Comparative evaluation of handheld 6-lead and standard 12-lead electrocardiograms in patients with arrhythmia
Y Park, S Eom, S J Lee, Y Na, J Lim, M Park, H J Ahn, M Chang, S Joo, M AhnAbstract
Aims
Standard 12-lead electrocardiograms (ECGs) require clinical infrastructure that can limit timely access, whereas portable 6-lead devices offer the potential to expand diagnostics into community and remote settings. We aimed to evaluate the signal equivalence and rhythm classification accuracy of a handheld 6-lead ECG (HATIV® P30) compared with a standard 12-lead ECG in patients with arrhythmia, considering postural and synchronisation effects.
Methods
In this prospective single-centre study, 235 paired ECG recordings were obtained from patients with arrhythmia. Each dataset included a simultaneous 10-second 12-lead ECG and a time-aligned 10-second segment extracted from a 30-second handheld 6-lead ECG, recorded in both supine and sitting positions. A blinded electrophysiologist annotated rhythm types and measured ECG intervals and amplitudes.
Results
Diagnostic concordance between the 6-lead and 12-lead ECGs was 99.1% in both supine (n = 113) and sitting (n = 116) positions, with a single atrial flutter misclassified as atrial fibrillation in each setting. Bland–Altman analyses showed minimal mean differences (12-lead minus 6-lead): PR +12.1/+7.4 ms (supine/sitting), QRS −6.4/−6.0 ms, QT −10.3/−5.3 ms, QTc −11.5/−6.4 ms, and heart rate ≈ 0.03 bpm. Absolute differences were <20 ms in ~70% of PR and ~55–62% of QT/QTc measurements. In an exploratory asynchronous pairing (supine 12-lead vs. sitting 6-lead; n = 103), diagnostic accuracy declined to 97.1% and interval discrepancies widened, reflecting postural and temporal variability.
Conclusions
Among patients with arrhythmia, the handheld 6-lead ECG demonstrated near-perfect rhythm agreement and small numerical deviations compared with the 12-lead ECG under synchronised acquisition in both supine and sitting positions. Asynchronous or posture-mismatched comparisons reduced agreement, highlighting the importance of acquisition consistency. The 6-lead device may serve as a practical alternative when 12-lead ECGs are unavailable, facilitating arrhythmia assessment in community and remote environments.