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What predicts durable symptom relief of uterine fibroids treated with MRI-guided focused ultrasound? A multicenter trial in 8 academic centers

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A Commentary to this article was published on 22 September 2023

Abstract

Objective

To identify variables predictive of durable clinical success after MRI-guided focused ultrasound (MRgFUS) treatment of uterine fibroids.

Materials and methods

In this prospective, multicenter trial, 99 women with symptomatic uterine fibroids were treated using MRgFUS. Pelvic MRI was obtained at baseline and treatment day. The Uterine Fibroid Symptom-Quality of Life questionnaire was used to calculate a symptom severity score (SSS) at baseline and 6, 12, 24, and 36 months following treatment. Clinical, imaging, and treatment variables were correlated with symptom reduction sustained through the 12- and 24-month time points using univariable and multivariable logistic regression analyses. A novel parameter, the ratio of non-perfused volume to total fibroid load (NPV/TFL), was developed to determine association with durable outcomes.

Results

Post-treatment, mean symptom severity decreased at the 6-, 12-, 24-, and 36-month follow-ups (p < 0.001, all time points). In univariable analysis, three variables predicted treatment success (defined by ≥ 30-point improvement in SSS) sustained at both the 12-month and 24-month time points: increasing ratio of NPV/TFL (p = 0.002), decreasing total fibroid load (p = 0.04), and the absence of T2-weighted Funaki type 2 fibroids (p = 0.02). In multivariable analysis, the NPV/TFL was the sole predictor of durable clinical success (p = 0.01). Patients with ratios below 30% had less improvement in SSS and lacked durable clinical response compared with those between 30–79 (p = 0.03) and ≥ 80% (p = 0.01).

Conclusion

Increased non-perfused volume relative to total fibroid volume was significantly associated with durable reduction of symptoms of abnormal uterine bleeding and bulk bother.

Clinical relevance statement

Patient selection for sustained clinical benefit should emphasize those with likelihood of achieving high ablation ratios, as determined by imaging (e.g., device access, Funaki type) and by considering the total fibroid load, not just the primary symptomatic fibroid.

Trial registration

Clinical trial ID: NCT01285960.

Key Points

• Patient selection/treatment approach associated with durable symptom relief in MRI-guided focused ultrasound ablation of uterine fibroids remains unclear.

• The ablation ratio, non-perfused volume/total fibroid volume, was positively associated with sustained symptom relief in both bleeding and bulk bother at 1- and 2-year follow-ups.

• Selecting patients with imaging features that favor a high ratio of ablation to total fibroid load (including non-targeted fibroids) is the main factor in predicting durability of symptom relief after uterine fibroid treatment.

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Abbreviations

CI:

Confidence interval

MRgFUS:

Magnetic resonance–guided focused ultrasound

NPV/TFL:

Non-perfused volume to total fibroid load ratio

NPVR:

Non-perfused volume ratio

OR:

Odds ratio

PRF:

Proton resonance frequency

SD:

Standard deviation

UFE:

Uterine fibroid embolization

UFS-QOL SSS:

Uterine Fibroid Quality of Life Symptom Severity Score

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Acknowledgements

The authors would like to thank Jarrett Rosenburg, Ph.D., for guidance and meaningful discussion regarding study analysis.

Initial outcome measure was designed for safety and short-term, not long-term, efficacy.

Funding

The clinical trial was funded by Insightec Inc.

The research for this manuscript was not funded by the original trial sponsor.

Author information

Authors and Affiliations

  1. Department of Radiology, Stanford University, 1024 Welch Road, MC 5488, Stanford, CA, 94305, USA

    Rachel R. Bitton, Angela Fast, Kim-Nhien Vu & Pejman Ghanouni

  2. Department of Obstetrics and Gynecology, Stanford University, Stanford, CA, USA

    Deirdre A. Lum & Bertha Chen

  3. Department of Radiology, Mayo Clinic, Rochester, MN, USA

    Gina K. Hesley

  4. Interventional Radiology, University of California Los Angeles, Los Angeles, CA, USA

    Steven S. Raman

  5. Interventional Radiology, University of Virginia, Charlottesville, VA, USA

    Alan H. Matsumoto

  6. Department of Obstetrics and Gynecology, Duke University, Durham, NC, USA

    Thomas M. Price

  7. Department of Radiology, Brigham and Women’s Hospital, Boston, MA, USA

    Clare Tempany & Fiona M. Fennessey

  8. Insightec, Inc., Dallas, TX, USA

    Neha Dhawan

  9. Ohio Health, Columbus, OH, USA

    Eric Dolen

  10. Vascular and Interventional Radiology, University of California San Francisco, San Francisco, CA, USA

    Maureen Kohi

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  1. Rachel R. Bitton
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Corresponding author

Correspondence to Rachel R. Bitton.

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Guarantor

The scientific guarantor of this publication is Rachelle Bitton.

Conflict of interest

The authors of this manuscript declare relationships with the following companies:

The author, Neha Dhawan, is employed by Insightec, Inc., Dallas, TX.

Statistics and biometry

Jarrett Rosenberg, Ph.D., kindly provided statistical advice for this manuscript.

Rachelle Bitton, Ph.D., of the authors, has significant statistical expertise.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

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Institutional Review Board approval was obtained.

Study subjects or cohorts overlap

There is no study subject overlap.

Methodology

• Retrospective study of prospective cohort

• Multicenter trial

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Bitton, R.R., Fast, A., Vu, KN. et al. What predicts durable symptom relief of uterine fibroids treated with MRI-guided focused ultrasound? A multicenter trial in 8 academic centers. Eur Radiol 33, 7360–7370 (2023). https://doi.org/10.1007/s00330-023-09984-4

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