DIGITAL, RISK-BASED SCREENING FOR ATRIAL FIBRILLATION IN THE EUROPEAN COMMUNITY

Rezultaty

Report on effectiveness of screening to reduce stroke/SE risk

Task 1.3 Assess screening yield and stroke/SE risk reduction Partners: REGIONH, CU, UOXF, UNIMORE, HSE, VHIR, RWTH, AMC, UKE. Duration: months 1 – 36. Deliverable: D1.3.Partners will quantify and compare the screening yield by different screening strategies in primary care (CU, UOXF, HSE, REGIONH, AMC) and in the community ( RWTH, VHIR, UNIMORE). Outcome data will be used to associate distinct modes of screening with stroke/systemic embolism. WP1 tests whether continuous monitoring coupled with a diagnostic algorithm will detect intermittent AF more effectively than single-time point or repeated patient-activated devices. AFFECT-EU assesses the prognostic significance of screen-detected AF from single time point ECG/rhythm snapshot to brief episodes detected over years of follow-up. This task will be accomplished by comparing non-invasive devices including prolonged Holter monitoring (Schiller medilog AR4 plus), hand-held rhythm recorders (Zenicor, MyDiagnostick), smartphone applications (CardioSecur) and wearables (two-week ECG Zio Patch) and insertable loop recorders (Reveal LINQ). Effectiveness of screening across the range of conventional and novel, digital deviceswill be associated with stroke/SE risk. The most efficient method for AF-screening will be defined.

Comprehensive and systematic review of economic evaluation literature of AF screening

Task 41 The development of a new decision analytic model including a variety of screening technologies with updated parameters of risks effects and costs Partners LIU MAC Duration months 1 24 Deliverables D41 42WP4s economic evaluations of screening programmes will assess the costs and consequences of broad management pathways encompassing the invitation and attendance to the screening tests interpretation of test results decision treatment or surveillance and implementation of chosen treatments In order to provide good value for money the cost of inviting an often large number of individuals to the screening tests must be reasonable in relation to the health benefits gained by treating a limited number of individuals Decisionanalytic modelling will be utilised to analyse this relationship in the costeffectiveness analyses of AFFECTEUs diverse screening programmes parameters will involve screening specific information such as attendance rates test characteristics decisionalteration parameters and the effect of implemented treatments themselves42 43 The decision analytic model will integrate data from WP1 WP2 WP3 which will provide new evidence on the stroke risk equation updated parameters on the prognosis of screendetected AF effectiveness and adherence of OAC treatment actual cost data for the different screening technologiesprocedures medical workup and longterm cost and effects of AF related complications including QoL Our new model will be informed by the finding in AFFECTEU and a systematic literature review and in addition to thromboembolic events also include other preventable AF comorbidities eg heart failure myocardial infarction and dementia The information on QoL available in all studies of the proposal will be integrated into the model improving the estimation of QoL in different screening strategiesWP2 results will permit other testsbiomarkersgenetics to enter the economic modelling which has the potential of improving the prognostic value of the screening strategies as well as the costeffectiveness due to better patient selection

Review of contemporary data sources and the literature for AF screening studies

WP1 will systematically identify all available biomedical AF screening study sources comprehensively characterize them for the research proposed in the consortium Table 11 Data in two outcome trials powered by primary care Danish LOOP SAFER are complemented by five clinical studies with different depth of additional phenotyping 200000 individuals Step 1 AFFECTEU will establish a data inventory by comprehensively characterizing the available data sources for accessibility size of dataset ie availability of risk factorshealth determinants number and type of blood samples spectrum of data collected selfreported data electronic health records clinical lifestyle imaging epigenetic and omics information type and duration of followup Important information will be the type and characteristics of screening the device applied the accuracy of AF diagnosis completeness of rhythm monitoring and additional details related to the screening process itself including barriers to screening Patientreported outcome measures POEMs PatientOriented Evidence that Matters quality of life and potential harms by screening and the inconveniences of the screening procedure itself will be captured A minimum of patientcentred outcomes data comprising patientreported clinicianreported and administrative metrics as well as outcome metrics for POEMs outcomes relevant for providerspayersregulators will be suggested for harmonization All partners will provide an overview of their data collection and variable manuals that will be harmonized and compiled in a central data base Interactive retrieval tools WP 6 will support the exploitation of variables through the established catalogue to get summary information and understand similarities and differences between the diverse studiesStep 2 A working platform for efficient data retrieval and exchange will be established technically supported by WP6

