Risk-Guided Atrial Fibrillation Screening With Artificial Intelligence-Enabled Electrocardiogram Models: A VITAL-AF Trial Analysis

Clinical Snapshot

Key Findings

• P Value: P < 0.05 for top decile comparison

• Effect Size: Screening effect observed only in top CH-AI risk decile: 2.32/100 person-years difference (10.07 vs 7.76/100 person-years)

• Primary Outcome: 2-year incident AF diagnosis rate difference between screening and control groups across risk deciles

• Nnt Or Sensitivity: Number-needed-to-screen: 43 per year in highest risk decile

• Confidence Interval: 95% CI: 0.01-4.63 per 100 person-years

Clinical Application

Requires access to 12-lead ECG data for risk stratification and single-lead ECG devices for screening. AI models need validation in local populations Relevant to Australian primary care given similar healthcare delivery models. Would need TGA approval for AI-ECG devices. Could integrate with existing cardiovascular risk assessment programs and PBS-subsidised anticoagulation pathways Adults aged ≥65 years in primary care settings, particularly those at high predicted AF risk based on clinical factors and ECG features

Abstract

BACKGROUND: Screening for atrial fibrillation (AF) may lead to earlier detection and initiation of preventive measures. Current AF screening approaches using a guideline age-based threshold of ≥65 years have shown limited yield. OBJECTIVES: In an AF screening trial, we assessed whether the screening effect was larger among individuals at elevated AF risk using validated clinical and electrocardiogram (ECG)-based artificial intelligence (AI) risk models. METHODS: VITAL-AF was a cluster-randomized trial of patients aged ≥65 years treated at 1 of 16 primary care practices affiliated with Massachusetts General Hospital. Patients randomized to a screening practice were screened using a single-lead ECG. Among VITAL-AF participants without prevalent AF with at least one 12-lead ECG within 3 years before enrollment, we estimated AF risk using 3 validated models derived outside of VITAL-AF: the Cohorts of Heart and Aging Research in Genomic Epidemiology-AF (CHARGE-AF) clinical score, an AI-based model using a 12-lead ECG alone (ECG-AI), and a model combining ECG-AI and CHARGE-AF (CH-AI). Two-year incident AF discrimination was assessed by the time-dependent area under the receiver-operating characteristic curve (AUROC) and average precision. AF screening effect was defined as the difference in 2-year incident AF diagnosis rate (per 100 person-years) in screening vs control across AF risk deciles. RESULTS: Of 30,630 VITAL-AF participants without prevalent AF, 16,937 had pretrial ECG and clinical data. Each score discriminated 2-year AF risk according to AUROC (CHARGE-AF: 0.711 [95% CI: 0.671-0.749]; ECG-AI: 0.784 [95% CI: 0.743-0.819]; CH-AI: 0.788 [95% CI: 0.754-0.824]) and average precision (0.0952 [95% CI: 0.0836-0.112]; 0.132 [95% CI: 0.113-0.157]; 0.133 [95% CI: 0.117-0.159]). An AF screening effect was observed in the top decile of CH-AI (AF diagnosis rate in screening 10.07/100 person-years [95% 8.28-11.87] vs 7.76 [95% 6.30-9.21] in control, P < 0.05), corresponding to a difference in AF diagnosis rate of 2.32/100 person-years (95% CI: 0.01-4.63) and number-needed-to-screen of 43 per year. CONCLUSIONS: Use of ECG-based AI and clinical factors identified individuals at particularly high risk for AF who may benefit from screening. Findings suggest a trade-off between increasing AF screening efficiency and decreasing population coverage (ie, restriction of the screening pool). Future studies are needed to determine whether a risk-based approach is optimal or whether consideration of additional clinical- and systems-level factors (eg, access, health care system engagement) can further refine AF screening strategies. (Screening for Atrial Fibrillation Among Older Patients in Primary Care Clinics [VITAL-AF]; NCT03515057).

References

1. 1.Vedage, N. A., Friedman, S. F., Chang, Y., Borowsky, L. H., Shah, S. J., McManus, D. D., Atlas, S. J., Singer, D. E., Lubitz, S. A., Maddah, M., Ellinor, P. T., & Khurshid, S. (2026). Risk-guided atrial fibrillation screening with artificial intelligence-enabled electrocardiogram models: A VITAL-AF trial analysis. Journal of the American College of Cardiology. https://doi.org/10.1016/j.jacc.2026.01.087