Study finds Sprint Fidelis lead fractures “increasing exponentially”

A large single-center study finds that the rate of Spring Fidelis lead fracture “is increasing exponentially with time and… occurring at a higher rate than the latest manufacturer’s performance update.” The study from the University of Rochester appears in the January 1 issue of the American Journal of Cardiology.

Based on 1,056 years of combined follow-up, the Rochester group found an 8.92% (38 of 426) failure rate. At 3 years the survival rate was 90.8%. The authors reported a 3.60% fracture rate per year and commented that “the rate we observed is considerably higher than the approximately 3% fracture rate at 3 years seen in the Medtronic CareLink study.”

The authors found that the chance a lead that was functioning normally at 1 year would survive another year was 97.4%, at two years the chance of surviving another year was 94.7%, and at 3 years the chance of surviving another year was 86.7%. According to the authors, other ICD leads have shown “no evidence of increased failure rates.”

The authors write that they “concur with the advocacy that detection of a lead fracture mandates a rapid response to deactivate the device as rapidly as possible, i.e., within hours of diagnosis” and that “increasing fracture rates with time tends to make a stronger case for lead replacement in a patient already undergoing ICD system operation, although such decisions should be individualized, weighing age, venous patency, pacemaker dependency, other morbidities, and patient wishes. Overall, we believe further data showing a higher fracture rate would be needed before such a recommendation would be appropriate.”

William Maisel told CardioBrief that he thinks “the Fidelis data is useful and provides additional information about failure rates, etc.  Most notable was that the annual failure rate in that study was increasing (i.e. it does not appear to be a constant rate).  This is an important observation with potential implication for patient care.”

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