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Uterine Fibroid Embolization (UFE) with Optisphere: A Prospective Study of a New, Spherical, Resorbable Embolic Agent

  • Clinical Investigation
  • EMBOLISATION (ARTERIAL)
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Introduction

Optisphere (Teleflex, Wayne, PA, USA, currently distributed by Medtronic, Minneapolis, MN, USA) is a new, resorbable, calibrated spherical embolic agent. We aimed to evaluate its clinical safety and effectiveness for fibroid embolization through a prospective case series.

Method

This prospective case series studied patients treated with fibroid embolization using Optisphere between July 2017 and June 2018. The primary outcomes were device-related adverse event assessments and MRI-determined percentage infarct of the dominant fibroid (DF %) and infarct of all fibroids (AF %) at 3 months post-embolization. Secondary outcomes included symptom improvement with the validated Uterine Fibroid Symptom Score and Quality of Life questionnaire (UFS-SS and UFS-QOL) at 3 months and 12 months post-embolization. Statistical analysis was through the Wilcoxon signed-rank test for nonparametric paired data.

Results

Twenty-three consecutive patients were treated with Optisphere (median age 44.0, uterine volume 484.0 ml, dominant fibroid volume 167.0 ml). The complete dominant fibroid infarction (DF %) rate was 91.3% (21/23 patients), and the complete all fibroid infarction rate (AF %) was 82.6% (19/23). No adverse device-related safety events were encountered. Significant improvement was demonstrated in 3-month UFS-SS (56 vs 19, p < 0.0001), UFS-QOL (40 vs 88, p = 0.0008), uterine volume (484 ml vs 246 ml, p < 0.0001) and dominant fibroid volume (167 vs 64 ml, p < 0.0001). Symptomatic improvement continued to 12 months (UFS-SS 56 vs 11, p = 0.0008, UFS-QOL 40 vs 98.7, p = 0.0008).

Conclusion

Optisphere is an effective embolic agent for fibroid embolization with good symptomatic response and percentage fibroid infarct.

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Funding

This study was fully funded by a grant from Teleflex (Wayne, Pennsylvania, USA) who produce Optisphere. Representatives from the company were involved in reviewing and critiquing the study design, report and publication draft. They also conducted a quality audit of the study data collection.

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Authors and Affiliations

  1. Department of Interventional Radiology, University Hospital Southampton, Tremona Road, Southampton, SO16 6YD, UK

    Nigel Hacking, Drew Maclean, Ganesh Vigneswaran, Timothy Bryant & Sachin Modi

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  1. Nigel Hacking
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  2. Drew Maclean
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  4. Timothy Bryant
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Corresponding author

Correspondence to Drew Maclean.

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Conflict of interest

Nigel Hacking has received honoraria from Boston Scientific and Celonova as a speaker and has been on Advisory boards for BTG. Tim Bryant has proctored for Boston Scientific and Terumo and has received speaker honorariums from Boston Scientific. Sachin Modi has received a speaker honorarium from Boston Scientific. The other authors declare no conflict of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. This study was approved by the institutional review board (IRB), regional ethics committee and national regulatory body.

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Informed consent was obtained from all individual participants included in the study.

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Consent for publication was obtained for every individual person’s data included in the study.

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Hacking, N., Maclean, D., Vigneswaran, G. et al. Uterine Fibroid Embolization (UFE) with Optisphere: A Prospective Study of a New, Spherical, Resorbable Embolic Agent. Cardiovasc Intervent Radiol 43, 897–903 (2020). https://doi.org/10.1007/s00270-020-02460-2

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  • DOI: https://doi.org/10.1007/s00270-020-02460-2

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