Helguera M E, Maloney J D, Pinski S L, Woscoboinik J R, Wilkoff B L, Castle L W
Department of Cardiology, Cleveland Clinic Foundation, Ohio.
Pacing Clin Electrophysiol. 1994 Jan;17(1):56-64. doi: 10.1111/j.1540-8159.1994.tb01351.x.
To assess the performance of endocardial pacemaker leads and to identify factors associated with structural lead failure, medical records of 2,611 endocardial pacing leads (in 1,518 patients) implanted between 1980 and 1991, having at least 1 month of follow-up, were reviewed. Leads without structural failure had normal function at the last follow-up date, or were discontinued for reasons other than structural failure (patient death, infection, dislodgment, lead-pacemaker incompatibility, operative complication, or abandonment by telemetry not related to failure). Leads with suspected structural failures were invasively or noninvasively disconnected because of clinical malfunction (loss of capture or sensing, oversensing, elevated thresholds, or skeletal muscular stimulation). Leads with verified structural failures met the criteria for suspected lead failure and also had a visible defect seen in the operating room or on chest roentgenograms, a change in the impedance interpreted by the physician as lead disruption, or a manufacturer's return product report that confirmed structural failure. Variables analyzed included patients' age and gender, paced chamber, venous access, insulation materials, fixation mechanism, coaxial design, polarity, and different lead models. The cumulative lead survival at 5 and 10 years were 97.4% and 92.9%, respectively, for suspected failures; and 98.7% and 97.3%, respectively, for verified failures. Leads in older patients (> or = 65 years old), and leads in atrial position had fewer verified failures (P = 0.014 and P = 0.007, respectively). Unipolar leads also tended to perform better according to the verified definition (P = 0.07).(ABSTRACT TRUNCATED AT 250 WORDS)
为评估心内膜起搏器导线的性能并确定与导线结构故障相关的因素，我们回顾了1980年至1991年间植入的2611根心内膜起搏导线（涉及1518例患者）的病历，这些导线至少有1个月的随访期。无结构故障的导线在最后随访日期功能正常，或因结构故障以外的原因（患者死亡、感染、脱位、导线与起搏器不兼容、手术并发症或与故障无关的遥测放弃）而停用。因临床故障（捕获或感知丧失、过感知、阈值升高或骨骼肌刺激）而怀疑有结构故障的导线通过侵入性或非侵入性方式断开连接。经证实有结构故障的导线符合疑似导线故障的标准，并且在手术室或胸部X线片上可见明显缺陷，医生将阻抗变化解释为导线中断，或制造商的退货产品报告证实有结构故障。分析的变量包括患者的年龄和性别、起搏腔室、静脉通路、绝缘材料、固定机制、同轴设计、极性和不同的导线型号。疑似故障导线在5年和10年时的累积导线生存率分别为97.4%和92.9%；经证实故障的导线分别为98.7%和97.3%。老年患者（≥65岁）的导线和心房位置的导线经证实的故障较少（分别为P = 0.014和P = 0.007）。根据经证实的定义，单极导线的性能也往往更好（P = 0.07）。（摘要截断于250字）
