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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。
OBJECTIVE: To evaluate the in vitro delivery and release performance of three kinds of interventional valves by a new vascular model. Based on this, the risk of introduction of delivery and release process was analyzed preliminarily. Methods: Artificial heart valve pulsatile flow testers were used in combination with silicone arterial and aortic valve models to simulate the surgical procedure of transcatheter transvascular delivery and release into the body to observe whether the valved valve could be successfully delivered and released. Results: There was no significant difference in delivery and release between all the tested interventional valves and the delivery system, which could lead to successful completion of the delivery and delivery process. CONCLUSIONS: Although some new risks may be introduced during the procedure of transvascular intervention, the results of in vitro tests show that under the corresponding risk analysis, risk control and risk management, the delivery and release performance of the interventional valve at home and abroad is better and there is no release of delivery Failure of the situation.