目的:最近对有机硅-聚氨酯共聚物(Optim™)引线绝缘系统的可靠性提出了严重的担忧。我们试图通过前瞻性定义的植入式心律转复除颤器(ICD)患者队列中的系统透视和电评估来识别绝缘缺陷和Optim导线故障。
结果:在2007年7月至2011年12月期间,234名患者在一个中心植入了413根optim涂层导线,作为ICD系统的一部分。向所有患者提供了以每秒30帧的高分辨率电影透视检查的透视筛查。此外,评估了所有植入导线的电完整性.杜拉塔,RiataSTOptim,在199、26和188例中植入了低压Optim导线,分别。在10036个前导月的总随访中,有7例Optim-导线故障(定义为导致更换导线的电气故障)和31例死亡;没有遇到电气噪音的情况。导线失效的总发生率为1.2vs.每100个铅年0.3个,对于高低压引线,分别(P=0.1)。一百五十一名患者同意接受透视检查;在植入后平均31个月后,没有发现264个分析的Optim导线具有任何透视可见的结构缺陷。
结论:本研究是首次在未经选择的大型ICD患者队列中对Optim涂层导线进行系统筛查。在5年的时间内,几乎没有观察到导线故障,并且所有患者的透视外观均正常。
OBJECTIVE: Serious concerns have been recently raised about the reliability of the silicone-polyurethane copolymer (Optim™) lead insulation system. We sought to identify insulation defects and Optim-lead failures by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of implantable cardioverter-defibrillator (ICD) patients.
RESULTS: Between July 2007 and December 2011, 234 patients were implanted with 413 optim-coated leads as part of an ICD system at a single centre. Fluoroscopic screening with high-resolution cine-fluoroscopy at 30 frames per second was offered to all patients. In addition, the electrical integrity of all implanted leads was assessed. Durata, Riata ST Optim, and low-voltage Optim leads were implanted in 199, 26, and 188 cases, respectively. During a total follow-up of 10 036 lead-months, there were 7 Optim-lead failures (defined as electrical malfunction resulting in lead replacement) and 31 deaths; no cases of electrical noises were encountered. The overall incidence of lead failure was 1.2 vs. 0.3 per 100 lead-years, for high- and low-voltage leads, respectively (P = 0.1). One hundred fifty-one patients agreed to undergo fluoroscopy screening; none of the 264 analysed Optim leads were found to have any fluoroscopically visible structural defects after an average of 31 months post-implant.
CONCLUSIONS: This study represents the first systematic screening of Optim-coated leads in a large unselected cohort of ICD patients. Over a 5-year period few lead failures were observed and normal fluoroscopic appearance was present in all patients.