Department of Interventional Radiology, University Hospital Southampton, Tremona Road, Southampton, SO16 6YD, UK.
Cardiovasc Intervent Radiol. 2020 Jun;43(6):897-903. doi: 10.1007/s00270-020-02460-2. Epub 2020 Mar 31.
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.
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.
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).
Optisphere is an effective embolic agent for fibroid embolization with good symptomatic response and percentage fibroid infarct.
Optisphere（Teleflex，美国韦恩，目前由美国明尼苏达州明尼阿波利斯的美敦力分销）是一种新型可吸收的校准球形栓塞剂。我们旨在通过前瞻性病例系列评估其在纤维瘤栓塞中的临床安全性和有效性。
本前瞻性病例系列研究了 2017 年 7 月至 2018 年 6 月期间使用 Optisphere 进行纤维瘤栓塞治疗的患者。主要结果是栓塞后 3 个月时与器械相关的不良事件评估和 MRI 确定的主要纤维瘤（DF%）和所有纤维瘤（AF%）梗死百分比。次要结果包括通过验证的子宫纤维瘤症状评分和生活质量问卷（UFS-SS 和 UFS-QOL）在栓塞后 3 个月和 12 个月时的症状改善。统计分析采用非参数配对数据的 Wilcoxon 符号秩检验。
23 例连续患者接受 Optisphere 治疗（中位年龄 44.0 岁，子宫体积 484.0ml，主要纤维瘤体积 167.0ml）。完全主要纤维瘤梗死（DF%）率为 91.3%（21/23 例患者），完全所有纤维瘤梗死率（AF%）为 82.6%（19/23 例患者）。未发生与器械相关的不良安全事件。3 个月时 UFS-SS（56 分比 19 分，p<0.0001）、UFS-QOL（40 分比 88 分，p=0.0008）、子宫体积（484ml 比 246ml，p<0.0001）和主要纤维瘤体积（167ml 比 64ml，p<0.0001）均有显著改善。症状改善持续到 12 个月（UFS-SS 56 分比 11 分，p=0.0008，UFS-QOL 40 分比 98.7 分，p=0.0008）。
Optisphere 是一种有效的纤维瘤栓塞剂，具有良好的症状反应和纤维瘤梗死百分比。
