title: Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark.
abstract: OBJECTIVE
  Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality.
  
  
  RESULTS
  Population-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1-1.6), underweight (aRR 1.5; 1.1-2.3), implanted in a centre with an annual volume <750 procedures (0-249 procedures: aRR 1.6; 1.1-2.2, 250-499: aRR 2.0; 1.6-2.7, 500-749: aRR 1.5; 1.2-1.8), received a dual-chamber ICD (aRR 2.0; 1.4-2.7) or CRT-D (aRR 2.6; 1.9-3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0-1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4-2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0-2.3).
  
  
  CONCLUSIONS
  CIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment.
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
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: Ole Dan
authors.initials: OD
authors.lastname: Jørgensen
authors.forename: Jens Cosedis
authors.initials: JC
authors.lastname: Nielsen
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D058409:Cardiac Resynchronization Therapy Devices / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D003718:Denmark / Q000453:epidemiology; D020878:Device Removal; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D011183:Postoperative Complications / Q000453:epidemiology; D011475:Prosthesis Failure; D012307:Risk Factors; D017678:Sex Distribution; D055815:Young Adult
keywords: Cardiac resynchronization therapy; Complication; Implantable cardioverter defibrillator; Pacemaker; Predictors