Abstract 15561: Does Lead Introduction Site Affect Pacing Lead Fracture Rate? Insights From a Long-Term Analysis in a Large Sample.
Introduction: Long-term data in a large sample investigating the affect of brady pacing lead introduction site on rate of lead fractures is not frequently reported. Data from Medtronic's System Longevity Study (SLS), was analyzed to determine the effect of site introduction on survival from fracture of brady pacing leads. The SLS is a prospective, multi-center registry evaluating performance of all Medtronic cardiac leads.
Methods: All brady pacing leads enrolled in the SLS from 1991 to present with lead introduction site of cephalic, subclavian, and axillary reported were included in the analysis. The Kaplan-Meier method was used to estimate the probability of survival from confirmed lead fracture or reports of oversensing or abnormal impedance. The marginal Cox regression model was used to adjust for other covariates including age, NYHA class, center, year implanted, lead model, lead type and implant location.
Results: A total of 11,838 leads were included in the analysis with 2537 in the Cephalic Group (CG), 7909 in the Subclavian Group (SG), and 1392 in the Axillary Group (AG). The Kaplan-Meier estimate of lead fracture free survival at 10 years was 99.6% in the CG, 99.5% in the AG, and 99.0% in the SG. Cox regression model revealed patient age was a significant factor for lead fracture with a higher rate in younger patients, p<0.0001. After adjusting for the age effect, introduction site remained significantly different between the CG and SG with no difference between CG and AG or SG and AG.
Conclusions: In this large multi-center study, brady lead survival at 10 years remains excellent despite site of introduction. Results indicate that the risk of lead fracture is higher for brady leads implanted by the subclavian approach as compared to those implanted by the cephalic or axillary approaches. Probability of brady pacing lead fracture with the subclavian site of introduction remains low despite previous reports of estimated high incidence of crush with this approach.
- © 2010 by American Heart Association, Inc.