Lo Chi-In, Chang Sheng-Shiung, Tsai Jui-Peng, Kuo Jen-Yuan, Chen Ying-Ju, Huang Ming-Yuan, Lee Chao-Hsiung, Sung Kuo-Tzu, Hung Chung-Lieh, Jia-Yin Hou Charles, Lai Edward, Yeh Hung-I, Chang Wen-Ling, Chang Wen-Han
Cardiovascular Division, Department of Internal Medicine, MacKay Memorial Hospital, Taipei.
Department of Medicine, Mackay Medical College, New Taipei City.
Acta Cardiol Sin. 2018 Mar;34(2):144-151. doi: 10.6515/ACS.201803_34(2).20170919A.
Remote cardiac rhythm monitoring and recording, using hand-carried electrocardiogram (ECG) device had been widely used in telemedicine. The feasibility and accuracy analysis on the data recorded by a new miniature ECG system-on-chip (SoC) system has not been explored before.
This study evaluated the accuracy of the ECG recordings captured by CardioChip - a single-channeled, low-powered, miniature ECG SoC designed for mobile applications; comparing against Philips Pagewriter Trim III - a Food and Drug Administration certified, widely-used standard 12-lead ECG recording device, within Mackay Memorial Hospital in Taiwan.
Total of 111 participants, age ranging from 39 to 87years old [mean age: 61.2 ± 13.4, 57 male (51.3%)] were enrolled. Two experienced cardiologists rated and scored the ECG morphology to be the same between the two devices, while CardioChip ECG was more sensitive to baseline noise. R-peak amplitudes measured both devices using single lead information (CardioChip ECG vs. Lead 1 in standard 12-lead ECG) showed statistical consistency. Offline analysis of signal correlation coefficients and coherence showed good correlation with both over 0.94 in average (0.94 ± 0.04 and 0.95 ± 0.04, respectively), high agreement between raters (94% agreement) for detecting abnormal cardiac rhythm with excellent R-peak amplitude (r = 0.98, p < 0.001) and PR interval (r = 0.91, p < 0.001) correlations, indicating excellent correlation between ECG recordings derived from two different modalities.
The results suggested that CardioChip ECG is comparable to medical industry standard ECG. The future implementation of wearable ECG device embedded with miniature ECG system-on-chip (SoC) system is ready for clinical use, which will potentially enhance efficacy on identifying subjects with suspected cardiac arrhythmias.
使用手持式心电图（ECG）设备进行远程心律监测和记录已在远程医疗中广泛应用。此前尚未对一种新型微型片上心电图系统（SoC）记录的数据进行可行性和准确性分析。
本研究评估了CardioChip（一种为移动应用设计的单通道、低功耗微型ECG SoC）所记录的ECG的准确性；在台湾马偕纪念医院内，与经美国食品药品监督管理局认证、广泛使用的标准12导联ECG记录设备飞利浦Pagewriter Trim III进行比较。
共纳入111名参与者，年龄在39至87岁之间[平均年龄：61.2±13.4岁，57名男性（51.3%）]。两名经验丰富的心脏病专家对两种设备的ECG形态进行评分，认为二者相同，而CardioChip ECG对基线噪声更敏感。使用单导联信息（CardioChip ECG与标准12导联ECG中的导联1）测量两种设备的R波振幅显示出统计学一致性。信号相关系数和相干性的离线分析显示二者具有良好相关性，平均均超过0.94（分别为0.94±0.04和0.95±0.04），评分者之间在检测异常心律方面具有高度一致性（一致性为94%），R波振幅（r = 0.98，p < 0.001）和PR间期（r = 0.91，p < 0.001）相关性良好，表明两种不同模式得出的ECG记录之间具有极好的相关性。
结果表明CardioChip ECG与医疗行业标准ECG相当。未来嵌入微型片上心电图系统（SoC）的可穿戴ECG设备可用于临床，这可能会提高识别疑似心律失常患者的效率。
