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双腔起搏器和植入式心律转复除颤器指导下基于连续房颤负荷监测的间断抗凝治疗:来自非持续房颤个体化抗凝治疗(TACTIC-AF)试验的研究结果。

Intermittent anticoagulation guided by continuous atrial fibrillation burden monitoring using dual-chamber pacemakers and implantable cardioverter-defibrillators: Results from the Tailored Anticoagulation for Non-Continuous Atrial Fibrillation (TACTIC-AF) pilot study.

机构信息

Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

Northwestern University Feinberg School of Medicine, Chicago, Illinois.

出版信息

Heart Rhythm. 2018 Nov;15(11):1601-1607. doi: 10.1016/j.hrthm.2018.06.027. Epub 2018 Jul 6.

Abstract

BACKGROUND

Chronic anticoagulation is recommended for atrial fibrillation (AF) patients with thromboembolic risk factors regardless of AF duration/frequency. Continuous rhythm assessment with pacemakers (PMs)/implantable cardioverter-defibrillators (ICDs) and use of direct-acting oral anticoagulants (DOACs) may allow anticoagulation only around AF episodes, reducing bleeding without increasing thromboembolic risk.

OBJECTIVE

The purpose of this study was to evaluate the feasibility/safety of intermittent DOAC use guided by continuous remote AF monitoring via dual-chamber PMs or ICDs.

METHODS

Patients with nonpermanent AF, current DOAC use, CHADS score ≤3, a St. Jude Medical dual-chamber PM or ICD, and rare AF episodes were followed with biweekly and AF-alert based remote transmissions. Patients free of AF episodes lasting ≥6 minutes with a total AF burden <6 hours/day for 30 consecutive days discontinued DOAC. If AF burden surpassed these limits, DOAC was restarted and/or continued. Total days on DOAC and adverse events were assessed.

RESULTS

Among 48 patients (mean age 71.3 years; 65% male; 79% paroxysmal AF; 87% CHADS score 1-2), 14,826 days of monitoring were completed. Patients used DOACs for 3763 days, representing a 74.6% reduction in anticoagulation time compared to chronic administration. Adverse events included 2 gastrointestinal bleeds (both on DOAC), 1 fatal intracerebral bleed (off DOAC), and no thromboembolic/stroke events.

CONCLUSION

Among patients with rare AF episodes and low-to-moderate stroke risk, PM/ICD-guided DOAC administration is feasible and decreased anticoagulation utilization by 75%. Few adverse events occurred, although the study was not powered to assess these outcomes. PM/ICD-guided DOAC administration may prove a viable alternative to chronic anticoagulation. Future studies are warranted.

摘要

背景

无论房颤(AF)持续时间/频率如何,有血栓栓塞危险因素的 AF 患者均推荐长期抗凝治疗。通过起搏器(PM)/植入式心律转复除颤器(ICD)持续评估节律和使用直接口服抗凝剂(DOAC),仅在 AF 发作期间进行抗凝治疗,可能会减少出血而不增加血栓栓塞风险。

目的

本研究旨在评估通过双腔 PM 或 ICD 进行连续远程 AF 监测指导间歇性 DOAC 使用的可行性/安全性。

方法

研究纳入非永久性 AF、正在使用 DOAC、CHADS 评分≤3、St. Jude Medical 双腔 PM 或 ICD 的患者,进行每两周一次的远程传输和 AF 报警监测。如果连续 30 天无持续≥6 分钟且总 AF 负荷<6 小时/天的 AF 发作,则停止 DOAC 治疗。如果 AF 负荷超过这些限制,则重新开始或继续使用 DOAC。评估 DOAC 的总使用天数和不良事件。

结果

48 例患者(平均年龄 71.3 岁;65%为男性;79%为阵发性 AF;87%的 CHADS 评分为 1-2)中,完成了 14826 天的监测。患者使用 DOAC 治疗了 3763 天,与长期给药相比,抗凝时间减少了 74.6%。不良事件包括 2 例胃肠道出血(均在使用 DOAC 时发生)、1 例致死性颅内出血(未使用 DOAC 时发生),无血栓栓塞/卒中事件。

结论

在 AF 发作频率低且中危的患者中,PM/ICD 指导的 DOAC 给药是可行的,可将抗凝治疗的使用率降低 75%。虽然本研究没有足够的效能来评估这些结果,但不良事件的发生较少。PM/ICD 指导的 DOAC 给药可能是一种可行的替代慢性抗凝治疗的方法。需要进一步的研究。

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