Division of Cardiology, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York.
Division of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.
JAMA Cardiol. 2021 Jan 1;6(1):102-112. doi: 10.1001/jamacardio.2020.3682.
Aortic valve stenosis (AS) is the most common manifestation of acquired valvular heart disease in developed countries. Several large-scale randomized clinical trials investigating the entire spectrum of patients with severe symptomatic AS from low to prohibitive risk have established transcatheter aortic valve replacement (TAVR) as a safe and effective alternative to surgical aortic valve replacement.
There are currently only 3 types of TAVR devices commercially available in the US, but several other valve types are undergoing clinical trials in the US. Because of fundamental differences in engineering features, each TAVR device type has specific strengths and limitations. This review aims to provide an overview of design features and clinical outcomes of various TAVR devices that are either commercially available or undergoing clinical investigation.
Given the lack of large-scale head-to-head comparisons of various TAVR devices and the rapid development of new device iterations, there is insufficient evidence to claim superiority of one device type over another. Nonetheless, as each TAVR device has unique design characteristics, certain patient-related and anatomy-related factors may slightly favor one or several particular designs.
在发达国家,主动脉瓣狭窄(AS)是获得性心脏瓣膜病最常见的表现。几项针对严重有症状 AS 患者的大规模随机临床试验,涵盖了从低危到高危的所有患者,已证实经导管主动脉瓣置换术(TAVR)是一种安全有效的外科主动脉瓣置换术替代方法。
目前美国仅有 3 种 TAVR 器械上市,但其他几种瓣膜类型正在美国进行临床试验。由于工程特征的根本差异,每种 TAVR 器械类型都有其特定的优势和局限性。本综述旨在概述已上市或正在进行临床研究的各种 TAVR 器械的设计特点和临床结果。
鉴于缺乏各种 TAVR 器械的大规模头对头比较以及新器械迭代的快速发展,尚无足够证据声称一种器械类型优于另一种。尽管如此,由于每种 TAVR 器械都具有独特的设计特点,某些与患者相关和解剖相关的因素可能会略微偏向于一种或几种特定设计。