Background: Lead complications are the main reason for reoperation after implantation of pacemakers (PM) or cardiac resynchronization therapy (CRT-P) devices.
Objective: This study sought to describe the incidence of lead complications causing reoperation after device implantation and to identify risk factors for lead complications.
Methods: A nationwide, population-based, historic cohort study was performed based on data from the Danish Pacemaker Register, which includes all Danish patients who received their first PM or CRT-P device from 1997 to 2008. Follow-up occurred 3 months after implantation.
Results: The study population consisted of 28,860 patients. The incidence of any lead complication was 3.6%, encompassing right atrial (RA; 2.3%), right ventricular (2.2%), and left ventricular (4.3%) lead complications. The lead complication risk declined during the first part of the study period and remained stable after 2002. Multivariate analysis identified the following significant risk factors: chronic heart failure as indication (adjusted odds ratio (aOR) 3.0; 95% confidence interval [CI] 2.1 to 4.3), implantation in a nonuniversity center (aOR 1.4; 95% CI 1.2 to 1.6), inexperienced operator with <25 implantations (aOR 1.6; 95% CI 1.3 to 2.0), single-lead RA device (aOR 1.4; 95% CI 1.1 to 1.8), dual-chamber pacing device (aOR 1.6; 95% CI 1.4 to 1.9), CRT-P device (aOR 3.3; 95% CI 2.4 to 4.4) and passive-fixation RA lead (aOR 2.2; 95% CI 1.7 to 2.9).
Conclusion: Lead complications causing reoperation remain a clinically important problem in device therapy. Mainly procedure-related factors were identified as independent risk factors for lead complications.
Trial registration: ClinicalTrials.gov NCT01038180.
Copyright © 2011 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.