Department of Cardiology and Center for Cardiovascular Research, Aalborg University Hospital, Aalborg, Denmark.
Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.
Heart Rhythm. 2014 Dec;11(12):2141-7. doi: 10.1016/j.hrthm.2014.07.003. Epub 2014 Jul 4.
Recalled St. Jude Medical Riata defibrillator leads are prone to insulation failures with externalized conductors (ECs). Longitudinal studies are needed to guide lead management.
The purpose of this study was to describe the dynamic nature of EC and the association with electrical abnormalities and lead extraction outcomes.
A nationwide cohort established in 2012 of 295 patients with recalled Riata leads with dwell time 5.1 ± 1.1 years, 34 ECs, and 19 electrical abnormalities were followed until death, lead discontinuation with fluoroscopy, or a new 2013 screening with fluoroscopy and device interrogation.
Fluoroscopic follow-up of 239 patients with normal baseline fluoroscopy revealed incident overt EC in 8 leads and borderline EC in 2 leads after 1.1 ± 0.2 years, with an incidence rate of 3.7 per 100 person-years (95% confidence interval 2.0-6.9). Fluoroscopic follow-up in 27 patients with baseline EC showed an increase in EC length of 4 ± 1 mm (P <.001) after 1.1 ± 0.3 years. Electrical follow-up in 276 patients with normal baseline electrical function demonstrated 20 incident electrical abnormalities after 1.0 ± 0.3 years, with an incidence rate of 7.1 per 100 person-years (95% confidence interval 4.6-11.0). This rate was significantly higher in leads with baseline EC, with an adjusted incidence rate ratio of 4.4 (95% confidence interval 1.7-11.5, P = .002). In 15 extractions, all leads were removed, with 2 major complications.
The development of EC is a dynamic process despite long lead dwell time. ECs are associated with a higher risk of electrical abnormalities. Therefore, lead replacement should be considered, especially in patients with a long life expectancy.
已召回的圣犹达 Riata 除颤器导联易发生带有外部导体（EC）的绝缘故障。需要进行纵向研究来指导导联管理。
本研究旨在描述 EC 的动态性质及其与电异常和导联拔除结果的关联。
2012 年建立了一个全国性队列，纳入 295 例 Riata 召回导联患者，留置时间为 5.1±1.1 年，有 34 个 EC，19 个电异常，随访至死亡、通过荧光透视法停止使用导联或在 2013 年进行新的荧光透视法和设备检查筛查。
239 例基线荧光透视法正常的患者进行荧光透视法随访，1.1±0.2 年后 8 个导联出现明显的 EC，2 个导联出现边界性 EC，发病率为 3.7/100 人年（95%置信区间 2.0-6.9）。27 例基线有 EC 的患者进行荧光透视法随访，1.1±0.3 年后 EC 长度增加 4±1mm（P<.001）。276 例基线电功能正常的患者进行电随访，1.0±0.3 年后发生 20 例电异常，发病率为 7.1/100 人年（95%置信区间 4.6-11.0）。在基线有 EC 的导联中，发病率明显更高，校正发病率比为 4.4（95%置信区间 1.7-11.5，P=.002）。在 15 次拔除中，所有导联均被拔除，发生 2 例重大并发症。
尽管留置时间较长，但 EC 的发展是一个动态过程。EC 与电异常的风险增加有关。因此，应考虑更换导联，尤其是在预期寿命较长的患者中。
