The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China.

Rui Chen,Minna Seppälä,Yueling Wang,Qinping Liao,Juan Wei,Xuedong Yang,Antti Viitala,Jian Yang,Bilgin Keserci,Wenpei Bai,Hui Bi,Xiaoying Wang,Xiaobing Han

doi:10.1186/s40349-016-0072-9

Abstract

BackgroundUterine fibroids are the most common benign tumor in women, and surgical intervention is still the main fibroid treatment. Patient demands have encouraged development of less-invasive methods such as high-intensity focused ultrasound (HIFU). This study aimed to evaluate the safety and effectiveness of magnetic resonance-guided high-intensity focused ultrasound therapy using a volumetric ablation technique in the treatment of symptomatic uterine fibroids in China.MethodsOne hundred and seven patients were enrolled and treated with magnetic resonance-guided high-intensity focused ultrasound in this study. Clinical efficacy was based on the proportion of patients with fibroid shrinkage (10 % volume reduction or more compared to baseline) at 6 months post treatment as measured with magnetic resonance imaging. The quality of life and symptom outcome was assessed using the uterine fibroid symptom and quality of life questionnaire with symptom severity scoring. Safety was primarily assessed by evaluating the reported adverse events.ResultsNinety nine of the 107 treated patients had fibroid shrinkage at 6 months post treatment. Resulting in an overall 93 % (95 % confidence interval 86–97 %) treatment success rate, p value <0.001; the symptom severity scoring and health-related quality of life at 6 months was statistically different from the screening symptom severity scoring at 0.05 level. Of 366 adverse events reported, there were no study procedure-related or device-related serious adverse events were in the study.ConclusionsThis study demonstrated that the volumetric magnetic resonance-guided high-intensity focused ultrasound device is safe and technically effective and can be utilized in clinically efficient treatments of symptomatic uterine fibroids.Trial registration NCT01588899

Highlights

Uterine fibroids are the most common benign tumor in women, and surgical intervention is still the main fibroid treatment
It has been estimated that 600,000 hysterectomies are performed per year in the USA and more than half of the conducted hysterectomies are due to fibroids [11, 12]
Written informed consent was obtained from each patient at the screening visit prior to the initiation of any study-related procedures

Summary

Introduction

Uterine fibroids are the most common benign tumor in women, and surgical intervention is still the main fibroid treatment. Patient demands have encouraged development of less-invasive methods such as high-intensity focused ultrasound (HIFU). This study aimed to evaluate the safety and effectiveness of magnetic resonance-guided high-intensity focused ultrasound therapy using a volumetric ablation technique in the treatment of symptomatic uterine fibroids in China. Uterine fibroids are the most common benign tumor in pre- and peri-menopausal women. Even though surgical interventions of uterine fibroids have been the most common treatment option, it requires anesthesia, hospital stays, and long recovery periods. Patient demands have encouraged development of lessinvasive methods such as UAE, ultrasound-guided highintensity focused ultrasound (US-HIFU) and magnetic resonance-guided high-intensity focused ultrasound (MRHIFU)

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