Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries
Andrea Scotti, Sara Baggio, Matteo Pagnesi, Marco Barbanti, Marianna Adamo, Amnon Eitan, Rodrigo Estévez‐Loureiro, Verena Veulemans, Stefan Toggweiler, Darren Mylotte, Federico De Marco, Francesco Giannini, Marco Ferlini, Christoph Naber, Andrea Buono, Joachim Schöfer, Wolfgang Rottbauer, Nicolas M. Van Mieghem, Saib Khogali, Maurizio Taramasso, Thomas Pilgrim, Jan‐Malte Sinning, David Zweiker, Matteo Montorfano, Jan A.S. Van der Heyden, Salvatore Brugaletta, Alfonso Ielasi, Christian W. Hamm, Maarten Vanhaverbeke, Giuliano Costa, Mauro Massussi, Robert Alarcón Cedeño, Tobias Zeus, Mattia Lunardi, Luca Testa, Luca Di Ienno, Giuseppe Lanzillo, Alexander Wolf, Diego Maffeo, Francesca Ziviello, Matteo Saccocci, Stephan Windecker, Alexander Sedaghat, Albrecht Schmidt, Jorn Brouwer, Ander Regueiro, Bernhard Reimers, Won‐Keun Kim, Lars Søndergaard, Antonio Colombo, Antonio Mangieri, Azeem Latib, on behalf of the NEOPRO and NEOPRO-2 Investigators‡
Abstract
Background: In recent years, transcatheter aortic valve replacement (TAVR) techniques and technology have continuously improved. Data regarding the impact of these advancements on outcomes in large real-world settings are still limited. The aim of this study was to investigate temporal trends and assess contemporary outcomes after TAVR with Evolut PRO/PRO+ supra-annular self-expanding valves. Methods: This study included patients enrolled in the multicenter NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) and NEOPRO-2 (A Multicenter Comparison of ACURATE NEO2 Versus Evolut PRO/PRO+ Transcatheter Heart Valves 2) registries who underwent transfemoral TAVR with Evolut PRO/PRO+. Procedural dates (August 2017 through November 2021) were stratified in quartiles (Q) and used to investigate temporal trends in TAVR outcomes. Predischarge, 30-day Valve Academic Research Consortium-3 defined, and 1-year outcomes were evaluated. Results: In total, 1616 patients from 28 centers were included. Over time, patients had lower Society of Thoracic Surgeon-Predicted Risk of Mortality score (Q1–4, 4.1% [2.8–6.3%], 3.7% [2.6–5.3%], 3.3% [2.4–4.9%], 2.9% [2.2–4.3%]; P <0.001) and more moderate or heavy valve calcification (Q1–4, 80%, 80%, 82%, 88%; P =0.038). Overall Valve Academic Research Consortium-3 technical success was 94.1%, with 30-day and 1-year all-cause mortality of 2.4% and 10%, respectively. Throughout the study period, procedures were associated with higher rates of 30-day device success (Q1–4, 81.2%, 82.2%, 82.0%, 88.0%; Cochran-Armitage P =0.023) and early safety (Q1–4, 66.8%, 67.5%, 74.0%, 77.6%; Cochran-Armitage P <0.001), with fewer permanent pacemaker implantations (Q1–4: 15.3%, 20.0%, 12.1%, 11.6%; Cochran-Armitage P =0.023) and residual mild or greater paravalvular leaks (Q1–4, 50.4%, 42.1%, 36.5%, 35.8%; Cochran-Armitage P <0.001). Conclusions: TAVR with Evolut PRO/PRO+ self-expanding valve is safe and effective. Despite the treatment of heavier calcified anatomies, procedural outcomes are improving over time with less need for pacemaker implantation and less significant paravalvular leaks.