Saito Tomonari, Nishiyama Yasuhiro, Otsuka Toshiaki, Sakamoto Yuki, Okubo Seiji, Iguchi Yasuyuki, Yamaguchi Keiji, Okada Yasushi, Hamaguchi Hirotoshi, Yonehara Toshiro, Fukuzawa Masayuki, Takita Atsushi, Katano Takehiro, Kimura Kazumi
Department of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
Division of Medicine, Department of Neurology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Front Neurol. 2025 Aug 13;16:1560495. doi: 10.3389/fneur.2025.1560495. eCollection 2025.
Stroke caused by atrial fibrillation (AF) is associated with high mortality and severe morbidity. Screening patients for AF may facilitate early initiation of anticoagulant therapy and prevent recurrent stroke; therefore, strategies to effectively detect AF in stroke patients are important.
This prospective multicenter study was conducted between April 27, 2020 and March 31, 2021 at seven sites in Japan, as a substudy of the STABLED trial, a multicenter prospective randomized study to evaluate the efficacy and safety of catheter ablation with anticoagulant therapy using edoxaban in patients with ischemic stroke and AF. This substudy included 241 patients who suffered ischemic stroke but had no diagnosis of AF. Patients were monitored with Duranta, a wearable non-invasive wireless patch ECG system. The primary outcome was the detection rate for AF while wearing Duranta.
Of the 241 patients, 66.8% were men, and the mean age was 71.0 years. AF was detected in 21 of the 241 patients (8.7, 95% CI: 5.4-12.4) during follow-up using the Duranta wearable ECG system. ECG data were recorded for 7 days in all patients. The median number of days from stroke onset to Duranta placement was 2.0, but this duration varied considerably (median; IQR, 0-22.0). An adverse event of dermal pruritus was observed in 1 of the 241 patients (0.4%). Determinants for the detection of AF in patients with no previous history of AF were dyslipidemia and left atrial dimension.
Wearable wireless patch ECG systems such as Duranta are simple and efficient devices for detecting AF. In patients with ischemic stroke and no diagnosis of AF, their use for detecting new AF may provide benefit through early initiation of anticoagulants and prevention of recurrent stroke.
心房颤动(AF)所致卒中与高死亡率和严重发病率相关。对患者进行AF筛查可能有助于早期启动抗凝治疗并预防复发性卒中;因此,有效检测卒中患者AF的策略很重要。
本前瞻性多中心研究于2020年4月27日至2021年3月31日在日本的7个地点进行,作为STABLED试验的一项子研究,STABLED试验是一项多中心前瞻性随机研究,旨在评估使用依度沙班进行抗凝治疗的导管消融术对缺血性卒中和AF患者的疗效和安全性。这项子研究纳入了241例发生缺血性卒中但未诊断为AF的患者。使用Duranta(一种可穿戴的无创无线贴片式心电图系统)对患者进行监测。主要结局是佩戴Duranta期间AF的检测率。
241例患者中,66.8%为男性,平均年龄为71.0岁。在随访期间,使用Duranta可穿戴心电图系统在241例患者中的21例(8.7%,95%CI:5.4 - 12.4)检测到AF。所有患者均记录了7天的心电图数据。从卒中发作到佩戴Duranta的天数中位数为2.0,但该持续时间差异很大(中位数;IQR,0 - 22.0)。241例患者中有1例(0.4%)出现皮肤瘙痒的不良事件。既往无AF病史患者中AF检测的决定因素是血脂异常和左心房大小。
Duranta等可穿戴无线贴片式心电图系统是检测AF的简单高效设备。在缺血性卒中和未诊断为AF的患者中,使用它们检测新发AF可能通过早期启动抗凝剂和预防复发性卒中而带来益处。