Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry
Germán Armijo, Gilbert H.L. Tang, Nynke H M Kooistra, Alfredo Nunes Ferreira‐Neto, Stefan Toggweiler, Ignacio J. Amat‐Santos, Lukas S. Keller, Marina Ureña, Hasan Ahmad, Jose Tafur Soto, Érika Muñoz-García, Ander Regueiro, Geert E. Leenders, Gabriela Tirado‐Conte, Aditya Sengupta, Angela McInerney, Thomas Couture, Oscar Cuevas Herreros, Tania Rodríguez‐Gabella, Annapoorna Kini, Mohammed Ahmed, Syed Zaid, Nieves Gonzalo, Iván J. Núñez‐Gil, Antonio J. Muñoz-García, Pilar Jiménez‐Quevedo, Antonio Fernández‐Ortíz, Dominique Himbert, Fabian Nietlispach, Pieter R. Stella, George Dangas, Javier Escaned, Carlos Macaya, Josep Rodés‐Cabau, Luis Nombela‐Franco
Abstract
Background: 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 mm 2 or perimeter ≥85 mm) and extra-large (≥683 mm 2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement. Methods: 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. Results: Median aortic annulus area and perimeter were 617 mm 2 (591–657) and 89.1 mm (87.0–92.1), respectively (704 mm 2 [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. Conclusions: 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.