Defining high bleeding risk in patients undergoing transcatheter aortic valve implantation: a VARC-HBR consensus document

Philippe Garot, Marie Claude Morice, Dominick J. Angiolillo, Josep Rodés-Cabau, Duk Woo Park, Nicolas M. Van Mieghem, Jean Philippe Collet, Martin B. Leon, Gunasekaran Sengottuvelu, Antoinette Neylon, Jurrien M. ten Berg, Darren Mylotte, Didier Tchétché, Mitchell W. Krucoff, Michael J. Reardon, Nicolo Piazza, Michael J. Mack, Philippe Généreux, Raj Makkar, Kentaro HayashidaYohei Ohno, Shuichi Mochizuki, Yuko Shirai, Ryosuke Matsumara, Yu Jin, John G. Webb, Donald E. Cutlip, Mao Chen, Ernest Spitzer, Roxana Mehran, Davide Capodanno

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)536-550
Number of pages15
JournalEuroIntervention
Volume20
Issue number9
DOIs
StatePublished - 2024

Keywords

  • TAVI
  • bleeding
  • outcomes
  • risk
  • survival
  • valves

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