Hayes D L, Graham K J, Irwin M, Vidaillet H, Disler G, Sweesy M, Kincaid D, Osborn M J, Suman V J, Neubauer S A
Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN 55905, USA.
Pacing Clin Electrophysiol. 1995 May;18(5 Pt 1):999-1004. doi: 10.1111/j.1540-8159.1995.tb04740.x.
A multicenter study was undertaken to determine the failure rate of a specific bipolar tined polyurethane ventricular pacing lead, the Medtronic 4004/4004M pacing lead. Seven centers in the United States and Canada implanted 586 Medtronic 4004/4004M pacing leads. The study was designed to determine the probability and clinical manifestations of lead failure. Only failures compatible with an insulation problem were included. The Kaplan-Meier estimate of the percentage of 4004/4004M lead failures within 4 years after implantation was 14.1% (95% confidence interval: 8.5%-19.3%). Failures were manifested as sensing abnormalities, failure to capture, early battery depletion, and significant decrease in measured impedance compared with previous impedance measurements. The observed rate of failure is unacceptable, and strong consideration should be given to replacing the 4004/4004M pacing lead in pacemaker dependent patients and closely monitoring nondependent patients.
开展了一项多中心研究，以确定特定的双极带尖聚氨酯心室起搏导线（美敦力4004/4004M起搏导线）的故障率。美国和加拿大的七个中心植入了586根美敦力4004/4004M起搏导线。该研究旨在确定导线故障的概率和临床表现。仅纳入与绝缘问题相符的故障。植入后4年内4004/4004M导线故障百分比的Kaplan-Meier估计值为14.1%（95%置信区间：8.5%-19.3%）。故障表现为感知异常、夺获失败、电池过早耗尽以及与先前阻抗测量相比测量阻抗显著降低。观察到的故障率是不可接受的，对于依赖起搏器的患者，应强烈考虑更换4004/4004M起搏导线，并密切监测非依赖起搏器的患者。
