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

Alonzo Armani Prata; Luís Fernando Ferreira Cavalcante; Gabriela Blanco Stutz; Thalia Melamed; Caio Rezende Lima; Andrew H Locke; Alexandra Régia Dantas Brígido

doi:10.1111/pace.70108

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

Pacing Clin Electrophysiol. 2025 Dec 26. doi: 10.1111/pace.70108. Online ahead of print.

Authors

Alonzo Armani Prata¹, Luís Fernando Ferreira Cavalcante², Gabriela Blanco Stutz³, Thalia Melamed⁴, Caio Rezende Lima³, Andrew H Locke⁵, Alexandra Régia Dantas Brígido⁶

Affiliations

¹ Federal University of Espírito Santo, Vitória, Brazil.
² Faculdade De Ciências Médicas da Santa Casa De São Paulo, São Paulo, Brazil.
³ Federal University of Rio de Janeiro, UFRJ, Rio de Janeiro, Brazil.
⁴ Queen Mary University of London Faculty of Medicine and Dentistry, London, England.
⁵ Beth Israel Deaconess Medical Center, Boston, USA.
⁶ Heart Institute - Incor - University of Sao Paulo, Sao Paulo, Brazil.

PMID: 41450085
DOI: 10.1111/pace.70108

Abstract

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; I² = 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; I² = 67%] and major CIED-related infection (HR 0.54; 95% CI 0.39-0.76; I² = 0%). Moreover, among high-risk patients, envelope implantation significantly reduced infection risk (RR 0.64; 95% CI 0.47-0.88; I² = 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.

Keywords: antibacterial envelope; antimicrobial envelope; cardiac implantable electronic device; cardiac resynchronization therapy; implantable cardioverter defibrillator; pacemaker.

Publication types

Review