Padfield Gareth J, Steinberg Christian, Karim Shahzad S, Tung Stanley, Bennett Matthew T, Le Maitre John P, Bashir Jamil
Divisions of Cardiovascular Surgery and Cardiology, University of British Columbia, St. Paul's Hospital, Vancouver, Canada.
J Cardiovasc Electrophysiol. 2015 Mar;26(3):274-81. doi: 10.1111/jce.12583. Epub 2014 Dec 22.
The Linox and Durata implantable cardioverter defibrillator (ICD) leads were introduced to British Columbia (BC) in 2008. We determined their performance and the potential risk factors for lead failure in a large population-based patient registry.
We used the BC Cardiac Registry, a mandatory Governmental database of ICD implants, to identify all recipients of Linox and Durata leads in BC between October 2008 and April 2012, and those subsequently undergoing reoperation. Lead failure was defined as recurrent nonphysiological high-rate sensing unrelated to external electromagnetic interference or T-wave oversensing; a sudden rise in impedance unrelated to perforation or lead dislodgement; or abnormal lead parameters with definite evidence of lead fracture or insulation failure. We determined the estimated cumulative lead survival by the Kaplan-Meier method, and the risk factors for lead failure in a proportional hazards model. Over a median of 39 (27-50) months, the Linox failed more frequently than the Durata (16/477 [3.4%] vs. 4/838 [0.4%]; P < 0.001), and had a significantly lower estimated cumulative survival (91.6 [80.6-96.5]% vs. 99.4 [98.4-99.8]% at 5 years; P < 0.0001). Linox failure was characterized by high-rate nonphysiological sensing (11 cases), and/or a sudden impedance rise (7 cases). Insulation failure was clearly confirmed in 6 cases of Linox failure. Female sex was a significant risk factor for Linox failure (adjusted HR = 2.1[1.3-3.4]; P = 0.004).
This multicenter registry indicates a high rate of Linox lead failure, particularly in female patients. Ongoing surveillance of the Linox ICD lead performance is recommended.
Linox和Durata植入式心律转复除颤器（ICD）导线于2008年引入不列颠哥伦比亚省（BC省）。我们在一个大型的基于人群的患者登记系统中确定了它们的性能以及导线故障的潜在风险因素。
我们使用BC省心脏登记系统，这是一个政府强制要求的ICD植入数据库，以识别2008年10月至2012年4月期间BC省所有接受Linox和Durata导线植入的患者，以及随后接受再次手术的患者。导线故障定义为与外部电磁干扰或T波感知过度无关的反复非生理性高频率感知；与穿孔或导线移位无关的阻抗突然升高；或有明确导线断裂或绝缘故障证据的异常导线参数。我们通过Kaplan-Meier方法确定估计的累积导线生存率，并在比例风险模型中确定导线故障的风险因素。在中位随访39（27 - 50）个月期间，Linox导线比Durata导线更频繁地发生故障（16/477 [3.4%] 对比 4/838 [0.4%]；P < 0.001），并且估计的累积生存率显著更低（5年时为91.6 [80.6 - 96.5]% 对比 99.4 [98.4 - 99.8]%；P < 0.0001）。Linox导线故障的特征为高频率非生理性感知（11例）和/或阻抗突然升高（7例）。在6例Linox导线故障中明确证实存在绝缘故障。女性是Linox导线故障的一个显著风险因素（调整后HR = 2.1[1.3 - 3.4]；P = 0.004）。
这个多中心登记系统表明Linox导线故障率很高，尤其是在女性患者中。建议对Linox ICD导线性能进行持续监测。
