Key result
AliveCor KardiaMobile six-lead ECG lacks sufficient accuracy for pediatric QTc measurement versus standard ECG.
Why the study?
Little research has been conducted on the accuracy of the AliveCor KardiaMobile six-lead ECG device in pediatric patients.
Does the AliveCor KardiaMobile six-lead ECG device accurately measure QTc, QRS, and axis compared to a standard fifteen-lead ECG in pediatric patients?
Cross-Sectional (n=141)
Single-blind
No
Does the AliveCor KardiaMobile six-lead ECG device accurately measure QTc, QRS, and axis compared to a standard fifteen-lead ECG in pediatric patients?
The AliveCor KardiaMobile six-lead ECG produces measurements within a clinically useful range for most pediatric patients but is not accurate enough to consistently replace standard ECG for QTc and QRS measurements.
Does not support replacing standard ECGs for pediatric QTc; leaves open whether device refinements could improve agreement in future studies.
Background: The AliveCor KardiaMobile (ACKM) is a remote electrocardiogram (ECG) monitoring device. Little research has been conducted on its accuracy with pediatric patients. This prospective study aims to compare the ACKM six-lead device with a standard fifteen-lead ECG in measuring the QTc, QRS, and axis in pediatric patients.Methods: Pediatric patients ages 5 to 21 years were enrolled prospectively to have their ECG recorded using an ACKM six-lead device following a recording with the standard fifteen-lead ECG. A pediatric electrophysiologist measured the QTc, QRS interval, and QRS axis for both ECGs. Bland-Altman analysis was performed to assess agreement among measurements.Results: The study included 141 patients. The mean age was 12.3 ± 4.4 years. Average heart rate was 79 ± 16 bpm. The mean difference in the QTc measurements for a paired standard ECG and ACKM was -0.6 ms [95% confidence interval -48 to 47 ms]. Of the ACKM QTc measurements, 117 (83%) were within 30 ms of the standard ECG. The mean difference in paired QRS measurements was -1.3 ms [95% confidence interval -23 to 21 ms]. Of the ACKM QRS measurements, 134 (95%) were within 20 ms of the standard ECG. The measured axis was the same for 84% of ACKM and standard ECGs. Conclusions: Over 80% of the ACKM six-lead ECGs produced QTc, QRS, and axis deviation measurements within a clinically useful range of the standard ECG. However, it is not accurate enough to be used consistently in place of a standard ECG for QTc and QRS measurement for pediatric patients.
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Girvin et al. (2022) conducted a cross-sectional in Pediatric patients referred to cardiology clinic (n=141). AliveCor KardiaMobile six-lead ECG vs. Standard fifteen-lead ECG was evaluated on QTc interval measurement agreement (MD -0.6 ms, 95% CI -48 to 47, p=0.78). The AliveCor KardiaMobile six-lead ECG yielded a mean QTc difference of -0.6 ms versus standard ECG, but wide limits of agreement (-48 to 47 ms) make it insufficiently accurate for pediatric use.
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