The role of an antibiotic envelope in the prevention of major cardiac implantable electronic device infections: A systematic review and meta-analysis

BACKGROUND: Over the past decade, rates of cardiac implantable electronic device (CIED) related infections have increased and been associated with increased morbidity, mortality and financial burden on healthcare systems. METHODS: To examine the effect of an antibacterial envelope in reducing major CIED related infections, we performed a systematic review and meta-analysis by searching PubMed/MEDLINE, CENTRAL, Google scholar and Clinicaltrials.gov for studies that examined the effect of an antibiotic envelope in reducing major related CIED infections, comprising of device-related endocarditis, systemic infection requiring systemic antibiotics and or device extraction, compared to control up till February 15th, 2020. A random-effects meta-analysis was conducted by calculating risk ratios (RR) and respective 95% confidence intervals (CI). RESULTS: We include 6 studies that comprise of 11,897 patients, of which 5844 received an antibiotic envelope and 6053 did not. Compared with control, utilization of an antibiotic envelope at the time of procedure was associated with a significant 74% relative risk reduction in major CIED related infections among patients at high risk for infection (RR: 0.26 [95% CI, 0.08–0.85]; P = .03), while no significant reduction was observed among patients enrolled from studies with any risk for infection (RR: 0.53 [95% CI, 0.06–4.52]; P = .56). Additionally, no reduction in mortality among patients that received an envelope compared to control was observed (RR: 1.15 [95% CI, 0.53–2.50]; P = .72). CONCLUSION: The utilization of an antibiotic envelope at the time of device implantation or upgrade reduces major CIED infections, especially if used in patients perceived to be at higher risk for infection.