Prevalence and prognostic implications of the Valve Academic Research Consortium-High Bleeding Risk criteria in patients undergoing transcatheter aortic valve implantation.
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Cao Davide, Sandri Marco, Garot Philippe, Pelliccia Francesco, Radico Francesco, Pasceri Vincenzo, Sartori Samantha, Dangas George D, Mehran Roxana, Capodanno Davide, Morice Marie-Claude, Porto Italo, Biancari Fausto, D'Ascenzo Fabrizio, Saia Francesco, Luzi Giampaolo, Bedogni Francesco, Amat-Santos Ignacio J, De Marzo Vincenzo, Dimagli Arnaldo, Mäkikallio Timo, Stabile Eugenio, García-Gómez Mario, Testa Luca, Barbanti Marco, Tamburino Corrado, Fabbiocchi Franco, Conrotto Federico, Costa Giuliano, Spaccarotella Carmen, Macchione Andrea, La Torre Michele, Bendandi Francesco, Juvonen Tatu, Wanha Wojciech, Wojakowski Wojtec, Benedetto Umberto, Indolfi Ciro, Hildick-Smith David, Miraldi Fabio, Zimarino Marco, Stefanini Giulio, TRITAVI investigators
Аннотация
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.