Percutaneous Vertebroplasty, Kyphoplasty and Sacroplasty
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.
Percutaneous sacroplasty is being investigated as a technique to provide stabilization to the sacral area. Percutaneous sacroplasty is a variation of the percutaneous vertebroplasty technique. It involves the injection of polymethylmethacrylate cement into sacral insufficiency fractures (SIFs) for stabilization using computerized tomography (CT) or fluoroscopic guidance. SFIs can cause low back pain in osteoporotic patients.
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.
Percutaneous sacroplasty for all indications 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 by the following:
Aggressive clinical signs (e.g., severe pain or nerve compression) and/or aggressive radiological signs
Radiation therapy failed to relieve symptoms
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is a lack of peer-reviewed literature to demonstrate the effects of sacroplasty on health outcomes. No well-designed studies regarding its safety and efficacy or long-term improved patient outcomes have been published in scientific peer-reviewed literature.
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
American Society of Spine Radiology. (2004). Percutaneous bone cement injection for sacral fractures (Sacroplasty). Bassem, G. Retrived December 11, 2009 from http://theassr.org/abstract/percutaneous-bone-cement-injection-for-sacral-fractures-sacroplasty/.
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2008). Percutaneous vertebroplasty (6.01.25). Retrieved October 2, 2009 from BlueWeb. (36 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2008). Percutaneous kyphoplasty (6.01.38). Retrieved October 2, 2009 from BlueWeb. (29 articles and/or guidelines reviewed)
BlueCross BlueShield of Tennessee network physicians. January-March 2004.
Bouza, C., Lopez-Cuadrado, T., Cediel, P., Saz-Parkinson, Z., & Amate, J. M. (2009). Balloon kyphoplasty in malignant spinal fractures: a systematic review and meta-analysis. BMC Palliative Care, 8, 12.
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ECRI Institute. Health Technology Information Service. Evidence Reports. (2008, December). Percutaneous vertebroplasty for the treatment of vertebral fractures. Retrieved October 13, 2009 from ECRI Institute. (210 articles and/or guidelines reviewed)
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.
Frey, M. E., DePalma, M. J., Cifu, D. X., Bhagia, S. M., and Daitch, J. S. (2007). Efficacy and safety of percutaneous sacroplasty for painful osteoporotic sacral insufficiency fractures. Spine, 32(15), 1635-1640. Abstract retrieved December 11, 1009 from PubMed database.
Frey, M. E., Depalma, M. J., Cifu, D. X., Bhagia, S. M., Carne, W., and Daitch, J. S. (2008). Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: A prospective, multicenter, observational pilot study. The Spine Journal, 8 (2), 367-373. Abstract retrieved December 11, 1009 from PubMed database.
Gregory, B. A. (2009). Percutaneous cement augmentations of malignant lesions of the sacrum and pelvis. American Journal Neuroradiology, 30(7):1357-1359. Abstract retrieved December 11, 1009 from PubMed database.
Hayes. Medical Technology Directory. (2008, February). Percutaneous kyphoplasty. Retrieved October 13, 2009 from www.Hayesinc.com/subscribers. (101 articles and/or guidelines reviewed)
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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.
Syed, M. I., Avutu, B., Shaikh, A., Sparks, H., Mohammed, M. I., & Morar, K. (2009). Vertebral osteomyelitis following vertebroplasty: Is acne a potential contraindication and are prophylactic antibiotics mandatory prior to vertebroplasty? Pain Physician, 12 (4), E285-E290.
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Wong, W., Reiley, M. A., & Garfin, S. (2000). Vertebroplasty/kyphoplasty. Journal of Women's Imaging, 2 (3), 117-124.
ORIGINAL EFFECTIVE DATE: 4/1/2001
MOST RECENT REVIEW DATE: 4/8/2010
ID_BT
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