May 18, 2026Journal of the American College of Cardiology
Prevention of Arrhythmia Device Infection Trial
Key result
Incremental perioperative antibiotics fail to reduce device infection hospitalizations vs conventional prophylaxis in high-risk patients.
- OR 0.82
- 95% CI 0.59 to 1.15
- P=0.26
- n=19,603
Why the study?
Standard pre-procedural cefazolin prophylaxis does not protect against methicillin-resistant gram-positive organisms, which are common pathogens in cardiac rhythm device infections.
Does incremental perioperative antibiotics reduce 1-year hospitalization for device infection in patients undergoing cardiac implantable electronic device procedures?
Key Points
- To assess whether an incremental perioperative antibiotic regimen reduces 1-year infection rates compared with standard prophylaxis in patients receiving cardiac implantable electronic devices.
- Cluster randomized crossover trial conducted across 28 centers involving 19,603 patients undergoing device procedures (12,842 classified as high risk) over four 6-month periods (NCT01002911).
- Centers alternated between conventional prophylaxis (pre-procedural cefazolin) and incremental treatment (pre-procedural cefazolin plus vancomycin, intraprocedural bacitracin pocket wash, and 2-day oral cephalexin).
- The primary endpoint was 1-year hospitalization for device infection in high-risk patients, evaluated using hierarchical logistic regression models adjusting for cluster-period effects.
- Among high-risk patients, infection-related hospitalization occurred in 77 patients (1.23%) on conventional therapy versus 66 patients (1.01%) on incremental therapy (OR: 0.82; 95% CI: 0.59 to 1.15; p = 0.26).
- Across the entire cohort, infections occurred in 99 patients (1.03%) with conventional treatment compared to 78 patients (0.78%) with incremental treatment (OR: 0.77; 95% CI: 0.56 to 1.05; p = 0.10).
- Subgroup analyses revealed no specific patient-level or site-level factors that derived a statistically significant benefit from the expanded antibiotic regimen.
Study Design
Type
RCT (n=19,603)
Randomization
Cluster randomized crossover
Multicenter
Yes
Structured PICO
Does incremental perioperative antibiotics reduce 1-year hospitalization for device infection in patients undergoing cardiac implantable electronic device procedures?
P
Population
19,603 patients undergoing cardiac implantable electronic device procedures across 28 centers, including a subgroup of 12,842 high-risk patients.
I
Intervention
Incremental perioperative antibiotics consisting of pre-procedural cefazolin plus vancomycin, intraprocedural bacitracin pocket wash, and 2-day post-procedural oral cephalexin.
C
Comparator
Conventional treatment consisting of pre-procedural cefazolin infusion.
O
Outcome
1-year hospitalization for device infection in the high-risk group.hard clinical
Main Result
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
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.
Discussion
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“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.”
“We found that you could estimate [a patient's risk of infection] very accurately, using the scoring system for device infection we developed.”
“Patients with pacemakers accounted for nearly half of the total cohort but had a major infection rate of only 0.4%. For the remaining patients, the good news is that the perception of infection risk has not matched the observed reality; the bad news is that it then becomes that much harder to budge the needle to a more favourable status for our patients.”
Implication
Does not support incremental perioperative antibiotics for CIED procedures; reinforces conventional prophylaxis as standard and leaves open alternative prevention strategies.
Cite This Study
Krahn et al. (2018) conducted an 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).