Reducing the Burden of Atrial Fibrillation
Atrial Fibrillation (AF) is a major cause of serious illness and death, particularly due to stroke and heart failure, accounting for an estimated 2–3% of total healthcare costs in Europe. Based on current estimates, one in three people over the age of 55 will develop AF in their lifetime. Today, AF is typically diagnosed in a simple yes/no manner, which has important limitations, as shown by low event rates in AF screening trials and in device-detected AF. This can lead to avoidable uncertainty and anxiety when implanted devices or consumer electronics detect short and infrequent AF episodes in real time. Furthermore, both overtreatment and undertreatment are likely based on this binary diagnosis. A better understanding and quantification of AF burden, and how it relates to health outcomes, can address these challenges and unlock the full potential of consumer-led AF detection. AF-B-STEP will determine which levels of AF burden meaningfully affect health outcomes in patients monitored with implanted devices and intermittent rhythm monitors, improving clinical care and enabling innovation.
AF-B-STEP brings together academia, patient organisations, and healthcare payers, and device-development, pharmaceutical, and digital health companies. The project will combine large, well-phenotyped datasets from more than 100,000 patients containing validated information on AF burden and relevant health outcomes including stroke, heart failure, cardiovascular death, quality of life, patient-reported outcomes, and cardiac and cognitive function. Randomised trials aimed at reducing AF burden will be analysed to validate these relationships and define actionable thresholds, alongside the development of universally applicable standards for reporting AF burden from implanted devices and consumer electronics. By defining and validating key markers of low and high AF burden, AF-B-STEP will generate robust evidence to support regulators, guideline developers, clinicians, and innovators in integrating AF burden into everyday practice. The project will work closely with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) to ensure high impact and rapid implementation of the project results.
