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Keywords:

  • implantable cardioverter defibrillator;
  • infection;
  • lead extraction;
  • pacemaker;
  • Riata lead;
  • Sprint Fidelis lead

Comparison of Extraction of Recalled Defibrillator Leads

Introduction

The FDA has issued class I advisories for Medtronic Sprint Fidelis® and St. Jude Medical RiataTM ICD lead families. Transvenous RiataTM ICD lead extraction is typically considered higher risk than Fidelis® extraction, based on longer duration from implant, presence of externalized conductors and lack of silicone backfill in the SVC and RV coils. However, published data comparing procedural outcomes between these leads are limited.

Methods

Records were reviewed for all patients undergoing transvenous extraction of Sprint Fidelis® or RiataTM ICD leads at the Vanderbilt Heart and Vascular Institute from July 2006 to April 2013 to ascertain indication for extraction, procedural details, complications, and 30-day mortality.

Results

There were significant differences between those undergoing extraction of a Sprint Fidelis® (n = 145) or RiataTM lead (n = 47). In the RiataTM group, device-related endocarditis was a more common indication for extraction, the mean duration of implant was longer, and larger excimer laser sheaths were required. Lead malfunction was a more common indication in the Fidelis® group. There were no statistically significant differences in median procedure duration, procedural success (97.9% vs 95.7%, P = 0.41), median length of hospital stay (1 day vs 1 day, P = 0.23), procedural complication rate (5.5% vs 10.6%, P = 0.23) or 30-day mortality (2.1% vs 2.1%, P = 0.98). Analyses excluding patients with device infection revealed similar results.

Conclusion

Despite differences in baseline characteristics, this study indicates that Medtronic Sprint Fidelis® and St. Jude RiataTM ICD leads have similar procedural outcomes with transvenous lead extraction.