A feasibility study of total endovascular aortic arch replacement--from stent-graft design to pre-clinical testing.
A feasibility study of total endovascular aortic arch replacement--from stent-graft design to pre-clinical testing.
复制标题
全血管内主动脉弓置换术的可行性研究——从覆膜支架设计到临床前测试。
DOI：
10.1016/j.jtcvs.2015.10.092
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发表时间：
2016
期刊：
影响因子：
--
通讯作者：
Ren Jun
中科院分区：
文献类型：
--
作者：
Yang Jian;Liu Yang;Duan Weixun;Yi Dinghua;Yu Shiqiang;Ma Rui;Ren Jun
本研究旨在评估使用一种新设计的覆膜支架系统（Yanger覆膜支架系统;先健科技，深圳，中国）在体外和犬model.MethodsThe Yanger覆膜支架系统是由主覆膜支架，分支覆膜支架，和输送系统的安全性和可行性的主动脉弓全腔内修复术。在离体主动脉弓模拟试验台上对系统进行测试，记录并分析覆膜支架释放、锚定和定位的成功率。同时，在16只健康成年杂种犬体内植入Yanger覆膜支架系统。使用这些支架移植物的可行性进行了评估，与血管造影，多层计算机断层扫描，和尸检6个月后proceed.ResultsAll支架移植物的释放和定位是成功的体外测试。在犬模型中，除2只死亡外，所有14只犬均成功将Yanger覆膜支架系统置入主动脉弓。所有犬均存活至少3个月，生理体征正常。主动脉造影、多层计算机断层扫描和动物尸检显示所有病例均固定良好。升主动脉、降主动脉、头臂动脉干和左锁骨下动脉均被覆盖，无内漏。有没有显着的阻塞或狭窄，头臂支在6个月follow.ConclusionsTotal腔内修复主动脉弓与新设计的杨格尔覆膜支架系统是安全可行的临床前研究。随着对临床前知识的更好理解，患者选择标准和首次人体研究将得到解决。
ObjectiveThis study aimed to evaluate the safety and feasibility of total endovascular repair of the aortic arch using a novel designed stent-graft system (Yanger stent-graft system; Lifetech Scientific, Shenzhen, China) in vitro and in a canine model.MethodsThe Yanger stent-graft system is composed of a main stent-graft, branched stent-graft, and a delivery system. In an in vitro aortic arch simulation test bench, the system was tested, and the success rate of stent-graft releasing, anchoring, and positioning was recorded and analyzed. Meanwhile, in vivo implantation of the Yanger stent-graft system was carried out in 16 healthy adult crossbreed dogs. The feasibility of using these stent-grafts was evaluated with aortography, multislice computed tomography, and autopsy 6 months after the procedure.ResultsAll stent-graft releasing and positioning were successful for in vitro test. In the canine model, the Yanger stent-graft system was placed successfully in the aortic arch in all 14 dogs with the exception of 2 mortalities. All dogs survived for at least 3 months with normal physiologic signs. Aortography, multislice computed tomography, and animal necropsy revealed good fixation in all cases. The ascending aorta, descending aorta, brachiocephalic trunk, and left subclavian artery were all covered without endoleak. There was no significant obstruction or stenosis in brachiocephalic branches at the 6-month follow-up.ConclusionsTotal endovascular repair of aortic arch with the novel designed Yanger stent-graft system is safe and feasible in preclinical studies. With a better understanding of preclinical knowledge, patient selection criteria and first-in-human studies will be addressed.