Abstract 17989: Generator Exchange is Associated with an Increased Rate of Sprint Fidelis Lead Failure
Background: The Medtronic Sprint Fidelis defibrillator lead is at an increased risk for failure and was recalled in October 2007. Approximately 268,000 leads were implanted and more than 100,000 patients still have active Sprint Fidelis leads. A number of studies have examined the rate and clinical predictors of lead failure, but none have addressed the effect of ICD generator exchange on subsequent lead failure. Although the manufacture claims that “Sprint Fidelis performance after device change-out is similar to lead performance without device change-out,” published data is lacking.
Objective: The purpose of this study is to assess the effect of ICD generator exchange on the rate of Sprint Fidelis lead failure.
Methods: A retrospective chart review was conducted in all patients who underwent implantation of a Sprint Fidelis lead at one academic medical center. All patients who had a normally functioning Sprint Fidelis lead at the time of generator exchange and elected to retain the lead were compared to controls with leads implanted for a comparable amount of time who did not undergo ICD replacement.
Results: 668 patients received a Sprint Fidelis lead prior to the recall. 42 patients with a functioning lead underwent generator exchange without lead replacement. Following generator replacement, 4 leads failed within 3 months and an additional 4 within 1 year (19%). In comparison, 41 of 626 control leads malfunctioned during the study period, a total of 6.5%. Generator exchange significantly increased the rate of lead failure (19% vs. 6.5%, p < 0.05).
Conclusions: Generator exchange is associated with a higher than expected rate of Fidelis lead failure, often within 3 months. These data suggest that the benefit-risk ratio of Fidelis lead replacement at the time of ICD generator exchange may be greater than previously appreciated and that increased frequency of monitoring may be appropriate when the lead is retained.
- © 2011 by American Heart Association, Inc.