Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR.
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Avvedimento Marisa, Cepas-Guillén Pedro, Ternacle Julien, Urena Marina, Alperi Alberto, Cheema Asim, Veiga-Fernandez Gabriela, Nombela-Franco Luis, Vilalta Victoria, Esposito Giovanni, Campelo-Parada Francisco, Indolfi Ciro, Del Trigo Maria, Muñoz-Garcia Antonio, Maneiro Nicolás, Asmarats Lluís, Regueiro Ander, Del Val David, Serra Vicenç, Auffret Vincent, Modine Thomas, Bonnet Guillaume, Mesnier Jules, Suc Gaspard, Avanzas Pablo, Rezaei Effat, Fradejas-Sastre Victor, Tirado-Conte Gabriela, Fernández-Nofrerias Eduard, Franzone Anna, Guitteny Thibaut, Sorrentino Sabato, Francisco Oteo Juan, Nuche Jorge, Gutiérrez-Alonso Lola, Flores-Umanzor Eduardo, Alfonso Fernando, Monastyrski Andrea, Nolf Maxime, Côté Mélanie, Mehran Roxana, Morice Marie-Claude, Capodanno Davide, Garot Philippe, Rodés-Cabau Josep
Аннотация
METHODS: Multicenter study including 10 449 patients undergoing transcatheter aortic valve replacement. Based on consensus, 21 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 the VARC-HBR definition. The primary end point was the rate of Bleeding Academic Research Consortium type 3 or 5 bleeding at 1 year, defined as the composite of periprocedural (within 30 days) or late (after 30 days) bleeding.
RESULTS: Patients with at least 1 VARC-HBR criterion (n=9267, 88.7%) had a higher risk of Bleeding Academic Research Consortium 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 receiver operating characteristic 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 (hazard ratio, 1.33 [95% CI, 1.04-1.70] and 1.97 [95% CI, 1.53-2.53], respectively).
CONCLUSIONS: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in transcatheter aortic valve replacement. The results of the present study would support the predictive validity of the new definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.