北京生物医学工程

经导管瓣膜瓣中瓣模式下流体力学性能体外测试及评价

Hydrodynamic performance testing and evaluation of the transcatheter heart valve in valve-in-valve model

作者：刘丽万辰杰柯林楠王春仁

单位：中国食品药品检定研究院（北京 102629） <p>通信作者：王春仁。E-mail:chunrenwang@263.net</p> <p> </p>

关键词：经导管瓣中瓣；经导管瓣膜；生物瓣膜；稳态前向流实验；稳态反向泄漏实验；脉动流实验

分类号：R318.01

出版年·卷·期（页码）：2021·40·4（393-399）

摘要：

目的随着生物瓣膜毁损病例的增加，越来越多的经导管瓣膜作为瓣中瓣被应用于二次瓣膜置换手术，但其流体力学性能鲜有报道。本文将经导管瓣膜安装在生物瓣膜内形成瓣中瓣结构，并对其流体力学性能进行体外测试及评价。方法将经导管瓣膜（23 mm、27 mm、29 mm）分别安装在对应规格生物瓣膜（23 mm、27 mm、29 mm）中形成瓣中瓣，进行稳态前向流实验、稳态反向泄漏实验、脉动流实验，对其流体力学性能进行评价，并与同规格生物瓣膜流体力学性能进行对比。结果稳态前向流实验中，同一规格的经导管瓣中瓣跨瓣压差随着前向流量的增大而增大。稳态反向泄漏实验中，同一规格的经导管瓣中瓣泄露量随着反向压力的增大而增大。脉动流实验中，经导管瓣中瓣和生物瓣膜的平均跨瓣压差、返流百分比和有效瓣口面积变化趋势相同的。对于同一规格的经导管瓣中瓣和生物瓣膜，随着心输出量的增加，跨瓣压差增大，返流百分比减小，有效瓣口面积增大；在同一心输出量下，随着经导管瓣中瓣和生物瓣膜规格的增大，跨瓣压差减小，返流百分比增大，有效瓣口面积增大。结论经导管瓣中瓣体外脉动流性能指标满足YY/T1449.3-2016标准中经导管瓣膜的性能要求，且其脉动流性能与同规格生物瓣膜相比无明显差异。该经导管瓣中瓣具有良好的血流动力学性能。

Objective With the increase of bioprosthetic valve damage cases, Valve in valve - transcatheter heart valves(ViV-THV) are used in secondary valve replacement. But there are few reports on its hydrodynamic performance . In this paper, the transcatheter heart valves is installed in the bioprostheticl valve to form a valve- in-valve model, and its hydrodynamic performance is tested and evaluated in vitro. Methods Transcatheter heart valves (23mm, 27mm and 29mm) were respectively installed in bioprosthetic valves(23mm, 27mm and 29mm) as ViV-THV. The steady forward-flow testing，the steady back-flow leakage testing and pulsatile-flow testing were carried out to evaluate the hydrodynamic properties of the ViV-THV, and the hydrodynamic properties were compared with bioprosthetic valves. Results In the steady forward-flow testing, the pressure gradients of ViV-THV increased with the increase of the forward flow rate. In the steady back-flow leakage testing, the leakage volume of the ViV-THV increased with the increase of the reverse pressure. In the pulsatile-flow testing, the mean pressure gradients, the paravalvular leakage and the effective orifice area had the same trend with the bioprosthetic valves. With the increase of cardiac output, the mean pressure gradients increased, the paravalvular leakage decreased and the effective orifice increased for the same size of ViV-THV and bioprosthetic valve. Under the same cardiac output, the mean pressure gradients decreased, the paravalvular leakage increased and the effective orifice area increased with the increase of the size of the ViV-THV and bioprosthetic valve. Conclusions Hydrodynamic performance of the ViV-THV were in line with the YY /T 1449.3-2016 standards, and there were no significant difference with the same size bioprosthetic valve. The transcatheter heart valve prostheses performed well in the described valve-in-valve settings.

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