Hayes D L, Holmes D R, Merideth J, Osborn M J, Vlietstra R E, Neubauer S A
Pacing Clin Electrophysiol. 1985 Mar;8(2):192-6. doi: 10.1111/j.1540-8159.1985.tb05750.x.
With the advent of polyurethane as an insulating material for permanent pacemaker leads, concern has arisen over the integrity and long-term durability of polyurethane-insulated pacing leads. Specific concern has arisen over particular bipolar tined polyurethane ventricular leads. We have assessed our 4-year experience with this lead. This experience involves two groups of patients, those with leads manufactured before a certain date and those with leads manufactured at a later date. In the first group (judged to be at increased risk) the failure rate was 8.8%, and in the second group (judged not to be at increased risk) the rate was 3.9%. Lead failure occurred at an average of 17.5 months in the first group. Adequate follow-up on the second group is not available to determine whether or not the failure rate may eventually be as high as that in the early group. Actuarial analysis suggests that survivorship free of lead failure is probably not significantly different in the two groups. This experience points out the need for determining lead failure rates, identifying optimal lead design and configuration, and establishing a lead registry or mechanism by which the integrity of various pacing leads can be evaluated.
随着聚氨酯作为永久起搏器导线绝缘材料的出现，人们对聚氨酯绝缘起搏导线的完整性和长期耐用性产生了担忧。对于特定的双极带倒刺聚氨酯心室导线，人们尤其担忧。我们评估了使用这种导线4年的经验。这段经验涉及两组患者，一组是在某一日期之前制造导线的患者，另一组是在该日期之后制造导线的患者。在第一组（被判定风险增加）中，故障率为8.8%，在第二组（被判定风险未增加）中，故障率为3.9%。第一组中导线故障平均发生在17.5个月时。第二组没有足够的随访数据来确定其故障率最终是否会与早期组一样高。精算分析表明，两组中无导线故障的生存率可能没有显著差异。这段经验指出了确定导线故障率、识别最佳导线设计和配置以及建立一个导线登记处或机制的必要性，通过该机制可以评估各种起搏导线的完整性。
