Real-world infection outcomes with TYRX antimicrobial envelope use in a predominantly high-risk CIED reintervention cohort
A Raghavan, J Tallman, C Khoo, C SeiferAbstract
Background
Cardiac Implantable Electronic Devices (CIEDs) improve cardiac outcomes but are associated with infection rates of 2-4%.1 CIED infections (CIEDI), while infrequent, significantly increase morbidity, mortality and health care costs.2 Risk factors for infection include patient comorbidities, complex or multiple devices, and procedural complications. The PADIT trial identified five non-modifiable predictors-age, renal dysfunction, immunocompromised status, procedure type, and prior CIED-and developed a validated risk score for infection prediction.1 Subsequently, the WRAP-IT trial demonstrated that use of the TYRX antimicrobial envelope was associated with a 40% relative risk reduction in CIEDI in selected high-risk patients.3 However, real-world outcomes in predominantly high PADIT score, reintervention-heavy populations remain limited.
Purpose
To evaluate real-world infectious outcomes following antimicrobial envelope use in a high-risk CIED cohort including high PADIT scores and complex reinterventions.
Methods
We retrospectively analyzed consecutive patients undergoing CIED procedures with antimicrobial envelope implantation between 2019-2025 at a tertiary care center in Canada. Patients 18 years and older receiving any CIED for any indication were included. The primary outcome was incidence of CIEDI 12 months post CIED implantation/revision. Major infection was defined as device-related infection requiring system revision or extraction.
Results
A total of 346 patients (mean age 66.5 +/- 14.5 years; 67.9% male) were included. The majority of procedures were device system replacements (58.7%) or device revisions (36.4%), with 47.7% being CRT systems. The population was comorbid, with 70.2% having heart failure, 23.4% having chronic kidney disease, and 43.4% having Type 2 diabetes mellitus. The Median PADIT score was 9 (IQR 3), and 78.8% were classified as high risk. Thirteen patients (3.8%) developed infection; four (1.2%) required device revision for major CIEDI. Two deaths occurred among infected patients (15.4%).
Conclusion(s)
In a heavily co-morbid, predominantly high PADIT-risk reintervention cohort, TYRX antimicrobial envelope use was associated with a low rate of major CIEDI despite substantial baseline and procedural risk. These findings extend randomized trial evidence by providing real-world data in a high infection risk population. Infections, when they occurred, were associated with significant morbidity and mortality, underscoring the importance of prevention in this setting. Ongoing analyses comparing these outcomes with a control cohort without TYRX use will further define the magnitude of benefit and inform risk-stratified infection prevention strategies in contemporary CIED practice.Table 1