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

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 pr...

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Bibliographic Details
Published in:Cardiovascular and interventional radiology 2020-06, Vol.43 (6), p.897-903
Main Authors: Hacking, Nigel, Maclean, Drew, Vigneswaran, Ganesh, Bryant, Timothy, Modi, Sachin
Format: Article
Language:English
Subjects:
Cardiology
Clinical Investigation
Current distribution
Embolisation (arterial)
Embolization
Fibroids
Imaging
Infarction
Magnetic resonance imaging
Medicine
Medicine & Public Health
Nuclear Medicine
Quality of life
Radiology
Rank tests
Statistical analysis
Ultrasound
Uterus
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Summary: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  
ISSN:0174-1551
1432-086X
DOI:10.1007/s00270-020-02460-2