Efficacy of the antibacterial envelope to prevent cardiac implantable electronic device infection in a high-risk population.

Abstract

Infection is a serious complication of cardiac implantable electronic device (CIED) therapy. An antibiotic-eluting absorbable envelope has been developed to reduce the infection rate, but studies investigating the efficacy and a reasonable number needed to treat in high-risk populations for infections are limited. One hundred and forty-four patients undergoing CIED implantation who received the antibacterial envelope were compared with a matched cohort of 382 CIED patients from our institution. The primary outcome was the occurrence of local infection, and secondary outcomes were any CIED-related local or systemic infections, including endocarditis, and all-cause mortality. The results were stratified by a risk score for CIED infection, PADIT. The envelope group had a higher PADIT score, 5.9 ± 3.1 vs. 3.9 ± 3.0 (P < 0.0001). For the primary endpoint, no local infections occurred in the envelope group, compared with 2.6% in the control group (P = 0.04), with a more pronounced difference in the stratum with a high (>7 points) PADIT score, 0 vs. 9.9% (P = 0.01). The total CIED-related infections were similar between groups, 6.3% compared with 5.0% (P = 0.567). Mortality after 1600 days of follow-up did not differ between groups, 22.9 vs. 26.4%, P = 0.475. Our study confirms the clinical efficacy of an antibacterial envelope in the prevention of local CIED infection in patients with a higher risk according to the PADIT score. In an effort to improve cost-benefit ratios, ration of use guided by the PADIT score is advocated. Further prospective randomized studies in high-risk populations are called for.