Percutaneous Vertebroplasty and Kyphoplasty
DESCRIPTION
Percutaneous vertebroplasty is an interventional radiology technique involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body. The technique has been investigated as an option to provide mechanical support and symptomatic relief in individuals with osteoporotic vertebral compression fracture, or in those with osteolytic lesions of the spine (i.e., multiple myeloma or metastatic malignancies). Percutaneous vertebroplasty has also been investigated as an adjunct to surgery for aggressive vertebral body hemangiomas, as a technique to limit blood loss related to surgery. The technique has been used in all levels of the vertebrae (i.e., cervical, thoracic, and lumbar).
A variant of vertebroplasty is percutaneous kyphoplasty, which uses a specialized bone tamp with an inflatable balloon. The balloon bone tamp is placed in a fractured vertebral body prior to injection of the PMMA bone cement into the resulting cavity. Published studies indicate there is significantly less extravertebral cement leakage associated with percutaneous kyphoplasty than with vertebroplasty. Cement leakage is reported to occur during as many as 73% of vertebroplasty procedures. While most cases of leakage are asymptomatic, the Food and Drug Administration (FDA) issued a public health notification in 2002 that serious soft tissue damage and nerve root pain and compression have been related specifically to the leakage of the PMMA bone cement. Kyphoplasty also provides an opportunity to reduce unwanted kyphosis before stabilization. By stabilizing and preventing further microfractures, vertebroplasty may leave a significant residual spinal deformity, including kyphosis; kyphoplasty reduces this risk.
It has been proposed that these procedures may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other possible mechanisms of effect have been postulated, including thermal damage to intraosseous nerve fibers, since PMMA undergoes a heat-releasing (exothermic) reaction during its hardening process. The procedures involve either a local or a general anesthesia and a one-day hospital stay.
POLICY
Percutaneous vertebroplasty or kyphoplasty for the treatment of pain associated with osteoporotic fractures, osteolytic vertebral metastasis or myeloma, or vertebral hemangioma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Percutaneous vertebroplasty or kyphoplasty for the treatment of pain associated with all other conditions/diseases including, but not limited to, traumatic vertebral fractures and vertebral eosinophilic granuloma is considered investigational.
MEDICAL APPROPRIATENESS
Percutaneous vertebroplasty or kyphoplasty is considered medically appropriate in the treatment of individuals that meet one of the following criteria:
Osteoporotic fractures with persistent debilitating pain not responding to standard medical therapy (e.g., initial bed rest with progressive activity, bisphosphonates, physical therapy, bracing, analgesics) for a period of more than six weeks that is documented in the medical records; or
Osteolytic vertebral metastasis or myeloma with severe back pain related to destruction of the vertebral body not involving the major part of the cortical bone, when chemotherapy and radiation therapy have failed to relieve symptoms; or
Vertebral hemangiomas with aggressive clinical signs (e.g., severe pain or nerve compression) and/or aggressive radiological signs, when radiation therapy has failed to relieve symptoms.
ADDITIONAL INFORMATION
There is a lack of significant evidence that percutaneous vertebroplasty or kyphoplasty are as beneficial as conventional therapies for the treatment of traumatic vertebral fractures, vertebral eosinophilic granuloma and conditions/diseases other than those considered medically necessary above.
Percutaneous vertebroplasty or kyphoplasty for all other conditions/diseases does not meet the following technology evaluation criteria:
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The technology must improve the net health outcome.
The technology must be as beneficial as any established alternatives.
In October 2002, the FDA published a notice related to the use of polymethylmethacrylate bone cement to treat osteoporotic compression fractures of the spine using kyphoplasty and vertebroplasty procedures. Complications related to these procedures have been reported in the literature and to the FDA. Reported complications are related to the leakage of bone cement, and include soft tissue damage, nerve root pain and compression. Other reported complications include pulmonary embolism, respiratory and cardiac failure, and death.
SOURCES
Barr, J. D., Barr, M. S., Lemley, T. J., & McCann, R. M. (2000). Percutaneous vertebroplasty for pain relief and spinal stabilization. Spine, 25 (8), 923-928. Abstract retrieved October 18, 2000 from PubMed database.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2006). Percutaneous kyphoplasty (6.01.38). Retrieved February 5, 2007 from BlueWeb.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2006). Percutaneous vertebroplasty (6.01.25). Retrieved February 5, 2007 from BlueWeb.
BlueCross BlueShield of Tennessee network physicians. January-March 2004.
