A feasibility study of total endovascular aortic arch replacement

Xu Chen-nian; Liu Yang; Duan Wei-xun; Jin Zhen-xiao; Chen Tao; Chen Wen-sheng; Yang Xiu-ling; Li Hong-ling; Zhao Hong-liang; Yang Jian; Yu Shi-qiang

doi:10.13498/j.cnki.chin.j.ecc.2016.04.13

Abstract：[ 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.