The Porous Titanium Steroid Eluting Electrode: A Double Blind Study Assessing the Stimulation Threshold Effects of Steroid

Abstract

A transvenous pacing lead with a porous electrode which slowly elutes the steroid, dexamethasone sodium phosphate, has been developed. Previous investigations show low and constant stimulation thresholds persisting over at least the first two years post-implantation. As it is not known whether this low threshold results from the steroid or electrode configuration, a double blind study was designed to compare the same electrode configuration with and without steroid over a 2-year follow-up period. There were ten patients in each group with similar age, sex, indications for pacing and implantation data. Regular measurements of postoperative pulse duration thresholds were performed using a customized VVIM pulse generator programmed to 1.5 V output. For the first two days post-implantation, there were no statistical differences in the pulse duration thresholds between the two pacing leads. From 2 weeks to 2 years the pulse duration thresholds for the steroid leads remained almost constant, whereas the leads without steroid showed a typical rise. The difference in pulse duration thresholds between the two groups of leads from two weeks onwards confirmed that it was the steroid rather than the electrode configuration which prevented the rise in chronic stimulation threshold.