Transcatheter aortic valve replacement: clinical safety and performance data. (3rd October 2019)

• Record Type: Journal Article
• Authors: van Baal, Jantine W. P. M; Roszek, Boris; van Elk, Merel; Geertsma, Robert E.
• Is Part Of: Expert review of medical devices. Volume 16:Number 10(2019)
• Page Start: 899
• Page End: 911
• Publication Date: 2019-10-03
• Subjects: Transcatheter aortic valve implantation (TAVI) -- transcatheter aortic valve replacement (TAVR) -- transcatheter heart valve (THV) -- clinical data -- VARC; Medical instruments and apparatus -- Periodicals; 610.28
• DOI: 10.1080/17434440.2019.1674138
• Languages: English
• ISSNs: 1743-4440

Abstract

ABSTRACT: Introduction : Patients with severe aortic stenosis and regurgitation who are inoperable or at high-risk for surgery can be treated with transcatheter aortic valve replacement (TAVR). The aim of this study was to provide a comprehensive overview of the literature of TAVR and reported clinical and performance outcomes. Areas covered : A total of 16 devices, described in 204 articles describing clinical and performance outcomes, were included. The most frequently observed outcome was 30-day mortality, ranging between 0-23%. Other commonly reported clinical outcomes were 30-day stroke, ranging between 0–14.3% and pacemaker implantation, ranging from 0–44.9%. The most common valve performance outcome was aortic valve regurgitation, however, mostly reported at 7 days follow-up. Next to a follow-up period of 30 days, numerous articles reported outcomes at 6 months and 1 year. The numbers of articles describing outcomes with a longer follow-up as well as including intermediate and low-risk patients were limited. Expert commentary : This literature review provided a clear overview of the reported clinical and performance outcomes of TAVR devices. Despite the frequently used VARC-2 definitions, we identified a huge variation across studies. Future studies using standardized definitions of study set-ups and outcomes are essential and might lead to better insights of TAVR.