title: Economic Analysis of Kiva VCF Treatment System Compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data.
abstract: BACKGROUND
  Vertebral compression fractures (VCFs) are the most common osteoporotic fractures and cause persistent pain, kyphotic deformity, weight loss, depression, reduced quality of life, and even death. Current surgical approaches for the treatment of VCF include vertebroplasty (VP) and balloon kyphoplasty (BK). The Kiva® VCF Treatment System (Kiva System) is a next-generation alternative surgical intervention in which a percutaneously introduced nitinol Osteo Coil guidewire is advanced through a deployment cannula and subsequently a PEEK Implant is implanted incrementally and fully coiled in the vertebral body. The Kiva System's effectiveness for the treatment of VCF has been evaluated in a large randomized controlled trial, the Kiva Safety and Effectiveness Trial (KAST). The Kiva System was non-inferior to BK with respect to pain reduction (70.8% vs. 71.8% in Visual Analogue Scale) and physical function restoration (38.1 % vs. 42.2% reduction in Oswestry Disability Index) while using less bone cement. The economic impact of the Kiva system has yet to be analyzed.
  
  
  OBJECTIVE
  To analyze hospital resource use and costs of the Kiva System over 2 years for the treatment of VCF compared to BK.
  
  
  METHODS
  A representative US hospital.
  
  
  METHODS
  Economic analysis of the KAST randomized trial, focusing on hospital resource use and costs.
  
  
  METHODS
  The analysis was conducted from a hospital perspective and utilized clinical data from KAST as well as unit-cost data from the published literature. The cost of initial VCF surgery, reoperation cost, device market cost, and other medical costs were compared between the Kiva System and BK. The relative risk reduction rate in adjacent-level fracture with Kiva [31.6% (95% CI: -22.5%, 61.9%)] demonstrated in KAST was used in this analysis.
  
  
  RESULTS
  With 304 vertebral augmentation procedures performed in a representative U.S. hospital over 2 years, the Kiva System will produce a direct medical cost savings of $1,118 per patient and $280,876 per hospital. This cost saving with the Kiva System was attributable to 19 reduced adjacent-level fractures with the Kiva System.
  
  
  CONCLUSIONS
  This study does not compare the Kiva System with VP or any other non-surgical procedures for the treatment of VCF.
  
  
  CONCLUSIONS
  This first-ever economic analysis of the KAST data showed that the Kiva System for vertebral augmentation is hospital resource and cost saving over BK in a hospital setting over 2 years. These savings are attributable to reduced risk of developing adjacent-level fractures with the Kiva System compared to BK.
authors.forename: Douglas P
authors.initials: DP
authors.lastname: Beall
authors.forename: Wayne J
authors.initials: WJ
authors.lastname: Olan
authors.forename: Priyanka
authors.initials: P
authors.lastname: Kakad
authors.forename: Qianyi
authors.initials: Q
authors.lastname: Li
authors.affiliation: Clinical Radiology of Oklahoma, Oklahoma City, OK; The George Washington University Medical Center, Washington, DC; Cedar Associates LLC, Menlo Park; CA; Department of Internal Medicine, Stanford University School of Medicine, Stanford, CA.
authors.forename: John
authors.initials: J
authors.lastname: Hornberger
mesh_terms: D001843:Bone Cements / Q000627:therapeutic use; D017046:Cost Savings; D003365:Costs and Cost Analysis / Q000379:methods; D050815:Fractures, Compression / Q000191:economics / Q000601:surgery; D006801:Humans; D058498:Kyphoplasty / Q000191:economics* / Q000379:methods; D019736:Prostheses and Implants / Q000191:economics; D016032:Randomized Controlled Trials as Topic; D016103:Spinal Fractures / Q000191:economics / Q000601:surgery; D013223:Statistics as Topic; D016896:Treatment Outcome; D014481:United States; D054854:Vertebroplasty / Q000191:economics* / Q000295:instrumentation / Q000379:methods
chemical_list: D001843:Bone Cements