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Accepted for/Published in: JMIR Cardio

Date Submitted: Jun 14, 2021
Date Accepted: May 2, 2022

The final, peer-reviewed published version of this preprint can be found here:

Continuous mHealth Patch Monitoring for the Algorithm-Based Detection of Atrial Fibrillation: Feasibility and Diagnostic Accuracy Study

Santala OE, Lipponen JA, Jäntti H, Rissanen TT, Tarvainen MP, Laitinen TP, Laitinen TM, Castrén M, Väliaho ES, Rantula OA, Naukkarinen NS, Hartikainen JEK, Halonen J, Martikainen TJ

Continuous mHealth Patch Monitoring for the Algorithm-Based Detection of Atrial Fibrillation: Feasibility and Diagnostic Accuracy Study

JMIR Cardio 2022;6(1):e31230

DOI: 10.2196/31230

PMID: 35727618

PMCID: 9257607

Continuous mobile health patch monitoring for the algorithm-based detection of atrial fibrillation: Feasibility and diagnostic accuracy study

  • Onni E Santala; 
  • Jukka A Lipponen; 
  • Helena Jäntti; 
  • Tuomas T Rissanen; 
  • Mika P Tarvainen; 
  • Tomi P Laitinen; 
  • Tiina M Laitinen; 
  • Maaret Castrén; 
  • Eemu-Samuli Väliaho; 
  • Olli A Rantula; 
  • Noora S Naukkarinen; 
  • Juha E K Hartikainen; 
  • Jari Halonen; 
  • Tero J Martikainen

ABSTRACT

Background:

The detection of Atrial fibrillation (AF) is a major clinical challenge as AF is often paroxysmal and asymptomatic. Novel mobile health technologies (mHealth) could provide a cost-effective and reliable solution for AF-screening. However, many of these techniques have not been clinically validated.

Objective:

The purpose of this study was to evaluate the feasibility and reliability of artificial intelligence (AI) arrhythmia analysis for AF detection with a mHealth patch device designed for personal well-being.

Methods:

Patients (n=178) with an AF (n=79) or sinus rhythm (SR) (n=99) were recruited from the emergency care department. A single-lead 24-hour ECG-based HRV measurement was recorded with the mHealth patch device and analysed with a novel AI arrhythmia analysis software. Simultaneously registered 3-lead ECGs (Holter) served as the gold standard for the final rhythm diagnostics.

Results:

Of the HRV data produced by the single-lead mHealth patch 81.5% (3099/3802 h) was interpretable and the subject-based median for interpretable HRV data was 99% (25th percentile=77%; 75th percentile=1.00%). The AI arrhythmia detection algorithm detected AF correctly in all patients in the AF group and suggested the presence of AF in five patients in the control group, resulting in a subject-based AF detection accuracy of 97.2%, a sensitivity of 100% and a specificity of 94.9%. The time-based AF detection accuracy, sensitivity, and specificity of the AI arrhythmia detection algorithm were 98.7%, 99.6% and 98.0%, respectively.

Conclusions:

24-hour HRV monitoring by the mHealth patch device enabled accurate automatic AF detection. Thus, the wearable mHealth patch device with AI arrhythmia analysis is a novel method for AF screening. Clinical Trial: ClinicalTrials.gov Identifier: NCT03507335


 Citation

Please cite as:

Santala OE, Lipponen JA, Jäntti H, Rissanen TT, Tarvainen MP, Laitinen TP, Laitinen TM, Castrén M, Väliaho ES, Rantula OA, Naukkarinen NS, Hartikainen JEK, Halonen J, Martikainen TJ

Continuous mHealth Patch Monitoring for the Algorithm-Based Detection of Atrial Fibrillation: Feasibility and Diagnostic Accuracy Study

JMIR Cardio 2022;6(1):e31230

DOI: 10.2196/31230

PMID: 35727618

PMCID: 9257607

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© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.

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