Abstract 19014: Significant Major Complication Occurrence in Extracting Riata Compared to Sprint Fidelis Leads
Introduction: Medtronic Sprint Fidelis and St. Jude Medical Riata defibrillator leads have been subject to class I recall. Extraction of these leads is a complex clinical decision with a case by case analysis. We compared the difference in the occurrence of major complications to understand the morbidity and mortality risk extracting either of these leads.
Methods: We retrospectively reviewed 86 consecutive cases (59 men, 27 women) of Sprint Fidelis (n = 72) or Riata (n = 14) lead extraction from 2007 to 2012 and compared the rate of major complications between the two. The only exclusion criteria were pocket infection or endocarditis as an indication for extraction. Major complications were defined as death, cardiac/vascular avulsion or tear, cardiac tamponade requiring pericardiocentesis and/or stroke. Minor complications were defined as pericardial effusion not requiring intervention, pneumothorax and/or hematoma at surgical site.
Results: The main indications for extraction included lead fracture (n = 36, 42%) and elective removal at pulse generator change (n = 28, 33%). There was a significant difference in occurrence of major complications with extraction of Riata as compared to Sprint Fidelis leads (2/14 vs. 1/72, p = 0.016). All 3 major complications occurred in dual coil leads. Within the Riata family of leads, there was no statistical difference in occurrence of major complications (1500 series 2/7 vs. 7000 series 0/7, p = 0.127). There was also no difference in patients with component failure versus prophylactic extraction (1/36 vs. 2/50, p = 0.76).
Conclusions: Major complication occurrences in extraction are higher with Riata as compared with Sprint Fidelis leads based on this large, single-center experience. There was no statistical difference between the 8-Fr 1500 and 7-Fr 7000 Riata series of leads.
Further investigation is needed to help guide clinical decision-making for patients presenting with these recalled leads.
- © 2013 by American Heart Association, Inc.