Diagnostic Accuracy of Artificial Intelligence for Arrhythmia Detection Using the 12-Lead Electrocardiogram: A Systematic Review and Meta-Analysis.

Background: Artificial intelligence (AI) has emerged as a promising tool for interpreting 12-lead electrocardiograms (ECGs), with the potential to enhance diagnostic accuracy for arrhythmia detection. However, published studies vary widely in methodology and validation strategy, warranting a quantitative synthesis of diagnostic performance. Methods: A systematic review and meta-analysis was conducted according to the PRISMA-DTA 2018 guidelines and registered in PROSPERO (CRD420251027264). Searches were performed in MEDLINE, Embase, and Cochrane Library through September 2025 without language restrictions. Studies evaluating AI algorithms for arrhythmia detection using 12-lead ECGs were included. Data on sensitivity, specificity, and area under the curve (AUC) were extracted. Pooled estimates were generated using a bivariate random-effects model. Risk of bias was assessed with QUADAS-2, and the certainty of evidence was quantified using GRADE. Results: 20 studies were included in the meta-analysis, encompassing over 5.5 million ECGs. The pooled sensitivity, specificity, and AUC for AI-based arrhythmia detection were 94.0% (95% CI 90.8-96.2; I Conclusions: AI models applied to 12-lead ECGs demonstrate excellent diagnostic performance for arrhythmia detection. Findings support potential integration into clinical workflows, particularly in settings with limited cardiology expertise. Given substantial heterogeneity, standardized datasets and multicenter prospective validation are essential to ensure effective and equitable implementation.