Comparison of active and passive adhering leads for endocardial pacing

The frequency of lead failure requiring invasive correction in a total of 276 implants of four different transvenous leads (6907, continuous lead, IE-65-I, and MIP 2000) was observed during a one-and-one-half year period with a minimum of two months follow-up post-implant. Implants were on a successive sequential basis, randomly distributed between the two surgeons normally performing implants, and unselected for presumed ease or difficulty of the procedure. Failure rates with the 6907 and continuous leads were 7 of 76, or 9.2%; with the IE-65-I, 2 of 76, or 2.6%; and with the MIP 2000, 8 of 45, or 17.8%. The difference between the IE-65-I and the two conventional leads was significant at the 5% level, and between the IE-65-I and the group of the other three at the 1.6% level. The MIP 2000 was significantly different from the other three leads at the 2.7% level. Previous clinical experience with 849 implants with continuous and 6807 leads indicated that the overall data was similar to that obtained in the present evaluation. No significant differences in failure rates between surgeons and no measurable "practice effect" could be detected. It was concluded that the design of the lead is a major factor in the differing need for early secondary intervention.