Economic Analysis of Kiva VCF Treatment System Compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data

Background: Vertebral compression fractures (VCFs) are the most common osteoporotic fracturesand cause persistent pain, kyphotic deformity, weight loss, depression, reduced quality of life, andeven death. Current surgical approaches for the treatment of VCF include vertebroplasty (VP) andballoon kyphoplasty (BK). The Kiva® VCF Treatment System (Kiva System) is a next-generationalternative surgical intervention in which a percutaneously introduced nitinol Osteo Coil guidewireis advanced through a deployment cannula and subsequently a PEEK Implant is implantedincrementally and fully coiled in the vertebral body. The Kiva System’s effectiveness for the treatmentof VCF has been evaluated in a large randomized controlled trial, the Kiva Safety and EffectivenessTrial (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 inOswestry Disability Index) while using less bone cement. The economic impact of the Kiva systemhas yet to be analyzed.Objective: To analyze hospital resource use and costs of the Kiva System over 2 years for thetreatment of VCF compared to BK.Setting: A representative US hospital.Study Design: Economic analysis of the KAST randomized trial, focusing on hospital resource useand costs.Methods: The analysis was conducted from a hospital perspective and utilized clinical datafrom 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 KivaSystem 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. hospitalover 2 years, the Kiva System will produce a direct medical cost savings of $1,118 per patientand $280,876 per hospital. This cost saving with the Kiva System was attributable to 19 reducedadjacent-level fractures with the Kiva System.Limitations: This study does not compare the Kiva System with VP or any other non-surgicalprocedures for the treatment of VCF.Conclusion: This first-ever economic analysis of the KAST data showed that the Kiva System forvertebral augmentation is hospital resource and cost saving over BK in a hospital setting over 2years. These savings are attributable to reduced risk of developing adjacent-level fractures with theKiva System compared to BK.Key words: Vertebral compression fracture, vertebral augmentation, osteoporosis, adjacent-levelfractures, kyphoplasty, balloon kyphoplasty, Kiva System