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 ANY ONE of the following criteria:
Osteoporotic fractures with ALL of the following:
Persistent debilitating pain not responding to standard medical therapy (e.g., initial bed rest with progressive activity, bisphosphonates, physical therapy, bracing, analgesics)
A period of more than six weeks that is documented in the medical records
Osteolytic vertebral metastasis or myeloma with ALL of the following:
Severe back pain related to destruction of the vertebral body not involving the major part of the cortical bone
Chemotherapy and radiation therapy have failed to relieve symptoms
Vertebral hemangiomas with ALL of the following:
Aggressive clinical signs (e.g., severe pain or nerve compression) and/or aggressive radiological signs
Radiation therapy 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.
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
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ECRI Institute. Health Technology Information Service. Evidence Reports. (2006, March). Percutaneous kyphoplasty for the treatment of vertebral fractures. Retrieved October 13, 2009 from ECRI Institute. (110 articles and/or guidelines reviewed)
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.
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ORIGINAL EFFECTIVE DATE: 4/1/2001
MOST RECENT REVIEW DATE: 11/12/2009
ID_BT
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.
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