Examination of explanted polyurethane pacemaker leads using the scanning electron microscope.

Abstract

Since 1978, 2,365 polyurethane (PU) insulated cardiac pacing leads were implanted transvenously at our institution. To date, there have been no insulation failures in those leads. Thirty-seven PU leads were explanted, mainly for exit block, and 28 of these were investigated using the scanning electron microscope. We found a homogeneous distribution of surface changes in all lead segments in 56% of the 28 examined. These changes were more pronounced at the ligature site; severe surface cracking was noticed in 21%, with the deepest crack being 40 micron (average range of 10-15 micron). There appeared to be no time-dependency of the surface changes as indicated by regression analysis (r = 0.32, p greater than 0.05). The ultimate severity and outcome of this degradation process in the leads reported in this study will only be known in the future after longer use. We conclude that excess stress must be avoided during the implantation procedure and that careful surveillance is necessary.