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Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients
© Korovessis et al; licensee BioMed Central Ltd. 2011
Received: 11 February 2011
Accepted: 22 September 2011
Published: 22 September 2011
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.
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® 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.
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 pre-treatment to the 6-month follow-up. Back function improved 56% from baseline to 6 months (p < 0.001).
The initial clinical experience with the Kiva® System demonstrated significant improvements in back pain and function with minimal and clinically insignificant procedural cement leakage.
Vertebral compression fractures are common injuries with an incidence of 1.4 million each year . Manifestations of fractured vertebrae include severe chronic back pain, disability, and reductions in quality of life [2–7] as well as greater risk for future vertebral fractures . Acute, symptomatic vertebral compression fractures are initially treated with conservative care, which may include bed rest, bracing, analgesic medication, and/or physical rehabilitation and exercise programs. However, vertebral deformity and back pain often persist despite these measures and, therefore, surgery may eventually be required . Minimally invasive vertebral augmentation procedures have been widely used to treat vertebral compression fractures caused by osteoporosis and, less commonly, osteolytic tumors [10–16]. Although the results of these trials are encouraging, procedural polymethylmethacrylate (PMMA) cement leakage remains common with a frequency of 7% to 72% per treated level [10, 17–20]. We report herein our initial experience with a novel vertebral augmentation system designed to treat painful vertebral osteoporotic fractures and osteolytic metastases with minimal cement extravasation.
This single-arm, feasibility trial was conducted at the first author's institution between January 2010 and April 2010. All study procedures were conducted in accordance with the ethical principles stated in the Declaration of Helsinki and this research was approved by the General Hospital "Agios Andreas" (Patras, Greece). Forty-two vertebral augmentation procedures were performed in 26 consecutive patients (mean age 74 ± 9 years; range: 58 to 86 years). 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. Symptomatic levels were confirmed with x-ray, computed tomography, and/or magnetic resonance imaging.
Patient outcomes were evaluated pre-treatment and at the 2- and 6-month follow-up visits. Patient-reported back pain was quantified using an 11-point (0 to 10) numeric scale. Back-specific functional disability was self-reported with the Oswestry Disability Index (ODI) (version 2) on a 0 to 100% scale . Postoperative cement extravasation and device-related adverse events were assessed with computed tomography and plain radiographs.
Data were analyzed using Predictive Analytics Software (v. 18, SPSS, Inc., Chicago, IL). Continuous data were reported as mean ± standard deviation and categorical data were reported as frequencies and percentages. Longitudinal changes in patient outcomes were analyzed with repeated measures analysis of variance.
The Kiva® System is a novel, safe technique for percutaneous vertebral body augmentation in patients with symptomatic osteoporotic fractures and osteolytic metastases. In our initial experience with this device, we demonstrated improvement in back pain and function through 6 months post-treatment with no significant procedural cement extravasation.
The results of this case series are encouraging. The mean reduction in post-operative pain by 6 months was approximately 5.0 units. These findings compare favorably with the findings from four separate meta-analyses of published studies of the clinical effectiveness of balloon kyphoplasty. Specifically, the mean reductions reported in these meta-analyses for post-operative pain severity scores were 5.1 units from Bouza et al. , 5.6 units from Gill et al. , 5.4 units from Taylor et al. , and 4.6 units from Eck et al. .
The effectiveness of vertebral augmentation remains controversial especially since vertebroplasty was reported to have only modest clinical benefit versus sham in two randomized controlled trials [23, 24]. These studies enrolled patients with vertebral fracture ages of less than 1 year. However, recent trials of vertebral augmentation that enrolled patients with more acute fractures (6 weeks to 3 months) have reported positive results [17, 18, 25]. Therefore, the application of vertebral augmentation techniques may be most beneficial when applied soon after fracture, a concept that is in agreement with the initial findings from the current series.
In kyphoplasty and vertebroplasty procedures, PMMA cement may leak laterally to the soft tissues, superiorly or inferiorly into the adjacent disc space, or posteriorly, where it may involve the exiting nerve root or the spinal canal . The Kiva® System, on the other hand, was designed to reduce and stabilize osteoporotic vertebral fractures by deploying a coiled PEEK implant which is then augmented with cement. This technique allows directional cement delivery, which helps to facilitate cement containment. Our first experience with 42 implants confirmed that the Kiva® System was able to control cement leakage with only 2 (7.7%) observed cases, none of which resulted in clinical sequelae. These results compare favorably to cement leakage rates of 7 to 72% reported with kyphoplasty and vertebroplasty [10, 17–20].
Limitations of this feasibility study include lack of a control group, a relatively short follow-up period, and lack of objective measures of vertebral height restoration. Despite these limitations, the initial clinical results of this trial are promising and warrant further study in larger series with longer follow-up periods.
The results from our initial clinical experience with the Kiva® VCF Treatment System demonstrated significant improvements in back pain and function with minimal and clinically insignificant procedural cement leakage.
We thank Mr. Randy Asher for graphical assistance.
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