介入瓣膜输送释放性能体外评价的初步研究.docx

介入瓣膜输送释放性能体外评价的初步研究*汤京龙1 ，王硕1 ，刘丽1 ，王迎1 ，尚汝瑶1 ，王健1 ，李守彦2 ，潘轶2 ，王春仁1 ，黄清泉1＊＊( 1． 中国食品药品检定研究院，北京 100050; 2． 苏州心伴测试科技有限公司，苏州 215123)摘要 目的: 采用一种新的血管模型对 3 种介入瓣输送释放性能进行体外评价，在此基础上就输送释放过程引入的风险进行初步分析。方法: 将人工心脏瓣膜脉动流测试仪和硅胶动脉血管及主动脉瓣模型联合使用 ，模拟介入瓣经血管输送并 释放到体内的手术过程 ，观察被测瓣膜能否成功完成输送 和释放。结果: 所有被测介入瓣及输送系统在输送释放性能 上没有明显差异，均可顺利完成整个输送释放过程 。结论: 虽然经血管介入的手术过程会引入一些新的风险 ，但 体外试 验结果显示，在相应的风险分析、风险控制和风险管理下 ，国 内外介入瓣的输送释放性能较好 ，没有出现输送释放失效 的情况。关键词: 微创介入; 生物瓣膜; 介入瓣; 主动脉瓣; 血管模型; 输送释放性能; 体外评价中图分类号: Ｒ917文献标识码: A文章编号: 0254 － 1793( 2014) 09 － 1680 － 04Preliminary study of heart valve prostheses implanted by transcathetertechnique: in vitro evaluation on delivery and deployment properties*TANG Jing － long1 ，WANG Shuo1 ，LIU Li1 ，WANG Ying1 ，SHANG Ｒu － yao1 ，WANG Jian1 ，LI Shou － yan2 ，PAN Yi2 ，WANG Chun － ren1 ，HUANG Qing － quan1 ＊＊( 1． National Institutes for Food and Drug Control，Beijing 100050，China; 2． Suzhou Xinban Testing Technology Co． ，Ltd． ，Suzhou 215123，China)Abstract Objective: To conduct the in vitro evaluation on the delivery and deployment properties of three heartvalve prostheses implanted by transcatheter technique( HVPTT) in a new mock silicone artery vessel and aortic valve model and analyze the risks induced by the delivery process． Methods: The pulsatile cardiac function simulator was used in combination with the mock silicone artery vessel and aortic valve model to simulate the operation processthat the HVPTT was delivered and deployed in vivo via femoral arteries． The tested valve was observed for the ac-complishment of delivery and deployment． Ｒesults: All of tested HVPTT could be delivered and deployed into the aortic valve position of the mock silicone artery vessel and aortic valve model with no obvious differences in the de- livery and deployment properties． Conclusion: Although new risks would be involved during transcatheter valve im-plantation，the in vitro results showed a satisfactory quality in delivery and deployment properties of the foreign anddomestic valves an