Analysis of early failure of Biotronik Linox Smart implantable cardioverter‐defibrillator leads: A comparative study of three defibrillator leads

BACKGROUND AND OBJECTIVES: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.