Atrial Fibrillation
Integrated Approach

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.