Cortet, B., Cotton, A., Boutry, N., Flipo, R. M., Duquesnoy, B., Chastanet, P., & Delcambre, B. (1999). Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: An open prospective study. Journal of Rheumatology, 26 (10), 2222-2228.
Cotton, A., Dewatre, F., Cortet, B., Assaker, R., Leblond, D., Duquesnoy, B., et al. (1996). Percutaneous vertebroplasty for osteolytic metastases and myeloma: Effects of the percentage of lesion filling and the leakage of methyl methacrylate at clinical follow-up. Radiology, 200 (2), 525-530. Abstract retrieved October 18, 2000 from PubMed database.
Coumans, J-V. C. E., Reinhardt, M-K., & Lieberman, I. H. (2003). Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. Journal of Neurosurgery (Spine 1), 99, 44-50.
Cyteval, C., Sarrabere, M. P., Roux, J. O., Thomas, E., Jorgensen, C., Blotman, F., et al. (1999). Acute osteoporotic vertebral collapse: Open study on percutaneous injection of acrylic surgical cement in 20 patients. American Journal of Roentgenology, 173 (6), 1685-1690. Abstract retrieved October 18, 2000 from PubMed database.
Dudeney, S., Lieberman, I. H., Reinhardt, M-K., & Hussein, M. (2002). Kyphoplasty in the treatment of osteolytic vertebral compression fractures as a result of multiple myeloma. Journal of Clinical Oncology, 20 (9), 2382-2387.
Eck, J. C., Hodges, S. D., & Humphreys, S. C. (2002, March). Vertebroplasty: A new treatment strategy for osteoporotic compression fractures. The American Journal of Orthopedics, 123-128.
Evans, A. J., Jensen, M. E., Kip, K. E., DeNardo, A. J., Lawler, G. J., Negin, G. A., et al. (2003). Vertebral compression fractures: Pain reduction and improvement in functional mobility after percutaneous polymethylmethacrylate vertebroplasty - retrospective report of 245 cases. Radiology, 226 (2), 366-371.
Fisher, A. (2002, May). Percutaneous vertebroplasty: A bone cement procedure for spinal pain relief. Issues in Emerging Health Technologies, (31), 1-4.
Fourney, D. R., Schomer, D. F., Nader, R., Chalan-Fourney, J., Suki, D., Ahrar, K., et al. (2003). Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. Journal of Neurosurgery (Spine 1), 98, 21-30.
Gangi, A., Dietemann, J-L., Mortazavi, R., Pfleger, D., Kauff, C., & Roy C. (1998). CT-guided interventional procedures for pain management in lumbosacral spine. Radiographics, 18 (3), 621-633.
Health Technology Assessment Information Services. Windows on medical technology. (2006, March). Percutaneous kyphoplasty for the treatment of vertebral fractures (No. 132). Retrieved February 5, 2007 from ECRI HTAIS.
Health Technology Assessment Information Services. Windows on medical technology. (2005, September). Percutaneous vertebroplasty for the treatment of vertebral fractures (No. 128). Retrieved February 5, 2007 from ECRI HTAIS.
Health Technology Assessment Information Services. Windows on medical technology. (2002, June). Percutaneous kyphoplasty for pain from osteoporotic spinal compression fracture (No. 77). Retrieved November 17, 2003 from ECRI HTAIS.
Health Technology Assessment Information Services. Windows on medical technology. (2001, January). Percutaneous vertebroplasty for pain from osteoporotic spinal compression fracture (No. 44). Retrieved June 14, 2002 from ECRI HTAIS.
Hoffmann, R. T., Jakobs, T. F., Wallnofer, A., Reiser, M. F., & Helmbergar, T. K. (2003). Percutaneous vertebroplasty (pv): Indications, contraindications, and technique. Der Radiologe, 43 (9), 709-717.
Kallmes, D. F., & Jensen, M. E. (2003). Percutaneous vertebroplasty. Radiology, 229 (1), 27-36.
Kallmes, D. F., Schweickert, P. A., Marx, W. F., & Jensen, M. E. (2002). Vertebroplasty in the mid- and upper thoracic spine. American Journal of Neuroradiology, 23, 1117-1120.
Lane, J. M., Johnson, C. E., Khan, S. N., Girardi, F. P., & Cammisa, F. P. (2002). Minimally invasive options for the treatment of osteoporotic vertebral compression fractures. The Orthopedic Clinics of North America, 33 (2), 431-438.
Levine, S. A., Perin, L. A., Hayes, D., & Hayes, W. S. (2000). An evidence-based evaluation of percutaneous vertebroplasty. Managed Care, 9 (3), 56-60 & 63. Abstract retrieved June 14, 2002 from PubMed database.
