Arrhythmias & electrophysiology
Clinical Validation of 5 Direct-to-Consumer Wearable Smart Devices to Detect Atrial Fibrillation: BASEL Wearable Study
Authors' conclusion
In this clinical validation of 5 direct-to-consumer smart devices, we found differences in the amount of inconclusive tracings diminishing sensitivity and specificity of the smart devices.
Study context
- Population
- Patients presenting to a cardiology service at a tertiary referral centerAtrial fibrillation (AF) present in 62 (31%)
- Participants
- 201 patients
- Comparison
- 5 direct-to-consumer smart devices vs physician-interpreted 12-lead ECG (reference standard) for AF detection
- Outcome
- Accuracy (sensitivity and specificity) in identifying AF vs physician-interpreted 12-lead ECG
Methodological detailsprospective, consecutive enrolment, tertiary referral centre
- Prospective
- Consecutive enrolment
- Tertiary referral centre
Performance
As reported in the abstract
Detection of AF
| Test or model | Sensitivity | Specificity |
|---|---|---|
| Apple Watch 6 | 85% | 75% |
| Samsung Galaxy Watch 3 | 85% | 75% |
| Withings Scanwatch | 58% | 75% |
| Fitbit Sense | 66% | 79% |
| AliveCor KardiaMobile | 79% | 69% |
Sensitivity
Apple Watch 685%
Samsung Galaxy Watch 385%
Withings Scanwatch58%
Fitbit Sense66%
AliveCor KardiaMobile79%
Specificity
Apple Watch 675%
Samsung Galaxy Watch 375%
Withings Scanwatch75%
Fitbit Sense79%
AliveCor KardiaMobile69%
Further findings
| Outcome | Values |
|---|---|
| Inconclusive tracings (algorithm unable to determine rhythm) | Apple Watch 6 18% · Samsung Galaxy Watch 3 17% · Withings Scanwatch 24% · Fitbit Sense 21% · AliveCor KardiaMobile 26% |
- Inconclusive tracings (algorithm unable to determine rhythm): P < 0.01 for pairwise comparison
Rhythm determined by manual review of inconclusive tracings
- Single-lead ECGs with rhythm determined
- 955 (99%) of 969
Patient acceptance
- Apple Watch ranked first
- 39% of participants
Original publication
Clinical Validation of 5 Direct-to-Consumer Wearable Smart Devices to Detect Atrial Fibrillation: BASEL Wearable Study. JACC Clin Electrophysiol. Published 18 January 2023. doi:10. 1016/ j. jacep. 2022. 09. 011
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