Briosa E Gala Andre, Sharp Alexander James, Schramm David, Pope Michael Timothy Brian, Leo Milena, Varini Richard, Banerjee Abhirup, Win Kyaw Zaw, Kalla Manish, Paisey John, Curzen Nick, Betts Timothy Rider
Department of Cardiology, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.
Faculty of Medicine, University of Southampton, Southampton, United Kingdom.
Heart Rhythm O2. 2025 Mar 26;6(6):808-817. doi: 10.1016/j.hroo.2025.03.019. eCollection 2025 Jun.
Wearable devices are widely used for atrial fibrillation (AF) detection, yet most validation studies include only sinus rhythm or AF, likely overestimating diagnostic performance.
This multicenter study assessed the performance of automated AF detection and physician interpretation of single-lead electrocardiograms (SL-ECGs) from the Apple Watch and CART Ring.
Participants underwent simultaneous 12-lead ECG and SL-ECGs from Apple Watch and CART Ring. Two cardiologists independently adjudicated all ECGs. Apple Watch and CART Ring classified recordings as "AF," "Not AF," or "Unclassified." Diagnostic performance for automated AF detection was evaluated in "worst-case" (all SL-ECGs) and lenient (excluding unclassified SL-ECGs) scenarios. Physician interpretation of SL-ECGs was also compared to 12-lead ECG.
Among 483 patients (median age, 66 years; 29% female), 196 (39%) had AF across 3 United Kingdom centers. A total of 2398 ECGs were analyzed. Interobserver variability was excellent (Cohen's kappa: Apple Watch, 0.85; CART Ring, 0.84). In the "worst-case" analysis, CART Ring outperformed Apple Watch (sensitivity, 84.6% vs 69.1%; specificity, 89.9% vs 72.6%). Apple Watch had more unclassified SL-ECGs (20.1%) than CART Ring (1.9%). The lenient analysis showed an improvement in sensitivity (CART Ring, 84.8 %; Apple Watch, 86.4%) and specificity (CART Ring, 91.2%; Apple Watch, 91.7%). Physician interpretation improved diagnostic performance for AF and sinus rhythm but remained limited for other arrhythmias.
Apple Watch missed approximately 1 in 3 episodes of AF and a high number of unclassified SL-ECG. CART Ring demonstrated superior performance. Physician interpretation significantly improved AF diagnosis but remained unreliable for other arrhythmias, emphasizing the need for cautious integration of wearable ECGs into clinical practice.
可穿戴设备广泛用于房颤(AF)检测,但大多数验证研究仅纳入窦性心律或房颤,可能高估了诊断性能。
这项多中心研究评估了Apple Watch和CART Ring自动检测房颤以及医生解读单导联心电图(SL-ECG)的性能。
参与者同时接受12导联心电图以及来自Apple Watch和CART Ring的单导联心电图检查。两名心脏病专家独立判定所有心电图。Apple Watch和CART Ring将记录分类为“房颤”“非房颤”或“未分类”。在“最坏情况”(所有单导联心电图)和宽松(排除未分类的单导联心电图)情况下评估自动房颤检测的诊断性能。还将医生对单导联心电图的解读与12导联心电图进行了比较。
在483例患者(中位年龄66岁;29%为女性)中,英国3个中心的196例(39%)患有房颤。共分析了2398份心电图。观察者间的一致性极佳(科恩kappa系数:Apple Watch为0.85;CART Ring为0.84)。在“最坏情况”分析中,CART Ring的表现优于Apple Watch(敏感性分别为84.6%和69.1%;特异性分别为89.9%和72.6%)。Apple Watch未分类的单导联心电图(20.1%)比CART Ring(1.9%)更多。宽松分析显示敏感性(CART Ring为84.8%;Apple Watch为86.4%)和特异性(CART Ring为91.2%;Apple Watch为91.7%)有所提高。医生的解读提高了房颤和窦性心律的诊断性能,但对其他心律失常的诊断仍然有限。
Apple Watch漏诊了约三分之一的房颤发作,且有大量未分类的单导联心电图。CART Ring表现更优。医生的解读显著改善了房颤诊断,但对其他心律失常仍不可靠,这强调了将可穿戴心电图谨慎整合到临床实践中的必要性。