Division of Clinical Electrophysiology, Department of Cardiology and Pneumology, University Medical Center Göttingen, Georg-August-University, Robert-Koch-Str. 40, 37075 Göttingen, Germany.
Europace. 2014 Feb;16(2):258-64. doi: 10.1093/europace/eut185. Epub 2013 Jun 28.
To evaluate passive-fixation lead failure rates and long-term patient survival in subjects implanted with Sprint Fidelis electrodes.
We identified 748 subjects who received a Sprint Fidelis (n = 429; Medtronic models 6948: 94.8%, 6949: 2.6%, 6930: 1.9%, 6931: 0.7%) or a Sprint 'non-Fidelis' implantable cardioverter defibrillator lead (n = 319, Medtronic models 6944: 68.6%, 6947: 17.9%, 6942: 7.8%, 6943: 3.4%, 6945: 2.2%) at our centre between 1998 and 2008. Kaplan-Meier patient survival was lower in the Fidelis group than in the Control cohort (68.4 vs. 77.0% at 5 years, P = 0.0061), but multivariate analyses revealed no significant association between mortality and implanted lead type. Passive-fixation lead failure rate at 5 years was 14.4% (95% confidence interval (CI) [9.2, 19.3]) in the Fidelis (n = 414) group and 1.8% (95% CI [0.0-3.8]) in the Control (n = 241) cohort (P < 0.001 upon multivariate comparison).
Failure rates of passive-fixation Sprint Fidelis leads are increased and similar to those previously reported for active-fixation Fidelis electrodes. Despite the elevated risk for lead failure and its potential sequelae, the Sprint Fidelis has no obvious impact on long-term mortality.
评估植入 Sprint Fidelis 电极的患者中被动固定导联的失败率和长期患者生存率。
我们确定了 748 名在我们中心接受 Sprint Fidelis（n = 429；Medtronic 模型 6948：94.8%，6949：2.6%，6930：1.9%，6931：0.7%）或 Sprint 非 Fidelis 植入式心脏复律除颤器导联植入的患者（n = 319，Medtronic 模型 6944：68.6%，6947：17.9%，6942：7.8%，6943：3.4%，6945：2.2%）。在我们中心接受 Sprint Fidelis 或 Sprint 非 Fidelis 植入式心脏复律除颤器导联植入的患者，在我们中心接受 Sprint Fidelis 或 Sprint 非 Fidelis 植入式心脏复律除颤器导联植入的患者，Kaplan-Meier 患者生存率在 Fidelis 组低于对照组（5 年时 68.4%对 77.0%，P = 0.0061），但多变量分析显示死亡率与植入导联类型之间无显著关联。在 Fidelis 组（n = 414）和对照组（n = 241）中，5 年时被动固定导联失败率分别为 14.4%（95%置信区间（CI）[9.2，19.3]）和 1.8%（95%CI [0.0-3.8]）（多变量比较时 P < 0.001）。
被动固定 Sprint Fidelis 导联的失败率增加，与之前报道的主动固定 Fidelis 电极相似。尽管被动固定 Sprint Fidelis 导联失败风险增加及其潜在后果，但对长期死亡率无明显影响。
