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. 2020 Nov 30:7:587945.
doi: 10.3389/fcvm.2020.587945. eCollection 2020.

Cardiac Ambulatory Monitoring: New Wireless Device Validated Against Conventional Holter Monitoring in a Case Series

Srinivasan Murali  1 , Nicolas Brugger  2 , Francisco Rincon  1 , Manoj Mashru  3 , Stéphane Cook  2 , Jean-Jacques Goy  4
Affiliations

Cardiac Ambulatory Monitoring: New Wireless Device Validated Against Conventional Holter Monitoring in a Case Series

Srinivasan Murali et al. Front Cardiovasc Med. .

Abstract

Background: Cardiac arrhythmias are very common but underdiagnosed due to their transient and asymptomatic nature. An optimization of arrhythmia detection would permit to better treat patients and could substantially reduce morbidity and mortality. The SmartCardia ScaAI wireless patch is a novel CE IIa approved, single-lead electrocardiographic (ECG) ambulatory monitor designed for cardiac arrhythmias detection. Hypothesis: The accuracy of the new SmartCardia wireless patch to detect arrhythmias is comparable to the conventional Holter monitoring. Methods: Patients referred for a suspicion of arrhythmia between February and March 2020 were included in the trial. Simultaneous ambulatory ECG were recorded using a conventional 24-h Holter and the SmartCardia. The primary endpoint was the detection of cardiac arrhythmias over the total wear time of the devices, defined as premature atrial contraction (PAC), supraventricular tachycardia ≥3 beats, premature ventricular contraction (PVC), and ventricular tachycardia ≥3 beats. Conduction abnormalities, pause ≥2 s and atrioventricular block (AVB), were also tracked. McNemar's test was used to compare the matched pairs of data from both devices. Results: A total of 40 patients were included in the trial. Over the total wear time, there was no significant difference between the devices for ventricular and supraventricular arrhythmias detection. Pauses and AVB were equally identified by the two devices in three patients. Conclusion: Over the total wear time, the SmartCardia device showed an accuracy to detect arrhythmia similar to the 24-h Holter monitoring: single-lead, adhesive-patch monitoring might become an interesting alternative to the conventional Holter monitoring.

Keywords: Holter monitoring; SmartCardia patch; atrial fibrillation; cardiac arrhythmias; electrocardiogram; wireless recorder.

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Conflict of interest statement

SM, FR, and MM are members of the board of SmartCardia. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
(A) Smartcardia Wireless Disposable, (B) PatchDevice patched on the patient's chest.
Figure 2
Figure 2
Comparison of the average heart rate between the two systems showing good correlation.
Figure 3
Figure 3
Bland-Altman plots for agreement between heart rate evaluation by the SmartCardia and 24-h Holter monitor. (A) Minimal, (B) maximal, and (C) average heart rate. HR, Heart Rate; BPM, Beat Per Minute; min, minimal; avrg, average; max, maximal.
Figure 4
Figure 4
Examples of traces from both devices. (A) PAC with some aberrant conduction correctly classified by the SmartCardia (the Holter monitoring classified the premature beats as PVC), (B) Short VT correctly classified by the SmartCardia, (C) Recording of the same episode of supraventricular tachycardia (above Holter, below SmartCardia).
See this image and copyright information in PMC

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