Key result
Steroid membrane leads lowered the stimulation threshold compared to nonsteroid leads at 2 weeks, but values were similar by 3 months.
Why the study?
Do steroid membrane leads reduce pacing thresholds compared to nonsteroid membrane leads in patients undergoing pacemaker implantation?
RCT (n=90)
Double-blind
Random sample
Yes
Do steroid membrane leads reduce pacing thresholds compared to nonsteroid membrane leads in patients undergoing pacemaker implantation?
Steroid-eluting pacemaker leads significantly reduce pacing thresholds in the first month post-implantation compared to non-steroid leads, though this benefit attenuates by 3 months.
Answers are grounded in this paper and cite their sources.
Early threshold benefit with steroid leads confers no sustained advantage; confirms transient effect only in pacemaker patients.
The aim of this study was to evaluate whether steroid membrane leads can reduce pacing thresholds and thereby save energy as compared to nonsteroid membrane leads. The study was a random sample, double blind test consisting of 90 patients between 49-94 years of age admitted to seven hospitals in Europe for pacemaker implantation. The two leads compared in this study had contoured activated carbon tips covered with ion exchange membranes. The leads were identical except that 30 micrograms of dexamethasone was dissolved in the ion exchange membrane of one of the leads. Normal lead implant procedures were used. Follow-up procedures were conducted at 2 weeks and 1, 3, 6, and 12 months after lead implantation. The pulse generator was programmed to an amplitude of 2.5 or 5 V and a duration of 0.5 msec. The stimulation threshold was measured using the VARIO function. The threshold was measured a total of three times in order to determine the presence of microdislocations. At the 2- and 4-week follow-ups, the stimulation threshold was significantly lower for the steroid leads than for the membrane leads without steroid (0.54 +/- 0.19 vs 0.76 +/- 0.25 V, P = 0.0005; and 0.59 +/- 0.19 vs 0.74 +/- 0.26 V, P = 0.005), but after 3 months, the threshold values were almost the same for both leads.
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Svensson et al. (1994) conducted an RCT in Pacemaker implantation (n=90). Steroid membrane leads vs. Nonsteroid membrane leads was evaluated on Stimulation threshold at 2 weeks (p=0.0005). Steroid membrane leads lowered the stimulation threshold compared to nonsteroid leads at 2 weeks, but values were similar by 3 months.
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