A feasibility analysis of the ArcBlate MR-guided high-intensity focused ultrasound system for the ablation of uterine fibroids

Chin-Jung Wang,Gigin Lin,Yu-Ying Su,Cindy Hsuan Weng,Kai-Yun Wu,Kit-Sum Mak,Yi-Ting Huang,Yu-Shan Lin

doi:10.1007/s00261-021-03203-8

Abstract

PurposeUterine fibroids are benign gynecologic tumors and commonly occur in women by the age of 50. Women with symptomatic uterine fibroids generally receive surgical intervention, while they do not favor the invasive therapies. To evaluate the feasibility and safety of a novel magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) modality, ArcBlate, in the treatment of uterine fibroids.MethodsNine patients with uterine fibroids and one patient with adenomyosis were treated with ArcBlate MRgHIFU. Tumor size and quality of life were evaluated postoperatively at 1 and 3 months by magnetic resonance imaging (MRI) and the 36-Item Short Form Survey (SF-36), respectively.ResultsAll patients completed the ArcBlate MRgHIFU procedure and there were no treatment-related adverse effects either during the procedure or during the 3 months of follow-up. Despite limiting the ablation volume to under 50% of the treated fibroid volume as a safety precaution, tumor volumes were markedly reduced in four patients by 15.78–58.87% at 3-month post-treatment. Moreover, SF-36 scale scores had improved at 3 months from baseline by 2–8 points in six patients, indicating relief of symptoms and improved quality of life.ConclusionThis study evidence demonstrates the safety and feasibility of ArcBlate MRgHIFU and suggests its potential for treating uterine fibroids.

Highlights

Uterine fibroids are benign gynecologic tumors found in the uterus [1, 2] and are the most common of all solid pelvic tumors, affecting 70% of women by age 50 years [3]
Noninvasive high-intensity focused ultrasound (HIFU) ablation has emerged as an alternative option to surgery for uterine fibroids, offering minimal invasiveness without an incision that can be performed as a uterine-conserving outpatient treatment in most types of uterine fibroids [11,12,13,14]
The first prototype of the ArcBlate focused ultrasound ablation system was developed by the Department of Biomedical Engineering in the National Health Research Institute (NHRI), which initially tested the prototype in 7 mini pigs between 2009 and 2011, conducted a pilot study involving 6 patients with uterine fibroids in BLINDED INFORMATION in 2015 (NCT02283502)

Summary

Introduction

Uterine fibroids are benign gynecologic tumors found in the uterus [1, 2] and are the most common of all solid pelvic tumors, affecting 70% of women by age 50 years [3]. Symptomatic uterine fibroids generally require surgical intervention, such as hysterectomy and myomectomy [10]. These invasive treatments are not popular choices among women, who often delay treatment by 5 years on average, and prefer uterine-conserving procedures [9]. Noninvasive high-intensity focused ultrasound (HIFU) ablation has emerged as an alternative option to surgery for uterine fibroids, offering minimal invasiveness without an incision that can be performed as a uterine-conserving outpatient treatment in most types of uterine fibroids [11,12,13,14]. Compared to the uterine artery embolization, another minimalinvasive treatment option, HIFU is preferred if clinicians and patients have concerns for low vascularity fibroids, high risk for anesthesia/sedation, radiation exposure, impaired

Methods

Results

Conclusion