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 Kooistra, Alfredo Nunes Ferreira-Neto, Stefan Toggweiler, Ignacio J Amat-Santos, Lukas S Keller, Marina Urena, Hasan Ahmad, Jose Tafur Soto, Erika Muñoz-Garcia, Ander Regueiro, Geert E Leenders, Gabriela Tirado-Conte, Aditya Sengupta, Angela McInerney, Thomas Couture, Oscar Cuevas Herreros, Tania Rodriguez-Gabella, Annapoorna KiniMohammed Ahmed, Syed Zaid, Nieves Gonzalo, Ivan J Nuñez-Gil, Antonio J Muñoz-Garcia, Pilar Jimenez-Quevedo, Antonio Fernández-Ortiz, Dominique Himbert, Fabian Nietlispach, Pieter Stella, George D Dangas, Javier Escaned, Carlos Macaya, Josep Rodés-Cabau, Luis Nombela-Franco

Research output: Contribution to journalArticleAcademicpeer-review


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 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 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 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.

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.

Original languageEnglish
Article numbere009047
Pages (from-to)1-9
Number of pages9
JournalCirculation. Cardiovascular Interventions
Issue number8
Publication statusPublished - Aug 2020


  • aortic valve stenosis
  • cohort studies
  • hemodynamics
  • humans
  • transcatheter aortic valve replacement


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