Novel stent design for transcatheter mitral valve implantation
Novel stent design for transcatheter mitral valve implantation
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DOI：
10.1093/icvts/ivx289
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发表时间：
2018-02-01
影响因子：
--
通讯作者：
Lutter, Georg
中科院分区：
文献类型：
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作者：
Loger, Klaas;Pokorny, Saskia;Lutter, Georg
目的：在本研究中，介绍了两种新开发的用于经导管二尖瓣植入的带瓣支架的功能性体外研究结果。方法：开发了两种新颖的支架设计，即带有支柱固定系统的椭圆形和 D 形支架。使用拉伸测试装置在猪心脏中体外测试了新型支架的固定力。在进一步的实验中，支架配备了圆形瓣膜支架，并在搏动心脏瓣膜测试仪中研究了瓣膜性能。 结果：对于不同的支架模型，测量到了在24.2+/-0.9N至28.6+/-1.9N范围内的足够的平均支架固定力。新型瓣膜支架在体外搏动心脏瓣膜测试仪中表现出良好的性能。所有测试的二尖瓣支架均测量到足够的开口面积和低的开口压力。与已建立的参考瓣膜相比，D形支架和椭圆形带瓣支架表现出较低的收缩期跨瓣膜压力梯度，这表明闭合带瓣支架的瓣膜渗漏程度稍大。然而，二尖瓣镍钛诺瓣膜支架表现出足够的耐用性。结论：这项研究表明，所测试的经导管二尖瓣植入瓣膜支架原型具有足够的环形固定力。因此，这些二尖瓣支架展示了一种新型的二尖瓣支架设计。
OBJECTIVES: In this study, results of a functional in vitro study of 2 newly developed valved stents for transcatheter mitral valve implantation are presented.METHODS: Two novel stent designs, an oval-shaped and a D-shaped stent with a strut fixation system were developed. The fixation force of the novel stents were tested in vitro in porcine hearts with a tensile test set-up. In further experiments, the stents were equipped with a circular valved stent, and the valve performances were investigated in a pulsatile heart valve tester.RESULTS: Sufficient mean stent fixation forces in the range of 24.2 +/- 0.9 N to 28.6 +/- 1.9 N were measured for the different stent models. The novel valved stents showed good performance in an in vitro pulsatile heart valve tester. A sufficient opening area and low opening pressures were measured for all tested mitral valved stents. Compared with an established reference valve, the D-shaped stent and the oval-shaped valved stent showed a lower systolic transvalvular pressure gradient, which indicates slightly greater extent of valvular leakage of the closed valved stents. However, the mitral nitinol valved stents demonstrated adequate durability.CONCLUSIONS: This study indicates a sufficient annular fixation force of the tested transcatheter mitral valve implantation valved stent prototypes. Therefore, these mitral valved stents demonstrate a new type of mitral valved stent design.