Universität zu Köln

Nienaber, Stephan ORCID: 0000-0001-5779-7549, Himken, Janosch, Meertens, Max, Mauri, Victor ORCID: 0000-0003-2678-3501, Lee, Samuel ORCID: 0000-0001-6768-7079, Curio, Jonathan ORCID: 0000-0002-3437-7450, Kuhn, Elmar ORCID: 0000-0001-6301-7422, Nies, Richard ORCID: 0000-0002-1336-6031, Eghbalzadeh, Kaveh ORCID: 0000-0001-6941-7785, Dohr, Johannes, Baldus, Stephan ORCID: 0000-0001-8259-1737, Wienemann, Hendrik ORCID: 0000-0001-5810-2868 and Adam, Matti ORCID: 0000-0002-6990-8135 (2025). Comparison of Valve Academic Research Consortium (VARC)‐2 and VARC‐3 Criteria for Bleeding Complications After Transcatheter Aortic Valve Replacement. Journal of the American Heart Association, 14 (15). pp. 1-13. American Heart Association / Wiley. ISSN 2047-9980

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Abstract

[Artikel-Nr.: e039342] Background: The Valve Academic Research Consortium (VARC) has updated criteria for periprocedural bleeding after transcatheter aortic valve replacement. However, clinical validation of the VARC‐3 bleeding definition is scarce. The aim of this study was to evaluate incidence, associated variables, and clinical impact of VARC‐3 bleeding. Methods The study included 2227 patients with severe aortic stenosis undergoing transcatheter aortic valve replacement between 2018 and 2023 at the University Hospital Cologne. VARC‐3 bleeding during the index hospitalization were analyzed. Incidence, variables associated with bleeding, and impact on 30‐day mortality were evaluated by comparison to the VARC‐2 criteria. All data were prospectively collected. Results: VARC‐3 bleeding was 2.5 times more prevalent than VARC‐2 (13.9% versus 34.4%), as VARC‐3 includes nonattributable blood loss >3 g/dL as a bleeding event. Chronic kidney disease, thoracotomy access, dual antiplatelet therapy (P<0.001 for all), and female sex (P=0.023) were variables associated with VARC‐3 bleedings. Type 3 bleeding (VARC‐3) was associated with an increased 30‐day mortality (hazard ratio [HR], 2.89 [95% CI, 1.35–6.19], P=0.006). VARC‐2 major and life‐threatening bleeding events were associated with increased 30‐day mortality as well (HR, 2.74 [95% CI, 1.26–5.95], P=0.011 and HR, 29.60 [95% CI, 17.42–50.30], P<0.001). Conclusions: The VARC‐3 criteria present a refined classification for bleeding with prognostic relevance. However, the VARC‐2 criteria demonstrate precision and clear correlation with increasing mortality risk proportional to the severity of bleeding too, showing even greater predictive accuracy in the transfemoral cohort. These findings require further validation with similar or even larger patient cohorts.

Item Type:	Article
Creators:	Creators Email ORCID ORCID Put Code Nienaber, Stephan UNSPECIFIED https://orcid.org/0000-0001-5779-7549 UNSPECIFIED Himken, Janosch UNSPECIFIED UNSPECIFIED UNSPECIFIED Meertens, Max UNSPECIFIED UNSPECIFIED UNSPECIFIED Mauri, Victor UNSPECIFIED https://orcid.org/0000-0003-2678-3501 UNSPECIFIED Lee, Samuel UNSPECIFIED https://orcid.org/0000-0001-6768-7079 UNSPECIFIED Curio, Jonathan UNSPECIFIED https://orcid.org/0000-0002-3437-7450 UNSPECIFIED Kuhn, Elmar UNSPECIFIED https://orcid.org/0000-0001-6301-7422 UNSPECIFIED Nies, Richard UNSPECIFIED https://orcid.org/0000-0002-1336-6031 UNSPECIFIED Eghbalzadeh, Kaveh UNSPECIFIED https://orcid.org/0000-0001-6941-7785 UNSPECIFIED Dohr, Johannes UNSPECIFIED UNSPECIFIED UNSPECIFIED Baldus, Stephan UNSPECIFIED https://orcid.org/0000-0001-8259-1737 UNSPECIFIED Wienemann, Hendrik UNSPECIFIED https://orcid.org/0000-0001-5810-2868 UNSPECIFIED Adam, Matti UNSPECIFIED https://orcid.org/0000-0002-6990-8135 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-810212
Identification Number:	10.1161/JAHA.124.039342
Journal or Publication Title:	Journal of the American Heart Association
Volume:	14
Number:	15
Page Range:	pp. 1-13
Number of Pages:	13
Date:	5 August 2025
Publisher:	American Heart Association / Wiley
ISSN:	2047-9980
Language:	English
Faculty:	Faculty of Medicine
Divisions:	Faculty of Medicine > Innere Medizin > Klinik III für Innere Medizin - Kardiologie, Pneumologie, Angiologie und internistische Intensivmedizin
Subjects:	Medical sciences Medicine
Uncontrolled Keywords:	Keywords Language bleeding complications after TAVR ; prognostic relevance of bleeding ; VARC-2 ; VARC-3 English
['eprint_fieldname_oa_funders' not defined]:	Publikationsfonds UzK
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/81021