Periodic Reporting for period 3 - AFFECT-EU (DIGITAL, RISK-BASED SCREENING FOR ATRIAL FIBRILLATION IN THE EUROPEAN COMMUNITY)
Reporting period: 2023-05-01 to 2024-03-31
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.
The Project brought together well-experienced international researchers with a longstanding interest in AF screening as well as opinion leaders, stakeholders and end-users to achieve our ambition “a feasible, screening strategy ready for implementation.
We have developed a data platform that include harmonized datasets of 16 clinical cohorts and RCTs that relate to atrial fibrillation screening strategies and the risk of adverse outcomes. An overall sample size of 244.000 participants and a detailed catalogue with associated variables for baseline data from electrocardiography, basic demography, medical history, and outcomes of AF detection and anticoagulation on all screenees have been set up. We have planned an individual participant data meta-analysis and set up a first pilot meta-analysis that summarized existing evidence from 4 RCTs. The pilot analysis identified that AF screening was associated with a reduction in stroke compared with no screening.
To refine our screening strategy and to reduce the number needed to screen we had access to contemporary European population cohorts. We used known and emerging predictors of AF including ECG markers, genome-wide genetic analyses, metabolome and microbiome information (omics) and classical circulating markers of cardiac stress (natriuretic peptides), autoimmune disorders, inflammation and renal function to identify the high-risk populations.
To identity cost effectiveness of the screening for AF we performed a comprehensive and systematic review of economic evaluation literature that showed that AF screening is in principle cost-effective regardless of strategy and method. In addition, we developed a simulation model estimating the cost-effectiveness of atrial fibrillation screening. The model was then adapted to eight different health care systems. We set up a budget impact analysis (BIA) calculator that estimate the financial impact of implementing a screening program that covers 5 years after implementation. We adapted the calculator to the eight different health care systems in Europe taking into consideration differences in population, treatment praxis and budget holders. This tool could guide regulators to find consensus about AF screening implementation in different settings.
Well implemented AF screening programmes could increase the number of new AF diagnoses and lead to guideline-adherent care, thereby reducing stroke risk. To implement AF Screening at scale we collect data on opportunities and health inequities related to screening across Europe. We set up a qualitative study of stakeholder views in 11 European countries and identified that there is an overall awareness of AF screening.18 Opportunistic screening appears the most feasible across Europe and challenges are health inequalities, identification of best target groups for screening, streamlined processes, the need for evidence of benefit and a tailored approach adapted to national realities. To validate the findings we evaluated the perception of general practitioners (GPs) in Europe concerning value and practicalities to implement AF screening in daily clinical practice, focussing on opportunistic single time point screening.
Based on our results we developed a provisional theory that determine the understanding for whom, under what conditions, and how an integrated approach to atrial fibrillation service delivery works.
To summarize our findings the AFFECT-EU consortium has jointly organized with the EHRA/ESC AFNET a conference and published a consensus statement for early diagnosis and precision treatment of AF in the digital era.
AFFECT-EU results addresses the issue towards risk-based screening strategies for AF. The implementation of a risk-based screening allows early detection of AF, an increasingly prevalent, non-communicable disease and have a major impact on healthy aging and wellbeing in older adults across Europe through prompt initiation of already existing effective treatment to prevent stroke and cardiovascular morbidity and mortality.
We have developed a data platform that include harmonized datasets of 16 clinical cohorts and RCTs that relate to atrial fibrillation screening strategies and the risk of adverse outcomes. An overall sample size of 244.000 participants and a detailed catalogue with associated variables for baseline data from electrocardiography, basic demography, medical history, and outcomes of AF detection and anticoagulation on all screenees have been set up. We have planned an individual participant data meta-analysis and set up a first pilot meta-analysis that summarized existing evidence from 4 RCTs. The pilot analysis identified that AF screening was associated with a reduction in stroke compared with no screening.
To refine our screening strategy and to reduce the number needed to screen we had access to contemporary European population cohorts. We used known and emerging predictors of AF including ECG markers, genome-wide genetic analyses, metabolome and microbiome information (omics) and classical circulating markers of cardiac stress (natriuretic peptides), autoimmune disorders, inflammation and renal function to identify the high-risk populations.
To identity cost effectiveness of the screening for AF we performed a comprehensive and systematic review of economic evaluation literature that showed that AF screening is in principle cost-effective regardless of strategy and method. In addition, we developed a simulation model estimating the cost-effectiveness of atrial fibrillation screening. The model was then adapted to eight different health care systems. We set up a budget impact analysis (BIA) calculator that estimate the financial impact of implementing a screening program that covers 5 years after implementation. We adapted the calculator to the eight different health care systems in Europe taking into consideration differences in population, treatment praxis and budget holders. This tool could guide regulators to find consensus about AF screening implementation in different settings.
Well implemented AF screening programmes could increase the number of new AF diagnoses and lead to guideline-adherent care, thereby reducing stroke risk. To implement AF Screening at scale we collect data on opportunities and health inequities related to screening across Europe. We set up a qualitative study of stakeholder views in 11 European countries and identified that there is an overall awareness of AF screening.18 Opportunistic screening appears the most feasible across Europe and challenges are health inequalities, identification of best target groups for screening, streamlined processes, the need for evidence of benefit and a tailored approach adapted to national realities. To validate the findings we evaluated the perception of general practitioners (GPs) in Europe concerning value and practicalities to implement AF screening in daily clinical practice, focussing on opportunistic single time point screening.
Based on our results we developed a provisional theory that determine the understanding for whom, under what conditions, and how an integrated approach to atrial fibrillation service delivery works.
To summarize our findings the AFFECT-EU consortium has jointly organized with the EHRA/ESC AFNET a conference and published a consensus statement for early diagnosis and precision treatment of AF in the digital era.
AFFECT-EU results addresses the issue towards risk-based screening strategies for AF. The implementation of a risk-based screening allows early detection of AF, an increasingly prevalent, non-communicable disease and have a major impact on healthy aging and wellbeing in older adults across Europe through prompt initiation of already existing effective treatment to prevent stroke and cardiovascular morbidity and mortality.
AFFECT-EU have increase awareness for AF as a disabling and potential fatal disease. Therfore, AFFECT-EU’s comprehensive dissemination and communication activities have raised 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 paved the way to disease prevention, thereby improved healthy and independent aging. We have improved 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 have been made widely available, AFFECT-EU have significantly enhanced patient management and facilitate workflows for sustainable implementation.
Results:
AFFECT-EU have provided 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 have 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 have demonstrated the effectiveness of our screening strategies using digital ECG recordings and have provided 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 have been interrogated to in-crease the yield of the screening algorithm and have been refined the target population for more effective AF screening.
AFFECT-EU is in the position to provide reliable cost estimates and have calculated 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.
Results:
AFFECT-EU have provided 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 have 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 have demonstrated the effectiveness of our screening strategies using digital ECG recordings and have provided 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 have been interrogated to in-crease the yield of the screening algorithm and have been refined the target population for more effective AF screening.
AFFECT-EU is in the position to provide reliable cost estimates and have calculated 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.