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The Sprint Fidelis lead fracture story: time to come to our senses?

作者信息

van Dessel P F H M

机构信息

Department of Cardiology, Academic Medical Center, Amsterdam, the Netherlands.

出版信息

Neth Heart J. 2010 Jan;18(1):4-6.

PMID:20111636
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2810028/
Abstract
摘要

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The Sprint Fidelis lead fracture story: time to come to our senses?美敦力 Sprint Fidelis 导线断裂事件:是时候清醒过来了吗?
Neth Heart J. 2010 Jan;18(1):4-6.
2
Factors predicting Sprint Fidelis lead fracture: Results at 5 years from a French multicentre registry.预测 Sprint Fidelis 导线断裂的因素:来自法国多中心注册研究的 5 年结果
Arch Cardiovasc Dis. 2015 Apr;108(4):220-6. doi: 10.1016/j.acvd.2014.11.006. Epub 2015 Apr 6.
3
Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure.美敦力 Sprint Fidelis植入式心脏复律除颤器导线故障风险增加。
Heart Rhythm. 2009 May;6(5):605-10. doi: 10.1016/j.hrthm.2009.02.024. Epub 2009 Feb 20.
4
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Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead.小直径高压植入式心脏复律除颤器导线的早期故障
Heart Rhythm. 2007 Jul;4(7):892-6. doi: 10.1016/j.hrthm.2007.03.041. Epub 2007 Apr 10.
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Medtronic Sprint Fidelis lead recall: determining the initial 5-year management cost to Medicare.美敦力 Sprint Fidelis 导联召回:确定医疗保险最初 5 年的管理成本。
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Lead electrical parameters may not predict integrity of the Sprint Fidelis ICD lead.主导电参数可能无法预测 Sprint Fidelis ICD 导联的完整性。
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Clinical outcome of implantable cardioverter defibrillators with recalled and non-recalled leads in Japanese patients. Increased failure rate of the Sprint Fidelis lead.日本患者中使用召回和未召回导线的植入式心脏复律除颤器的临床结果。美敦力 Sprint Fidelis 导线故障率增加。
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A Strategy of Lead Abandonment in a Large Cohort of Patients With Sprint Fidelis Leads.在 Sprint Fidelis 导联的大量患者队列中采用放弃铅策略。
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Lead integrity alert algorithm decreases inappropriate shocks in patients who have Sprint Fidelis pace-sense conductor fractures.导联完整性警示算法可降低 Sprint Fidelis 起搏感知导线断裂患者中不适当电击的发生率。
Heart Rhythm. 2010 Aug;7(8):1048-55. doi: 10.1016/j.hrthm.2010.05.015. Epub 2010 May 21.

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Remarkably high and accelerating failure rate of a widely used implantable cardioverter-defibrillator lead: A large-scale manufacturer-independent multicenter study with long accurate follow-up.一种广泛使用的植入式心脏复律除颤器导线的故障率极高且呈加速上升趋势:一项大规模、独立于制造商的多中心研究,随访时间长且数据准确。
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A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks.用于评估真实世界证据为不同利益相关者创造的价值的综合框架:以协作登记网络为例。
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Improvements in 25 Years of Implantable Cardioverter Defibrillator Therapy.25年植入式心脏复律除颤器治疗的进展。
Neth Heart J. 2011 Jan;19(1):24-30. doi: 10.1007/s12471-010-0047-3. Epub 2010 Dec 22.

本文引用的文献

1
Characteristics of Sprint Fidelis lead failure.Sprint Fidelis 导联故障的特征。
Neth Heart J. 2010 Jan;18(1):12-7.
2
The changing presentation of implantable cardioverter-defibrillator lead fractures.
Heart Rhythm. 2009 Apr;6(4):478-9. doi: 10.1016/j.hrthm.2009.01.027. Epub 2009 Jan 24.
3
Utilization of a national network for rapid response to the Medtronic Fidelis lead advisory: the Canadian Heart Rhythm Society Device Advisory Committee.
Heart Rhythm. 2009 Apr;6(4):474-7. doi: 10.1016/j.hrthm.2009.01.012. Epub 2009 Jan 18.
4
Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure.美敦力 Sprint Fidelis植入式心脏复律除颤器导线故障风险增加。
Heart Rhythm. 2009 May;6(5):605-10. doi: 10.1016/j.hrthm.2009.02.024. Epub 2009 Feb 20.
5
Implantable cardioverter-defibrillators after myocardial infarction.心肌梗死后的植入式心脏复律除颤器
N Engl J Med. 2008 Nov 20;359(21):2245-53. doi: 10.1056/NEJMra0803409.
6
The Sprint Fidelis lead fracture story: what do we really know and where do we go from here?
Heart Rhythm. 2008 Oct;5(10):1380-1. doi: 10.1016/j.hrthm.2008.08.001. Epub 2008 Aug 5.
7
Accelerating risk of Fidelis lead fracture.菲德利斯导线骨折风险加速。
Heart Rhythm. 2008 Oct;5(10):1375-9. doi: 10.1016/j.hrthm.2008.06.024. Epub 2008 Jul 3.
8
Necessity for surgical revision of defibrillator leads implanted long-term: causes and management.长期植入的除颤器导线进行外科翻修的必要性:原因与处理
Circulation. 2008 May 27;117(21):2727-33. doi: 10.1161/CIRCULATIONAHA.107.740670. Epub 2008 May 19.
9
Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: a report from the Canadian Heart Rhythm Society Device Advisory Committee.菲德利斯植入式心脏复律除颤器导线咨询的结果:加拿大心律学会设备咨询委员会的报告。
Heart Rhythm. 2008 May;5(5):639-42. doi: 10.1016/j.hrthm.2008.01.029. Epub 2008 Jan 29.
10
European perspective on lead extraction: part II.
Heart Rhythm. 2008 Feb;5(2):320-3. doi: 10.1016/j.hrthm.2007.09.014. Epub 2007 Sep 19.