title: Cable externalization and electrical failure of the Riata family of implantable cardioverter-defibrillator leads: A systematic review and meta-analysis.
abstract: BACKGROUND
  The Riata class of defibrillator leads were placed under US Food and Drug Association (FDA) advisory as of November 2011 because of high rates of cable externalization (CE) and electrical failure (EF). The overall rates of these complications remain unknown.
  
  
  OBJECTIVE
  The purpose of this study was to systematically search the literature for rates of Riata lead failure and to perform a meta-analysis to estimate failure rates.
  
  
  METHODS
  We conducted a meta-analysis of observational studies examining the rates of EF, CE, and the interaction of the two. We identified 23 English language manuscripts addressing 1 or more of these questions.
  
  
  RESULTS
  Across 23 studies, the overall CE rate was 23.1% (95% confidence interval [CI] 19.0%-27.6%). The overall EF rate was 6.3% (95% CI 4.7%-8.2%). The presence of CE was associated with a more than 6-fold increase in the rate of EF compared to no CE (17.3% [95% CI 11.2%-25.9%] vs 2.7% [95% CI 1.4%-5.2%], respectively). The rate of CE was 3-fold higher for 8Fr leads compared to 7Fr leads, but rates of EF were similar (4.6%; 95% CI 3.2-6.6] and 3.9%; 95% CI 2.4-6.1], respectively). Rates of both CE and EF were higher in dual coil vs single coil leads, but confidence intervals overlapped.
  
  
  CONCLUSIONS
  In clinical practice, rates of CE in Riata leads are substantial. While CE is associated with a significant increase in the risk of EF, the incidence of EF without externalization is not trivial.
authors.affiliation: Duke Clinical Research Institute, Duke University Medical System, Durham, North Carolina.
authors.forename: Emily P
authors.initials: EP
authors.lastname: Zeitler
authors.affiliation: Duke Clinical Research Institute, Duke University Medical System, Durham, North Carolina.
authors.forename: Sean D
authors.initials: SD
authors.lastname: Pokorney
authors.affiliation: Duke-NUS Graduate Medical School, Singapore.
authors.forename: Ke
authors.initials: K
authors.lastname: Zhou
authors.affiliation: University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Robert K
authors.initials: RK
authors.lastname: Lewis
authors.affiliation: Duke Clinical Research Institute, Duke University Medical System, Durham, North Carolina.
authors.forename: Ruth Ann
authors.initials: RA
authors.lastname: Greenfield
authors.affiliation: Duke Clinical Research Institute, Duke University Medical System, Durham, North Carolina.
authors.forename: James P
authors.initials: JP
authors.lastname: Daubert
authors.affiliation: Duke-NUS Graduate Medical School, Singapore; Duke University Medical System, Durham, North Carolina.
authors.forename: David B
authors.initials: DB
authors.lastname: Matchar
authors.affiliation: Duke Clinical Research Institute, Duke University Medical System, Durham, North Carolina. Electronic address: jonathan.piccini@duke.edu.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Piccini
mesh_terms: D017147:Defibrillators, Implantable; D004868:Equipment Failure / Q000706:statistics & numerical data; D006801:Humans; D057052:Medical Device Recalls
keywords: Advisory; Cable externalization; Electrical failure; Recall; Riata