Park Sang Min, Choi Kyung-Chan, Lee Byeong Han, Yoo Sang Yol, Kim Christopher Y
Division of Cardiology, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.
Department of Pathology, Cardiovascular Center, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea.
Korean Circ J. 2024 Aug;54(8):499-512. doi: 10.4070/kcj.2024.0049.
Arterial dissection during endovascular therapy rarely occurs but can be lethal. A fabric-based covered graft stents yield poor clinical outcomes. A novel balloon-expandable stent with biodegradable film graft for overcoming these issues was evaluated in a rabbit iliac artery model.
Eighteen rabbits with iliac artery dissections were induced by balloon over-inflation on angiography (Ellis type 2 or 3) and treated using the test device (3.0×24 mm). Subsequently, survived twelve animals underwent histologic examinations and micro-computed tomography (CT) at 0, 2, 4, and 8 weeks and 3, 6, 9, and 12 months and angiography at one-year.
There were no adverse cardiovascular events during the one-year. Early-stage histologic examination revealed complete sealing of disrupted vessels by the device, exhibiting mural hematoma, peri-stent red thrombi, and dense infiltration of inflammatory cells. Mid- and long-term histologic examination showed patent stents with neointimal hyperplasia over the stents (% area stenosis: 11.8 at 2 weeks, 26.1 at 1 month, 29.7 at 3 months, 49.2 at 9 months, and 51.0 at 1 year), along with mild peri-strut inflammatory response (Grade: 1-2 at mid-term and 0-1 at long-term). The graft film became scarcely visible after six months. Both CT and angiography revealed no instances of thrombotic occlusion or in-stent restenosis (% diameter stenosis: 5.7 at 2 weeks, 12.3 at 1 month, 14.2 at 3 months, 25.1 at 9 months, and 26.6 at 1 year).
The novel balloon-expandable stent with a biodegradable film graft demonstrates feasibility in managing severe artery dissection and preventing lethal vascular events in animal model.
血管内治疗期间动脉夹层很少发生，但可能致命。基于织物的覆膜支架临床效果不佳。在兔髂动脉模型中评估了一种用于克服这些问题的新型球囊扩张式可生物降解薄膜移植物支架。
通过血管造影术时球囊过度充盈诱导18只兔发生髂动脉夹层（埃利斯2型或3型），并使用测试装置（3.0×24 mm）进行治疗。随后，12只存活的动物在0、2、4和8周以及3、6、9和12个月时接受组织学检查和微型计算机断层扫描（CT），并在1年时进行血管造影。
1年期间无不良心血管事件发生。早期组织学检查显示该装置完全封闭了破裂的血管，表现为壁内血肿、支架周围红色血栓以及炎症细胞密集浸润。中长期组织学检查显示支架通畅，支架上有新生内膜增生（狭窄面积百分比：2周时为11.8，1个月时为26.1，3个月时为29.7，9个月时为49.2，1年时为51.0），同时伴有轻度的支架周围炎症反应（中期为1 - 2级，长期为0 - 1级）。6个月后移植物薄膜几乎不可见。CT和血管造影均未显示血栓形成闭塞或支架内再狭窄的情况（直径狭窄百分比：2周时为5.7，1个月时为12.3，3个月时为14.2，9个月时为25.1，1年时为26.6）。
新型球囊扩张式可生物降解薄膜移植物支架在动物模型中显示出治疗严重动脉夹层和预防致命性血管事件的可行性。
