Vertebral metastases are generally associated with significant pain, disability, and ultimately morbidity. In patients with vertebral metastases open surgery for fracture stabilization is, in most cases, considered inappropriate due to a poor risk-benefit profile, particularly if life expectancy is short. Percutaneous vertebroplasty and kyphoplasty may help alleviate intractable pain. However, these patients have higher risk of serious complications, including cement extravasation.
In a physician-driven prospective study patients with painful osteolytic vertebral metastases were treated with the Kiva VCF Treatment System by Benvenue Medical, Inc. The results showed that all patients experienced a clinically relevant improvement in pain and statistically significant functional improvement. The peer-reviewed study results were published online and in the March/April 2013 edition of Pain Physician Journal, the official publication of the American Society of Interventional Pain Physicians.
“The Kiva implant represents a new therapeutic option for treatment of painful vertebral metastasis where radiation therapy, traditional surgical stabilization, or balloon-based vertebral augmentation procedures may not be an option,” noted Giovanni Carlo Anselmetti, MD, Interventional Radiologist in Turin, Italy and author of the study. “Patients with osteolytic metastasis that involve the vertebral wall have a greater risk for cement extravasation, and in our experience, the design of the Kiva Implant may reduce the risk for PMMA extravasation versus traditional vertebral augmentation procedures.”
Osteolytic vertebral metastases
Osteolytic vertebral metastases are malignant bone tumors that can cause the spine to collapse, and they can cause significant pain, disability and even death. Many traditional treatments are inappropriate for patients suffering from vertebral metastases due to a poor risk-benefit profile. While vertebroplasty and kyphoplasty are often performed to alleviate pain, these patients have a higher risk of serious complications, especially cement extravasation.
The single-arm study included 40 patients suffering from osteolytic metastasis with vertebral wall involvement. All underwent a vertebral augmentation procedure with the Kiva System with its PEEK-OPTIMA? implant, and post-procedure they were evaluated using CT and the Oswestry Disability Index with self-evaluation questionnaire (ODI). Pain and analgesic drug use and the use of external braces were also recorded. The study results showed that participating patients:
- Achieved a clinically meaningful improvement in pain at one month (P < 0.001)
- Using opiates could be switched to NSAIDS or no treatment at all following surgery (P < 0.001)
The results also showed that patient cohort experienced a 95% median functional improvement during follow-up after the procedure (P < 0.001) and that none of the 37 patients who wore a brace prior to intervention required a brace post-procedure.
“This study adds to the growing breadth of published clinical evidence demonstrating Kiva’s performance in the treatment of VCFs as a result of osteoporosis, trauma, and now cancer. We’re pleased that the Kiva System offers a new option for the many patients in Europe who are suffering from the devastating pain of vertebral metastases,” said Robert K. Weigle, CEO of Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair.
The Implant is delivered percutaneously in a continuous loop into the vertebral body through a small diameter, single incision. The amount of the Kiva Implant delivered can be physician-customized during the procedure to adjust to various fracture types. Delivered over a removable guidewire, the Implant is designed to provide structural support to the vertebral body and to directionally control and contain bone cement.
The minimally invasive Kiva System is designed to offer the following potential benefits:
- Reduce polymethyl methacrylate (PMMA) bone cement volume
- Preserve cancellous (porous and mesh-like, as opposed to dense) bone structure
- Implant’s biomechanical properties may contribute to a reduced rate of adjacent level fractures
- Reduce extravasation rate (bone cement leakage into surrounding tissue)
Availability and ongoing trials
The Kiva VCF Treatment System is commercially available in Europe and is indicated for the treatment of vertebral compression fractures and the pain associated with osteolytic vertebral metastasis. In the United States Kiva is investigational and currently the subject of an approved IDE study – the KAST (Kiva System as a Vertebral Augmentation Treatment ? A Safety and Effectiveness Trial) clinical trial, sponsored by Benvenue Medical. The KAST trial completed enrollment of 300 patients in June 2012, more than 200 of whom completed their one-year follow-up. KAST is being conducted to support a 510(k) filing for market clearance from the U.S. Food and Drug Administration (FDA), which Benvenue Medical expects to submit in the third quarter of 2013.
For more information
–NCT01123512-The Kiva? System as a Vertebral Augmentation Treatment (KAST)
– Shi-Liang Han, Shuang-Lin Wan,Qing-Tao Li, et al.Vertebral Fracture Risk Is Not A Contraindication to Vertebroplasty or Kyphoplast. Pain Physician: March/April 2013; 16:E119-E123
-Anselmetti GC, Tutton SM, Facchini FR, Miller LE, Block JE.Percutaneousaugmentation for painful osteolytic vertebral metastasis: a case report. International Medical Case Reports Journal,March 2012Volume2012:5 Pages13 – 17.DOI:http://dx.doi.org/10.2147/IMCRJ.S29569.
– John M. Mathis, MD, MSc,Herv? Deramond, MD,Stephen M. Belkoff, PhD. Percutaneous Vertebroplasty and Kyphoplasty (Second Edition).Springer Science+Business Media, Inc. ISBN-10: 0-387-29078-8 / ISBN-13: 978-0387-29078-2
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