Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients

Background: Minimally invasive vertebral augmentation procedures are widely used to treat vertebral compression fractures although procedural polymethylmethacrylate cement leakage remains common. We report herein our initial experience with a novel vertebral augmentation technique designed to treat symptomatic vertebral osteoporotic fractures and osteolytic metastases with minimal cement extravasation. Methods: Forty-two vertebral fractures were identified in 26 consecutive patients (mean age 74 +/- 9 years). All patients were treated with a novel percutaneous vertebral augmentation device (Kiva (R) VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA). Indications for surgery included recent (<= 3 months) symptomatic osteoporotic vertebral fracture (n = 34) and pathologic vertebral fractures (e. g. metabolic bone disease, myeloma, metastasis) (n = 8) located between T10 and S1. Patient outcomes were evaluated pre-treatment and at 2- and 6-month follow-up visits. Postoperative cement extravasation was assessed with computed tomography. Patient-reported back pain was quantified using an 11-point numeric scale. Back-specific functional disability was self-reported with the Oswestry Disability Index on a 0 to 100% scale. Results: No cases of intraoperative hypotension, respiratory disturbance, neurological deterioration, infection, or death were observed. There were 2 (4.8%) levels where anterior cement leakage was visible radiographically in patients with osteolyses. No intracanal leakage was observed. Back pain scores improved 71% (p < 0.001) from pretreatment to the 6-month follow-up. Back function improved 56% from baseline to 6 months (p < 0.001). Conclusions: The initial clinical experience with the Kiva (R) System demonstrated significant improvements in back pain and function with minimal and clinically insignificant procedural cement leakage.