{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Biomedical Sciences, Humanitas University, Milan, Italy",
        "Institut Cardiovasculaire Paris-Sud (ICPS), Hôpital Privé Jacques Cartier, Massy, France"
      ],
      "name": "Davide Cao"
    },
    {
      "affiliations": [
        "Big and Open Data Innovation Laboratory (BODaI-Lab), University of Brescia, Brescia, Italy"
      ],
      "name": "Marco Sandri"
    },
    {
      "affiliations": [
        "Institut Cardiovasculaire Paris-Sud (ICPS), Hôpital Privé Jacques Cartier, Massy, France",
        "Cardiovascular European Research Center (CERC), Massy, France"
      ],
      "name": "Philippe Garot"
    },
    {
      "affiliations": [
        "Department of Internal, Clinical, Anesthesiological and Cardiovascular Sciences, University of Rome La Sapienza, Rome, Italy"
      ],
      "name": "Francesco Pelliccia"
    },
    {
      "affiliations": [
        "Department of Cardiology, ASL 2 Abruzzo, Chieti, Italy"
      ],
      "name": "Francesco Radico"
    },
    {
      "affiliations": [
        "Cardiology, San Filippo Neri Hospital, Rome, Italy"
      ],
      "name": "Vincenzo Pasceri"
    },
    {
      "affiliations": [
        "Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Samantha Sartori"
    },
    {
      "affiliations": [
        "Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "George D Dangas"
    },
    {
      "affiliations": [
        "Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Roxana Mehran"
    },
    {
      "affiliations": [
        "Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco, Catania, Italy"
      ],
      "name": "Davide Capodanno"
    },
    {
      "affiliations": [
        "Cardiovascular European Research Center (CERC), Massy, France"
      ],
      "name": "Marie-Claude Morice"
    },
    {
      "affiliations": [
        "Department of Internal Medicine and Specialties, University of Genoa, Genova, Italy",
        "Cardiology Unit, Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino, Genova, Italy"
      ],
      "name": "Italo Porto"
    },
    {
      "affiliations": [
        "Department Cardiovascular Surgery, Centro Cardiologico Monzino IRCCS, Milan, Italy"
      ],
      "name": "Fausto Biancari"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Città della Salute e della Scienza, Turin, Italy"
      ],
      "name": "Fabrizio D’Ascenzo"
    },
    {
      "affiliations": [
        "Department of Cardiothoracic Vascular Surgery, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant’Orsola, Bologna, Italy"
      ],
      "name": "Francesco Saia"
    },
    {
      "affiliations": [
        "Cardiovascular Department, Azienda Ospedaliera Regionale San Carlo, Potenza, Italy"
      ],
      "name": "Giampaolo Luzi"
    },
    {
      "affiliations": [
        "Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy"
      ],
      "name": "Francesco Bedogni"
    },
    {
      "affiliations": [
        "CIBERCV, Interventional Cardiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain"
      ],
      "name": "Ignacio J Amat-Santos"
    },
    {
      "affiliations": [
        "Department of Cardiology, ASL 2 Abruzzo, Chieti, Italy",
        "Cardiology Unit, Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino, Genova, Italy"
      ],
      "name": "Vincenzo De Marzo"
    },
    {
      "affiliations": [
        "Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA"
      ],
      "name": "Arnaldo Dimagli"
    },
    {
      "affiliations": [
        "Department of Medicine, South Karelia Central Hospital, University of Helsinki, Lappeenranta, Finland"
      ],
      "name": "Timo Mäkikallio"
    },
    {
      "affiliations": [
        "Cardiovascular Department, Azienda Ospedaliera Regionale San Carlo, Potenza, Italy"
      ],
      "name": "Eugenio Stabile"
    },
    {
      "affiliations": [
        "CIBERCV, Interventional Cardiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain"
      ],
      "name": "Mario García-Gómez"
    },
    {
      "affiliations": [
        "Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy"
      ],
      "name": "Luca Testa"
    },
    {
      "affiliations": [
        "Università degli Studi “Kore”, Enna, Italy"
      ],
      "name": "Marco Barbanti"
    },
    {
      "affiliations": [
        "Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco, Catania, Italy"
      ],
      "name": "Corrado Tamburino"
    },
    {
      "affiliations": [
        "Department of Cardiology, Galeazzi-Sant’Ambrogio Hospital IRCCS, Milan, Italy"
      ],
      "name": "Franco Fabbiocchi"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Città della Salute e della Scienza, Turin, Italy"
      ],
      "name": "Federico Conrotto"
    },
    {
      "affiliations": [
        "Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco, Catania, Italy"
      ],
      "name": "Giuliano Costa"
    },
    {
      "affiliations": [
        "Department of Advanced Biomedical Science, Federico II University, Naples, Italy"
      ],
      "name": "Carmen Spaccarotella"
    },
    {
      "affiliations": [
        "Department of Internal Medicine and Specialties, University of Genoa, Genova, Italy",
        "Cardiology Unit, Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino, Genova, Italy"
      ],
      "name": "Andrea Macchione"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Città della Salute e della Scienza, Turin, Italy"
      ],
      "name": "Michele La Torre"
    },
    {
      "affiliations": [
        "Department of Cardiothoracic Vascular Surgery, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant’Orsola, Bologna, Italy"
      ],
      "name": "Francesco Bendandi"
    },
    {
      "affiliations": [
        "Heart and Lung Center, Helsinki University Central Hospital, University of Helsinki, Helsinki, Finland"
      ],
      "name": "Tatu Juvonen"
    },
    {
      "affiliations": [
        "Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland"
      ],
      "name": "Wojciech Wanha"
    },
    {
      "affiliations": [
        "Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland"
      ],
      "name": "Wojtec Wojakowski"
    },
    {
      "affiliations": [
        "Department of Cardiac Surgery, Gabriele d’Annunzio University of Chieti and Pescara, Chieti, Italy"
      ],
      "name": "Umberto Benedetto"
    },
    {
      "affiliations": [
        "Cardiology, Magna Graecia University, Catanzaro, Italy"
      ],
      "name": "Ciro Indolfi"
    },
    {
      "affiliations": [
        "Department of Cardiology, Royal Sussex County Hospital, Brighton, UK"
      ],
      "name": "David Hildick-Smith"
    },
    {
      "affiliations": [
        "Department of Internal, Clinical, Anesthesiological and Cardiovascular Sciences, University of Rome La Sapienza, Rome, Italy"
      ],
      "name": "Fabio Miraldi"
    },
    {
      "affiliations": [
        "Department of Cardiology, ASL 2 Abruzzo, Chieti, Italy",
        "Department of Neuroscience, Imaging and Clinical Sciences, Department of Sciences, Gabriele d’Annunzio University of Chieti and Pescara, Chieti, Italy"
      ],
      "name": "Marco Zimarino"
    },
    {
      "affiliations": [
        "Department of Biomedical Sciences, Humanitas University, Milan, Italy",
        "Cardio Center, IRCSS Humanitas Research Hospital, Rozzano - Milan, Italy"
      ],
      "name": "Giulio Stefanini"
    },
    {
      "affiliations": [],
      "name": "on behalf of the TRITAVI investigators"
    }
  ],
  "title": "Prevalence and prognostic implications of the Valve Academic Research Consortium-High Bleeding Risk criteria in patients undergoing transcatheter aortic valve implantation",
  "uid": "ef388f0b-f13a-5b61-8264-36f2eaad91f9"
}