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Position-wise comparison of handheld 6-lead ECG versus the standard 12-lead ECG in patients with arrhythmia:
Young Jun Park1, Sujeong Eom2, Sang Jun Lee3
1Division of Cardiology, Department of Internal Medicine, Korea University College of Medicine and Korea University Anam Hospital, Seoul, Republic of Korea.
Insights
A handheld 6-lead electrocardiograph (ECG) closely matches the diagnostic accuracy of a standard 12-lead ECG for arrhythmia detection. This portable device offers a practical alternative when 12-lead ECGs are inaccessible.
Area of Science:
- Cardiology
- Medical Devices
- Diagnostic Technology
Background:
- Standard 12-lead electrocardiographs (ECGs) require clinical infrastructure, limiting accessibility.
- Portable 6-lead ECG devices offer potential for broader diagnostic reach in community and remote settings.
Purpose of the Study:
- To evaluate the signal equivalence between a handheld 6-lead ECG and a standard 12-lead ECG.
- To assess diagnostic accuracy and parameter agreement in an arrhythmia cohort, considering posture and synchrony.
Main Methods:
- Prospective single-center study involving simultaneous 10-second 12-lead ECGs and time-aligned 6-lead recordings.
- Recordings were obtained from arrhythmia patients in both supine and sitting positions.
- A blinded electrophysiologist classified rhythms and measured ECG parameters (PR, QRS, QT/QTc intervals, amplitudes).
Main Results:
- Near-perfect overall diagnostic accuracy (99.1%) for the 6-lead vs. 12-lead ECG in both supine and sitting positions.
- Small mean differences observed for PR, QRS, QT, and QTc intervals between the two devices.
- Absolute differences were <20 ms in approximately 70% for PR and 55-62% for QT/QTc intervals.
- Accuracy decreased when acquisition was asynchronous or posture-mismatched.
Conclusions:
- The handheld 6-lead ECG demonstrates high rhythm agreement and minimal numerical discrepancies compared to the 12-lead ECG under synchronized conditions.
- Acquisition conditions, including posture and synchrony, significantly impact agreement.
- The 6-lead device presents a viable alternative to the 12-lead ECG in arrhythmia patient management when the latter is unavailable.
Background:
As 12‑lead electrocardiographs (ECGs) require a clinical infrastructure that limits timely access, portable 6‑lead devices may extend diagnostics to community and remote settings. We evaluated the signal equivalence of a handheld 6‑lead ECG (HATIV® P30) versus the standard 12‑lead in an arrhythmia cohort, considering posture and synchrony.
Methods:
In this prospective single-center study, simultaneous 10-s 12-lead ECGs and time-aligned 10-s segments from 30-s 6-lead recordings were obtained from arrhythmia patients in both supine and sitting positions. A blinded electrophysiologist performed rhythm classification and ECG measurements. Diagnostic accuracy and numerical agreement of key parameters (PR interval, QRS duration, QT/QTc intervals, and amplitudes) were evaluated.
Results:
A total of 229 paired recordings were analyzed after excluding 6 pairs. The overall diagnostic accuracy of the 6‑lead versus 12‑lead was 99.1% in the supine position (n = 113) and 99.1% in the sitting position (n = 116); one atrial flutter was misclassified as atrial fibrillation in each position. Bland-Altman analyses showed small 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; heart‑rate difference ≈0.03 bpm. The absolute differences were < 20 ms in approximately ~ 70% for PR and ~ 55-62% for QT/QTc. In an exploratory asynchronous pairing (supine 12‑lead vs sitting 6‑lead; n = 103), accuracy decreased to 97.1% and parameter differences widened, consistent with postural/temporal effects.
Conclusions:
In patients with arrhythmia, the handheld 6‑lead showed near‑perfect rhythm agreement and small numerical differences versus the 12‑lead under synchronized acquisition in both positions. Asynchronous or posture-mismatched comparisons reduce the agreement, and acquisition conditions should be considered. The 6‑lead may be a practical alternative when the 12‑lead is unavailable in patients with arrhythmia.
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