Efficacy of Antibiotic Prophylaxis in Device Implantation

The administration of prophylactic antibiotics before pacemaker or internal cardioverter-defibrillator implantation has been implemented widely and routinely. The acceptance of this practice has occurred despite the absence of rigorous examination or definitive evidence. The existing data for the use of prophylactic antibiotic therapy in device implantation consist of 7 randomized, controlled trials, with all but 1 having an open design.1 Early trials yielded contradictory results, citing small study numbers, a low incidence of infection, and inconsistent definitions of infection as possible explanations.2–4 Four of the 7 trials found antibiotic prophylaxis effective in preventing infection; the lone double-blind, randomized, controlled study consisted of 106 patients and failed to demonstrate a difference in infection rate with antibiotic prophylaxis because there were no documented infections at 7 to 35 months of follow-up.3 In addition to their inconsistent results, widely varying antibiotic regimens were implemented in these trials, further confounding the ability of operators to interpret the available data and to implement evidence-based medicine into practice. Despite the equivocal findings of these individual studies, a meta-analysis of antibiotic prophylaxis for permanent pacemaker implantation by Da Costa et al1 in 1998 demonstrated a significant reduction in the incidence of infection. The study in this issue of Circulation: Arrhythmia and Electrophysiology by de Oliveira et al5 is the first large-scale, randomized, double-blind, placebo-controlled trial establishing the benefit of antibiotic prophylaxis in prevention of device implant infections.