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Background
Patients with atrial fibrillation (AF) often have concomitant long-term conditions that negatively impact their quality of life and the clinical management they receive. The AFFIRMO study aimed to identify the needs, quality performance indicators (QPIs), and outcomes relevant to patients, caregivers and healthcare professionals (HCPs) to improve the care of patients with AF.

Methods
An on-line survey to collect the key needs, QPIs, and outcomes relevant to patients with AF, their caregivers and HCPs, was distributed between May 2022 and January 2023 in five countries (UK, Italy, Denmark, Romania and Spain). Results from the on-line survey were discussed in a three-round Delphi process with international representatives of patients with AF, caregivers, and HCPs to determine the key needs, QPIs and outcomes for the management of patients with AF and multimorbidity.

Results
659 patients (47.2% males, mean (SD) age 70.9 (10.2) years), 201 caregivers (26.9%
males, mean (SD) age: 58.3 (SD 15.2) years), and 445 HCPs (57.8% males, mean (SD)
age 47.4 (10.6) years) participated in the survey. An initial list of 27 needs, 9 QPIs, and 17
outcomes were identified. Eight patients, two caregivers, and 11 HCPs participated in the Delphi process. Nineteen (70%) needs, 8 (89%) QPIs, and 13 (76%) outcomes reached
“consensus in”, and were included in the final list.

Conclusions
The final key needs, QPIs and outcomes obtained from the Delphi process will inform the
AFFIRMO clinical trial, which aims to test the iABC app which incorporates an empowerment toolbox for patients and their caregivers, providing information to improve patient engagement and empowerment to help improve the clinical and self-management of patients with AF in the context of multimorbidity.

Atrial fibrillation (AF) may be asymptomatic and the extensive monitoring capabilities of cardiac implantable electronic devices (CIEDs) revealed asymptomatic atrial tachi-arrhythmias of short duration (minutes-hours) occurring in patients with no prior history of AF and without AF detection at a conventional surface ECG. Both the terms “AHRE” (Atrial High-Rate Episodes) and subclinical AF were used in a series of prior studies, that evidenced the association with an increased risk of stroke. Two randomized controlled studies were planned in order to assess the risk-benefit profile of anticoagulation in patients with AHRE/subclinical AF: the NOAH and ARTESiA trials. The results of these two trials (6548 patients enrolled, overall) show that the risk of stroke/systemic embolism associated with AHRE/subclinical AF is in the range of 1–1.2 % per patient-year, but with an important proportion of severe/fatal strokes occurring in non-anticoagulated patients. The apparent discordance between ARTESiA and NOAH results may be approached by considering the related study-level meta-analysis, which highlights a consistent reduction of ischemic stroke with oral anticoagulants vs. aspirin/placebo (relative risk [RR] 0.68, 95 % CI 0.50–0.92). Oral anticoagulation was found to increase major bleeding (RR 1.62, 95 % CI 1.05–2.5), but no difference was found in fatal bleeding (RR 0.79, 95 % CI 0.37–1.69). Additionally, no difference was found in cardiovascular death or all-cause mortality. Taking into account these results, clinical decision-making for patients with AHRE/subclinical AF at risk of stroke, according to CHA₂DS₂-VASc, can now be evidence-based, considering the benefits and related risks of oral anticoagulants, to be shared with appropriately informed patients.

Objectives

Methods

Results

Conclusions

In most of the analyzed studies, inpatient care cost represents the main component of the mean direct medical cost per patient. Stroke and heart failure are responsible for a large share of the total costs; therefore, implementing guidelines to manage comorbidities in AF is a necessary step to improve health and mitigate healthcare costs.

This study sought to investigate the association with outcomes of ABC adherence in the prospective multinational Asia-Pacific Heart Rhythm Society (APHRS) Atrial Fibrillation registry. 

Aim

Polypharmacy in multimorbid older patients with atrial fibrillation (AF) is a risk factor for potentially inappropriate prescribing (PIP). We aimed to systematically assess the evidence on the prevalence of PIP and its impact on adverse health outcomes in this patient group.

Methods

A systematic search of the published peer-reviewed literature describing the prevalence of PIP and/or its association with adverse health outcomes in multimorbid (AF plus one comorbidity) and polymedicated (≥ 2 drugs) adults ≥ 65 years was done up to March 2023. A meta-analysis of the prevalence of PIP of (direct) oral anticoagulants ((D)OACs) was conducted using a random-effects model. Leave-one-out analysis was performed with R (version 4.2.2) and RStudio (version 2022.12.0+353).

