Postoperative antibiotic prophylaxis in the prevention of cardiac implantable electronic device infection

BACKGROUND: The aim of the present study was to determine whether postprocedural antibiotic reduces the risk of infection related to the cardiac implantable electronic device (CIED) implantations. METHODS: The present investigation is a randomized, prospective, single-blinded controlled trial. All consecutive patients who presented for new CIED implantation, generator replacement, or upgrade were randomized into the following three groups: (A) no antibiotic, (B) intravenous (IV) antibiotic for 1 day, (C) 1 day IV plus 7 days oral antibiotic. Follow-up was performed on 10-12 days; 1, 3, 6 months; and then every 6 months for 2 years. The primary endpoint was any evidence of infection at the generator pocket or systemic infection related to the procedure at short-term (6-month) and long-term (2-year) follow-ups. RESULTS: Of the 450 patients (72 patients with cardiac resynchronization device) included in the study, the primary endpoint of short-term infection was reached in one patient (0.2%) in group A and no patients in groups B and C. The endpoint of long-term infection was reached in nine patients (2%) with equal frequency between three randomized groups (three patients in each group). On multivariable analysis, the only independent predictor of infection was defibrillator implantation (odds ratio, 8.5; 95% confidence interval, 1.6-45). CONCLUSIONS: The results of this prospective study showed no benefit for the postoperative antibiotic for the prevention of CIED infection.