Olivier Piot1, Ronan Deballon2, Dorian Nitu3, Christelle Marquié4, Antoine da Costa5, Christophe Leclercq6, Pascal Defaye7, Nicolas Sadoul2. 1. Centre cardiologique du Nord, 32, rue des Moulins-Gémeaux, 93207 Saint-Denis cedex, France. Electronic address: o.piot@ccncardio.com. 2. Institut Lorrain du cœur et des vaisseaux, CHU de Nancy-Brabois, Vandœuvre-lès-Nancy, France. 3. Centre cardiologique du Nord, 32, rue des Moulins-Gémeaux, 93207 Saint-Denis cedex, France. 4. Centre hospitalier régional universitaire de Lille, Lille, France. 5. CHU de Saint-Étienne, Saint-Étienne, France. 6. CHU Pontchaillou, Rennes, France. 7. CHU Albert-Michallon, Grenoble, France.
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.
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.