Cost-Effectiveness of an Absorbable Antibacterial Envelope for Infection Control in Cardiac Implantable Electronic Device Procedures in Spain.

Background: Infections represent the most serious complication associated with cardiac implantable electronic devices (CIEDs). This can result in prolonged hospital stays, high morbidity and mortality, and a significant economic burden for healthcare systems. Objectives: This study aimed to evaluate the cost-effectiveness of the TYRX absorbable antibacterial envelope for CIED infection prevention from the Spanish Healthcare System perspective. Methods: A decision tree model with a lifetime horizon was developed to compare standard antibiotic prophylaxis with its combination with TYRX, regardless of infection risk. The model incorporated infection incidence, mortality, and utility values up to 36 months, derived from REINFORCE, AdaptResponse, and WRAP-IT studies. Unit costs (2025 euros) included prevention strategies and infection management. Lifetime costs and quality-adjusted life-years (QALYs) were assigned to survivors beyond 36 months. The incremental cost-effectiveness ratio (ICER) was reported by CIED and weighted by implant distribution (permanent pacemaker [PPM, 76.5%], implantable cardioverter-defibrillator [ICD, 15.2%], cardiac resynchronization therapy with defibrillator [CRT-D, 5.4%], and pacemaker [CRT-P, 2.9%]). A subgroup analysis was performed in high-risk patients (PADIT≥7), modifying infection rates based on PADIT risk stratification, along with sensitivity analyses. Model inputs were validated by an expert panel. Results: TYRX was the dominant strategy (more effective and less costly) for CRT-D and ICD recipients and cost-effective for those receiving PPM (€17 740/QALY) or CRT-P (€14 647/QALY), considering a willingness-to-pay threshold of €25 000/QALY. Across the spectrum of CIEDs, the ICER was €11 709/QALY. TYRX remained cost-effective in 77% of sensitivity analysis simulations. In high-risk patients, TYRX was dominant for all CIEDs. Discussion: This study is believed to be the first economic evaluation of TYRX in Spain and provides novel evidence in a broad, unselected population. Previous cost-effectiveness analyses conducted across different healthcare systems have consistently shown that TYRX is cost-effective in patients at elevated risk for device-related infections. Although the populations and healthcare settings differ, our findings are consistent with this body of evidence. Conclusions: TYRX represents a dominant strategy for infection prevention for CRT-D and ICD and is cost-effective for PPM and CRT-P, based on Spain's willingness to pay.