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

AbstractObjectives: 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 (NP...