Surgery Section - Trans-Sacral Lumbar Interbody Fusion

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

DESCRIPTION

Trans-sacral lumbar interbody fusion (LIF) is a minimally invasive approach to L4-S1 anterior interbody fusion. Using fluoroscopic guidance, discectomy, bone grafting and insertion of a fixation device is performed via a trocar passed upward along the front of the sacrum through a small incision near the base of the coccyx. This approach may also be referred to as a presacral or paracoccygeal lumbar interbody fusion.

The devices currently marketed in the United States are the TranS1® AxiaLIF® and the AxiaLIF II or 2-Level Systems (TranS1®, Inc.).

POLICY/CRITERIA

Trans-sacral lumbar interbody fusion is considered investigational.

POSITION SUMMARY

Effectiveness

It is uncertain whether trans-sacral lumbar interbody fusion (LIF) provides long-term pain reduction and restoration of function.

Published clinical trial data are limited to unreliable case series and retrospective reviews that do not permit conclusions about the long-term effectiveness or durability of trans-sacral LIF. (2-6) These types of studies do not control for potential bias, placebo effect or the natural course of the disease being treated, so it is not possible to reach conclusions about cause and effect.

There are no randomized studies comparing transsacral LIF with conventional open abdominal or laparoscopic anterior LIF or conservative, nonsurgical interventions.

Safety

The long-term safety and complication rate for transsacral LIF are unknown compared to other therapies. (2-7)

It is unknown whether the percutaneous transsacral approach for anterior LIF results in fewer complications than conventional open abdominal or laparoscopic approaches. Reported complications of trans-sacral LIF include but are not limited to the following:

• Perforation of the rectum or colon
• Temporary colostomy due to severe perforation of the rectum or colon
• Perforation of local blood vessels (e.g., median sacral artery)
• Damage to spinal nerves

It is unknown whether the percutaneous transsacral approach for anterior LIF results in a higher rate of fusion failure.

This technique requires frequent fluoroscopic (x-ray) images throughout the procedure for the surgeon to check the placement of the surgical instruments. The long-term effects of the higher radiation exposure with fluoroscopic guidance are unknown.

References

1. www.trans1.com/surgeons_axiaLifAnim.html (Verified 08/07/08)
2. Marotta N, Cosar M, Pimenta L, Khoo LT. A novel minimally invasive presacral approach and instrumentation technique for anterior L5-S1 intervertebral discectomy and fusion: technical description and case presentations. Neurosurg Focus. 2006;20(1):E9
3. Cragg A, Carl A, Casteneda F, et al. New percutaneous access method for minimally invasive anterior lumbosacral surgery. J Spinal Disord Tech. 2004;17(1):21-8
4. Macmillan M. Computer-guided percutaneous interbody fixation and fusion of the L5-S1 disc: a 2-year prospective study. J Spinal Disord Tech 2005;18(Suppl):S90-5
5. Bartolozzi P, Sandri A, Cassini M et al. One-stage posterior decompression-stabilization and trans-sacral interbody fusion after partial reduction for severe L5-S1 spondylolisthesis. Spine; 2003;28(11):1135-41
6. Smith JA, Deviren V, Berven S, et al.  Clinical outcome of trans-sacral interbody fusion after partial reduction for high-grade L5-S1 spondylolisthesis. Spine 2001;15:26(20):2227-34
7. Aryan HE, Newman CB, Gold JJ, et al. Percutaneous Axial Lumbar Interbody Fusion (AxiaLIF) of the L5-S1 Segment: Initial Clinical and Radiographic Experience. Minim Invasive Neurosurg 2008; 51(4):225-30

Cross References

Lumbar Spine Surgery, Regence Medical Policy Manual, Surgery, Policy No. 101

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