Wearable 12-Lead ECG Acquisition Using a Novel Deep Learning Approach from Frank or EASI Leads with Clinical Validation.

The 12-lead electrocardiogram (ECG) is crucial in assessing patient decisions. However, portable ECG devices capable of acquiring a complete 12-lead ECG are scarce. For the first time, a deep learning-based method is proposed to reconstruct the 12-lead ECG from Frank leads (V, V, and V) or EASI leads (V, V, and V). The innovative ECG reconstruction network called M2Eformer is composed of a 2D-ECGblock and a ProbDecoder module. The 2D-ECGblock module adaptively segments EASI leads into multi-periods based on frequency energy, transforming the 1D time series into a 2D tensor representing within-cycle and between-cycle variations. The ProbDecoder module aims to extract Probsparse self-attention and achieve one-step output for the target leads. Experimental results from comparing recorded and reconstructed 12-lead ECG using Frank leads indicate that M2Eformer outperforms traditional ECG reconstruction methods on a public database. In this study, a self-constructed database (10 healthy individuals + 15 patients) was utilized for the clinical diagnostic validation of ECG reconstructed from EASI leads. Subsequently, both the ECG reconstructed using EASI and the recorded 12-lead ECG were subjected to a double-blind diagnostic experiment conducted by three cardiologists. The overall diagnostic consensus among three cardiology experts, reaching a rate of 96%, indicates the significant utility of EASI-reconstructed 12-lead ECG in facilitating the diagnosis of cardiac conditions.