ABSTRACT
Since 1990, 558 Medtronic 5524 bipolar, silicone-insulated, J-shaped, tined, steroid-eluting atrial leads have been implanted at the Mayo Clinic (Rochester, MN, USA) and the Midelfort Clinic (Eau Claire, WI, USA). Implantation data were favorable, with pacing thresholds at implantation (median threshold, 0.6 V) better than most published data on other atrial leads. The rate of acute lead-related complications (dislodgment and diaphragmatic pacing) necessitating reoperation or electrical abandonment of the atrial lead was 0.9%. This rate is lower than that in most published series of atrial leads. Over a median follow-up time of 17.5 months (up to 69 months), there were no chronic lead-related complications and no definite or suspected failures of lead material. This rate is much lower than that with other atrial leads studied previously. We conclude that the Medtronic 5524 atrial lead combines the reliability of silicone insulation with a lack of chronic complications and high thresholds due to its steroid elution and with stability in the atrium due to its J shape despite a passive fixation mechanism. There is no evidence of lead material failure during up to 6 years of follow-up.
Subject(s)
Anti-Inflammatory Agents/administration & dosage , Coated Materials, Biocompatible , Dexamethasone/administration & dosage , Electrodes, Implanted , Equipment Failure Analysis , Pacemaker, Artificial , Silicones , Administration, Topical , Electrocardiography , Follow-Up Studies , Glucocorticoids , Humans , Product Surveillance, Postmarketing , Reproducibility of Results , TelemetryABSTRACT
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 omega. 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.
