Early safety after TAVR according to VARC-3 criteria: incidence, predictors, and clinical impact

• Published in: Revista española de cardiología (English ed.) 2024-12
• Main Authors: Gonzálvez-García, Ariana, Cepas-Guillén, Pedro, Ternacle, Julien, Urena, Marina, Alperi, Alberto, Cheema, Asim, Veiga-Fernández, Gabriela, Nombela-Franco, Luis, Vilalta, Victoria, Esposito, Giovanni, Campelo-Parada, Francisco, Idolfi, Ciro, Trigo, María Del, Muñoz-García, Antonio, Maneiro, Nicolás, Asmarats, Luis, Regueiro, Ander, Val, David Del, Serra, Vicenç, Auffret, Vincent, Jonveaux, Melchior, Bonnet, Guillaume, Mesnier, Jules, Gaspard, Suc, Avanzas, Pablo, Rezaei, Effat, Fradejas-Sastre, Víctor, Tirado-Conte, Gabriela, Fernández-Nofrerías, Eduard, Franzone, Anna, Guitteny, Thibaut, Sorrentino, Sabato, Oteo, Juan Francisco, Diez-Delhoyo, Felipe, Gutiérrez-Alonso, Lola, Vidal, Pablo, Alfonso, Fernando, Monastyrski, Andrea, Nolf, Maxime, Pelletier-Beaumont, Emilie, Avvedimento, Marisa, Rodés-Cabau, Josep
• Format: Article
• Language: eng ; spa
• ISSN: 1885-5857; 1885-5857
• DOI: 10.1016/j.rec.2024.12.005

The Valve Academic Research Consortium (VARC)-3 definition of the early safety (ES) composite endpoint after transcatheter aortic valve replacement (TAVR) lacks clinical validation. The aim of this study was to determine the incidence, predictors, and clinical impact of ES after TAVR as defined by VARC-3 criteria. We performed a multicenter study including 10 078 patients with severe aortic stenosis undergoing transarterial TAVR. According to VARC-3 criteria, ES at 30 days was defined as freedom from all-cause mortality, stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complications, acute kidney injury stages 3-4, moderate or severe aortic regurgitation, new permanent pacemaker implantation, and surgery or intervention related to the device. Baseline, procedural, and follow-up data were prospectively collected in a dedicated database. ES was achieved in 6598 patients (65.5%). The main factors associated with a lack of ES were the occurrence of type 2-4 bleeding (18.9%), and new pacemaker implantation (13.6%). Advanced age, peripheral artery disease, chronic kidney disease, and balloon postdilation were associated with an increased risk of no-ES (P