Abstract 16842: Cost-Effectiveness of Antibiotic-Eluting Envelopes for Prevention of Infections Associated With Cardiac Implantable Electronic Devices

Introduction: Infections of cardiac implantable electronic devices result in substantial morbidity and healthcare costs. Using an antibiotic-eluting envelope (AEE) during implantation may reduce the incidence of device-related infection. We examined the cost-effectiveness of an AEE in patients receiving CRT-D devices. Methods: This analysis was conducted independent of the trial sponsor. We developed a state-transition Markov model to compare the use of an AEE with usual care during CRT-D initial implantation or reimplantation. Effectiveness of the AEE (unit cost $1000) was estimated from the Worldwide Randomized Antibiotic Envelope Infection Prevention Trial. Other inputs were derived from prior trials, registries, vital statistics, and nationally representative datasets. Long-term survival was projected using a non-parametric approach. The model reported incidence of infections, mortality, quality-adjusted life years (QALYs), and direct healthcare costs. Future costs and QALYs were discounted by 3% annually. The primary outcome was the incremental cost-effectiveness ratio (ICER) of AEE use from the US healthcare sector perspective over a lifetime analytic horizon. We assumed a cost-effectiveness threshold of $100,000 per QALY gained. Results: Use of an AEE at initial CRT-D implantation added 0.008 QALYs per patient at an incremental cost of $918 (ICER $118,000/QALY). Due to higher infection rates, the use of AEE in reimplantation procedures was more economically attractive (ICER $55,900/QALY). One-way sensitivity analyses showed an inverse relationship between ICER and rate of infection. The ICER was less than $100,000/QALY with infection rate greater than 2.42% in the first year after new CRT-D (Figure 1). Conclusions: At current prices, use of AEE is cost-effective for CRT-D reimplantation procedures but not for initial CRT-D implants. Cost-effectiveness of AEEs may be improved by restricting use to patients at increased risk of infection.