Efficacy of a Bio‐Absorbable Antibacterial Envelope to Prevent Cardiac Implantable Electronic Device Infections in High‐Risk Subjects

Efficacy of Bio-Absorbable Antibacterial Envelope IntroductionCardiac implantable electronic device (CIED) infections are potentially preventable complications associated with high morbidity, mortality, and cost. A recently developed bio-absorbable antibacterial envelope (TYRX-A) might prevent CIED infections in high-risk subjects. However, data regarding safety and efficacy have not been published. Methods and ResultsIn a single-center retrospective cohort study, we compared the prevalence of CIED infections among subjects with 2 risk factors treated with the TYRX-A envelope (N = 135), the nonabsorbable TYRX envelope (N = 353), and controls who did not receive an envelope (N = 636). Infection was ascertained by individual chart review. The mean (95% confidence interval) number of risk factors was 3.08 (2.84-3.32) for TYRX-A, 3.20 (3.07-3.34) for TYRX, and 3.09 (2.99-3.20) for controls, P = 0.3. After a minimum 300 days follow-up, the prevalence of CIED infection was 0 (0%) for TYRX-A, 1 (0.3%) for TYRX, and 20 (3.1%) for controls (P = 1 for TYRX-A vs. TYRX, P = 0.03 for TYRX-A vs. controls, and P = 0.002 for TYRX vs. controls). In a propensity score-matched cohort of 316 recipients of either envelope and 316 controls, the prevalence of infection was 0 (0%) and 9 (2.8%), respectively, P = 0.004. When limited to 122 TYRX-A recipients and 122 propensity-matched controls, the prevalence of CIED infections was 0 (0%) and 5 (4.1%), respectively, P = 0.024. ConclusionsAmong high-risk subjects, the TYRX-A bio-absorbable envelope was associated with a very low prevalence of CIED related infections that was comparable to that seen with the nonabsorbable envelope.