title: 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.
  
  
  OBJECTIVE
  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.
authors: Centre cardiologique du Nord, 32, rue des Moulins-Gémeaux, 93207 Saint-Denis cedex, France. Electronic address: o.piot@ccncardio.com.
authors: Olivier
authors: O
authors: Piot
authors: Institut Lorrain du cœur et des vaisseaux, CHU de Nancy-Brabois, Vandœuvre-lès-Nancy, France.
authors: Ronan
authors: R
authors: Deballon
authors: Centre cardiologique du Nord, 32, rue des Moulins-Gémeaux, 93207 Saint-Denis cedex, France.
authors: Dorian
authors: D
authors: Nitu
authors: Centre hospitalier régional universitaire de Lille, Lille, France.
authors: Christelle
authors: C
authors: Marquié
authors: CHU de Saint-Étienne, Saint-Étienne, France.
authors: Antoine
authors: A
authors: da Costa
authors: CHU Pontchaillou, Rennes, France.
authors: Christophe
authors: C
authors: Leclercq
authors: CHU Albert-Michallon, Grenoble, France.
authors: Pascal
authors: P
authors: Defaye
authors: Institut Lorrain du cœur et des vaisseaux, CHU de Nancy-Brabois, Vandœuvre-lès-Nancy, France.
authors: Nicolas
authors: N
authors: Sadoul
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005602:France; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012042:Registries; D012307:Risk Factors; D013997:Time Factors
keywords: Defibrillator; Défibrillateur; Facteurs de risque; Fracture d’électrode; Inappropriate therapies; Lead fracture; Risk factors; Sprint Fidelis lead; Thérapies inappropriées; Électrode Sprint Fidelis