Atrial fibrillation burden in clinical practice, research, and technology development: a clinical consensus statement of the European Society of Cardiology Council on Stroke and the European Heart Rhythm Association
- PMID: 40073206
- PMCID: PMC11901050
- DOI: 10.1093/europace/euaf019
Atrial fibrillation burden in clinical practice, research, and technology development: a clinical consensus statement of the European Society of Cardiology Council on Stroke and the European Heart Rhythm Association
Abstract
Atrial fibrillation (AF) is one of the most common cardiac diseases and a complicating comorbidity for multiple associated diseases. Many clinical decisions regarding AF are currently based on the binary recognition of AF being present or absent with the categorical appraisal of AF as continued or intermittent. Assessment of AF in clinical trials is largely limited to the time to (first) detection of an AF episode. Substantial evidence shows, however, that the quantitative characteristic of intermittent AF has a relevant impact on symptoms, onset, and progression of AF and AF-related outcomes, including mortality. Atrial fibrillation burden is increasingly recognized as a suitable quantitative measure of intermittent AF that provides an estimate of risk attributable to AF, the efficacy of antiarrhythmic treatment, and the need for oral anticoagulation. However, the diversity of assessment methods and the lack of a consistent definition of AF burden prevent a wider clinical applicability and validation of actionable thresholds of AF burden. To facilitate progress in this field, the AF burden Consensus Group, an international and multidisciplinary collaboration, proposes a unified definition of AF burden. Based on current evidence and using a modified Delphi technique, consensus statements were attained on the four main areas describing AF burden: Defining the characteristics of AF burden, the recording principles, the clinical relevance in major clinical conditions, and implementation as an outcome in the clinic and in clinical trials. According to this consensus, AF burden is defined as the proportion of time spent in AF expressed as a percentage of the recording time, undertaken during a specified monitoring duration. A pivotal requirement for validity and comparability of AF burden assessment is a continuous or near-continuous duration of monitoring that needs to be reported together with the AF burden assessment. This proposed unified definition of AF burden applies independent of comorbidities and outcomes. However, the disease-specific actionable thresholds of AF burden need to be defined according to the targeted clinical outcomes in specific populations. The duration of the longest episode of uninterrupted AF expressed as a time duration should also be reported when appropriate. A unified definition of AF burden will allow for comparability of clinical study data to expand evidence and to establish actionable thresholds of AF burden in various clinical conditions. This proposed definition of AF burden will support risk evaluation and clinical treatment decisions in AF-related disease. It will further promote the development of clinical trials studying the clinical relevance of intermittent AF. A unified approach on AF burden will finally inform the technology development of heart rhythm monitoring towards validated technology to meet clinical needs.
Keywords: AF burden; Atrial fibrillation; Clinical outcome; ECG monitoring; Heart failure; Mortality; Quality of life; Stroke.
