Department of Medicine, Division of Cardiology, Electrophysiology Section, University of California, San Francisco, California, USA.
Heart Rhythm. 2012 Dec;9(12):1954-61. doi: 10.1016/j.hrthm.2012.08.006. Epub 2012 Aug 4.
A medical device advisory issued by St Jude Medical in November 2011 estimated 0.63% all-cause abrasion rate on their Riata and Riata ST silicone high-voltage lead families (Riata/ST), leading to Food and Drug Administration class I recall. We performed an independent comparative, long-term electrical survival analysis of Riata/ST and 3 other high-voltage lead families in a large national cohort of patients.
To evaluate long-term electrical survival of Riata/ST leads relative to other commonly evaluated high-voltage leads.
Failure rates of Riata/ST, Sprint Quattro Secure (Quattro), Sprint Fidelis (Fidelis), and Endotak Reliance G/SG (Endotak) leads from the Veterans Administration's National Cardiac Device Surveillance Center database, consisting of 24,145 patients with remote transmissions since 2003, were analyzed. Survival Probabilities were determined with Kaplan-Meier survival analysis and compared using the log-rank test.
Of 1,403 Riata/ST, 6,091 Quattro, 5,073 Fidelis, and 2,401 Endotak leads identified, 5-year survival probability of Riata/ST leads (97.5%) was significantly lower than that of Quattro (99.3%) and Endotak (99.4%) leads (P <.0001) but higher than that of Fidelis leads (89.6%) (P <.0001). Riata ST leads showed a 5-year survival of 95.5% (95% confidence interval 92.4-97.4) compared to 98.4% (95% confidence interval 97.1-99.1) in Riata leads (P = .003).
There is decreased survival probability of Riata/ST leads compared to other contemporary high-voltage leads, with decreased survival of Riata ST silicone compared to Riata lead series. Careful long-term follow-up should be maintained in patients with Riata/ST leads in order to prevent inappropriate shocks or failed device interventions. Our results were determined in advance of Food and Drug Administration class I recall, which suggested that large-scale remote monitoring may be an effective tool for continued implantable cardioverter-defibrillator system surveillance.
圣犹达医疗公司于 2011 年 11 月发布了一份医疗器械咨询报告，报告估计其 Riata 和 Riata ST 硅酮高压导联系列的总磨损率为 0.63%，这导致了食品和药物管理局的 I 类召回。我们对一个大型的全国患者队列中的 Riata/ST 导联和其他 3 种高压导联进行了独立的、长期的电生存分析。
评估 Riata/ST 导联与其他常用的高压导联的长期电生存情况。
我们分析了退伍军人事务部国家心脏设备监测中心数据库中 Riata/ST、Sprint Quattro Secure（Quattro）、Sprint Fidelis（Fidelis）和 Endotak Reliance G/SG（Endotak）导联的故障率。该数据库由 2003 年以来进行远程传输的 24145 例患者组成。采用 Kaplan-Meier 生存分析法确定生存率，并采用对数秩检验进行比较。
在 1403 例 Riata/ST、6091 例 Quattro、5073 例 Fidelis 和 2401 例 Endotak 导联中，5 年生存率为 97.5%的 Riata/ST 导联明显低于 99.3%的 Quattro 和 99.4%的 Endotak 导联（P<.0001），但高于 89.6%的 Fidelis 导联（P<.0001）。与 Riata 导联的 5 年生存率 98.4%（95%置信区间 97.1-99.1）相比，Riata ST 导联的 5 年生存率为 95.5%（95%置信区间 92.4-97.4）（P=.003）。
与其他当代高压导联相比，Riata/ST 导联的生存率较低，其中 Riata ST 硅酮导联的生存率较 Riata 导联系列更低。为了防止不适当的电击或设备故障干预，应密切对 Riata/ST 导联患者进行长期随访。我们的研究结果是在食品和药物管理局 I 类召回之前确定的，这表明大规模远程监测可能是一种有效的植入式心脏复律除颤器系统监测工具。
