Transcatheter aortic valve replacement: clinical safety and performance data

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.

KEYWORDS:

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

Acknowledgments

This investigation has been performed by order and for the account of Dutch Health and Youth Care Inspectorate, within the framework of project V080168 Supporting the Dutch Health and Youth Care Inspectorate on Medical Technology.

Article highlights

• Despite the frequently used VARC-2 definitions, we identified a huge variation across studies in terms of follow-up, number of patients, patients’ risk groups, clinical and performance outcomes.

• 30-day mortality decreased with the newer generation THVs.

• Except for the THVs that entered the market first, articles describing follow-up periods longer than 1 year were very limited.

• More data specific for intermediate- and low-risk patients, including younger patients are necessary.

Author contributions

JWPM van Baal study concept and design, collection, analysis and interpretation of data, statistical analysis and drafting of the manuscript. B Roszek collection, analysis and interpretation of data, critical revision. M van Elk analysis of data, critical revision. RE Geertsma study supervision, critical revision.

Data availability statement

All data obtained in this literature review (regarding VARC clinical and performance outcomes) are incorporated as Supplemental material (https://doi.org/10.6084/m9.figshare.7964363 DOI: 10.6084/m9.figshare.7964363).

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One reviewer is a consultant for Medtronic, Abbott, and Boston Scientific. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.