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

Abstract Cardiac implantable electronic device (CIED) procedures have become increasingly common, accompanied by the challenge of CIED infections. This review aims to synthesise the available evidence to evaluate the efficacy of antibiotic eluting envelopes (AEEs) in preventing CIED infections and its effects on mortality. All randomised controlled trials and observational studies that evaluated the efficacy of AEE use in reducing risk of CIED infections were included. Use of the TYRX AEE and CanGaroo envelopes hydrated in antibiotic solutions were considered for inclusion. The initial search yielded 493 articles, with 14 studies relevant for inclusion. A total of 87184 patients were included, with 14650 patients who received an AEE and 72534 patients who did not. AEE use did not result in a statistically significant reduction in the odds of any CIED infection over total study duration (OR 0.73, 95% CI: 0.49-1.08), or within 12 months following CIED implantation (OR 0.85, 95% CI: 0.62-1.18). There was no reduction in odds of major CIED infection over total study duration (OR 0.73, 95% CI: 0.44-1.22) or within 12 months (OR 0.79, 95% CI: 0.46-1.37). The odds of minor CIED infection over any time (OR 0.75, 95% CI: 0.48-1.18) and overall mortality (OR 1.07, 95% CI: 0.60-1.88) were also not reduced. However, subgroup analysis for patients at high risk of infection found that AEE use was associated with a reduction in total CIED infections over total study duration (OR 0.66, 95% CI: 0.45-0.97) and within 12 months (OR 0.73, 95% CI: 0.56-0.95). Competing Interest Statement The authors have declared no competing interest. Funding Statement No external funding was received for this research. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Not applicable for this manuscript as it is a systematic review and meta-analysis I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data supporting the findings of this study are available within the paper and its Supplementary Materials.