Necklace-embedded electrocardiogram for the detection and diagnosis of atrial fibrillation

Onni E Santala, Jukka A Lipponen, Helena Jäntti, Tuomas T Rissanen, Jari Halonen, Indrek Kolk, Hanna Pohjantähti-Maaroos, Mika P Tarvainen, Eemu-Samuli Väliaho, Juha Hartikainen, Tero Martikainen, Onni E Santala, Jukka A Lipponen, Helena Jäntti, Tuomas T Rissanen, Jari Halonen, Indrek Kolk, Hanna Pohjantähti-Maaroos, Mika P Tarvainen, Eemu-Samuli Väliaho, Juha Hartikainen, Tero Martikainen

Abstract

Background: Atrial fibrillation (AF) is the major cause of stroke since approximately 25% of all strokes are of cardioembolic-origin. The detection and diagnosis of AF are often challenging due to the asymptomatic and intermittent nature of AF.

Hypothesis: A wearable electrocardiogram (ECG)-device could increase the likelihood of AF detection. The aim of this study was to evaluate the feasibility and reliability of a novel, consumer-grade, single-lead ECG recording device (Necklace-ECG) for screening, identifying and diagnosing of AF both by a cardiologist and automated AF-detection algorithms.

Methods: A thirty-second ECG was recorded with the Necklace-ECG device from two positions; between the palms (palm) and between the palm and the chest (chest). Simultaneously registered 3-lead ECGs (Holter) served as a golden standard for the final rhythm diagnosis. Two cardiologists interpreted independently in a blinded fashion the Necklace-ECG recordings from 145 patients (66 AF and 79 sinus rhythm, SR). In addition, the Necklace-ECG recordings were analyzed with an automatic AF detection algorithm.

Results: Two cardiologists diagnosed the correct rhythm of the interpretable Necklace-ECG with a mean sensitivity of 97.2% and 99.1% (palm and chest, respectively) and specificity of 100% and 98.5%. The automatic arrhythmia algorithm detected the correct rhythm with a sensitivity of 94.7% and 98.3% (palm and chest) and specificity of 100% of the interpretable measurements.

Conclusions: The novel Necklace-ECG device is able to detect AF with high sensitivity and specificity as evaluated both by cardiologists and an automated AF-detection algorithm. Thus, the wearable Necklace-ECG is a new, promising method for AF screening.

Clinical trial registration: Study was registered in the ClinicalTrials.gov database (NCT03753139).

Keywords: Awario analysis service; ECG; Suunto Movesense; arrhythmia; atrial fibrillation; stroke.

Conflict of interest statement

Jukka A. Lipponen, Tuomas T. Rissanen, Tero Martikainen, Helena Jäntti, Jari Halonen and Mika P. Tarvainen are shareholders of a company (Heart2Save) that designs ECG‐based software for medical equipment. Kuoppa P, Jukka A. Lipponen, Mika P. Tarvainen and Helena Jäntti report personal fees from Heart2Save. There are no other conflicts of interest to declare.

© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.

Figures

FIGURE 1
FIGURE 1
Study population flow chart. AF, atrial fibrillation; SR, sinus rhythm
FIGURE 2
FIGURE 2
Schematic presentation of Necklace‐electrocardiogram enabled automatic arrhythmia analysis

