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Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves

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Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves. / Pagnesi, Matteo; Kim, Won-Keun; Conradi, Lenard; Barbanti, Marco; Stefanini, Giulio G; Zeus, Tobias; Pilgrim, Thomas; Schofer, Joachim; Zweiker, David; Testa, Luca; Taramasso, Maurizio; Hildick-Smith, David; Abizaid, Alexandre; Wolf, Alexander; Van Mieghem, Nicolas M; Sedaghat, Alexander; Wöhrle, Jochen; Khogali, Saib; Van der Heyden, Jan A S; Webb, John G; Estévez-Loureiro, Rodrigo; Mylotte, Darren; MacCarthy, Philip; Brugaletta, Salvatore; Hamm, Christian W; Bhadra, Oliver D; Schäfer, Ulrich; Costa, Giuliano; Tamburino, Corrado; Cannata, Francesco; Reimers, Bernhard; Veulemans, Verena; Asami, Masahiko; Windecker, Stephan; Eitan, Amnon; Schmidt, Albrecht; Bianchi, Giovanni; Bedogni, Francesco; Saccocci, Matteo; Maisano, Francesco; Alsanjari, Osama; Siqueira, Dimytri; Jensen, Christoph J; Naber, Christoph K; Ziviello, Francesca; Sinning, Jan-Malte; Seeger, Julia; Rottbauer, Wolfgang; Brouwer, Jorn; Alenezi, Abdullah; Wood, David A; Tzalamouras, Vasileios; Regueiro, Ander; Colombo, Antonio; Latib, Azeem.

in: JACC-CARDIOVASC INTE, Jahrgang 12, Nr. 5, 11.03.2019, S. 433-443.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Pagnesi, M, Kim, W-K, Conradi, L, Barbanti, M, Stefanini, GG, Zeus, T, Pilgrim, T, Schofer, J, Zweiker, D, Testa, L, Taramasso, M, Hildick-Smith, D, Abizaid, A, Wolf, A, Van Mieghem, NM, Sedaghat, A, Wöhrle, J, Khogali, S, Van der Heyden, JAS, Webb, JG, Estévez-Loureiro, R, Mylotte, D, MacCarthy, P, Brugaletta, S, Hamm, CW, Bhadra, OD, Schäfer, U, Costa, G, Tamburino, C, Cannata, F, Reimers, B, Veulemans, V, Asami, M, Windecker, S, Eitan, A, Schmidt, A, Bianchi, G, Bedogni, F, Saccocci, M, Maisano, F, Alsanjari, O, Siqueira, D, Jensen, CJ, Naber, CK, Ziviello, F, Sinning, J-M, Seeger, J, Rottbauer, W, Brouwer, J, Alenezi, A, Wood, DA, Tzalamouras, V, Regueiro, A, Colombo, A & Latib, A 2019, 'Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves', JACC-CARDIOVASC INTE, Jg. 12, Nr. 5, S. 433-443. https://doi.org/10.1016/j.jcin.2018.11.036

APA

Pagnesi, M., Kim, W-K., Conradi, L., Barbanti, M., Stefanini, G. G., Zeus, T., Pilgrim, T., Schofer, J., Zweiker, D., Testa, L., Taramasso, M., Hildick-Smith, D., Abizaid, A., Wolf, A., Van Mieghem, N. M., Sedaghat, A., Wöhrle, J., Khogali, S., Van der Heyden, J. A. S., ... Latib, A. (2019). Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves. JACC-CARDIOVASC INTE, 12(5), 433-443. https://doi.org/10.1016/j.jcin.2018.11.036

Vancouver

Pagnesi M, Kim W-K, Conradi L, Barbanti M, Stefanini GG, Zeus T et al. Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves. JACC-CARDIOVASC INTE. 2019 Mär 11;12(5):433-443. https://doi.org/10.1016/j.jcin.2018.11.036