Results

Of the 12 studies included, only one reported on the prevalence of overall PIP (65%). The meta-analysis of 10 studies assessing PIP of (D)OACs produced a pooled prevalence [95% confidence interval (CI)] of 35% [30–40%], with significant heterogeneity between the included studies (I² 95%). No statistically significant association was reported in three studies between PIP of (D)OACs, cardiovascular (CV) and all-cause mortality, hospital readmission, CV hospitalisation and stroke. Reported associations between PIP and major bleeding differed, with one study demonstrating a significant association (odds ratio 2.17; 95% CI 1.14–4.12) and the other study not showing such association.

Conclusion

This systematic review highlights the scarce evidence regarding the prevalence of PIP and its association with adverse health outcomes in multimorbid older adults with AF. Large, prospective and better-designed studies are needed.

Atrial fibrillation (AF) patients are often high risk being elderly and having multiple comorbidities. Many risk factors are established to be associated with new onset incident AF, as well as AF-related complications such as stroke and hospitalisations. Multimorbidity AF patients are high risk and require a holistic approach to care, which should be proactively managing with an integrated care or holistic approach as per the ABC (atrial fibrillation better care) pathway.

Cryptogenic stroke, defined as acute ischemic stroke without a clear identifiable cause, accounts for approximately 1/3 of acute ischemic stroke cases. Undiagnosed atrial fibrillation (AF) is likely the leading underlying cause of such presentations; hence, cardiac rhythm monitoring is key to the diagnostic work-up. Commonly, long-term monitoring (LTM) using implantable cardiac monitors (ICMs) is indicated after a negative period of short-term monitoring (STM). However, the low diagnostic yield of STM prompts the question: would directly proceeding to LTM represent a more cost-effective approach?

Background: Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are effective anti-diabetic drugs improving cardiovascular outcomes in type 2 diabetes mellitus (T2DM) patients. This study investigated cardiovascular, cerebrovascular and cognitive outcomes of SGLT2i therapy in patients with atrial fibrillation (AF) and T2DM. Methods: Observational study using TriNetX, a global health research network of anonymised electronic medical records from real-world patients between January 2018 and December 2019. The network includes healthcare organisations globally but predominately in the United States. AF patients (ICD-10-CM code: I48) with T2DM were divided according to SGLT2i use or not, and balanced using propensity score matching (PSM). Patients were followed-up for 3-years. The primary endpoints were ischaemic stroke/transient ischemic attack (TIA), intracranial haemorrhage (ICH), and incident dementia. Secondary endpoints were incident heart failure and mortality. Results: We identified 89,356 AF patients with T2DM of which 5061 (5.7%) were taking a SGLT2i. After PSM, 5049 patients (mean age 66.7 ± 10.6 years; 28.9% female) were included in each group. At 3-years follow-up, the risk of ischaemic stroke/TIA was higher in patients not receiving SGLT2i (HR 1.12, 95% CI 1.01–1.24) and for ICH (HR 1.57, 95% CI 1.25–1.99) and incident dementia (HR 1.66, 95% CI 1.30–2.12). Incident heart failure (HR 1.50, 95% CI 1.34–1.68) and mortality (HR 1.77, 95% CI 1.58–1.99) risks were increased in AF patients not receiving SGLT2i. Conclusions: In our large ‘real world’ analysis of patients with concomitant AF and T2DM, SGLT2i reduced the risk of cerebrovascular events, incident dementia, heart failure and death

The increasing ageing of the general population has led to a significant burden of multimorbidity in the general population, requiring significant changes to healthcare and management, as well as clinical approaches. Hence, increasing attention to the progressively increasing burden of multimorbidity and the need for more integrated care management in patients with chronic long-term conditions. Even in the most common heart rhythm disorder, atrial fibrillation (AF), the presence of multimorbidity has proven to significantly influence clinical management and prognosis.

In a recent position paper, the European Heart Rhythm Association (EHRA) proposed an algorithm for the screening and management of arrhythmias using digital devices. In patients with prior stroke, a systematic screening approach for atrial fibrillation (AF) should always be implemented, preferably immediately after the event. Patients with increasing age and with specific cardiovascular or non-cardiovascular comorbidities are also deemed to be at higher risk. From a large nationwide database, the aim was to analyse AF incidence rates derived from this new EHRA algorithm. These findings at a nationwide scale confirm the relevance of the subgroups in the EHRA algorithm for identifying a higher risk of AF incidence, showing that older patients (>75 years, regardless of comorbidities) have a higher incidence of AF than those with prior ischaemic stroke. Further studies are needed to evaluate the usefulness of algorithm-based risk stratification strategies for AF screening and the impact of screening on major cardiovascular event rates

Background

Clinical complexity is increasingly prevalent among patients with atrial fibrillation (AF). The ‘Atrial fibrillation Better Care’ (ABC) pathway approach has been proposed to streamline a more holistic and integrated approach to AF care; however, there are limited data on its usefulness among clinically complex patients. We aim to determine the impact of ABC pathway in a contemporary cohort of clinically complex AF patients.

