Outcomes of Sprint Fidelis and Riata lead extraction: Data from 2 high-volume centers

Background: The Sprint Fidelis (SF) and the Riata (RT) implantable cardioverter-defibrillator leads have been recalled for premature failure.

Objective: Data on SF and RT extractions are limited; therefore, we performed a pooled analysis to compare the safety and efficacy of lead extraction for the SF and RT lead families.

Methods: We retrospectively reviewed consecutive patients undergoing transvenous extraction of SF and RT leads at Emory University and the University of Pittsburgh Medical Center from January 2007 to October 2013. Patients were placed into 2 groups based on the presence of an SF or RT lead. The primary endpoint was a major procedural complication, defined as death, need for urgent cardiac surgery, and hemopericardium or hemothorax that required an intervention.

Results: A total of 462 patients underwent extraction of recalled leads (SF, n = 360; RT, n = 102). The mean number of leads extracted in the RT group was higher than in the SF group (1.8 ± 0.9 vs 1.3 ± 0.7, P < .001), and there was a longer implantation time in the RT group (5.5 ± 2.5 vs 4.3 ± 2.0 years, P < .001). Complete procedural success was higher in the SF group (99.4% vs 96.1%, P =.024). Clinical success was similar (SF 99.4% vs RT 97.1%, P = .075). There were 6 major procedural complications in the entire cohort (1.3%). The rate of major complications was not different between the SF and RT groups (SF 1.1% vs RT 2.0%, P = .618). Total mortality was 0.65%, with no difference between the groups

Conclusion: Our data from 2 high-volume centers suggest that extraction of SF and RT leads is associated with excellent clinical success and a similar rate of major procedural complications.