an 11.8% incidence of surgical reinterventions over 5.4 years of average follow-up, with 2 hysterectomies occurring after 3.5 and 4 years postablation, respectively (event rate: 2.2% per year; 95% confidence interval; 0.3%, 7.9%). Freedom from surgical reintervention at 1, 2, and 3 years was 100%, and, at 4 and 5 years, was 88.2%\u2009±\u20097.8%. There was a single pregnancy occurring within the first year of treatment leading to a normal-term delivery by elective repeat cesarean section. Conclusions: Transcervical radiofrequency ablation with the Sonata System produced substantial durable clinical benefits beyond 5 years with a low reintervention rate.