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

• Published in: Journal of cardiovascular electrophysiology 2015-10, Vol.26 (10), p.1111-1116
• Main Authors: KOLEK, MATTHEW J., PATEL, NEEL J., CLAIR, WALTER K., WHALEN, S. PATRICK, ROTTMAN, JEFFREY N., KANAGASUNDRAM, ARVINDH, SHEN, SHARON T., SAAVEDRA, PABLO J., ESTRADA, JUAN C., ABRAHAM, ROBERT L., ELLIS, CHRISTOPHER R.
• Format: Article
• Language: English
• Subjects: Absorbable Implants - statistics & numerical data; Aged; Anti-Bacterial Agents - administration & dosage; antibacterial envelope; cardiac implantable electronic device; Causality; Cohort Studies; Confidence intervals; Defibrillators, Implantable - statistics & numerical data; Delayed-Action Preparations - administration & dosage; Drug Implants - administration & dosage; Female; Humans; infection; Infections; Male; Middle Aged; Pacemaker, Artificial - statistics & numerical data; Prevalence; Prosthesis-Related Infections - diagnosis; Prosthesis-Related Infections - epidemiology; Prosthesis-Related Infections - prevention & control; Retrospective Studies; Risk Factors; Sex Distribution; Survival Rate; Tennessee - epidemiology; Treatment Outcome
• ISSN: 1045-3873; 1540-8167
• DOI: 10.1111/jce.12768

Efficacy of Bio‐Absorbable Antibacterial Envelope Introduction Cardiac 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 Results In 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. Conclusions Among 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.