BlueCross BlueShield of Tennessee Medical Policy Manual

Axial Lumbosacral Interbody Fusion

DESCRIPTION

Axial lumbosacral interbody fusion (LIF) may also be referred to as pre-sacral, trans-sacral or paracoccygeal interbody fusion.  It is a minimally invasive technique designed to provide anterior access to the L4-S1 disc spaces for interbody fusion (e.g. AxiaLIF® and AxiaLIF® II Level systems) The procedure has been proposed to relieve back pain by providing anterior stabilization of the spinal segments as an adjunct to spinal fusion.  

The LIF procedure is distinctly different from other open fusion approaches. The lumbar vertebrae are accessed via a small incision in the precoccygeal area perpendicular to the plane that is used for other fusion procedures. Fluoroscopy is utilized for guidance of the instrumentation as well as peri-operative monitoring of the surgical manipulation. Following debulking of the nucleus pulposus, bone graft material is injected to fill the disc space. A threaded rod designed to distract the vertebral bodies and to restore disc and neural foramen height is implanted in the affected vertebrae. Additional graft material is injected to secure the rod. Percutaneous placement of pedicle or facet screws may be used to provide supplemental fixation.

While this procedure may allow preservation of the annulus and paraspinous soft tissue structures, there is an inability to address intracanal pathology or visualize the discectomy procedure directly. Complications of the axial approach may include perforation of the bowel and injury to blood vessels and/or nerves.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

The published literature on axial lumbar interbody fusion consists of retrospective reviews.  Due to the variable natural history of the disorder and the subjective nature of the main outcomes, this evidence is insufficient to evaluate whether axial LIF is as effective or as safe as other surgical approaches to lumbosacral interbody fusion.

SOURCES 

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2017). Axial lumbosacral interbody fusion (7.01.130). Retrieved September 11, 2017 from BlueWeb. (14 articles and/or guidelines reviewed)

Gerszten, P. C., Tobler, W., Raley, T. J., Miller, L. E., Block, & Nasca, R. J. (2012). Axial presacral lumbar interbody fusion and percutaneous posterior fixation for stabilization of lumbosacral isthmic spondylolisthesis. Journal of Spinal Disorders & Techniques, 25 (2), E36-E40. (Level 3 evidence - Industry sponsored)

Gundanna, M. I., Miller, L. E., and Block, J. E. (2011). Complications with axial presacral lumbar interbody fusion: A 5-year postmarketing surveillance experience. International Journal of Spine Surgery, 5 (3), 90-94. (Level 3 evidence - Industry sponsored)

Issack, P., & Boachie-Adjei, O. (2012). Axial lumbosacral interbody fusion appears safe as a method to obtain lumbosacral arthrodesis distal to long fusion constructs. HSS Journal: The Musculoskeletal Journal of Hospital for Special Surgery, 8 (2), 116-121. (Level 4 evidence - Industry Supported)

National Institute for Health and Care Excellence. (2011, March). Interventional procedures guidance:transaxial interbody lumbosacral fusion. Retrieved September 11, 2017 from www.nice.org.uk .

Schroeder, G. D., Kepler, C. K., Mba, M. D., & Vaccaro, A. R. (2015). Axial interbody arthrodesis of the L5-S1 segment: a systematic review of the literature. Journal of Neurosurgery: Spine, 23 (3), 314-319. Abstract retrieved October 21, 2015 from PubMed database.

Tobler , W. D., Gerszten, P. C., Bradley, W. D., Raley, T. D., Nasca, R. J., & Block, J. E. (2011). Minimally invasive axial presacral L5-S1 interbody fusion: Two-year clinical and radiographic outcomes. Spine, 36 (20), 1-6. (Level 3 evidence - Industry sponsored)

Tobler, W., & Ferrara, L. (2011). The presacral retroperitoneal approach for axial lumbar interbody fusion: A prospective study of clinical outcomes, complications and fusion rates at a follow-up of two years in 26 patients. The Journal of Bone and Joint Surgery, 93-B (7), 955-960. (Level 3 evidence)

Tobler, W., Melgar, M., Raley, T., Anand, N., Miller, L., & Nasca, R. (2013).  Clinical and radiographic outcomes with L4–S1 axial lumbar interbody fusion (AxiaLIF) and posterior instrumentation: a multicenter study. Medical Devices: Evidence and Research, 13 (6), 155-161. (Level 3 evidence - Industry Supported)

U. S. Food and Drug Administration. (2008, April). Center for Devices and Radiological Health. 501(k) Summary. K050965. Retrieved April 23, 2014 from: http://www.accessdata.fda.gov

Zeilstra, D., Miller, L., Block, J. (2013).  Axial lumbar interbody fusion: a 6-year single-center experience. Clinical Interventions in Aging, 13 (8), 1063-1069. (Level 3 evidence - Industry Supported)

Zeilstra, D., Staartjes, V., and Schröder, M. (2017, January). Minimally invasive transaxial lumbosacral interbody fusion: a ten year single-centre experience. International Orthopedics, 41 (1), 113-119. Abstract  retrieved September 11, 2017 from PubMed database.

ORIGINAL EFFECTIVE DATE:  5/11/2013

MOST RECENT REVIEW DATE:  10/26/2017

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