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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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
Аннотация
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.