Background

What is Atrial Fibrillation?

Atrial fibrillation (AF) is a heart rhythm disease characterized by an irregular beating of the atrial chambers of the heart. AF is the most common form of arrhythmia and it is associated with a 5-10 fold increased risk of cardiovascular and neurological conditions such as heart failure, stroke and dementia. These medical conditions have a high negative impact on quality of life (QoL) and increase mortality. It is estimated that 2% of the general western population suffers from AF, resulting in 14.6 million AF patients in Europe. More than 10.6 million (70%) of all AF patients are in the elderly group (≥65 years of age). The incidence and prevalence of AF is steadily increasing as the population ages and predisposing factors (e.g. hypertension, obesity, diabetes) become more prominent in our society. As a result, the prevalence of AF is expected to reach a staggering 20 million elderly patients in 2060, representing 9.5% of the total elderly population. The proportion of individuals ≥80 years old with AF will rise from 51% to 65%, a particularly worrisome trend considering that 1 in 4 AF patients ≥80 years of age dies of AF-induced stroke.

Why is it a priority for the years to come?’

AF represents an immense public health challenge with major economic implications. The high AF prevalence, together with the associated morbidity and mortality, result in frequent emergency department visits, increased hospital admissions, prolonged hospital stays, increased disability, and the need for long-term care. All these interventions put a significant strain on the healthcare budget. The estimated annual proportions of overall healthcare expenditures attributed to AF range from 0.81% to 2.49% depending on the country, with hospitalizations as the largest contributor. A systematic review from 2011 showed a direct-cost estimate for the treatment of AF ranging up to €3,000 – €8,848 per patient per year in Europe.

Objectives

The EHRA-PATHS project aims to transform and improve the clinical practice in the field of AF to holistic, inclusive and personalised treatment strategies. It will change the single-disease focused approach to a multi-factorial approach considering multimorbidity, polypharmacy, and sex. This transformation will lead to an estimated reduction of € 20 billion in the yearly European healthcare burden of multimorbid, elderly AF patients (>65 years of age).

  • Identify patterns in multimorbidity, polypharmacy, and sex differences in elderly AF patients
  • Map current clinical practice and identify unmet needs concerning multimorbid, elderly AF patient management.
  • Develop new care pathways to detect, tackle, and follow-up on multimorbidity and polypharmacy in elderly AF patients using an integrated, multidisciplinary, and patient centred-approach.
  • Evaluate the clinical and health economic benefit of the newly developed care pathways in
    multimorbid elderly AF patients.
  • Disseminate the insights, care pathways and implementation strategy learned from this project through international conferences, national meetings and practice guidance of the ESC/EHRA, the European leading societies in cardiology, and through a website integrated into the ESC/EHRA web, the go-to website in cardiology.
  • EU-wide utilisation in clinical practice of the key performance indicators defined in this project
  • EU-wide implementation of interdisciplinary, patient-centred, systematic care pathways developed in this project, transforming the management of multimorbid, elderly AF patients.
  • Wide influence on the medical community, posing the results of this project in a key position to be included in the ESC guidelines (to be updated in 2026-2027) and other ESC guidance documents and support materials.
  • EU-wide reduction in healthcare expenditures associated with the management of multimorbid, elderly AF patients, by means of reducing hospitalizations and ineffective treatment plans.

Approach

EHRA-PATHS approach is built on 4 pillars:

  1. Identification of current needs in clinical practice for the treatment of multimorbid, elderly AF patients (WP1 & WP2)
  2. Design and development of new interdisciplinary, patient-centred, systematic care pathways to tackle multimorbidity, polypharmacy and sex differences in elderly AF patients (WP3)
  3. Implementation for systematic and uniform adoption and evaluation of these new care pathways in Europe (WP4 & WP5)
  4. Dissemination and communication for a maximum societal impact (WP6 & WP7)

Lead beneficiary: Faculty of Medicine, University of Belgrade (MFUB)

Duration: Month 1-6

Objectives: Characterisation of multimorbidity, polypharmacy and sex-related aspects in AF patients using the registry-based dataset derived from 3 large prospective AF registries conducted under the ESC-EurObservational Research Programme (EORP).

Tasks: In this WP, ESC/SEC and MFUB will undertake the legal framework necessary to grant MFUB access to three data registries. In this task, MFUB will collaborate with LHI and NIC. These partners will define a detailed data analysis plan that aims at characterising a) comorbidities, b) polypharmacy, c) demographic aspects including sex and sociodemographic, and d) time-related trends to investigate the effects of changes in care of elderly AF patients over the years. Data will be exclusively analysed by MFUB, which will eventually compile the results in a report that will be distributed within the consortium and used for peer-reviewed publications.

Lead beneficiary: King’s College London (KCL)

Duration: Month 4-12

Objectives: Mapping current clinical practice for the management of multimorbid elderly AF patients in Europe and identifying unmet gaps and needs in the management of multimorbid elderly AF patients.

