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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.

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/6325/3224223/141bb42cc8a1/10840_2011_9611_Fig1_HTML.jpg

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