Antibacterial Envelope Use in Cardiac Implantable Electronic Devices: A Systematic Review and Meta-Analysis

Georgios E Papadopoulos; Paris Pentousis; Ilias Ninios; Sotirios Evangelou; Andreas Ioannides; Dimitrios Pentousis; Vlasis Ninios

doi:10.1111/pace.70153

Antibacterial Envelope Use in Cardiac Implantable Electronic Devices: A Systematic Review and Meta-Analysis

Pacing Clin Electrophysiol. 2026 Feb 17. doi: 10.1111/pace.70153. Online ahead of print.

Authors

Georgios E Papadopoulos¹, Paris Pentousis¹, Ilias Ninios¹, Sotirios Evangelou¹, Andreas Ioannides¹, Dimitrios Pentousis¹, Vlasis Ninios¹

Affiliation

¹ Cardiology Department, Interbalkan Medical Center, Thessaloniki, Greece.

PMID: 41703424
DOI: 10.1111/pace.70153

Abstract

Background: Antimicrobial envelopes are increasingly used to prevent cardiac implantable electronic device (CIED) infections, but prior meta-analyses-performed largely before the accumulation of contemporary cohorts-reported heterogeneous effects and limited exploration of effect-modifiers.

Objective: To update the evidence on antibacterial envelope effectiveness using contemporary studies and standardized infection definitions, and to quantify absolute and relative risk reductions across clinically relevant subgroups (device power, de novo vs. reintervention) with rigorous bias and robustness analyses.

Methods: We conducted a systematic review and meta-analysis adhering to PRISMA. We included randomized and observational studies comparing absorbable antibiotic-eluting or antibacterial envelopes versus standard care at CIED implantation or revision. "Major CIED infection" was prespecified per international consensus criteria. We used Mantel-Haenszel random-effects models, prespecified subgroup analyses, leave-one-out sensitivity analyses, and GRADE. Risk of bias was assessed with RoB2/ROBINS-I.

Results: Seven studies (13,306 patients; one randomized trial, six observational cohorts) met inclusion criteria. Antibacterial envelope use significantly reduced overall CIED infection (OR 0.55, 95% CI 0.33-0.92; p = 0.02), driven by a marked reduction in pocket infections (OR 0.32, 95% CI 0.19-0.52; p < 0.01). Systemic infection (OR 1.33, 95% CI 0.46-3.81; p = 0.60) and all-cause mortality (OR 0.83, 95% CI 0.59-1.19; p = 0.32) were not significantly affected. Benefits were most pronounced in high-risk subgroups.

Conclusion: Antibacterial envelopes substantially reduce pocket-related CIED infections without altering systemic infection or mortality. These findings support their selective use in patients at elevated risk, particularly those undergoing generator replacement, pocket revision, or CRT implantation.

Keywords: antibacterial envelope; cardiac implantable electronic devices; device‐related infection; meta‐analysis; risk stratification; systematic review.