RT Journal Article
T1 Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry.
A1 Armijo, Germán
A1 Tang, Gilbert H L
A1 Kooistra, Nynke
A1 Ferreira-Neto, Alfredo Nunes
A1 Toggweiler, Stefan
A1 Amat-Santos, Ignacio J
A1 Keller, Lukas S
A1 Urena, Marina
A1 Ahmad, Hasan
A1 Tafur Soto, Jose
A1 Muñoz-Garcia, Erika
A1 Regueiro, Ander
A1 Leenders, Geert E
A1 Tirado-Conte, Gabriela
A1 Sengupta, Aditya
A1 McInerney, Angela
A1 Couture, Thomas
A1 Cuevas Herreros, Oscar
A1 Rodriguez-Gabella, Tania
A1 Kini, Annapoorna
A1 Ahmed, Mohammed
A1 Zaid, Syed
A1 Gonzalo, Nieves
A1 Nuñez-Gil, Ivan J
A1 Muñoz-Garcia, Antonio J
A1 Jimenez-Quevedo, Pilar
A1 Fernández-Ortiz, Antonio
A1 Himbert, Dominique
A1 Nietlispach, Fabian
A1 Stella, Pieter
A1 Dangas, George D
A1 Escaned, Javier
A1 Macaya, Carlos
A1 Rodés-Cabau, Josep
A1 Nombela-Franco, Luis
K1 aortic valve stenosis
K1 cohort studies
K1 hemodynamics
K1 humans
K1 transcatheter aortic valve replacement
AB Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement. A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported. Median aortic annulus area and perimeter were 617 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group. In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.
YR 2020
FD 2020-08-06
LK http://hdl.handle.net/10668/16057
UL http://hdl.handle.net/10668/16057
LA en
DS RISalud
RD Apr 15, 2025