Failure rate of the Riata lead under advisory: A report from the CHRS Device Committee Academic Article uri icon

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abstract

  • BACKGROUND: A unique form of lead failure has been described in the Riata (8-F) and Riata ST (7-F) silicone defibrillation lead degradation of the outer insulation, resulting in the externalization of conductor cables. OBJECTIVE: To assess rates of lead revision due to lead failure in Riata leads affected by the Riata advisory. METHODS: Nineteen implantable cardioverter-defibrillator implant and follow-up centers were surveyed. RESULTS: As of March 1, 2012, there were 5043 known affected leads implanted in Canada. Data on 4358 (86.4%) leads were obtained; 65.3% of these were Riata (8-F) and 32.4% were Riata ST (7-F) leads. The median time from implant to last follow-up was 5 years. Electrical abnormalities were reported in 4.6% of the affected leads; 8.0% of these were found to have concomitant radiographic evidence of externalization. The rate of electrical failure was higher in the 8-F (5.2%) vs 7-F (3.3%) leads (P = .007). Oversensing with or without inappropriate shocks was reported in 39.8% of the leads with confirmed failure. Abnormally high or low impedance values (29.9%) and elevated pacing capture thresholds (43.8%) were frequently reported. One death (0.5%) attributed to lead failure was reported. Among the leads that were replaced, 21% were extracted. Two major complications (1.0%) were attributed to extraction of these leads. CONCLUSIONS: The overall rate of lead failure in the Riata (8-F) and Riata ST (7-F) leads is higher than previously reported by using passive surveillance data. The impact of recent advisories related to these leads is not yet apparent.

authors

  • Parkash, Ratika
  • Exner, Derek
  • Champagne, Jean
  • Mangat, Iqwal
  • Thibault, Bernard
  • Healey, Jeffrey Sean
  • Tung, Stanley
  • Crystal, Eugene
  • Simpson, Christopher
  • Nery, Pablo B
  • Sterns, Laurence
  • Connors, Sean
  • Cameron, Doug
  • Verma, Atul
  • Beardsall, Marianne
  • Wolfe, Kevin
  • Essebag, Vidal
  • Ayala-Paredes, Felix
  • Sanatani, Shubhayan
  • Coutu, Benoit
  • Fraser, Jennifer
  • Toal, Satish
  • Philippon, Francois
  • Tang, Anthony SL
  • Yee, Raymond
  • Krahn, Andrew

publication date

  • May 2013