title: Estimating the Risks and Benefits of Implantable Cardioverter Defibrillator Generator Replacement: A Systematic Review.
abstract: BACKGROUND
  Every 4-7 years an implantable cardioverter defibrillator (ICD) pulse generator must be replaced surgically. This procedure is not without risk. In some cases, the risk versus benefit ratio may be against replacement. We aimed to synthesize the evidence on risks, benefits, and costs related to ICD replacement.
  
  
  METHODS
  A systematic review was conducted using electronic databases from 2000 onward. Literature screening, quality appraisal, and data extraction were independently conducted by two reviewers. Outcomes included major and minor complications, ICD therapies, and costs, which were synthesized descriptively.
  
  
  RESULTS
  Of 1,483 citations, 17 nonrandomized studies met criteria. Median rate of major complications was 4.05% (range 0.55-7.37%) and minor complications was 3.50% (range 0.36-7.37%). Without non-ICD control groups, the true risk reduction provided by the ICD following replacement is unknown. Following ICD replacement, annualized rate of appropriate ICD therapy was 10.52% (range 2.42-75.00%). Of these, patients without therapies during their first generator life and those no longer meeting ICD criteria received appropriate therapies at nontrivial rates.
  
  
  CONCLUSIONS
  Rates of complications associated with ICD replacement are substantial. No study had nonreplacement groups, hence the true risk reduction provided by the ICD following replacement is unknown. Our analysis did not identify a subgroup at low risk of therapies following replacement. Shared discussions should occur with patients about the evidence, healthcare goals, risk tolerances, and feelings about life and death trade-offs to enable high-quality decisions about ICD replacement.
authors.affiliation: School of Nursing, University of Ottawa, Ottawa, Canada.|University of Ottawa Heart Institute, Ottawa, Canada.
authors.forename: Krystina B
authors.initials: KB
authors.lastname: Lewis
authors.affiliation: School of Nursing, University of Ottawa, Ottawa, Canada.|Ottawa Hospital Research Institute, Ottawa, Canada.
authors.forename: Dawn
authors.initials: D
authors.lastname: Stacey
authors.affiliation: School of Nursing, McMaster University, Hamilton, Canada.
authors.forename: Sandra L
authors.initials: SL
authors.lastname: Carroll
authors.affiliation: Interdisciplinary School of Health Sciences, University of Ottawa, Ottawa, Canada.
authors.forename: Laura
authors.initials: L
authors.lastname: Boland
authors.affiliation: Health Sciences Library, University of Ottawa, Ottawa, Canada.
authors.forename: Lindsey
authors.initials: L
authors.lastname: Sikora
authors.affiliation: University of Ottawa Heart Institute, Ottawa, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Birnie
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016757:Death, Sudden, Cardiac / Q000453:epidemiology* / Q000517:prevention & control*; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D020878:Device Removal / Q000401:mortality*; D004868:Equipment Failure / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019919:Prosthesis Implantation / Q000401:mortality* / Q000706:statistics & numerical data*; D018570:Risk Assessment / Q000379:methods; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
keywords: benefit; complication; cost; implantable cardioverter defibrillator; systematic review