VARC-HBR criteria validation in TAVI patients on oral anticoagulation

Daniël C. Overduin¹, MD; Dirk Jan van Ginkel¹, MD; Willem L. Bor¹, MD; Yusuke Kobari², MD, PhD; Hugo M. Aarts³^,⁴, MD; Christophe Dubois⁵, MD, PhD; Ole De Backer², MD, PhD; Maxim J.P. Rooijakkers⁶, MD; Liesbeth Rosseel⁷, MD, PhD; Leo Veenstra⁸^,⁹, MD; Frank van der Kley¹⁰, MD, PhD; Kees H. van Bergeijk¹¹, MD; Nicolas M. van Mieghem¹², MD, PhD; Pierfrancesco Agostoni¹³, MD, PhD; Michiel Voskuil⁴, MD, PhD; Carl E. Schotborgh¹⁴, MD; Alexander J.J. Ijsselmuiden⁸^,⁹, MD, PhD; Jan A.S. Van Heyden¹⁵, MD, PhD; Renicus S. Hermanides¹⁶, MD, PhD; Emanuele Barbato¹⁷^,¹⁸, MD, PhD; Darren Mylotte¹⁹, MD, PhD; Enrico Fabris²⁰, MD, PhD; Peter Frambach²¹, MD; Karl Dujardin²², MD, PhD; Bert Ferdinande²³, MD; Joyce Peper¹, PhD; Benno J.W.M. Rensing¹, MD, PhD; Leo Timmers¹, MD, PhD; Martin J. Swaans¹, MD, PhD; Jorn Brouwer¹, MD, PhD; Vincent J. Nijenhuis¹^,⁶, MD, PhD; Tom Adriaenssens⁵, MD, PhD; Pieter A. Vriesendorp⁸^,⁹, MD, PhD; Jose M. Montero-Cabezas¹⁰, MD, PhD; Hicham El Jattari¹³, MD; Jonathan Halim²⁴, MD; Ben J.L. Van den Branden²⁵, MD, PhD; Remigio Leonora¹⁶, MD; Marc Vanderheyden⁷, MD; Michael Lauterbach²², MD, PhD; Joanna J. Wykrzykowska¹¹, MD, PhD; Arnoud W.J. van ’t Hof⁸^,⁹, MD, PhD; Niels van Royen⁶, MD, PhD; Jan G.P. Tijssen³, PhD; Ronak Delewi³, MD, PhD; Jurriën M. Ten Berg¹^,⁸^,⁹, MD, PhD

1. Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands; 2. The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 3. Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands; 4. Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands; 5. Department of Cardiovascular Medicine, University Hospital Leuven, Leuven, Belgium; 6. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands; 7. Department of Cardiology, Hartcentrum Aalst, Aalst, Belgium; 8. Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands; 9. Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands; 10. Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands; 11. Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands; 12. Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands; 13. Department of Cardiology, Hospital Aan de Stroom (ZAS) Middelheim, Antwerp, Belgium; 14. Department of Cardiology, Haga Hospital, The Hague, the Netherlands; 15. Department of Cardiology, Sint-Jan Hospital, Brugge, Belgium; 16. Department of Cardiology, Isala Hospital, Zwolle, the Netherlands; 17. Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy; 18. Department of Cardiology, Sant’Andrea University Hospital, Rome, Italy; 19. Department of Cardiology, University Hospital Galway, Galway, Ireland; 20. Cardiothoracovascular Department, University of Trieste, Trieste, Italy; 21. Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg; 22. Department of Cardiology, AZ Delta, Roeselare, Belgium; 23. Department of Cardiology, Hospital Oost-Limburg, Genk, Belgium; 24. Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, the Netherlands; 25. Department of Cardiology, Amphia Hospital, Breda, the Netherlands

Abstract

Background: Bleeding remains a frequent complication after transcatheter aortic valve implantation (TAVI). Recently, the Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) criteria were introduced to identify patients at (very) high risk of bleeding.

Aims: This study aimed to evaluate the validity of the VARC-HBR criteria for predicting bleeding risk in TAVI patients and to compare its performance with other existing criteria.

Methods: Data were obtained from the POPular PAUSE TAVI trial, a randomised clinical trial that evaluated the safety and efficacy of continuation versus interruption of oral anticoagulation during TAVI. Major and minor bleeding risk criteria were identified at baseline, and bleeding events were recorded up to 30 days after TAVI. Patients were classified into three groups: those with ≤1 minor criterion (moderate risk), those with 1 major or 2 minor criteria (high risk), and those with ≥2 major or ≥3 minor criteria (very high risk).

Results: A total of 856 patients were included: 332 (39%) were classified at moderate bleeding risk, 337 (39%) at high bleeding risk, and 187 (22%) at very high bleeding risk. Major bleeding occurred in 4.2% of moderate-risk patients, 9.5% in the high-risk group, and 15.0% in the very high-risk group (p<0.001). Receiver operating characteristic analysis showed moderate discriminative performance (area under the curve=0.64, 95% confidence interval: 0.58-0.70). Despite higher-than-expected event rates, the VARC-HBR criteria demonstrated good calibration with observed outcomes.

Conclusions: The VARC-HBR criteria effectively identified distinct subgroups with a stepwise increase in major bleeding post-TAVI. However, their predictive performance for individual risk was moderate.

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