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.