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人类中的第一个多中心体验是最新一代超年式自我扩张的Evolut FX TAVR系统

Syed Zaid¹, Guilherme F Attizzani², Parasuram Krishnamoorthy³

¹Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.

JACC. Cardiovascular interventions

|July 12, 2023

概括

与PRO+系统相比,Evolut FX系统在跨导管大动脉置换 (TAVR) 中显示出更好的结果,与PRO+系统相比,对齐性更好,复发次数更少. 这些进展可能特别有利于年轻的患者,需要终身门管理.

科学领域:

心血管医学心血管医学
干预心脏病学干预心脏病学
医疗器械技术医疗器械技术

背景情况:

最新的Medtronic的Evolut FX TAVR系统引入了与之前的模型相比的设计增强.
对于Evolut FX系统,早期临床数据有限.

研究的目的:

报告最初的多中心,有限的市场发布,第一次在人类体验Evolut FX TAVR系统.
使用Evolut PRO+系统,将Evolut FX系统的性能与使用Evolut PRO+系统的单中心体验进行比较.

主要方法:

在美国9个中心,226名患者使用Evolut FX系统进行了膜输血TAVR.
数据包括患者特征,解剖学,手术细节以及根据VARC-3定义的30天临床/心声学结果.
佣金对齐被定义为原生和外汇佣金之间的0°至30°.

主要成果:

在98.4%的案例中,Evolut FX系统实现了最佳的帽子标记定向,96.5%的案例中实现了最佳的帽子标记定向和 commissural alignment.
在30天后,在14.3%的患者中观察到轻微的副膜泄漏,在0.9%的患者中观察到中度的泄漏,没有严重的泄漏.
与Evolut PRO+相比,FX系统显示出更对称的植入 (P < 0.001),较少的重新捕获 (26.1%与39.5%相比; P = 0.004),以及改善的指针对齐 (96.5%与80.2%相比; P < 0.001).

结论:

Evolut FX 系统在30天内表现出良好的结果,在指导线对齐,设备回收和植入对称性方面超过了 PRO+ 系统.
这些改善表明,对于年轻的TAVR患者,需要长期使用超状,自我扩张的门进行治疗,可能会有潜在的好处.

关键词:

演化外汇交易演化外汇交易在TAVRR中,我们可以看到.长的对齐是指长的对齐.

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