ANTIBIOTIC-PROPHYLAXIS IN PERMANENT PACEMAKER IMPLANTATION - A PROSPECTIVE RANDOMIZED TRIAL

Background-Pacemaker pocket infection is a potentially serious problem after permanent pacemaker implantation. Antibiotic prophylaxis is com monly prescribed to reduce the incidence of this complication, but cur rent trial evidence of its efficacy is conflicting. A large prospectiv e randomised trial was therefore performed of antibiotic prophylaxis i n permanent pacemaker implantation. The intention was firstly to deter mine whether antibiotic prophylaxis is efficacious in these patients a nd secondly to identify which patients are at the highest risk of infe ction. Methods-A prospective randomised open trial of flucloxacillin ( clindamycin if the patient was allergic to penicillin) v no antibiotic was performed in a cohort of patients undergoing first implantation o f a permanent pacing system over a 17 month period. Intravenous antibi otics were started at the time of implantation and continued for 48 ho urs. The trial endpoint was a repeat operation for an infective compli cation. Results-473 patients were entered into a randomised trial. 224 received antibiotic prophylaxis and 249 received no antibiotics. A fu rther 183 patients were not randomised but were treated according to t he operator's preference (64 antibiotics, 119 no antibiotics); these p atients are included only in the analysis of predictors of infection. Patients were followed up for a mean (SD) of 19(5) months. Among the p atients in the randomised group there were nine infections requiring a repeat operation, all in the group not receiving antibiotic (P = 0.00 3). In the total patient cohort there were 13 infections, all but one in the non-antibiotic group (P = 0.006). Nine of the infections presen ted as erosion of the pulse generator or electrode, three as septicaem ia secondary to Staphylococcus aureus, and one as a pocket abscess sec ondary to Staphylococcus epidermidis. Infections were significantly mo re common when the operator was inexperienced (less than or equal to 1 00 previous patients), the operation was prolonged, or after a repeat operation for non-infective complications (principally lead displaceme nt). Infection was not significantly more common in patients identifie d preoperatively as being at high risk (for example patients with diab etes mellitus, patients receiving long term steroid treatment), althou gh there was a trend in this direction. Conclusions-Antibiotic prophyl axis significantly reduced the incidence of infective complications re quiring a repeat operation after permanent pacemaker implantation. It is suggested that antibiotics should be used routinely.