Insulation lead failure: is it a matter of insulation coating, venous approach, or both?

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.