Cost-Effectiveness of an Antibacterial Envelope for CIED Infection Prevention in the US Healthcare System from the WRAP-IT Trial

• Published in: Circulation. Arrhythmia and electrophysiology
• Main Authors: Wilkoff, Bruce L, Boriani, Giuseppe, Mittal, Suneet, Poole, Jeanne E, Kennergren, Charles, Corey, Ralph, Krahn, Andrew D, Schloss, Edward J, Gallastegui, Jose L, Pickett, Robert A, Evonich, Rudolph F, Roark, Steven F, Sorrentino, Denise M, Sholevar, Darius P, Cronin, Edmond M, Berman, Brett J, Riggio, David W, Khan, Hafiza H, Silver, Marc T, Collier, Jack, Eldadah, Zayd, Holbrook, Reece, Lande, Jeff D, Lexcen, Daniel R, Seshadri, Swathi, Tarakji, Khaldoun G
• Format: Journal Article
• Language: English
• Published: American Heart Association, Inc 06.10.2020
• ISSN: 1941-3149; 1941-3084
• DOI: 10.1161/CIRCEP.120.008503

BACKGROUND–In the WRAP-IT trial, adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device (CIED) infection without increased risk of complication in 6,983 patients undergoing CIED revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator (CRT-D) implant. There is limited information on the cost-effectiveness of this strategy. As a pre-specified objective, we evaluated antibacterial envelope cost-effectiveness compared to standard-of-care infection prevention strategies in the US healthcare system. METHODS–A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention vs. standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years (QALYs) were discounted at 3%. An upper willingness-to-pay (WTP) threshold of $150,000 per QALY was used to determine cost-effectiveness, in alignment with American College of Cardiology and American Heart Association (ACC/AHA) practice guidelines and as supported by the World Health Organization (WHO) and contemporary literature. RESULTS–The base-case incremental cost-effectiveness ratio (ICER) of the antibacterial envelope compared to standard-of-care was $112,603/QALY. The ICER remained lower than the WTP threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputsinfection-related mortality, life expectancy, and infection cost. CONCLUSIONS–The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of CIED infection. REGISTRATION:Clinicaltrials.gov; Unique IdentifierNCT02277990