Transparent and Robust Artificial Intelligence-Driven Electrocardiogram Model for Left Ventricular Systolic...

Background/Objectives: Heart failure (HF) is a growing global health burden, yet early detection remains challenging due to the limitations of traditional diagnostic tools such as electrocardiograms (ECGs). Recent advances in deep learning offer new opportunities to identify left ventricular systolic dysfunction (LVSD), a key indicator of HF, from ECG data. This study validates AiTiALVSD, our previously developed artificial intelligence (AI)-enabled ECG Software as a Medical Device, for its accuracy, transparency, and robustness in detecting LVSD. Methods: This retrospective single-center cohort study involved patients suspected of LVSD. The AiTiALVSD model, based on a deep learning algorithm, was evaluated against echocardiographic ejection fraction values. To enhance model transparency, the study employed Testing with Concept Activation Vectors (TCAV), clustering analysis, and robustness testing against ECG noise and lead reversals. Results: The study involved 688 participants and found AiTiALVSD to have a high diagnostic performance, with an AUROC of 0.919. There was a significant correlation between AiTiALVSD scores and left ventricular ejection fraction values, confirming the model's predictive accuracy. TCAV analysis showed the model's alignment with medical knowledge, establishing its clinical plausibility. Despite its robustness to ECG artifacts, there was a noted decrease in specificity in the presence of ECG noise. Conclusions: AiTiALVSD's high diagnostic accuracy, transparency, and resilience to common ECG discrepancies underscore its potential for early LVSD detection in clinical settings. This study highlights the importance of transparency and robustness in AI-ECG, setting a new benchmark in cardiac care.