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Published on: December 11, 2019
Atrial Fibrillation Detection With an Analog Smartwatch: Prospective Clinical Study and Algorithm Validation
David Campo1, Valery Elie1, Tristan de Gallard1
1Withings, Issy Les Moulineaux, France.
Insights
A new algorithm accurately detects atrial fibrillation using smartwatch ECGs, improving diagnosis for this common heart rhythm disorder. This technology offers a promising tool for early detection and management of atrial fibrillation.
Area of Science:
- Cardiology
- Digital Health
- Medical Devices
Background:
- Atrial fibrillation affects 4% of the global population, increasing stroke and heart failure risk.
- Diagnosis can be challenging, especially for asymptomatic or paroxysmal cases.
- Wearable devices offer potential for improved atrial fibrillation detection.
Purpose of the Study:
- To validate an algorithm for automatic atrial fibrillation detection using single-lead ECGs from a smartwatch.
- To assess the diagnostic performance and reliability of smartwatch-based ECG analysis.
Main Methods:
- Recruited 262 patients across 4 French sites for simultaneous 12-lead and single-lead ECG capture.
- Independent cardiologists reviewed ECGs; algorithm performance (sensitivity, specificity) was calculated.
- Assessed single-lead ECG quality (wave visibility, intervals, heart rate) against the 12-lead gold standard.
Main Results:
- The algorithm achieved high sensitivity (0.963) and specificity (1.000) for atrial fibrillation detection, excluding noise and other arrhythmias.
- Single-lead ECGs showed good accuracy for P waves (96.9%), QRS complexes (99.2%), and T waves (91.2%).
- Minimal differences in PR duration (<3 ms) and QRS width (<40 ms), and heart rate (<0.55 bpm) were observed compared to cardiologists.
Conclusions:
- The algorithm demonstrates excellent diagnostic performance for detecting atrial fibrillation.
- Smartwatch-derived single-lead ECGs provide sufficient quality for clinical use in routine care.
Background:
Atrial fibrillation affects approximately 4% of the world's population and is one of the major causes of stroke, heart failure, sudden death, and cardiovascular morbidity. It can be difficult to diagnose when asymptomatic or in the paroxysmal stage, and its natural history is not well understood. New wearables and connected devices offer an opportunity to improve on this situation.
Objective:
We aimed to validate an algorithm for the automatic detection of atrial fibrillation from a single-lead electrocardiogram taken with a smartwatch.
Methods:
Eligible patients were recruited from 4 sites in Paris, France. Electrocardiograms (12-lead reference and single lead) were captured simultaneously. The electrocardiograms were reviewed by independent, blinded board-certified cardiologists. The sensitivity and specificity of the algorithm to detect atrial fibrillation and normal sinus rhythm were calculated. The quality of single-lead electrocardiograms (visibility and polarity of waves, interval durations, heart rate) was assessed in comparison with the gold standard (12-lead electrocardiogram).
Results:
A total of 262 patients (atrial fibrillation: n=100, age: mean 74.3 years, SD 12.3; normal sinus rhythm: n=113, age: 61.8 years, SD 14.3; other arrhythmia: n=45, 66.9 years, SD 15.2; unreadable electrocardiograms: n=4) were included in the final analysis; 6.9% (18/262) were classified as Noise by the algorithm. Excluding other arrhythmias and Noise, the sensitivity for atrial fibrillation detection was 0.963 (95% CI lower bound 0.894), and the specificity was 1.000 (95% CI lower bound 0.967). Visibility and polarity accuracies were similar (1-lead electrocardiogram: P waves: 96.9%, QRS complexes: 99.2%, T waves: 91.2%; 12-lead electrocardiogram: P waves: 100%, QRS complexes: 98.8%, T waves: 99.5%). P-wave visibility accuracy was 99% (99/100) for patients with atrial fibrillation and 95.7% (155/162) for patients with normal sinus rhythm, other arrhythmias, and unreadable electrocardiograms. The absolute values of the mean differences in PR duration and QRS width were <3 ms, and more than 97% were <40 ms. The mean difference between the heart rates from the 1-lead electrocardiogram calculated by the algorithm and those calculated by cardiologists was 0.55 bpm.
Conclusions:
The algorithm demonstrated great diagnostic performance for atrial fibrillation detection. The smartwatch's single-lead electrocardiogram also demonstrated good quality for physician use in daily routine care.
Trial Registration:
ClinicalTrials.gov NCT04351386; http://clinicaltrials.gov/ct2/show/NCT04351386.
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