Periodic Reporting for period 1 - AFFECT-EU (DIGITAL, RISK-BASED SCREENING FOR ATRIAL FIBRILLATION IN THE EUROPEAN COMMUNITY) Reporting period: 2020-01-01 to 2021-06-30 Summary of the context and overall objectives of the project Owing to the demographic changes, we are facing an arrhythmia epidemic of atrial fibrillation (AF) in the aging European population with a prevalence of approximately 2.5-3% (twice as high in men and 5% prevalence in individuals ≥65 years) and a projected doubling of this number by 2050. AF carries a high risk of stroke, as close to 1/3 of all ischemic strokes occur in patients with AF. AF is often asymptomatic with its first manifestation being debilitating stroke in 11.5% of patients. AF produces significant healthcare costs for the European society and precludes healthy aging. The European Society of Cardiology (ESC) guidelines recommend early detection of AF to prevent complications and optimise treatment, including the use of highly effective oral anticoagulation (OAC) in patients at risk of stroke. However, questions on whom to screen, how to screen and the optimal setting for screening with highest efficiency remain unanswered. The consequence is that, to date, an appropriate risk-based screening algorithm and systematic screening programmes do not exist. AFFECT-EU aims at developing a risk-based AF screening strategy using digital applications for rhythm monitoring to reduce the burden of stroke and other AF-related comorbidities in aging Europe. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Overall, the AFFECT-EU project has achieved its aims for the reporting period 1 in line with the DoA. All applicable deliverables and milestones are complete for the first period and the project as a whole.WP1:In WP1 we established the working group and reviewed the published data on AF screening. We developed a catalogue available new data across the Consortium beneficiaries. By summer 2021, available data from 10 partner studies has been prepared for data sharing, and a database has been assembled, ready to receive the data. In general, the merged AFFECT-EU database will have baseline data from electrocardiography (ECG), basic demography (age and sex), and medical history, and outcomes of atrial fibrillation detection and anticoagulation on all screenees. Further, additional baseline risk factors such as smoking, alcohol consumption, vital signs and drug prescptions, and outcomes of stroke will be available for most screenees. A subset will have additional data such as blood tests, socioeconomy and more.WP2:WP 2 will refine the AF screening strategy. Therefore, five partners with large-scale population cohort data on atrial fibrillation outcomes will harmonize AF-related health determinants data.The data from three of five cohorts have been received and are being harmonized into the database at THL. One study have been prepared data and will be transferred to the data centre once an updated data transfer agreement has been prepared. Manuscripts on the association between alcohol consumption and incident atrial fibrillation, as well as on the relation of conventional atrial fibrillation risk factors and atrial fibrillation in different age groups have been published.WP3:A list of ongoing (11 studies) and upcoming screening trials (11 studies) were collated and maintained for use beyond the project duration. A detailed planning for a patient-meta-analysis has resulted in a required size of >120,000 individuals, 60,000 per arm to give sufficient statistical power (80%) to determine if AF screening prevents stroke. In advance to the publication of the primary trial outcomes, the WP 3 have developed a formal systematic review to identify all studies available in D3.2. WP4:In a comprehensive and systematic review of economic evaluation literature of AF screening we showed that AF screening is in principle cost-effective regardless of strategy and method. Opportunistic screening (lower costs) seems to be most cost-effective (uptake of screening is a possible problem). However, population screening programs find more AF and save more QALYs. So that the results are driven by: How effective are the program at discovering new AF cases and how well are newly discovered AF patients treated concerning compliance.WP5:Accounts for Facebook , Twitter and LinkedIn have been established. Several conference lectures from AFFECT-EU partners has been held regarding AF Screening. Within the first period of the project we planned the AFFECT-EU face to face meeting in October in Hamburg and currently organizing the 8th Joint AFNET/EHRA Consensus Conference titled right after the AFFECT-EU meeting. We developed and integrated a risk information into a software decision support tool for general practices (n=700) to decrease the burden of action and decision-making. We identified possible opportunities and obstacles to implement AF screening strategies into healthcare settings across Europe though a qualitative research approach. WP6:We lunched a (internal and external) project web site. A project management plan (D6.1) and an internal project webpage (D6.3) with guidelines and reporting templates for the proper and effective management has been developed. We adapted a data management plan for the data procession.WP7:Ethics Advisory Board is established and consortium dealt in a proper manner with all arising privacy and data protection issues, demonstrating a high level of awareness, attention and knowledge in relation to ethical, privacy, data protection and societal implications. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) AFFECT-EU will increase awareness for AF as a disabling and potential fatal disease. Therfore, AFFECT-EU’s comprehensive dissemination and communication activities will raise awareness across a broad range of stakeholders, including healthcare providers, patients, policy-makers and the general public. Better awareness of AF-related risks in the aging European population will pave the way to disease prevention, thereby improving healthy and independent aging. We will improve the digital risk stratification and decision support tools, through the development and programming of risk prediction models and decision support tools for screening and consequent treatment recommendations, which will be made widely available, AFFECT-EU will significantly enhance patient management and facilitate workflows for sustainable implementation.Expected results:AFFECT-EU will provide an easy-to-apply, risk-based screening strategy for AF detection in a high risk population using digital ECG recordings ready for implementation. Thus, AFFECT-EU will lastingly affect screening policy across Europe and change clinical practice by change of guidelines, outline reimbursement strategies, advocating screening education training and raising awareness on the disease.Different independent studies in AFFECT-EU with high quality data will demonstrate the effectiveness of our screening strategies using digital ECG recordings and provide sound evidence to inform the development of the optimal, risk-based AF screening strategy that merits implementation. We can expect a reduction in strokes. In addition, the evaluation of an abundance of known and emerging AF risk determinants will be interrogated to in-crease the yield of the screening algorithm and refine the target population for more effective AF screening.AFFECT-EU is in the position to provide reliable cost estimates and to calculate QUALYs gained by screening. Based on prior estimates for nationwide opportunistic screening, we expect to observe an incremental cost-effectiveness of quality-adjusted life-year compared with routine care.