User-reported abrasion-related lead failure is more common with durata compared to other implantable cardiac defibrillator leads
User-reported abrasion-related lead failure is more common with durata compared to other implantable cardiac defibrillator leads
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DOI：
10.1016/j.hrthm.2015.07.013
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发表时间：
2015-12-01
期刊：
影响因子：
5.5
通讯作者：
Langberg, Jonathan J.
中科院分区：
文献类型：
--
作者：
Shah, Anand D.;Hirsh, David S.;Langberg, Jonathan J.
背景：随着St Jude Medical Riata引线由内到外磨损率的增加，Durata植入式心脏除颤器（ICD）引线经过修改后引入，旨在增加耐磨性。最近的案例报告描述了Durata的绝缘故障。目的：确定Durata导联是否增加了与磨损相关的失败率。方法查询美国食品药品监督管理局制造商和用户设施设备体验数据库中2014年以来Durata引线绝缘失效的报告。与其他ICD导联进行比较。估计发病率并比较病例特征。结果Durata导联的磨损发生率明显高于Boston Scientific Endotak或Medtronic Quattro导联。与Riata引线的“由内到外”磨损相比，磨损模式通常是铅到罐。全层磨损与除颤器失败或不适当的治疗有关。4例患者治疗失败或死亡。结论：研究结果表明，尽管设计修改，Durata引线的绝缘失败率较高。从脉冲发生器到设备口袋内邻近导线的外部磨损是最常见的病因。电击暴露了先前未被发现的磨损，导致除颤器失效。数据显示磨损风险可能与时间有关。这个有限的查询表明需要持续审查杜拉塔铅性能。在更换ICD时仔细检查Durata导联是有必要的，同时也要积极收集使用Durata导联的患者的临终事件信息。
BACKGROUND Following increased rates of inside-out abrasion with the St Jude Medical Riata lead, the Durata implantable cardiac defibrillator (ICD) lead was introduced with modifications intended to increase abrasion resistance. Recent case reports have described insulation failures of the Durata.OBJECTIVE To determine if increased rates of abrasion-related failure are present with the Durata lead.METHODS The Food and Drug Administration Manufacturer and User Facility Device Experience database was queried for reports of insulation failure of the Durata lead from 2014. Comparison was made to other ICD leads. Incidence was estimated and case characteristics were compared.RESULTS The estimated incidence of abrasion was significantly higher for the Durata lead than for the Boston Scientific Endotak or the Medtronic Quattro leads. The mode of abrasion was most often lead-to-can, as compared to "inside-out" abrasion with the Riata lead. Full-thickness abrasion was associated with failure to defibrillate or inappropriate therapy. Four patients had failure of therapy or death.CONCLUSIONS The findings indicate higher rates of insulation failures of the Durata lead, despite design modifications. External abrasion from the pulse generator to the adjacent lead within the device pocket was the most common etiology. Shocks unmasked previously undetected abrasion, resulting in failure to defibrillate. Data are presented indicating a possible time dependency to abrasion risk. This limited query suggests need for ongoing scrutiny of Durata lead performance. Careful inspection of Durata leads at the time of ICD replacement is warranted, as are vigorous attempts to gather information about terminal events in patients with Durata leads.