Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices
| Autor: | Verena Veulemans, Lenard Conradi, Abdullah Alenezi, Masahiko Asami, Christoph Naber, Philip MacCarthy, Marco Barbanti, Luca Testa, Nicolas M. Van Mieghem, Amnon Eitan, Antonio Colombo, Ander Regueiro, Giuliano Costa, Corrado Tamburino, Matteo Pagnesi, Won-Keun Kim, Francesca Ziviello, Azeem Latib, Francesco Bedogni, Jan Van der Heyden, David A. Wood, Osama Alsanjari, Julia Seeger, Salvatore Brugaletta, Giovanni Bianchi, Bernhard Reimers, Stephan Windecker, Vasileios Tzalamouras, Jan Malte Sinning, Maurizio Taramasso, Alexander Wolf, Alexander Sedaghat, Francesco Maisano, Christoph J Jensen, Christian W. Hamm, Matteo Saccocci, Jochen Wöhrle, Jorn Brouwer, David Zweiker, Saib Khogali, Albrecht Schmidt, John G. Webb, Thomas Pilgrim, David Hildick-Smith, Tobias Zeus, Rodrigo Estévez-Loureiro, Darren Mylotte, Francesco Cannata, Dimytri Siqueira, Alexandre Abizaid, Giulio G. Stefanini, Oliver D. Bhadra, Wolfgang Rottbauer, Joachim Schofer, Ulrich Schäfer |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Transcatheter aortic business.industry medicine.medical_treatment Confounding 030204 cardiovascular system & hematology medicine.disease Logistic regression 03 medical and health sciences 0302 clinical medicine Valve replacement Internal medicine Propensity score matching Cohort medicine Cardiology 030212 general & internal medicine Permanent pacemaker Cardiology and Cardiovascular Medicine business Stroke |
| Zdroj: | JACC: Cardiovascular Interventions. 12:433-443 |
| ISSN: | 1936-8798 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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