Small-Caliber Lead Failure After Generator Exchange

The Sprint Fidelis defibrillator lead (Medtronic) was recalled in 2007 due to an increased risk of failure. The generator exchange (GE) procedure has been associated with the development of Fidelis lead dysfunction. The aim of this study was to compare the rate of dysfunction between Sprint Fidelis and other defibrillator leads during the first year after GE.

A multicenter retrospective study involving patients from the UMBRELLA database who underwent GE with previous normal lead function and minimum follow-up of 1 year after the procedure was performed. The incidence of lead dysfunction was determined via remote monitoring and defined as pacing impedance > 1,500 ohm, high-voltage impedance > 100 ohm, R wave sensing under 2 mV, or the presence of VT/VF episodes classified as noise.

A total of 531 patients were included (114 Fidelis). In the first year after GE, the total incidence of lead dysfunction was 3.6%. No significant differences were found between Fidelis and the others in survival analysis (3.5% vs. 3.6%, respectively, log-rank 0.002, P = 0.962).

According to our results, the preventive removal/replacement of the Sprint Fidelis leads with normal function until GE is not a recommended practice since the rate of dysfunction after the procedure in this subgroup is no different compared with other defibrillator leads.