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Clinical Validation of a Smartphone-Based Handheld Ecg Device: A Validation Study Publisher Pubmed



Ahmadirenani S1 ; Gharebaghi M2 ; Kamalian E3 ; Hajghassem H4 ; Ghanbari A5 ; Karimi A6 ; Mansoury B7 ; Dayari MS8 ; Khatmi Nemati M9 ; Karimi A6 ; Zarghami MH11 ; Vasheghanifarahani A12
Authors
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Authors Affiliations
  1. 1. Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Electrical Engineering, Sharif University of Technology, Tehran, Iran
  4. 4. Faculty of New Sciences and Technologies, University of Tehran, Tehran, Iran
  5. 5. Department of Computer Engineering, Sharif University of Technology, Tehran, Iran
  6. 6. Department of Electrical and Computer Engineering, Qom University of Technology, Qom, Iran
  7. 7. Department of Mechanical Engineering, Sharif University of Technology, Tehran, Iran
  8. 8. Department of Electrical Engineering, Kn Toosi University of Technology, Tehran, Iran
  9. 9. Iran University of Science and Technology, Tehran, Iran
  10. 10. Department of Mechanical Engineering, Iran University of Science and Technology, Tehran, Iran
  11. 11. University of Science and Research, Tehran, Iran
  12. 12. Cardiac Primary Prevention Research Center, Cardiovascular Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran

Source: Critical Pathways in Cardiology Published:2022


Abstract

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.