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.