Efficacy of antibacterial envelope use in cardiac implantable electronic device infection prevention: insights from real world data

FUNDING ACKNOWLEDGEMENTS: Type of funding sources: None. BACKGROUND: Infections of Cardiac implantable electronic device (CIED) are rare but serious complications impacting patients and the whole heath care system. Recently, a significative reduction in major CIED infections within 12 months of the procedure has been showed by the use of an absorbable antibiotic-eluting envelope. The aim of the analysis is to evaluate the impact of the use of the envelope on infection-related clinical events (including pocket hematoma, infection, and systemic infection) reduction in a real word patient population METHODS: Data on patients underwent CIED implantation or replacement were collected prospectively in the framework of One HospitalClinicalService project. Patients were divided into two groups according to the utilization of an absorbable antibiotic-eluting envelope or the non-usage of the envelope. RESULTS: Out of 1819 patients, 872 (47.9%) were implanted with an absorbable antibiotic-eluting envelope and denoted as the Envelope group. Accordingly, 947 (52.1%) patients were categorized as the control group. As compared to control, patients with envelope had higher thrombo-embolic risk, higher BMI, lower LV ejection fraction and in general had more comorbidities. During a mean follow-up of 1.4 year, the incidence rate per 100 patients-months of infective related events were significantly greater in the control compared to the Envelope group (2.85% vs 1.26%, p< 0.001). The 48-month cumulative incidence of infective related events was 6.7% in the control and 2.9% in the Envelope group (HR:0.47; 95%CI: 0.27-0.95, p= 0.032). Fig1 When considering a subgroup of 1170 patients matched by PADIT score, the incidence of infective related events was 1.0 % (6/585) in the envelope and 3.8% (22/585) in the envelope and control group, respectively, p=0.002. CONCLUSIONS: In our analysis, the use of envelope in the general CIED population was effective to reduce the risk of systemic or pocket infection, or pocket hematoma [Figure: see text]