Volumetric ablation of uterine fibroids using Sonalleve high-intensity focused ultrasound in a 3 Tesla scanner – first clinical assessment

Abstract Introduction: The purpose of this study was to evaluate the feasibility and safety of the Sonalleve high-intensity focused ultrasound (HIFU; Philips Healthcare, Vantaa, Finland) system in ablating uterine fibroids in a 3T magnet. Material and methods: Seven women were included in this study. Treatment was performed according to the manufacturer's recommendation. Technical data describing the HIFU procedures were collected. On MR images at baseline, immediately and 30 days after ablation, we evaluated the volumes of the uterus, the dominant fibroid and the ablation zone. The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire was used to assess potential clinical response. Results: The procedure was technically feasible in all patients. The median number of sonications performed during each procedure was 20 (range 2–27) per patient, the maximum temperature in all sonication cells was about 68°C. The median procedure time was 156 minutes (range 95–164). The non-perfused volume after treatment ranged from 1 to 27 ml and was unchanged or decreased in all but one patient at 30 days follow-up. There were no major adverse events. Discussion: In our 3T magnet the system was able to heat tissue and induce areas of non-enhancement within uterine fibroids without major complications. Clinical benefit remains to be proven.