Abstract 4659: Risk of Failure of Transvenous Implantable Cardioverter Defibrillator Leads
Despite the positive effect on mortality in selected patients, implantable cardioverter defibrillator (ICD) therapy is also associated with potential malfunction of the implanted system. Objective comparing data on lead models is scarce. The present study provides the long-term failure rate in a large cohort. Since 1992, all ICD-recipients in the Leiden University Medical Center were registered in a standardized database system. Data of the implant procedure and all periodical three-six months follow-up visits were recorded. All cases of lead removal or capping, or placing of an additional pace or sense lead because of lead failure were noted. For analysis purpose, leads models were grouped by manufacturer and approximate lead diameter in French (Fr). A total of 2161 defibrillation leads were followed for a mean of 36 months. Eighty-two (3.8%) cases of lead failure were identified. Cumulative incidence of lead failure-free follow-up at one year was 99.4%, at two years 98.6%, at five years 93.5% and 83.6% at ten years. Kaplan-Meier curves for the different groups of leads are shown in Figure 1⇓, where the bold line represents all 2161 leads together and the dashed lines the specific group. Highest failure rates were found in the small diameter leads with up to 2.8 (95% CI 1.6 – 4.5) per 100 lead-years for Medtronic 7Fr and St Jude Medical 7Fr combined. In this large single-center experience, the overall incidence of lead failure is 1.3 (95% CI 1.0 –1.6) per 100 lead-years. Comparison of different groups of leads shows major differences in event rates. Small diameter defibrillation leads seem to be prone to early lead failure.