University of British Columbia, Vancouver, British Columbia, Canada.
Heart Rhythm. 2013 Oct;10(10):1478-81. doi: 10.1016/j.hrthm.2013.07.050. Epub 2013 Aug 22.
The St. Jude Medical Riata family of implantable cardioverter-defibrillator (ICD) leads has demonstrated a high rate of externalized conductors and electrical failure.
Given similar design elements of Durata to Riata, the purpose of this study was to assess the rates of failure of the Riata ST Optim and Durata lead families in Canada.
All Canadian ICD-implanting centers were invited to submit follow-up information on all Optim-coated ICD leads implanted. Electrical failure was defined as a rapid change in impedance or pacing capture threshold leading to lead revision, or oversensing due to noise. Externalized conductors were defined as appearance of conductor wires outside the lead body. Systematic fluoroscopic screening for externalized conductors was not performed.
As of December 1, 2012, 15 of 25 centers provided data on 3981 leads (44% of those sold in Canada during the same timeframe): 3477 Durata and 504 Riata ST Optim leads. The most common model numbers were 7122 (1516 leads [38%]), 7121 (707 leads [18%]), and 7120 (622 leads [16%]). Mean follow-up duration from implant to December 1, 2012, was 4.47 ± 0.48 years for Riata ST Optim leads and 2.00 ± 1.10 years for Durata leads. The annual rate of lead failure was 0.27% per year for Riata ST Optim leads and 0.24% per year for Durata leads. No instances of externalized conductors were identified in the failed leads. No deaths were attributed to lead failure; however, 2 patients experienced inappropriate shocks due to lead failure.
The overall electrical failure rates of the Riata ST Optim and Durata leads appear to be low, and no instances of externalized conductors were observed.
圣犹达医疗 Riata 系列植入式心脏复律除颤器（ICD）导联的外部导体和电气故障发生率较高。
鉴于 Durata 与 Riata 具有相似的设计元素，本研究旨在评估加拿大 Riata ST Optim 和 Durata 导联系列的故障发生率。
所有加拿大 ICD 植入中心都被邀请提交所有 Optim 涂层 ICD 导联植入的随访信息。电气故障定义为阻抗或起搏捕获阈值的快速变化，导致导联修改，或因噪声导致的过感。外部导体定义为导体线出现在导联体外部。未进行系统性荧光透视筛查以发现外部导体。
截至 2012 年 12 月 1 日，25 个中心中的 15 个提供了 3981 个导联的数据（占同期在加拿大销售的导联的 44%）：3477 个 Durata 和 504 个 Riata ST Optim 导联。最常见的型号编号是 7122（1516 个导联[38%]）、7121（707 个导联[18%]）和 7120（622 个导联[16%]）。从植入到 2012 年 12 月 1 日的平均随访时间为 Riata ST Optim 导联 4.47±0.48 年，Durata 导联 2.00±1.10 年。Riata ST Optim 导联的年故障发生率为 0.27%，Durata 导联的年故障发生率为 0.24%。在故障导联中未发现外部导体的实例。没有因导联故障导致的死亡，但有 2 例患者因导联故障导致不适当的电击。
Riata ST Optim 和 Durata 导联的总体电气故障率似乎较低，且未观察到外部导体的实例。
