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.
Keywords: Artery; Embolic; Embolization; Fibroid; Resorbable; Uterine.