Long-term longevity and clinical outcomes of Linox S/SD implantable cardioverter-defibrillator leads: a single-center experience.

ABSTRACT

PURPOSE: Since the introduction of the Biotronik Linox S/SD leads in 2006, there have been multiple reports of premature lead failure. The purpose of this study was to investigate the longevity of the Linox S/SD leads and to identify the possible predictors of lead failure in a single tertiary implant center. METHODS: We retrospectively reviewed patients who underwent implantation of Linox S/SD leads or Sorin Vigila 1CR/2CR leads (the same Linox S/SD leads marketed by Sorin) at our center. The cumulative lead survival was estimated using the Kaplan-Meier curve, and variables associated with lead failure were assessed by Cox proportional hazard model. RESULTS: A total of 187 patients (154 (82%) male) underwent Linox S/SD or Vigila 1CR/2CR implantation between 2007 and 2013. During follow-up with a median time of 75 months, nine lead failures were identified (4.8%). The mean and median times from lead implantation to lead failure were 70.7 ± 21 months and 64 (45-111) months, respectively. The cumulative survival probability for the Linox S/SD at 5 years was 97.1% and at 12 years was 90.3%. Non-physiological high-rate sensing was the most common type of lead failure in patients. In two-thirds of these patients, this led to inappropriate shock. We did not find any significant relationships between patients' clinical and procedural characteristics and lead failure. CONCLUSIONS: At our center, the 5-year lead survival of the Linox S/SD has been better than reports from other centers. The majority of lead failures presented as non-physiological high-rate sensing with subsequent inappropriate therapy.