Prevalence and prognostic implications of the Valve Academic Research Consortium-High Bleeding Risk criteria in patients undergoing transcatheter aortic valve implantation

Background The Valve Academic Research Consortium (VARC) recently proposed a definition of high bleeding risk (HBR) for patients undergoing transcatheter aortic valve implantation (TAVI). This study aims to evaluate the prevalence and distribution of the VARC-HBR criteria and their ability to predict in-hospital bleeding. Methods Patients undergoing TAVI at 18 European sites between 2007 and 2022 and included in the Transfusion Requirements in Transcatheter Aortic Valve Implantation ( NCT03740425 ) registry were stratified into low, moderate, high or very high bleeding risk using the VARC-HBR criteria. The primary outcome was in-hospital major or life-threatening bleeding (VARC-2 definition). Results Among 8464 patients, bleeding risk was very high in 1966 (23.2%), high in 3311 (39.1%), moderate in 2075 (24.5%) and low in 1112 (13.1%). In-hospital bleeding occurred in 11.0% of those at low risk, compared with 17.2%, 20.0% and 22.2% of patients at moderate, high and very high risk (p<0.001). The association between VARC-HBR criteria and bleeding remained significant after adjustment for calendar time. At 2 years, the incidence of major adverse cardiovascular events ranged from 13.8% in low-risk patients to 13.1%, 18.6% and 25.4% among those at moderate, high and very high risk (p<0.001). Mortality was higher after a bleeding event (HR 1.71, 95% CI 1.50 to 1.95), especially within the first 3 months (HR 2.88, 95% CI 2.33 to 3.56). Conclusions Up to 60% of patients undergoing TAVI are at high or very high bleeding risk. The VARC-HBR criteria identified those at greater risk of adverse events. In-hospital bleeding complications and long-term cardiovascular events increased progressively across VARC-HBR categories.