Evidence map›Paper›PMID 39475194›Full record

ArticleCirculation. Cardiovascular interventions2025

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

Marisa Avvedimento, Pedro Cepas-Guillén, Julien Ternacle, Marina Urena, Alberto Alperi, Asim Cheema, Gabriela Veiga-Fernandez, Luis Nombela-Franco, Victoria Vilalta, Giovanni Esposito and 35 more

Abstract readMulticenter StudyValidation Study
In one paragraph

Article in Circulation. Cardiovascular interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Observational
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

45 authors.

Marisa Avvedimento *Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (M.A., P.C.-G., J.N., M.C., J.R.-C.).ORCID 0000-0002-8443-7888
Pedro Cepas-Guillén *Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (M.A., P.C.-G., J.N., M.C., J.R.-C.).ORCID 0000-0001-8814-7039
Julien TernacleHôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, Pessac, France (J.T., T.M., G.B.).ORCID 0000-0002-9629-5864
Marina UrenaCardiology Department, Bichat-Claude Bernard Hospital, Paris, France (M.U., J.M., G.S.).ORCID 0000-0002-4150-290X
Alberto AlperiCardiology Department, Hospital Universitario Central de Asturias, Oviedo, Spain (A.A., P.A.).ORCID 0000-0002-9939-8949
Asim CheemaSouthlake Regional Health Centre Newmarket, Ontario, Canada (A.C., E.R.).ORCID 0000-0002-3174-8957
Gabriela Veiga-FernandezCardiology Department, Hospital Marques de Valdecilla, Santander, Spain (G.V.-F., V.F.-S.).ORCID 0000-0002-5512-3820
Luis Nombela-FrancoCardiology Department, Instituto Cardiovascular, Hospital Clinico San Carlos, Instituto de Investigación Sanitariadel Hospital Clínico de San Carlos, Madrid, Spain (L.N.-F., G.T.-C.).ORCID 0000-0003-3438-8907
Victoria VilaltaCardiology Department, Hospital Germans Trias i Pujol, Badalona, Spain (V.V., E.F.-N.).ORCID 0000-0003-1767-5963
Giovanni EspositoDepartment of Advanced Biomedical Sciences, University of Naples Federico II, Italy (G.E., A.F.).ORCID 0000-0003-0565-7127
Francisco Campelo-ParadaCardiology Department, Toulouse University Hospital, France (F.C.-P., T.G.).ORCID 0000-0003-1821-0658
Ciro IndolfiDepartment of Medical and Surgical Sciences, Division of Cardiology, 'Magna Graecia' University, Catanzaro, Italy (C.I., S.S.).ORCID 0000-0003-1241-6487
Maria Del TrigoCardiology Department, Hospital Puerta de Hierro, Madrid, Spain (M.d.T., J.F.O.).ORCID 0000-0001-8276-7325
Antonio Muñoz-GarciaCardiology Department, Hospital Regional Virgen de la Victoria, Malaga, Spain (A.M.-G.).
Nicolás ManeiroCardiology Department, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria 12 de Octubre (imas12), Madrid, Spain. Centro de Investigación Biomédica En Red de enfermedades CardioVasculares, Madrid, Spain (N.M., J.N.).ORCID 0000-0003-0957-8434
Lluís AsmaratsCardiology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (L.A., L.G.-A.).ORCID 0000-0002-3357-5834
Ander RegueiroCardiology Department, Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer, Barcelona, Spain (A.R., E.F.-U.).
David Del ValCardiology Department, Hospital de La Princesa, Madrid, Spain (D.d.V., F.A.).ORCID 0000-0001-7784-5501
Vicenç SerraCardiology Department, Vall d'Hebron University Hospital, Barcelona, Spain (V.S., A.M.).
Vincent AuffretDepartment of Cardiology, Rennes University Hospital, University of Rennes, France (V.A., M.N.).ORCID 0000-0003-0535-2120
Thomas ModineHôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, Pessac, France (J.T., T.M., G.B.).ORCID 0000-0003-4169-3766
Guillaume BonnetHôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, Pessac, France (J.T., T.M., G.B.).ORCID 0000-0002-3027-1771
