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隐源性卒中后房颤检测的持续评估:来自使用Confirm Rx ICM的多中心研究的2年结果

Continuing evaluation of atrial fibrillation detection after cryptogenic stroke: 2-year findings from a multicentre study with Confirm Rx ICM.

作者信息

Quartieri Fabio, Baek Yong-Soo, Park Jong-Sung, Kim Tae-Hoon, Honma Kazunari, Morimoto Masafumi, Kang Ki-Woon, Feng Lin, Lee Kwangdeok, Grammatico Andrea, Kaiser Lukas

机构信息

Arcispedale Santa Maria Nuova di Reggio Emilia, Reggio Emilia, Italy

Cardiology, Inha University Hospital, Incheon, Korea (the Republic of).

出版信息

Open Heart. 2025 Jun 12;12(1):e003242. doi: 10.1136/openhrt-2025-003242.

Abstract

BACKGROUND

The detection of atrial fibrillation (AF) after a cryptogenic stroke (CS) carries important therapeutic implications. In this study, we aimed to accurately assess the incidence of AF among CS subjects by using an insertable cardiac monitor (ICM).

METHODS

A prospective, single-arm, multicentre registry was conducted to identify AF in 155 CS subjects using the Confirm Rx ICM (Abbott, California, USA) across 20 global sites. Inclusion criteria comprised participants aged 40 years or older who had experienced CS within a 90-day window. At each follow-up visit, expert electrophysiologists reviewed and adjudicated ICM detected AF episodes. The primary endpoint was the cumulative incidence of true device-detected AF (lasting more than 30 s) at 6 months, evaluated with Kaplan-Meier methods.

RESULTS

AF incidence was 21.3% (95% CI 15.3% to 29.1%) at 6 months, increasing to 48.8% (95% CI 34.7% to 64.9%) at 24 months. Subjects with AF detection experienced an average of 50.9 true AF episodes per subject per year. The median time from implantation to AF detection (>30 s) was 72 days (IQR 7-261). Among subjects with 30 s AF detection, anticoagulation therapy was initiated in 65.2% (30/46) of subjects. Oral anticoagulation medication was prescribed in 8.3% (9/109) of subjects without AF. Recurrent ischaemic stroke or transient ischaemic attack occurred in 5 subjects (3.2%, 5/155).

CONCLUSION

These results show that ICM-driven long-term continuous AF monitoring is associated with high diagnostic yield in CS subjects.

TRIAL REGISTRATION NUMBER

NCT03505801.

摘要

背景

隐源性卒中(CS)后房颤(AF)的检测具有重要的治疗意义。在本研究中,我们旨在通过使用植入式心脏监测器(ICM)准确评估CS患者中AF的发生率。

方法

进行了一项前瞻性、单臂、多中心注册研究,以使用Confirm Rx ICM(美国加利福尼亚州雅培公司)在20个全球地点识别155例CS患者中的AF。纳入标准包括年龄在40岁及以上且在90天内发生CS的参与者。在每次随访时,专家电生理学家对ICM检测到的AF发作进行审查和判定。主要终点是6个月时真正由设备检测到的AF(持续超过30秒)的累积发生率,采用Kaplan-Meier方法进行评估。

结果

6个月时AF发生率为21.3%(95%CI 15.3%至29.1%),24个月时增至48.8%(95%CI 34.7%至64.9%)。检测到AF的患者平均每年每人发生50.9次真正的AF发作。从植入到检测到AF(>30秒)的中位时间为72天(IQR 7-261)。在检测到AF持续30秒的患者中,65.2%(30/46)的患者开始了抗凝治疗。未发生AF的患者中有8.3%(9/109)接受了口服抗凝药物治疗。5名患者(3.2%,5/155)发生了复发性缺血性卒中或短暂性脑缺血发作。

结论

这些结果表明,ICM驱动的长期持续AF监测在CS患者中具有较高的诊断率。

试验注册号

NCT03505801。

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