title: Long-Term Risk for Device-Related Complications and Reoperations After Implantable Cardioverter-Defibrillator Implantation: An Observational Cohort Study.
abstract: BACKGROUND
  Long-term nonfatal outcomes after implantable cardioverter-defibrillator (ICD) placement are poorly defined.
  
  
  OBJECTIVE
  To determine the long-term risk for ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications, and to assess associated patient and device characteristics.
  
  
  METHODS
  Observational cohort study of ICD implantations from the National Cardiovascular Data Registry ICD registry linked with Medicare fee-for-service claims data.
  
  
  METHODS
  1437 U.S. hospitals.
  
  
  METHODS
  114 484 patients aged 65 years or older (mean, 74.8 years [SD, 6.2]; 72.4% male) receiving an ICD for the first time from 2006 to 2010 (single-chamber, 19.8%; dual-chamber, 41.3%; cardiac resynchronization therapy with a defibrillator [CRT-D], 38.9%).
  
  
  METHODS
  Rate and cumulative incidence of ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications.
  
  
  RESULTS
  During a median follow-up of 2.7 years (interquartile range, 1.8 to 3.9 years), 40 072 patients died, representing 12.6 (95% CI, 12.5 to 12.7) deaths per 100 patient-years of follow-up. When the risk for death was accounted for, there were 6.1 (CI, 6.0 to 6.2) ICD-related complications per 100 patient-years that required reoperation or hospitalization and 3.9 (CI, 3.8 to 4.0) reoperations per 100 patient-years for reasons other than complications. Overall, 10 patients had complications or reoperation per 100 patient-years of follow-up. Younger age at implantation (65 to 69 vs. >85 years) (hazard ratio [HR], 1.55 [CI, 1.43 to 1.69]), receipt of a CRT-D device (HR, 1.38 [CI, 1.31 to 1.45]) versus a single-chamber device, female sex (HR, 1.16 [CI, 1.12 to 1.21]), and black race (HR, 1.14 [CI, 1.05 to 1.23]) were associated with the greatest increased risks for ICD-related complications.
  
  
  CONCLUSIONS
  The analysis was limited to Medicare fee-for-service patients aged 65 years or older.
  
  
  CONCLUSIONS
  Patients have a high rate of device-related complications and reoperation for other causes after ICD implantation. Risks of ICD implantation and strategies to reduce them should be actively considered before implantation.
  
  
  BACKGROUND
  American College of Cardiology Foundation's National Cardiovascular Data Registry.
authors.forename: Isuru
authors.initials: I
authors.lastname: Ranasinghe
authors.forename: Craig S
authors.initials: CS
authors.lastname: Parzynski
authors.forename: James V
authors.initials: JV
authors.lastname: Freeman
authors.forename: Rachel P
authors.initials: RP
authors.lastname: Dreyer
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Ross
authors.forename: Joseph G
authors.initials: JG
authors.lastname: Akar
authors.forename: Harlan M
authors.initials: HM
authors.lastname: Krumholz
authors.forename: Jeptha P
authors.initials: JP
authors.lastname: Curtis