Key result
A 6-lead consumer-grade ECG demonstrated higher diagnostic agreement sensitivity for arrhythmia diagnosis (97.79%) compared to a 1-lead ECG (93.37%) when referenced against a standard 12-lead ECG.
Why the study?
Multiple consumer-driven rhythm detection devices are available, but most are single lead, prompting a comparison of single-lead and 6-lead consumer devices against standard 12-lead ECG.
Do 6-lead and single-lead consumer-grade ECG devices provide accurate arrhythmia diagnosis and numerical accuracy compared to a standard 12-lead ECG?
Cross-Sectional (n=187)
Do 6-lead and single-lead consumer-grade ECG devices provide accurate arrhythmia diagnosis and numerical accuracy compared to a standard 12-lead ECG?
Absolute Event Rate: 97.79% vs 93.37%
6-lead consumer-grade ECG devices demonstrate superior diagnostic concordance and numerical accuracy compared to single-lead devices when validated against standard 12-lead ECGs.
May support preferring 6-lead over 1-lead consumer ECGs for arrhythmia screening; hypothesis-generating and requires prospective validation before practice change.
Background and Objectives Multiple consumer driven devices to detect cardiac rhythm are available these days. However, most devices are single lead. This study aimed to compare the diagnostic accuracy and performance of electrocardiogram (ECG) readings from consumer-grade devices, the single-lead(1L) and the 6-lead(6L), against a standard 12-lead(12L) ECG system. Subjects and Methods A total of 187 patients participated in the study. 6L and 12L ECGs were recorded simultaneously, while the 1L measurements were slightly delayed. Diagnostic agreement and the accuracy of numerical values were analyzed across the devices using sensitivity and the Bland-Altman method. Two criteria were applied: ECG criterion (all pairs from one visit) and patient identification criterion (most recent ECG pair per patient) (figure1). Results 6L ECG had a diagnostic agreement sensitivity of 97.79% with 12-lead ECG for arrhythmia diagnosis, while the 1L ECG had 93.37%. Outlier rates, reflecting numerical accuracy for PR/QRS/QT intervals, were lower for 6L ECG: PR interval outliers were 1.10% (6L) vs. 3.35% (1L); QRS complex outliers were 4.42% (6L) vs. 5.03% (1L); and QT interval outliers were 4.97% (6L) vs. 5.03% (1L) (figure 2). Conclusion Both the 6L and 1L ECGs demonstrated acceptable diagnostic accuracy compared to the 12-lead ECG system. However, the 6L ECG device outperformed the 1L ECG in terms of better diagnostic concordance and lower outlier rates. The results suggest that consumer-grade ECG devices could serve as reliable alternatives for preliminary cardiac assessments, particularly in remote settings, with the 6L ECG system showing a more favorable performance.
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Kim et al. (2025) conducted a cross-sectional in Arrhythmia (n=187). 6-lead consumer-grade ECG vs. 1-lead consumer-grade ECG was evaluated on Diagnostic agreement sensitivity for arrhythmia diagnosis compared to 12-lead ECG. A 6-lead consumer-grade ECG demonstrated higher diagnostic agreement sensitivity for arrhythmia diagnosis (97.79%) compared to a 1-lead ECG (93.37%) when referenced against a standard 12-lead ECG.
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