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如何在临床试验和混合疗法中使用植入式循环记录仪。

How to use implantable loop recorders in clinical trials and hybrid therapy.

作者信息

Jung Werner, Zvereva Vlada, Rillig Andreas, Roggenbuck Birge, Sadeghzadeh Gholam, Kohler Johannes

机构信息

Department of Cardiology, Academic Teaching Hospital of the University of Freiburg, Schwarzwald-Baar Klinikum, Vöhrenbacher Street 23, 78050, Villingen-Schwenningen, Germany.

出版信息

J Interv Card Electrophysiol. 2011 Dec;32(3):227-32. doi: 10.1007/s10840-011-9611-z. Epub 2011 Oct 13.

DOI:10.1007/s10840-011-9611-z
PMID:21993595
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3224223/
Abstract

Epidemiological studies show that atrial fibrillation (AF) is associated with a doubling of mortality, even after adjustment for confounders. AF can be asymptomatic, but this does not decrease the thromboembolic risk of the patient. Office ECGs, occasional 24-h Holter recordings and long-term ECG event recording might not be sensitive and accurate enough in patients with AF, especially in those with paroxysmal episodes. In one study, 7 days of continuous monitoring with event recorders detected paroxysmal AF in 20 of 65 patients with a previous negative 24-h Holter recording. Over the last decade, enormous improvements have been made in the technology of implantable devices, which can now store significant information regarding heart rhythm. The first subcutaneous implantable monitor (Reveal XT, Medtronic) was validated for continuous AF monitoring by the XPECT study. The dedicated AF detection algorithm uses irregularity and incoherence of R-R intervals to identify and classify patterns in ventricular conduction. Its sensitivity in identifying patients with AF is >96%. Numerous clinical data from continuous monitoring of AF have recently been published. The first applications of this technology have been in the field of surgical and catheter AF ablation. With regard to cryptogenic stroke, an international randomized trial is ongoing to compare standard care with standard care plus the implantable cardiac monitor for AF detection in patients discharged with the diagnosis of cryptogenic stroke: the Crystal AF trial. Continuous AF monitoring provides an optimal picture of daily AF burden, both symptomatic and asymptomatic. Implantable cardiac monitors have high sensitivity, enable better assessment of therapy success and may guide further AF therapy.

摘要

流行病学研究表明,即便在对混杂因素进行校正之后,心房颤动(AF)仍与死亡率翻倍相关。AF可能无症状,但这并不会降低患者的血栓栓塞风险。对于AF患者,门诊心电图、偶尔的24小时动态心电图记录以及长期心电图事件记录可能不够敏感和准确,尤其是对阵发性发作的患者。在一项研究中,使用事件记录仪进行7天的连续监测,在65例此前24小时动态心电图记录为阴性的患者中,有20例检测到阵发性AF。在过去十年中,可植入设备技术取得了巨大进步,现在能够存储有关心律的大量信息。首个皮下植入式监测器(Reveal XT,美敦力公司)通过XPECT研究验证了其对AF连续监测的有效性。专用的AF检测算法利用R-R间期的不规则性和不连贯性来识别和分类心室传导模式。其在识别AF患者方面的敏感性>96%。最近已发表了大量来自AF连续监测的临床数据。这项技术的首次应用是在外科手术和导管消融治疗AF领域。关于隐源性卒中,一项国际随机试验正在进行,以比较标准治疗与标准治疗加植入式心脏监测器用于诊断为隐源性卒中出院患者AF检测的效果:即Crystal AF试验。AF连续监测可提供每日AF负荷的最佳情况,包括有症状和无症状的情况。植入式心脏监测器具有高敏感性,能够更好地评估治疗效果,并可能指导进一步的AF治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6325/3224223/de941e232d20/10840_2011_9611_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6325/3224223/141bb42cc8a1/10840_2011_9611_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6325/3224223/de941e232d20/10840_2011_9611_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6325/3224223/141bb42cc8a1/10840_2011_9611_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6325/3224223/de941e232d20/10840_2011_9611_Fig2_HTML.jpg

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本文引用的文献

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Design of the Multi-Sensor Monitoring in Congestive Heart Failure (MUSIC) study: prospective trial to assess the utility of continuous wireless physiologic monitoring in heart failure.多传感器监测充血性心力衰竭(MUSIC)研究的设计:前瞻性试验评估连续无线生理监测在心衰中的应用价值。
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Cryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL AF): design and rationale.不明原因性卒中与潜在心房颤动(CRYSTAL AF):设计与原理。
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Left atrial ablation at the anatomic areas of ganglionated plexi for paroxysmal atrial fibrillation.
针对阵发性心房颤动,在神经节丛的解剖区域进行左心房消融。
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Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial.新型无导线植入式心脏监测仪在检测和量化心房颤动中的性能:XPECT 试验结果。
Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16.
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The relationship between daily atrial tachyarrhythmia burden from implantable device diagnostics and stroke risk: the TRENDS study.植入式设备诊断的每日房性快速性心律失常负荷与卒中风险之间的关系:TRENDS研究
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Twenty-four-hour holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel permanently implantable heart rhythm monitor device.术后心房颤动消融治疗后,24小时动态心电图监测无法提供准确的心律状态:新型永久植入式心律监测设备长达12个月的经验。
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Early and comprehensive management of atrial fibrillation: proceedings from the 2nd AFNET/EHRA consensus conference on atrial fibrillation entitled 'research perspectives in atrial fibrillation'.心房颤动的早期综合管理:第二届AFNET/EHRA心房颤动共识会议“心房颤动研究展望”会议纪要
Europace. 2009 Jul;11(7):860-85. doi: 10.1093/europace/eup124. Epub 2009 Jun 16.