Transcervical Fibroid Ablation (TFA) with the Sonata System: Updated Review of a New Paradigm for Myoma Treatment

Abstract

Abstract Purpose of Review This paper provides an update of the recent evidence related to transcervical fibroid ablation (TFA) with the Sonata® System. Recent Findings An additional 27 papers representing over 400 women and more than 800 treated fibroids have been published. These demonstrate consistent, positive results, representing multiple prospective clinical trials, subgroup analyses, health economic analyses, case series, and systematic reviews of TFA. These include a 147-patient prospective clinical trial of TFA (the SONATA Clinical Trial) that demonstrated sustained symptom relief and an 8.2% cumulative reintervention rate through 3 years, a long-term study (VITALITY) confirming durable symptom relief with an 11.8% reintervention rate over > 5 years of mean follow-up, a clinical trial (OPEN) suggesting minimal potential for intrauterine adhesiogenesis post-TFA, preliminary results of a global registry (SAGE), and two subgroup analyses of TFA reporting favorable and safe outcomes in women with large fibroids > 5 cm in diameter. Three comparative health economic studies demonstrate favorable economic outcomes against both myomectomy and hysterectomy. A recent ACOG Practice Bulletin also noted equivalent outcomes for transcervical, laparoscopic, and transvaginal fibroid ablation. Summary Accumulated clinical evidence, including systematic reviews and longitudinal prospective clinical trials, continues to confirm the safety and efficacy of TFA in women with symptomatic fibroids, including myomata > 5 cm. As a transcervical treatment modality that can safely address all nonpedunculated uterine fibroid types, the continued evidence base confirms TFA as an innovative and useful treatment option that meets a significant unmet clinical need, including among underserved populations, delivering significant durable reductions in fibroid symptoms.