title: Long-term electrical survival analysis of Riata and Riata ST silicone leads: National Veterans Affairs experience.
abstract: BACKGROUND
  A medical device advisory issued by St Jude Medical in November 2011 estimated 0.63% all-cause abrasion rate on their Riata and Riata ST silicone high-voltage lead families (Riata/ST), leading to Food and Drug Administration class I recall. We performed an independent comparative, long-term electrical survival analysis of Riata/ST and 3 other high-voltage lead families in a large national cohort of patients.
  
  
  OBJECTIVE
  To evaluate long-term electrical survival of Riata/ST leads relative to other commonly evaluated high-voltage leads.
  
  
  METHODS
  Failure rates of Riata/ST, Sprint Quattro Secure (Quattro), Sprint Fidelis (Fidelis), and Endotak Reliance G/SG (Endotak) leads from the Veterans Administration's National Cardiac Device Surveillance Center database, consisting of 24,145 patients with remote transmissions since 2003, were analyzed. Survival Probabilities were determined with Kaplan-Meier survival analysis and compared using the log-rank test.
  
  
  RESULTS
  Of 1,403 Riata/ST, 6,091 Quattro, 5,073 Fidelis, and 2,401 Endotak leads identified, 5-year survival probability of Riata/ST leads (97.5%) was significantly lower than that of Quattro (99.3%) and Endotak (99.4%) leads (P <.0001) but higher than that of Fidelis leads (89.6%) (P <.0001). Riata ST leads showed a 5-year survival of 95.5% (95% confidence interval 92.4-97.4) compared to 98.4% (95% confidence interval 97.1-99.1) in Riata leads (P = .003).
  
  
  CONCLUSIONS
  There is decreased survival probability of Riata/ST leads compared to other contemporary high-voltage leads, with decreased survival of Riata ST silicone compared to Riata lead series. Careful long-term follow-up should be maintained in patients with Riata/ST leads in order to prevent inappropriate shocks or failed device interventions. Our results were determined in advance of Food and Drug Administration class I recall, which suggested that large-scale remote monitoring may be an effective tool for continued implantable cardioverter-defibrillator system surveillance.
authors.affiliation: Department of Medicine, Division of Cardiology, Electrophysiology Section, University of California, San Francisco, California, USA.
authors.forename: Raphael K
authors.initials: RK
authors.lastname: Sung
authors.forename: Barry M
authors.initials: BM
authors.lastname: Massie
authors.forename: Paul D
authors.initials: PD
authors.lastname: Varosy
authors.forename: Hans
authors.initials: H
authors.lastname: Moore
authors.forename: John
authors.initials: J
authors.lastname: Rumsfeld
authors.forename: Byron K
authors.initials: BK
authors.lastname: Lee
authors.forename: Edmund
authors.initials: E
authors.lastname: Keung
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001145:Arrhythmias, Cardiac / Q000401:mortality* / Q000628:therapy; D017147:Defibrillators, Implantable; D004567:Electrodes, Implanted; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012828:Silicones; D015996:Survival Rate / Q000639:trends; D014481:United States / Q000453:epidemiology; D014493:United States Department of Veterans Affairs / Q000706:statistics & numerical data*; D014728:Veterans / Q000706:statistics & numerical data*
chemical_list: D012828:Silicones