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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.

Publication ,  Journal Article
Zeitler, EP; Patel, D; Hasselblad, V; Sanders, GD; Al-Khatib, SM
Published in: Heart Rhythm
July 2015

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.

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Published In

Heart Rhythm

DOI

EISSN

1556-3871

Publication Date

July 2015

Volume

12

Issue

7

Start / End Page

1558 / 1564

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Risk Assessment
  • Reoperation
  • Postoperative Complications
  • Medical Device Recalls
  • Humans
  • Equipment Failure
  • Device Removal
  • Defibrillators, Implantable
 

Citation

APA
Chicago
ICMJE
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Zeitler, E. P., Patel, D., Hasselblad, V., Sanders, G. D., & Al-Khatib, S. M. (2015). 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, 12(7), 1558–1564. https://doi.org/10.1016/j.hrthm.2015.04.003
Zeitler, Emily P., Divyang Patel, Vic Hasselblad, Gillian D. Sanders, and Sana M. Al-Khatib. “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 12, no. 7 (July 2015): 1558–64. https://doi.org/10.1016/j.hrthm.2015.04.003.
Journal cover image

Published In

Heart Rhythm

DOI

EISSN

1556-3871

Publication Date

July 2015

Volume

12

Issue

7

Start / End Page

1558 / 1564

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Risk Assessment
  • Reoperation
  • Postoperative Complications
  • Medical Device Recalls
  • Humans
  • Equipment Failure
  • Device Removal
  • Defibrillators, Implantable