Prospective, multicentre validation of a simple, patient-operated electrocardiographic system for the detection of arrhythmias and electrocardiographic changes
Open accessAbstract
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.
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Several patient-operated devices and extended continuous ECG monitoring using skin patch recorders have been validated for detection of paroxysmal AF.
“Several patientoperated devices 136,137 and extended continuous ECG monitoring using skin patch recorders 138 have been validated for detection of paroxysmal AF. 139”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [136]
Event recorders or handheld patient-operated ECG systems improve the diagnosis of transient ECG changes in patients with palpitations.
“Event recorders or handheld patient-operated ECG systems have been shown to improve the diagnosis of transient ECG changes in patients with palpitations.71,72”
From Management of patients with palpitations: a position paper from the European Heart Rhythm Association (2011) · cites this paper as [72]
In Kaleschke et al., Omron HeartScan had 99% sensitivity and 96% specificity for detection of atrial fibrillation.
“In a study by Gerrit Kaleschke et al18 diagnostic yield of Omron HeartScan in detection of atrial fibrillation was sensitivity 99% and specificity 96%.”
From Portable out-of-hospital electrocardiography: A review of current technologies (2018) · cites this paper as [18]
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- Authors
- Kaleschke, G., Hoffmann, B., Drewitz, I., Steinbeck, G., Naebauer, M., Goette, A., Breithardt, G., & Kirchhof, P.
- Affiliations
- University Hospital Münster (DE)
- Universität Hamburg (DE)
- Ludwig-Maximilians-Universität München (DE)
- Otto-von-Guericke-Universität Magdeburg (DE)
- Corresponding author
- Kirchhof, P.
- Venue
- Europace
- Publisher
- Oxford University Press (OUP)
- Published
- 2009-09-24
- Volume
- 11
- Issue
- 10
- Pages
- 1362-1368
- ISSN
- 1099-5129 (ISSN-L)
- 1532-2092
- OpenAlex
- W2143975628
- Cited by
- 81
- References
- 28
- Citations by year
- 2025: 4 · 2024: 5 · 2023: 6 · 2022: 8 · 2021: 6 · 2020: 4 · 2019: 6 · 2018: 5 · 2017: 7 · 2016: 9 · 2015: 7 · 2014: 5 · 2013: 4 · 2012: 2
- FWCI
- 1.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- EP Europace (publishedVersion)
- PubMed (publishedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Funders
- Omron Healthcare
- Kompetenznetz Vorhofflimmern
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › ECG Monitoring and Analysis
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Keywords
- wearable ECG, arrhythmia detection, atrial fibrillation, paroxysmal atrial fibrillation, syncope, palpitations, atrioventricular nodal block, T wave changes, diagnostic accuracy, 12-lead ECG comparison, QTc interval
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Arrhythmias, Cardiac, Electrocardiography, Equipment Design, Female, Germany, Humans, Male, Middle Aged, Self Care, Sensitivity and Specificity, Reproducibility of Results, Electrocardiography, Ambulatory, Telemedicine, Equipment Failure Analysis, Young Adult
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