Abstract
Background: Low left ventricular ejection fraction (LEF) can progress undiagnosed. Artificial intelligence–based electrocardiogram (ECG-AI) screening may provide a scalable means to detect LEF.
Objectives: The purpose of this study was to validate a complete ECG-AI software as a medical device for LEF detection.
Methods: Four geographically diverse sites in the United States identified patients with both ECGs and transthoracic echocardiograms performed within 30 days of each other in clinical practice. Data were electronically extracted to specific guidelines and transmitted to the coordinating center for analysis.
Results: Records of 16,000 subjects were extracted, resulting in an evaluable set of 13,960 subjects (mean age 66 years; 52% male). The device demonstrated excellent discrimination (AUROC: 0.92 [95% CI: 0.91-0.93]) and was 84.5% (95% CI: 82.2%-86.6%) sensitive and 83.6% (95% CI: 82.9%-84.2%) specific for LEF. The overall prevalence of LEF in the study data set was 7.9%, with LEF among 1.6% of the ECG-AI negative and 30.5% of ECG-AI positive subjects, contributing to positive and negative predictive values of 30.5% (95% CI: 28.8%-32.1%) and 98.4% (95% CI: 98.2%-98.7%), respectively.
Conclusions: External validation studies such as this one provide a rigorous framework to validate an algorithm’s performance. This study demonstrated the algorithm’s strong diagnostic accuracy over a geographically diverse, independent set of patients. In this generally unselected population, the algorithm produced a test negative result in 78% of the cases, suggesting potential utility as a rule-out strategy to defer echocardiography when other clinical findings are absent.