Clinical Validation of 5 Direct-to-Consumer Wearable Smart Devices to Detect Atrial Fibrillation BASEL Wearable Study
Clinical Validation of 5 Direct-to-Consumer Wearable Smart Devices to Detect Atrial Fibrillation BASEL Wearable Study
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DOI：
10.1016/j.jacep.2022.09.011
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发表时间：
2023-02-27
影响因子：
7
通讯作者：
Badertscher, Patrick
中科院分区：
文献类型：
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作者：
Mannhart, Diego;Lischer, Mirko;Badertscher, Patrick
能够检测心房纤颤（AF）的多个智能设备目前是可用的。检测AF的灵敏度和特异性在可用的智能设备之间可能不同，目的是评估5种智能设备识别AF的准确性，并与医生解释的12导联心电图作为真实的参考标准进行比较。世界患者队列。方法我们连续招募在三级转诊中心接受心脏病服务的患者，结果：我们前瞻性分析了201例患者（31%为女性，中位年龄66.7岁）。62例（31%）患者存在AF。两种设备检测AF的灵敏度和特异性相当：Apple Watch 6为85%和75%，Samsung Galaxy Watch 3为85%和75%，Withings Scanwatch为58%和75%，Fitbit Sense为66%和79%，AliveCor KardiaMobile为79%和69%。Apple Watch 6、Samsung Galaxy Watch 3、Withings Scan Watch、Fitbit Sense和AliveCor KardiaMobile的不确定性描记率（算法无法确定心律）分别为18%、17%、24%、21%和26%（成对比较P < 0.01）。通过对不确定的描记进行人工审查，969个单导联心电图中有955个（99%）可以确定心律。在患者接受度方面，Apple Watch排名第一（39%的参与者）。结论在对5种直接面向消费者的智能设备进行的临床验证中，我们发现不确定的痕迹数量存在差异，从而降低了智能设备的灵敏度和特异性。在临床环境中，大约四分之一的病例需要手动审查描记。(c)2023由Elsevier代表美国心脏病学会基金会出版。
BACKGROUND Multiple smart devices capable to detect atrial fibrillation (AF) are presently available. Sensitivity and specificity for the detection of AF may differ between available smart devices, and this has not yet been adequately investigated.OBJECTIVES The aim was to assess the accuracy of 5 smart devices in identifying AF compared with a physicianinterpreted 12-lead electrocardiogram as the reference standard in a real-world cohort of patients.METHODS We consecutively enrolled patients presenting to a cardiology service at a tertiary referral center in a prospective, diagnostic study.RESULTS We prospectively analyzed 201 patients (31% women, median age 66.7 years). AF was present in 62 (31%) patients. Sensitivity and specificity for the detection of AF were comparable between devices: 85% and 75% for the Apple Watch 6, 85% and 75% for the Samsung Galaxy Watch 3, 58% and 75% for the Withings Scanwatch, 66% and 79% for the Fitbit Sense, and 79% and 69% for the AliveCor KardiaMobile, respectively. The rate of inconclusive tracings (the algorithm was unable to determine the heart rhythm) was 18%, 17%, 24%, 21%, and 26% for the Apple Watch 6, Samsung Galaxy Watch 3, Withings Scan Watch, Fitbit Sense, and AliveCor KardiaMobile (P < 0.01 for pairwise comparison), respectively. By manual review of inconclusive tracings, the rhythm could be determined in 955 (99%) of 969 single-lead electrocardiograms. Regarding patient acceptance, the Apple Watch was ranked first (39% of participants).CONCLUSIONS 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. In a clinical setting, manual review of tracings is required in about one-fourth of cases. (c) 2023 Published by Elsevier on behalf of the American College of Cardiology Foundation.