Defining high bleeding risk in patients undergoing transcatheter aortic valve implantation: a VARC-HBR consensus document.
Philippe GarotMarie-Claude MoriceDominick J AngiolilloJosep Rodés- CabauDuk-Woo ParkNicolas M Van MieghemJean-Philippe ColletMartin B LeonGunasekaran SengottuveluAntoinette NeylonJurrien M Ten BergDarren MylotteDidier TchétchéMitchell W KrucoffMichael J ReardonNicolo PiazzaMichael J MackPhilippe GénéreuxRaj MakkarKentaro HayashidaYohei OhnoShuichi MochizukiYuko ShiraiRyosuke MatsumaraYu JinJohn G WebbDonald E CutlipMao ChenErnest SpitzerRoxana MehranDavide CapodannoPublished in: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (2024)
<span style="font-size:12pt"><span style="font-family:Aptos,sans-serif">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.</span></span>.
Keyphrases
- transcatheter aortic valve implantation
- aortic valve
- aortic stenosis
- aortic valve replacement
- patients undergoing
- decision making
- transcatheter aortic valve replacement
- clinical trial
- atrial fibrillation
- ejection fraction
- left ventricular
- primary care
- study protocol
- emergency department
- coronary artery disease
- phase ii
- clinical practice
- machine learning
- artificial intelligence
- heart failure
- deep learning
- medical students
- big data