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感知噪声:皮下植入式心律转复除颤器中不明原因电击的罪魁祸首。

Sense-B-noise: an enigmatic cause for inappropriate shocks in subcutaneous implantable cardioverter defibrillators.

机构信息

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland.

出版信息

Europace. 2023 Feb 16;25(2):767-774. doi: 10.1093/europace/euac202.

DOI:10.1093/europace/euac202
PMID:36353759
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9935013/
Abstract

AIMS

Subcutaneous implantable cardioverter defibrillators (S-ICDs) are well established. However, inappropriate shocks (IAS) remain a source of concern since S-ICDs offer very limited troubleshooting options. In our multicentre case series, we describe several patients who experienced IAS due to a previously unknown S-ICD system issue.

METHODS AND RESULTS

We observed six patients suffering from this novel IAS entity. The IAS occurred exclusively in primary or alternate S-ICD sensing vector configuration (therefore called 'Sense-B-noise'). IAS were caused by non-physiologic oversensing episodes characterized by intermittent signal saturation, diminished QRS amplitudes, and disappearance of the artefacts after the IAS. Noise/oversensing could not be provoked by manipulation, X-ray did not show evidence for lead/header issues and impedance measurements were within normal limits. The pooled experience of our centres implies that up to ∼5% of S-ICDs may be affected. The underlying root cause was discussed extensively with the manufacturer but remains unknown and is under further investigation.

CONCLUSION

Sense-B-noise is a novel cause for IAS due to non-physiologic signal oversensing, arising from a previously unknown S-ICD system issue. Sense-B-noise may be suspected if episodes of signal saturation in primary or alternate vector configuration are present, oversensing cannot be provoked, and X-ray and electrical measurements appear normal. The issue can be resolved by reprogramming the device to secondary sensing vector.

摘要

目的

皮下植入式心律转复除颤器(S-ICD)已经得到广泛应用。然而,不适当的电击(IAS)仍然是一个令人担忧的问题,因为 S-ICD 提供的故障排除选项非常有限。在我们的多中心病例系列中,我们描述了几位因先前未知的 S-ICD 系统问题而经历 IAS 的患者。

方法和结果

我们观察到六名患有这种新型 IAS 实体的患者。IAS 仅发生在原发性或备用 S-ICD 感测向量配置中(因此称为“感测-B-噪声”)。IAS 是由非生理过度感测事件引起的,其特征为间歇性信号饱和、QRS 幅度降低以及 IAS 后伪影消失。通过操作无法引发噪声/过度感测,X 射线未显示出导联/头端问题的证据,阻抗测量值在正常范围内。我们中心的经验表明,高达约 5%的 S-ICD 可能受到影响。与制造商广泛讨论了根本原因,但仍不清楚,正在进一步调查中。

结论

感测-B-噪声是一种由于非生理信号过度感测引起的新型 IAS 原因,源自先前未知的 S-ICD 系统问题。如果在原发性或备用向量配置中存在信号饱和的事件,过度感测无法引发,并且 X 射线和电测量看起来正常,则可以怀疑存在感测-B-噪声。可以通过将设备重新编程到次要感测向量来解决此问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/5bc14de47cbb/euac202f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/f95474db8b4a/euac202f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/e14bf01f35c8/euac202f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/02c2dfd2911b/euac202f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/1217777030ae/euac202f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/5bc14de47cbb/euac202f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/f95474db8b4a/euac202f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/e14bf01f35c8/euac202f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/02c2dfd2911b/euac202f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/1217777030ae/euac202f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/24c0/9935013/5bc14de47cbb/euac202f5.jpg

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本文引用的文献

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Air entrapment as a potential cause of early subcutaneous implantable cardioverter defibrillator malfunction: a systematic review of the literature.空气栓塞作为早期皮下植入式心脏除颤器故障的潜在原因:文献系统回顾。
Europace. 2022 Oct 13;24(10):1608-1616. doi: 10.1093/europace/euac046.
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Longevity of model 3501 subcutaneous implantable cardioverter-defibrillator leads in clinical practice.3501型皮下植入式心律转复除颤器导线在临床实践中的使用寿命
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比较接受皮下植入式心脏除颤器患者的术前心电图筛查和基于设备的向量分析。
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Subcutaneous implantable cardioverter-defibrillator electrode fracture: Follow-up, troubleshooting, and evaluation.皮下植入式心脏除颤器电极断裂:随访、故障排除和评估。
J Cardiovasc Electrophysiol. 2021 May;32(5):1452-1457. doi: 10.1111/jce.14994. Epub 2021 Mar 19.
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Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.UNTOUCHED 试验:在射血分数较低的原发性预防患者中使用 S-ICD 的主要结果。
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Subcutaneous or Transvenous Defibrillator Therapy.皮下或经静脉除颤器治疗。
N Engl J Med. 2020 Aug 6;383(6):526-536. doi: 10.1056/NEJMoa1915932.
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Early inappropriate shock in a subcutaneous cardiac defibrillator due to subcutaneous air.皮下心脏除颤器因皮下气肿导致早期不适当电击。
J Arrhythm. 2019 Jun 17;35(4):682-684. doi: 10.1002/joa3.12210. eCollection 2019 Aug.
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Oversensing issues leading to device extraction: When subcutaneous implantable cardioverter-defibrillator reached a dead-end.导致设备取出的感知过度问题:当皮下植入式心律转复除颤器走到尽头时。
Heart Rhythm. 2020 Jan;17(1):66-74. doi: 10.1016/j.hrthm.2019.07.004. Epub 2019 Jul 8.
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