Department of Cardiology, Isala Clinics, Zwolle, the Netherlands.
Neth Heart J. 2010 Jan;18(1):12-7.
Background. The Medtronic Sprint Fidelis ICD lead is prone to failure and the rate of failure seems to be increasing. The aim of this study was to investigate the rate of Sprint Fidelis lead failure, the characteristics, the mode of presentation and possible predictors of lead failure.Methods and Results. The rate, characteristics and presentation of Sprint Fidelis lead failure was assessed in this single-centre survey. 619 Sprint Fidelis ICD leads were implanted at our centre between December 2004 and August 2007. The mean follow-up was 32+/-10 (range 22-60) months; 35 patients (5.7%) required a lead re-implantation because of failure of the pace-sense conductor. Mean duration of lead survival was 23+/-12 (2-46) months and the rate of failure did not stabilise during follow-up. The mode of presentation was inappropriate shocks in 16 patients (45.7%), alarm alert in 12 patients (34.3%), and detection at routine follow-up in seven patients (20%). In 31 patients (89%), interrogation data revealed a sudden rise in impedance and/or frequent short VV intervals prior to lead failure and in five patients an isolated decrease of R wave (<2.5 mV). The interrogation data were not different from patients with shocks compared with patients without shocks. The interrogation data at routine follow-up in the first three months after implant were normal and stable.Conclusion. The rate of Sprint Fidelis lead failure reaches 5.7% at a mean follow-up duration of 32 months. The rate of failure does not seem to stabilise. Routine follow-up can not predict lead failure or prevent inappropriate shocks. (Neth Heart J 2010;18:12-7.).
背景。美敦力 Sprint Fidelis 心脏 ICD 导联易于发生故障,且故障发生率似乎呈上升趋势。本研究旨在探讨 Sprint Fidelis 导联故障的发生率、特点、表现形式以及可能的预测因素。
方法和结果。本单中心研究评估了 Sprint Fidelis 导联故障的发生率、特点和表现形式。2004 年 12 月至 2007 年 8 月期间,我们中心共植入 619 根 Sprint Fidelis ICD 导联。平均随访时间为 32+/-10(范围 22-60)个月;35 例患者(5.7%)因起搏感知导体故障需要重新植入导联。平均导联生存时间为 23+/-12(2-46)个月,且在随访期间故障率并未稳定。表现形式为 16 例患者(45.7%)发生不适当电击,12 例患者(34.3%)报警提示,7 例患者(20%)在常规随访中发现。在 31 例患者(89%)中,在导联故障发生前,检测数据显示阻抗突然升高和/或频繁出现短 VV 间期,5 例患者的 R 波孤立性降低(<2.5 mV)。检测数据与发生电击的患者相比,与未发生电击的患者无差异。植入后前三个月的常规随访中的检测数据正常且稳定。
结论。在平均 32 个月的随访期间,Sprint Fidelis 导联故障的发生率达到 5.7%。故障发生率似乎并未稳定。常规随访无法预测导联故障或防止不适当电击。(荷兰心脏杂志 2010;18:12-7。)