AF-B-STEP: Global collaboration
- The new international research project AF-B-STEP aims to systematically record for the first time how long atrial fibrillation lasts in each individual (the respective atrial fibrillation burden) and determine the extent to which this burden influences the risk of stroke or heart failure and affects overall quality of life.
- The project aims to develop uniform standards for how medical devices and technologies, from implantable cardiac devices to smartwatches, quantify atrial fibrillation and the atrial fibrillation burden.
- Eighteen partners from Europe and Canada have joined forces with the aim of fundamentally improving the diagnosis and treatment of people with atrial fibrillation.
At present, atrial fibrillation is not diagnosed quantitatively. The international research project AF-B-STEP aims to change this: for the first time, it will systematically record how long atrial fibrillation lasts in individual patients and to what extent this atrial fibrillation burden influences the risk of stroke or heart failure or affects other aspects of patients' lives. In addition, the project will develop uniform standards for quantifying atrial fibrillation and the burden of atrial fibrillation using medical devices (such as implantable cardiac devices or insertable event recorders) or wearable electronics (e.g. smartwatches). The aim is to fundamentally improve the diagnosis and care of people with atrial fibrillation. To this end, 18 European and Canadian partners from science and industry have joined forces. The project is coordinated by the Department of Cardiology at the University Medical Centre Hamburg-Eppendorf (UKE) and the Medtronic Bakken Research Centre in Maastricht (Netherlands) as the project leader from industry. Over the next four years, the project will receive a total of around €18 million in funding from the Innovative Health Initiative (IHI), with contributions from both the European Union and industry.
‘The results should help doctors to decide more precisely who needs which treatment based on the atrial fibrillation burden. The aim of AF-B-STEP is to contribute to a measurable reduction in strokes and heart failure in the long term, while at the same time avoiding unnecessary treatment for people with a low atrial fibrillation burden,’ says Prof. Dr. Paulus Kirchhof, Director of the Clinic for Cardiology at the UKE and coordinator of the AF-B-STEP project (full title: Quantifying Atrial Fibrillation Burden for Better Screening, Treatment, and HEalth Policy).
Atrial fibrillation increases the risk of stroke and heart failure and is the most common persistent cardiac arrhythmia worldwide. It affects about one-third of people over the age of 55 and accounts for two to three per cent of healthcare costs in Europe and North America. Currently, atrial fibrillation is usually diagnosed simply with a ‘yes’ or ‘no’ answer, and therapeutic decisions are also based predominantly on this simple classification. However, atrial fibrillation occurs in patients in varying degrees and intensities, from rare, short episodes to frequent attacks to permanent atrial fibrillation. The duration of atrial fibrillation, known as atrial fibrillation burden, can significantly influence symptoms, prognosis and therapeutic decisions. Greater atrial fibrillation burden increases the risk of stroke, heart failure, hospital admissions and other adverse effects. Pacemakers and other electronic implants, as well as increasingly smartwatches, fitness trackers and other wearable technologies, now enable the detection of even short and rare episodes of atrial fibrillation. However, there is currently no standardised method for reliably quantifying atrial fibrillation burden and accurately assessing the resulting health risks. In addition, there is no uniform reporting of the data collected by implanted and wearable devices, which makes comparisons between different systems difficult.
Evaluation of data from more than 100,000 patients worldwide
This is where AF-B-STEP comes in, by first compiling and analysing existing data on atrial fibrillation burden and health consequences. To this end, the project partners from science and industry are providing anonymised data sets from more than 100,000 patients. By linking atrial fibrillation burden and clinical outcomes, it should be possible to calculate precisely how much atrial fibrillation contributes to the risk of stroke, heart failure and cardiovascular death, and how atrial fibrillation affects quality of life and heart and brain function. Together with manufacturers of implantable cardiac devices and wearable technologies, the consortium will also develop standardised methods for recording and displaying atrial fibrillation burden to those affected. Ideally, three categories will emerge: low atrial fibrillation burden (no further examinations or therapies required), moderate atrial fibrillation burden (further diagnostics necessary for therapy decision) and high atrial fibrillation burden (immediate initiation of anticoagulation and rhythm control therapy). Improved patient stratification and mechanistic findings can then be incorporated into future treatment guidelines and give greater consideration to the role of atrial fibrillation burden in treatment decisions.
