000			05382nam a22006977a 4500
008			201006s20202020 xxu||||| |||| 00| 0 eng d
022			_a1941-3084
024			_a10.1161/CIRCEP.120.008503 [doi]
040			_aOvid MEDLINE(R)
099			_a32915063
245			_aCost-Effectiveness of an Antibacterial Envelope for CIED Infection Prevention in the US Healthcare System from the WRAP-IT Trial.
247			_aCost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.
251			_aCirculation: Arrhythmia and Electrophysiology. 13(10):e008503, 2020 10.
252			_aCirc. Arrhythm. electrophysiol.. 13(10):e008503, 2020 10.
252			_zCirc. Arrhythm. electrophysiol.. 2020 Sep 11
253			_aCirculation. Arrhythmia and electrophysiology
260			_c2020
260			_fFY2021
265			_saheadofprint
265			_sppublish
266			_d2020-10-06
268			_aCirculation: Arrhythmia and Electrophysiology. 2020 Sep 11
501			_aAvailable online from MWHC library: 2008 - present
520			_aBackground - 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 inputs: infection-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.
546			_aEnglish
650			_a*Anti-Bacterial Agents/ec [Economics]
650			_a*Antibiotic Prophylaxis/ec [Economics]
650			_a*Cardiac Resynchronization Therapy Devices/ec [Economics]
650			_a*Defibrillators, Implantable/ec [Economics]
650			_a*Drug Costs
650			_a*Prosthesis Implantation/ec [Economics]
650			_a*Prosthesis-Related Infections/ec [Economics]
650			_aAbsorbable Implants/ec [Economics]
650			_aAnti-Bacterial Agents/tu [Therapeutic Use]
650			_aCardiac Resynchronization Therapy Devices/ae [Adverse Effects]
650			_aClinical Decision-Making
650			_aCost Savings
650			_aCost-Benefit Analysis
650			_aDecision Trees
650			_aDefibrillators, Implantable/ae [Adverse Effects]
650			_aHumans
650			_aModels, Economic
650			_aMulticenter Studies as Topic
650			_aProsthesis Implantation/ae [Adverse Effects]
650			_aProsthesis Implantation/is [Instrumentation]
650			_aProsthesis-Related Infections/mi [Microbiology]
650			_aProsthesis-Related Infections/pc [Prevention & Control]
650			_aQuality of Life
650			_aQuality-Adjusted Life Years
650			_aRandomized Controlled Trials as Topic
650			_aRisk Factors
650			_aTime Factors
650			_aTreatment Outcome
650			_aUnited States
651			_aMedStar Heart & Vascular Institute
657			_aJournal Article
700			_aEldadah, Zayd A
790			_aBerman BJ, Boriani G, Collier J, Corey R, Cronin EM, Eldadah Z, Evonich RF, Gallastegui JL, Holbrook RW, Kennergren C, Khan HH, Krahn AD, Lande JD, Lexcen DR, Mittal S, Pickett RA, Poole JE, Riggio DW, Roark SF, Schloss EJ, Seshadri S, Sholevar DP, Silver MT, Sorrentino DM, Tarakji KG, Wilkoff BL
856			_uhttps://dx.doi.org/10.1161/CIRCEP.120.008503 _zhttps://dx.doi.org/10.1161/CIRCEP.120.008503
942			_cART _dArticle
999			_c5577 _d5577