Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
J Korean Med Sci. 2017 Oct;32(10):1610-1615. doi: 10.3346/jkms.2017.32.10.1610.
Riata defibrillator leads were recalled due to a high failure rate. This study measured the incidence of externalized conductor (EC) and electrical dysfunction (ED) and sought to determine the predictors of ED with Riata defibrillator leads. We enrolled patients who received Riata® or Riata® ST silicone defibrillator leads at our center between January 2003 and December 2010. The presence of EC was evaluated with chest radiography. The incidence rates were measured at < 3 years, 3-5 years, and > 5 years after lead implantation. We also investigated the rates of ED and other clinical events during the follow-up period. A total of 44 patients were analyzed. The total cumulative incidence of EC was 27.3%. During the median dwell time (80 months), the incidence of ED was 22.7%. Patients with ED were younger (46.5 vs. 56.5 years, P = 0.018) and had a higher prevalence of cardiomyopathy than those without ED (60.0% vs. 20.6%, P = 0.043). ECs were most frequently detected in patients who underwent X-ray analysis 3-5 years after lead implantation (44.4%). In contrast, ED had a bimodal incidence pattern, with peaks at 5 years (7.0%) and 9 years (5.3%). There was no difference in ED-free survival rate between patients with and without EC (P = 0.628). Given the delayed occurrence of EC and ED after implantation of Riata defibrillator leads, long-term close monitoring is critically important.
由于高故障率，Riata 除颤器导线被召回。本研究测量了外部化导体 (EC) 和电功能障碍 (ED) 的发生率，并试图确定 Riata 除颤器导线 ED 的预测因素。我们招募了 2003 年 1 月至 2010 年 12 月期间在我们中心接受 Riata®或 Riata®ST 硅酮除颤器导线的患者。通过胸部 X 射线评估 EC 的存在。在植入导线后<3 年、3-5 年和>5 年测量发生率。我们还调查了随访期间 ED 和其他临床事件的发生率。共分析了 44 例患者。EC 的总累积发生率为 27.3%。在中位随访时间（80 个月）期间，ED 的发生率为 22.7%。ED 患者比无 ED 患者年轻（46.5 岁 vs. 56.5 岁，P = 0.018），且心肌病患病率更高（60.0% vs. 20.6%，P = 0.043）。在植入导线后 3-5 年进行 X 射线分析的患者中，EC 最常被检测到（44.4%）。相比之下，ED 的发生率呈双峰模式，峰值出现在 5 年（7.0%）和 9 年（5.3%）。有无 EC 的患者 ED 无事件生存率无差异（P = 0.628）。鉴于 Riata 除颤器导线植入后 EC 和 ED 的发生延迟，长期密切监测至关重要。