Lieberman, I. H., Dudeney, S., Reinhardt, M-K., & Bell, G. (2001). Initial outcome and efficacy of "kyphoplasty" in the treatment of painful osteoporotic vertebral compression fractures. Spine, 26 (14), 1631-1637.
Lin, J. T., & Lane, J. M. (2002). Nonmedical management of osteoporosis. Current Opinion in Rheumatology, 14 (4), 441-446.
Linville, D. A. (2002). Vertebroplasty and kyphoplasty. Southern Medical Journal, 95 (6), 583-587.
Martin, J. B., Jean, B., Sugiu, K., San Millan Ruiz, D., Piotin, M., Murphy, K., et al. (1999). Vertebroplasty: Clinical experience and follow-up results. Bone, 25 (2 Suppl.), 11S-15S. Abstract retrieved October 18, 2000 from PubMed database.
Martin, J. B., Wetzel, S. G., Seium, Y., Dietrich, P. Y., Somon, T., Gailloud, P., et al. (2003). Percutaneous vertebroplasty in metastatic disease: Transpedicular access and treatment of lysed pedicles--initial experience. Radiology, 229 (2), 593-597.
National Institutes of Health Osteoporosis and Related Bone Diseases National Resource Center. (2000, September). The impact of vertebral fractures. Retrieved November 13, 2000 from http://www.osteo.org/newfile.
National Institutes of Health. (2000, September). Consensus panel addresses osteoporosis prevention, diagnosis, and therapy. Retrieved November 13, 2000 from http://www.niams.nih.gov/ne/press/2000.
Peh, W. C. G., Gelbart, M. S., Gilula, L. A., & Peck, D. D. (2003). Percutaneous vertebroplasty: Treatment of painful vertebral compression fractures with intraosseous vacuum phenomena. American Journal of Roentgenology, 180 (5), 1411-1417.
Phillips, F. M., Wetzel, F. T., Lieberman, I., & Campbell-Hupp, M. (2002). An in vivo comparison of the potential for extravertebral cement leak after vertebroplasty and kyphoplasty. Spine, 27 (19), 2173-2178.
The Technology Evaluation Center [Computer software]. (2001, March). Percutaneous vertebroplasty (Vol. 15, No.21). Washington, DC: BlueCross BlueShield Association.
The Technology Evaluation Center. (2004, December.) Percutaneous vertebroplasty for vertebral fractures caused by osteoporosis, malignancy, or hemangioma (Vol. 19, No. 13). Retrieved February 5, 2007 from http://www.bcbs.com/betterknowledge/tec/vols/19/19_13.pdf.
The Technology Evaluation Center. (2004, December.) Percutaneous kyphoplasty for vertebral fractures caused by osteoporosis, malignancy, or hemangioma (Vol. 19, No. 12). Chicago: BlueCross BlueShield Association.
The Technology Evaluation Center. (2005, August). Percutaneous kyphoplasty for vertebral fractures caused by osteoporosis or malignancy (Vol. 20, No. 7). Retrieved February 5, 2007 from http://www.bcbs.com/betterknowledge/tec/vols/20/20_07.pdf.
The Technology Evaluation Center. (2005, August). Percutaneous vertebroplasty for vertebral fractures caused by osteoporosis or malignancy (Vol. 20, No. 6). Retrieved February 5, 2007 from http://www.bcbs.com/betterknowledge/tec/vols/20/20_06.pdf.
Trout, A. T., Kallmes, D. F., & Kaufmann, T. J. (2006). New fractures after vertebroplasty: Adjacent fractures occur significantly sooner. American Journal of Neuroradiology, 27, 217-223.
U. S. Food and Drug Administration. (2002, October). Center for Devices and Radiological Health. FDA public health web notification: complications related to the use of bone cement in vertebroplasty and kyphoplasty procedures. Retrieved January 10, 2003 from http://www.fda.gov/cdrh/pmafeb01.html.
Weill, A., Chiras, J., Simon, J. M., Rose, M., Sola-Martinez, T., & Enkaoua, E. (1996). Spinal metastases: Indications for and results of percutaneous injection of acrylic surgical cement. Radiology, 199 (1), 241-247. Abstract retrieved October 18, 2000 from PubMed database.
Wong, W., Reiley, M. A., & Garfin, S. (2000). Vertebroplasty/kyphoplasty. Journal of Women's Imaging, 2 (3), 117-124.
|
EFFECTIVE DATE |
3/8/2007 |
|
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.