Clinical Validation of a 13-Lead Electrocardiogram Derived from a Self-Applicable 3-Lead Recording for Diagnosis of Myocardial Supply Ischaemia and Common Non-Ischaemic Electrocardiogram Abnormalities at Rest

Aims:In this study, we compare the diagnostic accuracy of a standard 12-lead electrocardiogram (ECG) with a novel 13-lead ECG derived from a self-applicable 3-lead ECG recorded with the right exploratory left foot (RELF) device. The 13th lead is a novel age and sex orthonormalized computed ST (ASO-ST) lead to increase the sensitivity for detecting ischaemia during acute coronary artery occlusion.Methods and results:A database of simultaneously recorded 12-lead ECGs and RELF recordings from 110 patients undergoing coronary angioplasty and 30 healthy subjects was used. Five cardiologists scored the learning data set and five other cardiologists scored the validation data set. In addition, the presence of non-ischaemic ECG abnormalities was compared. The accuracy for detection of myocardial supply ischaemia with the derived 12 leads was comparable with that of the standard 12-lead ECG (P = 0.126). By adding the ASO-ST lead, the accuracy increased to 77.4% [95% confidence interval (CI): 72.4-82.3; P < 0.001], which was attributed to a higher sensitivity of 81.9% (95% CI: 74.8-89.1) for the RELF 13-lead ECG compared with a sensitivity of 76.8% (95% CI: 71.9-81.7; P < 0.001) for the 12-lead ECG. There was no significant difference in the diagnosis of non-ischaemic ECG abnormalities, except for Q-waves that were more frequently detected on the standard ECG compared with the derived ECG (25.9 vs. 13.8%; P < 0.001).Conclusion:A self-applicable and easy-to-use 3-lead RELF device can compute a 12-lead ECG plus an ischaemia-specific 13th lead that is, compared with the standard 12-lead ECG, more accurate for the visual diagnosis of myocardial supply ischaemia by cardiologists.