Antimicrobial Envelopes for Cardiac Device Infection Prevention: A Meta‐Analysis of Randomized and Matched Studies

Introduction Cardiac implantable electronic device (CIED)‐associated infections are a significant procedural complication. Antibacterial envelopes have emerged as a potential strategy to mitigate this risk, though the evidence regarding their prognostic benefit remains inconclusive. Objectives We performed a meta‐analysis of randomized controlled trials (RCTs) and propensity score–matched cohorts evaluating the efficacy of the adjunctive use of antimicrobial envelopes in preventing CIED‐related infections compared to standard prophylactic measures alone. Methods We searched through PubMed, Cochrane, and Embase databases. Our primary outcomes were (1) any CIED‐related infection and (2) major CIED‐related infection. We conducted a sensitivity analysis in high‐risk patients. Results A total of one RCT and eight observational studies were included, involving 78,587 patients, of whom 12,290 (15.6%) received antimicrobial envelopes. The overall risk ratio (RR) analysis showed no significant difference in the incidence of any CIED‐related infections between the antimicrobial envelope and standard prophylaxis groups (RR 0.55; 95% CI 0.30–1.01; I 2 = 75%). However, time‐to‐event analysis demonstrated that the use of antimicrobial envelopes was associated with a significantly lower risk of any CIED‐related infection [hazard ratio (HR) 0.38; 95% CI 0.17–0.87; I 2 = 67%] and major CIED‐related infection (HR 0.54; 95% CI 0.39–0.76; I 2 = 0%). Moreover, among high‐risk patients, envelope implantation significantly reduced infection risk (RR 0.64; 95% CI 0.47–0.88; I 2 = 22%). Conclusion Our analysis demonstrates that antibacterial envelopes significantly reduce the risk of CIED‐related infections, particularly in high‐risk patients. Although the additional cost remains a consideration, the time‐to‐event findings and benefit observed in selected high‐risk populations may support their use in appropriately stratified patients.