Catalogue detailing the available datasets and associated variables in the consortium

WP1 will systematically identify all available biomedical AF screening study sources comprehensively characterize them for the research proposed in the consortium Table 11 Data in three outcome trials powered for strokeSE 160000 participants in the community STROKESTOP studies and primary care Danish LOOP SAFER are complemented by five clinical studies with different depth of additional phenotyping 200000 individuals Step 1 AFFECTEU will establish a data inventory by comprehensively characterizing the available data sources for accessibility size of dataset ie availability of risk factorshealth determinants number and type of blood samples spectrum of data collected selfreported data electronic health records clinical lifestyle imaging epigenetic and omics information type and duration of followup Important information will be the type and characteristics of screening the device applied the accuracy of AF diagnosis completeness of rhythm monitoring and additional details related to the screening process itself including barriers to screening Patientreported outcome measures POEMs PatientOriented Evidence that Matters quality of life and potential harms by screening and the inconveniences of the screening procedure itself will be captured A minimum of patientcentred outcomes data comprising patientreported clinicianreported and administrative metrics as well as outcome metrics for POEMs outcomes relevant for providerspayersregulators will be suggested for harmonization All partners will provide an overview of their data collection and variable manuals that will be harmonized and compiled in a central data base Interactive retrieval tools WP 6 will support the exploitation of variables through the established catalogue to get summary information and understand similarities and differences between the diverse studiesStep 2 A working platform for efficient data retrieval and exchange will be established technically supported by WP6

Fact sheets and education materials on AF screening

Task 5.1 General and specific involvement of stakeholders Partners: EHRA/ESC, NAPIER, MFUB, UKE, AFNET, UNIMORE, REGIONH, VHIR, ROCHE. Duration: months 1 – 36. Deliverables: D5.1-5.3.AFFECT-EU will systematically involve stakeholders across the bandwidth of opinion leaders (Table 2.1) through EHRA/ESC, AFNET, MFUB and personal contacts. EHRA/ESC (chair dis-semination, exploitation and communication committee) will compile a list of key stakeholders who will be approached for input during conferences, workshops. Partners and their personal contacts will be responsible for stakeholder involvement, data and advocacy. A dynamic strategic plan presented to all consortium members will support systematic and efficient dissemination and exploitation.EHRA/ESC will develop structured education and training concepts to increase the number of healthcare professionals qualified to perform screening and educate patients. Our suggested standardized, structured screening programme with minimal workload for the healthcare profes-sional and screenee embedded in a straightforward, simple workflow will be tested and refined in close interaction with healthcare professionals (UKE, MFUB, AFNET). Health insuranceU. Marschall (BARMER) will outline and discuss implementation strategies to operationalize up-take of systematic/opportunistic screening in primary care. In close exchange she will seek solu-tions to overcome obstacles, review health economics and provide implementation pathways. AFFECT-EU will provide data and succinctly answer cost-related questions essential for imple-mentation of screening from the perspective of a healthcare payer. In a feedback loop, AFFECT-EU’s risk-based screening strategy will continuously be scrutinized for efficiency and applicabil-ity. The consortium will provide general recommendations and cost-effectiveness data (WP4) to support health insurance driven efforts at AF screening. BARMER will pilot implementation star-tegies in Germany Outreach to other countries will follow supported by EHRA/ESC. AFFECT-EU will provide hard facts and project results in intelligible fashion on the requirements for the implementation of comprehensive screening programmes, calculate the budget (WP4, Tasks 4.2 to 4.4) and suggest indicators to monitor AF screening trends needed for broad screen-ing implementation and continuous screening programme evaluation.Task 5.2 Develop locally tailored logic models using Medical Research Framework for com-plex interventionsPartner: NAPIER. Duration: months 1 – 36.Following the Medical Research Council framework for evaluating complex interventions: 1) We will examine implementation of AF screening across participating European countries (N=21) to determine how AF screening is delivered in practice; 2) We will develop an understanding of how mechanisms of impact of AF screening relate to the mechanisms through which the intervention works and produces changes in the intervention recipients.46 3) We will determine if the interven-tions achieve the intended outcomes of detecting AF to prevent stroke; 4) Finally, we will exam-ine the country specific context to determine how factors external to the intervention that might influence how the intervention operates. Results will be reported following the Standards for Re-porting Implementation Studies.47

