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.

中文翻译：

---

Optisphere子宫肌瘤栓塞术（UFE）：新型球形可吸收栓塞剂的前瞻性研究。

简介Optisphere（美国宾夕法尼亚州韦恩市的Teleflex公司，目前由美国明尼苏达州明尼阿波利斯市的Medtronic公司销售）是一种新型的，可吸收的，校准过的球形栓塞剂。我们旨在通过一个预期病例系列评估其对肌瘤栓塞的临床安全性和有效性。方法该前瞻性病例系列研究了2017年7月至2018年6月期间使用Optisphere进行肌瘤栓塞治疗的患者。主要结局是与设备相关的不良事件评估以及MRI确定的占优势的肌瘤梗死率（DF％）和所有肌瘤的梗死率（栓塞后3个月时的AF％）。次要结果包括在栓塞后3个月和12个月使用经验证的子宫肌瘤症状评分和生活质量问卷（UFS-SS和UFS-QOL）改善症状。通过Wilcoxon符号秩检验对非参数配对数据进行统计分析。结果连续23例患者接受Optisphere治疗（中位年龄44.0，子宫体积484.0 ml，优势肌瘤体积167.0 ml）。完全性占优势的肌瘤梗死率（DF％）为91.3％（21/23例），完全性所有肌瘤梗塞率（AF％）为82.6％（19/23）。没有遇到与设备相关的不利安全事件。在3个月的UFS-SS（56 vs 19，p <0.0001），UFS-QOL（40 vs 88，p = 0.0008），子宫容量（484 ml vs 246 ml，p <0.0001）和显性肌瘤中显示出显着改善体积（167 vs 64 ml，p <0.0001）。症状改善持续了12个月（UFS-SS 56 vs 11，p = 0.0008，UFS-QOL 40 vs 98.7，p = 0.0008）。