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      Detection of Atrial Fibrillation Using a Ring-Type Wearable Device (CardioTracker) and Deep Learning Analysis of Photoplethysmography Signals: Prospective Observational Proof-of-Concept Study

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          Abstract

          Background

          Continuous photoplethysmography (PPG) monitoring with a wearable device may aid the early detection of atrial fibrillation (AF).

          Objective

          We aimed to evaluate the diagnostic performance of a ring-type wearable device (CardioTracker, CART), which can detect AF using deep learning analysis of PPG signals.

          Methods

          Patients with persistent AF who underwent cardioversion were recruited prospectively. We recorded PPG signals at the finger with CART and a conventional pulse oximeter before and after cardioversion over a period of 15 min (each instrument). Cardiologists validated the PPG rhythms with simultaneous single-lead electrocardiography. The PPG data were transmitted to a smartphone wirelessly and analyzed with a deep learning algorithm. We also validated the deep learning algorithm in 20 healthy subjects with sinus rhythm (SR).

          Results

          In 100 study participants, CART generated a total of 13,038 30-s PPG samples (5850 for SR and 7188 for AF). Using the deep learning algorithm, the diagnostic accuracy, sensitivity, specificity, positive-predictive value, and negative-predictive value were 96.9%, 99.0%, 94.3%, 95.6%, and 98.7%, respectively. Although the diagnostic accuracy decreased with shorter sample lengths, the accuracy was maintained at 94.7% with 10-s measurements. For SR, the specificity decreased with higher variability of peak-to-peak intervals. However, for AF, CART maintained consistent sensitivity regardless of variability. Pulse rates had a lower impact on sensitivity than on specificity. The performance of CART was comparable to that of the conventional device when using a proper threshold. External validation showed that 94.99% (16,529/17,400) of the PPG samples from the control group were correctly identified with SR.

          Conclusions

          A ring-type wearable device with deep learning analysis of PPG signals could accurately diagnose AF without relying on electrocardiography. With this device, continuous monitoring for AF may be promising in high-risk populations.

          Trial Registration

          ClinicalTrials.gov NCT04023188; https://clinicaltrials.gov/ct2/show/NCT04023188

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          Most cited references21

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          Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration.

          Approximately 10% of ischemic strokes are associated with atrial fibrillation (AF) first diagnosed at the time of stroke. Detecting asymptomatic AF would provide an opportunity to prevent these strokes by instituting appropriate anticoagulation. The AF-SCREEN international collaboration was formed in September 2015 to promote discussion and research about AF screening as a strategy to reduce stroke and death and to provide advocacy for implementation of country-specific AF screening programs. During 2016, 60 expert members of AF-SCREEN, including physicians, nurses, allied health professionals, health economists, and patient advocates, were invited to prepare sections of a draft document. In August 2016, 51 members met in Rome to discuss the draft document and consider the key points arising from it using a Delphi process. These key points emphasize that screen-detected AF found at a single timepoint or by intermittent ECG recordings over 2 weeks is not a benign condition and, with additional stroke factors, carries sufficient risk of stroke to justify consideration of anticoagulation. With regard to the methods of mass screening, handheld ECG devices have the advantage of providing a verifiable ECG trace that guidelines require for AF diagnosis and would therefore be preferred as screening tools. Certain patient groups, such as those with recent embolic stroke of uncertain source (ESUS), require more intensive monitoring for AF. Settings for screening include various venues in both the community and the clinic, but they must be linked to a pathway for appropriate diagnosis and management for screening to be effective. It is recognized that health resources vary widely between countries and health systems, so the setting for AF screening should be both country- and health system-specific. Based on current knowledge, this white paper provides a strong case for AF screening now while recognizing that large randomized outcomes studies would be helpful to strengthen the evidence base.
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            Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch

