Faculty of Medicine, Department of Cardiology, University of Tsukuba, Tsukuba, Japan.
Faculty of Medicine, Department of Clinical Research and Regional Innovation, University of Tsukuba, Tsukuba, Japan.
PLoS One. 2023 Feb 24;18(2):e0281818. doi: 10.1371/journal.pone.0281818. eCollection 2023.
Atrial fibrillation (AF) is the most common arrhythmia and often recurs despite catheter ablation. The recurrence of AF is often underdiagnosed by standard 24-hour electrocardiogram (ECG) because of its transient and silent nature. A garment-style ECG with a highly conductive textile electrode made of poly(3,4-ethylenedioxythiophene) poly(styrenesulfonate)(PEDOTPSS) and nanofiber (Garment ECG) has been developed that can provide longer-term continuous monitoring. This study investigated whether 2-week Garment ECG can reveal instances of AF recurrence in patients who are diagnosed as remaining in sinus rhythm by 24-hour Holter ECG.
The open-label randomized crossover study enrolled 67 patients (63.1±10.6 years old, 53 men) who had undergone initial AF ablation. Three months after ablation, patients were randomly assigned to group 1 (n = 35), 2-week Garment ECG followed by 24-hour Holter ECG, or group 2 (n = 32), 24-hour Holter ECG followed by 2-week Garment ECG. The detection of AF recurrence was compared between the two devices.
The Garment ECG showed AF recurrence in 12 patients (18%) compared to 4 patients for the Holter ECG (6%, p = 0.008). The ECG acquisition rate was higher for Holter ECG than for Garment ECG (100.0% [interquartile range 100.0-100.0%] versus 82.4% [71.1-91.0%], p<0.001), but the Garment ECG provided longer total analysis time (11.0 days [9.0-12.2 days] for Garment; 1.0 day [1.0-1.0 day] for Holter, p<0.001).
Despite the lower ECG acquisition rate, the 2-week Garment ECG revealed instances of AF recurrence after ablation in patients who were underdiagnosed by 24-hour Holter ECG.
Clinical Trial Registration: URL: https://jrct.niph.go.jp/en-latest-detail/jRCTs032180018 Unique Identifier: jRCTs032180018.
心房颤动（AF）是最常见的心律失常，尽管进行了导管消融，但其仍经常复发。由于其短暂和隐匿的性质，标准的 24 小时心电图（ECG）常常会漏诊 AF 的复发。已经开发出一种带有高度导电的纺织电极的服装式心电图，该电极由聚（3,4-亚乙基二氧噻吩）聚（苯乙烯磺酸盐）（PEDOTPSS）和纳米纤维制成（服装式心电图），可以提供更长时间的连续监测。本研究旨在探讨 2 周的服装式心电图是否可以发现通过 24 小时动态心电图诊断为窦性心律的患者中的 AF 复发。
这项开放标签、随机交叉研究纳入了 67 名（63.1±10.6 岁，53 名男性）接受初始 AF 消融的患者。消融后 3 个月，患者被随机分为 1 组（n=35），接受 2 周的服装式心电图检查，然后进行 24 小时动态心电图检查；或 2 组（n=32），先进行 24 小时动态心电图检查，然后进行 2 周的服装式心电图检查。比较两种设备对 AF 复发的检测结果。
与 Holter ECG 相比，服装式心电图在 12 名患者（18%）中显示出 AF 复发，而 Holter ECG 仅在 4 名患者中显示出（6%，p=0.008）。Holter ECG 的心电图采集率高于服装式心电图（100.0%[四分位距 100.0-100.0%]与 82.4%[71.1-91.0%]，p<0.001），但服装式心电图提供了更长的总分析时间（11.0 天[9.0-12.2 天]与 1.0 天[1.0-1.0 天]，p<0.001）。
尽管心电图采集率较低，但在 24 小时动态心电图漏诊的患者中，2 周的服装式心电图揭示了消融后的 AF 复发。
临床试验注册：网址：https://jrct.niph.go.jp/en-latest-detail/jRCTs032180018 独特标识符：jRCTs032180018。
