Validation of a handheld single-lead ECG algorithm for atrial fibrillation detection after coronary revascularization
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Sofia Skröder1,2, Anders Wickbom2,3, Anna Björkenheim2,4
1Centre for Clinical Research and Education, Region Värmland, Karlstad, Sweden.
Insights
Atrial fibrillation (AF) detection using a thumb ECG algorithm shows high accuracy in ruling out AF post-coronary revascularization. However, manual review is essential due to frequent false positives, ensuring accurate AF diagnosis.
Area of Science:
- Cardiology
- Medical Technology
- Digital Health
Background:
- Atrial fibrillation (AF) is a growing global health issue linked to a high stroke risk, often preventable with anticoagulation.
- Underdiagnosis of AF is common, particularly in patients with coronary artery disease, necessitating reliable detection methods.
- Coronary revascularization patients are a key group for AF screening due to shared risk factors.
Purpose of the Study:
- To validate an automatic rhythm interpretation algorithm for atrial fibrillation detection using a thumb ECG device.
- To assess the algorithm's performance in patients who recently underwent coronary revascularization.
- To compare automated thumb ECG interpretation against manual interpretation for AF diagnosis.
Main Methods:
- A handheld, single-lead thumb ECG device with an automated interpretation algorithm was used.
- Recordings were taken three times daily for one month post-procedure, and at 3, 12, and 24 months.
- Algorithm performance was evaluated by comparing its AF detection to manual interpretation at both subject and single-strip ECG levels.
Main Results:
- Analysis included 48,308 ECG recordings from 255 subjects.
- The algorithm demonstrated 100% sensitivity and 100% negative predictive value (NPV) at the subject level for ruling out AF.
- At the single-strip level, sensitivity was 87.6% and specificity was 94.0%, with a high false positive rate (16.8%) attributed to technical issues and ectopic beats.
Conclusions:
- The thumb ECG's automatic algorithm effectively rules out AF in recent coronary revascularization patients with high accuracy.
- Manual confirmation is crucial for diagnosing AF due to the algorithm's high false positive rate.
- This technology shows promise for AF screening in at-risk populations, pending algorithm refinement.
Background:
Atrial fibrillation (AF) is a rapidly increasing global public health concern entailing a high risk for ischemic stroke that can largely be avoided with anticoagulation therapy. AF is often underdiagnosed and there is a need for a reliable method of detection in individuals with additional risk factors for stroke such as coronary artery disease. We aimed to validate an automatic rhythm interpretation algorithm in thumb ECG in subjects with recent coronary revascularization.
Methods:
Thumb ECG, a patient-operated handheld single-lead ECG recording device with an automatic interpretation algorithm, was performed three times daily for a month after coronary revascularization and 2-week periods 3, 12, and 24 months post-procedure. The detection of AF by the automatic algorithm on subject and single-strip ECG level was compared to manual interpretation.
Results:
48,308 of 30 s thumb ECG recordings from 255 subjects (mean 212 ± 3.5 recordings per subject) were retrieved from a database (AF 47 subjects/655 recordings; non-AF 208 subjects/47,653 recordings). The algorithm sensitivity at subject level was 100%, specificity 11.2%, positive predictive value (PPV) 20.2%, and negative predictive value (NPV) 100%. At the single-strip ECG level, sensitivity was 87.6%, specificity 94.0%, PPV 16.8%, and NPV 99.8%. The most common reasons for false positive results were technical disturbance and frequent ectopic beats.
Conclusions:
The automatic interpretation algorithm in a handheld thumb ECG device can rule out AF in patients recently undergoing coronary revascularization with high accuracy, but manual confirmation is needed to confirm the diagnose of AF because of high false positive rates.
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