Comparison of Two Generations of Self-Expandable Transcatheter Heart Valves in Nine Surgical Valves: An In Vitro Study

N. Sadat, M. Scharfschwerdt, Stephan Ensminger, B. Fujita
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Abstract

(1) Background: This study aimed to analyse the hydrodynamic performance of two generations of self-expanding transcatheter heart valves (THV) as a valve-in-valve (ViV) in different surgical aortic valve (SAV) models under standardised conditions. The nitinol-based Evolut R valve is frequently used in ViV procedures. It is unclear whether its successor, the Evolut PRO, is superior in ViV procedures, particularly considering the previously implanted SAV model. (2) Methods: EvolutTM R 26 mm and EvolutTM PRO 26 mm prostheses were implanted in nine 21 mm labelled size SAV models (Hancock® II, Mosaic® UltraTM, EpicTM Supra, TrifectaTM GT, Perimount®, Perimount® Magna Ease, AvalusTM, IntuityTM, Freestyle®) to analyse their hydrodynamic performance under defined circulatory conditions in a pulse duplicator. (3) Results: Both THVs presented with the lowest effective orifice area (EOA) and highest mean pressure gradient (MPG) inside Hancock® II, whereas THVs in Intuity showed the highest EOA and lowest MPG. Evolut R and Evolut PRO showed significant hydrodynamic differences depending on the SAV. Both THVs performed similarly in porcine valves. Although the Evolut R performed better than Evolut PRO in stented bovine SAVs, the Evolut PRO was superior inside the Intuity. Further, the SAV model design markedly influenced the TAV’s geometric orifice area and pin-wheeling index. (4) Conclusions: These findings show that the Evolut R and Evolut PRO perform differently depending on the previously implanted SAV model. THV selection for treatment of a specific SAV model should consider these results.
两代可自行扩张的经导管心脏瓣膜与九个手术瓣膜的比较:体外研究
(1) 背景:本研究旨在分析两代自扩张经导管心脏瓣膜(THV)作为瓣中瓣(ViV)在不同手术主动脉瓣(SAV)模型中的标准化条件下的流体力学性能。以镍钛诺为基础的 Evolut R 瓣膜经常用于 ViV 手术。目前还不清楚其后继产品 Evolut PRO 在 ViV 手术中是否更具优势,特别是考虑到之前植入的 SAV 模型。(2)方法:将 EvolutTM R 26 mm 和 EvolutTM PRO 26 mm 假体植入九个 21 mm 标签尺寸的 SAV 模型(Hancock® II、Mosaic® UltraTM、EpicTM Supra、TrifectaTM GT、Perimount®、Perimount® Magna Ease、AvalusTM、IntuityTM、Freestyle®),在脉冲复制器中分析它们在确定循环条件下的流体动力学性能。(3) 结果:在 Hancock® II 中,两种 THV 的有效孔面积(EOA)最小,平均压力梯度(MPG)最大,而 Intuity 中的 THV 的有效孔面积(EOA)最大,平均压力梯度(MPG)最小。Evolut R 和 Evolut PRO 根据 SAV 的不同显示出显著的流体动力学差异。两种 THV 在猪瓣膜中的表现相似。虽然 Evolut R 在有支架的牛瓣膜中的表现优于 Evolut PRO,但 Evolut PRO 在 Intuity 中的表现更好。此外,SAV模型设计对TAV的几何孔口面积和针轮指数有明显影响。(4) 结论:这些研究结果表明,Evolut R 和 Evolut PRO 的性能因先前植入的 SAV 型号而异。在选择治疗特定 SAV 型号的 THV 时应考虑这些结果。
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