Abstract 14686: Behaviour of a Population of Patients with the Sprint Fidelis Lead
Background: The Medtronic Sprint Fidelis ICD lead was recalled in October 2007 due to a high rate of fracture. The true incidence, pattern and outcome of lead failure have been controversial subjects. In particular, failure rates may be inaccurate due to referral bias in large centers. British Columbia (BC) has a population of 4.4 million people yet only 2 centers implanted ICD systems during the time this lead was used. Due to the nature of the publicly funded medical system, geography and low rates of emigration, analysis of this group provides valid population rates. We performed a detailed retrospective analysis of the largest of these 2 groups and determined the failure rate, time to lead failure, rate of intervention and death rate.
Methods and Results: All ICD implants in BC are recorded in a Provincial device registry. An original list of patients receiving this lead was derived from this registry and meticulous data collection was then performed using multiple sources including Pace-art, chart review, and telephone interview with outside physicians and patients. 346 patients received 350 SF leads. Only 7 were lost to follow-up (2%). Median follow-up was 4.03 years (2.88, 4.77). Almost one third (28.29%) of the group had a Fidelis lead related procedure, including laser extraction, addition of a pace-sense or ICD lead and transplant (10 patients). Lead failure occurred in 13.14% or 46 of the patients at a median time of 2.86 years (2.32, 3.51). The vast majority of lead failures occurred in year 2 post -implant. Over 20% of the population died (71/346) with a median time to death of 2.56 years (1.02, 3.95). To date just over half of the population still has an intact lead or is alive.
Conclusion: To our knowledge this is the first population-based analysis of a group of patients with a recalled device lead. The mortality rate of 20% at 3 years highlights the frailty of this group. Incidence of lead fracture is highest in the second year post implant and appears to stabilize thereafter.
- © 2011 by American Heart Association, Inc.