3-Year Outcomes From the Evolut Low Risk TAVR Bicuspid Study.
JACC Cardiovasc Interv
; 17(14): 1667-1675, 2024 Jul 22.
Article
em En
| MEDLINE
| ID: mdl-39048253
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Valva Aórtica
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Estenose da Valva Aórtica
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Desenho de Prótese
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Bioprótese
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Próteses Valvulares Cardíacas
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Substituição da Valva Aórtica Transcateter
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Doença da Válvula Aórtica Bicúspide
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Hemodinâmica
Limite:
Aged80
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article