Methods

From the ESC-EHRA EORP-AF General Long-Term Registry, we analysed clinically complex AF patients, defined as the presence of frailty, multimorbidity and/or polypharmacy. A K-medoids cluster analysis was performed to identify different groups of clinical complexity. The impact of an ABC-adherent approach on major outcomes was analysed through Cox-regression analyses and delay of event (DoE) analyses.

Results

Among 9966 AF patients included, 8289 (83.1%) were clinically complex. Adherence to the ABC pathway in the clinically complex group reduced the risk of all-cause death (adjusted HR [aHR]: 0.72, 95%CI 0.58–0.91), major adverse cardiovascular events (MACEs; aHR: 0.68, 95%CI 0.52–0.87) and composite outcome (aHR: 0.70, 95%CI: 0.58–0.85). Adherence to the ABC pathway was associated with a significant reduction in the risk of death (aHR: 0.74, 95%CI 0.56–0.98) and composite outcome (aHR: 0.76, 95%CI 0.60–0.96) also in the high-complexity cluster; similar trends were observed for MACEs. In DoE analyses, an ABC-adherent approach resulted in significant gains in event-free survival for all the outcomes investigated in clinically complex patients. Based on absolute risk reduction at 1 year of follow-up, the number needed to treat for ABC pathway adherence was 24 for all-cause death, 31 for MACEs and 20 for the composite outcome.

Conclusions

An ABC-adherent approach reduces the risk of major outcomes in clinically complex AF patients. Ensuring adherence to the ABC pathway is essential to improve clinical outcomes among clinically complex AF patients.

Background

Clinical complexity is common in atrial fibrillation (AF) patients. We assessed the impact of clinical complexity on oral anticoagulant (OAC) treatment patterns and major adverse outcomes in a contemporary cohort of AF patients.

Methods 

The GLORIA-AF Phase II and III Registry enrolled newly diagnosed AF patients with at least one stroke risk factor. Among patients with CHA₂DS₂-VASc score ≥2, we defined four domains of perceived clinical complexity: frail elderly (age ≥75 years and body mass index <23 kg/m²), chronic kidney disease (CKD, creatinine clearance <60 mL/min), history of bleeding, and those with ≥2 of the above conditions. We evaluated the associations between clinical complexity domains and antithrombotic treatment prescription, risk of OAC discontinuation, and major adverse outcomes.

Results 

Among the 29,625 patients included (mean age 69.6 ± 10.7 years, 44.2% females), 9,504 (32.1%) presented with at least one complexity criterion. Clinical complexity was associated with lower OAC prescription, with stronger associations in frail elderly (odds ratio [OR]: 0.47, 95% confidence interval [CI]: 0.36–0.62) and those with ≥2 complexity domains (OR: 0.50, 95% CI: 0.44–0.57). Risk of OAC discontinuation was higher among frail elderly (hazard ratio [HR]: 1.30, 95% CI: 1.00–1.69), CKD (HR: 1.10, 95% CI: 1.02–1.20), and those with ≥2 complexity domains (HR: 1.39, 95% CI: 1.23–1.57). Clinical complexity was associated with higher risk of the primary outcome of all-cause death, thromboembolism, and major bleeding, with the highest magnitude in those with ≥2 criteria (HR: 1.63, 95% CI: 1.43–1.86).

Conclusion 

In AF patients, clinical complexity influences OAC treatment management, and increases the risk of poor clinical outcomes. These patients require additional efforts, such as integrated care approach, to improve their management and prognosis.

This document outlines the development and delivery process of the AFFIRMO Study app (iABC), previously referred to as the iABC digital platform. The initial phases of this digital tool's development, led by UNIMAN, involve completed deliverables such as D5.1 (High-level requirements document), D5.5 (Software Architecture Designs), and D5.6 (Prototypes). The requirements were collected from consortium members and prioritized using the MoSCoW approach.

Interactive prototypes are valuable tools for visually representing the iABC platform, providing a cost-effective means to test ideas with minimal risk. Leveraging the expertise of a UNIMAN User Experience expert, these prototypes can be created and shared with stakeholders to gather feedback. This iterative process will continue throughout the development of the iABC platform. The use of prototypes complements software development by allowing the project team to grasp the platform's visual representation before the software is fully developed. Collaboration with the Arrhythmia Alliance partner enables input on imagery and wording within the iABC.

