Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA.
Circ Arrhythm Electrophysiol. 2012 Aug 1;5(4):809-14. doi: 10.1161/CIRCEP.112.973081. Epub 2012 Jul 11.
The Food and Drug Administration recently issued a class I recall of the St. Jude Medical Riata implantable cardioverter-defibrillator lead presumably because of increased risk of electric failure and mechanical separation via inside-out abrasion. We sought to examine the incidence and time dependence of inside-out abrasion in asymptomatic patients implanted with the Riata lead.
Asymptomatic patients implanted with the Riata lead at our institution were offered voluntary fluoroscopic screening in 3 views. Electric testing of the Riata lead with provocative isometric muscle contraction was performed at the time of fluoroscopic screening. Of the 245 patients undergoing fluoroscopic screening, 53 (21.6%) patients showed clear evidence of lead separation. Of these externalized leads, 0%, 13%, and 26% had a dwell time of <3 years, 3 to 5 years, and >5 years, respectively (P=0.037). Externalized leads had a significantly pronounced decrease in R-wave amplitude (-1.7±2.9 mV versus +0.35±2.5 mV; P<0.001), and more patients with externalized leads had ≥25% decrease in R-wave amplitude from baseline (28.0% versus 8.1%; P=0.018). One patient with externalization exhibited new noise on near-field electrogram.
The Riata lead exhibits time-dependent high rates of cable externalization exceeding 20% at >5 years of dwell time. Externalized leads are associated with a more pronounced decrease in R-wave amplitude, which may be an early marker of future electric failure. The use of fluoroscopic and electric screening of asymptomatic patients with the Riata lead remains controversial in the management of patients affected by the recent Food and Drug Administration recall.
美国食品和药物管理局最近发布了一级召回圣犹达医疗 Riata 植入式心脏复律除颤器导线，可能是由于内部到外部磨损导致电气故障和机械分离的风险增加。我们试图研究无症状患者植入 Riata 导联后的内部到外部磨损的发生率和时间依赖性。
我们机构中植入 Riata 导联的无症状患者被提供自愿性荧光透视筛查 3 个视角。在荧光透视筛查时，对 Riata 导联进行电测试，用刺激性等长肌肉收缩。在接受荧光透视筛查的 245 名患者中，53 名（21.6%）患者显示出明确的导联分离证据。在这些暴露的导联中，分别有 0%、13%和 26%的留置时间<3 年、3-5 年和>5 年（P=0.037）。暴露的导联的 R 波振幅明显下降（-1.7±2.9 mV 与+0.35±2.5 mV；P<0.001），更多的暴露导联患者的 R 波振幅较基线下降≥25%（28.0%与 8.1%；P=0.018）。一名暴露患者的近场心电图出现新的噪声。
Riata 导联在>5 年的留置时间内表现出电缆暴露的时间依赖性高发生率，超过 20%。暴露的导联与 R 波振幅的更明显下降相关，这可能是未来电气故障的早期标志物。在管理受美国食品和药物管理局最近召回影响的患者时，对无症状患者使用 Riata 导联进行荧光透视和电筛查的使用仍然存在争议。
