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

Area of Science:

• Cardiology
• Interventional Cardiology
• Clinical Risk Stratification

Background:

• The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) developed a consensus document to identify high bleeding risk in patients undergoing transcatheter aortic valve replacement (TAVR).
• Evaluating the prevalence and predictive value of the VARC-HBR definition in a large TAVR population is crucial for clinical application.

Purpose of the Study:

• To assess the prevalence and predictive accuracy of the VARC-HBR bleeding risk definition.
• To evaluate the association between VARC-HBR risk categories and clinical outcomes, including bleeding events and mortality, in TAVR patients.

Main Methods:

• A multicenter study included 10,449 patients undergoing TAVR.
• Patients were stratified into low, moderate, high, and very-high bleeding risk groups based on 21 VARC-HBR clinical and laboratory criteria.
• The primary endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 1 year.

Main Results:

• 88.7% of patients met at least one VARC-HBR criterion, with increased BARC 3/5 bleeding rates (10.8% to 24.6%) corresponding to higher risk strata.
• A gradual increase in 1-year all-cause mortality was observed with increasing VARC-HBR risk categories.
• High and very-high-risk groups showed up to a 2-fold increased mortality risk (HR 1.33 and 1.97, respectively).

Conclusions:

• The VARC-HBR consensus provides a pragmatic framework for bleeding risk stratification in TAVR.
• The study supports the predictive validity of the VARC-HBR definition for bleeding events and mortality.
• Applying the VARC-HBR definition in clinical practice may help minimize bleeding risk and improve TAVR patient outcomes.