3-Year Outcomes From the Evolut Low Risk TAVR Bicuspid Study.
Document Type
Article
Publication Title
JACC Cardiovasc Interv
Abstract
BACKGROUND: Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited.
OBJECTIVES: This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
First Page
1667
Last Page
1675
DOI
10.1016/j.jcin.2024.05.017
Publication Date
7-22-2024
Recommended Citation
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; and Forrest, John K, "3-Year Outcomes From the Evolut Low Risk TAVR Bicuspid Study." (2024). Heart and Vascular Articles. 55.
https://scholarlyworks.ohiohealth.com/heart-vascular-articles/55