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3-Year Outcomes From the Evolut Low Risk TAVR Bicuspid Study.

Authors :
Zahr, Firas
Ramlawi, Basel
Reardon, Michael J.
Deeb, G. Michael
Yakubov, Steven J.
Song, Howard K.
Kleiman, Neal S.
Chetcuti, Stanley J.
Gada, Hemal
Mumtaz, Mubashir
Leung, Stephane
Merhi, William
Rovin, Joshua D.
DeFrain, Michael
Muppala, Murali
Kauten, James
Rajagopal, Vivek
Huang, Jiang
Ito, Saki
Forrest, John K.
Source :
JACC: Cardiovascular Interventions; Jul2024, Vol. 17 Issue 14, p1667-1675, 9p
Publication Year :
2024

Abstract

Outcomes from transcatheter aortic valve replacement (TAVR) in low–surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited. This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study. The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.S. centers. Patients with severe aortic stenosis at low surgical risk with bicuspid aortic valve anatomy (all subtypes) underwent TAVR with a self-expanding, supra-annular Evolut R or PRO (Medtronic) bioprosthesis. An independent clinical events committee adjudicated all deaths and endpoint-related adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. An attempted implant was performed in 150 patients from December 2018 to October 2019. The mean age was 70.3 ± 5.5 years, 48% (72/150) of the patients were women, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.3% (Q1-Q3: 0.9%-1.7%). Sievers type 1 was the dominant bicuspid morphology (90.7%, 136/150). The Kaplan-Meier rates of all-cause mortality or disabling stroke were 1.3% (95% CI: 0.3%-5.3%) at 1 year, 3.4% (95% CI: 1.4%-8.1%) at 2 years, and 4.1% (95% CI: 1.6%-10.7%) at 3 years. The incidence of new permanent pacemaker implantation was 19.4% (95% CI: 12.4%-29.6%) at 3 years. There were no instances of moderate or severe paravalvular aortic regurgitation at 2 and 3 years after TAVR. The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance. [Display omitted] [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
19368798
Volume :
17
Issue :
14
Database :
Supplemental Index
Journal :
JACC: Cardiovascular Interventions
Publication Type :
Academic Journal
Accession number :
178401657
Full Text :
https://doi.org/10.1016/j.jcin.2024.05.017