Validation and clinical use of a novel diagnostic device for screening of atrial fibrillation

R. G. Tieleman*, Y. Plantinga, D. Rinkes, G. L. Bartels, J. L. Posma, R. Cator, C. Hofman, R. P. Houben

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Patients with asymptomatic and undiagnosed atrial fibrillation (AF) are at increased risk of heart failure and ischaemic stroke. In this study, we validated a new diagnostic device, the MyDiagnostick, for detection of AF by general practitioners and patients. It records and stores a Lead I electrocardiogram (ECG) which is automatically analysed for the presence of AF.In total, 192 patients (age 69.4 ? 12.6 years) were asked to hold the MyDiagnostick for 1 min, immediately before a routine 12-lead ECG was recorded. Atrial fibrillation detection and ECGs stored by the MyDiagnostick were compared with the cardiac rhythm on the 12-lead ECG. In a second part of the study, the MyDiagnostick was used to screen for AF during influenza vaccination in the general practitioner's office. Atrial fibrillation was present in 53 out of the 192 patients (27.6%). All AF patients were correctly detected by the MyDiagnostick (sensitivity 100%; 95% confidence interval 93-100%). MyDiagnostick AF classification in 6 out of 139 patients in sinus rhythm was considered false positive (specificity 95.9%; 95% confidence interval 91.3-98.1%). During 4 h of influenza vaccination in 676 patients (age 74 ? 7.1 years), the MyDiagnostick correctly diagnosed AF in all 55 patients (prevalence 8.1%). In 11 patients (1.6%), AF was not diagnosed before, all with a CHA2DS2VASc score of >1.The high AF detection performance of the MyDiagnostick, combined with the ease of use of the device, enables large screening programmes for detection of undiagnosed AF.? The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.
Original languageEnglish
Pages (from-to)1291-1295
JournalEP Europace
Volume16
Issue number9
DOIs
Publication statusPublished - Sep 2014

Keywords

  • Atrial fibrillation
  • Screening
  • Electrocardiogram

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