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


Journal Article

© 2015 Heart Rhythm Society. 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.

Full Text

Duke Authors

Cited Authors

  • Zeitler, EP; Patel, D; Hasselblad, V; Sanders, GD; Al-Khatib, SM

Published Date

  • January 1, 2015

Published In

Volume / Issue

  • 12 / 7

Start / End Page

  • 1558 - 1564

Electronic International Standard Serial Number (EISSN)

  • 1556-3871

International Standard Serial Number (ISSN)

  • 1547-5271

Digital Object Identifier (DOI)

  • 10.1016/j.hrthm.2015.04.003

Citation Source

  • Scopus