OBJECTIVES: Infection is a serious complication of cardiac implantable electronic device (CIED) implantation that is difficult to diagnose and treat, usually associated with prolonged hospital stays, substantial morbidity, and death. Our aim is to model the cost-effectiveness of the Absorbable Antibacterial Envelope for infection prevention in patients undergoing a CIED implantation in the context of the Spanish healthcare system.

METHODS: A decision tree model with a lifetime horizon was populated to compare standard of care (SoC), consisting of one course of pre-operative antibiotic prophylaxis only, versus SoC plus the envelope in patients undergoing a CIED implantation. The model considers clinical inputs for infection (REINFORCE) and mortality rates (AdaptResponse, WRAP-IT) at 12-, 24- and 36-months post-implant; costs (€, 2023) from Spanish databases and benefits in quality-adjusted life-years (QALY) gained using the EQ-5D-5L data from WRAP-IT. The incremental cost-effectiveness ratio (ICER) is presented per device type and aggregated according to the current Spanish treatment mix [77% pacemaker (PM), 15% Implantable Cardiac Defibrillator (ICD), 5% Cardiac Resynchronization Therapy-Defibrillator (CRT-D), 3% Cardiac Resynchronization Therapy-Pacemaker (CRT-P)]. Probabilistic sensitivity analysis (PSA) was conducted to test the robustness of the analysis.

RESULTS: For CRT-D and ICD patients, the envelope is a dominant alternative, and cost-effective for PM (€18,160/QALY) and CRT-P (€14,627/QALY) when compared to the SoC considering a willingness to pay (WTP) threshold of €25.000/QALY. Averaging across all devices, the ICER was €10,798/QALY. PSA corroborates the base-case results as the envelope remained cost-effective for all-devices in 69%, 80%, 89% of model replications at €20,000/QALY, €30,000/QALY and €50,000/QALY WTP thresholds, respectively, compared with SoC.

CONCLUSIONS: The absorbable antibacterial envelope was associated with ICER values below the Spanish WTP regardless of the implanted CIED, suggesting the envelope provides value for the Spanish healthcare system by preventing CIED infections.