Antibiotic Prophylaxis in Pacemaker Surgery; A Prospective Trial With Local or Systemic Administration of Antibiotics at Generator Replacements

Abstract

To evaluate the effect of short‐term antibiotic prophylaxis at pacemaker surgery, consecutive patients scheduled for routine generator replacements were randomly assigned to a double blind study. One group received systemic prophylactic (SP) antibiotics and one group was given local prophylactic (LP) antibiotics. One‐hundred and eight patients entered the study, but three were subsequently excluded. The SP group received flucloxacillin 2 gm intravenously 1 hour before surgery, then 1 gm orally every 8 hours for the following 5 days. In the LP group, 10 ml of a dextran emulsion with 5% cloxacillin was instilled in the generator pocket at the end of the operation. Infection developed in 0/53 in the SP group and 2/52 in the LP group. Tissue fluid was drawn 24 hours postoperatively from the generator pocket for determination of pocket concentration of antibiotics and culture tests. The concentration of flucloxacillin in tissue fluid from the pacemaker pocket 1 day postoperatively could be measured in 29 patients in the SP group with a median of 7.2 μg/ml. Median level of pocket fluid concentration of cloxacillin was 58.5 μg/ml in 31 patients in the LP group. Bacteriological cultures were positive in 1/32 patients in the SP group and in 1/33 in the LP group, but none of these patients developed infection. In conclusion, there was a low infection rate, both with systemic prophylaxis with flucloxacillin for a short period of time and with local prophylaxis with cloxacillin perioperatively.