Dataset Information

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

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).

SUBMITTER: Fan YY

PROVIDER: S-EPMC6423467 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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

Fan Yong-Yan YY Li Yan-Guang YG Li Jian J Cheng Wen-Kun WK Shan Zhao-Liang ZL Wang Yu-Tang YT Guo Yu-Tao YT

JMIR mHealth and uHealth 20190305 3

<h4>Background</h4>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).<h4>Objective</h4>We investigated the feasibility and accuracy of a mobile phone and smart band fo ...[more]

PMID: 30835243

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Project description:BackgroundConsumer smartwatches have gained attention as mobile health (mHealth) tools able to detect atrial fibrillation (AF) using photoplethysmography (PPG) or a short strip of electrocardiogram (ECG). PPG has limited accuracy due to the movement artifacts, whereas ECG cannot be used continuously, is usually displayed as a single-lead signal and is limited in asymptomatic cases.ObjectiveDoubleCheck-AF is a validation study of a wrist-worn device dedicated to providing both continuous PPG-based rhythm monitoring and instant 6-lead ECG with no wires. We evaluated its ability to differentiate between AF and sinus rhythm (SR) with particular emphasis on the challenge of frequent premature beats.Methods and resultsWe performed a prospective, non-randomized study of 344 participants including 121 patients in AF. To challenge the specificity of the device two control groups were selected: 95 patients in stable SR and 128 patients in SR with frequent premature ventricular or atrial contractions (PVCs/PACs). All ECG tracings were labeled by two independent diagnosis-blinded cardiologists as "AF," "SR" or "Cannot be concluded." In case of disagreement, a third cardiologist was consulted. A simultaneously recorded ECG of Holter monitor served as a reference. It revealed a high burden of ectopy in the corresponding control group: 6.2 PVCs/PACs per minute, bigeminy/trigeminy episodes in 24.2% (31/128) and runs of ≥3 beats in 9.4% (12/128) of patients. AF detection with PPG-based algorithm, ECG of the wearable and combination of both yielded sensitivity and specificity of 94.2 and 96.9%; 99.2 and 99.1%; 94.2 and 99.6%, respectively. All seven false-positive PPG-based cases were from the frequent PVCs/PACs group compared to none from the stable SR group (P < 0.001). In the majority of these cases (6/7) cardiologists were able to correct the diagnosis to SR with the help of the ECG of the device (P = 0.012).ConclusionsThis is the first wearable combining PPG-based AF detection algorithm for screening of AF together with an instant 6-lead ECG with no wires for manual rhythm confirmation. The system maintained high specificity despite a remarkable amount of frequent single or multiple premature contractions.

Project description:Atrial fibrillation (AF)-induced peripheral microcirculatory alterations have poorly been investigated. The present study aims to expand current knowledge through a beat-to-beat analysis of non-invasive finger photoplethysmography (PPG) in AF patients restoring sinus rhythm by electrical cardioversion (ECV). Continuous non-invasive arterial blood pressure and left middle finger PPG pulse oximetry waveform (POW) signals were continuously recorded before and after elective ECV of consecutive AF or atrial flutter (AFL) patients. The main metrics (mean, standard deviation, coefficient of variation), as well as a beat-to-beat analysis of the pulse pressure (PP) and POW beat-averaged value (aPOW), were computed to compare pre- and post-ECV phases. 53 patients (mean age 69 ± 8 years, 79% males) were enrolled; cardioversion was successful in restoring SR in 51 (96%) and signal post-processing was feasible in 46 (87%) patients. In front of a non-significant difference in mean PP (pre-ECV: 51.96 ± 13.25, post-ECV: 49.58 ± 10.41 mmHg; p = 0.45), mean aPOW significantly increased after SR restoration (pre-ECV: 0.39 ± 0.09, post-ECV: 0.44 ± 0.06 a.u.; p < 0.001). Moreover, at beat-to-beat analysis linear regression yielded significantly different slope (m) for the PP (RR) relationship compared to aPOW(RR) [PP(RR): 0.43 ± 0.18; aPOW(RR): 1.06 ± 0.17; p < 0.001]. Long (> 95th percentile) and short (< 5th percentile) RR intervals were significantly more irregular in the pre-ECV phases for both PP and aPOW; however, aPOW signal suffered more fluctuations compared to PP (p < 0.001 in both phases). Present findings suggest that AF-related hemodynamic alterations are more manifest at the peripheral (aPOW) rather than at the upstream macrocirculatory level (PP). Restoring sinus rhythm increases mean peripheral microvascular perfusion and decreases variability of the microvascular hemodynamic signals. Future dedicated studies are required to determine if AF-induced peripheral microvascular alterations might relate to long-term prognostic effects.

Project description:Atrial fibrillation is often asymptomatic and intermittent making its detection challenging. A photoplethysmography (PPG) provides a promising option for atrial fibrillation detection. However, the shapes of pulse waves vary in atrial fibrillation decreasing pulse and atrial fibrillation detection accuracy. This study evaluated ten robust photoplethysmography features for detection of atrial fibrillation. The study was a national multi-center clinical study in Finland and the data were combined from two broader research projects (NCT03721601, URL: https://clinicaltrials.gov/ct2/show/NCT03721601 and NCT03753139, URL: https://clinicaltrials.gov/ct2/show/NCT03753139). A photoplethysmography signal was recorded with a wrist band. Five pulse interval variability, four amplitude features and a novel autocorrelation-based morphology feature were calculated and evaluated independently as predictors of atrial fibrillation. A multivariate predictor model including only the most significant features was established. The models were 10-fold cross-validated. 359 patients were included in the study (atrial fibrillation n = 169, sinus rhythm n = 190). The autocorrelation univariate predictor model detected atrial fibrillation with the highest area under receiver operating characteristic curve (AUC) value of 0.982 (sensitivity 95.1%, specificity 93.7%). Autocorrelation was also the most significant individual feature (p < 0.00001) in the multivariate predictor model, detecting atrial fibrillation with AUC of 0.993 (sensitivity 96.4%, specificity 96.3%). Our results demonstrated that the autocorrelation independently detects atrial fibrillation reliably without the need of pulse detection. Combining pulse wave morphology-based features such as autocorrelation with information from pulse-interval variability it is possible to detect atrial fibrillation with high accuracy with a commercial wrist band. Photoplethysmography wrist bands accompanied with atrial fibrillation detection algorithms utilizing autocorrelation could provide a computationally very effective and reliable wearable monitoring method in screening of atrial fibrillation.

Project description: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.

Dataset Information

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

Publications

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

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