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Multicenter Study
. 2025 Jan;18(1):e014800.
doi: 10.1161/CIRCINTERVENTIONS.124.014800. Epub 2024 Oct 30.

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

Marisa Avvedimento #  1 , Pedro Cepas-Guillén #  1 , Julien Ternacle  2 , Marina Urena  3 , Alberto Alperi  4 , Asim Cheema  5 , Gabriela Veiga-Fernandez  6 , Luis Nombela-Franco  7 , Victoria Vilalta  8 , Giovanni Esposito  9 , Francisco Campelo-Parada  10 , Ciro Indolfi  11 , Maria Del Trigo  12 , Antonio Muñoz-Garcia  13 , Nicolás Maneiro  14 , Lluís Asmarats  15 , Ander Regueiro  16 , David Del Val  17 , Vicenç Serra  18 , Vincent Auffret  19 , Thomas Modine  2 , Guillaume Bonnet  2 , Jules Mesnier  3 , Gaspard Suc  3 , Pablo Avanzas  4 , Effat Rezaei  5 , Victor Fradejas-Sastre  6 , Gabriela Tirado-Conte  7 , Eduard Fernández-Nofrerias  8 , Anna Franzone  9 , Thibaut Guitteny  10 , Sabato Sorrentino  11 , Juan Francisco Oteo  12 , Jorge Nuche  1   14 , Lola Gutiérrez-Alonso  15 , Eduardo Flores-Umanzor  16 , Fernando Alfonso  17 , Andrea Monastyrski  18 , Maxime Nolf  19 , Mélanie Côté  1 , Roxana Mehran  20 , Marie-Claude Morice  21 , Davide Capodanno  22 , Philippe Garot  21 , Josep Rodés-Cabau  1
Affiliations
Multicenter Study

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

Marisa Avvedimento et al. Circ Cardiovasc Interv. 2025 Jan.

Abstract

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.

Keywords: VARC-HBR; bleeding; bleeding risk assessment; transcatheter aortic valve replacement.

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Conflict of interest statement

Dr Ternacle is a consultant for Abbott. Dr Modine is a consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Asmarats has received speaker fees from Edwards Lifesciences. Dr Capodanno has received payments to the institution from Medtronic and personal fees from Sanofi, Novo Nordisk, and Terumo. Dr Morice served as a shareholder and chief executive officer (CEO) of Cardiovascular European Research Center (CERC) and minor shareholder of Electroducer. Dr Garot has received proctor/advisory fees from Abbott, Biosensors, Boston Scientific, Cordis, General Electric HealthCare, and Terumo. He served as co-medical director and shareholder of CERC Contract Research Organization (CRO), organizing the Valve Academic Research Consortium for High Bleeding Risk initiative (nonprofit initiative, as per Academic Research Consortium [ARC] Charter). Dr Rodés-Cabau has received institutional research grants and consultant/speaker fees from Edwards Lifesciences and Medtronic. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
Prevalence of the Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) criteria. Bars indicate the overall prevalence of each major and minor VARC-HBR criteria. APT indicates antiplatelet therapy; BMI, body mass index; CKD, chronic kidney disease; DAPT, dual antiplatelet therapy; OAC, oral anticoagulation; PAD, peripheral artery disease; and SFAR, sheath-to-femoral artery ratio.
Figure 2.
Figure 2.
Cumulative incidence of the primary bleeding end point at 1 year. Kaplan-Meier curves showing rates of the primary bleeding end point (Bleeding Academic Research Consortium [BARC] 3 or 5 bleeding) at 1 year according to the presence or absence of Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) criteria in patients transcatheter aortic valve replacement (TAVR). HR indicates hazard ratio.
Figure 3.
Figure 3.
Periprocedural and late bleeding risk according to periprocedural and non-periprocedural risk factors. A, Distribution of Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) bleeding risk defined according to the presence of periprocedural factors (top, left). Risk of periprocedural Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (within 30 days) according to patient bleeding risk (top, right). B, Distribution of VARC-HBR bleeding risk defined according to the presence of non-periprocedural factors (bottom, left). Risk of late BARC 3 or 5 bleeding (after 30 days) according to patient bleeding risk (bottom, right).
Figure 4.
Figure 4.
Additive effect of multiple Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) criteria. Risk of the primary bleeding end point at 1 year for each increased number of VARC-HBR criteria. Compared with patients without VARC-HBR criteria, those with VARC-HBR criteria have an increased risk of Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding, with a gradual increase as a function of the coexisting risk factors.
Figure 5.
Figure 5.
Kaplan-Meier curves for all-cause mortality stratified according to Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) risk stratification. Kaplan-Meier estimates for 1-year all-cause mortality according to VARC-HBR risk. One-year all-cause mortality: 7.3% in low risk (95% CI, 5.9–9.1), 6.5% in moderate risk (95% CI, 5.6–7.5), 9.8% in high risk (95% CI, 8.9–10.8), and 14.0% in very high risk (95% CI, 12.7–15.5). HR indicates hazard ratio; Ref, reference; and TAVR, transcatheter aortic valve replacement.
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