BlueCross BlueShield of Tennessee Medical Policy Manual

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.

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. SIFs can cause low back pain in osteoporotic patients.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

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 health 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 Academy of Orthopaedic Surgeons. (2010). The treatment of symptomatic osteoporotic spinal compression fractures guideline and evidence report. Retrieved August 7, 2012 from http://www.aaos.org/research/guidelines/SCFguideline.pdf.

American College of Radiology. (2013). ACR Appropriateness Criteria® management of vertebral compression fractures. Retrieved April 4, 2014 from http://www.guideline.gov.

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2013). Percutaneous kyphoplasty (6.01.38). Retrieved August 6, 2012 from BlueWeb. (35 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2013). Percutaneous vertebroplasty and sacroplasty (6.01.25). Retrieved April 4, 2014 from BlueWeb. (40 articles and/or guidelines reviewed)

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. (Level 1 Evidence)

Buchbinder, R., Osborne, R. H., Ebeling, P. R., Wark, J. D., Mitchell, P., Wriedt, C., et al. (2009). A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. New England Journal of Medicine, 361 (6), 557-568. (Level 2 Evidence – Independent)

California Technology Assessment Forum. (2009). Balloon kyphoplasty as a treatment for vertebral compression fractures. Retrieved April 4, 2014 from http://www.ctaf.org/assessments/balloon-kyphoplasty-treatment-vertebral-compression-fractures.

California Technology Assessment Forum. (2010; updated 2011). Vertebroplasty as a treatment for osteoporotic compression fractures. Retrieved April 4, 2014 from http://www.ctaf.org/assessments/vertebroplasty-treatment-osteoporotic-compression-fractures.

Denaro, L., Longo, U. G., & Denaro, V. (2009). Vertebroplasty and kyphoplasty: Reasons for concern? The Orthopedic Clinics of North America, 40 (4), 465-471.

Hsieh, M., Chen, L., Chen, W. (2013). Current concepts of percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures: evidencebased review. Biomedical Journal, 36 (4), 154-161.

Jensen, M. E., McGraw, J. K., Cardella, J. F., & Hirsch, J. A. (2009). Position statement on percutaneous vertebral augmentation: A consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. Retrieved August 7, 2012 from http://www.jvir.org/article/S1051-0443(09)00319-4/fulltext.

Jones, J. O., Bruel, B. M., & Vattam, S. R. (2009). Management of painful vertebral hemangiomas with kyphoplasty: A report of two cases and a literature review. Pain Physician, 12 (4), E297-E303. (Level 4 Evidence - Independent study)

Kallmes, D. V., Comstock, B. A., Heagerty, P. J., Turner, J. A., Wilson, D. J., Diamond, et al. (2009). A randomized trial of vertebroplasty for osteoporotic spinal fractures. New England Journal of Medicine, 360 (6), 569-579. (Level 2 Evidence- Industry supported)

Lim, B. S., Chang, U. K., & Youn, S. M. (2009). Clinical outcomes after percutaneous vertebroplasty for pathologic compression fractures in osteolytic metastatic spinal disease. Journal of Korean Neurosurgical Society, 45 (6), 369-374. (Level 3 Evidence)

National Institute for Health Research. Health Technology Assessment. (2014). Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral fractures: a systematic review and cost-effectiveness analysis. Retrieved April 4, 2014 from http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0017/114317/FullReport-hta18170.pdf.

National Institute of Health and Clinical Excellence. (2013). Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. Retrieved April 4, 2014 from www.guideline.gov

Technology Evaluation Center. (2012, June). Percutaneous vertebroplasty or kyphoplasty for vertebral fractures caused by osteoporosis. (Vol. 25, No. 9). Chicago: BlueCross BlueShield Association. (96 articles and/or guidelines reviewed)

U. S. Food and Drug Administration. (2007, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K070015. Retrieved October 13, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070015.pdf.

U. S. Food and Drug Administration. (2007, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K072496. Retrieved October 13, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072496.pdf.

U. S. Food and Drug Administration. (2011, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K093477. Retrieved August 7, 2012 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093477.pdf.

U. S. Food and Drug Administration. (2014, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K132817. Retrieved April 21. 2014 from http://www.accessdata.fda.gov/cdrh_docs/pdf13/k132817.pdf.

Van Meirhaeghe, J., Bastian, L., Boonen, S., Ranstam, J., Tillman, J., Wardlaw, D. (2013). A randomized trial of balloon kyphoplasty and nonsurgical management for the treatment of acute vertebral compression fractures. Spine, 38 (12), 971-983. (Level 2 Evidence – Industry supported)

Winifred S. Hayes, Inc. Medical Technology Directory. (2012, April; Last updates April, 2013). Percutaneous kyphoplasty. Retrieved April 4. 2014 from www.Hayesinc.com/subscribers. (99 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2012, April; Last updated March, 2014). Percutaneous vertebroplasty. Retrieved April 4, 2014 from www.Hayesinc.com/subscribers. (108 articles and/or guidelines reviewed)

Wisconsin Physicians Service Insurance Corporation (2013, October). LCD for vertebroplasty (percutaneous) and vertebral augmentation including cavity creation (L30516). Retrieved April 4, 2014 from http://www.cms.gov/medicare-coverage-database/shared/handlers/highwire.ashx?url=http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx@@@LCDId$$$30516***ContrId$$$268***ver$$$25***ContrVer$$$1***CoverageSelection$$$Both***ArticleType$$$All***PolicyType$$$Final***s$$$Tennessee***KeyWord$$$vertebroplasty***KeyWordLookUp$$$Title***KeyWordSearchType$$$And***from2$$$search.asp***bc$$$gAAAABAAAAAAAA$$$$$$***&session=x0edfj55ptta3iqhrbraxq45&kq=1427111062.

Work Loss Data Institute. (2011). Low back - lumbar & thoracic (acute & chronic). Retrieved August 8, 2012 from http://www.guideline.gov/content.aspx?id=33184&search=vertebroplasty.

Yu, C., Hsieh, M., Chen, L., Niu, C., Fu, T., Lai, P., et al. (2014), Percutaneous balloon kyphoplasty for the treatment of vertebral compression fractures. BMC Surgery, 14 (3), (Level 3 Evidence - Independent)

ORIGINAL EFFECTIVE DATE:  4/1/2001

MOST RECENT REVIEW DATE:  7/10/2014

ID_BT

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