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

ABSTRACT

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.