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Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR
Marisa Avvedimento1, Pedro Cepas-Guillén1, Julien Ternacle2
1Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (M.A., P.C.-G., J.N., M.C., J.R.-C.).
Insights
The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) definition effectively identifies patients at increased risk of bleeding and mortality after transcatheter aortic valve replacement. This consensus approach aids clinical practice in managing bleeding risk and improving outcomes.
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.
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.
