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New international research project AF-B-STEP will for the first time systematically assess how much time individuals spend in atrial fibrillation (AF) — their AF burden — and determine how this burden affects risks such as stroke, heart failure, and overall quality of life.
The project will develop uniform standards for how medical devices and consumer technologies from implantable monitors to smartwatches detect and quantify AF and its burden.
Eighteen partners from Europe and Canada have joined forces in this initiative with the aim of fundamentally improving the diagnosis and care of people with AF. AFNET is one of these partners.
Atrial fibrillation (AF) affects millions of people worldwide – yet the condition is rarely quantified upon diagnosis. The international research project AF-B-STEP aims to change this: for the first time, it will systematically assess how much time individuals spend in AF, expressed as their AF burden, and determine the extent to which the AF burden influences the risk of stroke, heart failure and other aspects of patients´ lives. Furthermore, the project will develop uniform standards for how medical devices (such as cardiac implantable devices or insertable cardiac monitors) and consumer electronics (e.g., smartwatches) quantify AF and its burden. The goal is to fundamentally improve the diagnosis and care of people with AF. 18 partners across Europe and Canada from academia and industry have joined forces for this project, coordinated by the Department of Cardiology at the University Heart and Vascular Center of the University Medical Center Hamburg-Eppendorf (UKE) in Hamburg, Germany, and by the Medtronic Bakken Research Center in Maastricht, The Netherlands, as industry lead. The project will be funded over the next four years with a total of approximately 18 million euros by the Innovative Health Initiative (IHI) with contributions from both the European Union and industry.
“The results are intended to help physicians make more precise decisions about who needs which treatment based on the AF burden. The goal of AF-B-STEP is to contribute to a measurable reduction in strokes and heart failure in the long term, while simultaneously avoiding unnecessary treatments in people with a low atrial fibrillation burden,” says Prof. Dr. Paulus Kirchhof, Director of the Department of Cardiology at the University Medical Center Hamburg-Eppendorf (UKE), AFNET board chair, and coordinator of the AF-B-STEP project (full project title: Quantifying Atrial Fibrillation Burden for Better Screening, Treatment, and HEalth Policy).
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide and increases the risk of stroke and heart failure. It affects about one-third of people over the age of 55 and accounts for two to three percent of healthcare costs in Europe and North America. Currently, AF is usually diagnosed simply with “yes” or “no,” and therapeutic decisions are also predominantly based on this simple classification. However, patients experience many different patterns and intensities of AF: from rare, short episodes to frequent episodes and chronic forms when AF is present all of the time. The time in AF, the so-called AF burden, has an important impact on symptoms, prognosis, and therapeutic decisions. The risk of stroke, heart failure, hospital admissions and other adverse outcomes increases with a higher AF burden. Implantable cardiac devices and, increasingly, smartwatches, fitness trackers, and other wearable technologies now allow even short and infrequent episodes to be detected. However, a standardised method for accurately quantifying AF burden and precisely assessing the resulting health risks is still lacking. Furthermore, the data collected by implanted and wearable devices are not reported uniformly, which complicates comparisons between different systems.
Analysis of data from more than 100,000 patients worldwide
This is the starting point of AF-B-STEP, which initially compiles and analyzes existing data on AF burden and its health consequences. For this purpose, consortium partners from academia and industry are providing anonymised data from more than 100,000 patients. By linking AF burden with clinical outcomes, it should be possible to precisely calculate its contribution to stroke, heart failure, and cardiovascular death, as well as how AF affects quality of life as well as cardiac and brain function. Together with manufacturers of implantable cardiac devices and wearable technologies, the consortium will also develop standardised methods for recording and displaying AF burden to affected individuals. Ideally, three categories will emerge: low AF burden (no further investigations or therapies required), moderate AF burden (further diagnostics necessary for treatment decisions), and high AF burden (immediate initiation of anticoagulation and rhythm control therapy). Better patient stratification and mechanistic results can then inform future treatment guidelines and strengthen the role of AF burden in treatment decisions.
“By addressing the unmet needs in atrial fibrillation management, this large concerted collaboration will be foundational to help guide future efforts to improve the management of AF globally,” said Dr. Mirko De Melis, Distinguished Clinical Research Advisor at Medtronic Bakken Research Center in Maastricht, The Netherlands and Industry Lead of the AF-B-STEP project.
“While atrial fibrillation burden is widely discussed, its clinical application remains limited by the absence of validated thresholds. AF-B-STEP will address this gap by uniting exceptional datasets, experienced investigators, and industry collaborators to enable the practical use of AF burden in clinical care,” said Dr. William McIntyre, project lead and scientist at the Population Health Research Institute, a joint institute of McMaster University and Hamilton Health Sciences.
