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Updated: Sep 11, 2025

Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
Published on: August 8, 2025
Prevalence and prognostic implications of the Valve Academic Research Consortium-High Bleeding Risk criteria in
Davide Cao1,2, Marco Sandri3, Philippe Garot2,4
1Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Insights
Nearly 60% of patients undergoing transcatheter aortic valve implantation (TAVI) face high bleeding risk. The Valve Academic Research Consortium (VARC) criteria effectively predict bleeding complications and adverse events in TAVI patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Medicine
Background:
- The Valve Academic Research Consortium (VARC) established criteria for high bleeding risk (HBR) in transcatheter aortic valve implantation (TAVI) patients.
- Evaluating the prevalence and predictive value of these VARC-HBR criteria for in-hospital bleeding is crucial.
Purpose of the Study:
- To assess the distribution of VARC-HBR categories in TAVI patients.
- To determine the association between VARC-HBR criteria and in-hospital bleeding events.
- To evaluate the predictive capability of VARC-HBR for adverse cardiovascular events and mortality.
Main Methods:
- Analysis of 8464 patients undergoing TAVI across 18 European sites (2007-2022) from the Transfusion Requirements in Transcatheter Aortic Valve Implantation registry.
- Stratification of patients into low, moderate, high, or very high bleeding risk groups using VARC-HBR criteria.
- Primary outcome: in-hospital major or life-threatening bleeding (VARC-2 definition).
Main Results:
- A significant proportion of patients were classified as high (39.1%) or very high (23.2%) bleeding risk.
- In-hospital bleeding rates increased progressively with higher VARC-HBR categories (11.0% low risk to 22.2% very high risk; p<0.001).
- Higher bleeding risk correlated with increased major adverse cardiovascular events and mortality, particularly within 3 months post-event.
Conclusions:
- The VARC-HBR criteria identify a substantial number of TAVI patients at elevated risk for bleeding and adverse outcomes.
- These criteria are valuable for risk stratification and may inform clinical management strategies in TAVI.
- Progressive increase in adverse events across bleeding risk categories underscores the importance of bleeding risk assessment in TAVI.
Background:
The Valve Academic Research Consortium (VARC) recently proposed a definition of high bleeding risk (HBR) for patients undergoing transcatheter aortic valve implantation (TAVI). This study aims to evaluate the prevalence and distribution of the VARC-HBR criteria and their ability to predict in-hospital bleeding.
Methods:
Patients undergoing TAVI at 18 European sites between 2007 and 2022 and included in the Transfusion Requirements in Transcatheter Aortic Valve Implantation (NCT03740425) registry were stratified into low, moderate, high or very high bleeding risk using the VARC-HBR criteria. The primary outcome was in-hospital major or life-threatening bleeding (VARC-2 definition).
Results:
Among 8464 patients, bleeding risk was very high in 1966 (23.2%), high in 3311 (39.1%), moderate in 2075 (24.5%) and low in 1112 (13.1%). In-hospital bleeding occurred in 11.0% of those at low risk, compared with 17.2%, 20.0% and 22.2% of patients at moderate, high and very high risk (p<0.001). The association between VARC-HBR criteria and bleeding remained significant after adjustment for calendar time. At 2 years, the incidence of major adverse cardiovascular events ranged from 13.8% in low-risk patients to 13.1%, 18.6% and 25.4% among those at moderate, high and very high risk (p<0.001). Mortality was higher after a bleeding event (HR 1.71, 95% CI 1.50 to 1.95), especially within the first 3 months (HR 2.88, 95% CI 2.33 to 3.56).
Conclusions:
Up to 60% of patients undergoing TAVI are at high or very high bleeding risk. The VARC-HBR criteria identified those at greater risk of adverse events. In-hospital bleeding complications and long-term cardiovascular events increased progressively across VARC-HBR categories.
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