Furman S, Benedek Z M
Department of Cardiothoracic Surgery, Montefiore Medical Center, Bronx, New York 10467.
Pacing Clin Electrophysiol. 1990 Dec;13(12 Pt 2):1910-4. doi: 10.1111/j.1540-8159.1990.tb06915.x.
Early polyurethane leads were reported to have a high incidence of materials failure. In 1979 a six-center registry was begun. By October 31, 1989, 7,311 leads had been registered and lead longevity was calculated by individual manufacturer, cumulatively for all manufacturers and for individual leads. Each lead was registered at implant and at removal from service as having been removed for materials failure or for unrelated reasons. Calculations were made for 23 models and for a total of three manufacturers with more than 100 leads implanted. Four thousand seven hundred and sixty three leads (65.1%) were from Medtronic; 2,177 (29.8%) from Cordis; 297 (4.1%) from Intermedics; and 77 (1.0%) were from all others. The 10-year cumulative survival of Medtronic leads was 96.6 +/- 0.4%; for Cordis leads it was 99.9 +/- 0.1% and for Intermediates leads 97.7 +/- 0.9%. Three lead models registered over 100 units and had poorer survival at 5 years than the remainder of all manufacturers' experience. They were #6972 (n = 107) with 78.6 +/- 4.5%; #6991U (n = 294) with 90.6 +/- 1.9%; and #4012 (n = 288) with 97.3 +/- 1.5%. Other possibly failed models did not achieve statistical significance. It can be anticipated that a lead which survives to the seventh year will have prolonged longevity as thereafter additional failures are uncommon.
早期的聚氨酯导线据报道材料故障率很高。1979年启动了一个六中心注册项目。到1989年10月31日，已注册7311根导线，并按单个制造商、所有制造商累计以及单个导线计算导线使用寿命。每根导线在植入时和因材料故障或无关原因退出服务时进行注册。对23种型号以及总共三家植入导线超过100根的制造商进行了计算。4763根导线（65.1%）来自美敦力公司；2177根（29.8%）来自科迪斯公司；297根（4.1%）来自英特美迪克公司；77根（1.0%）来自其他所有公司。美敦力导线的10年累积生存率为96.6±0.4%；科迪斯导线为99.9±0.1%，英特美迪克导线为97.7±0.9%。有三种导线型号注册数量超过100台，其5年生存率低于所有制造商的其余产品经验。它们分别是#6972（n = 107），生存率为78.6±4.5%；#6991U（n = 294），生存率为90.6±1.9%；以及#4012（n = 288），生存率为97.3±1.5%。其他可能出现故障的型号未达到统计学显著性。可以预期，存活到第七年的导线将具有更长的使用寿命，因为此后额外的故障并不常见。
