BlueCross BlueShield of Tennessee Medical Policy Manual

Percutaneous Vertebroplasty and Kyphoplasty

DESCRIPTION

Percutaneous vertebral augmentation (e.g. vertebroplasty, kyphoplasty, sacroplasty) encompasses a variety of minimally invasive procedures for treating vertebral compression fractures (VCF). Clinical symptoms associated with VCFs include: back pain, limited spinal mobility, height loss, and/or deformity and disability. Compression fractures are diagnosed using a combination of medical history and physical examination and may be confirmed using imaging techniques. On x-ray a wedge-shaped vertebra may be visible or there may be loss of height of the vertebra. The weakened bone compresses, or collapses in on itself; a fracture may occur while one is bending, twisting, or a fall from standing height or less. Only about one-third of vertebral compression fractures reach clinical diagnosis, with most symptomatic fractures healing within a few weeks. Medical management, including nonsteroidal anti-inflammatory drugs, oral analgesics, bracing and physical therapy remains the first-line therapy for individuals with a vertebral compression fracture. If medical management is unsuccessful or unfeasible surgical management can include:

Vertebroplasty - performed by percutaneous injection of radiopaque bone cement, usually polymethyl-methacrylate (PMMA) (e.g.,Spine-Fix® Biomimetic Bone Cement, Osteopal® V) into a painful osteoporotic or neoplastic compression fracture. Percutaneous vertebroplasty has also been used as to treat osteolytic vertebral metastasis or myeloma, and 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).

Kyphoplasty - a variant of vertebroplasty and has traditionally been done by inflation of a balloon (e.g., Kyphoon®) in the fractured vertebral body to restore vertebral height before the balloon is removed and cement injected. Newer techniques also known as mechanical vertebral augmentation include implantation of a continuous loop-like spinal device (i.e., Kiva® VCF Treatment System) through which the cement is injected with the device remaining in place. 

Radiofrequency targeted vertebral augmentation - a modified technique being investigated to treat vertebral compression fractures where a motorized cement delivery system in vertebroplasty or kyphoplasty allows for radiofrequency warming of high viscosity cement during delivery. The high viscosity cement is designed to restore height and alignment to the fractured vertebra, along with stabilizing the fracture. However, thermal damage to intraosseous nerve fibers is a concern.

These procedures require fluoroscopic or ultrasound guidance. With any type of vertebral augmentation, there is risk of the bone cement migrating out of place (called extravasation). In some cases this has led to transient radicular pain, neurologic symptoms, pulmonary embolism, deep vein thrombosis, and/or pneumonia. Evidence also suggests there may be an increased rate of subsequent fractures in adjacent vertebrae.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Devices for kyphoplasty, other than the Kiva® VCS Treatment System, have few or no high quality clinical studies to demonstrate safety and/or effectiveness.

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.

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). (2017) Practice parameter for the performance of vertebral augmentation (Resolution 16, Revised 2017). Retrieved August 21, 2017 from http://www.acr.org/guidelines.

BlueCross BlueShield Association. Evidence Positioning System. (4:2018). Percutaneous vertebroplasty and sacroplasty (6.01.25). Retrieved February 25, 2019 from https://www.evidencepositioningsystem.com/. (45 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Evidence Positioning System. (4:2018). Percutaneous balloon kyphoplasty, radiofrequency kyphoplasty, and mechanical vertebral augmentation. (6.01.38). Retrieved February 25, 2019 from https://www.evidencepositioningsystem.com/. (31 articles and/or guidelines reviewed)

Buchbinder, R., Golmohammadi, K., Johnston, R., Owen, R., Homik, J., Jones, A., et al. (2015). Percutaneous vertebroplasty for osteoporotic vertebral compression fracture.Cochrane Database Systems Review, (4), CD006349. Abstract retrieved August 31, 2017 from PubMed database.

Ebeling, P.R., Akesson, K., Bauer, D.C., Buchbinder, R., Eastell, R., Fink, H.A., Giangregorio, L., et al. (2019). The efficacy and safety of verterbral augmentation: A second ASBMR task force report. Journal of Bone and Mineral Research, 34 (1), 3-21. (Level 1 evidence)

Fan, J., Shen, Y., Zhan, N., Ren, Y., Cai, W., Yu, L., et al. (2016). Evaluation of surgical outcome of Jack vertebral dilator kyphoplasty for osteoporotic vertebral compression fracture-linical experience of 218 cases. Journal of Orthopedic Surgery and Research, 11 (56). (Level 4 evidence)

Feng, L., Shen, J., Feng, C., Chen, C., and Wu, Y. (2017). Comparison of radiofrequency kyphoplasty (RFK) and balloon kyphoplasty (BKP) in the treatment of vertebral compression fractures. Medicine, 96 (25). (Level 2 evidence)

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. (Level 1 evidence)

Korovessis, P., Vardakastanis, K., Repantis, T., and Vitsas, V. (2013). Balloon kyphoplasty versus KIVA vertebral augmentation-- comparison of 2 techniques for osteoporotic vertebral body fractures: a prospective randomized study. Spine, 38 (4), 292-9. Abstract retrieved August 31, 2017 from PubMed database.

