Department of Clinical Electrophysiology, Thorax Center, Erasmus Medical Center, Room Ba 591, Thorax Center, 's Gravendijkwal 230, 3015 CE, Rotterdam, the Netherlands.
Neth Heart J. 2013 Mar;21(3):127-34. doi: 10.1007/s12471-012-0341-3.
Safety concerns about the Riata ICD shock lead were recently raised, with insulation failure due to conductor externalisation. Its incidence and presentation were assessed, and predictors of insulation failure and lead survival of the Riata 1580-1582 were studied, retrospectively, before the official recall.
All 374 patients at the Erasmus Medical Center between July 2003 and December 2007 with a 1580, 1581 or 1582 shock lead.
The majority of the patients were male (78 %), with a median age of 60 years (IQR 52-70); primary prevention in 61 %. Median follow-up was 60.3 months (IQR 35.5-73.2), with 117 (31 %) patients dying. Electrical abnormalities (mainly noise, 65 %) were observed in 20/257 patients (7.8 %). Definite conductor externalisation was confirmed with fluoroscopy or chest X-ray in 16 patients, and in one after extraction. One patient presented with a drop in the high-voltage impedance trend with a short circuit of the ICD system during defibrillation testing, and needed to be shocked externally. In 8 more patients, conductor externalisation was found during an elective procedure. No predictors of externalisation could be found, except for the use of single coil (p = 0.02). Median time to conductor externalisation was 5 years (IQR 3.1-6.2). Lead externalisation was observed in 5.4 % (95 % CI 3.1-9.3) at 5 years and 22.7 % (95 % CI 13.6-36.6) at 8 years.
A high incidence of insulation defects associated with conductor externalisation in the Riata ICD lead family is observed. The mode of presentation is diverse. This type of insulation failure can lead to failure of therapy delivery.
最近，由于导体外露，Riata ICD 电击导联的安全性问题受到关注，其发生和表现得到了评估，并在正式召回之前回顾性地研究了 Riata 1580-1582 导联的绝缘故障和导联存活率的预测因素。
2003 年 7 月至 2007 年 12 月期间，在伊拉斯谟医疗中心的 374 例患者中，有 1580、1581 或 1582 电击导联。
大多数患者为男性（78%），中位年龄为 60 岁（IQR 52-70）；主要为一级预防（61%）。中位随访时间为 60.3 个月（IQR 35.5-73.2），117 例（31%）患者死亡。20/257 例（7.8%）患者观察到电异常（主要为噪声，65%）。16 例患者经透视或胸部 X 线证实存在明确的导体外露，1 例患者在取出后证实。1 例患者在除颤测试过程中，因 ICD 系统的高压阻抗趋势下降和短路，需要外部电击。在另外 8 例患者中，在择期手术中发现导体外露。除了使用单线圈（p=0.02）外，未发现导体外露的预测因素。导体外露的中位时间为 5 年（IQR 3.1-6.2）。5 年时，导联外露发生率为 5.4%（95%CI 3.1-9.3），8 年时为 22.7%（95%CI 13.6-36.6）。
观察到 Riata ICD 导联家族中存在与导体外露相关的绝缘缺陷发生率高。表现形式多种多样。这种类型的绝缘故障可导致治疗失败。
