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Indian Journal of Thoracic and Cardiovascular Surgery
Published in:

03-01-2024 | Aortic Valve Replacement | Critical Appraisal of Trials

EVOLUT Low-Risk Trial data: “We see what we want to see!”

Author: Pradeep Narayan

Published in: Indian Journal of Thoracic and Cardiovascular Surgery | Issue 2/2024

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Abstract

In the 4-year update of the EVOLUT Low-Risk Trial (NCT02701283), the authors highlight a non-significant improvement in the primary endpoint and a statistically significant, yet clinically irrelevant, enhancement in hemodynamics with transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR). Overlooking the concurrent surgical procedures in SAVR patients, mortality rates remain similar at 4 years. Unaddressed is the substantial increase in permanent pacemaker implantations with TAVR and the fate of patients with paravalvular leaks.
Literature
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Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O’Hair D, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380:1706–15.CrossRefPubMed
2.
Forrest JK, Deeb GM, Yakubov SJ, Gada H, Mumtaz MA, Ramlawi B, et al. 3-Year outcomes after transcatheter or surgical aortic valve replacement in low-risk patients with aortic stenosis. J Am Coll Cardiol. 2023;81:1663–74.CrossRefPubMed
3.
Forrest JK, Deeb GM, Yakubov SJ, Gada H, Mumtaz MA, Ramlawi B, et al. 4-Year outcomes of patients with aortic stenosis in the EVOLUT Low Risk Trial. J Am Coll Cardiol. 2023;82:2163–5.CrossRefPubMed
4.
Narayan P. Transcatheter aortic valve replacement in low-risk patients: superiority or shifting goalposts and statistical crystal-gazing? Indian J Thorac Cardiovasc Surg. 2019;35:596.CrossRefPubMedPubMedCentral
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Sponga S, Perron J, Dagenais F, Mohammadi S, Baillot R, Doyle D, et al. Impact of residual regurgitation after aortic valve replacement. Eur J Cardiothorac Surg. 2012;42:486–92.CrossRefPubMed
6.
Metadata
Title
EVOLUT Low-Risk Trial data: “We see what we want to see!”
Author
Pradeep Narayan
Publication date
03-01-2024
Publisher
Springer Nature Singapore
Published in
Indian Journal of Thoracic and Cardiovascular Surgery / Issue 2/2024
Print ISSN: 0970-9134
Electronic ISSN: 0973-7723
DOI
https://doi.org/10.1007/s12055-023-01674-6

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