Atrial Fibrillation Detection With an Analog Smartwatch : Prospective Clinical Study and Algorithm Validation
©David Campo, Valery Elie, Tristan de Gallard, Pierre Bartet, Tristan Morichau-Beauchant, Nicolas Genain, Antoine Fayol, David Fouassier, Adrien Pasteur-Rousseau, Etienne Puymirat, Julien Nahum. Originally published in JMIR Formative Research (https://formative.jmir.org), 04.11.2022..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:6 |
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| Enthalten in: |
JMIR formative research - 6(2022), 11 vom: 04. Nov., Seite e37280 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Campo, David [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Revised 21.11.2022 published: Electronic ClinicalTrials.gov: NCT04351386 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.2196/37280 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM340104406 |
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| 245 | 1 | 0 | |a Atrial Fibrillation Detection With an Analog Smartwatch |b Prospective Clinical Study and Algorithm Validation |
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| 500 | |a ClinicalTrials.gov: NCT04351386 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a ©David Campo, Valery Elie, Tristan de Gallard, Pierre Bartet, Tristan Morichau-Beauchant, Nicolas Genain, Antoine Fayol, David Fouassier, Adrien Pasteur-Rousseau, Etienne Puymirat, Julien Nahum. Originally published in JMIR Formative Research (https://formative.jmir.org), 04.11.2022. | ||
| 520 | |a 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 | ||
| 520 | |a OBJECTIVE: We aimed to validate an algorithm for the automatic detection of atrial fibrillation from a single-lead electrocardiogram taken with a smartwatch | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov NCT04351386; http://clinicaltrials.gov/ct2/show/NCT04351386 | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a heart disease | |
| 650 | 4 | |a heart failure | |
| 650 | 4 | |a mHealth | |
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| 650 | 4 | |a morbidity | |
| 650 | 4 | |a physician | |
| 650 | 4 | |a sensor | |
| 650 | 4 | |a smart technology | |
| 650 | 4 | |a smartwatch | |
| 650 | 4 | |a wearable | |
| 700 | 1 | |a Elie, Valery |e verfasserin |4 aut | |
| 700 | 1 | |a de Gallard, Tristan |e verfasserin |4 aut | |
| 700 | 1 | |a Bartet, Pierre |e verfasserin |4 aut | |
| 700 | 1 | |a Morichau-Beauchant, Tristan |e verfasserin |4 aut | |
| 700 | 1 | |a Genain, Nicolas |e verfasserin |4 aut | |
| 700 | 1 | |a Fayol, Antoine |e verfasserin |4 aut | |
| 700 | 1 | |a Fouassier, David |e verfasserin |4 aut | |
| 700 | 1 | |a Pasteur-Rousseau, Adrien |e verfasserin |4 aut | |
| 700 | 1 | |a Puymirat, Etienne |e verfasserin |4 aut | |
| 700 | 1 | |a Nahum, Julien |e verfasserin |4 aut | |
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