Although rates of device infection were low with the use of incremental perioperative antibiotics for patients receiving cardiac implantable electronic devices (CIED), the observed difference in rates of infection compared with conventional perioperative antibiotic treatments was not statistically significant, according to a study published in the Journal of the American College of Cardiology.
This cluster randomized crossover design trial tested the clinical effectiveness of incremental periprocedural antibiotics for patients receiving CIEDs. During 4 randomly assigned, 6-month time periods, 28 cardiac centers either used conventional or incremental periprocedural antibiotic treatments for CIED surgery patients (N=19,603).
Conventional treatment included a single dose of IV cefazolin (or vancomycin for patients allergic to penicillin) before implantation procedures. Incremental treatment included preoperative vancomycin plus cefazolin (or vancomycin for patients allergic to penicillin), intraoperative wound wash with bacitracin diluted in saline before skin closure, and 2 days of oral cephalexin or cefadroxil post-procedure (or clindamycin for patients allergic to penicillin).
At sites where bacitracin was unavailable, a cefazolin or saline pocket wound wash was used. Hierarchical logistic regression modeling, adjusted for cluster-period and random cluster effects, was used to calculate the primary study outcome, which was hospitalization for proven pocket or CIED infection within one year of the implantation procedure.
Of the 19,603 CIED procedures, hospitalization for device infection occurred in 1.03% of patients in conventional treatment clusters (n=99), and 0.78% (n=78) of patients in incremental treatment clusters (odds ration [OR]=0.77; 95% CI, 0.56-1.05; P =.10).
Of the 12,842 patients considered high risk, hospitalization for device infection occurred in 1.23% of patients in conventional treatment clusters (n=77), and 1.01% of patients in incremental treatment clusters (n=66) (OR=0.82; 95% CI, 0.59-1.15; P =.26).
Researchers note that the cluster randomized crossover design, the choice of agents, and the pragmatic nature of the trial were potential limitations to this study.
Study investigators concluded, “This cluster randomized crossover trial failed to demonstrate a significant reduction in device infection with a policy of multiple-component incremental antibiotics, though a uniform effect across subgroups was noted.” They go on to add that the study did show the cluster crossover design was “highly efficient, practical, and inexpensive for testing changes in treatment policy, and the design could be used in many areas of medical and surgical practice.”
Krahn AD, Longtin Y, Philippon F, et al. Prevention of arrhythmia device infection trial: the PADIT trial. [published online December 18, 2018]. J Am Coll Cardiol. doi:10.1016/j.jacc.2018.09.068