Digital screening for atrial fibrillation to prevent stroke: the Austrian Digital Heart Program

Atrial fibrillation (AF) affects ∼59 million individuals globally and is a leading cause of stroke, heart failure, and mortality.1 Austria ranks among the European countries with the highest age-standardized AF incidence.2 Importantly, up to one-third of patients experience AF-related complications prior to a formal arrhythmia diagnosis.3,4 Therefore, AF screening with subsequent holistic management holds the promise to mitigate AF-related disease burden, yet early AF detection remains challenging in clinical practice. Current ESC guidelines recommend routine heart rhythm assessment for early AF detection during healthcare contact for all individuals aged ≥65 years (Class I, Level C) and consider population-based non-invasive ECG screening in those aged ≥75 years or ≥65 years with additional CHA₂DS₂-VA risk factors (Class IIa, Level B).5 Nevertheless, routine implementation remains limited also because the clinical benefit of AF screening on hard cardiovascular outcomes is still uncertain.5,6 Digital screening technologies, particularly those leveraging photoplethysmography (PPG) via smartphones, offer scalable and cost-effective solutions for earlier AF identification.7 Our academic siteless eBRAVE-AF trial was the first randomized study to demonstrate the diagnostic efficacy of smartphone-based AF screening in an at-risk population.8 Among 67 488 invited policyholders in Germany, 5551 participants (median age, 65 years) were randomized to digital screening or usual care. Smartphone-based PPG screening more than doubled the detection of treatment-relevant AF, with odds ratios of 2.12 and 2.75 in the two study phases (P = .010 and P = .003, respectively). However, despite this evidence and widespread smartphone availability, no randomized trial has yet shown that digital AF screening improves clinical outcomes. The Austrian Digital Heart Program is a publicly funded national initiative that develops and validates tailored digital technologies for AF detection and management, integrating them into a cohesive system embedded within Austria’s public healthcare infrastructure. Following development and pilot validation, the programme’s core is a nationwide, siteless randomized trial enrolling 100 060 individuals aged ≥65 years insured with the largest public health insurance in Austria (Österreichische Gesundheitskasse), covering ∼90% of the Austrian population. Participants will be randomized 1:1 by household to either a digital screening and guidance strategy or routine care. Figure 1 summarizes key aspects of the research programme. Overview of the Austrian Digital Heart Program: development and validation of digital tools for atrial fibrillation screening and management, integration into national healthcare infrastructure, and implementation of a large-scale, siteless randomized outcome trial across Austria. Created with BioRender.com. The digital strategy is structured around a CE-certified PPG app installed on participants’ own smartphones. Participants will perform PPG measurements twice daily for 14 days, followed by weekly monitoring. If irregularities suggestive of AF are detected, a 7-day ECG patch will be mailed for confirmation. Participants with ECG confirmed AF will receive structured, guideline-based digital education and telehealth guidance to facilitate implementation of optimal care according to the CARE pathway.5 We also aim to enable automatic transmission of diagnostic reports to Austria’s national electronic health record (ELGA), ensuring accessibility for treating physicians. The primary endpoint is hospitalization for stroke (ischaemic or haemorrhagic) within 4 years. Key secondary endpoints include cardiovascular and all-cause mortality, heart failure hospitalizations, and bleeding events. The Austrian Digital Heart Program is the first nationwide initiative to develop, optimize, and clinically validate digital AF screening and management tools, culminating in a large-scale randomized outcome trial. Conducted in close collaboration with major stakeholders including the Medical Universities of Innsbruck and Graz, Austrian Institute of Technology AIT, ‘Österreichische Gesundheitskasse’, the Austrian Society of Cardiology, and others, the programme integrates technological development, pilot testing, and population-level evaluation within Austria’s public healthcare infrastructure. The programme incorporates several key innovations. Population-level scale: With over 100 000 participants, the study is powered to detect clinically meaningful outcome differences. Structured AF screening program: Smartphone-based AF screening linked to structured, guideline-based digital education and telehealth support. Technology independence: Use of brand-independent, CE-certified tools compatible with standard smartphone. Fully digital workflow: Remote recruitment, onboarding, and outcome collection ensure high scalability and cost-effectiveness. In addition, the trial also includes a health economic evaluation, modelling the cost-effectiveness of digital AF screening relative to usual care from a payer perspective. In parallel, digital biosignal data will be stored on secure research servers, creating a unique biobank for future artificial intelligence-driven risk stratification models. The Austrian Digital Heart Program is publicly funded by the Federal Ministry of Women, Science and Research and the Ludwig Boltzmann Gesellschaft (LBG). The programme has been funded for a total of 8 years. It was launched in 2023, with the first patient for the large outcome study expected in Q3 2026. In conclusion, the Austrian Digital Heart Program will establish a scalable strategy for digital AF screening in individuals aged 65 years and older and may serve as a blueprint for similar initiatives across Europe and beyond. All authors declare no disclosure of interest for this contribution. This project was funded by the Federal Ministry of Women, Science and Research and the Ludwig Boltzmann Gesellschaft (LBG) as part of the Clinical Research Groups programme, Nr. LBG_KFG_2022_24. This project is endorsed by the Austrian Society of Cardiology.