title: Impact of implanted recalled sprint Fidelis lead on patient mortality.
abstract: OBJECTIVE
  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.
authors: Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.
authors: Thomas B
authors: TB
authors: Morrison
authors: Paul A
authors: PA
authors: Friedman
authors: Linda M
authors: LM
authors: Kallinen
authors: David O
authors: DO
authors: Hodge
authors: Daniel
authors: D
authors: Crusan
authors: Kapil
authors: K
authors: Kumar
authors: David L
authors: DL
authors: Hayes
authors: Robert F
authors: RF
authors: Rea
authors: Robert G
authors: RG
authors: Hauser
mesh_terms: D001145:Arrhythmias, Cardiac / Q000209:etiology / Q000401:mortality / Q000628:therapy; D016757:Death, Sudden, Cardiac / Q000209:etiology*; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004567:Electrodes, Implanted / Q000009:adverse effects*; D004868:Equipment Failure; D005260:Female; D006801:Humans; D008297:Male