European Multicenter Study for the Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms: The European Flow-Redirection Intraluminal Device Study
European Multicenter Study for the Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms: The European Flow-Redirection Intraluminal Device Study
复制标题
DOI：
10.3174/ajnr.a5592
复制
发表时间：
2018-05-01
影响因子：
3.5
通讯作者：
Moehlenbruch, M.
中科院分区：
文献类型：
--
作者：
Killer-Oberpfalzer, M.;Kocer, N.;Moehlenbruch, M.
背景和目的：血管分流支架腔内重建术是治疗复杂颅内动脉瘤的一种被广泛接受的技术。这项欧洲注册研究分析了15个神经血管中心使用血流重定向血管内装置(FRED)系统的初步经验。材料和方法：对2012年2月至2015年3月期间连续使用FRED治疗的颅内动脉瘤患者进行了回顾。评估并发症和不良事件、暂时性和永久性发病率、死亡率和闭塞率。结果：在确定的研究期间，531名患者(平均年龄54岁，范围13-86岁)的579个动脉瘤接受了FRED治疗。7%的患者在动脉瘤破裂的急性期(3天)接受治疗。动脉瘤平均直径7.6 mm(1~36.6 mm)，平均颈直径4.5 mm(1~30 mm)。516个动脉瘤(89.1%)的血管造影随访时间为3个月。随时间推移呈进行性闭塞，其中18个(20%)动脉瘤完全闭塞时间达90~14天，141个(82.5%)为180+/-20天，116个(91.3%)为1年+/-24天，122个(95.3%)为1年以上。暂时性和永久性发病率分别为3.2%和0.8%。总死亡率为1.5%。结论：这项针对真实患者的回顾性研究证明了FRED治疗颅内动脉瘤的安全性和有效性。在大多数情况下，单一的FRED治疗导致1年后血管造影完全闭塞。
BACKGROUND AND PURPOSE: Endoluminal reconstruction with flow-diverting stents represents a widely accepted technique for the treatment of complex intracranial aneurysms. This European registry study analyzed the initial experience of 15 neurovascular centers with the Flow-Redirection Intraluminal Device (FRED) system.MATERIALS AND METHODS: Consecutive patients with intracranial aneurysms treated with the FRED between February 2012 and March 2015 were retrospectively reviewed. Complications and adverse events, transient and permanent morbidity, mortality, and occlusion rates were evaluated. RESULTS: During the defined study period, 579 aneurysms in 531 patients (median age, 54 years; range, 13-86 years) were treated with the FRED. Seven percent of patients were treated in the acute phase (3 days) of aneurysm rupture. The median aneurysm size was 7.6 mm (range, 1-36.6 mm), and the median neck size 4.5 mm (range, 1-30 mm). Angiographic follow-up of >3 months was available for 516 (89.1%) aneurysms. There was progressive occlusion witnessed with time, with complete occlusion in 18 (20%) aneurysms followed for up to 90 14 days, 141 (82.5%) for 180 +/- 20 days, 116 (91.3%) for 1 year +/- 24 days, and 122 (95.3%) aneurysms followed for >1 year. Transient and permanent morbidity occurred in 3.2% and 0.8% of procedures, respectively. The overall mortality rate was 1.5%.CONCLUSIONS: This retrospective study in real-world patients demonstrated the safety and efficacy of the FRED for the treatment of intracranial aneurysms. In most cases, treatment with a single FRED resulted in complete angiographic occlusion at 1 year.