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. 2019 Mar 5;7(3):e11437.
doi: 10.2196/11437.

Diagnostic Performance of a Smart Device With Photoplethysmography Technology for Atrial Fibrillation Detection: Pilot Study (Pre-mAFA II Registry)

Affiliations

Diagnostic Performance of a Smart Device With Photoplethysmography Technology for Atrial Fibrillation Detection: Pilot Study (Pre-mAFA II Registry)

Yong-Yan Fan et al. JMIR Mhealth Uhealth. .

Abstract

Background: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. The asymptomatic nature and paroxysmal frequency of AF lead to suboptimal early detection. A novel technology, photoplethysmography (PPG), has been developed for AF screening. However, there has been limited validation of mobile phone and smart band apps with PPG compared to 12-lead electrocardiograms (ECG).

Objective: We investigated the feasibility and accuracy of a mobile phone and smart band for AF detection using pulse data measured by PPG.

Methods: A total of 112 consecutive inpatients were recruited from the Chinese PLA General Hospital from March 15 to April 1, 2018. Participants were simultaneously tested with mobile phones (HUAWEI Mate 9, HUAWEI Honor 7X), smart bands (HUAWEI Band 2), and 12-lead ECG for 3 minutes.

Results: In all, 108 patients (56 with normal sinus rhythm, 52 with persistent AF) were enrolled in the final analysis after excluding four patients with unclear cardiac rhythms. The corresponding sensitivity and specificity of the smart band PPG were 95.36% (95% CI 92.00%-97.40%) and 99.70% (95% CI 98.08%-99.98%), respectively. The positive predictive value of the smart band PPG was 99.63% (95% CI 97.61%-99.98%), the negative predictive value was 96.24% (95% CI 93.50%-97.90%), and the accuracy was 97.72% (95% CI 96.11%-98.70%). Moreover, the diagnostic sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of mobile phones with PPG for AF detection were over 94%. There was no significant difference after further statistical analysis of the results from the different smart devices compared with the gold-standard ECG (P>.99).

Conclusions: The algorithm based on mobile phones and smart bands with PPG demonstrated good performance in detecting AF and may represent a convenient tool for AF detection in at-risk individuals, allowing widespread screening of AF in the population.

Trial registration: Chinese Clinical Trial Registry ChiCTR-OOC-17014138; http://www.chictr.org.cn/showproj.aspx?proj=24191 (Archived by WebCite at http://www.webcitation/76WXknvE6).

Keywords: accuracy; algorithm; atrial fibrillation; detection; mobile phone; photoplethysmography; smart band.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
A prototype for atrial fibrillation detection using HUAWEI mobile phones and smart bands. A: A patient is simultaneously checked with HUAWEI mobile phones (Mate 9, Honor 7X), HUAWEI smart bands (Band 2), and 12-lead ECG. B: A fingertip is placed in contact with the built-in camera lens of a HUAWEI Mate 9 mobile phone and is illuminated by the adjacent LED flash. C: A screenshot of the pulse waveform data collection app (Heartbeats) running on a HUAWEI Mate 9 mobile phone. D: Representative pulse waveform recording from a patient with normal sinus rhythm. E: Representative pulse waveform recording from a patient with persistent atrial fibrillation.
Figure 2
Figure 2
A flowchart of the study. AF: atrial fibrillation; ECG: electrocardiogram; SR: sinus rhythm.

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