Abstract No. 389 - Evaluation of the safety and short-term clinical outcomes in the treatment of uterine fibroids with MR-guided focused ultrasound

Abstract

Purpose This study was performed to evaluate the safety and clinical efficacy of treatment of symptomatic uterine fibroids using magnetic resonance-guided focused ultrasound therapy (MRgFUS). Materials and Methods The study was approved by our IRB and data was collected prospectively on a nonrandomized basis. Baseline, 1 week, and 1 month clinical history and physical exam were performed, and pre- and post-procedural MRI’s were reviewed. Symptom Severity Scores (SSS) and Uterine Fibroid Symptom and Health-Related Quality of Life Surveys (UFS-QOL) were obtained at baseline and 6 months. Inclusion criteria were pre-menopausal women over 18 years of age who were family complete with enhancing, device-accessible, symptomatic fibroids. Patients were excluded for excessive uterine fibroid size, pedunculation or significant calcification/heterogeneity of fibroids, overlying abdominal wall scar, or location inaccessible to the device. Treatment of 1-3 fibroids over 1-2 sessions was performed on the Insightec (Dallas, TX) ExAblate MRgFUS system per manufacturer instructions. Results 18 women (mean age 43; range 27-52) completed MRgFUS with 14/18 (77.8%) receiving 2 MRgFUS sessions. Mean baseline SSS and UFS-QOL scores were 29.3 (max = 40) and 123.6 (max = 175), respectively. The mean fibroid volume pretreatment was 244 ml (range 28-554 ml). The mean and range of %-nonperfused volume of fibroids post-MRgFUS was 57.8% and 12.4-98%, respectively. At both 1 week and 1 month, 14/18 (77.8%) patients demonstrated clinical improvement. Mean SSS and UFS-QOL scores at six months were 17.3 and 75.9, with 15/17 (88.2%) patients demonstrating improvement in both of these scores at 6 months with 1 patient lost to follow up, and the two unimproved patients pursuing further treatment (1 UAE and 1 hysterectomy). There were no major complications. Minor complications occurred in 2/18 (11.1%) patients, including irritable bowel syndrome flare, UTI, and superficial skin burn at a scar site. Conclusion Treatment of uterine fibroids using MRgFUS is safe and effective in the short-term, with no major complications observed. However, this study is limited by the small sample size.