title: Complications from prophylactic replacement of cardiac implantable electronic device generators in response to United States Food and Drug Administration recall: A systematic review and meta-analysis.
abstract: BACKGROUND
  The number of cardiac implantable electronic device (CIED) recalls and advisories has increased over the past 3 decades, yet no consensus exists on how to best manage patients with these CIEDs, partially because rates of complications from prophylactic replacement are unknown.
  
  
  OBJECTIVE
  The purpose of this study was to establish rates of complications when recalled CIED generators are replaced prophylactically.
  
  
  METHODS
  We searched MEDLINE and the Cochrane Controlled Trials Register for reports of prophylactic replacement of recalled CIED generators. Studies with <20 subjects were excluded. We then conducted a meta-analysis of qualifying studies to determine the rates of combined major complications, mortality, and reoperation.
  
  
  RESULTS
  We identified 7 citations that met our inclusion criteria and reported ≥1 end-points of interest. Four were single center, and 3 were multicenter. Six studies collected data retrospectively (n = 1213) and 1 prospectively (n = 222). Using a random effects model to combine data from all included studies, the rate of major complications was 2.5% (95% confidence interval [CI] 1.0%-4.5%). Combining data from 6 studies reporting mortality and reoperation, the rates were 0.5% (95% CI 0.1%-0.9%) and 2.5% (95% CI 0.8%-4.5%), respectively.
  
  
  CONCLUSIONS
  Prophylactic replacement of recalled CIED generators is associated with a low mortality rate but nontrivial rates of other major complications similar to those reported when CIED generators are replaced for other reasons. Thus, when considering replacing a recalled CIED generator, known risks of elective generator replacement likely apply and can be weighed against risks associated with device failure.
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina; Duke University Medical System, Durham, North Carolina.
authors.forename: Emily P
authors.initials: EP
authors.lastname: Zeitler
authors.affiliation: Duke University Medical System, Durham, North Carolina.
authors.forename: Divyang
authors.initials: D
authors.lastname: Patel
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Vic
authors.initials: V
authors.lastname: Hasselblad
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Gillian D
authors.initials: GD
authors.lastname: Sanders
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina; Duke University Medical System, Durham, North Carolina. Electronic address: alkha001@mc.duke.edu.
authors.forename: Sana M
authors.initials: SM
authors.lastname: Al-Khatib
mesh_terms: D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000706:statistics & numerical data; D020878:Device Removal / Q000009:adverse effects / Q000379:methods / Q000706:statistics & numerical data; D004868:Equipment Failure / Q000706:statistics & numerical data*; D006801:Humans; D057052:Medical Device Recalls; D011183:Postoperative Complications / Q000145:classification / Q000453:epidemiology; D012086:Reoperation / Q000009:adverse effects / Q000379:methods / Q000706:statistics & numerical data; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
keywords: Cardiac implantable electronic devices; Complications; Mortality; Recall
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