The 6-lead handheld ECG demonstrated higher overall diagnostic accuracy (98.6% vs 96.9%) and closer quantitative agreement with a 12-lead reference ECG than the single-lead smartwatch ECG.
Cross-Sectional (n=194)
Blinded interpreters
No
Does a 6-lead consumer ECG improve diagnostic accuracy and waveform agreement compared to a single-lead consumer ECG in arrhythmia-clinic patients?
A 6-lead handheld consumer ECG provides higher diagnostic accuracy and closer waveform agreement with a standard 12-lead ECG compared to a single-lead smartwatch ECG.
Absolute Event Rate: 98.6% vs 96.9%
Abstract Background Consumer-grade electrocardiogram (ECG) devices enable accessible rhythm monitoring. Recently developed six-lead handheld ECGs promise improved signal quality and diagnostic performance; however, comparative validation remains limited. Objective Using 12-lead ECGs as reference, we compared diagnostic performance and quantitative agreement of a 6-lead and single-lead consumer ECGs. Methods In this prospective single-center study, 194 arrhythmia-clinic patients (498 paired recordings) underwent simultaneous 10-second 12-lead and 30-second 6-lead ECG acquisition, followed by sequential 30-second single-lead recording. Two blinded electrophysiologists interpreted ECGs. Diagnostic performance for predefined rhythm categories (sinus rhythm, atrial/ventricular premature complex, atrial fibrillation/flutter/tachycardia, atrioventricular block, others) was assessed by sensitivity, specificity, and accuracy. Waveform agreement was evaluated using Bland–Altman analysis and intraclass correlation coefficients (ICC) accounting for repeated measures. Results Sensitivity was higher for the 6-lead ECG for ectopic beats, atrial flutter, and first-degree atrioventricular block, with comparable specificity across categories. Overall diagnostic accuracy was 98.6% (95% confidence interval CI, 97.4–99.6) for the 6-lead and 96.9% (94.7–98.7) for the single-lead ECG. Agreement with the 12-lead ECG was higher for the 6-lead device for PR interval (ICC 0.89; 0.85–0.92) and QRS amplitude (0.96; 0.94–0.97) than for the single-lead device (0.57; 0.48–0.63 and 0.04; −0.13–0.21, respectively). Bland–Altman analysis demonstrated generally narrower limits of agreement for the 6-lead ECG. Findings were consistent in patient-level sensitivity analyses. Conclusions The 6-lead handheld ECG demonstrated a higher point estimate for diagnostic accuracy and closer agreement with the 12-lead ECG than the single-lead smartwatch ECG, supporting its use for arrhythmia assessment and interval measurement.
Kim et al. (Wed,) conducted a cross-sectional in Arrhythmia (n=194). 6-lead consumer-grade ECG vs. Single-lead consumer ECG was evaluated on Overall diagnostic accuracy for predefined rhythm categories. The 6-lead handheld ECG demonstrated higher overall diagnostic accuracy (98.6% vs 96.9%) and closer quantitative agreement with a 12-lead reference ECG than the single-lead smartwatch ECG.