Procedural and Hemodynamic Outcomes of Contemporary Self-Expanding Valves for Transcatheter Aortic Valve Replacement: A Multicenter Comparison From the AMTRAC Registry.
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Levi Amos, Talmor-Barkan Yeela, Barbanti Marco, Sammartino Sofia, Costa Giuliano, Grasso Carmelo, De Backer Ole, Lulic Davorka, Rodriguez Fernanda, Olmos Carmen, Masiero Giulia, Adamo Marianna, Arzamendi Dabit, García-Gómez Mario, Baz Jose A, Steblovnik Klemen, Mauri Victor, Adam Matti, Wienemann Hendrik, Hein Manuel, Ruile Philipp, Thaddeus Soh Bing Wei, Patel Kush P, Branca Luca, Estévez-Loureiro Rodrigo, Amat-Santos Ignacio J, Mylotte Darren, Bunc Matjaz, Tarantini Giuseppe, Mullen Michael J, Nombela-Franco Luis, Codner Pablo, Rotholz Aviad, Lerman Tsahi T, Perl Leor, Kornowski Ran, Witberg Guy
Аннотация
METHODS: This multicenter cohort study utilized the AMTRAC registry to evaluate consecutive patients treated with either Evolut PRO/PRO+/FX or Navitor. The primary analysis employed a 1:1 propensity score-matched cohort, utilizing multilevel mixed-effects models to adjust for center-level clustering. The primary endpoint was 1-year all-cause mortality.
RESULTS: Of 2673 patients, propensity score matching yielded a balanced cohort of 1200 patients. At 1-year, all-cause mortality was similar between groups (Navitor: 7.1% vs. Evolut: 9.2%; hazard ratio 0.75; 95% CI: 0.47-1.21; p = 0.24). In-hospital mortality (0.8%), periprocedural stroke (2.3%), permanent pacemaker implantation (Navitor: 14.4% vs. Evolut: 15.9%; p = 0.554), and paravalvular leak (p = 0.221) were comparable. Initial differences showing lower vascular and bleeding events with Navitor were completely attenuated after accounting for center-level clustering (vascular: p = 0.838; bleeding: p = 0.745). Conversely, postprocedural mean transaortic gradient was lower with Evolut (7.3 ± 3.9 mmHg vs. 8.6 ± 4.1 mmHg; p < 0.001), a hemodynamic advantage that remained highly robust after center adjustment (odds ratio 2.43; 95% CI: 1.66-3.58; p < 0.001). Sensitivity analyses yielded consistent results.
CONCLUSIONS: Contemporary self-expanding platforms demonstrate comparable 1-year mortality and stroke rates. Periprocedural vascular and bleeding safety profiles are strongly modulated by center-specific clustering and practice variations. Conversely, the superior hemodynamic performance of the Evolut platform remains independent of institutional factors. These findings support an anatomy-driven approach to valve selection integrating patient profiles with institutional practices.