A Systematic Review of the Treatment of Uterine Myomas Using Transcervical Ultrasound-Guided Radiofrequency Ablation with the Sonata System

Abstract

Objective: To evaluate the treatment success, possible side effects, and safety of radiofrequency ablation with the Sonata System.

Data sources: An electronic literature search in the PubMed and Medline databases was carried out from inception to August 2020.

Methods of study selection: The review was performed in accordance with the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Keywords such as "Sonata," "transcervical ablation," and "uterine myoma" were used to identify all relevant articles independently by both authors. Full-text articles in English that reported at least 1 of the following outcomes were included in the study: reduction in perfused/total myoma volume, effect of treatment on bleeding intensity and myoma-related symptoms, number of surgical reinterventions, adverse events, return to activities of daily life, effects on surrounding tissue, and safety during pregnancy.

Tabulation, integration, and results: 10 studies matching the inclusion criteria were identified and used for further analysis. A reduction in total and perfused myoma volume of 63.2% and 64.5% was achieved. One of the studies showed a 53.8 ± 50.5% (n = 48) reduction in Menstrual Pictogram Score, and another study showed a 51.1 ± 40.9% (n = 142) reduction in Pictorial Blood Loss Assessment Chart at 12 months. 87.2% (n = 190) of the patients reported a clinically meaningful reduction in menstrual blood loss after 12 months. While Symptom Severity Scores dropped by 28.8 ± 19.3, 23.3 ± 23.7, and 23.7 ± 19.4 points at 3, 6, and 12 months, respectively, Health-Related Quality of Life Scores increased to 77.5 ± 22.0, 82.8 ± 19.0, and 83.3 ± 20.5 points. One study had an 8% reintervention rate after 12 months, and another study showed a 0.7% and 5.2% rate after 12 and 24 months. After an average of 64 months after ablation, the reintervention rate was 11.8%. Time to return to activities of daily life was 2.9 ± 2.5 days. No related complications during pregnancy and delivery were reported.

Conclusion: Radiofrequency ablation with the Sonata System represents a minimally invasive, organ-preserving treatment option in patients with symptomatic uterine myomas, associated with clinically meaningful improvement of myoma-related symptoms.

Keywords: Myoma ablation; Radiofrequency ablation; Sonata; Transcervical; Uterine myomas.