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Defining high bleeding risk in patients undergoing transcatheter aortic valve implantation: a VARC-HBR consensus
Philippe Garot1,2, Marie-Claude Morice1,2, Dominick J Angiolillo3
1Institut Cardiovasculaire Paris-Sud (ICPS), Hôpital privé Jacques Cartier, Ramsay-Santé, Massy, France.
Summary
Identifying patients at high bleeding risk (HBR) for transcatheter aortic valve implantation (TAVI) is crucial. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) developed a consensus definition for consistent clinical practice and research.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Accurate identification and management of high bleeding risk (HBR) patients undergoing transcatheter aortic valve implantation (TAVI) are critical.
- Current lack of standardized definitions for HBR poses challenges in TAVI trial design, data interpretation, and clinical decision-making.
Purpose of the Study:
- To develop a consensus definition of HBR in TAVI patients.
- To provide consistency for future clinical trials, clinical decision-making, and regulatory review.
- To establish a pragmatic approach for evaluating safety and effectiveness in HBR TAVI patients.
Main Methods:
- Systematic review of available evidence on TAVI-related bleeding.
- Collaboration among international research organizations, regulatory authorities, and physician-scientists.
- Development of a consensus definition for HBR in the context of TAVI.
Main Results:
- The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) initiative focused on TAVI-related bleeding.
- A pragmatic approach to defining HBR in TAVI patients was established.
- This definition aims to standardize evaluation of procedures, devices, and drug regimens.
Conclusions:
- A consensus definition for HBR in TAVI patients is essential for advancing research and clinical practice.
- The VARC-HBR definition provides a foundation for consistent patient identification and management.
- This initiative promotes improved safety and effectiveness evaluations for HBR patients undergoing TAVI.
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