High Specificity Wearable Device With Photoplethysmography and Six-Lead Electrocardiography for Atrial Fibrillation Detection Challenged by Frequent Premature Contractions: DoubleCheck-AF

Justinas Bacevicius; Zygimantas Abramikas; Ernestas Dvinelis; Deimile Audzijoniene; Marija Petrylaite; Julija Marinskiene; Justina Staigyte; Albinas Karuzas; Vytautas Juknevicius; Rusne Jakaite; Viktorija Basyte-Bacevice; Neringa Bileisiene; Andrius Solosenko; Daivaras Sokas; Andrius Petrenas; Monika Butkuviene; Birute Paliakaite; Saulius Daukantas; Andrius Rapalis; Germanas Marinskis; Eugenijus Jasiunas; Angeliki Darma; Vaidotas Marozas; Audrius Aidietis

doi:10.3389/fcvm.2022.869730

High Specificity Wearable Device With Photoplethysmography and Six-Lead Electrocardiography for Atrial Fibrillation Detection Challenged by Frequent Premature Contractions: DoubleCheck-AF

Front Cardiovasc Med. 2022 Apr 6:9:869730. doi: 10.3389/fcvm.2022.869730. eCollection 2022.

Authors

Justinas Bacevicius^{1

2}, Zygimantas Abramikas^{1

2}, Ernestas Dvinelis^{1

2}, Deimile Audzijoniene^{1

2}, Marija Petrylaite^{1

2}, Julija Marinskiene^{1

2}, Justina Staigyte^{1

2}, Albinas Karuzas^{1

2}, Vytautas Juknevicius^{1

2}, Rusne Jakaite^{1

2}, Viktorija Basyte-Bacevice¹, Neringa Bileisiene^{1

2}, Andrius Solosenko³, Daivaras Sokas³, Andrius Petrenas³, Monika Butkuviene³, Birute Paliakaite³, Saulius Daukantas³, Andrius Rapalis³, Germanas Marinskis^{1

2}, Eugenijus Jasiunas⁴, Angeliki Darma⁵, Vaidotas Marozas^{3

6}, Audrius Aidietis^{1

2}

Affiliations

¹ Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
² Center of Cardiology and Angiology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
³ Biomedical Engineering Institute, Kaunas University of Technology, Kaunas, Lithuania.
⁴ Center of Informatics and Development, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
⁵ Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.
⁶ Department of Electronics Engineering, Kaunas University of Technology, Kaunas, Lithuania.

Abstract

Background: Consumer 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.

Objective: DoubleCheck-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 results: We 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).

Conclusions: This 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.

Keywords: digital health; mhealth; multiple-lead portable ECG; remote monitoring; telemedicine; wrist-worn device.

Copyright © 2022 Bacevicius, Abramikas, Dvinelis, Audzijoniene, Petrylaite, Marinskiene, Staigyte, Karuzas, Juknevicius, Jakaite, Basyte-Bacevice, Bileisiene, Solosenko, Sokas, Petrenas, Butkuviene, Paliakaite, Daukantas, Rapalis, Marinskis, Jasiunas, Darma, Marozas and Aidietis.