Quantifying Atrial Fibrillation Burden to inform Screening, Treatment, and hEalth Policy

Atrial fibrillation (AF) affects every 3rd 55 year-old and causes severe death and severe morbidity, especially stroke and heart failure. AF consumes 2-3% of total healthcare cost in Europe. AF is currently diagnosed in a binary (yes/no) fashion. This has critical limitations, illustrated by low event rates in AF screening trials and in device-detected AF. This creates avoidable uncertainty and anxiety when implanted devices and consumer electronics detect short and rare episodes of AF in real-time. Quantification of AF burden and knowledge on its relation to outcomes can resolve this and harness the health opportunities of consumer-led AF detection. AF-B-STEP will define which AF burden affects health outcomes in patients with AF for implanted devices and intermittent rhythm monitors. This will improve clinical care and facilitate AF innovations.In AF-B-STEP, a public-private partnership, academia, industry, patients and payors work hand-in-glove with device, drug, and m-health industry. Integration of patient voices, health economics, an international external steering committee and of the European Medicines Agency and the FDA ensure high impact and rapid implementation. Multiple large, well-phenotyped, data sets containing AF burden and health outcomes from over 100,000 patients will be combined. This data set will be used to quantify AF burden and to define which AF burden contributes to stroke, heart failure, cardiovascular death and to patient-reported outcomes, cardiac and cognitive function. AF burden-reducing randomized trials will be analysed to validate these effects and to estimate actionable AF burden thresholds. We will define universally applicable standards for the reporting of AF burden by implanted devices and by consumer electronics. Key markers for low and high AF burden will be defined and validated. The project will provide robust data on the impact of AF burden on health. This will enable regulators, guideline writers, clinicians and innovators to integrate AF burden into their work.