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Conflict of interest statement
Conflict of interest: A.J.C.: personal consulting fees from: Acesion, InCarda, Menarini, Milestone, Sanofi, Anthos, Bayer, Daiichi Sankyo, Pfizer, Abbott, Biosense Webster, Biotronik, Boston Scientific, Medtronic, GlaxoSmithKline, and Johnson & Johnson. B.F.: consultancy fees and speaker fees from BMS/Pfizer Alliance, Speaker fees from Omron, Investigator initiated study grant to the institution BMS/Pfizer Alliance. C.B.-L.: personal consulting fees from Bayer, Medtronic, CathPrint, Philips, Sanofi-Aventis, Boston Scientific, Abbott, Milestone, Organon, Johnson & Johnson, and Merck Sharp & Dohme outside the submitted work. D.D.: speaker/consultancy honoraria from Daiichi Sankyo and AbbVie, outside the submitted work. E.S.: institutional consulting fees or lecture honoraria from Abbott, Astra Zenca, Bayer, Bristol-Myers Squibb-Pfizer, Boehringer Ingelheim, Johnson & Johnson, and Merck Sharp & Dohme. G.B.: speaker fees from Bayer, Boston Scientific, Daiichi Sankyo, Microport, Janssen, and Sanofi outside the submitted work. G.N.: speaker fees/advisory boards/research support from Abbott, AstraZeneca, Boehringer Ingelheim, Javelin, Novartis, Sanofi, and Winmedica; and clinical trial steering/executive committees for Janssen and Javelin Medical. G.Y.H.L.: consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, and Anthos. No fees are received personally. He is a National Institute for Health and Care Research (NIHR) Senior Investigator and co-PI of the AFFIRMO project on multimorbidity in AF (grant agreement no. 899871), TARGET project on digital twins for personalized management of atrial fibrillation and stroke (grant agreement no. 101136244), and ARISTOTELES project on artificial intelligence for management of chronic long-term conditions (grant agreement no. 101080189), which are all funded by the EU’s Horizon Europe Research & Innovation programme. I.C.v.G.: research grant from Medtronic to the institute; funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 945260, EHRA-PATHs; funding from The Netherlands Cardiovascular Research Initiative: an initiative with support of the Dutch Heart Foundation, CVON 2014-9: reappraisal of atrial fibrillation: interaction between hypercoagulability, electrical remodelling, and vascular destabilization in the progression of AF (RACE V) and advisory board Bayer. J.H.S.: speaker fee from Medtronic; advisory board member in Vital Beats and Medtronic; and institutional research grants from European Union (Horizon 2020 and EUROSTARS), Innovation Fund Denmark, and Medtronic. J.L.M.: fees and honoraria for lectures, education, and scientific advice from Biotronik, Microport, and Zoll outside the submitted work. J.S.H.: research grants and speaking fees from Medtronic, Boston Scientific, Bristol Myers Squibb, Bayer, and Servier. K.G.H.: consulting fees or lecture honoraria from Abbott, Alexion, Amarin, AstraZeneca, Bayer Healthcare, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Portola, Premier Research, Sanofi, SUN Pharma, and W.L. Gore and Associates. L.A.S.: speaker honoraria from Pfizer, Boehringer Ingelheim, and Medtronic, research funding from Medtronic. R.B.S.: grants from the European Research Council (ERC) under the European Union’s Horizon 2020 research and innovation programme (grant agreement no. 648131), EU Horizon 2020 programme (grant agreement no. 847770 (AFFECT-EU)), EU Horizon Europe (grant agreement ID: 101095480), German Center for Cardiovascular Research (DZHK e.V.; 81Z1710103 and 81Z0710114), German Ministry of Research and Education (BMBF 01ZX1408A), and ERACoSysMed3 (031L0239); project funding German Heart Foundation; lecture fees and advisory board fees from BMS/Pfizer and Bayer outside this work. R.P.: research support from the National Institute of Health, American Heart Association, Abbott; consulting fees from Abbott, Medtronic, Boston Scientific, Johnson & Johnson, iRhythm; and royalties from UpToDate. R.W.: consulting fees, lecture honoraria, or travel support from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CVRx, Daiichi Sankyo, Medtronic, Novartis, Pfizer, Pharmacosmos, Sciarc, Servier, and Vifor; research grants from Bundesministerium für Bildung und Forschung, Deutsche Forschungsgemeinschaft, Deutsches Zentrum für Herz-Kreislaufforschung, European Union, and Medtronic. T.V.G.: speaker fees and/or consulting fees from Medtronic, Abbott, and Boston Scientific. T.K.: speaker fees and/or consulting fees and/or travel grants from AbbVie, Boehringer Ingelheim, Ipsen, Pfizer, and Viatris. T.P.: none declared. W.D.: personal fees from Aimediq, Bayer, Boehringer Ingelheim, Boston Scientific, Cardiomatics, Medtronic, and Vifor Pharma; travel support from Pharmacosmos; and research support to the institute from EU (Horizon2020), German Ministry of Education and Research, German Center for Cardiovascular Research, Boehringer Ingelheim, and Vifor Pharma.
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