‘By addressing the previously unmet needs in atrial fibrillation management, this large-scale collaborative effort will be fundamental to future efforts to improve the treatment of atrial fibrillation worldwide,’ said Dr Mirko De Melis, Distinguished Clinical Research Advisor at the Medtronic Bakken Research Centre in Maastricht, Netherlands, and industry project leader of AF-B-STEP.
'While atrial fibrillation burden is widely discussed, its clinical application remains limited due to a lack of validated thresholds. AF-B-STEP will fill this gap by bringing together exceptional data sets, experienced researchers and industry partners to enable the practical application of atrial fibrillation burden in clinical care,' says Dr William McIntyre, project leader 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), says: 'Atrial fibrillation is a major global health problem, and the number of people affected – millions worldwide – continues to grow year after year. This project offers a groundbreaking opportunity for researchers, scientists and clinicians to join forces and develop the best approaches for identifying, risk stratifying and caring for people with atrial fibrillation. We hope and believe that in four years' time we will reach a significant turning point in the diagnosis and management 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 investigating the relationship between atrial fibrillation burden and significant outcomes such as stroke and heart failure; This will result in improved care for millions of patients worldwide,' says Prof. Dr. Helmut Pürerfellner, President of the European Heart Rhythm Association (EHRA), partner of AF-B-STEP and specialist unit of the European Society of Cardiology.
‘At BIOTRONIK, we are convinced that clear and consistent reporting standards are crucial for effective research into atrial fibrillation burden and, ultimately, for improving patient care. BIOTRONIK supports the AF-B-STEP project with data and scientific expertise in the development of broadly applicable definitions and methodologies,’ says Dr. Volker Lang, Senior Vice President of Research & Development at BIOTRONIK.
'The scale, scope and strength of this collaboration between science and industry promise not only to create a standardised framework for recording and quantifying atrial fibrillation burden, but above all to link atrial fibrillation burden to serious clinical outcomes. Understanding its relationship to atrial fibrillation burden is critical to deriving clinically relevant endpoints for the future development of urgently needed therapies for this increasing disease risk and growing population burden,' says Dr. Amy Sehnert of Thryv Therapeutics Inc.
International consortium
AF-B-STEP is an international research project that brings together university hospitals, industry representatives from the medical technology, pharmaceutical and digital health sectors, international cardiology organisations, patient groups, project management and knowledge transfer experts, and healthcare payers from Europe and Canada.
The partners are:
- University Medical Centre Hamburg-Eppendorf
- Medtronic Bakken Research Centre 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
- Competence Network Atrial Fibrillation e.V. (AFNET)
- McMaster University
- Medicalgorithmics SA
- Novartis Pharma AG
- Preventicus GmbH
- Societé Europénne de la Cardiologie
- Techniker Krankenkasse
- Thryv Therapeutics Inc.
- Maastricht University
- Withings France SAS
Kick-off Meeting
The AF-B-STEP consortium will meet for the first time in Amsterdam (Netherlands) from 3 to 5 February. The kick-off meeting aims to motivate the team to coordinate and optimise their work with commitment and a clear goal in mind – namely to reduce the burden of atrial fibrillation worldwide and to advance its quantification and treatment.
Funding
The 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, as well as from COCIR, EFPIA, EuropaBio, MedTech Europe, Vaccines Europe and consortium partners Acesion Pharma ApS, Medical Algorithmics, Preventicus GmbH, Thryv Therapeutics Inc. and Withings. The views and opinions expressed are solely those of the authors and do not necessarily reflect those of the above parties. None of the above parties are liable for them.
Further information on the AF-B-STEP project here.
Source: Press release University Medical Centre Hamburg-Eppendorf
