QEII Health Sciences Centre, Halifax, Nova Scotia, Canada.
Heart Rhythm. 2013 May;10(5):692-5. doi: 10.1016/j.hrthm.2013.01.018. Epub 2013 Jan 17.
A unique form of lead failure has been described in the Riata (8-F) and Riata ST (7-F) silicone defibrillation lead degradation of the outer insulation, resulting in the externalization of conductor cables.
To assess rates of lead revision due to lead failure in Riata leads affected by the Riata advisory.
Nineteen implantable cardioverter-defibrillator implant and follow-up centers were surveyed.
As of March 1, 2012, there were 5043 known affected leads implanted in Canada. Data on 4358 (86.4%) leads were obtained; 65.3% of these were Riata (8-F) and 32.4% were Riata ST (7-F) leads. The median time from implant to last follow-up was 5 years. Electrical abnormalities were reported in 4.6% of the affected leads; 8.0% of these were found to have concomitant radiographic evidence of externalization. The rate of electrical failure was higher in the 8-F (5.2%) vs 7-F (3.3%) leads (P = .007). Oversensing with or without inappropriate shocks was reported in 39.8% of the leads with confirmed failure. Abnormally high or low impedance values (29.9%) and elevated pacing capture thresholds (43.8%) were frequently reported. One death (0.5%) attributed to lead failure was reported. Among the leads that were replaced, 21% were extracted. Two major complications (1.0%) were attributed to extraction of these leads.
The overall rate of lead failure in the Riata (8-F) and Riata ST (7-F) leads is higher than previously reported by using passive surveillance data. The impact of recent advisories related to these leads is not yet apparent.
在 Riata（8-F）和 Riata ST（7-F）硅胶除颤导联的外层绝缘退化中，已经描述了一种独特的导联失效形式，导致导体电缆外露。
评估受 Riata 咨询影响的 Riata 导联因导联故障导致的导联修正率。
对 19 个植入式心脏复律除颤器植入和随访中心进行了调查。
截至 2012 年 3 月 1 日，加拿大共植入了 5043 根已知受影响的导联。获得了 4358 根（86.4%）导联的数据；其中 65.3%为 Riata（8-F）导联，32.4%为 Riata ST（7-F）导联。从植入到最后一次随访的中位时间为 5 年。受影响导联中报告了 4.6%的电气异常；其中 8.0%的导联发现有外部化的相应放射学证据。8-F（5.2%）导联的电气故障发生率高于 7-F（3.3%）导联（P=0.007）。在确认故障的导联中，39.8%报告有感知异常伴或不伴不适当电击。异常高或低的阻抗值（29.9%）和升高的起搏捕获阈值（43.8%）经常被报告。报告了 1 例（0.5%）归因于导联故障的死亡。在更换的导联中，21%是被取出的。这两条导联的取出导致了 2 例主要并发症（1.0%）。
使用被动监测数据，Riata（8-F）和 Riata ST（7-F）导联的总故障发生率高于之前的报告。最近与这些导联相关的咨询的影响尚不清楚。
