Time to benefit of antibacterial envelope use to prevent cardiac implantable device infection: a meta-analysis of reconstructed individual patient data
L Barbosa, V M R Oliveira, L Guedes, C Pisani, B R Nascimento, F Darrieux, M I ScanavaccaAbstract
Background
Major infections after cardiac implantable electronic device (CIED) implantation have been associated with substantial morbidity and mortality, however, the benefit profile of antibacterial envelopes for CIED procedures remains incompletely characterized.
Purpose
To quantify the time-dependent absolute and relative benefits of antibacterial envelopes for preventing major infections in patients undergoing CIED procedures.
Methods
We systematically searched PubMed, Embase, and Cochrane databases for studies comparing antibacterial envelope use versus its absence in CIED procedures. Individual patient data were reconstructed from Kaplan–Meier curves. Hazard ratios (HRs) with 95% confidence intervals (CI) were estimated using Cox regression. Time-to-benefit analysis was performed to determine when clinically meaningful differences emerged. Additionally, we conducted Restricted Mean Survival Time (RMST) analysis at 1, 2, 3, and 4 years to quantify absolute treatment effect in terms of infection-free days, providing a clinically interpretable measure of benefit expressed in units of time. All statistical analyses were performed using R version 4.5.0.
Results
Six studies including 16,103 patients were analyzed, of whom 7,240 (45%) received envelope implantation. The use of antibacterial envelopes reveals significantly higher freedom from major CIED infection compared to controls (HR 0.40, 95% CI: 0.27-0.54, P<0.001), representing a 60% relative risk reduction. The time-to-benefit analysis shows that absolute risk reduction (ARR) progressively increases throughout follow-up, reaching a maximum of 1.65% at day 1201, corresponding to a number needed to treat of 61 patients (Figure 1). The RMST analysis demonstrated a progressively increasing benefit of antibacterial envelopes over time. At 1 year, patients with envelopes gained 2.1 infection-free days (95% CI: 1.1-3.0, p<0.001) compared to controls. This benefit increased to 6.2 days at 2 years, 11.0 days at 3 years, and 17.0 days at 4 years (all p<0.001). Both ARR and RMST analyses indicate that the protective benefit not only persists but amplifies over time, with no plateau observed within the 4-year observation period.
Conclusion
Among patients undergoing CIED procedure, antibacterial envelopes implantation was associated with a significant reduction in the incidence of major infections. These findings have significant implications for clinical decision-making, particularly for patients with longer life expectancy who may derive greater cumulative benefit from this preventive intervention.Individual Patient Data