Jules MesnierCardiology Department, Bichat-Claude Bernard Hospital, Paris, France (M.U., J.M., G.S.).ORCID 0000-0002-2131-6763
Gaspard SucCardiology Department, Bichat-Claude Bernard Hospital, Paris, France (M.U., J.M., G.S.).ORCID 0000-0003-2273-1528
Pablo AvanzasCardiology Department, Hospital Universitario Central de Asturias, Oviedo, Spain (A.A., P.A.).ORCID 0000-0002-4958-6108
Effat RezaeiSouthlake Regional Health Centre Newmarket, Ontario, Canada (A.C., E.R.).
Victor Fradejas-SastreCardiology Department, Hospital Marques de Valdecilla, Santander, Spain (G.V.-F., V.F.-S.).ORCID 0000-0002-4434-0264
Gabriela Tirado-ConteCardiology Department, Instituto Cardiovascular, Hospital Clinico San Carlos, Instituto de Investigación Sanitariadel Hospital Clínico de San Carlos, Madrid, Spain (L.N.-F., G.T.-C.).ORCID 0000-0002-7093-3936
Eduard Fernández-NofreriasCardiology Department, Hospital Germans Trias i Pujol, Badalona, Spain (V.V., E.F.-N.).ORCID 0000-0003-2219-921X
Anna FranzoneDepartment of Advanced Biomedical Sciences, University of Naples Federico II, Italy (G.E., A.F.).
Thibaut GuittenyCardiology Department, Toulouse University Hospital, France (F.C.-P., T.G.).ORCID 0009-0001-3673-6760
Sabato SorrentinoDepartment of Medical and Surgical Sciences, Division of Cardiology, 'Magna Graecia' University, Catanzaro, Italy (C.I., S.S.).
Juan Francisco OteoCardiology Department, Hospital Puerta de Hierro, Madrid, Spain (M.d.T., J.F.O.).ORCID 0000-0002-2641-4135
Jorge NucheQuebec Heart and Lung Institute, Laval University, Quebec City, Canada (M.A., P.C.-G., J.N., M.C., J.R.-C.).ORCID 0000-0002-8269-2244
Lola Gutiérrez-AlonsoCardiology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (L.A., L.G.-A.).ORCID 0000-0002-5435-1100
Eduardo Flores-UmanzorCardiology Department, Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer, Barcelona, Spain (A.R., E.F.-U.).ORCID 0000-0002-6428-241X
Fernando AlfonsoCardiology Department, Hospital de La Princesa, Madrid, Spain (D.d.V., F.A.).ORCID 0000-0002-7480-2511
Andrea MonastyrskiCardiology Department, Vall d'Hebron University Hospital, Barcelona, Spain (V.S., A.M.).
Maxime NolfDepartment of Cardiology, Rennes University Hospital, University of Rennes, France (V.A., M.N.).
Mélanie CôtéQuebec Heart and Lung Institute, Laval University, Quebec City, Canada (M.A., P.C.-G., J.N., M.C., J.R.-C.).
Roxana MehranIcahn School of Medicine at Mount Sinai, New York, NY (R.M.).ORCID 0000-0002-5546-262X
Marie-Claude MoriceInstitut Cardiovasculaire Paris-Sud, Hôpital privé Jacques Cartier, Ramsay-Santé, Massy, France (M.-C.M., P.G.).
Davide CapodannoDivision of Cardiology, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico-San Marco," University of Catania, Italy (D.C.).ORCID 0000-0002-5156-7723
Philippe GarotInstitut Cardiovasculaire Paris-Sud, Hôpital privé Jacques Cartier, Ramsay-Santé, Massy, France (M.-C.M., P.G.).ORCID 0009-0001-8960-7006
Josep Rodés-CabauQuebec Heart and Lung Institute, Laval University, Quebec City, Canada (M.A., P.C.-G., J.N., M.C., J.R.-C.).ORCID 0000-0001-8237-7095

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsMulticenter 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.

resultsPatients 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).

conclusionsThe 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.

Indexed as

Aortic Valve StenosisHemorrhagePostoperative HemorrhageTranscatheter Aortic Valve ReplacementAgedAged, 80 and overFemaleHumansMalePredictive Value of TestsReproducibility of ResultsRisk AssessmentRisk FactorsTime FactorsTreatment Outcomebleedingbleeding risk assessmenttranscatheter aortic valve replacementVARC-HBR

Identifiers

PMID39475194
PMCPMC11748903

What Socratic holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.