目的 通过体外测试和动物实验，采用经导管逆行主动脉瓣植入的方法，评价一种新型主动脉瓣膜支架的可行性和安全性。方法 采用猪的心包制作一种新型主动脉瓣膜支架。所有支架在体外均进行流体力学、扩张和释放实验。将这些支架采用逆行经导管的方法植入6头猪体内。这些猪在植入12 h后进行分析。结果 离体实验显示这种新型主动脉瓣膜支架的瓣叶的闭合是有效的，支架可以通过导管释放，然后完全开展并迅速固定。左右冠状动脉血流量在瓣膜支架植入后没有显著的变化。在体内试验中，逆行经导管植入主动脉瓣膜支架于6头猪体内。然后，有一头猪在植入10 h候因为支架没有完全打开导致死亡。在其余5头猪中，瓣膜支架打开良好，无主动脉瓣逆流，也没有血栓形成。结论 该新型主动脉瓣膜支架稳定性好，可以避免瓣叶对冠状动脉的影响。
Objective To evaluated feasibility and safety of a new type of aortic valved stent in transcatheter aortic valve implantation (TAVI) using retrograde approach by testing and animal implantation in vitro.Methods Firstly,a new type of aortic valve stent sutured with porcine pericardium valves was made.The fluid passing test,expanding and releasing tests,static and releasing tests in tube were peformed in vitro for all stents.Then,the stents were implanted in six pigs using retrograde approach.These pigs were euthanized 12 h after implantation for anatomic evaluation.Results In vitro the tests showed that closure of new type of aortic valved stent leaflets were effective,and stents could be released through catheter,then expanded completely and could fix fast in tube.Left and right coronary artery flow rates did not change significantly when the stents were released above valve leaflets (P=0.7426,P=0.1487) after implantation.In vivo experiments indicated that TAVI was successfully performed in six pigs using retrograde approach.However,one pig died 10h after implantation because stents were not expanded completely.The leaflets in stents opened well and no valvular regurgitation was observed in the rest five pigs.And no thrombosis was found.Conclusion The new type of aortic valved stent designed in this study was characterised with good stability and could avoid the impact caused by valve leaflets on the coronary artery.
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