Continuous heart rhythm monitoring using mobile photoplethysmography in ambulatory patients.
Atrial fibrillation
Continuous monitoring
Photoplethysmography
Wearable diagnostics
Journal
Journal of electrocardiology
ISSN: 1532-8430
Titre abrégé: J Electrocardiol
Pays: United States
ID NLM: 0153605
Informations de publication
Date de publication:
Historique:
received:
21
03
2020
revised:
18
04
2020
accepted:
23
04
2020
pubmed:
4
5
2020
medline:
22
6
2021
entrez:
4
5
2020
Statut:
ppublish
Résumé
Wearable devices using photo-plethysmography (PPG) can accurately detect heart beats and may be useful for heart rate measurement and diagnosis of arrhythmias such as atrial fibrillation (AF). A previous study of a new portable PPG sensor (CardiacSense) showed high accuracy in heart rate measurement and AF detection in resting patients. We report a trial done to test the same device in active ambulatory patients with diverse characteristics. A cohort of 24 ambulatory volunteers, underwent simultaneous PPG recording and continuous electrocardiogram (ECG) recording under different environmental conditions and situations. Per study protocol, the subjects were diverse in age, BMI, hair density and skin tone. Four subjects had AF. Heart rate measurement using the PPG device was compared to measurements by ECG. Of 163,527 recorded ECG-detected beats in the trial, 86,929 (53.2%) were also recorded by the PPG device. Most undetected heart beats were due to motion induced noise. Correlation between ECG and PPG was high (R = 0.94, p < 0.0001), yet in subjects with AF correlation was lower (R = 0.80, p < 0.0001). A Bland-Altman analysis showed the mean difference between measurements was -0.7 ms (95% limit of agreement -93.8 to 92.2). A total of 86,217 (99.9%) of all RR measurements were reliably measured (RR difference within 100 ms). Reliability was sustained (>99.8%) in subjects of all groups including subjects with AF. This study showed that, in the absence of movement-related noise, the CardiacSense PPG device can reliably detect HR in a variety of situations and subjects' characteristics.
Sections du résumé
BACKGROUND
Wearable devices using photo-plethysmography (PPG) can accurately detect heart beats and may be useful for heart rate measurement and diagnosis of arrhythmias such as atrial fibrillation (AF). A previous study of a new portable PPG sensor (CardiacSense) showed high accuracy in heart rate measurement and AF detection in resting patients. We report a trial done to test the same device in active ambulatory patients with diverse characteristics.
METHODS
A cohort of 24 ambulatory volunteers, underwent simultaneous PPG recording and continuous electrocardiogram (ECG) recording under different environmental conditions and situations. Per study protocol, the subjects were diverse in age, BMI, hair density and skin tone. Four subjects had AF. Heart rate measurement using the PPG device was compared to measurements by ECG.
RESULTS
Of 163,527 recorded ECG-detected beats in the trial, 86,929 (53.2%) were also recorded by the PPG device. Most undetected heart beats were due to motion induced noise. Correlation between ECG and PPG was high (R = 0.94, p < 0.0001), yet in subjects with AF correlation was lower (R = 0.80, p < 0.0001). A Bland-Altman analysis showed the mean difference between measurements was -0.7 ms (95% limit of agreement -93.8 to 92.2). A total of 86,217 (99.9%) of all RR measurements were reliably measured (RR difference within 100 ms). Reliability was sustained (>99.8%) in subjects of all groups including subjects with AF.
CONCLUSIONS
This study showed that, in the absence of movement-related noise, the CardiacSense PPG device can reliably detect HR in a variety of situations and subjects' characteristics.
Identifiants
pubmed: 32361522
pii: S0022-0736(20)30189-8
doi: 10.1016/j.jelectrocard.2020.04.017
pii:
doi:
Types de publication
Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
138-141Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest Natan Lubman designed the atrial fibrillation detection algorithm for CardiacSense. Sami Viskin is Chief Medical Officer for the cardiac arrhythmia section at CardiacSense. The funders designed the study and collected the data according to guidance from the FDA for a new medical device application. Analyses, interpretation of data; the writing of the manuscript, and the decision to publish the results were done by the manuscript writers alone.