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In Vitro Function and Durability Assessment of a Novel Polyurethane Heart Valve Prosthesis

机译:新型聚氨酯心脏瓣膜假体的体外功能和耐久性评估

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AbstractWhile flexible‐leaflet, central‐flow prosthetic heart valves promise relief from anticoagulation therapy, they continue to be restricted by inadequate durability. In consequence, a novel trileaflet valve, made entirely from polyurethane, has been developed. A batch of 6 consecutively manufactured polyurethane valves was subjected to hydrodynamic function and accelerated fatigue testing. Computerized data acquisition and control systems have been introduced to improve valve testing methodologies. In terms of hydrodynamic function, the polyurethane valve demonstrates transvalvular pressure gradients similar to those for a bioprosthetic valve (Carpentier‐Edwards) and levels of retrograde flow significantly less than those for either the bioprosthetic valve or a bileaflet mechanical valve (St Jude Medical). The equivalent of 10 years of cycling without failure has been exceeded by all 6 polyurethane valves in accelerated fatigue tests with 2 valves remaining intact after 674 million cycles (equivalent to approximately 17 years) in continuing tests. Highspeed photography revealed considerable differences in leaflet motion between valves cycled at accelerated and physiological
机译:摘要虽然柔性瓣膜、中心血流人工心脏瓣膜有望缓解抗凝治疗,但它们仍然受到耐久性不足的限制。因此,开发了一种完全由聚氨酯制成的新型三叶阀。对一批6个连续生产的聚氨酯阀门进行了流体动力学功能和加速疲劳试验。引入了计算机化的数据采集和控制系统,以改进阀门测试方法。在流体动力学功能方面,聚氨酯瓣膜表现出与生物瓣膜(Carpentier-Edwards)相似的跨瓣膜压力梯度,并且逆行流量水平明显低于生物瓣膜或双叶机械瓣膜(St Jude Medical)。在加速疲劳试验中,所有 6 个聚氨酯阀门都超过了 10 年无故障循环的量,在连续试验中,2 个阀门在 6.74 亿次循环(相当于大约 17 年)后仍然完好无损。高速摄影显示,加速和生理循环的瓣膜之间的瓣叶运动存在相当大的差异

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