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Publications

Journal Article Review Epublish

PubMed: 42491935 DOI: 10.1093/ehjdh/ztag074

Digital biomarkers in cardiovascular medicine: a scientific statement of the ESC Working Group on e-Cardiology, the ESC Working Group on Cardiovascular Pharmacotherapy, the European Heart Rhythm Association (EHRA) of the ESC, the Association for Acute Cardiovascular Care (ACVC) of the ESC, the Heart Failure Association (HFA) of the ESC, the European Association of Preventive Cardiology (EAPC) of the ESC, the European Association of Cardiovascular Imaging (EACVI) of the ESC, in collaboration with the Digital Cardiology and Artificial Intelligence Committee of the ESC, and the ESC Regulatory Affairs Committee.

Eur Heart J Digit Health 7(6):ztag074

Authors: Pablo M Corredoira, Juan Carlos Kaski, David Duncker, Marcus Dörr, Matthias Wilhelm, Marco Tubaro, Mark J Schuuring, Mamas Mamas, Steffen E Petersen, Rafael Vidal-Pérez, Hareld M C Kemps, Emanuela T Locati, Christian Mueller, Magnus T Jensen, Raffaele De Lucia, Loreena Hill, Julia Ramírez, Matthijs Cluitmans, Nurgül Keser, Axel Verstrael, Polychronis E Dilaveris, Paul A Friedman, Rubén Casado-Arroyo

Affiliations

  • Department of Cardiology, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
  • Molecular and Clinical Sciences Research Institute, St George's, University of London, London, UK.
  • Department of Cardiology and Angiology, Hannover Heart Rhythm Center, Hannover Medical School, Hannover, Germany.
  • Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany.
  • German Centre for Cardiovascular Research (DZHK), partner site Greifswald, Greifswald, Germany.
  • Centre for Rehabilitation and Sports Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Intensive and Interventional Cardiology Unit, P.O. San Filippo Neri, ASL Roma 1, Rome, Italy.
  • Department of Cardiology, Medical Spectrum Twente, Enschede, The Netherlands.
  • Department of Biomedical Signals and Systems, University of Twente, Enschede, The Netherlands.
  • Keele Cardiovascular Research Group, Centre for Prognosis Research, Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
  • William Harvey Research Institute, NIHR Barts Biomedical Research Centre, Queen Mary University of London, London, UK.
  • Barts Heart Centre, St Bartholomew's Hospital, Barts Health NHS Trust, London, UK.
  • Servicio de Cardiología, Unidad de Imagen y Función Cardíaca, Complexo Hospitalario Universitario A Coruña, A Coruña, Spain.
  • Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.
  • Department of Cardiology, Máxima Medical Center, Veldhoven, The Netherlands.
  • Department of Industrial Design, Eindhoven University of Technology, Eindhoven, The Netherlands.
  • Department of Arrhythmology and Electrophysiology, IRCCS Policlinico San Donato, Milan, Italy.
  • Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
  • GREAT Network, Rome, Italy.
  • Steno Diabetes Center Copenhagen, Herlev, Denmark.
  • Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
  • Second Division of Cardiology, Cardiothoracic and Vascular Department, Pisa University Hospital, Pisa, Italy.
  • School of Nursing and Midwifery, Queen's University Belfast, Belfast, UK.
  • Clinical Pharmacology and Precision Medicine, William Harvey Research Institute, Queen Mary University of London, London, UK.
  • Aragon Institute for Engineering Research (I3A), University of Zaragoza, Zaragoza, Spain.
  • Department of Cardiology, Cardiovascular Research Institute Maastricht, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.
  • Department of Cardiology, Health Sciences University, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
  • ESC Patient's Platform, European Society of Cardiology, Sophia Antipolis, France.
  • Research Group Healthcare and Ethics, Faculty of Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium.
  • First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.
  • Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.

Abstract

Cardiovascular disease is the leading cause of morbidity and mortality globally, imposing a substantial patient burden. Digital biomarkers derived from digital health technologies enable quantifiable, near-continuous, real-world capture of pathophysiological signals and are increasingly used across cardiovascular medicine. Their growth is often supported by big data analytics, artificial intelligence and connected sensors within the Internet of Things. This scientific statement systematically reviews digital biomarkers, their clinical utility across the cardiovascular care continuum, and summarizes major methodological and implementation challenges. We searched PubMed/MEDLINE, Embase and Scopus for phase III-IV cardiovascular trials published between 1 January 2019 and 1 August 2024 that collected digital biomarkers. We identified 541 records and included 32 trials (40 reports) enrolling 32 246 participants (44.71% women; mean age 66.2 ± 11.0 years). Heart failure was the most frequent target condition (16 trials, 50%), followed by cardiac implantable electronic devices trials (12 trials, 38%). Digital biomarkers included cardiac rhythm and heart rate, blood pressure, body weight, impedance-based measures, haemodynamic pressures, and physical activity and sleep patterns captured using diverse sensor technologies. Methodological quality was good (modal quality score 5; range 3-7), although most trials were unblinded. Current studies suggest potential clinical utility in selected cardiovascular conditions. Implementation remains challenging because of measurement variability, privacy and regulatory requirements, affordability and reimbursement barriers and inequities in access. Robust validation and outcome- and cost-effectiveness evidence are still needed. Registration number: CRD42024573879.

MeSH

Intelligence, Heart Failure, Heart, Drug Therapy, Cardiology, Biomarkers, Artificial Intelligence, Digital Biomarkers, Digital Health