Temporal Trends and Contemporary Outcomes After Transcatheter Aortic Valve Replacement With Evolut PRO/PRO+ Self-Expanding Valves: Insights From the NEOPRO/NEOPRO-2 Registries.
Options
BORIS DOI
Publisher DOI
PubMed ID
36649387
Description
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.
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.
Date of Publication
2023-01
Publication Type
Article
Subject(s)
Keyword(s)
aortic stenosis bioprosthesis heart valve prosthesis pacemaker transcatheter aortic valve replacement treatment outcome
Language(s)
en
Contributor(s)
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 | |
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 |
Additional Credits
Series
Circulation. Cardiovascular interventions
Publisher
American Heart Association
ISSN
1941-7632
Access(Rights)
restricted