Percutaneous Vertebroplasty, Kyphoplasty, and Mechanical Vertebral Augmentation
DESCRIPTION
Percutaneous vertebroplasty, balloon kyphoplasty, radiofrequency kyphoplasty, and mechanical vertebral augmentation are percutaneous vertebral augmentation interventional techniques proposed for treating vertebral compression fractures. Osteoporotic compression fractures are common. It is estimated that up to one-half of women and approximately one-quarter of men will have a vertebral fracture at some point in their lives; however, only about one-third of vertebral fractures reach clinical diagnosis, and most symptomatic fractures heal within a few weeks. Some individuals will exhibit chronic pain following osteoporotic compression fracture that presents challenges for medical management. Vertebral fractures can also be pathologic, due to osteolytic lesions, most commonly from metastatic tumors.
Percutaneous vertebroplasty involves the injection of bone cement into a fractured vertebra under image guidance. Once in place, the cement hardens and stabilizes the fractured vertebra, preventing further fracture or collapse, and potentially providing an analgesic effect. Vertebroplasty does not restore the original height and shape to the vertebra.
Balloon kyphoplasty is a variant of vertebroplasty and uses a specialized bone tamp with an inflatable balloon to expand a collapsed vertebral body as close as possible to its natural height before injection of bone cement. Radiofrequency kyphoplasty (also known as radiofrequency targeted vertebral augmentation) is a modification of balloon kyphoplasty. In this procedure, a small diameter articulating osteotome creates paths across the vertebra. An ultra-high viscosity cement is injected into the fractured vertebral body, and radiofrequency is used to achieve the desired consistency of the cement. The ultra-high viscosity cement is designed to restore height and alignment to the fractured vertebra, along with stabilizing the fracture.
Mechanical vertebral augmentation (e.g., Kiva®, SpineJack®, V-Strut®) is a technique that uses an implant for structural support of the vertebral body to provide a reservoir for bone cement. This technique is proposed to restore vertebral height and shape in addition to providing support and symptomatic relief.
POLICY
Percutaneous vertebroplasty, balloon kyphoplasty, and mechanical vertebral augmentation are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Percutaneous vertebroplasty, kyphoplasty, and mechanical vertebral augmentation for the treatment of symptoms associated with other conditions/diseases is considered investigational.
Percutaneous radiofrequency targeted kyphoplasty for all indications is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Percutaneous vertebroplasty augmentation is considered medically appropriate if ALL of the following are met:
Documentation confirming the absence of ALL of the following:
Current diagnosis of discitis
Current diagnosis of vertebral osteomyelitis
Percutaneous vertebral augmentation is performed using ANY ONE of the following procedures:
Percutaneous vertebroplasty for ANY ONE of the following conditions:
Osteoporotic vertebral compression fracture with ANY ONE of the following:
Symptoms for less than 6 weeks that are so severe they prevent ambulation
Symptoms for 6 weeks or longer that have not responded to standard medical therapy (e.g., initial bed rest with progressive activity, physical therapy, bracing, analgesics)
Osteolytic vertebral lesions related to metastasis or myeloma with severe back pain
Vertebral hemangiomas with ALL of the following:
Aggressive clinical signs (e.g., severe pain or nerve compression) and/or aggressive radiological signs
Radiation therapy has failed to relieve symptoms
Percutaneous balloon kyphoplasty for ANY ONE of the following conditions:
Thoracolumbar osteoporotic vertebral compression fracture that has not responded to 6 weeks of standard medical therapy (e.g., initial bed rest with progressive activity, physical therapy, bracing, analgesics)
Osteolytic vertebral lesions related to metastasis or myeloma with severe back pain
Vertebral hemangiomas with ALL of the following:
Aggressive clinical signs (e.g., severe pain or nerve compression) and/or aggressive radiological signs
Radiation therapy has failed to relieve symptoms
Mechanical vertebral augmentation for ANY ONE of the following conditions:
Thoracolumbar osteoporotic vertebral compression fracture that has not responded to 6 weeks of standard medical therapy (e.g., initial bed rest with progressive activity, physical therapy, bracing, analgesics)
Osteolytic vertebral lesions related to metastasis or myeloma with severe back pain
Vertebral hemangiomas with ALL of the following:
Aggressive clinical signs (e.g., severe pain or nerve compression) and/or aggressive radiological signs
Radiation therapy has failed to relieve symptoms
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Evidence to support other methods of performing vertebral augmentation to treat vertebral fractures is lacking. High-quality, sham-controlled studies are required for radiofrequency kyphoplasty to determine if this procedure has outcomes similar to balloon kyphoplasty.
