A novel contact-free atrial fibrillation monitor: a pilot study

Author:

Sadeh Ben1,Merdler Ilan1,Sadon Sapir1,Lupu Lior1,Borohovitz Ariel1,Ghantous Eihab1,Taieb Philippe1,Granot Yoav1,Goldstein Orit2,Soriano Jonathan Calderón2,Rubio-Oliver Ricardo2,Ruiz-Rivas Joaquin2,Zalevsky Zeev23,Garcia-Monreal Javier24,Shatsky Maxim2,Polani Sagi2,Arbel Yaron12ORCID

Affiliation:

1. Department of Cardiology, Tel Aviv Medical Center, Sackler Faculty of Medicine, affiliated Tel Aviv University, Tel Aviv, Israel

2. Donisi Health (formerly ContinUse Biometrics Ltd.), HaNechoshet 6, Tel Aviv, 6971070, Israel

3. Faculty of Engineering, Bar-Ilan University, Ramat Gan, 5290002, Israel

4. Department of Optics, University of Valencia, Spain

Abstract

Abstract Aims Atrial fibrillation (AF) is a major cause of morbidity and mortality. Current guidelines support performing electrocardiogram (ECG) screenings to spot AF in high-risk patients. The purpose of this study was to validate a new algorithm aimed to identify AF in patients measured with a recent FDA-cleared contact-free optical device. Methods and results Study participants were measured simultaneously using two devices: a contact-free optical system that measures chest motion vibrations (investigational device, ‘Gili’) and a standard reference bed-side ECG monitor (Mindray®). Each reference ECG was evaluated by two board certified cardiologists that defined each trace as: regular rhythm, AF, other irregular rhythm or indecipherable/missing. A total of 3582, 30-s intervals, pertaining to 444 patients (41.9% with a history of AF) were made available for analysis. Distribution of patients with active AF, other irregular rhythm, and regular rhythm was 16.9%, 29.5%, and 53.6% respectively. Following application of cross-validated machine learning approach, the observed sensitivity and specificity were 0.92 [95% confidence interval (CI): 0.91–0.93] and 0.96 (95% CI: 0.95–0.96), respectively. Conclusion This study demonstrates for the first time the efficacy of a contact-free optical device for detecting AF.

Funder

Donisi Health

Publisher

Oxford University Press (OUP)

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