Prof. Dr. Barbara Casadei, Head of the National Heart and Lung Institute at Imperial College London, UK, said: “Atrial fibrillation is a major global health concern, and the numbers – in the millions - continue to increase every year. This project is a landmark opportunity for researchers, scientists and clinicians to seize the initiative and find the best ways to assess, risk-stratify and manage people with the condition. We hope and believe that in four years’ time we will be embarking on a significant step change in the diagnosis and care of atrial fibrillation.”
“For too long, atrial fibrillation has been treated as a simple ‘yes or no’ condition. AF-B-STEP has the potential to change clinical practice by linking AF burden to meaningful outcomes such as stroke and heart failure, ultimately improving care for millions of patients worldwide,” says Prof. Dr. Helmut Pürerfellner, President of the European Heart Rhythm Association (EHRA), an AF-B-STEP partner and a branch of the European Society of Cardiology.
“At BIOTRONIK, we believe that clear, consistent standards for reporting are essential to effectively researching atrial fibrillation burden and ultimately improving patient care. Through our data and scientific expertise, we support the AF B STEP project in developing definitions and methodologies that can be broadly applied,” said Dr. Volker Lang, Senior Vice President Research & Development at BIOTRONIK.
“The magnitude, scope and strength of this academic - industry collaboration promises to deliver not only a standardized framework to measure and quantify atrial fibrillation burden, but importantly to link AF burden to serious outcomes. Understanding this relationship between AF burden and outcomes is key to defining clinically meaningful endpoints for future development of much needed treatments in this growing area of disease risk and population burden,” said Dr. Amy Sehnert from Thryv Therapeutics Inc.
International Consortium
AF-B-STEP is an international research project bringing together university medical centres, industry representatives from the medical device, pharmaceutical, and digital health sectors, international cardiology organisations, patient groups, management and dissemination professionals, and healthcare payers from Europe and Canada.
The partners include:
• Universitätsklinikum Hamburg-Eppendorf
• Medtronic Bakken Research Center B.V.
• Acesion Pharma ApS
• BIOTRONIK SE & Co. KG
• Boston Scientific International SA
• concentris research management GmbH
• IDM gGmbH
• Imperial College of Science Technology and Medicine
• Kompetenznetz Vorhofflimmern e.V. (AFNET)
• McMaster University
• Medicalgorithmics SA
• Novartis Pharma AG
• Preventicus GmbH
• Societé Europénne de la Cardiologie
• Techniker Krankenkasse
• Thryv Therapeutics Inc.
• Universiteit Maastricht
• Withings France SAS
Kick-off Meeting
The AF-B-STEP Consortium convenes for the first time in Amsterdam, The Netherlands, from 3rd-5th February. The kick-off meeting is intended to motivate the team to coordinate and streamline the work with dedication and a clear purpose – to reduce the global burden of AF and advance its quantification and treatment.
Funding
This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101252780. The JU receives support from the European Union’s Horizon Europe research and innovation programme, COCIR, EFPIA, EuropaBio, MedTech Europe, Vaccines Europe, and from consortium partners Acesion Pharma ApS, Medical Algorithmics, Preventicus GmbH, Thryv Therapeutics Inc., and Withings. Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.
For more information
For more information on AF-B-STEP, please visit https://afbstep.eu/ or any of the project’s social media channels: LinkedIn, BlueSky or X. You can also contact the project via email: info@afbstep.eu
About the Atrial Fibrillation NETwork (AFNET)
The Atrial Fibrillation NETwork is an interdisciplinary research network comprising scientists and physicians from hospitals and practices dedicated to improving the management of atrial fibrillation through coordinated research in Germany, Europe, and worldwide. Its main objective is to conduct high quality investigator-initiated clinical trials and registries on a national and international level as well as translational research projects. The AFNET continues the long-term activities of the network which has been funded by the German Federal Ministry of Research and Education over a decade. Since January 2015, specific projects and infrastructures of the AFNET are funded by the German Centre for Cardiovascular Research (DZHK), and some projects by EU research grants. AFNET has long expertise in the management of atrial fibrillation, but also provides support for work in other fields informing cardiovascular care. The results of 20 years of clinical and translational research improved the lives of patients with cardiovascular diseases and influenced treatment guidelines.
https://www.af-net.eu
Press Contact
Angelika Leute, PhD
Phone: +49 202 2623395
a.leute@t-online.de
https://afbstep.eu/
https://www.linkedin.com/company/af-b-step
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https://x.com/AF_B_STEP
https://www.af-net.eu
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