Mid-term clinical efficacy of a volumetric magnetic resonance-guided high-intensity focused ultrasound technique for treatment of symptomatic uterine fibroids.

OBJECTIVE: To assess the mid-term efficacy of magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) using a volumetric ablation technique for treating uterine fibroids.
METHODS: Forty-six premenopausal women with 58 symptomatic uterine fibroids were prospectively included for MR-HIFU. After treatment, CE-MRI allowed measurement of the non-perfused volume (NPV) ratio, defined as the non-enhancing part of the fibroid divided by fibroid volume. Clinical symptoms and fibroid size on T2W-MRI were quantified at 3 and 6 months' follow-up. The primary endpoint was a clinically relevant improvement in the transformed Symptom Severity Score (tSSS) of the Uterine Fibroid Symptom and Quality of Life questionnaire, defined as a 10-point reduction.
RESULTS: Volumetric ablation resulted in a mean NPV ratio of 0.40 ± 0.22, with a mean NPV of 141 ± 135 cm(3). Mean fibroid volume was 353 ± 269 cm(3) at baseline, which decreased to 271 ± 225 cm(3) at 6 months (P < 0.001), corresponding to a mean volume reduction of 29 % ± 20 %. Clinical follow-up showed that 54 % (25/46) of the patients reported a more than 10-point reduction in the tSSS. Mean tSSS improved from 50.9 ± 18.4 at baseline to 34.7 ± 20.2 after 6 months (P < 0.001).
CONCLUSION: Volumetric MR-HIFU is effective for patients with symptomatic uterine fibroids. At 6 months, significant symptom improvement was observed in 54 % of patients. KEY POINTS: • Volumetric MR-guided high-intensity focused ultrasound is a novel ablation technique for leiomyomatosis. • We prospectively evaluated the outcome of volumetric MR-HIFU ablation for symptomatic fibroids. • This study showed that volumetric MR-HIFU results in an effective treatment. • A randomised controlled trial would set this technique in an appropriate context.

RCT Entities:   Population Interventions Outcomes