Efficacy of antimicrobial envelopes in preventing cardiac implantable electronic device infection – systematic review and meta-analysis

BACKGROUND AND OBJECTIVES: Cardiac implantable electronic device (CIED) infections remain a significant complication of increasingly common CIED procedures. This systematic review aims to evaluate the efficacy of antibiotic eluting envelopes (AEEs) in preventing CIED infections. METHODS: A systematic search of MEDLINE, CINAHL, Embase, Scopus, and Cochrane Library was conducted from inception to September 2024. Human studies evaluating TYRX AEE or CanGaroo envelopes hydrated in antibiotics were eligible. Studies on CanGaroo envelope were excluded from meta-analysis. RoB 2 and ROBINS-I tools were used to assess risk of bias. RESULTS: 14 studies and 87,184 patients were included. AEE use did not result in statistically significant reduction in odds of any CIED infection over entire study duration (odds ratio [OR], 0.73; 95% confidence interval [CI], 0.49-1.08) or within 12 months (OR, 0.85; 95% CI, 0.62-1.18), major CIED infection over entire study duration (OR, 0.73; 95% CI, 0.44-1.22) or within 12 months (OR, 0.79; 95% CI, 0.46-1.37), minor CIED infection (OR, 0.75; 95% CI, 0.48-1.18) or mortality (OR, 1.07; 95% CI, 0.60-1.88). However, in high infection risk patients, AEE use was associated with reduction in any infections over entire study duration (OR, 0.66; 95% CI, 0.45-0.97) and within 12 months (OR, 0.73; 95% CI, 0.56-0.95). CONCLUSIONS: Limitations of this review include group difference and scarcity of data regarding comorbidities in some studiesk. Overall, AEE use is not effective in reducing odds of CIED infection, although it may benefit high infection risk patients. TRIAL REGISTRATION: International Register of Prospective Systematic Reviews (PROSPERO) Identifier: CRD42024588950.