TY - JOUR
T1 - Defining high bleeding risk in patients undergoing transcatheter aortic valve implantation
T2 - a VARC-HBR consensus document
AU - Garot, Philippe
AU - Morice, Marie-Claude
AU - Angiolillo, Dominick J
AU - Cabau, Josep Rodés-
AU - Park, Duk-Woo
AU - Van Mieghem, Nicolas M
AU - Collet, Jean-Philippe
AU - Leon, Martin B
AU - Sengottuvelu, Gunasekaran
AU - Neylon, Antoinette
AU - Ten Berg, Jurrien M
AU - Mylotte, Darren
AU - Tchétché, Didier
AU - Krucoff, Mitchell W
AU - Reardon, Michael J
AU - Piazza, Nicolo
AU - Mack, Michael J
AU - Généreux, Philippe
AU - Makkar, Raj
AU - Hayashida, Kentaro
AU - Ohno, Yohei
AU - Mochizuki, Shuichi
AU - Shirai, Yuko
AU - Matsumara, Ryosuke
AU - Jin, Yu
AU - Webb, John G
AU - Cutlip, Donald E
AU - Chen, Mao
AU - Spitzer, Ernest
AU - Mehran, Roxana
AU - Capodanno, Davide
PY - 2024/5/10
Y1 - 2024/5/10
N2 - The identification and management of patients at high bleeding risk (HBR) undergoing transcatheter aortic valve implantation (TAVI) are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. VARC-HBR is an initiative of the CERC (Cardiovascular European Research Center), aiming to develop a consensus definition of TAVI patients at HBR, based on a systematic review of the available evidence, to provide consistency for future clinical trials, clinical decision-making, and regulatory review. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI..
AB - The identification and management of patients at high bleeding risk (HBR) undergoing transcatheter aortic valve implantation (TAVI) are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. VARC-HBR is an initiative of the CERC (Cardiovascular European Research Center), aiming to develop a consensus definition of TAVI patients at HBR, based on a systematic review of the available evidence, to provide consistency for future clinical trials, clinical decision-making, and regulatory review. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI..
KW - Humans
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Consensus
KW - Risk Factors
KW - Hemorrhage/etiology
KW - Risk Assessment
KW - Aortic Valve Stenosis/surgery
KW - Aortic Valve/surgery
U2 - 10.4244/EIJ-D-23-01020
DO - 10.4244/EIJ-D-23-01020
M3 - Article
SN - 1774-024X
VL - 20
SP - 536
EP - 550
JO - Eurointervention
JF - Eurointervention
IS - 9
ER -