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Magnetic resonance-high intensity focused ultrasound (MR-HIFU) therapy of symptomatic uterine fibroids with unrestrictive treatment protocols: A systematic review and meta-analysis

Published:October 15, 2019DOI:https://doi.org/10.1016/j.ejrad.2019.108700

      Highlights

      • The elimination of studies using restrictive treatment protocols enhanced outcomes.
      • Symptom improvement in this review was greater compared to other MR-HIFU reviews.
      • The re-intervention rate after MR-HIFU at 24-months follow-up is comparable to UAE.
      • Future trials should follow-up on patients until menopause or beyond 33.6 months.

      Abstract

      Purpose

      Reevaluation of the effectiveness of Magnetic Resonance-High Intensity Focused Ultrasound (MR-HIFU) therapy for uterine fibroids by excluding studies with restrictive treatment protocols that are no longer used.

      Methods

      The National Guideline Clearinghouse, Cochrane Library, TRIP, MEDLINE, EMBASE and WHO International Clinical Trials Registry Platform (ICTRP) databases were searched from inception until the 22nd of June 2018. Keywords included “MR-HIFU”, “MRgFUS”, and “Leiomyoma”. Only studies about MR-HIFU treatment of uterine fibroids with at least three months of clinical follow-up were evaluated for inclusion. Treatments with ultrasound-guided HIFU devices or protocols not aiming for complete ablation were eliminated. The primary outcome was the improvement in fibroid-related symptoms. Technical outcomes included screening and treatment failures, treatment time, application of bowel-interference mitigation strategies and the Non-Perfused Volume (NPV) percentage. Other secondary outcomes were the quality of life, fibroid shrinkage, safety, re-interventions, reproductive outcomes, and costs. Meta-analysis was performed using a random-effects model (DerSimonian and Laird).

      Results

      A total of 18 articles (1323 treated patients) met the inclusion criteria. All selected studies were case series except for one cross-over trial. Overall, the quality of the evidence was poor to moderate. The mean NPV% directly post-treatment was 68.1%. The use of bowel-interference mitigation strategies may lead to increased NPV%. The mean symptom reduction at 12-months was 59.9% and fibroid shrinkage was 37.7%. The number of adverse events was low (8.7%), stratification showed a difference between HIFU systems. The re-intervention percentage at 3–33.6 months follow-up ranged from 0 to 21%. Longer follow-up was associated with a higher risk at re-interventions. Reproductive outcomes and costs couldn’t be analyzed.

      Conclusions

      Treatment guidelines aiming for complete ablation enhanced the effectiveness of MR-HIFU therapy. However, controlled trials should define the role of MR-HIFU in the management of uterine fibroids.

      Abbreviations:

      MR-HIFU (magnetic resonance imaging-guided high intensity focused ultrasound), MRgFUS (magnetic resonance guided focused ultrasound surgery), NPVN (on-perfused volume), UFS-QoL (uterine fibroid symptom and quality of life), tSSS (transformed symptom severity score), UAE (uterine artery embolization)

      Keywords

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