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

Abstract

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, P < .001) and subclavian access (hazard ratio 1.46, 95% confidence interval 1.18–1.81, P < .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.