Comparison of Clinical Performance Between Two Generations of Magnetic Resonance-guided Focused Ultrasound Systems in Treatments of Uterine Leiomyomas

Abstract

Objectives: The aim of this study was to evaluate the impact of technology improvements on the outcomes of magnetic resonance-guided focused ultrasound (MRgFUS) treatments of symptomatic uterine leiomyomas (uterine fibroids). The study compared ablation volumes and incidence of adverse events in patient groups treated with two generations of MRgFUS systems from a single vendor.

Methods: The present study describes the results of a retrospective comparative study of two groups of women with symptomatic uterine leiomyomas who were clinically treated with MRgFUS at a single institution. Group 1 (n = 130) was treated using the first-generation system between March 2005 and December 2009. Group 2 (n = 71) was treated using the second-generation between December 2013 and September 2019.

Results: The second-generation MRgFUS system resulted in significantly improved nonperfused volume ratios in both dark and bright T2 fibroid categories compared with the first-generation system (dark - 80% versus46 %, p = 0.00002 and bright - 46% versus 32%, p = 0.001). There have been no recorded hospital admissions, no skins burns, and no reported major adverse events since the introduction of this second-generation ExAblate 2100 system with advanced safety and treatment planning features.

Conclusion: This study has demonstrated that improvements to current MRgFUS technology resulted in significantly increased efficacy and patient safety of clinical treatments of patients with symptomatic uterine leiomyomas.

Keywords: Uterine fibroids; magnetic resonance-guided focused ultrasound; nonperfused volume.