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.

• Authors: Matteo Pagnesi, Won-Keun Kim, Lenard Conradi, Marco Barbanti, Giulio G Stefanini, Tobias Zeus, Thomas Pilgrim, Joachim Schofer, David Zweiker, Luca Testa, Maurizio Taramasso, David Hildick-Smith, Alexandre Abizaid, Alexander Wolf, Nicolas M Van Mieghem, Alexander Sedaghat, Jochen Wöhrle, Saib Khogali, Jan A S Van der Heyden, John G Webb, Rodrigo Estévez-Loureiro, Darren Mylotte, Philip MacCarthy, Salvatore Brugaletta, Christian W Hamm, Oliver D Bhadra, Ulrich Schäfer, Giuliano Costa, Corrado Tamburino, Francesco Cannata, Bernhard Reimers, Verena Veulemans, Masahiko Asami, Stephan Windecker, Amnon Eitan, Albrecht Schmidt, Giovanni Bianchi, Francesco Bedogni, Matteo Saccocci, Francesco Maisano, Osama Alsanjari, Dimytri Siqueira, Christoph J Jensen, Christoph K Naber, Francesca Ziviello, Jan-Malte Sinning, Julia Seeger, Wolfgang Rottbauer, Jorn Brouwer, Abdullah Alenezi, David A Wood, Vasileios Tzalamouras, Ander Regueiro, Antonio Colombo, Azeem Latib
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 12 Issue 5 Pg. 433-443 (03 11 2019) ISSN: 1876-7605 [Electronic] United States
• PMID: 30846081 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019. Published by Elsevier Inc.

Topics

• Aged
• Aged, 80 and over
• Aortic Valve (diagnostic imaging, physiopathology, surgery)
• Aortic Valve Stenosis (diagnostic imaging, mortality, physiopathology, surgery)
• Bioprosthesis
• Female
• Heart Valve Prosthesis
• Humans
• Male
• Postoperative Complications (etiology, mortality)
• Propensity Score
• Prosthesis Design
• Registries
• Retrospective Studies
• Risk Assessment
• Risk Factors
• Time Factors
• Transcatheter Aortic Valve Replacement (adverse effects, instrumentation, mortality)
• Treatment Outcome