A single-centre experience concerning the safety of Sprint Fidelis defibrillator lead extraction at the time of pulse generator replacement or in case of evidence of lead failure

Abstract

Background: The reported failure rate of the Sprint Fidelis defibrillator lead (SFDL) has increased more than initially expected, with emerging evidence of accelerating fracture rates. Current consensus guidelines continue to discourage prophylactic lead extraction, citing major complication rates of 1.4-7.3%. Therefore, data relating to the risks of systematic SFDL extraction are lacking, with no methodical extraction protocol reported to date. Moreover, few statistical analyses have identified predictors of SFDL failure.

Objectives: The aims of this single-centre study were: to examine the safety and feasibility of systematic SFDL extraction at the time of pulse generator replacement or in case of lead failure; and to identify predictors of SFDL failure.

Methods: Between January 2005 and October 2007, 218 consecutive patients underwent transvenous SFDL implantation in our centre.

Results: During a mean follow-up of 43 ± 15 months, SFDL extraction was performed in 49 patients (22.5%) for the following reasons: inappropriate shocks (n = 21; 9.6%), systematic extraction at time of pulse generator extraction (n = 23; 10.5%), high impedance (n = 3; 1.4%), high SFDL threshold (n = 1; 0.4%) and cardiac device-related infection (n = 1; 0.4%). No severe complications occurred, although two minor complications were reported (lead dislodgments). SFDL fracture was observed in 25 patients (11.5%; 3.2%/year incidence). The only predictor associated with SFDL fracture was the number of leads (P = 0.01).

Conclusion: In our series, SFDL extraction at the time of pulse generator extraction or in case of evidence of lead failure was feasible and safe. Number of leads was identified as a new predictive factor for SFDL fracture.