全血管腔内主动脉弓置换术的可行性研究

摘要

[ Abstract]:Objective This study aimed to evaluate the safety and feasibility of total endovascular repair of the aortic arch u⁃sing a novel self-designed large vessel stent-graft system with branches in vitro and in a canine model. Methods Thenovel large ves⁃sel stent-graft system with branches is composed of the main stent-graft, branched stent-graft and the 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 re⁃corded and analyzed. Meanwhile, in vivo implantation of the large vessel stent-graft system with branches was carried out in 12 healthy adult crossbreed dogs. The feasibility of using these stent grafts was evaluated with aortography, multi-sliced CT and autopsy six months following the procedure. Results All stent-graft releasing and positioning were successful in the in vitro test. In the canine model, the large vessel stent-graft systemwith branches was placed successfully in the aortic arch in all fourteen dogs except for one death. All dogs survived for at least three months with normal biological behavior. Aortography, MSCT and animal necropsy revealed good fixation in all cases. The ascending aorta, the descending aorta, the brachiocephalic trunk and left subclavian artery were all covered without en⁃doleak. There was no significant obstruction or stenosis in the brachiocephalic branches at the 6 months follow-up. Conclusion Total endovascular repair of the aortic arch with the novel self-designed large vessel stent-graft system with branches is safe and feasible in pre-clinical studies. With increasing preclinical knowledge, first-in-human studies will be addressed.%目的自主研发了一种新型带分支大血管支架系统，用于全血管腔内修复主动脉弓，在体外及动物模型评价其安全性及可行性。方法新型带分支大血管支架系统由主支架，分支支架和输送系统组成。在体外主动脉弓模拟试验台对支架系统进行了测试，记录和分析了支架系统的定位、释放、锚定的过程及成功率。同时，在12只健康成年杂种犬进行带分支大血管支架系统植入。通过主动脉造影，多排CT和术后6个月解剖观察等检查手段评估该方法的安全性和可行性。结果所有支架系统的定位及释放均在体外实验中取得成功。在实验犬模型中，除1例死亡，带分支大血管支架系统在11只犬的主动脉弓中成功植入，实验犬正常存活至少3个月。主动脉造影，CT和动物尸检发现支架固定良好，升主动脉、降主动脉、头臂干、左锁骨下动脉均覆盖无内漏。在6个月的随访中，头臂分支没有明显的梗阻或狭窄。结论利用新型带分支大血管支架系统全血管腔内修复主动脉弓安全可行。随着临床前经验的不断积累，将有可能进行临床人体试验。