A new endoluminal, flow-disrupting device for treatment of saccular aneurysms

A new endoluminal, flow-disrupting device for treatment of saccular aneurysms
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DOI:
10.1161/strokeaha.106.479576
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发表时间:
2007-08-01
期刊:
影响因子:
8.3
通讯作者:
Cloft, Harry J.
Cloft, Harry J.
中科院分区:
医学1区
文献类型:
--
作者:
Kallmes, David F.;Ding, Yong Hong;Cloft, Harry J.

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背景和目的-我们报告了一项关于用于动脉瘤闭塞的新型腔内器械的临床前研究,以检验该器械即使不使用囊内弹簧圈放置也可以闭塞囊状动脉瘤而不会造成实质性载瘤动脉受损或邻近小分支动脉受损的假设。(Pipeline NED; Chestnut Medical Technologies,Inc)是一种编织管状腔内植入物,旨在通过沿着动脉瘤颈的血流中断闭塞囊状动脉瘤。在新西兰白色家兔模型中,将该器械植入17个弹性蛋白酶诱导动脉瘤的瘤颈,并随访1个月(n=6)、3个月(n=5)和6个月(n=6)。在每例受试者中,在腹主动脉中植入第二件器械,以覆盖腰动脉的起源。记录血管造影的动脉瘤闭塞率(1级,完全闭塞; 2级,接近完全闭塞; 3级,不完全闭塞)。计算载瘤动脉的狭窄面积百分比。载瘤动脉和分支动脉狭窄或闭塞的下游血管远端栓塞的存在notice.Results -1级,2级和3级闭塞率分别为9(53%),6(35%)和2(12%)的17个动脉瘤,分别表示88%的率完全或接近完全闭塞。未观察到载瘤动脉下游血管(特别是锁骨下动脉)中的分支动脉闭塞或远端栓子。新生内膜增生对载瘤动脉的损害在大多数cases.Conclusions中是最小的-Pipeline NED是一种可跟踪的生物和血液相容性器械,能够闭塞囊状动脉瘤,保留载瘤动脉和相邻的小分支血管。
Background and Purpose - We report a preclinical study of a new endoluminal device for aneurysm occlusion to test the hypothesis that the device, even without use of intrasaccular coil placement, could occlude saccular aneurysms without causing substantial parent artery compromise or compromise of adjacent, small branch arteries.Methods - The Pipeline Neuroendovascular Device (Pipeline NED; Chestnut Medical Technologies, Inc) is a braided, tubular, bimetallic endoluminal implant aimed at occlusion of saccular aneurysms through flow disruption along the aneurysm neck. The device was implanted across the necks of 17 elastase-induced aneurysms in the New Zealand white rabbit model and followed for 1 month (n=6), 3 months (n=5), and 6 months(n=6). In each subject, a second device was implanted in the abdominal aorta to cover the origins of lumbar arteries. Aneurysm occlusion rates by angiography (grade 1, complete occlusion; grade 2, near- complete occlusion; and grade 3, incomplete occlusion) were documented. Percent area stenosis of the parent arteries was calculated. Presence of distal emboli in the downstream vessels in the parent artery and branch artery stenosis or occlusion was noted.Results - Grades 1, 2, and 3 occlusion rates were noted in 9 (53%), 6 (35%), and 2 (12%) of 17 aneurysms, respectively, indicating an 88% rate of complete or near complete occlusion. No cases of branch artery occlusion or distal emboli in the downstream vessels of the parent artery, specifically the subclavian artery, were seen. Parent artery compromise from neointimal hyperplasia was minimal in most cases.Conclusions - The Pipeline NED is a trackable, bio- and hemocompatible device able to occlude saccular aneurysms with preservation of the parent artery and small, adjacent branch vessels.