Evidence Gaps and Lessons in the Early Detection of Atrial Fibrillation: A Prospective Study in a Primary Care Setting (PREFATE Study)

Abstract

Background/Objectives: In Europe, the prevalence of AF is expected to increase 2.5-fold over the next 50 years with a lifetime risk of 1 in 3-5 individuals after the age of 55 years and a 34% rise in AF-related strokes. The PREFATE project investigates evidence gaps in the early detection of atrial fibrillation in high-risk populations within primary care. This study aims to estimate the prevalence of device-detected atrial fibrillation (DDAF) and assess the feasibility and impact of systematic screening in routine primary care. Methods: The prospective cohort study (NCT05772806) included 149 patients aged 65-85 years, identified as high-risk for AF. Participants underwent 14 days of cardiac rhythm monitoring using the Fibricheck® app (CE certificate number BE16/819942412), alongside evaluations with standard ECG and transthoracic echocardiography. The primary endpoint was a new AF diagnosis confirmed by ECG or Holter monitoring. Statistical analyses examined relationships between AF and clinical, echocardiographic, and biomarker variables. Results: A total of 18 cases (12.08%) were identified as positive for possible DDAF using FibriCheck® and 13 new cases of AF were diagnosed during follow-up, with a 71.4-fold higher probability of confirming AF in FibriCheck®-positive individuals than in FibriCheck®-negative individuals, resulting in a post-test odds of 87.7%. Significant echocardiographic markers of AF included reduced left atrial strain (<26%) and left atrial ejection fraction (<50%). MVP ECG risk scores ≥ 4 strongly predicted new AF diagnoses. However, inconsistencies in monitoring outcomes and limitations in current guidelines, particularly regarding AF burden, were observed. Conclusions: The study underscores the feasibility and utility of AF screening in primary care but identifies critical gaps in diagnostic criteria, anticoagulation thresholds, and guideline recommendations.