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.
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.
Authors: K J Anneveldt; I M Verpalen; I M Nijholt; J R Dijkstra; R D van den Hoed; M Van't Veer-Ten Kate; E de Boer; J A C van Osch; E Heijman; H R Naber; E Ista; A Franx; S Veersema; J A F Huirne; J M Schutte; M F Boomsma Journal: Insights Imaging Date: 2021-12-18