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

BACKGROUND

The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk in patients undergoing transcatheter aortic valve replacement. The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale transcatheter aortic valve replacement population.

METHODS

Multicenter study including 10 449 patients undergoing transcatheter aortic valve replacement. Based on consensus, 21 clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to the VARC-HBR definition. The primary end point was the rate of Bleeding Academic Research Consortium type 3 or 5 bleeding at 1 year, defined as the composite of periprocedural (within 30 days) or late (after 30 days) bleeding.

RESULTS

Patients with at least 1 VARC-HBR criterion (n=9267, 88.7%) had a higher risk of Bleeding Academic Research Consortium 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very-high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under receiver operating characteristic curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very-high-risk groups (hazard ratio, 1.33 [95% CI, 1.04-1.70] and 1.97 [95% CI, 1.53-2.53], respectively).

CONCLUSIONS

The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in transcatheter aortic valve replacement. The results of the present study would support the predictive validity of the new definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.