Impact of implanted recalled sprint fidelis lead on patient mortality

Thomas B. Morrison, Paul A. Friedman, Linda M. Kallinen, David O. Hodge, Daniel Crusan, Kapil Kumar, David L. Hayes, Robert F. Rea, Robert G. Hauser

Research output: Contribution to journalArticle

32 Scopus citations

Abstract

Objectives: This study sought to compare all-cause mortality in patients with Fidelis leads (Medtronic, Minneapolis, Minnesota) to those with a nonadvisory lead. Background: Although Fidelis leads are prone to fracture, and rare deaths due to lead failure have been reported, it is unclear whether the presence of a Fidelis lead is associated with increased mortality. This study compares all-cause mortality in a large cohort of patients with Fidelis and Quattro implantable cardioverter-defibrillator (ICD) leads. Methods: All patients with Fidelis (Medtronic models 6931, 6948, and 6949) and Quattro (Medtronic model 6947) leads followed at 3 tertiary care centers were identified from the medical records (implant dates: November 19, 2001, to December 23, 2008). Clinical and device-specific data were collected into a common database. Deaths were identified from medical records and the Social Security Death Index. Survival was estimated using the Kaplan-Meier method. Results: A total of 2,671 patients (1,030 Fidelis and 1,641 Quattro) were identified. There were 398 deaths: 147 in the Fidelis group (mean follow-up: 34.4 months) and 251 in the Quattro group (mean follow-up: 39.9 months). No deaths were associated with 85 Fidelis and 23 Quattro failures. At 4 years, survival was diminished in patients with Fidelis compared with Quattro leads (80.7% vs. 83.9%, p = 0.025). After adjustment for factors associated with mortality, survival was similar between groups. One hundred percent pacing was not associated with mortality. Elective removal of nonfailed leads was performed in 5.1% of Fidelis and 0.9% of Quattro patients. Conclusions: In a conservatively managed cohort, in whom observation was predominantly utilized, adjusted survival is similar between patients with Fidelis and Quattro ICD leads.

Original languageEnglish (US)
Pages (from-to)278-283
Number of pages6
JournalJournal of the American College of Cardiology
Volume58
Issue number3
DOIs
StatePublished - Jul 12 2011

Keywords

  • Fidelis
  • ICD lead
  • Quattro
  • implantable cardioverter-defibrillator
  • mortality

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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  • Cite this

    Morrison, T. B., Friedman, P. A., Kallinen, L. M., Hodge, D. O., Crusan, D., Kumar, K., Hayes, D. L., Rea, R. F., & Hauser, R. G. (2011). Impact of implanted recalled sprint fidelis lead on patient mortality. Journal of the American College of Cardiology, 58(3), 278-283. https://doi.org/10.1016/j.jacc.2011.03.027