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Clinical validation of a smartphone-based handheld ECG device: A validation study

Ahmadi-Renani, S ; Sharif University of Technology | 2022

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  1. Type of Document: Article
  2. DOI: 10.1097/HPC.0000000000000303
  3. Publisher: Lippincott Williams and Wilkins , 2022
  4. Abstract:
  5. Background: Remote cardiac monitoring and screening have already become an integral telemedicine component. The wide usage of several different wireless electrocardiography (ECG) devices warrants a validation study on their accuracy and reliability. Methods: Totally, 300 inpatients with the Nabz Hooshmand-1 handheld ECG device and the GE MAC 1200 ECG system (as the reference) were studied to check the accuracy of the devices in 1 and 6-limb lead performance. Simultaneous 10-second resting ECGs were assessed for the most common ECG parameters in lead I. Afterward, 6-lead ECGs (limb leads), were performed immediately and studied for their morphologies. Results: Of the 300 patients, 297 had acceptable ECG quality in both devices for simultaneous lead I ECGs. The ECGs were inspected on-screen by a cardiologist for their rhythms, rates, axes, numbers, morphologies of premature atrial and ventricular beats, morphologies and amplitudes of PQRST waves, P-wave durations, QRS-wave durations, P-R intervals, and QT intervals. No significant differences were detected between the devices, and no major abnormalities were missed. Six-limb lead ECGs were obtained in 284 patients, of whom 281 had acceptable quality in ECGs by both devices. The morphology matching evaluation of the ECGs demonstrated an overall 98% compatibility rate, with the highest compatibility in lead I and the lowest in lead augmented vector foot. Conclusions: The diagnosis of critical pathological rhythms, including atrial fibrillation and high-grade atrioventricular node block, was not missed by the Nabz Hooshmand-1 and GE MAC 1200 ECG devices. Accordingly, rhythm detection as the primary purpose of handheld ECG devices was highly accurate. Both devices had acceptable sensitivity to diagnose long P-R and long and short QT intervals. Although the modern technology of smartphones and the physical inability for the 6-limb mode might cause old patients difficulty in utilizing such devices, their use for screening and follow-up is safe. Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved
  6. Keywords:
  7. Handheld electrocardiography ; Mobile-based electrocardiography ; Remote cardiac monitoring ; Adult ; Angiography ; Atrial fibrillation ; Atrioventricular block ; Atrioventricular junction arrhythmia ; Diagnostic test accuracy study ; Female ; Heart atrioventricular node ; Heart atrium flutter ; Heart failure ; Heart muscle conduction system ; Heart rate and rhythm ; Heart ventricle extrasystole ; Human ; Ischemic heart disease ; Limb tremor ; Major clinical study ; Male ; Measurement accuracy ; Middle aged ; P wave ; PR interval ; QRS amplitude ; QRS complex ; QRS interval ; QT interval ; QT prolongation ; R wave amplitude ; Sensitivity analysis ; Short QT interval ; ST segment depression ; ST segment elevation ; Supraventricular premature beat ; T wave ; Valvular heart disease ; Wireless communication ; Electrocardiography ; Reproducibility ; Smartphone ; Humans ; Reproducibility of Results
  8. Source: Critical Pathways in Cardiology ; Volume 21, Issue 4 , 2022 , Pages 165-171 ; 1535282X (ISSN)
  9. URL: https://pubmed.ncbi.nlm.nih.gov/36413393