Can we predict and prevent adverse events related to high-voltage implantable cardioverter defibrillator lead failure?

Abstract

Background: In 2007, great concern arose regarding failure of implantable cardioverter defibrillator (ICD) leads from several manufacturers.

Objective: Of this analysis was to evaluate the incidence and predictors of Sprint Fidelis lead failure in order to find the best clinical strategy to prevent lead-related adverse events.

Methods: Four hundred fourteen patients (357 male, 67 ± 12 years) with ICD equipped with right ventricular Sprint Fidelis leads were followed up in our institution.

Results: Over a median follow-up of 35 months (25th-75th percentile = 27-47 months) and a total follow-up of 1,231 patient-years, lead failures occurred in 40 of 414 (9.7%) patients. The annual rate was 3.2% per patient-year. Thirty-five (87.5%) failures were caused by pacing-sensing connector fracture. The risk of lead fracture was higher in patients younger than 70 years (odds ratio = 2.31; 95% confidence interval = 1.14-4.68, p = 0.02). Among 30 patients with pacing-sensing conductor failure and available device diagnostics for failure alerting, the diagnostic parameter which first responded to lead failure was the sensing integrity counter in 15 of 30 (50%), pacing impedance in 12 of 30 (40%), and non-sustained ventricular tachycardia in 3 of 30 (10%). The median time (25th-75th percentile) between diagnostics alert and lead failure-related adverse events or failure acknowledgment was 2.2 (0.3-13.0) days. Twenty-two patients suffered inappropriate shocks due to lead failure. In 50% of patients, daily monitoring by device diagnostics would have alerted physicians to impending lead failure at least 1 day in advance.

Conclusions: Automatic algorithms based on device diagnostics may detect impending lead failure in nearly 50% of cases. Remote monitoring may prevent failure-related adverse events.