Validation of Adhesive Single-Lead ECG Device Compared with Holter Monitoring among Non-Atrial Fibrillation Patients

Figures

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  Figure 1. The measurement setting for ECG monitoring of a study participant. The left panel shows a participant wearing a Holter monitoring and an adhesive single-lead ECG monitoring device (mobiCARE-MC100) simultaneously. The right panel shows the product appearance of mobiCARE-MC100. Abbreviation: ECG, electrocardiogram.

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  Figure 2. The Bland–Altman plots for ECG parameters, including total QRS complexes/VEBs/ SVEBs, and burdens of VEBs/SVEBs. The plots drew with 95% CI of limits of agreement and 95% CI of mean difference. The mobiCARE-MC100 served as a reference. Abbreviations: CI, confidence interval; ECG, electrocardiogram; ICC, intraclass correlation coefficient; SD, standard deviation; SVEB, supraventricular ectopic beat; VEB, ventricular ectopic beat.

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  Figure 3. The Bland–Altman plots for ECG parameters, including minimum/average/maximum HR and maximum RR interval. The plots drew with 95% CI of limits of agreement and 95% CI of mean difference. The mobiCARE-MC100 served as a reference. Abbreviations: CI, confidence interval; ECG, electrocardiogram; HR, heart rate; ICC, intraclass correlation coefficient; SD, standard deviation.

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  Figure 4. An exemplary case of reporting more VEBs with a single-lead ECG monitoring than with Holter monitoring. The participant had PACs with aberrant conduction (red arrows) in Holter monitoring. However, the aberrant conduction was less clear in this participant because the P-waves are unclear in the single-lead ECG monitoring. Therefore, for the patients with P-waves of low amplitude, a compensatory pause should be considered in addition to the change in QRS morphology when judging a premature ventricular complex or aberrant conduction with the single-lead ECG monitoring. Abbreviations: ECG, electrocardiogram; PAC, premature atrial complex; VEB, ventricular ectopic beat.

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  Figure 5. An exemplary case of reporting more SVEBs with a single-lead ECG monitoring than with Holter monitoring. In this participant, non-conducted PACs (red arrows) and conducted PACs (blue arrows) were observed in Holter monitoring, whereas P-waves were rarely visible with the single-lead monitoring. Compared to the sinus rhythm, the P-wave morphology was different in non-conducted and conducted PACs in Holter monitoring. Therefore, detecting SVEBs with single-lead monitoring mostly depends on evaluating RR intervals and QRS morphology. As a result, SVEBs may be overestimated with the single-lead monitoring than with Holter for this case. Abbreviations: ECG, electrocardiogram; PAC, premature atrial complex; SVEB, supraventricular ectopic beat.

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  Figure 6. The heart rate trend with adhesive patch-type ECG monitoring device. The raw data from the outlier with significantly higher total QRS complexes with Holter monitoring showed there were significant Bluetooth disconnection periods during the nocturnal period (within the red-rectangled area). Abbreviations: ECG, electrocardiogram.

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  Figure 7. The outlier with significantly higher maximum heart rate with Holter monitoring. The amplitude of a particular QRS complex (red arrow) was lower than other complexes in the lead I, and this led to undersensing of the QRS complex with the MC-100. Such a particular undersensing led to different measurements of the maximum heart rate.

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  Figure 8. The outlier with different maximum RR intervals between the two devices. Both devices detected the same episode for their detection of the maximum RR interval. However, there was a minute difference in maximum RR intervals (red lines) between both devices (less than 50 ms). We concluded there existed minute differences in detecting R-wave peaks between both devices.