van Malderen Sophie C H, Szili-Torok Tamas, Yap Sing C, Hoeks Sanne E, Zijlstra Felix, Theuns Dominic A M J
Departments of Cardiology, Erasmus MC, Rotterdam, The Netherlands.
Anesthesiology, Erasmus MC, Rotterdam, The Netherlands.
Heart Rhythm. 2016 Dec;13(12):2299-2305. doi: 10.1016/j.hrthm.2016.08.001. Epub 2016 Aug 2.
After the introduction of the Biotronik Linox S/SD high-voltage lead, several cases of early failure have been observed.
The purpose of this article was to assess the performance of the Linox S/SD lead in comparison to 2 other contemporary leads.
We used the prospective Erasmus MC ICD registry to identify all implanted Linox S/SD (n = 408), Durata (St. Jude Medical, model 7122) (n = 340), and Endotak Reliance (Boston Scientific, models 0155, 0138, and 0158) (n = 343) leads. Lead failure was defined by low- or high-voltage impedance, failure to capture, sense or defibrillate, or the presence of nonphysiological signals not due to external interference.
During a median follow-up of 5.1 years, 24 Linox (5.9%), 5 Endotak (1.5%), and 5 Durata (1.5%) leads failed. At 5-year follow-up, the cumulative failure rate of Linox leads (6.4%) was higher than that of Endotak (0.4%; P < .0001) and Durata (2.0%; P = .003) leads. The incidence rate was higher in Linox leads (1.3 per 100 patient-years) than in Endotak and Durata leads (0.2 and 0.3 per 100 patient-years, respectively; P < .001). A log-log analysis of the cumulative hazard for Linox leads functioning at 3-year follow-up revealed a stable failure rate of 3% per year. The majority of failures consisted of noise (62.5%) and abnormal impedance (33.3%).
This study demonstrates a higher failure rate of Linox S/SD high-voltage leads compared to contemporary leads. Although the mechanism of lead failure is unclear, the majority presents with abnormal electrical parameters. Comprehensive monitoring of Linox S/SD high-voltage leads includes remote monitoring to facilitate early detection of lead failure.
在引入百多力Linox S/SD高压导联后，观察到了几例早期失效的情况。
本文旨在评估Linox S/SD导联与其他两种当代导联相比的性能。
我们使用前瞻性伊拉斯谟医学中心植入式心律转复除颤器登记系统，识别出所有植入的Linox S/SD导联（n = 408）、Durata导联（圣犹达医疗公司，型号7122）（n = 340）和Endotak Reliance导联（波士顿科学公司，型号0155、0138和0158）（n = 343）。导联失效的定义为低电压或高电压阻抗、不能夺获、感知或除颤，或存在非生理性信号（并非由外部干扰所致）。
在中位随访5.1年期间，24根Linox导联（5.9%）、5根Endotak导联（1.5%）和5根Durata导联（1.5%）失效。在5年随访时，Linox导联的累积失效率（6.4%）高于Endotak导联（0.4%；P <.0001）和Durata导联（2.0%；P =.003）。Linox导联的发生率（每100患者年1.3例）高于Endotak导联和Durata导联（分别为每100患者年0.2例和0.
