The effect of an antibacterial envelope on cardiac implantable device-related infection - A real-world analysis from a tertiary center.

Abstract

Background: Infections related to cardiac implantable electronic devices (CIED) are associated with significant morbidity and mortality. Antibiotic-eluting envelopes have been introduced as a technology to prevent CIED infections. The aim of this study was to evaluate the effectiveness of the antibacterial envelope in the real-world population of a tertiary center.

Methods: This cohort study includes consecutively enrolled patients undergoing a device procedure from 01/2014 to 12/2020 at the University Hospital in Zurich. During period A (01/2014-12/2019) antibacterial envelopes were not used, whereas during period B (01/2020-12/2020) antibacterial envelopes were used in all device interventions. Follow-up was conducted by assessing all available patient records from patient visits and hospitalization.

Results: 1757 patients (male 70.5%, mean age 67.1 ± 16 years), were analyzed during a follow-up of 24 months. In 302 patients (17.2%) an antibacterial envelope was used. The overall occurrence of a device infection was low (n = 15, 0.85%). Factors that were associated with the incidence of an infection were not undergoing a primary implantation procedure (p = 0.024) and a CRT-P/D intervention (p = 0.022). There was no difference in the rate of infection between patients in whom a bacterial envelope was implanted vs. those in whom it was not used (0.6 vs. 0.9%, p = 0.693).

Conclusion: In a contemporary cohort of consecutive, unselected patients undergoing a device intervention at a large tertiary care center, the rate of device infection was low and not significantly different with vs. without the use of an antibacterial envelope. The data have important practical as well as economic implications for physicians performing such procedures.