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.
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%.
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.
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.
• 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.
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Common Terminology Criteria for Adverse Events
Direct skin cooling
Medical Research Ethics Committee Board
Magnetic resonance image-guided high-intensity-focused ultrasound
Magnetic resonance imaging
Uterine artery embolization
University Medical Centre Utrecht
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No grant or financial support was used for this research project. No author had any financial interest in the subject matter discussed in the submitted manuscript. All the authors state that this study complies with the Declaration of Helsinki.
The scientific guarantor of this publication is M.F. Boomsma, M.D., Ph.D.
Conflict of interest
The authors declare that they have no conflict of interest.
Statistics and biometry
One of the authors has significant statistical expertise: I.M. Nijholt, Ph.D. No complex statistical methods were necessary for this paper.
Written informed consent was obtained from all subjects (patients) in this study.
Institutional Review Board approval was obtained.
Study subjects or cohorts overlap
The short- and mid-term results of some study subjects have been previously reported in the following:
• Ikink ME, Nijenhuis RJ, Verkooijen HM et al (2014) Volumetric MR-guided high-intensity focused ultrasound versus uterine artery embolisation for treatment of symptomatic uterine fibroids: comparison of symptom improvement and reintervention rates. Eur Radiol 24:2649–2657. https://doi.org/10.1007/s00330-014-3295-6
• Ikink ME, Voogt MJ, Verkooijen HM et al (2013) Mid-term clinical efficacy of a volumetric magnetic resonance-guided high-intensity focused ultrasound technique for treatment of symptomatic uterine fibroids. Eur Radiol 23:3054–61. https://doi.org/10.1007/s00330-013-2915-x
• Voogt MJ, Trillaud H, Kim YS et al (2012) Volumetric feedback ablation of uterine fibroids using magnetic resonance-guided high intensity focused ultrasound therapy. Eur Radiol 22:411–417. https://doi.org/10.1007/s00330-011-2262-8
• Ikink ME, van Breugel JMM, Schubert G et al (2015) Volumetric MR-guided high-intensity focused ultrasound with direct skin cooling for the treatment of symptomatic uterine fibroids: proof-of-concept study. BioMed Research International 2015:1–10. https://doi.org/10.1155/2015/684250
• Case–control study
• Performed at one institution
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Verpalen, I.M., de Boer, J.P., Linstra, M. et al. The Focused Ultrasound Myoma Outcome Study (FUMOS); a retrospective cohort study on long-term outcomes of MR-HIFU therapy. Eur Radiol 30, 2473–2482 (2020). https://doi.org/10.1007/s00330-019-06641-7
- Uterine fibroids
- MR-guided interventional procedures
- High-intensity-focused ultrasound ablation