Pérez Díez Diego, Rubín José Manuel, Calvo Cuervo David, García Iglesias Daniel, Morís De La Tassa César
Arrhythmia Unit, Cardiology Department, Hospital Universitario Central de Asturias, Oviedo, Spain.
Pacing Clin Electrophysiol. 2018 Sep;41(9):1165-1170. doi: 10.1111/pace.13385. Epub 2018 Jul 11.
Early failure of Biotronik Linox and Linox Smart leads (Biotronik, Berlin, Germany) has been reported in numerous recent publications. The aim of this study was to assess the performance of this lead compared with that of two other contemporary leads.
We conducted an ambispective study of all consecutive first implantations of defibrillator leads carried out in our center: Endotak (model 148, 158, Boston Scientific, Marlborough, MA, USA) (n = 173), Sprint Quattro (model 6644, 6947, Medtronic, Dublin, Ireland) (n = 145), and Linox Smart (Biotronik, model SD 65/16) (n = 120).
During a median follow-up of 4.6 ± 2.1 years, failure occurred in nine Linox Smart (7.5%), one Endotak Reliance (0.6%), and no Sprint Quattro leads. The survival probability of the Linox Smart group was significantly lower than that of the Endotak and Sprint Quattro groups measured by the log-rank test (Linox vs Endotak; P < 0.001 and Linox vs Sprint Quattro; P < 0.001). Nonphysiological signals not due to external interference were observed in all Linox Smart leads, with normal parameters and without visible anomalies on chest x-ray.
In this single-center experience, the survival rate of Linox Smart leads was 88% at 5 years of follow-up, which was significantly lower than that of the other leads. Comprehensive vigilance of Linox Smart leads, including home monitoring, may be advisable to facilitate early detection of lead failure and avoid inappropriate shocks.
近期众多出版物报道了百多力公司的Linox和Linox Smart导线（德国柏林百多力公司）早期失效的情况。本研究旨在评估该导线与其他两种同期导线相比的性能。
我们对在本中心连续进行的所有首次植入除颤导线进行了一项前瞻性研究：Endotak（型号148、158，美国马萨诸塞州马尔伯勒市波士顿科学公司）（n = 173）、Sprint Quattro（型号6644、6947，爱尔兰都柏林美敦力公司）（n = 145）以及Linox Smart（百多力公司，型号SD 65/16）（n = 120）。
在中位随访4.6±2.1年期间，9根Linox Smart导线（7.5%）、1根Endotak Reliance导线（0.6%）出现失效，而Sprint Quattro导线未出现失效。通过对数秩检验测量，Linox Smart组的生存概率显著低于Endotak组和Sprint Quattro组（Linox与Endotak比较；P < 0.001，Linox与Sprint Quattro比较；P < 0.001）。在所有Linox Smart导线上均观察到非外部干扰导致的非生理性信号，参数正常且胸部X线未见明显异常。
在本单中心经验中，Linox Smart导线在随访5年时的生存率为88%，显著低于其他导线。对Linox Smart导线进行全面监测，包括家庭监测，可能有助于早期发现导线失效并避免不适当电击。
