Magnetic resonance-guided high-intensity focused ultrasound for uterine fibroids: Mid-term outcomes of 36 patients treated with the Sonalleve system

Abstract

Objectives: This study sought to assess the mid-term efficacy of magnetic resonance-guided high-intensity focused ultrasound (MRgFUS) (Sonalleve system) for uterine fibroids.Methods: We retrospectively included patients treated by MRgFUS controlled by real-time MR-thermometry. Clinical efficacy was defined as the minimum reduction of ten points in the Transformed Symptom Severity Score (tSSS) without additional treatment. Fibroid volumes were assessed at 6 months, and patients were contacted to assess mid-term efficacy using tSSS.Results: Thirty-six patients were included; 22 patients (61.1%) exhibited clinical efficacy with a mean follow-up duration of 21.4 (95%CI: 16.3–26.5) months. In addition, the tSSS mean decreased significantly from 42.8 ± 16 to 25.4 ± 18 (p < 0.0001). MRgFUS exhibited a preferential effect on menorrhagia (p = 0.001) and symptoms related to pelvic heaviness and swelling (p = 0.004). The volume reduction was 27% (p < 0.001) and was correlated with the non-perfused volume (NPV) after treatment (r = 0.373; p = 0.028). Cumulative re-intervention rates (surgery or uterine artery embolisation) at 12 months, 18 months and 24 months were 2.8%, 8.5% and 21.6%, respectively. No serious adverse events were reported. Two pregnancies occurred during the follow-up period.Conclusions: Treatment of uterine fibroids by MRgFUS is efficient and results in low morbidity and satisfactory clinical efficacy with a mean follow-up of 21.4 months.