title: Increasing lead burden correlates with externalized cables during systematic fluoroscopic screening of Riata leads.
abstract: OBJECTIVE
  Riata and Riata ST defibrillator leads (St. Jude Medical, Sylmar, CA, USA) have been recalled due to increased risk of insulation failure leading to externalized cables. As this mechanical failure does not necessarily correlate with electrical failure, it can be difficult to diagnose. Fluoroscopic screening can identify insulation failure. Studies have suggested that insulation failure is predominantly seen in 8-Fr, single-coil models. Our patients have exclusively dual-coil leads and a high proportion of 7-Fr leads.
  
  
  METHODS
  Fluoroscopic screening was performed in 48 patients with recalled Riata leads. Twenty-three patients had 8-Fr Riata leads and 25 patients had 7-Fr Riata ST leads. Images were recorded in at least three projections and studies were reviewed by seven attending electrophysiologists.
  
  
  RESULTS
  Externalized cables were seen in ten patients (21 %), and another five patients (10 %) had abnormal cable spacing. All device interrogations showed normal parameters. Patients with abnormal leads had more leads in situ (2.5 ± 0.7 vs. 1.6 ± 0.8 leads; P = 0.002) and a higher rate of nonischemic cardiomyopathy (80 vs. 24 %; P = 0.03). There were no differences between the groups with regards to patient age, body mass index, lead age, lead parameters, or vascular access site. There was no difference with regard to lead size (P = 0.76).
  
  
  CONCLUSIONS
  The Riata family of leads has a high incidence of mechanical failure, as demonstrated on fluoroscopic screening. In this study, the 7-Fr models were just as likely to mechanically fail as the 8-Fr models. Increasing lead burden and a diagnosis of nonischemic cardiomyopathy correlated with insulation failure.
authors.affiliation: University of Virginia Health System, Charlottesville, VA 22908, USA.
authors.forename: Liza P
authors.initials: LP
authors.lastname: Moorman
authors.forename: J Randall
authors.initials: JR
authors.lastname: Moorman
authors.forename: John P
authors.initials: JP
authors.lastname: DiMarco
authors.forename: Rohit
authors.initials: R
authors.lastname: Malhotra
authors.forename: Andrew
authors.initials: A
authors.lastname: Darby
authors.forename: Kenneth
authors.initials: K
authors.lastname: Bilchick
authors.forename: John D
authors.initials: JD
authors.lastname: Ferguson
authors.forename: J Michael
authors.initials: JM
authors.lastname: Mangrum
authors.forename: Sandeep
authors.initials: S
authors.lastname: Kamath
authors.forename: Pamela K
authors.initials: PK
authors.lastname: Mason
mesh_terms: D017147:Defibrillators, Implantable; D004567:Electrodes, Implanted; D004868:Equipment Failure; D019544:Equipment Failure Analysis / Q000379:methods*; D005260:Female; D005471:Fluoroscopy / Q000379:methods*; D006321:Heart / Q000000981:diagnostic imaging*; D006801:Humans; D008297:Male; D057052:Medical Device Recalls; D008875:Middle Aged; D018570:Risk Assessment; D013223:Statistics as Topic