Prospective, multicentre validation of a simple, patient-operated electrocardiographic system for the detection of arrhythmias and electrocardiographic changes

Europace. 2009 Oct;11(10):1362-8. doi: 10.1093/europace/eup262.


Aims: Electrocardiographic changes, e.g. arrhythmias causing syncope or palpitations, are often transient and therefore difficult to diagnose. Systematic and symptom-activated ECG recordings can increase diagnostic yield in such patients. We evaluated the diagnostic accuracy of a simple, leadless, patient-operated ECG device compared with a standard 12-lead ECG.

Methods and results: We recorded a standard 12-lead surface ECG and a patient-activated ECG in direct succession in 508 consecutive patients enrolled in four centres. All ECGs were analysed by a single, blinded observer. ECGs were analysable in 505 (99.4%) patients (66% male, age 61 +/- 15 years, and body mass index 27 +/- 4). Analysis of the patient-activated ECG adequately detected a normal ECG (sensitivity 91% and specificity 95%), atrial fibrillation (AF) (sensitivity 99% and specificity 96%), and even T-wave abnormalities (sensitivity 90% and specificity 75%). Diagnostic accuracy for atrioventricular nodal block was moderate (sensitivity 79% and specificity 99%). Continuous parameters correlated well: (r(2) = 0.89 for heart rate, 0.83 for PR interval, 0.78 for QRS duration, and 0.89 for QTc).

Conclusion: Recordings made by this patient-operated ECG device allow to detect arrhythmias and other ECG changes with high accuracy compared with a standard ECG. It may help to improve accurate diagnosis of transient ECG changes such as paroxysmal AF in palpitations or other unexplained cardiac symptoms.

Publication types

  • Evaluation Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Arrhythmias, Cardiac / diagnosis*
  • Electrocardiography / instrumentation*
  • Electrocardiography, Ambulatory / instrumentation*
  • Equipment Design
  • Equipment Failure Analysis
  • Female
  • Germany
  • Humans
  • Male
  • Middle Aged
  • Reproducibility of Results
  • Self Care / instrumentation*
  • Sensitivity and Specificity
  • Telemedicine / instrumentation*
  • Young Adult