Portable ultrasound-guided high-intensity focused ultrasound with functions for safe and rapid ablation: prospective clinical trial for uterine fibroids-short-term and long-term results.

Abstract

To investigate the efficacy and safety of a new portable ultrasound-guided high-intensity focused ultrasound system (USgHIFU) with advanced targeting and beam steering technology for the treatment of uterine fibroids. Fifty-nine uterine fibroids from 36 participants (mean age, 44.9 ± 4.1 years) were included from November 2013 to November 2015. All participants were treated with HIFU, with 3D electronic steering. MR imaging studies were performed before HIFU, immediately after HIFU, and 1 month and 3 (or 5) months after the HIFU treatment. The non-perfused volume ratio (NPVR), fibroid volume shrinkage (FVS), symptom improvement, quantified life quality assessment, and safety were analyzed. A long-term follow-up was conducted in July to December 2017 (mean, 32.2 months). The volume of the treated uterine fibroids ranged from 7.5 to 274.4 cm³ (mean, 69.8 cm³; SD, 64.3 cm³). The mean NPVR on the immediate post-HIFU MR imaging was 74.8 ± 25.2%. The mean FVS was 17.3% at 1 month, 33.3% at 3 months, and 45.1% at 5 months after HIFU treatment. The mean treatment time was 44.6 ± 28.2 min per fibroid and 72.9 ± 31.4 min per participant. Uterine fibroid-related symptoms and quality of life showed statistically significant improvement after the HIFU treatment. No significant symptoms related to safety or complications occurred. In the long-term follow-up, 78.8% of those surveyed were satisfied with their HIFU treatment. This clinical trial showed that a portable USgHIFU with advanced functions may safely and effectively treat uterine fibroids. • A portable compact ultrasound-guided high-intensity focused ultrasound (HIFU) can effectively and safely treat uterine fibroids. • Advanced functions, such as portability, targeted forecasting, electronic beam steering, and interleaved scanning, might be helpful in enhancing the clinical applicability of ultrasound-guided high-intensity focused ultrasound. • In the long-term follow-up of more than 2 years, approximately 80% of those surveyed were satisfied with their HIFU treatment.