Incremental perioperative antibiotics did not significantly reduce 1-year hospitalization for device infection in high-risk patients vs conventional prophylaxis (OR 0.82; 95% CI 0.59-1.15; p=0.26).
RCT (n=19,603)
Cluster randomized crossover
Yes
Does incremental perioperative antibiotics reduce 1-year hospitalization for device infection in patients undergoing cardiac implantable electronic device procedures?
An incremental perioperative antibiotic regimen did not significantly reduce the rate of 1-year hospitalization for device infection compared to conventional pre-procedural cefazolin in patients undergoing cardiac device procedures.
Effect estimate: OR 0.82 (95% CI 0.59 to 1.15)
Absolute Event Rate: 1.01% vs 1.23%
p-value: p=0.26
BACKGROUND Infection of implanted medical devices has catastrophic consequences. For cardiac rhythm devices, pre-procedural cefazolin is standard prophylaxis but does not protect against methicillin-resistant gram-positive organisms, which are common pathogens in device infections. OBJECTIVE This study tested the clinical effectiveness of incremental perioperative antibiotics to reduce device infection. METHODS The authors performed a cluster randomized crossover trial with 4 randomly assigned 6-month periods, during which centers used either conventional or incremental periprocedural antibiotics for all cardiac implantable electronic device procedures as standard procedure. Conventional treatment was pre-procedural cefazolin infusion. Incremental treatment was pre-procedural cefazolin plus vancomycin, intraprocedural bacitracin pocket wash, and 2-day post-procedural oral cephalexin. The primary outcome was 1-year hospitalization for device infection in the high-risk group, analyzed by hierarchical logistic regression modeling, adjusting for random cluster and cluster-period effects. RESULTS Device procedures were performed in 28 centers in 19,603 patients, of whom 12,842 were high risk. Infection occurred in 99 patients (1.03%) receiving conventional treatment, and in 78 (0.78%) receiving incremental treatment (odds ratio: 0.77; 95% confidence interval: 0.56 to 1.05; p = 0.10). In high-risk patients, hospitalization for infection occurred in 77 patients (1.23%) receiving conventional antibiotics and in 66 (1.01%) receiving incremental antibiotics (odds ratio: 0.82; 95% confidence interval: 0.59 to 1.15; p = 0.26). Subgroup analysis did not identify relevant patient or site characteristics with significant benefit from incremental therapy. CONCLUSIONS The cluster crossover design efficiently tested clinical effectiveness of incremental antibiotics to reduce device infection. Device infection rates were low. The observed difference in infection rates was not statistically significant. (Prevention of Arrhythmia Device Infection Trial PADIT Pilot PADIT; NCT01002911).
“Infections of these devices, while not very common, can have a long-lasting and devastating impact on patients. It's really important that we explore robust measures to prevent infections from occurring. Our results show that incremental antibiotics strategy can have a modest, positive effect when the infection rate is low. We hope that our study will help clinicians identify patients that may benefit from this treatment option and utilize a targeted, high intensive antibiotic strategy to reduce and prevent infections.”
Krahn et al. (Sat,) conducted a rct in Cardiac implantable electronic device procedures (n=19,603). Incremental periprocedural antibiotics vs. Conventional treatment (pre-procedural cefazolin infusion) was evaluated on 1-year hospitalization for device infection in the high-risk group (OR 0.82, 95% CI 0.59 to 1.15, p=0.26). Incremental perioperative antibiotics did not significantly reduce 1-year hospitalization for device infection in high-risk patients vs conventional prophylaxis (OR 0.82; 95% CI 0.59-1.15; p=0.26).