Khattak Furqan, Gupta Aman, Alluri Krishna, Shariff Nasir, Saba Samir
Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Franciscan Heart & Vascular Associates Gig Harbor, WA, 98332, USA.
Indian Pacing Electrophysiol J. 2019 May-Jun;19(3):100-103. doi: 10.1016/j.ipej.2018.12.001. Epub 2018 Dec 18.
Implantable cardioverter defibrillator (ICD) leads are considered as the 'weakest link' in defibrillator systems due to FDA recalls and advisories involving popular lead models from major manufacturers. The rate of electrical failure of ICD leads not implicated in a recall is however not well determined.
Medical records of patients implanted with ICDs at hospitals of the University of Pittsburgh Medical Center between 2002 and 2014 were analyzed. Leads were classified as having electrically failed if removed or replaced for reasons other than infection or heart transplantation. Patients were followed to endpoint of death or electrical lead failure.
2410 consecutive ICD recipients (mean age 66 ± 13 years, women 22%, single/dual/biventricular-ICD 20%/44%/36%) were included. During a mean follow-up of 3.9 ± 3.3 years, 1272 patients (53%) died, 55 patients (2.3%) had ICD lead electrical failure, and 1052 (44%) patients were alive with functional leads at the time of last follow-up. Patients with failed leads had higher BMI (p = 0.07), better functional status (p = 0.04), higher serum creatinine (p = 0.004), wider QRS complex (p = 0.01), higher number of implanted leads (p = 0.06) and were more likely to have ischemic cardiomyopathy (p = 0.03). After adjusting for these variables in a binary logistic regression model, only a lower BMI, presence of non-ischemic cardiomyopathy, and a better functional status remained independently predictive of electrical failure.
Only 2.3% of non-recalled ICD leads experience electrical failure (annual failure rate of 0.6%). A higher patient functional status, lower BMI, and non-ischemic etiology of cardiomyopathy are independently associated with higher rates of ICD lead failure.
由于美国食品药品监督管理局（FDA）对主要制造商的主流导联型号进行召回并发布相关建议，植入式心脏复律除颤器（ICD）导联被视为除颤器系统中的“最薄弱环节”。然而，未被召回的ICD导联的电气故障发生率尚未得到很好的确定。
分析了2002年至2014年期间在匹兹堡大学医学中心医院植入ICD的患者的病历。如果导联因感染或心脏移植以外的原因被移除或更换，则被归类为发生了电气故障。对患者进行随访直至死亡或导联电气故障的终点。
纳入了2410例连续的ICD接受者（平均年龄66±13岁，女性占22%，单腔/双腔/双心室ICD分别占20%/44%/36%）。在平均3.9±3.3年的随访期间，1272例患者（53%）死亡，55例患者（2.3%）发生ICD导联电气故障，1052例（44%）患者在最后一次随访时仍存活且导联功能正常。导联发生故障的患者体重指数较高（p=0.07），功能状态较好（p=0.04），血清肌酐水平较高（p=0.004），QRS波群较宽（p=0.01），植入导联数量较多（p=0.06），且更有可能患有缺血性心肌病（p=0.03）。在二元逻辑回归模型中对这些变量进行调整后，只有较低的体重指数、非缺血性心肌病的存在以及较好的功能状态仍然是电气故障的独立预测因素。
只有2.3%的未被召回的ICD导联发生电气故障（年故障率为0.6%）。较高的患者功能状态、较低的体重指数以及心肌病的非缺血性病因与ICD导联较高的故障率独立相关。
