Antonelli D, Rosenfeld T, Freedberg N A, Palma E, Gross J N, Furman S
Department of Cardiology, Central Emek Hospital, Afula, Israel.
Pacing Clin Electrophysiol. 1998 Feb;21(2):418-21. doi: 10.1111/j.1540-8159.1998.tb00066.x.
Lead insulation material and implant route have a major impact on lead reliability and durability. We compare the incidence of lead insulation failure resulting from both the venous approach and insulation type. Two hundred ninety consecutive leads were followed for a mean period of 57 +/- 30 months; leads with < 1 year follow-up were excluded. There were 116 Silicone Rubber insulated leads and 174 with polyurethane (151 Pellethane 80A and 23 Pellethane 55D) insulation; 279 leads were bipolar and 11 unipolar; 274 leads were implanted in the ventricle and 66 in the atrium. The venous route was the subclavian vein for 170 leads (58%) and the cephalic vein for 120 leads (42%). Insulation failure was diagnosed when a single sign of oversensing, undersensing, failure to capture, early pulse battery depletion, and lead impedance < 250 omega was present. Measurement of lead impedance was performed intraoperatively at implantation and during lead revision or pulse generator replacement. Lead failure caused by conductor coil fracture was not considered. There were 13 lead insulation failures, all among leads with polyurethane insulation (12 Pellethane 80A and 1 Pellethane 55D). Eleven failures (10%) occurred when the subclavian vein and 2 (3%) when the cephalic vein approach was used. The cumulative survival rate of polyurethane and silicone rubber insulated leads was 88.7% and 100%, respectively (P = 0.02); the cumulative survival rate of polyurethane insulated leads was 83.2% when the subclavian vein and 95.1% when the cephalic vein were used (P = 0.03). The mean time to polyurethane lead failure when the subclavian vein approach was used was 54 +/- 17 months and when the cephalic route was 73 +/- 4 months (P < 0.02). By multivariate analysis, the route of entry was found to be a significant variable related to polyurethane insulated lead failure (P < 0.05). At lead revision failure to capture was present in 7, oversensing in 4, and undersensing in 2 instances; impedance was < 250 omega in all cases. Pellethane 80A insulated leads are prone to insulation failure, but more when the subclavian vein is used, rather than the cephalic vein.
导线绝缘材料和植入途径对导线的可靠性和耐用性有重大影响。我们比较了经静脉途径和绝缘类型导致的导线绝缘故障发生率。对连续290根导线进行了平均57±30个月的随访；随访时间不足1年的导线被排除。有116根硅橡胶绝缘导线和174根聚氨酯（151根Pellethane 80A和23根Pellethane 55D）绝缘导线；279根导线为双极，11根为单极；274根导线植入心室，66根植入心房。静脉途径中，170根导线（58%）经锁骨下静脉植入，120根导线（42%）经头静脉植入。当出现过感知、感知不足、无法夺获、早期脉冲电池耗尽以及导线阻抗<250Ω的单一迹象时，诊断为绝缘故障。在植入时以及导线翻修或更换脉冲发生器期间术中测量导线阻抗。不考虑由导体线圈断裂导致的导线故障。共有13例导线绝缘故障，均发生在聚氨酯绝缘导线上（12根Pellethane 80A和1根Pellethane 55D）。使用锁骨下静脉时发生11例故障（10%），使用头静脉时发生2例故障（3%）。聚氨酯和硅橡胶绝缘导线的累积生存率分别为88.7%和100%（P = 0.02）；使用锁骨下静脉时聚氨酯绝缘导线的累积生存率为83.2%，使用头静脉时为95.1%（P = 0.03）。使用锁骨下静脉途径时聚氨酯导线发生故障的平均时间为54±17个月，使用头静脉途径时为73±4个月（P < 0.02）。多因素分析显示，植入途径是与聚氨酯绝缘导线故障相关的一个显著变量（P < 0.05）。在导线翻修时，7例出现无法夺获，4例出现过感知，2例出现感知不足；所有病例的阻抗均<250Ω。Pellethane 80A绝缘导线容易发生绝缘故障，但在使用锁骨下静脉而非头静脉时更易发生。
