Clinical surveillance of a tined, bipolar, steroid-eluting, silicone- insulated ventricular pacing lead

Since 1990, 1,068 Medtronic 5024 bipolar, silicone-insulated, tined, steroid-eluting ventricular leads have been implanted at the Mayo Clinic (Rochester, MN) and Midelfort Clinic (Eau Claire, WI). Implantation data were favorable: median pacing thresholds of 0.5 V at 0.5 ms, median R wave of 13.4 mV, and median impedance of 593 Ω. Of the 2.1% acute lead-related complications (dislodgment, microdislocation, diaphragmatic pacing, and undersensing), 1.2% necessitated reoperation. This rate is lower than that in most published series of other leads. During a median follow-up of 23 months (up to 76 months), 12 (1.1%) chronic lead-related complications (high thresholds, loss of capture, and undersensing) and no instances of definite or suspected lead material failure occurred. This rate is much lower than that in studies of other leads. Thus, the 5024 lead combines the reliability of silicone insulation with a low rate of chronic complications that is probably the result of its steroid elution. No evidence of failure of lead material has appeared up to 6 years after implantation.