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 K. Naber; Andrea Buono; Joachim Schofer; 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; 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 Sondergaard; Antonio Colombo; Antonio Mangieri; Azeem Latib

doi:10.1161/CIRCINTERVENTIONS.122.012538

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 K. Naber, Andrea Buono, Joachim Schofer, Wolfgang Rottbauer, Nicolas M. Van Mieghem, Saib Khogali, Maurizio TaramassoThomas 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, 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 Sondergaard, Antonio Colombo, Antonio Mangieri, Azeem Latib^*

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › Research › peer-review

15 Citations (Scopus)

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.

Original language	English
Article number	E012538
Journal	Circulation: Cardiovascular Interventions
Volume	16
Issue number	1
Number of pages	11
ISSN	1941-7640
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.122.012538
Publication status	Published - 2023

Bibliographical note

Publisher Copyright:
© 2022 Authors. All rights reserved.

Keywords

aortic stenosis
bioprosthesis
heart valve prosthesis
pacemaker
transcatheter aortic valve replacement
treatment outcome

Access to Document

10.1161/CIRCINTERVENTIONS.122.012538

Cite this

Scotti, A., Baggio, S., Pagnesi, M., Barbanti, M., Adamo, M., Eitan, A., Estévez-Loureiro, R., Veulemans, V., Toggweiler, S., Mylotte, D., De Marco, F., Giannini, F., Ferlini, M., Naber, C. K., Buono, A., Schofer, J., Rottbauer, W., Van Mieghem, N. M., Khogali, S., ... Latib, A. (2023). Temporal Trends and Contemporary Outcomes after Transcatheter Aortic Valve Replacement with Evolut PRO/PRO+ Self-Expanding Valves: Insights from the NEOPRO/NEOPRO-2 Registries. Circulation: Cardiovascular Interventions, 16(1), [E012538]. https://doi.org/10.1161/CIRCINTERVENTIONS.122.012538

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.

In: Circulation: Cardiovascular Interventions, Vol. 16, No. 1, E012538, 2023.

Research output: Contribution to journal › Journal article › Research › peer-review

Scotti, A, Baggio, S, Pagnesi, M, Barbanti, M, Adamo, M, Eitan, A, Estévez-Loureiro, R, Veulemans, V, Toggweiler, S, Mylotte, D, De Marco, F, Giannini, F, Ferlini, M, Naber, CK, Buono, A, Schofer, J, Rottbauer, W, Van Mieghem, NM, Khogali, S, Taramasso, M, Pilgrim, T, Sinning, JM, Zweiker, D, Montorfano, M, Van Der Heyden, JAS, Brugaletta, S, Ielasi, A, Hamm, CW, Vanhaverbeke, M, Costa, G, Massussi, M, Alarcón, R, Zeus, T, Lunardi, M, Testa, L, Di Ienno, L, Lanzillo, G, Wolf, A, Maffeo, D, Ziviello, F, Saccocci, M, Windecker, S, Sedaghat, A, Schmidt, A, Brouwer, J, Regueiro, A, Reimers, B, Kim, WK, Sondergaard, L, Colombo, A, Mangieri, A & Latib, A 2023, 'Temporal Trends and Contemporary Outcomes after Transcatheter Aortic Valve Replacement with Evolut PRO/PRO+ Self-Expanding Valves: Insights from the NEOPRO/NEOPRO-2 Registries', Circulation: Cardiovascular Interventions, vol. 16, no. 1, E012538. https://doi.org/10.1161/CIRCINTERVENTIONS.122.012538

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. / Temporal Trends and Contemporary Outcomes after Transcatheter Aortic Valve Replacement with Evolut PRO/PRO+ Self-Expanding Valves : Insights from the NEOPRO/NEOPRO-2 Registries. In: Circulation: Cardiovascular Interventions. 2023 ; Vol. 16, No. 1.

@article{73799e1949e64159baf93aea9e61d958,

title = "Temporal Trends and Contemporary Outcomes after Transcatheter Aortic Valve Replacement with Evolut PRO/PRO+ Self-Expanding Valves: Insights from the NEOPRO/NEOPRO-2 Registries",

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.",

keywords = "aortic stenosis, bioprosthesis, heart valve prosthesis, pacemaker, transcatheter aortic valve replacement, treatment outcome",

author = "Andrea Scotti and Sara Baggio and Matteo Pagnesi and Marco Barbanti and Marianna Adamo and Amnon Eitan and Rodrigo Est{\'e}vez-Loureiro and Verena Veulemans and Stefan Toggweiler and Darren Mylotte and {De Marco}, Federico and Francesco Giannini and Marco Ferlini and Naber, {Christoph K.} and Andrea Buono and Joachim Schofer and Wolfgang Rottbauer and {Van Mieghem}, {Nicolas M.} and Saib Khogali and Maurizio Taramasso and Thomas Pilgrim and Sinning, {Jan Malte} and David Zweiker and Matteo Montorfano and {Van Der Heyden}, {Jan A.S.} and Salvatore Brugaletta and Alfonso Ielasi and Hamm, {Christian W.} and Maarten Vanhaverbeke and Giuliano Costa and Mauro Massussi and Robert Alarc{\'o}n and Tobias Zeus and Mattia Lunardi and Luca Testa and {Di Ienno}, Luca and Giuseppe Lanzillo and Alexander Wolf and Diego Maffeo and Francesca Ziviello and Matteo Saccocci and Stephan Windecker and Alexander Sedaghat and Albrecht Schmidt and Jorn Brouwer and Ander Regueiro and Bernhard Reimers and Kim, {Won Keun} and Lars Sondergaard and Antonio Colombo and Antonio Mangieri and Azeem Latib",

year = "2023",

doi = "10.1161/CIRCINTERVENTIONS.122.012538",

language = "English",

volume = "16",

journal = "Circulation: Cardiovascular Interventions",

issn = "1941-7640",

publisher = "Lippincott Williams & Wilkins",

number = "1",

}

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

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 -