Cardiac Electrophysiology Section, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, USA.
Heart Rhythm. 2012 Aug;9(8):1251-5. doi: 10.1016/j.hrthm.2012.04.003. Epub 2012 Apr 3.
In recent years, 2 popular implantable cardioverter-defibrillator (ICD) leads have undergone a class I recall by the Food and Drug Administration (FDA): the Sprint Fidelis and the Riata leads.
To examine the failure rates of these 2 leads with respect to their date of FDA recall.
All patients implanted with a Sprint Fidelis, Riata, or Sprint Quattro lead at our institution were included. Kaplan-Meier failure-free survival curves were constructed with and without censoring at the dates of announcement of the FDA recall for each lead.
A total of 2270 patients (623 Sprint Fidelis, 627 Riata, and 1020 Sprint Quattro) were included. The failure-free survival of the Sprint Quattro lead was significantly better than that of the Riata lead (P <.0001), which in turn was better than that of the Sprint Fidelis lead (P = .0214). After censoring events at the time of the FDA recall for each lead, the failure-free survival of the Sprint Quattro lead continued to be superior to that of the Riata (P <.0001) and Sprint Fidelis (P = .0124) leads but the difference between the Riata and Sprint Fidelis leads was eliminated (P = .123).
In this study, a comparative analysis of the failure-free survival of 2 recalled leads demonstrates discrepancies in the timing of the recall despite comparable failure-free survival patterns leading to the recall. The causes of these discrepancies are unclear and raise questions regarding the consistency of postmarketing surveillance and manufacturers' reporting of malfunctions of medical devices.
近年来，食品和药物管理局（FDA）对 2 种流行的植入式心脏复律除颤器（ICD）导线进行了 I 类召回：Sprint Fidelis 和 Riata 导线。
根据 FDA 召回日期，检查这 2 种导线的故障发生率。
本研究纳入了在我院植入 Sprint Fidelis、Riata 或 Sprint Quattro 导线的所有患者。对每条导线 FDA 召回日期进行删失，构建 Kaplan-Meier 无失败生存曲线。
共纳入 2270 例患者（623 例 Sprint Fidelis、627 例 Riata 和 1020 例 Sprint Quattro）。Sprint Quattro 导线的无失败生存显著优于 Riata 导线（P <.0001），而后者又优于 Sprint Fidelis 导线（P =.0214）。在每条导线 FDA 召回时对事件进行删失后，Sprint Quattro 导线的无失败生存仍优于 Riata（P <.0001）和 Sprint Fidelis（P =.0124）导线，但 Riata 和 Sprint Fidelis 导线之间的差异消失（P =.123）。
在这项研究中，对 2 种召回导线的无失败生存进行了比较分析，尽管召回的无失败生存模式相似，但召回的时间存在差异。这些差异的原因尚不清楚，这引发了对上市后监测和制造商报告医疗器械故障的一致性的质疑。
