Amsterdam UMC, University of Amsterdam, Department of General Practice, Amsterdam Public Health, Amsterdam, The Netherlands
Amsterdam UMC, University of Amsterdam, Department of General Practice, Amsterdam Public Health, Amsterdam, The Netherlands.
Ann Fam Med. 2019 Sep;17(5):403-411. doi: 10.1370/afm.2438.
To validate a smartphone-operated, single-lead electrocardiography (1L-ECG) device (AliveCor KardiaMobile) with an integrated algorithm for atrial fibrillation (AF) against 12-lead ECG (12L-ECG) in a primary care population.
We recruited consecutive patients who underwent 12L-ECG for any nonacute indication. Patients held a smartphone with connected 1L-ECG while local personnel simultaneously performed 12L-ECG. All 1L-ECG recordings were assessed by blinded cardiologists as well as by the smartphone-integrated algorithm. The study cardiologists also assessed all 12L-recordings in random order as the reference standard. We determined the diagnostic accuracy of the 1L-ECG in detecting AF or atrial flutter (AFL) as well as any rhythm abnormality and any conduction abnormality with the simultaneously performed 12L-ECG as the reference standard.
We included 214 patients from 10 Dutch general practices. Mean ± SD age was 64.1 ± 14.7 years, and 53.7% of the patients were male. The 12L-ECG diagnosed AF/AFL, any rhythm abnormality, and any conduction abnormality in 23, 44, and 28 patients, respectively. The 1L-ECG as assessed by cardiologists had a sensitivity and specificity for AF/AFL of 100% (95% CI, 85.2%-100%) and 100% (95% CI, 98.1%-100%). The AF detection algorithm had a sensitivity and specificity of 87.0% (95% CI, 66.4%-97.2%) and 97.9% (95% CI, 94.7%-99.4%). The 1L-ECG as assessed by cardiologists had a sensitivity and specificity for any rhythm abnormality of 90.9% (95% CI, 78.3%-97.5%) and 93.5% (95% CI, 88.7%-96.7%) and for any conduction abnormality of 46.4% (95% CI, 27.5%-66.1%) and 100% (95% CI, 98.0%-100%).
In a primary care population, a smartphone-operated, 1L-ECG device showed excellent diagnostic accuracy for AF/AFL and good diagnostic accuracy for other rhythm abnormalities. The 1L-ECG device was less sensitive for conduction abnormalities.
验证一款智能手机操作的单导联心电图（1L-ECG）设备（AliveCor KardiaMobile），该设备配备了用于心房颤动（AF）的集成算法，在初级保健人群中与 12 导联心电图（12L-ECG）进行对比。
我们招募了因非急性原因接受 12L-ECG 检查的连续患者。患者在当地人员同时进行 12L-ECG 检查的同时，手持连接着 1L-ECG 的智能手机。所有 1L-ECG 记录均由盲法心脏病专家以及智能手机集成算法进行评估。研究心脏病专家还随机评估所有 12L 记录作为参考标准。我们确定了 1L-ECG 在检测 AF 或心房扑动（AFL）以及任何节律异常和任何传导异常方面的诊断准确性，同时进行的 12L-ECG 作为参考标准。
我们纳入了来自 10 家荷兰普通诊所的 214 名患者。平均年龄±标准差为 64.1±14.7 岁，53.7%的患者为男性。12L-ECG 诊断出 AF/AFL、任何节律异常和任何传导异常的患者分别为 23、44 和 28 例。心脏病专家评估的 1L-ECG 对 AF/AFL 的灵敏度和特异性为 100%（95%CI，85.2%-100%）和 100%（95%CI，98.1%-100%）。AF 检测算法的灵敏度和特异性分别为 87.0%（95%CI，66.4%-97.2%）和 97.9%（95%CI，94.7%-99.4%）。心脏病专家评估的 1L-ECG 对任何节律异常的灵敏度和特异性分别为 90.9%（95%CI，78.3%-97.5%）和 93.5%（95%CI，88.7%-96.7%），对任何传导异常的灵敏度和特异性分别为 46.4%（95%CI，27.5%-66.1%）和 100%（95%CI，98.0%-100%）。
在初级保健人群中，智能手机操作的 1L-ECG 设备对 AF/AFL 具有出色的诊断准确性，对其他节律异常也具有良好的诊断准确性。1L-ECG 设备对传导异常的敏感性较低。
