Factors predicting Sprint Fidelis lead fracture: Results at 5 years from a French multicentre registry

Abstract

Background: The small diameter Sprint Fidelis defibrillation lead has not been implanted in patients since 2007 due to its unusually high rate of fracture. Predictors of lead fracture risk were identified in several studies, mainly in North American studies.

Aim: We established a multicentre registry to determine the lead fracture rate and predictors of fracture in a large cohort of French patients.

Methods: Nine hundred and eighty-six patients implanted with a Sprint Fidelis lead at six centres between December 2004 and November 2007 were included in this registry.

Results: Over a mean follow-up of 51.4±20 months, the mean fracture rate was 11.2%, and increased over time: 1.2% at 1 year, 3.8% at 2 years, 7.4% at 3 years, 13.9% at 4 years, and 20.7% at 5 years. In multivariable analysis, younger age (<40 years) was associated with a higher risk of fracture compared to patients<40 years, patients aged between 40-60 years had a relative risk of 0.53 (95% confidence interval [CI] 0.29-0.98) and patients>60 years had a relative risk of 0.45 (95% CI 0.24-0.84) and subpectoral implantation (at 3 years) with a relative risk of 2.35 (95% CI 1.29-4.28). Lead model 6930 (single-coil, passive-fixation) had a relative risk of 3.47 (95% CI 1.13-10.7) compared with the 6949 model (double coil, active-fixation). No other predictor of fracture was identified.

Conclusions: In a large multicentre cohort of French patients implanted with a Sprint Fidelis electrode, the fracture rate remains high, especially in young patients with submuscular implant and the 6930 electrode model.

Keywords: Defibrillator; Défibrillateur; Facteurs de risque; Fracture d’électrode; Inappropriate therapies; Lead fracture; Risk factors; Sprint Fidelis lead; Thérapies inappropriées; Électrode Sprint Fidelis.