Temporal Trends and Contemporary Outcomes after Transcatheter Aortic Valve Replacement with Evolut PRO/PRO+ Self-Expanding Valves: Insights from the NEOPRO/NEOPRO-2 Registries
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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Temporal Trends and Contemporary Outcomes after Transcatheter Aortic Valve Replacement with Evolut PRO/PRO+ Self-Expanding Valves : Insights from the NEOPRO/NEOPRO-2 Registries. / 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.
I: Circulation: Cardiovascular Interventions, Bind 16, Nr. 1, E012538, 2023.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Temporal Trends and Contemporary Outcomes after Transcatheter Aortic Valve Replacement with Evolut PRO/PRO+ Self-Expanding Valves
T2 - Insights from the NEOPRO/NEOPRO-2 Registries
AU - Scotti, Andrea
AU - Baggio, Sara
AU - Pagnesi, Matteo
AU - Barbanti, Marco
AU - Adamo, Marianna
AU - Eitan, Amnon
AU - Estévez-Loureiro, Rodrigo
AU - Veulemans, Verena
AU - Toggweiler, Stefan
AU - Mylotte, Darren
AU - De Marco, Federico
AU - Giannini, Francesco
AU - Ferlini, Marco
AU - Naber, Christoph K.
AU - Buono, Andrea
AU - Schofer, Joachim
AU - Rottbauer, Wolfgang
AU - Van Mieghem, Nicolas M.
AU - Khogali, Saib
AU - Taramasso, Maurizio
AU - Pilgrim, Thomas
AU - Sinning, Jan Malte
AU - Zweiker, David
AU - Montorfano, Matteo
AU - Van Der Heyden, Jan A.S.
AU - Brugaletta, Salvatore
AU - Ielasi, Alfonso
AU - Hamm, Christian W.
AU - Vanhaverbeke, Maarten
AU - Costa, Giuliano
AU - Massussi, Mauro
AU - Alarcón, Robert
AU - Zeus, Tobias
AU - Lunardi, Mattia
AU - Testa, Luca
AU - Di Ienno, Luca
AU - Lanzillo, Giuseppe
AU - Wolf, Alexander
AU - Maffeo, Diego
AU - Ziviello, Francesca
AU - Saccocci, Matteo
AU - Windecker, Stephan
AU - Sedaghat, Alexander
AU - Schmidt, Albrecht
AU - Brouwer, Jorn
AU - Regueiro, Ander
AU - Reimers, Bernhard
AU - Kim, Won Keun
AU - Sondergaard, Lars
AU - Colombo, Antonio
AU - Mangieri, Antonio
AU - Latib, Azeem
N1 - Publisher Copyright: © 2022 Authors. All rights reserved.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - aortic stenosis
KW - bioprosthesis
KW - heart valve prosthesis
KW - pacemaker
KW - transcatheter aortic valve replacement
KW - treatment outcome
U2 - 10.1161/CIRCINTERVENTIONS.122.012538
DO - 10.1161/CIRCINTERVENTIONS.122.012538
M3 - Journal article
C2 - 36649387
AN - SCOPUS:85146401273
VL - 16
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
SN - 1941-7640
IS - 1
M1 - E012538
ER -
ID: 362897085