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Expert Rev Med Devices. 2019 Oct;16(10):899-911. doi: 10.1080/17434440.2019.1674138. Epub 2019 Oct 4.

Transcatheter aortic valve replacement: clinical safety and performance data.

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Centre for Health Protection, National Institute for Public Health and the Environment (RIVM) , Bilthoven , the Netherlands.


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.


Transcatheter aortic valve implantation (TAVI); VARC; clinical data; transcatheter aortic valve replacement (TAVR); transcatheter heart valve (THV)

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