TY - JOUR
T1 - Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices
T2 - 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 - Publisher Copyright:
© 2019
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 - Acurate neo
KW - Evolut PRO
KW - TAVR
KW - VARC-2
KW - self-expanding
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U2 - 10.1016/j.jcin.2018.11.036
DO - 10.1016/j.jcin.2018.11.036
M3 - Article
C2 - 30846081
AN - SCOPUS:85061917944
SN - 1936-8798
VL - 12
SP - 433
EP - 443
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 5
ER -