Safety assessment and biodistribution of povidone as a coating material for cardiac pacing leads.

Abstract

Cardiac pacing leads coated with povidone-[131I] were implanted in dogs and the leaching of radioactivity from the leads was monitored by external scintigraphy. The activity which had dissipated from the pacing leads was not as [131I]-iodide, but as povidone-[131I]. Only 50% (mean) of the activity remained on the pacing leads after two weeks while a significant amount of radioactivity was eliminated via urine and feces. The liver was a major site of accumulation of retained activity which had leached off the pacing leads. There was no evidence of large pieces of povidone-[131I] in the lungs of the dogs, all of which appeared healthy at the time of sacrifice. The results of this study support the conclusions of a long-term study indicating that povidone is a safe and suitable coating material for pacing leads.