REACTION OF THE SKIN-IMPLANT INTERFACE WITH PERCUTANEOUS LEADS

Abstract

The purpose of these experiments was to evaluate the biocompatibility of materials for potential use as long-term percutaneous leads. Six different leads were designed in our laboratory: 1) No flange, 2) polyester felt, 3) Proplast, 4) epoxy, 5) polyester felt with RFGD and 6) Proplast with RFGD. These 6 leads were implanted subcutaneously along the dorsum of 5 sheep, 2 of which were terminated at 2 months and 3 of them terminated at 6 months after surgery. In the 2-month group all 12 percutaneous leads were infection-free at autopsy. Polyester felt with and without RFGD showed the least microscopic skin reactions. In the 6-month group 7 of 18 percutaneous leads had infection at the implant-skin juncture. The no-flange and polyester felt percutaneous leads showed no infection, in this group. In both groups Proplast percutaneous leads were poorer than polyester felt. From the bacteriological experimentation, flanges were useful as a barrier to prevent migration of infection along the drive lines. In the clinical observation of the drive lines in calves with a TAH, the incidence of infection in the polyester felt group was greatly reduced.