Liang, L., Chen, X., Jiang, W., Li, W., Chen, J., Wu, L., et al. (2016). Balloon kyphoplasty or percutaneous vertebroplasty for osteoporotic vertebral compression fracture? An updated systematic review and meta-analysis. Annals of Saudi Medicine, 36 (3), 165-174. (Level 1 evidence)

Mattie, R., Laimi, K., Yu, S., & Saltychev, M. (2016). Comparing percutaneous vertebroplasty and conservative therapy for treating osteoporotic compression fractures in the thoracic and lumbar spine: A systematic review and meta-analysis. The Journal of Bone and Joint Surgery-American, 98 (12), 1041-1051. Abstract retrieved September 13, 2016 from PubMed database. (Level 1 evidence)

National Institute of Health and Clinical Excellence. (2006). Balloon kyphoplasty for vertebral compression fractures, interventional procedures guidance. Retrieved August 21, 2017 from www.nice.org.uk.

National Institute of Health and Clinical Excellence. (2013). Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. Technology appraisal guidance. Retrieved August 21, 2017 from www.nice.org.uk.

Noriega, D., Maestretti, G., Renaud, C. Francaviglia, N., Ould-Slimane, M., Queinnec, S. et al. (2015). Clinical performance and safety of 108 SpineJack implantations: 1-year results of a prospective multicentre single-arm registry study. BioMed Research International, article ID: 173872. (Level 4 evidence)

Olivarez, L., Dipp, J., Escamilla, R., Bajares, G., Perez, A., Stubbs, H., et al. (2011). Vertebral augmentation treatment of painful osteoporotic compression fractures with the Kiva VCF Treatment System. SAS Journal 5 (2011) 114-119. (Level 4 evidence)

Rodriguez, A., Fink, H., Mirigian, L., Guañabens, N., Eastell, R., Akesson, K., et al. (2017). Pain, quality of life, and safety outcomes of kyphoplasty for vertebral compression fractures: report of a task force of the American Society for Bone and Mineral Research. Journal of Bone & Mineral Research, 32 (9), 1935-44. Abstract retrieved September 1, 2017 from PubMed database.

Tutton, S., Pflugmacher, R., Davidian, M., Beall, D., Facchini, F., and Garfin, S. (2015). KAST Study: The Kiva System as a vertebral augmentation treatment-s safety and effectiveness trial: a randomized, noninferiority trial comparing the Kiva system with balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures. Spine, 15 (12), 865-75. Abstract retrieved September 1, 2017 from PubMed database.

U. S. Food and Drug Administration. (2006, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053336 (StaXx™ FX System). Retrieved April 31. 2014 from http://www.accessdata.fda.gov.

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

U. S. Food and Drug Administration. (2009, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K090986 (StabiliT ER™ RFA Bone Cement Dispenser). Retrieved April 31. 2014 from http://www.accessdata.fda.gov.

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

U. S. Food and Drug Administration. (2013 April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K130402 (Spider System). Retrieved April 31. 2014 from http://www.accessdata.fda.gov.

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

Wallace, A., Tomasian, A., Vaswani, R., Chang, R., and Jennings, J. (2016). Radiographic local control of spinal metastases with percutaneous radiofrequency ablation and vertebral augmentation. American Journal of Neuroradiology, 37, 579-565. (Level 4 evidence)

Wang, B., Zhao, C.P., Song, L., & Zhu, L. (2018). Balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral compression fracture: a meta-analysis and systematic review. Journal of Orthopaedic Surgery and Research, 13, 264. (Level 2 evidence)

Wang, H., Sribastav, S., Ye, F., Yang, C., Wang, J., Liu, H., et al. (2015). Comparison of percutaneous vertebroplasty and balloon kyphoplasty for the treatment of single level vertebral compression fractures: A meta-analysis of the literature. Pain Physician, 18 (3), 209-222. Abstract retrieved September 13, 2016 from PubMed database. (Level 1 evidence)

Winifred S. Hayes, Inc. Medical Technology Directory. (2016, December; latest update search November 2018) Comparative effectiveness of percutaneous vertebroplasty versus sham, conservative treatment, or kyphoplasty for osteoporotic vertebral compression fractures. Retrieved February 27, 2019 from www.Hayesinc.com/subscribers. (63 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2017, March; latest update search March 2018). Percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Retrieved April 20, 2018 from www.Hayesinc.com. (62 articles and/or guidelines reviewed)

Yi, H. J., Jeong, J. H., Im, S. B., & Lee, J. K. (2016). Percutaneous vertebroplasty versus conservative treatment for one level thoracolumbar osteoporotic compression fracture: Results of an over 2-year follow-up. Pain Physician, 19 (5), 743-750.

Zhu, R.S., Kan, S.L., Ning, G.Z., Chen, L.X., Cao, Z.G., Jiang, Z.H., et al. (2019). Which is the best treatment of osteoporotic vertebral compression fractures: balloon kyphoplasty, percutaneous vertebroplasty, or non-surgical treatment? A Bayesian network meta-analysis. Osteoporosis International, doi: 10.1007/s00198-018-4804-2. [Epub ahead of print]

ORIGINAL EFFECTIVE DATE:  4/1/2001

MOST RECENT REVIEW DATE:  3/28/2019

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