title: Clinical outcomes in patients with implantable cardioverter defibrillators and Sprint Fidelis leads.
abstract: OBJECTIVE
  The performances of implantable cardioverter defibrillators and leads are important issues for healthcare providers and patients. In 2007 Sprint Fidelis leads were found to be associated with an increased failure rate and so the purpose of the study was to evaluate long-term mortality and clinical outcomes in patients implanted with Sprint Fidelis leads compared with Sprint Quattro leads.
  
  
  METHODS
  508 patients with Sprint Fidelis leads and 468 with Sprint Quattro leads were prospectively followed in 12 Italian cardiology centres.
  
  
  METHODS
  Information on hospitalisations and other clinical events were collected during scheduled and unscheduled hospital visits. Deaths were identified from medical records or via phone contacts with patients' family members or through the National Office of Vital Statistics.
  
  
  RESULTS
  Over a mean follow-up of 27±18 months 141 deaths occurred in the overall population. No death was observed in patients with diagnosed failing lead. Kaplan-Meier patient survival differed between the two lead groups (80±2% in Fidelis leads vs 70±4% in the Sprint Quattro leads at 4 years, p=0.002). Multivariate analyses showed that mortality was neither associated with lead type nor with diagnosed failed lead. The annual rate of lead failure was 1.8% patient-year for Fidelis leads and 0.2% for the Sprint Quattro leads.
  
  
  CONCLUSIONS
  In our multicentre research, the clinical outcomes of patients with Fidelis leads differed from those of patients with Sprint Quattro leads. Nevertheless, neither mortality nor the combined endpoint of mortality and heart failure hospitalisations was associated with the lead type. http://clinicaltrials.gov/ct2/show/NCT01007474.
authors: Department of Cardiology, General Hospital Cosma, Via P Cosma 1, Camposampiero 35012, Italy. roberto.verlato@libero.it
authors: Roberto
authors: R
authors: Verlato
authors: Domenico
authors: D
authors: Facchin
authors: Domenico
authors: D
authors: Catanzariti
authors: Giulio
authors: G
authors: Molon
authors: Gabriele
authors: G
authors: Zanotto
authors: Giovanni
authors: G
authors: Morani
authors: Marco
authors: M
authors: Brieda
authors: Francesco
authors: F
authors: Zanon
authors: Pietro
authors: P
authors: Delise
authors: Loira
authors: L
authors: Leoni
authors: Jennifer
authors: J
authors: Comisso
authors: Claudia
authors: C
authors: Campo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001145:Arrhythmias, Cardiac / Q000401:mortality / Q000628:therapy*; D017147:Defibrillators, Implantable; D004567:Electrodes, Implanted; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D055815:Young Adult