The quality of ECG data acquisition, and diagnostic performance of a novel adhesive patch for ambulatory cardiac rhythm monitoring in arrhythmia detection

M. Remzi Karaoğuz, Ece Yurtseven, Gamze Aslan, Bilgen Gülşen Deliormanlı, Ömer Adıgüzel, Mehmet Gonen, Ko Mai Li, Elif Nur Yılmaz

Research output: Contribution to journalArticle

Abstract

Background: Short and long ambulatory electrocardiographic monitoring with different systems is a widely used method to detect cardiac arrhythmias. In this study, we aimed to evaluate the effectiveness of a novel monitoring device on cardiac arrhythmia detection. Methods: We used two different protocols to evaluate device performance. For the first one, 36 healthy subjects were enrolled. The standard 12‑lead, 24-h Holter monitoring and the novel single lead electrocardiogram (ECG) Patch Monitor (EPM) device (BeyondCare® Rooti Labs Ltd., Taipei, Taiwan) were simultaneously applied to all subjects for 24 h. The quality of ECG data acquisition of novel system was compared to that of standard Holter. The second phase included 73 patients that were referred from our outpatient arrhythmia clinic for evaluation of their symptoms relevant to the cardiac arrhythmias. Advanced algorithms, statistical methods (cross-correlation method, Pearson's correlation coefficient, Bland-Altman plots) were used to process and verify the acquired data. Results: The overall average beat per minute correlation between BeyondCare® and standard 12‑lead Holter was found 98% in 33 healthy subjects. The mean percentage of invalid measurements in BeyondCare® was 1.6% while the Holter's was 1.7%. In the second protocol of the study, prospective data from 67 patients who were referred for evaluation of their symptoms relevant to cardiac arrhythmias, showed that the mean BeyondCare® wear time was 4.7 ± 0.5 days out of five total days per protocol. The mean analyzable wear time was 93.6%. The water-resistant design enabled 73.5% of the participants to take a shower. 7.3% of participants had minor skin irritations related to the electrodes. Among the patients with detected arrhythmia (40.2% of all patients), 29.6% had their first arrhythmia after the initial two days period. A clinically significant pause was detected in one patient, ventricular tachycardia was detected in four patients, and supraventricular tachycardia was detected in 15 patients. Paroxysmal atrial fibrillation was identified in seven patients. Three of them had their first episodes after the second day of monitoring. Conclusion: BeyondCare® Patch was well-tolerated and allowed prolonged time periods for continuous ECG monitoring, may result in an improvement in clinical accuracy and detection of arrhythmias by cloud-based artificial intelligence operating system.

Original languageEnglish (US)
Pages (from-to)28-35
Number of pages8
JournalJournal of Electrocardiology
Volume54
DOIs
StatePublished - May 1 2019
Externally publishedYes

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Adhesives
Cardiac Arrhythmias
Electrocardiography
Ambulatory Electrocardiography
Symptom Assessment
Equipment and Supplies
Healthy Volunteers
Supraventricular Tachycardia
Data Accuracy
Artificial Intelligence
Ventricular Tachycardia
Ambulatory Care Facilities
Taiwan
Atrial Fibrillation
Electrodes
Prospective Studies
Skin
Water

Keywords

  • Ambulatory electrocardiographic monitoring
  • Cardiac arrhythmias
  • ECG patch monitoring device

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

The quality of ECG data acquisition, and diagnostic performance of a novel adhesive patch for ambulatory cardiac rhythm monitoring in arrhythmia detection. / Karaoğuz, M. Remzi; Yurtseven, Ece; Aslan, Gamze; Deliormanlı, Bilgen Gülşen; Adıgüzel, Ömer; Gonen, Mehmet; Li, Ko Mai; Yılmaz, Elif Nur.

In: Journal of Electrocardiology, Vol. 54, 01.05.2019, p. 28-35.

Research output: Contribution to journalArticle

Karaoğuz, M. Remzi ; Yurtseven, Ece ; Aslan, Gamze ; Deliormanlı, Bilgen Gülşen ; Adıgüzel, Ömer ; Gonen, Mehmet ; Li, Ko Mai ; Yılmaz, Elif Nur. / The quality of ECG data acquisition, and diagnostic performance of a novel adhesive patch for ambulatory cardiac rhythm monitoring in arrhythmia detection. In: Journal of Electrocardiology. 2019 ; Vol. 54. pp. 28-35.
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AU - Adıgüzel, Ömer

AU - Gonen, Mehmet

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