Twelve Years of Clinical Experience with Lithium Pulse Generators

The clinical performance of 9,651 lithium pulse generators, which were implanted at our registry hospitals since 1973, was assessed by analysis of actuarial survival data and information obtained at the time of pacemaker failure. Cumulative survival estimates for all units were: 5 years, 94 percent, 7 years, 81 percent, 10 years, 62 percent. Discriminant actuarial analysis revealed no differences between lithium iodine and lithium cupric sulfide longevity. Battery depletion was found in 49.1 percent of 277 units subjected to detailed explant analysis, while 31 percent and 8.7 percent had component and hermetic seal defects, respectively. Of the pulse generators with battery depletion, ail but two units exhibited normal end-of-battery life behavior. We conclude that the lithium iodine and lithium cupric sulfide batteries are safe, long-term energy sources; however, the impact of reduced battery size and dual chamber pacing on these performance parameters is unknown.