Use of an Antibacterial Envelope is Associated with Reduced Cardiac Implantable Electronic Device Infections in High‐Risk Patients

Abstract

Introduction The incidence of cardiac implantable electronic device (CIED) infections has risen rapidly since 2004. A commercially available minocycline and rifampin impregnated antibacterial envelope has been associated with a low CIED infection rate. We performed a retrospective cohort study analyzing CIED infection rates in patients receiving an antibacterial envelope. Methods Prospectively applied criteria for use of the antibacterial envelope included ≥2 of the following: diabetes, renal insufficiency, anticoagulation, chronic corticosteroid use, fever or leukocytosis at the time of implantation, prior CIED infection, ≥3 leads (cardiac resynchronization therapy or abandoned leads), pacemaker dependence, or early pocket reentry. CIED infection rate was compared to a cohort of patients with matched risk factors and a CIED implanted prior to use of the antibacterial envelope. Results A total of 260 antibacterial envelopes were implanted from November 1, 2009 to April 30, 2012. The mean number of CIED infection risk factors was 2.8 ± 1.2. The control cohort (N = 639) was matched for mean number of CIED infection risk factors (2.8 ± 1.2), though individual risk factors differed. After a minimum of 90 days of follow-up, there was one CIED infection among patients who received an antibacterial envelope (0.4%), compared to 19 (3%) in controls (odds ratio [95% confidence interval] 0.13 [0.02–0.95], P = 0.04). This difference persisted after adjustment for covariates (0.09 [0.01–0.73], P = 0.02) and propensity score matching (0.11 [0.01–0.85], P = 0.04). Conclusions In patients prospectively identified at high risk for CIED infection, use of a commercially available antibacterial envelope was associated with a marked reduction in CIED infections when compared to a matched control cohort.

Management of Cardiac Electronic Device Infections: Challenges and Outcomes

“…This envelope eliminates staphylococcal species and prevents biofilm formation on implanted pacing devices in animal studies, 44 and reduces CIED infections in high-risk patients in observational studies. [45][46][47] The most recent version is bio-absorbable and disappears within 9 weeks after implantation. In a single-centre observational study including 1,124 high-risk patients, infection …”

Polymeric nanofiber coating with tunable combinatorial antibiotic delivery prevents biofilm-associated infection in vivo

“…This may compromise the treatment efficiency and it increases the likelihood of the development of antibiotic resistance while patients are on therapy (21,22), which has been seen in as high as 50% of patients with PJI treated with gentamicin or tobramycin spacers (43). A recently approved dual antibiotic release mesh envelope impregnated with minocycline and rifampin has proven effective in preventing CIED infection in patients (44,45). However, although this approach uses two antibiotics, it is not feasible for implants that require a secure fit Fig.…”

Cardiac Implantable Electronic Device Infection in Patients at Risk

“…The TYRX™ non-absorbable envelope (Medtronic) has shown substantial efficacy in clinical studies in reducing the infection rate. 23,79,80 This has led to the development of the TYRX absorbable envelope, which is constructed from a fully bioabsorbable multifilament mesh (see Figure 4). The envelope holds the CIED in place, preventing device migration, elutes antimicrobial agents minocycline and rifampicin for a minimum of 7 days; and then is fully absorbed approximately 9 weeks after implantation.…”