Novel In Vitro Test Systems and Insights for Transcatheter Mitral Valve Design, Part I: Paravalvular Leakage.
Novel In Vitro Test Systems and Insights for Transcatheter Mitral Valve Design, Part I: Paravalvular Leakage.
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DOI：
10.1007/s10439-018-02154-4
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发表时间：
2019-03
影响因子：
3.8
通讯作者：
Yoganathan AP
中科院分区：
文献类型：
--
作者：
Pierce EL;Sadri V;Ncho B;Kohli K;Shah S;Yoganathan AP
虽然经导管二尖瓣（TMV）置换技术对于无法手术的二尖瓣返流患者具有巨大的临床潜力，但尚未有TMV获得监管部门的批准。目前正在开发的设备的多样性反映了对最佳设计方法缺乏共识。在这项由两部分组成的研究的第一部分中，开发了一种测试系统，用于在加压、外植的猪心脏（N=7）中部署TMV或类似TMV的装置后量化瓣旁漏（PVL）。使用该系统，使用一系列“模拟TMV塞”装置，研究PVL率作为稳定的二尖瓣压（ΔP）、TMV形状和TMV环过大的函数。在所有设备中，PVL与ΔP的平方近似呈趋势。低血压时PVL速率约为0-15ml /秒，正常血压时为10-40ml /秒，严重高血压时为30 - 85ml /秒。与圆形器件相比，d形器件显著降低了PVL；然而，当环形装置扩大到环空6mm的三角间距离时，这种效果就会减弱。总之，这种稳定压力的体外测试系统可以有效地比较不同tmv设计的PVL性能。PVL对跨瓣压力和TMV剖面的响应表现出复杂的动态。
While transcatheter mitral valve (TMV) replacement technology has great clinical potential for surgically inoperable patients suffering from mitral regurgitation, no TMV has yet achieved regulatory approval. The diversity of devices currently under development reflects a lack of consensus regarding optimal design approaches. In Part I of this two-part study, a test system was developed for the quantification of paravalvular leakage (PVL) following deployment of a TMV or TMV-like device in pressurized, explanted porcine hearts (N=7). Using this system, PVL rate was investigated as a function of steady trans-mitral pressure (ΔP), TMV shape, and TMV-annular oversizing, using a series of “mock TMV plug” devices. Across all devices, PVL was found to approximately trend with the square of ΔP. PVL rates were approximately 0–15ml/sec under hypotensive pressure, 10–40ml/sec under normotension, and 30–85 ml/sec under severely hypertension. D-shaped devices significantly reduced PVL versus circular devices; however, this effect was diminished when the circular device was oversized to the annulus by 6mm inter-trigonal distance. In conclusion, this steady pressure, in vitro test system was effective to compare PVL performance across TMV-like designs. PVL exhibited complex dynamics in terms of its response to transvalvular pressure and TMV profile.
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