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Radioisotopic pacemaker: long-term clinical results
C Chauvel1, T Lavergne, A Cohen
1Cardiology Department, Saint-Antoine University Hospital, Paris, France.
Pacing and Clinical Electrophysiology : PACE
|February 1, 1995
Summary
Isotopic pacemakers powered by Pu238 demonstrated high reliability for long-term cardiac pacing. These generators showed excellent device survival and minimal pacing parameter changes over 18.5 years.
Area of Science:
- Cardiology
- Biomedical Engineering
- Nuclear Medicine
Background:
- Isotopic pacemakers utilizing Plutonium-238 (Pu238) were developed to extend generator service life.
- These devices were implanted in patients starting in 1970.
Purpose of the Study:
- To evaluate the long-term reliability and performance of isotopic pulse generators.
- To assess patient outcomes and device survival following implantation.
Main Methods:
- Follow-up study of 325 patients implanted with Medtronic 9000/9090 isotopic pulse generators between 1970 and 1982.
- Analysis of device parameters, reoperation rates, and patient survival over a mean follow-up of 12 years (up to 18.5 years).
Main Results:
- The isotopic generator demonstrated high reliability with 97% actuarial survival at 18.5 years.
- Pacing rate decreased minimally (0.9 beats/min), and pulse width remained stable.
- Lead dysfunction was the primary reason for reoperations (68%), while generator failure was low (6%).
- 73% of patients were alive after 18.5 years, with most deaths of non-sudden cardiovascular origin.
Conclusions:
- Isotopic pacemakers are highly reliable for long-term cardiac pacing.
- The radioisotope power source showed no attributable side effects.
- These devices offer a durable solution for patients requiring permanent cardiac pacing.