Publikacje

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Vorhofflimmern und kognitive Störung – Bedeutung für die Geriatrie

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Natriuretic Peptides and Risk of Type 2 Diabetes: Results From the Biomarkers for Cardiovascular Risk Assessment in Europe (BiomarCaRE) Consortium

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Atrial fibrillation: villain or bystander in vascular brain injury

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How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme

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Refined atrial fibrillation screening and cost-effectiveness in the German population

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Pragmatic screening for heart failure in the general population using an electrocardiogram-based neural network

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Systematic monitoring for detection of atrial fibrillation in patients with acute ischaemic stroke (MonDAFIS): a randomised, open-label, multicentre study

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Chronic kidney disease and risk of atrial fibrillation and heart failure in general population-based cohorts: the BiomarCaRE project

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Expert opinion paper on cardiac imaging after ischemic stroke

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Mobile health for walking on the tightrope of optimal physical activity to reduce the risk of atrial fibrillation

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World Heart Federation Roadmap on Atrial Fibrillation – A 2020 Update

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Alcohol and atrial fibrillation: dose matters, not so much the type

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Dynamic risk assessment to improve quality of care in patients with atrial fibrillation: the 7th AFNET/EHRA Consensus Conference

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Research Priorities in Atrial Fibrillation Screening

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P-wave signal-averaged electrocardiography: Reference values, clinical correlates, and heritability in the Framingham Heart Study

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New biomarkers from multiomics approaches: improving risk prediction of atrial fibrillation

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Atrial fibrillation screening perspectives after STROKESTOP and LOOP

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Progression of stroke risk in atrial fibrillation: cohort study in general practice

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Heart and brain interactions

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Associations of the vasoactive peptides CT-proET-1 and MR-proADM with incident type 2 diabetes: results from the BiomarCaRE Consortium

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Comparison of Cardiovascular Risk Factors in European Population Cohorts for Predicting Atrial Fibrillation and Heart Failure, Their Subsequent Onset, and Death

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Gut microbiome and atrial fibrillation – results from a large population-based study

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Alcohol consumption, cardiac biomarkers, and risk of atrial fibrillation and adverse outcomes

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AN ARTIFICIAL INTELLIGENCE-BASED MODEL FOR PREDICTION OF ATRIAL FIBRILLATION FROM SINGLE-LEAD SINUS RHYTHM ECGS ENABLING SCREENING

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Disease awareness and knowledge of stroke- and atrial fibrillation risk factors in cardiovascular patients

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Prioritising Electrocardiograms for Manual Review to Improve the Efficiency of Atrial Fibrillation Screening

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Electrocardiographic markers of subclinical atrial fibrillation detected by implantable loop recorder

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Atrial fibrillation screening to prevent stroke in patients with high NT-proBNP-a post-hoc analysis of the randomized LOOP study

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The association between social network index, atrial fibrillation, and mortality in the Framingham Heart Study.

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Rationale kardiale Diagnostik nach ischämischem Schlaganfall oder TIA

Autorzy: Renate B. Schnabel, Karl Georg Häusler
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Tissue-specific multiOMICs analysis of atrial fibrillation

Autorzy: Ines Assum, Julia Krause, Markus O. Scheinhardt, Christian Müller, Elke Hammer, Christin S. Börschel, Uwe Völker, Lenard Conradi, Bastiaan Geelhoed, Tanja Zeller, Renate B. Schnabel, Matthias Heinig
Opublikowane w: 2021
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