Evaluation of a novel endoluminal vascular occlusion device in a porcine model: Early and late follow-up
Evaluation of a novel endoluminal vascular occlusion device in a porcine model: Early and late follow-up
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DOI：
10.1583/05-1543.1
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发表时间：
2005-08-01
影响因子：
2.6
通讯作者：
Leon, MB
中科院分区：
文献类型：
--
作者：
Kipshidze, N;Sadzaglishvili, K;Leon, MB
目的：评价一种新的血管闭塞装置（VOID）在临床前对照研究中与栓塞coiling.Methods的有效性：Biomerix VOID由生物耐久性多孔聚氨酯基质制成，其形状为长1.5 cm宽6.0 mm的圆柱体。选择33只猪，使用单个VOID（27只动物）或足够的Cook纤维不锈钢弹簧圈栓塞直径为3 - 5 mm的髂动脉，以实现血管造影闭塞（6只对照）。试验动物被分配在1周（n=11）、1个月（n=6）、3个月（n=6）或6个月（n=4）时接受血管造影术。在1周、1个月和3个月时，将两只对照动物分配至血管造影随访。在每个时间点对试验和对照动物实施安乐死，以取出闭塞血管进行组织学分析。研究终点为装置利用率、闭塞时间、展开后移位和7、30、90和180天时的持续血管造影闭塞。结果：在每只试验动物中展开一个VOID，而在6只对照动物中平均需要3.3 +/- 0.8个线圈才能实现血管造影闭塞（p < 0.001）。VOID组的闭塞时间显著缩短（1.46 +/- 0.73 vs 5.83 +/- 1.60分钟; P < 0.001）。在VOID展开部位没有再通或充盈缺损的证据，而在6个弹簧圈治疗的对照中的3个中观察到充盈缺损。VOID组在1周、1个月和3个月血管造影随访时间点的血管造影闭塞上级弹簧圈组。组织学评价显示，在1周（n=6）和1个月（n=6）终点（100%管腔闭塞）时，VOID与栓塞弹簧圈等同。在3个月组（n=6）中，VOID显示95%-100%管腔闭塞，而对照组动物为90%-95%。在6个月组中，VOID显示85%至95%的闭塞率。结论：与纤维不锈钢栓塞弹簧圈相比，Biomerix VOID表现出高度有效和可靠，导致明显更快和更持久的闭塞。
Purpose: To evaluate the efficacy of a new vascular occlusion device (VOID) in a preclinical controlled study versus embolization coils.Methods: The Biomerix VOID was made from a biodurable porous polyurethane matrix in the shape of a cylinder measuring 1.5 cm long by 6.0 mm wide. Thirty-three swine were selected to undergo embolization of a 3 to 5-mm-diameter iliac artery using either a single VOID (27 animals) or sufficient Cook fibered stainless steel coils to achieve angiographic occlusion (6 controls). Test animals were assigned to undergo angiography at 1 week (n=11), 1 month (n=6), 3 months (n=6), or 6 months (n=4). Two control animals were assigned to angiographic follow-up at 1 week, 1 month, and 3 months. Test and control animals were euthanized at each time point to explant occluded vessels for histological analysis. Study endpoints were device utilization, time to occlusion, postdeployment migration, and persistent angiographic occlusion at 7, 30, 90, and 180 days.Results: One VOID was deployed in each test animal, whereas a mean 3.3 +/- 0.8 coils were needed to achieve angiographic occlusion in the 6 controls (p < 0.001). The time to occlusion was significantly shorter with the VOID (1.46 +/- 0.73 versus 5.83 +/- 1.60 minutes for the coils; P < 0.001). There was no evidence of recanalization or filling defects at the site of VOID deployment, while filling defects were seen in 3 of 6 coil-treated controls. The VOID arm showed superior angiographic occlusion versus coils at the 1-week, 1-month, and 3-month angiographic follow-up time points. Histological evaluation showed that the VOID was equivalent to the embolization coils at the 1-week (n=6) and 1-month (n=6) endpoint (100% luminal occlusion). In the 3-month group (n=6), the VOID showed 95% to 100% luminal occlusion versus 90% to 95% in the control animals. In the 6-month group, VOID showed 85% to 95% occlusion.Conclusions: The Biomerix VOID appears highly effective and reliable, resulting in significantly faster and longer lasting occlusion compared with fibered stainless steel embolization coils.