Abstract

Abstract Background Screening for left ventricular (LV) systolic dysfunction (defined as ejection fraction ≤35%) based on data from a standard 12-lead electrocardiogram (ECG) has become well established when standard digital ECGs are available–8 independent leads sampled at least 250 hertz for 10 seconds. As the algorithm has been incorporated into various clinical scenarios and ancillary research projects, a limitation of the binary classification at 35% has become apparent. Purpose The objective of this study was to develop and validate a deep learning-based algorithm that would classify LVEF into three categories based on only the digital ECG input. Methods After IRB approval, native digital resting ECGs acquired between 1/1/2010 and 12/31/2021 on patients seen in Mayo Clinic in Jacksonville were extracted from the institutional electronic ECG database management system (MUSE, GE Healthcare). These ECGs were matched with transthoracic echocardiograms obtained up to four days prior or 30 days after the ECGs acquisition. A convolutional neural network consisting of 8 layers of convolutions, batch normalization and pooling was trained using Keras and Tensorflow with hyper-parameter optimization for L1 and L2 regularization, learning rate adjustments, and class weights to predict three classes of LVEF: ≤35%, 36–51%, and ≥52% based on clinical relevance. The primary measure of overall performance was the detection of LVEF ≤35%; however, the triad of model predictions was also considered in translating the model output to human interpretable findings. Results A total of 30,153 patients (60,169 ECG pairings; mean age 63 years; 48% male) were randomly split at the patient level into training (24,172 patients), validation (2,973 patients) and testing (3,008 patients). The trained model provided robust discrimination in the withheld testing data – AUROC of 0.941 (95% CI: 0.931 to 0.950). Using the optimal model threshold based on Youden's index from the validation data (0.186), sensitivity and specificity were estimated to be 87.9% (95% CI: 83.8% to 91.2%) and 86.3% (95% CI: 85.4% to 87.2%) in the testing data. In instances where discordant predictions were observed, the posterior distribution of model probabilities provide additional insights into the possible underlying value of LVEF (Figure 1). Conclusions The utilization of a multi-category deep learning classification model for the detection of reduced ejection fraction adds new dimensions to the use of AI technologies on digital ECGs. This work shows high discrimination can still be obtained when using three classes of LVEF. Funding Acknowledgement Type of funding sources: None.

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