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

Heart Rhythm. 2015 Jul;12(7):1558-64. doi: 10.1016/j.hrthm.2015.04.003. Epub 2015 Apr 3.

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.

Conclusion: 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.

Keywords: Cardiac implantable electronic devices; Complications; Mortality; Recall.

Publication types

  • Meta-Analysis
  • Research Support, N.I.H., Extramural
  • Review
  • Systematic Review

MeSH terms

  • Defibrillators, Implantable* / adverse effects
  • Defibrillators, Implantable* / statistics & numerical data
  • Device Removal* / adverse effects
  • Device Removal* / methods
  • Device Removal* / statistics & numerical data
  • Equipment Failure / statistics & numerical data*
  • Humans
  • Medical Device Recalls*
  • Postoperative Complications* / classification
  • Postoperative Complications* / epidemiology
  • Reoperation* / adverse effects
  • Reoperation* / methods
  • Reoperation* / statistics & numerical data
  • Risk Assessment
  • United States
  • United States Food and Drug Administration