Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.
Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.
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DOI：
10.1136/neurintsurg-2017-013448
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发表时间：
2018-06
影响因子：
4.8
通讯作者：
Spelle L
中科院分区：
文献类型：
--
作者：
Pierot L;Moret J;Barreau X;Szikora I;Herbreteau D;Turjman F;Holtmannspötter M;Januel AC;Costalat V;Fiehler J;Klisch J;Gauvrit JY;Weber W;Desal H;Velasco S;Liebig T;Stockx L;Berkefeld J;Molyneux A;Byrne J;Spelle L
使用WEB中断血流是治疗宽颈分叉部动脉瘤的一种创新血管内方法。初步研究表明，并发症发生率低，疗效好。报告3项药物临床试验质量管理规范（GCP）研究累积人群中WEB治疗的临床和解剖学结果：WEBCAST（WEB囊内动脉瘤临床评估）、French Observatory和WEBCAST-2。WEBCAST、French Observatory和WEBCAST-2是致力于评价WEB治疗的单臂、前瞻性、多中心、GCP研究。独立评价临床数据。使用3级量表独立评价术后和1年动脉瘤闭塞：完全闭塞、瘤颈残留和动脉瘤残留。累积人群包括168例患者（169个动脉瘤），包括112例女性受试者（66.7%）。患者年龄27 ~ 77岁（平均55.5±10.2岁）。动脉瘤位置为大脑中动脉86/169（50.9%），前交通动脉36/169（21.3%），基底动脉30/169（17.8%），颈内动脉终末17/169（10.1%）。动脉瘤破裂14/169（8.3%）。1个月时无死亡，手术/器械相关发病率为1.2%（2/168）。1年时，在81/153个动脉瘤（52.9%）中观察到动脉瘤完全闭塞，在40/153个动脉瘤（26.1%）中观察到瘤颈残留，在32/153个动脉瘤（20.9%）中观察到动脉瘤残留。6.9%的患者进行了再治疗。该系列是目前最大的前瞻性，多中心，GCP系列的动脉瘤患者治疗WEB。表明该疗法安全性高，中期疗效好。法国天文台：唯一标识符（NCT 18069）; WEBCAST和WEBCAST-2：唯一标识符（NCT 01778322）。
Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy. To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2. WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%. This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment. French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).
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