Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries. (17th January 2023)

• Record Type: Journal Article
• Authors: Scotti, Andrea; Baggio, Sara; Pagnesi, Matteo; Barbanti, Marco; Adamo, Marianna; Eitan, Amnon; Estévez-Loureiro, Rodrigo; Veulemans, Verena; Toggweiler, Stefan; Mylotte, Darren; De Marco, Federico; Giannini, Francesco; Ferlini, Marco; Naber, Christoph K.; Buono, Andrea; Schofer, Joachim; Rottbauer, Wolfgang; Van Mieghem, Nicolas M.; Khogali, Saib; Taramasso, Maurizio; Pilgrim, Thomas; Sinning, Jan-Malte; Zweiker, David; Montorfano, Matteo; Van der Heyden, Jan A.S.; Brugaletta, Salvatore; Ielasi, Alfonso; Hamm, Christian W.; Vanhaverbeke, Maarten; Costa, Giuliano; Massussi, Mauro; Alarcón, Robert; Zeus, Tobias; Lunardi, Mattia; Testa, Luca; Di Ienno, Luca; Lanzillo, Giuseppe; Wolf, Alexander; Maffeo, Diego; Ziviello, Francesca; Saccocci, Matteo; Windecker, Stephan; Sedaghat, Alexander; Schmidt, Albrecht; Brouwer, Jorn; Regueiro, Ander; Reimers, Bernhard; Kim, Won-Keun; Sondergaard, Lars; Colombo, Antonio; Mangieri, Antonio; Latib, Azeem;
• Is Part Of: Circulation. Volume 16:Number 1(2023)
• Page Start: e012538
• Publication Date: 2023-01-17
• Subjects: aortic stenosis -- bioprosthesis -- heart valve prosthesis -- pacemaker -- transcatheter aortic valve replacement -- treatment outcome; Cardiovascular system -- Surgery -- Periodicals; Cardiovascular system -- Diseases -- Treatment -- Periodicals; 616.105
• DOI: 10.1161/CIRCINTERVENTIONS.122.012538
• Languages: English
• ISSNs: 1941-7640

Abstract

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.