Piot Olivier, Deballon Ronan, Nitu Dorian, Marquié Christelle, da Costa Antoine, Leclercq Christophe, Defaye Pascal, Sadoul Nicolas
Centre cardiologique du Nord, 32, rue des Moulins-Gémeaux, 93207 Saint-Denis cedex, France.
Institut Lorrain du cœur et des vaisseaux, CHU de Nancy-Brabois, Vandœuvre-lès-Nancy, France.
Arch Cardiovasc Dis. 2015 Apr;108(4):220-6. doi: 10.1016/j.acvd.2014.11.006. Epub 2015 Apr 6.
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.
We established a multicentre registry to determine the lead fracture rate and predictors of fracture in a large cohort of French patients.
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.
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.
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.
自2007年以来，直径较小的Sprint Fidelis除颤导线因其异常高的断裂率而未再植入患者体内。在多项研究中确定了导线断裂风险的预测因素，主要是在北美进行的研究。
我们建立了一个多中心登记处，以确定一大群法国患者中导线的断裂率及断裂的预测因素。
该登记处纳入了2004年12月至2007年11月期间在六个中心植入Sprint Fidelis导线的986例患者。
平均随访51.4±20个月，平均断裂率为11.2%，且随时间增加：1年时为1.2%，2年时为3.8%，3年时为7.4%，4年时为13.9%，5年时为20.7%。在多变量分析中，与年龄≥40岁的患者相比，年龄<40岁与更高的断裂风险相关，40至60岁的患者相对风险为0.53（95%置信区间[CI]0.29 - 0.98），年龄>60岁的患者相对风险为0.45（95%CI 0.24 - 0.84），以及胸肌下植入（3年时）相对风险为2.35（95%CI 1.29 - 4.28）。与6949型号（双线圈、主动固定）相比，6930型号（单线圈、被动固定）导线的相对风险为3.47（95%CI 1.13 - 10.7）。未发现其他断裂预测因素。
在一大群植入Sprint Fidelis电极的法国多中心患者中，断裂率仍然很高，尤其是在胸肌下植入的年轻患者和6930电极型号的患者中。