References

    1. Morillo CA, Banerjee A, Perel P, Wood D, Jouven X. Atrial fibrillation: the current epidemic. J Geriatr Cardiol. 2017;14(3):195‐203. 10.11909/j.issn.1671-5411.2017.03.011.
    1. Lloyd‐Jones M, Wang J, Leip P, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004;110(9):1042‐1046. 10.1161/01.CIR.0000140263.20897.42.
    1. Heeringa J, van der Kuip D, Hofman A, et al. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J. 2006;27(8):949‐953. 10.1093/eurheartj/ehi825.
    1. Go A, Hylek E, Phillips K, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001;285(18):2370‐2375. 10.1001/jama.285.18.2370.
    1. Ball J, Carrington M, Mcmurray J, et al. Atrial fibrillation: profile and burden of an evolving epidemic in the 21st century. Int J Cardiol. 2013;167:1807‐1824. 10.1016/j.ijcard.2012.12.093.
    1. Wilkins E, Wilson L, Wickramasinghe K, et al. European Cardiovascular Disease Statistics 2017. Brussels, Belgium: European Heart Network; 2017. .
    1. Benjamin J, Virani S, Callaway W, et al. Heart disease and stroke statistics‐2018 update: a report from the American Heart Association. Circulation. 2018;137(12):e67‐e492. 10.1161/CIR.0000000000000558.
    1. Ruff C, Giugliano R, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta‐analysis of randomised trials. Lancet. 2014;383:955‐962. 10.1016/S0140-6736(13)62343-0.
    1. Pereira T, Tran N, Gadhoumi K, et al. Photoplethysmography based atrial fibrillation detection: a review. NPJ Digit Med. 2020;3(1):1‐12. 10.1038/s41746-019-0207-9.
    1. Hagiwara Y, Fujita H, Oh S, et al. Computer‐aided diagnosis of atrial fibrillation based on ECG signals: a review. Inform Sci. 2018;467:99‐114. 10.1016/j.ins.2018.07.063.
    1. Jonas DE, Kahwati LC, Yun JD, et al. Screening for atrial fibrillation with electrocardiography: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;320(5):485‐498. 10.1001/jama.2018.4190.
    1. Hindricks G, Potpara T, Dagres N, et al. ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio‐Thoracic Surgery (EACTS). Eur Heart J. 2020;42:2020‐2498. 10.1093/eurheartj/ehaa612.
    1. Seet RC, Friedman PA, Rabinstein AA. Prolonged rhythm monitoring for the detection of occult paroxysmal atrial fibrillation in ischemic stroke of unknown cause. Circulation. 2011;124:477‐486. 10.1161/CIRCULATIONAHA.111.029801.
    1. William A, Kanbour M, Callahan T, et al. Assessing the accuracy of an automated atrial fibrillation detection algorithm using smartphone technology: the iREAD study. Heart Rhythm. 2018;15(10):1561‐1565. 10.1016/j.hrthm.2018.06.037.
    1. Desteghe L, Raymaekers Z, Lutin M, et al. Performance of handheld electrocardiogram devices to detect atrial fibrillation in a cardiology and geriatric ward setting. Eurospace. 2017;19(1):29‐39. 10.1093/europace/euw025.
    1. Lau J, Lowres N, Neubeck L, et al. iPhone ECG application for community screening to detect silent atrial fibrillation: a novel technology to prevent stroke. Int J Cardiol. 2013;165(1):193‐194. 10.1016/j.ijcard.2013.01.220.
    1. Koshy A, Sajeev J, Negishi K, et al. Accuracy of blinded clinician interpretation of single‐lead smartphone electrocardiograms and a proposed clinical workflow. Am Heart J. 2018;205:149‐153. 10.1016/j.ahj.2018.08.001.
    1. Hartikainen S, Lipponen JA, Hiltunen P, et al. Effectiveness of the chest strap electrocardiogram to detect atrial fibrillation. Am J Cardiol. 2019;123(10):1643‐1648. 10.1016/j.amjcard.2019.02.028.
    1. Väliaho E‐S, Kuoppa P, Lipponen JA, et al. Wrist band photoplethysmography in detection of individual pulses in atrial fibrillation and algorithm‐based detection of atrial fibrillation. Eurospace. 2019;21(7):1031‐1038. 10.1093/europace/euz060.
    1. Bruce M, Daly L. Design and marketing connections: creating added value. J Mark Manag. 2007;23(9–10):929‐953. 10.1362/026725707X250403.
    1. Zapata BC, Fernández‐Alemán JL, Idri A, Toval A. Empirical studies on usability of mHealth apps: a systematic literature review. J Med Syst. 2015;39(2):1‐19. 10.1007/s10916-014-0182-2.
    1. Brasier N, Raichle C, Dörr M, et al. Detection of atrial fibrillation with a smartphone camera: first prospective, international, two‐centre, clinical validation study (DETECT AF PRO). Eurospace. 2018;21(1):41‐47. 10.1093/europace/euy176.
    1. Bumgarner J, Lambert C, Cantillon D, et al. Assessing the accuracy of an automated atrial fibrillation detection algorithm using novel smartwatch technology among patients presenting for elective cardioversion. J Am Coll Cardiol. 2018;71(11):A411‐A411. 10.1016/S0735-1097(18)30952-5.
    1. Paré G, Poba‐Nzaou P, Sicotte C. Home telemonitoring for chronic disease management: an economic assessment. Int J Technol Assess. 2013;29(2):155‐161. 10.1017/S0266462313000111.
    1. Aronsson M, Svennberg E, Rosenqvist M, et al. Cost‐effectiveness of mass screening for untreated atrial fibrillation using intermittent ECG recording. Eurospace. 2015;17(7):1023‐1029. 10.1093/europace/euv083.
    1. Berti D, Moors E, Moons P, Heidbuchel H. Prevalence and antithrombotic management of atrial fibrillation in hospitalised patients. Heart. 2015;101(11):884‐893. 10.1136/heartjnl-2014-307059.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera