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Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR

2024; Lippincott Williams & Wilkins; Linguagem: Inglês

10.1161/circinterventions.124.014800

1941-7632

Marisa Avvedimento, Pedro Cepas‐Guillén, Julien Ternacle, Marina Ureña, Alberto Alperi, Asim N. Cheema, Gabriela Veiga Fernández, Luis Nombela‐Franco, Victòria Vilalta, Giovanni Esposito, Francisco Campelo-Parada, Ciro Indolfi, María Del Trigo, Antonio J. Muñoz-García, Nicolás Manuel Maneiro Melón, Lluís Asmarats, Ander Regueiro, David del Val, Violeta Serra, Vincent Auffret, Thomas Modine, Guillaume Bonnet, Jules Mesnier, Gaspard Suc, Pablo Avanzas, Effat Rezaei, Víctor Fradejas-Sastre, Gabriela Tirado‐Conte, Eduard Fernández‐Nofrerías, Anna Franzone, Thibaut Guitteny, Sabato Sorrentino, J. Domínguez, Jorge Nuche, Lola Gutiérrez-Alonso, Eduardo Flores‐Umanzor, Fernándo Alfonso, Andrea Monastyrski, M. Nolf, Mélanie Côté, R. Mehran, Marie‐Claude Morice, Davide Capodanno, Philippe Garot, Josep Rodés‐Cabau,

Atrial Fibrillation Management and Outcomes

Background: The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk (HBR) in patients undergoing transcatheter aortic valve replacement (TAVR). The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale TAVR population. Methods: Multicenter study including 10,449 patients undergoing TAVR. Based on consensus, twenty-one clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to VARC-HBR definition. The primary endpoint was the rate of BARC type 3 or 5 bleeding at 1 year, defined as the composite of peri-procedural (within 30 days) or late (after 30 days) bleeding. Results: Patients with at least one VARC-HBR criterion (n=9,267, 88.7%) had a higher risk of BARC 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under ROC curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very high-risk groups (HR: 1.33, 95% CI: 1.04-1.70; and HR: 1.97, 95% CI: 1.53-2.53, respectively). Conclusions: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in TAVR. The results of the present study would support the predictive validity of the newly definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.