The Focused Ultrasound Myoma Outcome Study (FUMOS); a retrospective cohort study on long-term outcomes of MR-HIFU therapy.

Abstract

OBJECTIVES:

Since 2004, uterine fibroids have been treated with MR-HIFU, but there are persevering doubts on long-term efficacy to date. In the Focused Ultrasound Myoma Outcome Study (FUMOS), we evaluated long-term outcomes after MR-HIFU therapy, primarily to assess the reintervention rate.

METHODS:

Data was retrospectively collected from 123 patients treated with MR-HIFU at our hospital from 2010 to 2017. Follow-up duration and baseline (MRI) characteristics were retrieved from medical records. Treatment failures, adverse events, and the nonperfused volume percentage (NPV%) were determined. Patients received a questionnaire about reinterventions, recovery time, satisfaction, and pregnancy outcomes. Restrictive treatment protocols were compared with unrestrictive (aiming for complete ablation) treatments. Subgroups were analyzed based on the achieved NPV < 50 or ≥ 50%.

RESULTS:

Treatment failures occurred in 12.1% and the number of adverse events was 13.7%. Implementation of an unrestrictive treatment protocol significantly (p = 0.006) increased the mean NPV% from 37.4% [24.3-53.0] to 57.4% [33.5-76.5]. At 63.5 ± 29.0 months follow-up, the overall reintervention rate was 33.3% (n = 87). All reinterventions were performed within 34 months follow-up, but within 21 months in the unrestrictive group. The reintervention rate significantly (p = 0.002) decreased from 48.8% in the restrictive group (n = 43; follow-up 87.5 ± 7.3 months) to 18.2% in the unrestrictive group (n = 44; follow-up 40.0 ± 22.1 months). The median recovery time was 2.0 [1.0-7.0] days. Treatment satisfaction rate was 72.4% and 4/11 women completed family planning after MR-HIFU.

CONCLUSIONS:

The unrestrictive treatment protocol significantly increased the NPV%. Unrestrictive MR-HIFU treatments led to acceptable reintervention rates comparable to other reimbursed uterine-sparing treatments, and no reinterventions were reported beyond 21 months follow-up.

KEY POINTS:

• All reinterventions were performed within 34 months follow-up, but in the unrestrictive treatment protocol group, no reinterventions were reported beyond 21 months follow-up. • The NPV% was negatively associated with the risk of reintervention; thus, operators should aim for complete ablation during MR-guided HIFU therapy of uterine fibroids. • Unrestrictive treatments have led to acceptable reintervention rates after MR-guided HIFU therapy compared to other reimbursed uterine-sparing treatments.

• Authors: Inez M Verpalen, Jolien P de Boer, Marlot Linstra, Roelien L I Pol, Ingrid M Nijholt, Chrit T W Moonen, Lambertus W Bartels, Arie Franx, Martijn F Boomsma, Manon N G Braat
• Journal: European radiology (Eur Radiol) Vol. 30 Issue 5 Pg. 2473-2482 (May 2020) ISSN: 1432-1084 [Electronic] Germany
• PMID: 32040725 (Publication Type: Journal Article)

Topics

• Adult
• Clinical Protocols
• Female
• Follow-Up Studies
• High-Intensity Focused Ultrasound Ablation (methods)
• Humans
• Leiomyoma (surgery)
• Magnetic Resonance Imaging, Interventional (methods)
• Male
• Middle Aged
• Myoma (diagnosis, therapy)
• Retrospective Studies
• Surveys and Questionnaires
• Time Factors
• Treatment Outcome
• Uterine Neoplasms (diagnosis, surgery, therapy)