This document serves as the software requirements specification for the randomized control trial, guiding the software development activities. It builds upon the high-level requirements from deliverable 5.1, using the MoSCoW approach. The iterative development of the iABC platform may lead to changes in the defined requirements based on feedback from clinical and patient-group representatives. Additionally, the document includes a proposed technical architecture and a summary of security activities.

This document outlines the high-level requirements that will serve as the foundation for software architecture designs (D5.5), interactive prototypes (D5.6), and the iABC platform (D5.7). The requirements have been documented and prioritized using the MoSCoW approach. Currently, the specific co-morbidities and details of the digital intervention have not been finalized in this stage of the project.

Work Package 4 of the AFFIRMO project conducts a mixed-methods study to understand the needs of patients, caregivers, and healthcare professionals in managing multimorbidity, including atrial fibrillation (AF). The goal is to develop a patient-centered approach for older multimorbid AF patients. This report focuses on the online survey results, which involved 1,305 participants and identified 53 items, including key needs, quality performance indicators, and outcomes. Sex differences impact patient engagement, with men generally more engaged and satisfied with care. Age, education, and the number of co-morbidities also influence engagement levels. Caregiver findings show age and education affecting quality of life, and country-specific differences. Engagement personas are defined based on characteristics and empowerment levels using different scales for patients and caregivers, highlighting varying aspects of the engagement process.

Teaser for the Serie "AFFIRMO - the Interviews" where you will get to meet the behind the AFFIRMO project.

Caterina Bosio is a Project Manager at EnageMinds HUB, a scientific health engagement research center founded at Università Cattolica del Sacro Cuore.

Get to know the people behind the AFFIRMO project with the series "AFFIRMO - the Interviews" .

José Miguel Rivera-Caravaca currently works at the Department of Cardiology of the Hospital Clínico Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria (IMIB-Arrixaca) and he is Assistant Professor at the Department of Nursing (Faculty of Nursing, University of Murcia), Get to know the people behind the AFFIRMO project with the series "AFFIRMO - the Interviews".

Malnutrition and obesity are interdependent pathologies along the same spectrum. We examined global trends and projections of disability-adjusted life years (DALYs) and deaths from malnutrition and obesity until 2030.

Atrial fibrillation (AF) is the most prevalent arrhythmia worldwide. The presence of AF is associated with increased risk of systemic thromboembolism, but with the uptake of oral anticoagulant (OAC) and implementation of a holistic and integrated care management, this risk is substantially reduced. The diagnosis of AF requires a 30-s-long electrocardiographic (ECG) trace, irrespective of the presence of symptoms, which may represent the main indication for an ECG tracing. However, almost half patients are asymptomatic at the time of incidental AF diagnosis, with similar risk of stroke of those with clinical AF. This has led to a crucial role of screening for AF, to increase the diagnosis of population at risk of clinical events. The aim of this review is to give a comprehensive overview about the epidemiology of asymptomatic AF, the different screening technologies, the yield of diagnosis in asymptomatic population, and the benefit derived from screening in terms of reduction of clinical adverse events, such as stroke, cardiovascular, and all-cause death. We aim to underline the importance of implementing AF screening programmes and reporting about the debate between scientific societies’ clinical guidelines recommendations and the concerns expressed by the regulatory authorities, which still do not recommend population-wide screening. This review summarizes data on the ongoing trials specifically designed to investigate the benefit of screening in terms of risk of adverse events which will further elucidate the importance of screening in reducing risk of outcomes and influence and inform clinical practice in the next future

Despite marked progress in the management of atrial fibrillation (AF), detecting AF remains difficult and AF-related com- This document summarizes the key outcomes of the 8th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). Eighty-three international experts met in Hamburg for 2 days in October 2021. Results of the interdisciplinary, hybrid discussions in breakout groups and the plen- ary based on recently published and unpublished observations are summarized in this consensus paper to support im- proved care for patients with AF by guiding prevention, individualized management, and research strategies. The main outcomes are (i) new evidence supports a simple, scalable, and pragmatic population-based AF screening pathway; (ii) rhythm management is evolving from therapy aimed at improving symptoms to an integrated domain in the prevention of AF-related outcomes, especially in patients with recently diagnosed AF; (iii) improved characterization of atrial cardio- myopathy may help to identify patients in need for therapy; (iv) standardized assessment of cognitive function in patients with AF could lead to improvement in patient outcomes; and (v) artificial intelligence (AI) can support all of the above aims, but requires advanced interdisciplinary knowledge and collaboration as well as a better medico-legal framework. plications cause unacceptable morbidity and mortality even on optimal current therapy.