Tasks: A systematic (needs) assessment study will be set up to a) evaluate how the current multimorbidity management of AF patients is structured in Europe, b) assess the interdisciplinarity of multimorbidity management of AF patients, and c) investigate the behaviour of patients and their caregivers regarding multimorbidity and polypharmacy to obtain insights into multimorbidity and polypharmacy-related inappropriate interventions, delays in the care pathways, adverse drug reactions and non-adherence to treatments. This systematic mixed-methods (needs) assessment will consist of 2 parts: 1) an online questionnaire for healthcare professionals and patients and 2) face-to-face interviews with patients and clinicians.

Lead beneficiary: Antwerp University Hospital (UZA) 

Duration: Month 13-21

Objectives: Aim of this work package is 1) to design and development of new interdisciplinary, patient-centred, systematic care pathways to tackle multimorbidity in elderly AF patients, and 2) to identify KPIs to evaluate the implementation of the care pathways, i.e. the effective management of comorbidities in elderly AF patients.

Tasks: The consortium partners will develop care pathways for polypharmacy (NIC), cardiology (UHASSELT and UM), pneumology (UZA and UM), geriatrics and neurology (TUH), endocrinology and nephrology (MFUB and RS), oncology (SERMAS) and general practitioners (UZH). Each care pathways includes a specific ‘toolbox’ with concrete information on how to systematically assess a specific comorbidity (questionnaire and/or parameter and/or diagnostic test) and how treatment should be initiated conform the latest Guidelines. Toolboxes can be adapted to hospital, regional or national realities (e.g. availability of resources; reimbursement). The different new care pathways will be brought together into an overall care program by UZA.

Lead beneficiary: Antwerp University Hospital (UZA) 

Duration: Month 10-27

Objectives: Implementation of the interdisciplinary, patient-centred, systematic care pathways to tackle multimorbidity in elderly AF patients in 11 reference centres (consortium partners).

Tasks: This work package consists of the implementation of the new care program developed in WP3 into a care-management software tool. The implementation phase planned in this WP will ensure that the newly developed care pathways can be implemented throughout Europe and carried out in a standardized (yet locally adapted) way in order to provide the best care for the individual elderly AF patient. Additionally, various support materials and tools will be developed, both for patients and caregivers. The care pathways will first be implemented in the reference partner hospitals

Lead beneficiary: University Medical Center Groningen (UMCG)

Duration: Month 19-57

Objectives: Implementation of the new, interdisciplinary, patient-centred, systematic care pathways to systematically assess and initiate treatment for multimorbidity in elderly AF patients

Tasks: The newly developed care program to tackle multimorbidity in elderly AF patients will be evaluated in this work package. For the main study, we aim to recruit 2,380 patients (in 2 parts) in about 65 hospitals located in about 15-20 European countries. Such a wide coverage of the European territory will ensure to assess not only the benefit but also the generalizability of our solution. The partners of the EHRA-PATHS consortium will not include patients themselves (to
avoid bias). Rather, they will assist in the recruitment of the study centres through EHRA’s and the partners’ networks. The study will be divided in two parts. Part 1 will consist of a prospective observational trial of each site’s standard care pathways, which will serve as “base mapping” of the current management of comorbidities in elderly patients newly diagnosed with AF. Part 2 will be a prospective, cluster-randomised controlled study at the same centres to investigate if the newly developed care program leads to a better evaluation of comorbidities and adequate treatment initiation in new AF patients. 

Lead beneficiary: European Society of Cardiology (ESC)

Duration: Month 1-60

Objectives: The objective of this WP is to maximize the potential societal and scientific impact of EHRA-PATHS by a) ensuring the inclusion of the new interdisciplinary, patient-centred,systematic care pathwaysin European clinical practice guidelines depending on the project results, and b) disseminating and communicating the project results to various stakeholders. 

Tasks: We will identify, manage, disseminate and exploit the knowledge related to this EHRA-PATHS project. We will disseminate the activities, progress, and achievements beyond the project partners to the scientific and clinical community, the broad public, and interested stakeholders. Dissemination on a European level will also include: 1) healthcare provider training (webinars and dedicated booth at conferences); 2) participation and presenting the results of this project at national and international congresses; 3) publication of practice guidance documents with all the concrete aspects learned from this project; 4) publications in peer-reviewed journals; 5) disseminating the care pathways and care-management software tools, which were used in this study, to a wider audience, and 6) creating awareness via information (on a non-specialist level).

Lead beneficiary: European Society of Cardiology (ESC)

Duration: Month 1-60

Objectives:  The aim of this work package is 1) to ensure productive project execution and realization of main objectives in time and within budget, and 2) to ensure performance of activities by project partners and reporting according to EC regulations.

Tasks: This WP includes overall scientific, legal, financial, and administrative management of the project. Project Coordinator ESC/SEC, herein supported by CAT, will ensure the efficient and effective coordination and management of the project. Professional management will ensure that the project’s main objectives are realized in a timely fashion and within budgetary limits.