TYRX absorbable antibacterial envelope was cost-effective with an ICER of €11,709 per QALY gained over standard prophylaxis in patients undergoing CIED implantation in Spain, and dominant for CRT-D and ICD recipients.
Decision-analytic cost-effectiveness model
Yes
Does the TYRX absorbable antibacterial envelope combined with standard antibiotic prophylaxis improve cost-effectiveness for infection prevention in patients undergoing CIED implantation compared to standard prophylaxis alone?
The TYRX absorbable antibacterial envelope is a cost-effective or dominant strategy for preventing CIED infections across all device types in the Spanish healthcare system.
Effect estimate: ICER €11,709/QALY
Absolute Event Rate: 4.35% vs 4.33%
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.
Datino et al. (Fri,) conducted a decision-analytic cost-effectiveness model in Patients undergoing cardiac implantable electronic device implantation in Spain including permanent pacemaker recipients, implantable cardioverter-defibrillator recipients, cardiac resynchronization therapy with defibrillator recipients, and cardiac resynchronization therapy with pacemaker recipients. TYRX absorbable antibacterial envelope plus standard antibiotic prophylaxis vs. Standard antibiotic prophylaxis alone was evaluated on Cost-effectiveness measured by incremental cost-effectiveness ratio (ICER) in euros per quality-adjusted life-year (QALY) gained (ICER €11,709/QALY). TYRX absorbable antibacterial envelope was cost-effective with an ICER of €11,709 per QALY gained over standard prophylaxis in patients undergoing CIED implantation in Spain, and dominant for CRT-D and ICD recipients.