Remarkably high and accelerating failure rate of a widely used implantable cardioverter-defibrillator lead: A large-scale manufacturer-independent multicenter study with long accurate follow-up.

Background: A high annual failure rate of the Linox family defibrillator lead was reported in various small single-center studies. No independent multicenter long-term performance information exists for this lead.

Objective: Our aim was to assess the longevity of the Linox family leads and to evaluate clinical variables and adverse events associated with failure.

Methods: This 4-center study included adults >18 years of age who received Linox family leads for the prevention of sudden cardiac death. From November 2006 to November 2016, a total of 3993 high-voltage leads of the Linox family were implanted and followed up on.

Results: The absolute failure rate was 10.6% (dwell time to lead failure of 6.3 ± 3.4 years). Multivariate analysis confirmed younger age (for every 5 years younger than 65 years) (hazard ratio 1.09, 95% confidence interval 1.05-1.14, < .001) and subclavian access (hazard ratio 1.46, 95% confidence interval 1.18-1.81, < .001) as independent risk factors for lead failure. Patients frequently presented themselves with inappropriate shocks (20% in patients with lead failure) due to detection of nonphysiologic high-rate signals/noise.

Conclusion: This is the largest physician-driven multicenter study on the very long-term performance of Linox family leads. Our data report a remarkably high failure rate of these leads. Our findings have significant implications for the management of patients. Monitoring by remote care should be available for all active Linox family leads.