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与之前型号(已召回的Riata除颤导线)相比,Durata除颤导线的长期性能及导线故障分析。

Long-term performance and lead failure analysis of the Durata defibrillation lead compared to its previous model, the recalled Riata defibrillation lead.

作者信息

Kleemann Thomas, Nonnenmacher Florian, Strauss Margit, Kouraki Kleopatra, Werner Nicolas, Fendt Andràs, Zahn Ralf

机构信息

Klinikum Ludwigshafen, Medizinische Klinik B, Ludwigshafen, Germany.

出版信息

J Cardiovasc Electrophysiol. 2019 Oct;30(10):2012-2019. doi: 10.1111/jce.14087. Epub 2019 Aug 1.

Abstract

INTRODUCTION

Data on long-term durability of St Jude Medical Durata defibrillation leads compared to its previous model, the St Jude Medical Riata leads in clinical practice are missing. Aim of the study was to analyze the long-term performance of the Durata defibrillation leads compared to the Riata leads in clinical practice.

METHODS AND RESULTS

A total of 1407 consecutive patients of a prospective single-centre implantable cardioverter defibrillator (ICD)-registry were analyzed who underwent ICD implantation with a Durata (n = 913) or Riata (n = 494) ICD lead between 2002 and 2017. Most of the leads were implanted via a subclavian vein access. The estimated lead defect rates after 5 and 10 years were not different between the Durata (11% and 36%) and Riata leads (13% and 38%). Among Durata leads single coil and DF-4 connector ICD leads had a lower incidence of lead failure. Major causes of lead failure were compression of the lead in the clavicular region, generator to lead friction and distal fatigue fracture whereas lead defect due to externalization was a rare cause of lead defect in Riata leads (3%).

CONCLUSION

Among ICD leads implanted via the subclavian vein access the lead defect rate of Durata leads after 10 years is similar to that of Riata leads. Single coil and DF-4 ICD leads are associated with a lower lead failure rate. Mechanical stress represents a major cause of lead failure mechanism whereas externalization might only play a minor role in clinical practice.

摘要

引言

圣犹达医疗公司的Durata除颤导线与其前一代产品Riata导线相比,在临床实践中的长期耐用性数据尚属空白。本研究旨在分析Durata除颤导线与Riata导线在临床实践中的长期性能。

方法与结果

对前瞻性单中心植入式心律转复除颤器(ICD)注册研究中的1407例连续患者进行分析,这些患者在2002年至2017年间接受了Durata(n = 913)或Riata(n = 494)ICD导线植入。大多数导线通过锁骨下静脉途径植入。Durata导线和Riata导线在5年和10年后的估计导线缺陷率并无差异(分别为11%和36%以及13%和38%)。在Durata导线中,单线圈和DF - 4连接器ICD导线的导线故障发生率较低。导线故障的主要原因是导线在锁骨区域受压、发生器与导线之间的摩擦以及远端疲劳骨折,而对于Riata导线,导线外露导致的导线缺陷是一种罕见的导线缺陷原因(3%)。

结论

在通过锁骨下静脉途径植入的ICD导线中,Durata导线10年后的导线缺陷率与Riata导线相似。单线圈和DF - 4 ICD导线的导线故障率较低。机械应力是导线故障机制的主要原因,而导线外露在临床实践中可能仅起次要作用。

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