General Session: MIS-2
Presented by: D. Beall - View Audio/Video Presentation (Members Only)
S. Garfin(1), D. Beall(2), S. Tutton(3), P. Kakad(4), Q. Li(4), J. Hornberger(5)
(1) UC San Diego, Orthopaedic Surgery, San Diego, CA, United States
(2) Clinical Radiology of Oklahoma, Edmond, OK, United States
(3) Medical College of Wisconsin, Milwaukee, WI, United States
(4) Cedar Associates, LLC, Menlo Park, CA, United States
(5) Stanford University, Stanford, CA, United States
Background: The Kiva System (Kiva; Benvenue Medical Inc., Santa Clara, CA) is indicated for use in the treatment of vertebral compression fractures (VCFs) in the thoracic and/or lumbar spine from T6 to L5. The KAST randomized, controlled (FDA) trial showed non-inferiority of Kiva to balloon kyphoplasty (BK; Medtronic, Minneapolis, MN) in pain reduction and functional gain.
Objective: To compare Kiva and BK for incidence and cost of serious adverse events (SAEs) requiring hospital re-admission during the 12 months following each of these vertebral augmentation approaches.
Methods: Study subjects consisted of the as-treated (AT) population from the KAST trial. One hundred forty four patients were assigned to Kiva and 141 were assigned to BK. SAEs were categorized using the standardized terminology from Medical Dictionary for Regulatory Activities. Primary study endpoints were the total number of events and the number of events per person-month for each SAE requiring hospitalization. Diagnostic Related Groups (DRG) codes were used to estimate the costs associated with hospital re-admissions due to SAEs.
Results: The 144 Kiva patients had 69 SAEs requiring hospital re-admission and the 141 BK patients had 103 events. Event rates were 0.041 per person-month for Kiva compared to 0.063 per person-month for BK; the difference was 0.022 events per person-month (95% CI: -0.037, -0.007; p< 0.01). Re-admissions and related costs were significantly reduced in the Kiva group compared to the BK group for DRG codes associated with cardiac disorders, injury and post-procedural complications, and vascular disorders. The average cost of SAEs requiring hospital re-admission were $1,208 lower for Kiva than for BK ($2,433 versus $3,641 per subject per year).
Conclusion: The lower incidence and cost of SAEs requiring hospital re-admission after vertebral augmentation using the Kiva System compared to balloon kyphoplasty are salient to health care organizations operating under new initiatives to reduce the burden of hospital re-admissions.