Ikeda Takanori, Ashihara Takashi, Iwasaki Yu-Ki, Ono Maki, Kagiyama Nobuyuki, Kimura Takehiro, Kusano Kengo, Kohno Ritsuko, Saku Keita, Sasano Tetsuo, Senoo Keitaro, Takatsuki Seiji, Takahashi Naohiko, Takami Mitsuru, Nakano Yukiko, Hashimoto Kenichi, Fujiu Katsuhito, Fujino Tadashi, Mizuno Atsushi, Yoshioka Koichiro, Watanabe Eiichi, Shimizu Wataru, Node Koichi
J Arrhythm. 2025 May 23;41(3):e70059. doi: 10.1002/joa3.70059. eCollection 2025 Jun.
Recently, some clinicians have been diagnosing and treating arrhythmias on the basis of electrocardiogram (ECG) devices with low accuracy. In Europe and the US, several statements on the use of ECGs have already been published by related academic societies. In addition, with the relaxation of regulations on media advertising ambulatory/wearable ECG devices, the frequency of use of simple ECG devices by the general public will increase in the future. Therefore, this statement describes the functions and features of non-invasive ambulatory or wearable ECG devices that have been approved as medical devices in Japan (and that can record ECGs remotely), as well as points to note when using them; provides an overview of data storage and security for ambulatory/wearable ECG devices and implantable loop recorders (ILRs), as well as discussing differences between their use and the use of non-invasive ambulatory/wearable ECG devices; and provides classes of recommendation for the use of these devices and their evaluation for each arrhythmia type or condition. We describe lead-based ambulatory ECG devices (classical 24-h Holter ECG monitoring), handheld ECG devices, handheld-based ECG devices using a smartphone, wearable ECG devices (smartwatch and garment ECG devices), and patch ECG devices. In addition, we provide information on methods that are not based on the original ECG, such as photoplethysmography and oscillometric blood pressure measurement, and describe the limitations of their use. We hope that the publication of this statement will lead to the appropriate use of ambulatory/wearable ECG devices in Japan.
最近，一些临床医生一直在使用准确性较低的心电图（ECG）设备来诊断和治疗心律失常。在欧洲和美国，相关学术协会已经发表了几份关于心电图使用的声明。此外，随着对动态/可穿戴式心电图设备媒体广告监管的放宽，未来普通公众使用简单心电图设备的频率将会增加。因此，本声明描述了在日本已被批准为医疗设备（且可远程记录心电图）的非侵入性动态或可穿戴式心电图设备的功能和特点，以及使用时的注意事项；概述了动态/可穿戴式心电图设备和植入式循环记录仪（ILR）的数据存储和安全性，并讨论了它们与非侵入性动态/可穿戴式心电图设备使用的差异；还提供了这些设备使用的推荐类别以及针对每种心律失常类型或病症的评估。我们描述了基于导联的动态心电图设备（经典的24小时动态心电图监测）、手持式心电图设备、使用智能手机的手持式心电图设备、可穿戴式心电图设备（智能手表和服装式心电图设备）以及贴片式心电图设备。此外，我们还提供了非基于原始心电图的方法的信息，如光电容积脉搏波描记法和示波血压测量，并描述了其使用的局限性。我们希望本声明的发表将促使日本合理使用动态/可穿戴式心电图设备。