Bibtex

@article{311f2018c9ee4083b1e0bd2d8b2974de,
title = "Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves",
abstract = "OBJECTIVES: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices.BACKGROUND: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR.METHODS: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles.RESULTS: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation.CONCLUSIONS: In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.",
keywords = "Aged, Aged, 80 and over, Aortic Valve/diagnostic imaging, Aortic Valve Stenosis/diagnostic imaging, Bioprosthesis, Female, Heart Valve Prosthesis, Humans, Male, Postoperative Complications/etiology, Propensity Score, Prosthesis Design, Registries, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome",
author = "Matteo Pagnesi and Won-Keun Kim and Lenard Conradi and Marco Barbanti and Stefanini, {Giulio G} and Tobias Zeus and Thomas Pilgrim and Joachim Schofer and David Zweiker and Luca Testa and Maurizio Taramasso and David Hildick-Smith and Alexandre Abizaid and Alexander Wolf and {Van Mieghem}, {Nicolas M} and Alexander Sedaghat and Jochen W{\"o}hrle and Saib Khogali and {Van der Heyden}, {Jan A S} and Webb, {John G} and Rodrigo Est{\'e}vez-Loureiro and Darren Mylotte and Philip MacCarthy and Salvatore Brugaletta and Hamm, {Christian W} and Bhadra, {Oliver D} and Ulrich Sch{\"a}fer and Giuliano Costa and Corrado Tamburino and Francesco Cannata and Bernhard Reimers and Verena Veulemans and Masahiko Asami and Stephan Windecker and Amnon Eitan and Albrecht Schmidt and Giovanni Bianchi and Francesco Bedogni and Matteo Saccocci and Francesco Maisano and Osama Alsanjari and Dimytri Siqueira and Jensen, {Christoph J} and Naber, {Christoph K} and Francesca Ziviello and Jan-Malte Sinning and Julia Seeger and Wolfgang Rottbauer and Jorn Brouwer and Abdullah Alenezi and Wood, {David A} and Vasileios Tzalamouras and Ander Regueiro and Antonio Colombo and Azeem Latib",
note = "Copyright {\textcopyright} 2019. Published by Elsevier Inc.",
year = "2019",
month = mar,
day = "11",
doi = "10.1016/j.jcin.2018.11.036",
language = "English",
volume = "12",
pages = "433--443",
journal = "JACC-CARDIOVASC INTE",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "5",

}

RIS

TY - JOUR

T1 - Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves

AU - Pagnesi, Matteo

AU - Kim, Won-Keun

AU - Conradi, Lenard

AU - Barbanti, Marco

AU - Stefanini, Giulio G

AU - Zeus, Tobias

AU - Pilgrim, Thomas

AU - Schofer, Joachim

AU - Zweiker, David

AU - Testa, Luca

AU - Taramasso, Maurizio

AU - Hildick-Smith, David

AU - Abizaid, Alexandre

AU - Wolf, Alexander

AU - Van Mieghem, Nicolas M

AU - Sedaghat, Alexander

AU - Wöhrle, Jochen

AU - Khogali, Saib

AU - Van der Heyden, Jan A S

AU - Webb, John G

AU - Estévez-Loureiro, Rodrigo

AU - Mylotte, Darren

AU - MacCarthy, Philip

AU - Brugaletta, Salvatore

AU - Hamm, Christian W

AU - Bhadra, Oliver D

AU - Schäfer, Ulrich

AU - Costa, Giuliano

AU - Tamburino, Corrado

AU - Cannata, Francesco

AU - Reimers, Bernhard

AU - Veulemans, Verena

AU - Asami, Masahiko

AU - Windecker, Stephan

AU - Eitan, Amnon

AU - Schmidt, Albrecht

AU - Bianchi, Giovanni

AU - Bedogni, Francesco

AU - Saccocci, Matteo

AU - Maisano, Francesco

AU - Alsanjari, Osama

AU - Siqueira, Dimytri

AU - Jensen, Christoph J

AU - Naber, Christoph K

AU - Ziviello, Francesca

AU - Sinning, Jan-Malte

AU - Seeger, Julia

AU - Rottbauer, Wolfgang

AU - Brouwer, Jorn

AU - Alenezi, Abdullah

AU - Wood, David A

AU - Tzalamouras, Vasileios

AU - Regueiro, Ander

AU - Colombo, Antonio

AU - Latib, Azeem

N1 - Copyright © 2019. Published by Elsevier Inc.

PY - 2019/3/11

Y1 - 2019/3/11

N2 - OBJECTIVES: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices.BACKGROUND: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR.METHODS: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles.RESULTS: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation.CONCLUSIONS: In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.

AB - OBJECTIVES: The aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices.BACKGROUND: The NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR.METHODS: The NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles.RESULTS: A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation.CONCLUSIONS: In this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Bioprosthesis

KW - Female

KW - Heart Valve Prosthesis

KW - Humans

KW - Male

KW - Postoperative Complications/etiology

KW - Propensity Score

KW - Prosthesis Design

KW - Registries

KW - Retrospective Studies

KW - Risk Assessment

KW - Risk Factors

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

U2 - 10.1016/j.jcin.2018.11.036

DO - 10.1016/j.jcin.2018.11.036

M3 - SCORING: Journal article

C2 - 30846081

VL - 12

SP - 433

EP - 443

JO - JACC-CARDIOVASC INTE

JF - JACC-CARDIOVASC INTE

SN - 1936-8798

IS - 5

ER -