title: Risk factors for lead complications in cardiac pacing: a population-based cohort study of 28,860 Danish patients.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Brendstrupgaardsvej, Aarhus, Denmark. reki@svf.au.dk
authors.forename: Rikke Esberg
authors.initials: RE
authors.lastname: Kirkfeldt
authors.forename: Jens Brock
authors.initials: JB
authors.lastname: Johansen
authors.forename: Ellen Aagaard
authors.initials: EA
authors.lastname: Nohr
authors.forename: Mogens
authors.initials: M
authors.lastname: Moller
authors.forename: Per
authors.initials: P
authors.lastname: Arnsbo
authors.forename: Jens Cosedis
authors.initials: JC
authors.lastname: Nielsen
mesh_terms: D002304:Cardiac Pacing, Artificial / Q000009:adverse effects*; D016009:Chi-Square Distribution; D015331:Cohort Studies; D003718:Denmark / Q000453:epidemiology; D004567:Electrodes, Implanted / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D012042:Registries; D012086:Reoperation; D012307:Risk Factors