CIED infections are associated with significant morbidity and mortality. Perioperative systemic intravenous antibiotics with more aggressive antibacterial prophylaxis strategies have been introduced to help reduce rate of CIED infections. AIGISRx (TYRX, Inc.) antibacterial envelope is a polymer mesh implanted in the generator pocket with the CIED and releases two antibiotics, minocycline and rifampin after implantation to help reduce infections.
Retrospective chart review of 184 patients who underwent CIED implantation, 92 patients had implantation of AIGISRx antibacterial envelope compared to control group. In addition to demographics, we collected data on predefined risk factors for CIED infections (congestive heart failure, renal insufficiency with Cr>1.5, chronic kidney disease, oral anticoagulant use, chronic steroid use, need for lead replacement or revision, temporary pacing, early re-intervention or having more than two leads in place). Rates of CIED implantation success, major infections and mortality was compared between the two groups.
Mean age for AIGIS group was 69 vs 73 years in the control group. There were 57% males in the AIGIS group vs 63% in control group. Mean duration of follow up was 9 months in both groups. All patients had standard perioperative doses of systemic antibiotics. AIGIS group had shorter hospitalization (6.8 vs 9, p=0.001), higher chronic steroid use (5.4% vs. 1.1%, p=0.048), were mostly undergoing replacement or revision (51.1% vs 8.7%, p=0.001), and had more device implantation with more than two intracardiac leads (42.4% vs 29.3%, p=0.03). Successful CIED implantation occurred in 97% of patients in both groups. The rate of major infections were 5.4% in AIGIS group and 1.1% in non-AIGIS group (p=0.048), and need for device removal was 3.3% in AIGIS group vs 1.1% in non-AIGIS group (p=0.16). Two patients died (2.2%) as a result of CIED related infection in the AIGIS group. There was no CIED related mortality in the placebo group (p=0.08). Most common organisms were MRSA, MSSA and Enterococcus faecalis.
Patients with CIED implantation with antibacterial envelope had higher rate of major infection but more predefined risk factors. In addition, there was increase in device extraction and mortality in the AIGIS group.
M. Scully, None
A. Hassoun, None