Methodist University Hospital, and University of Tennessee Health Science Center, 1211 Union Ave., Suite 475, Memphis, TN 38104, USA.
J Cardiovasc Electrophysiol. 2010 May;21(5):551-6. doi: 10.1111/j.1540-8167.2009.01651.x. Epub 2009 Nov 17.
The purpose of this large multicenter study was to evaluate the long-term reliability of an implantable cardioverter defibrillator (ICD) lead to determine the incidence of adverse events (AEs).
A recent concern has been the performance of cardiac defibrillator leads. There have been conflicting reports regarding the rate of lead perforation and other AEs.
Medical records from patients implanted from 6-1-2001 to 11-27-2007 with the St. Jude Medical Riata family of RV leads at 23 US (N = 12,969) and 5 German (N = 2,418) centers were reviewed for chronic lead-related AEs. These included perforation, dislodgment, conductor fracture and insulation damage. The mean follow-up period was 18.0 months. AEs were defined as those that required Riata lead revision, extraction, or replacement.
The incidence of lead AEs was <1% for each AE type. Perforation occurred in 0.38%, dislodgement in 0.93%, conductor fracture in 0.18%, and insulation damage in 0.21% of patients studied.
During the follow-up of the 15,387 patients with Riata leads, the incidence of AEs which included perforation, dislodgement, conductor fraction and insulation damage was low and within the range of what is considered clinically acceptable.
本大规模多中心研究旨在评估植入式心脏复律除颤器（ICD）导线的长期可靠性，以确定不良事件（AE）的发生率。
最近人们对心脏除颤器导线的性能表示担忧。关于导线穿孔和其他不良事件的发生率，已有相互矛盾的报告。
对 2001 年 6 月 1 日至 2007 年 11 月 27 日期间在 23 个美国（N=12969）和 5 个德国（N=2418）中心植入圣犹达医疗 Riata 系列 RV 导联的患者的医疗记录进行了回顾，以评估慢性与导联相关的 AE。这些 AE 包括穿孔、脱位、导体断裂和绝缘损坏。平均随访期为 18.0 个月。AE 定义为需要 Riata 导联修正、提取或更换的 AE。
每种 AE 类型的发生率均<1%。穿孔发生率为 0.38%，脱位发生率为 0.93%，导体断裂发生率为 0.18%，绝缘损坏发生率为 0.21%。
在对 15387 例使用 Riata 导联的患者进行随访期间，穿孔、脱位、导体断裂和绝缘损坏等 AE 的发生率较低，处于可接受的临床范围之内。
