Repeated procedures at the generator pocket are a determinant of implantable cardioverter-defibrillator infection.

Background: Rates of cardiac-device infections have increased in recent years, but the current incidence and risk factors for infection in patients with implantable cardioverter-defibrillators (ICDs) are not well known.

Hypothesis: The increasing number of ICD infections is related to accumulated pocket manipulations over time.

Methods: This single-center, prospective study included patients that underwent ICD implantation from 2008 to 2015. The endpoint was time to infection. Multivariate analysis was performed to identify independent risk factors related to infection.

Results: The study included a total of 570 patients, of whom 419 (73.5%) underwent a first implantation. Mean age was 59 ± 14 years, and 80% were male. During a median follow-up of 36 months (interquartile range, 18-61 months; 1887 patient-years), infection was identified in 26 patients (4.56%), an incidence of 14.9 × 1000 patient-years. Median time to infection was 9.7 months (interquartile range, 1.35-23.4 months), and 38.5% were late infections (beyond 12 months of follow-up). In patients with replacement implants, the incidence was 3-fold higher than in first implantations (27.7 vs 9.1 × 1000 patient-years; P = 0.002). Cox regression identified 2 independent predictors of ICD infection: cumulative number of interventions at the generator pocket (hazard ratio: 1.92, 95% confidence interval: 1.42-2.6, P < 0.001) and pocket hematoma (hazard ratio: 7.0, 95% confidence interval: 2.7-17.9, P < 0.0001).

Conclusions: The incidence of infection in ICD patients is greater than previously reported, largely due to late infections. Each new cumulative intervention at the same generator pocket nearly doubles the risk of infection.