title: High prevalence of insulation failure with externalized cables in St. Jude Medical Riata family ICD leads: fluoroscopic grading scale and correlation to extracted leads.
abstract: BACKGROUND
  Inside-out abrasion with externalization of sensing ring or high-voltage cables in St Jude Medical Riata implantable cardioverter-defibrillator leads has been reported. The prevalence of extruded cables, rate of electrical abnormalities, and predictors of failure in Riata leads are unknown.
  
  
  OBJECTIVE
  To estimate the incidence of lead failure in the St Jude Medical Riata implantable cardioverter-defibrillator leads and to propose a standard for the fluoroscopic assessment of insulation breakdown.
  
  
  METHODS
  Patients undergoing cine-fluoroscopy on Riata implantable cardioverter-defibrillator leads at our institution before January 25, 2012, were included (n = 87). Leads were graded as types 0-3 (0 = normal, 1 = abnormal conductor spacing, 2 ≤1 cm cable extrusion, 3 = >1 cm length extrusion). Comparison to extracted leads (n = 15) was documented. Device interrogation data were used for electrical analysis.
  
  
  RESULTS
  The mean time from implant was 5.9 ± 3.45 years. Structural lead failure with externalized cables was seen in 33.3% (29 of 87) of the patients. Thirty-one percent (9 of 29) of the leads with exposed cables showed electrical failure, and 29.7% (19 of 64) of the leads with normal electrical data contained externalized cables. Time from implant ≥5 years predicted structural lead failure (P < 0.05). X-ray grade compared with extracted leads demonstrated a sensitivity and specificity of 86% and 100%, respectively.
  
  
  CONCLUSIONS
  Cine-fluoroscopy using a simple scale correlated with the structural integrity of extracted Riata leads. A high percentage of leads with extrusion showed electrical failure. Leads ≥5 years from implant showed a high rate of externalized cables. A large independent multicenter study to determine the prevalence and clinical sequelae of Riata lead failures is warranted.
authors.affiliation: Veterans Administration Tennessee Valley Health System, Nashville, TN 37232, USA. sparvat1@yahoo.com
authors.forename: Sunthosh V
authors.initials: SV
authors.lastname: Parvathaneni
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Ellis
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Rottman
mesh_terms: D017147:Defibrillators, Implantable / Q000009:adverse effects; D004553:Electric Conductivity; D004567:Electrodes, Implanted; D004868:Equipment Failure; D019544:Equipment Failure Analysis; D005471:Fluoroscopy; D006801:Humans; D015995:Prevalence; D057053:Safety-Based Medical Device Withdrawals; D012828:Silicones
chemical_list: D012828:Silicones