Radioisotopic Pacemaker: Long‐Term Clinical Results

In order to prolong the service life of the generator, the isotopic pacemakers, powered by Pu238, have been developed and implanted since 1970. We report the follow-up of 325 patients (mean age 39 +/- 18 years) implanted with an isotopic pulse generator (Medtronic 9000/9090) between April 1970 and July 1982. The mean follow-up was 12 years (range 6 days to 18.5 years). The generator was highly reliable; the mean value of pacing rate between implantation and last follow-up decreased significantly but no more than 1 beat/min (72.7 vs 71.8 beats/min; P < 0.001) and the pulse width did not change significantly. The actuarial survival of the device was 97% at 18.5 years. During the follow-up period, 122 reoperations were performed in 85 patients: 88 explanations of the entire pacing system and 34 modifications of the lead system. Lead dysfunction accounted for 68% of the 122 reoperations, generator failure for 6%, and miscellaneous reasons for 26%. However, 72% of patients remain free of intervention during the follow-up period and 61 patients (20%) died during this period. Most deaths (52%) were of nonsudden cardiovascular origin, 17% were related to cancer, and 13% to sudden death. After 5, 10, and 18.5 years, 94%, 89%, and 73% of the patients were alive, respectively. No side effect could be attributed to the radioisotope. We conclude that this isotopic pacemaker demonstrated its reliability for long-term cardiac pacing.