Impact of generator replacement on the risk of Fidelis lead fracture

Background: A dilemma arises about the merits of conservative management vs lead replacement and/or extraction when patients with a Medtronic Sprint Fidelis lead undergo generator replacement. Conflicting reports suggest that the fracture rate may increase after generator change.

Objective: The purpose of this study was to investigate the effect of generator replacement on Fidelis lead performance.

Methods: The Carelink PLUS cohort is composed of 21,500 Fidelis leads (model 6949) implanted in 1,006 centers. The survival rate for leads that remained active after the first generator replacement was compared with that for a control group with matched lead implant duration, patient age, patient sex, and generator type using the Kaplan-Meier method. The control group's starting point was adjusted to match the implant duration of each lead in the replacement group to allow for the comparison of similarly aged leads.

Results: Of the 2,988 implanted leads in each group, there was no statistical difference in the number of lead fractures between cases and controls (replacement, n = 227; no replacement, n = 257; Fisher exact, P = .169). Lead survival analysis demonstrated that lead performance since the first replacement procedure did not differ from that of the matched control group.

Conclusion: The Fidelis lead survival rate after generator replacement does not differ from that of the Fidelis leads that have not had replacement. In the event of generator replacement with no manifestation of lead fracture, the lead model, patient age and life expectancy, ejection fraction, comorbidities, ease of extraction, local extraction expertise, and patient preference should be considered to determine the best course of action.