            Question How well can smartwatch sensor data analyzed by a deep neural network identify atrial fibrillation? Findings In this cohort study of 51 participants presenting for cardioversion, a commercially available smartwatch was able to detect atrial fibrillation with high accuracy. Among 1617 ambulatory individuals who wore a smartwatch, those with self-reported atrial fibrillation were correctly classified with moderate accuracy. Meaning These data support the proof of concept that a commercially available smartwatch coupled with a deep neural network classifier can passively detect atrial fibrillation. This study aims to develop and validate a deep neural network to detect atrial fibrillation using smartwatch data. Importance Atrial fibrillation (AF) affects 34 million people worldwide and is a leading cause of stroke. A readily accessible means to continuously monitor for AF could prevent large numbers of strokes and death. Objective To develop and validate a deep neural network to detect AF using smartwatch data. Design, Setting, and Participants In this multinational cardiovascular remote cohort study coordinated at the University of California, San Francisco, smartwatches were used to obtain heart rate and step count data for algorithm development. A total of 9750 participants enrolled in the Health eHeart Study and 51 patients undergoing cardioversion at the University of California, San Francisco, were enrolled between February 2016 and March 2017. A deep neural network was trained using a method called heuristic pretraining in which the network approximated representations of the R-R interval (ie, time between heartbeats) without manual labeling of training data. Validation was performed against the reference standard 12-lead electrocardiography (ECG) in a separate cohort of patients undergoing cardioversion. A second exploratory validation was performed using smartwatch data from ambulatory individuals against the reference standard of self-reported history of persistent AF. Data were analyzed from March 2017 to September 2017. Main Outcomes and Measures The sensitivity, specificity, and receiver operating characteristic C statistic for the algorithm to detect AF were generated based on the reference standard of 12-lead ECG–diagnosed AF. Results Of the 9750 participants enrolled in the remote cohort, including 347 participants with AF, 6143 (63.0%) were male, and the mean (SD) age was 42 (12) years. There were more than 139 million heart rate measurements on which the deep neural network was trained. The deep neural network exhibited a C statistic of 0.97 (95% CI, 0.94-1.00; P  < .001) to detect AF against the reference standard 12-lead ECG–diagnosed AF in the external validation cohort of 51 patients undergoing cardioversion; sensitivity was 98.0% and specificity was 90.2%. In an exploratory analysis relying on self-report of persistent AF in ambulatory participants, the C statistic was 0.72 (95% CI, 0.64-0.78); sensitivity was 67.7% and specificity was 67.6%. Conclusions and Relevance This proof-of-concept study found that smartwatch photoplethysmography coupled with a deep neural network can passively detect AF but with some loss of sensitivity and specificity against a criterion-standard ECG. Further studies will help identify the optimal role for smartwatch-guided rhythm assessment.
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              Diagnostic Performance of a Smartphone‐Based Photoplethysmographic Application for Atrial Fibrillation Screening in a Primary Care Setting

              Background Diagnosing atrial fibrillation (AF) before ischemic stroke occurs is a priority for stroke prevention in AF. Smartphone camera–based photoplethysmographic (PPG) pulse waveform measurement discriminates between different heart rhythms, but its ability to diagnose AF in real‐world situations has not been adequately investigated. We sought to assess the diagnostic performance of a standalone smartphone PPG application, Cardiio Rhythm, for AF screening in primary care setting. Methods and Results Patients with hypertension, with diabetes mellitus, and/or aged ≥65 years were recruited. A single‐lead ECG was recorded by using the AliveCor heart monitor with tracings reviewed subsequently by 2 cardiologists to provide the reference standard. PPG measurements were performed by using the Cardiio Rhythm smartphone application. AF was diagnosed in 28 (2.76%) of 1013 participants. The diagnostic sensitivity of the Cardiio Rhythm for AF detection was 92.9% (95% CI] 77–99%) and was higher than that of the AliveCor automated algorithm (71.4% [95% CI 51–87%]). The specificities of Cardiio Rhythm and the AliveCor automated algorithm were comparable (97.7% [95% CI: 97–99%] versus 99.4% [95% CI 99–100%]). The positive predictive value of the Cardiio Rhythm was lower than that of the AliveCor automated algorithm (53.1% [95% CI 38–67%] versus 76.9% [95% CI 56–91%]); both had a very high negative predictive value (99.8% [95% CI 99–100%] versus 99.2% [95% CI 98–100%]). Conclusions The Cardiio Rhythm smartphone PPG application provides an accurate and reliable means to detect AF in patients at risk of developing AF and has the potential to enable population‐based screening for AF.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                J. Med. Internet Res
                JMIR
                Journal of Medical Internet Research
                JMIR Publications (Toronto, Canada )
                1439-4456
                1438-8871
                May 2020
                21 May 2020
                : 22
                : 5
                : e16443
                Affiliations
                [1 ] Seoul National University Hospital Seoul Republic of Korea
                [2 ] Department of Electrical Engineering Korea Advanced Institute of Science and Technology Daejeon Republic of Korea
                [3 ] Sky Labs Inc Seongnam Republic of Korea
                [4 ] Department of Information and Communication Engineering Hanbat National University Daejeon Republic of Korea
                Author notes
                Corresponding Author: Eue-Keun Choi choiek417@ 123456gmail.com
                Author information
                https://orcid.org/0000-0002-4791-6855
                https://orcid.org/0000-0002-8378-3332
                https://orcid.org/0000-0002-0411-6372
                https://orcid.org/0000-0003-1930-6926
                https://orcid.org/0000-0002-4002-0407
                https://orcid.org/0000-0002-8735-5474
                https://orcid.org/0000-0002-8708-6235
                https://orcid.org/0000-0002-8188-3348
                https://orcid.org/0000-0002-2504-9615
                https://orcid.org/0000-0002-6955-3135
                Article
                v22i5e16443
                10.2196/16443
                7273241
                32348254
                68da8531-184a-4eb8-a4ae-afbb242afdd3
                ©Soonil Kwon, Joonki Hong, Eue-Keun Choi, Byunghwan Lee, Changhyun Baik, Euijae Lee, Eui-Rim Jeong, Bon-Kwon Koo, Seil Oh, Yung Yi. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 21.05.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

                History
                : 30 September 2019
                : 26 November 2019
                : 24 February 2020
                : 21 March 2020
                Categories
                Original Paper
                Original Paper

                Medicine
                atrial fibrillation,deep learning,diagnosis,photoplethysmography,wearable electronic devices

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