Health and Economic Outcomes Associated with Use of an Antimicrobial Envelope as a Standard of Care for Cardiac Implantable Electronic Device Implantation

INTRODUCTION: Infection of cardiac implanted electrical devices (CIED) is a problem. In selected patients, use of an "antibacterial envelope" (AIGISRx®) is associated with low CIED infection rates. The value of this device when used as a standard of care is unclear. METHODS AND RESULTS: Retrospective analysis of all patients (N = 1, 476) who underwent CIED implantation at a single hospital. During the study period, some implanters used the AIGISRx as a standard of care (Yes-AIGISRx Group, N = 365), whereas others did not use it at all (No-AIGISRx Group, N = 1, 111). A risk score based on preoperative factors was calculated for each patient. Rates of CIED infection within 6 months were measured, and associated costs were estimated. The Yes-AIGISRx and No-AIGISRx groups had similar preoperative infection risk. In the No-AIGISRx group, 19 infections were observed (1. 7%), versus 0 in the Yes-AIGISRx group (P = 0. 006). The 6-month mortality rate among patients with infection was significantly greater than among those without infection (15. 7% vs. 4. 5%, P = 0. 021). The average hospital duration for infection care was 13 days. By extrapolating the infection rate and costs observed in the No-AIGISRx group to the Yes-AIGISRx group, we estimated that there would have been 6. 2 additional infections costing approximately 340, 000. This cost was similar to the actual cost of the devices in the Yes-AIGISRx group, estimated at 320, 000. CONCLUSIONS: Standard of care use of an antibacterial envelope as a standard of care was associated with a significantly lower rate of CIED infection, and appeared to be economically reasonable. Prospective trials to address these findings may be worthwhile.