BlueCross BlueShield of Tennessee Medical Policy Manual

Percutaneous Vertebroplasty, Kyphoplasty and Sacroplasty

DESCRIPTION

Percutaneous vertebroplasty is a minimally invasive surgical or interventional procedure, performed by injecting radiopaque bone cement (polymethylmethacrylate or PMMA) into a painful osteoporotic or neoplastic compression fracture or a painful vertebral body weakened by any other etiology. 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 is an image-guided percutaneous procedure that creates a cavity within the bone that is then filled with material. Published studies indicate there is significantly less extravertebral cement leakage associated with percutaneous kyphoplasty than with vertebroplasty. 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.

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 PMMA into sacral insufficiency fractures (SIFs) for stabilization using computerized tomography (CT) or fluoroscopic guidance. It has been proposed that these procedures may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body

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. Therefore, sacroplasty remains investigational.

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 (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Society of Interventional Radiology (SIR), and Society of NeuroInterventional Surgery (SNIS). (2014) Practice parameter for the performance of vertebral augmentation (Resolution 39). Retrieved November 6, 2015 from: http://www.acr.org/guidelines.

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 vertebroplasty and sacroplasty (6.01.25). Retrieved November 6, 2015 from BlueWeb. (48 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: evidence-based 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. (2006). Balloon kyphoplasty for vertebral compression fractures. Retrieved November 6, 2015 from www.guideline.gov.

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 update March 2015). Percutaneous kyphoplasty. Retrieved November 6, 2016 from www.Hayesinc.com  (124 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2012, April; Last updated March, 2015). Percutaneous vertebroplasty. Retrieved November 6, 2015 from www.Hayesinc.com  (133 articles and/or guidelines reviewed)

Wisconsin Physicians Service Insurance Corporation (2015, October). LCD for vertebroplasty (percutaneous) and vertebral augmentation including cavity creation (L34592). Retrieved November 6, 2015 from: http://www.cms.gov/medicare-coverage.

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:  12/10/2015

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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