MR-guided High-intensity Focused Ultrasound Treatment for Symptomatic Uterine Leiomyomata. Long-term Outcomes

Rationale and Objectives: To evaluate the long-term clinical outcomes of magnetic resonance-guided high-intensity focused ultrasound (MR-g HIFU) treatments for symptomatic uterine leiomyomata. Materials and Methods: Patients were recruited for a prospective study for MR-g HIFU treatments of symptomatic leiomyomata, with up to 3-year follow-up. The study was approved by the institutional review board and was Health Insurance Portability and Accountability Act-compliant. Clinical assessments were obtained at 3 months, 6 months, and 1, 2, and 3 years after MR-g HIFU, as well as uterine fibroid symptom severity scores (SSS) and health-related quality of life questionnaires (UFS-QOL). MR imaging was performed at each follow-up to assess the efficacy of the treatment at 6 months, 1 year, 2 years, and 3 years. Results: Fifty-one leiomyomata in 40 patients were treated. All patients were treated within the US Food and Drug Administration guidelines with leiomyomata localized on MR and treated with sonication. The mean baseline volume of treated leiomyomata was 336.9 cm ³. The mean improvement scores for transformed SSS was 47.8 (P < .001) and for tUFS-QOL was 39.8 (P < .001) at 3 years. The mean volume decrease in treated leiomyomata was 32.0% (P < .001), and, in the uterus, the volume decrease was 27.7% (P < .001) at 3 years. There were no long-term complications. Conclusions: Long-term follow-up data from MR-g HIFU treatments show sustained symptomatic relief among enrolled patients. Although the results are preliminary, MR-g HIFU for the treatment of uterine leiomyomata may result in acceptable long-term outcomes at 3 years.