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

Abstract

Aims 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. Methods and results 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. Conclusion 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.

Low Occurrence of Infections and Death in a Real-World Cohort of Patients with Cardiac Implantable Electronic Devices

“…A recent study showed that patients at high risk of CIED-related infection treated with a prolonged 9-day protocol of periprocedural antibiotics had a similar rate of infection as compared to low-risk patients treated with only two antibiotic administrations (1.98% vs. 1.08%, respectively, p = 0.32, at 250 days of follow-up) [ 30 , 31 ]. The antibiotic-eluting envelope in addition to antibiotic prophylaxis was associated with reduced CIED-related major infections and local CIED infections in randomized controlled trials and real-world populations at high risk of infection [ 12 , 32 , 33 , 34 ]. Cost-effectiveness data support its use in selected high-risk patients whereby, by reducing CIED infections, it provides value for healthcare systems [ 13 , 35 ].…”

Strategies for surface coatings of implantable cardiac medical devices

“…Another technique is TYRX, where CMDs like ICDs are wrapped with the TYRX bag. This bag or antibacterial envelope is designed to elute minocycline and rifampicin into surrounding pocket tissue, protecting the device from local infection for at least 7 days after implantation ( Tarakji et al, 2019 ; Mittal et al, 2020 ; Chaudhry et al, 2022 ). All these new strategies to combat bacterial infections involve antibiotics.…”

Cardiac pacing and lead devices management: 25 years of research at EP Europace journal

“…An antibacterial envelop was shown to reduce the risk of CIED infection in high-risk subgroups. 56 , 57 This therapy should be considered in those patients considered at high risk of infection. Prevention of pocket haematoma is also important to reduce CIED infection.…”