SOURCES
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). (2022) Practice parameter for the performance of vertebral augmentation (Resolution 19, Revised 2022). Retrieved May 31, 2023 from http://www.acr.org/guidelines.
American College of Radiology (ACR). (2022). Appropriateness criteria management of vertebral compression fractures. Retrieved May 31, 2023 from https://www.acr.org/Clinical-Resources/ACR-Appropriateness-Criteria.
BlueCross BlueShield Association. Evidence Positioning System. (5:2023). Percutaneous vertebroplasty and sacroplasty (6.01.25). Retrieved May 24, 2023 from www.bcbsaoca.com/eps/. (49 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (5:2023). Percutaneous balloon kyphoplasty, radiofrequency kyphoplasty, and mechanical vertebral augmentation. (6.01.38). Retrieved May 24, 2023 from www.bcbsaoca.com/eps/. (32 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. (Level 1 evidence)
Chou, R., Fu R., Dana T., Pappas, M., Hart, E., Mauer, K.M. (2021). Interventional treatments for acute and chronic pain: Systematic review. Comparative effectiveness review no. 247. Agency for Healthcare Research and Quality, Publication No. 21-EHC030. doi: 10.23970/AHRQEPCCER247. (Level 1 evidence)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2022, August). Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) (LCD ID L38737). Retrieved May 24, 2023 from https://www.cms.gov.
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 vertebral 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—clinical experience of 218 cases. Journal of Orthopedic Surgery and Research, 11 (56). (Level 4 evidence)
Feng, L., Shen, J., Feng, C., Chen, C., & Wu, Y. (2017). Comparison of radiofrequency kyphoplasty (RFK) and balloon kyphoplasty (BKP) in the treatment of vertebral compression fractures. A meta-analysis. Medicine, 96 (25). (Level 2 evidence)
Health Quality Ontario. (2016). Vertebral augmentation involving vertebroplasty or kyphoplasty for cancer-related vertebral compression fractures: a systematic review. Ontario Health Technology Assessment Series, 16 (11), 1-202. (Level 1 evidence)
Korovessis, P., Vardakastanis, K., Repantis, T., & 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), 292-299. 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)
Lin, S., Cheng, M., Liang, W., & Yuan, X. (2021). Efficacy of vertebral augmentation in the treatment of osteoporotic vertebral compression fractures: a systematic review and meta-analysis. Annals of Palliative Medicine, 10 (11), 11767–11775. (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.
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)
Pron, G., Hwang, M., Smith, R., Cheung, A., & Murphy, K. (2022). Cost-effectiveness studies of vertebral augmentation for osteoporotic vertebral fractures: a systematic review. The Spine Journal: Official Journal of the North American Spine Society, S1529-9430 (22), 00093-6. doi: 10.1016/j.spinee.2022.02.013 (Level 1 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), 1935-1944. (Level 2 evidence)
Tutton, S., Pflugmacher, R., Davidian, M., Beall, D., Facchini, F., & Garfin, S. (2015). KAST Study: The Kiva System as a vertebral augmentation treatment-A 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), 865-875. Abstract retrieved September 1, 2017 from PubMed database.
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. (Level 1 evidence)
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. (Level 4 evidence)
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, 30 (2), 287-298. Abstract retrieved January 10, 2020 from PubMed database.
ORIGINAL EFFECTIVE DATE: 4/1/2001
MOST RECENT REVIEW DATE: 7/13/2023
ID_BT
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