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Clinical Presentation, Timing, and Microbiology of CIED Infections: An Analysis of the WRAP-IT Trial
M Rizwan Sohail1, G Ralph Corey2, Bruce L Wilkoff3
1Department of Medicine and Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.
Objectives:
This study characterized the microbiology of major cardiac implantable electronic device (CIED) infections that occurred during the WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) study.
Background:
The WRAP-IT study offers a unique opportunity for further understanding of the pathogens involved in major CIED infections in a prospective dataset, with implications for clinical practice and infection management.
Methods:
A total of 6,800 patients randomized 1:1 to receive an antibacterial envelope or not (control subjects) were included in this analysis. Patient characteristics, infection manifestation (pocket vs. systemic), and infection microbiology were evaluated through all follow-up (36 months). Data were analyzed using Cox proportional hazards regression.
Results:
A total of 3,371 patients received an envelope, and 3,429 patients were control subjects. Major CIED infection occurred in 32 patients who received an envelope and 51 control subjects (36-month Kaplan-Meier estimated event rate, 1.3% and 1.9%, respectively; p = 0.046). A 61% reduction in major pocket infection was observed within 12 months of the procedure in the envelope group (hazard ratio: 0.39, 95% confidence interval: 0.21 to 0.73; p = 0.003). Among 76 patients with major infections who had a sample taken, causative pathogens were identified in 47 patients. Staphylococcus species were the predominate pathogen (n = 31) and envelope use resulted in a 76% reduction in Staphylococcus-related pocket infections (n = 4 vs. 17; p = 0.010). Envelope use was not associated with delayed onset of pocket infections and did not affect the presentation of infections.
Conclusions:
Antibacterial envelope use resulted in a significant reduction of major CIED pocket infections and was particularly effective against Staphylococcus species, the predominant cause of pocket infections. (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial [WRAP-IT]; NCT02277990).
Insights
Antibacterial envelopes significantly reduced cardiac implantable electronic device (CIED) infections, especially those caused by Staphylococcus. This finding from the WRAP-IT trial offers improved infection prevention strategies for CIED patients.
Area of Science:
- Cardiology
- Infectious Diseases
- Medical Devices
Background:
- Cardiac implantable electronic device (CIED) infections pose significant risks.
- Understanding the microbiology of CIED infections is crucial for effective prevention and treatment.
- The Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) provides a unique dataset for this investigation.
Purpose of the Study:
- To characterize the microbiology of major CIED infections within the WRAP-IT study cohort.
- To evaluate the impact of antibacterial envelopes on CIED infection pathogens.
- To inform clinical practice and infection management strategies for CIED procedures.
Main Methods:
- Analysis of a prospective dataset from the WRAP-IT study involving 6,800 patients randomized to receive an antibacterial envelope or not.
- Evaluation of patient characteristics, infection manifestation (pocket vs. systemic), and microbiology over 36 months.
- Cox proportional hazards regression used for data analysis.
Main Results:
- Major CIED infections occurred in 1.3% of the envelope group vs. 1.9% of the control group (p=0.046).
- A 61% reduction in major pocket infections was observed within 12 months in the envelope group (HR: 0.39; p=0.003).
- Staphylococcus species were the predominant pathogen (n=31); envelope use reduced Staphylococcus-related pocket infections by 76% (p=0.010).
Conclusions:
- Antibacterial envelope use significantly reduces major CIED pocket infections.
- The antibacterial envelope demonstrated particular efficacy against Staphylococcus species, the primary cause of pocket infections.
- Envelope use did not alter the timing or presentation of CIED infections.
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