insulation breach

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  • 文章类型: Journal Article
    最近,据报道,植入式心脏复律除颤器中的极性依赖性电击失败是由高压馈通的结构故障引起的。当右心室线圈在双相电击(阴极电击)的1阶段处于阴极状态时,可能会发生短路。这种观点提出了一种观察到的极性依赖性的机制,并考虑了相同的机制是否可能适用于其他冲击引起的,短路。植入式心律转复除颤器与导线的连接穿过馈通进入密封外壳(“Can”)。馈通包括2个同心,导电金属圆筒,右心室线圈和外部Can的内部引脚导体,由不透水的绝缘隔开。冲击失效取决于3个条件:1)馈通中流体层的发展,创建与冲击路径平行的传导路径;2)流体中电场的径向梯度,因此,冲击过程中的电阻加热使水蒸发,在引脚周围形成高电阻气泡;3)阴极处电子的场发射,速率和能量取决于场的强度和阴极的势能势垒发射。对于阴极冲击,在金属引脚处发射的电子可能会在气体中引发电离雪崩,直到它“分解”为低电阻等离子体,导致短路。对于阳极电击,有效的阴极是液-气界面,其中磁场比引脚处弱。此外,水溶液中的溶剂化电子必须克服更高的势能势垒才能发射。这允许高阻力气泡稳定,从而完成冲击。
    Recently, polarity-dependent shock failures were reported in implantable cardioverter-defibrillators caused by structural failure in the high-voltage feedthrough. Short circuits may occur when the right ventricular coil is cathodal for phase 1 of biphasic shocks (cathodal shock). This viewpoint proposes a mechanism for observed polarity dependence and considers whether the same mechanism may apply in other shock-induced, short circuits. Implantable cardioverter-defibrillator connections to the lead traverse feedthroughs into the hermetically sealed housing (\"Can\"). The feedthrough comprises 2 concentric, conducting metal cylinders, the inner pin-conductor to the right ventricular coil and outer Can, separated by impermeable insulation. Shock failure depends on 3 conditions: 1) development of a fluid layer in the feedthrough, creating a conduction path in parallel with the shock pathway; 2) the radial gradient of the electric field in the fluid, so resistive heating during a shock vaporizes water to form a high-resistance gas bubble around the pin; and 3) field emission of electrons at the cathode, with rate and energy dependent on the field\'s strength and the cathode\'s potential-energy barrier to emission. For cathodal shocks, electrons emitted at the metal pin may initiate an ionization avalanche in the gas until it \"breaks down\" into a low-resistance plasma, resulting in a short circuit. For anodal shocks, the effective cathode is the liquid-gas interface, where the field is weaker than at the pin. Additionally, solvated electrons in aqueous solution must overcome a higher potential-energy barrier to be emitted. This permits the high-resistance gas bubble to stabilize so that the shock is completed.
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  • 文章类型: Journal Article
    BACKGROUND: Recent reports describe a high rate of premature lead failure in the St Jude/Abbott TendrilTM 2088 (St. Jude Medical Inc., St. Paul, MN, USA) pacing lead principally manifested by electrical noise. This finding awaits confirmation.
    METHODS: We performed a retrospective analysis of 2088 TendrilTM leads among 362 patients implanted from 2010 to 2018. Eligible leads were those with device interrogations beyond one month from lead implantation. Review of serial device interrogations was conducted for each lead, particularly focussing on electrical noise as a marker of premature lead dysfunction.
    RESULTS: Four hundred and eight (408) leads among 337 patients were included in this study, with an average patient age of 81±11 years at the time of lead implantation. Mean follow-up was 2.5±1.8 years. There were eight leads with electrical noise indicating premature lead failure. This reflects an overall 1.7% rate of lead dysfunction; the failure rate was 6.2% at 4 years. The majority of cases were detected during routine checks without adverse clinical consequences. Four (4) cases required device reprogramming to avoid interference or inhibition due to noise.
    CONCLUSIONS: The rate of Tendril TM 2088 premature lead failure appears to be similar to recent local and international studies. This study reports a significantly higher rate of lead dysfunction at 4 years (6.2%) than the published Abbott product performance reports.
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  • 文章类型: Comparative Study
    Noise oversensing encountered in patients with Abbott Tendril leads in our hospital triggered an internal investigation.
    We retrospectively analyzed patients with a Tendril lead model 1688, 1788, 1888, and 2088. Most leads were connected to Abbott generators. To exclude a primary generator issue as the cause of noise oversensing, we enrolled a cohort of patients in whom Medtronic CapSureFix leads model 4076 and 5076 were prospectively connected to similar Abbott generators.
    A total of 1063 Tendril leads were implanted in 869 patients. Noise was encountered in 66 leads (6.2%) during a follow-up of 3.9 years. Most affected leads had normal impedance and only a few of these patients were symptomatic. Reprogramming was attempted in 44 of 66 (67%), and reduced oversensing in 34 of 44 (77%) of these patients. Seventeen malfunctioning leads (1.5%) were replaced, including 16 of 66 (24%) of those with noise. Of the four leads with noise extracted and returned to the manufacturer, lead to device abrasion was identified in two and inner insulation breach in one. None of the 145 Medtronic CapSureFix leads connected to Abbott generators had noise during a follow-up of 3.6 years.
    Noise oversensing was relatively common in Tendril leads, but was not detected in Medtronic leads despite connecting to Abbott generators. Although the majority of the affected leads did not show abnormal impedance, outer or inner insulation breach was identified in three of the four returned leads. As patients with affected leads are generally asymptomatic, most of them can be managed conservatively.
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  • 文章类型: Journal Article
    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.
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