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

Autor: Avvedimento M; Quebec Heart and Lung Institute, Laval University, Quebec City, Canada., Cepas-Guillén P; Quebec Heart and Lung Institute, Laval University, Quebec City, Canada., Ternacle J; Hôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, France., Urena M; Cardiology Department, Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France., Alperi A; Cardiology Department, Hospital Universitario Central de Asturias, Oviedo, Spain., Cheema A; Southlake Regional Health Centre Newmarket, Ontario, Canada., Veiga G; Cardiology Department, Hospital Marques de Valdecilla, Santander, Spain., Nombela-Franco L; Cardiology Department, Instituto Cardiovascular, Hospital Clinico San Carlos, IdISSC, Madrid, Spain., Vilalta V; Cardiology Department, Hospital Germans Trias i Pujol, Badalona, Spain., Esposito G; Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy., Campelo-Parada F; Cardiology Department, Toulouse University Hospital, Toulouse, France., Indolfi C; Department of Medical and Surgical Sciences, Division of Cardiology, 'Magna Graecia' University, Catanzaro, Italy., Del Trigo M; Cardiology Department, Hospital Puerta de Hierro, Madrid, Spain., Muñoz-Garcia A; Cardiology Department, Hospital Regional Virgen de la Victoria, Malaga, Spain., Maneiro-Melón NM; Cardiology Department, Hospital Universitario 12 de Octubre. Instituto de Investigación Sanitaria 12 de Octubre (imas12). Madrid, Spain. Centro de Investigación Biomédica En Red de enfermedades CardioVasculares (CIBERCV). Spain., Asmarats L; Cardiology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Regueiro A; Cardiology Department, Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain., Del Val D; Cardiology Department, Hospital de La Princesa, Madrid, Spain., Serra V; Cardiology Department, Vall d'Hebron University Hospital, Barcelona, Spain., Auffret V; University of Rennes, Rennes University Hospital, Department of Cardiology, Rennes, France., Modine T; Hôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, France., Bonnet G; Hôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, France., Mesnier J; Cardiology Department, Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France., Suc G; Cardiology Department, Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France., Avanzas P; Cardiology Department, Hospital Universitario Central de Asturias, Oviedo, Spain., Rezaei E; Southlake Regional Health Centre Newmarket, Ontario, Canada., Fradejas-Sastre V; Cardiology Department, Hospital Marques de Valdecilla, Santander, Spain., Tirado-Conte G; Cardiology Department, Instituto Cardiovascular, Hospital Clinico San Carlos, IdISSC, Madrid, Spain., Fernandez-Nofrerias E; Cardiology Department, Hospital Germans Trias i Pujol, Badalona, Spain., Franzone A; Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy., Guitteny T; Cardiology Department, Toulouse University Hospital, Toulouse, France., Sorrentino S; Department of Medical and Surgical Sciences, Division of Cardiology, 'Magna Graecia' University, Catanzaro, Italy., Oteo JF; Cardiology Department, Hospital Puerta de Hierro, Madrid, Spain., Nuche J; Quebec Heart and Lung Institute, Laval University, Quebec City, Canada; Cardiology Department, Hospital Universitario 12 de Octubre. Instituto de Investigación Sanitaria 12 de Octubre (imas12). Madrid, Spain. Centro de Investigación Biomédica En Red de enfermedades CardioVasculares (CIBERCV). Spain., Gutiérrez-Alonso L; Cardiology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Flores Umanzor E; Cardiology Department, Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain., Alfonso F; Cardiology Department, Hospital de La Princesa, Madrid, Spain., Monastyrski A; Cardiology Department, Vall d'Hebron University Hospital, Barcelona, Spain, Spain., Nolf M; University of Rennes, Rennes University Hospital, Department of Cardiology, Rennes, France, France., Côté M; Quebec Heart and Lung Institute, Laval University, Quebec City, Canada., Mehran R; Icahn School of Medicine at Mount Sinai, New York, NY, USA., Morice MC; Institut Cardiovasculaire Paris-Sud (ICPS), Hôpital privé Jacques Cartier, Ramsay-Santé, Massy, France., Capodanno D; Division of Cardiology, Azienda Ospedaliero-Universitaria Policlinico 'G. Rodolico-San Marco', University of Catania, Catania, Italy., Garot P; Institut Cardiovasculaire Paris-Sud (ICPS), Hôpital privé Jacques Cartier, Ramsay-Santé, Massy, France., Rodés-Cabau J; Quebec Heart and Lung Institute, Laval University, Quebec City, Canada.
Jazyk: angličtina
Zdroj: Circulation. Cardiovascular interventions [Circ Cardiovasc Interv] 2024 Oct 30. Date of Electronic Publication: 2024 Oct 30.
DOI: 10.1161/CIRCINTERVENTIONS.124.014800
Abstrakt: 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.
Databáze: MEDLINE
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