Surgery Section - Decompression of Intervertebral Discs Using Laser (Laser Discectomy) or Radiofrequency Energy (Disc Nucleoplasty™)

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

A variety of minimally invasive techniques have been investigated over the years as a treatment of low back pain related to disc disease. Techniques can be broadly divided into those techniques that are designed to remove or ablate disc material and thus decompress the disc, or those that are designed to alter the biomechanics of the disc annulus. The former category includes chemonucleolysis with chymopapain injection, automated percutaneous lumbar discectomy, laser discectomy, and most recently disc decompression using radiofrequency energy, referred to as a DISC nucleoplasty™. Techniques that alter the biomechanics of the disc include intradiscal electrothermal annuloplasty (i.e. the IDET procedure) or percutaneous intradiscal radiofrequency thermocoagulation (PIRT). It should be noted that three of these procedures use radiofrequency energy DISC nucleoplasty™, IDET and PIRT – but apply the energy in distinctly different ways such that the three procedures are unique and are considered separately.* Note also that the IDET, PIRT and percutaneous discectomy procedures are considered in separate policies (Surgery Policies No. 118 and No.145 ). Chemonucleolysis with chymopapain injection is no longer performed and thus the policy has been archived. Laser discectomy and DISC nucleoplasty™ are the subjects of this policy. (For further discussion on the distinction between IDET, PIRT and DISC nucleoplasty™ see note below*.)

A variety of different lasers have been investigated for laser discectomy, including YAG, KTP, holmium, argon and carbon dioxide lasers. Regardless of the type of laser, the procedure involves placement of the laser within the nucleus under fluoroscopic guidance followed by activation. Due to differences in absorption, the energy requirements and the rate of application differ among the lasers. Additionally, it is unknown how much disc material must be removed to achieve decompression. Therefore, protocols vary according to the length of treatment, but typically the laser is activated for brief periods only.

The Disc nucleoplasty™ procedure uses bipolar radiofrequency energy in a process referred to as Coblation technology. The technique consists of small, multiple electrodes that emit a fraction of the energy required by traditional radiofrequency energy systems. The result is that a portion of nucleus tissue is ablated not with heat, but with a low-temperature plasma field of ionized particles. These particles have sufficient energy to break organic molecular bonds within tissue, creating small channels in the disc. The proposed advantage of this Coblation technology is that the procedure provides for a controlled and highly localized ablation, resulting in minimal therapy damage to surrounding tissue.

Patients considered candidates for DISC nucleoplasty™ or laser discectomy include those patients with bulging discs and sciatica. In contrast, the presence of a herniated disc is typically considered a contraindication for the IDET or PIRT procedure.

*Note: PIRT describes the direct application of radiofrequency energy to the disc material to gently heat the disc material for 90 seconds at a temperature of 70 degrees centigrade. This procedure is not designed to ablate disc material, but rather to alter the biomechanics of the disc or by destroying nociceptive pain fibers. The IDET procedure involves the use of radiofrequency energy which is translated into electrothermal heat using an electroresistive coil. The coil is placed along the annulus, which is then heated for up to 20 minutes. Similar to the PIRT procedure, IDET is not designed to coagulate, burn or ablate tissue. Again, the mechanism of action is not well understood, but is thought to be related to either shrinkage of the collagen fibers within the annulus or destruction of the adjacent nociceptive pain fibers. These two procedures contrast with DISC nucleoplasty™, which while also using radiofrequency energy, in contrast to the above procedures is specifically designed to ablate disc material and thus decompress the disc.

Chemonucleolysis involves the injection of the protein dissolving enzyme, chymopapain, into a disc for the treatment of ruptured or bulging disc.  Chemonucleolysis has been used for a number of years in the United States but largely fell out of favor following disclosure of neurological sequelae and other complications.  Chymopapain was FDA approved in 1982.  Most recently, chemonucleolysis with chymopapain injections has been proposed to pre-treat the disc prior to percutaneous disc decompression procedures.

Policy/Criteria

Laser discectomy and radiofrequency Disc nucleoplasty™ are considered investigational as techniques of disc decompression and treatment of associated pain.

Chemonucleolysis as an adjunct to percutaneous disc decompression procedures including, but not limited to DISC Nucleoplasty, is considered investigational.

Scientific Background

Randomized, placebo controlled trials are considered particularly important when assessing treatment of low back pain, to eliminate patient selection bias and to control not only for the expected placebo effect, but to also control for the variable natural history of low back pain, which may resolve with conservative treatment alone. In addition, the assessment of the durability of surgical treatment for lumbar spinal disorders requires long-term follow-up data since the results of lumbar surgeries are known to deteriorate over time.  Finally, since many of the advantages of radiofrequency or laser ablation are related to minimal invasiveness, clinical trial data comparing these procedures with standard disc decompression techniques is needed.

The bulk of the current published literature related to radiofrequency ablation or laser ablation for disc decompression consists of lower levels of evidence such as retrospective reviews and poorly designed studies.  Design flaws included nonrandomized or poorly randomized clinical trials, small size, very short duration (generally one year or less), no control group for comparison or with the groups in the study receiving treatment during different time frames rather than simultaneously.  Such lower levels of evidence preclude scientific interpretation.

Laser Discectomy

Laser discectomy has been practiced for over a decade, and there is fairly extensive literature describing different techniques using different types of lasers, a large number of case series and a number of review articles. (2-11) However, there are no published randomized, placebo controlled trials. Gibson and colleagues published a Cochrane review of surgery for lumbar disc prolapse, which included a review of laser discectomy. (12) The review aimed to determine the relative treatment effectiveness of laser discectomy compared to either no treatment, discectomy or automated percutaneous discectomy. The review also included chemonucleolysis and open surgical discectomy. In their overall review of all surgeries, 27 randomized controlled clinical trials were identified, but none addressed laser discectomy. This review concluded that unless or until better scientific evidence is available, laser discectomy should be regarded as a research technique.  In a 2007, Gibson and Waddell included forty randomized controlled trials and two quasirandomized controlled trials in an update of this Cochrane review. (13) The authors noted the generally poor methodological quality of the available studies. Only three small randomized controlled trials of laser discectomy were found and the authors concluded that these data do not provide conclusive evidence of its efficacy.

In the largest study to date, Tassi retrospectively reviewed the outcomes from 500 patients with discogenic pain and herniated discs treated with microdiscectomy (1997–2001 by 6 surgeons) and 500 patients treated with percutaneous laser disc decompression (2002–2004 by a single surgeon). (14) Patients with sequestered discs were excluded. This retrospective review found that the hospital stay (six vs. two days), overall recovery time (60 vs. 35 days) and repeat procedure rates (7% vs. 3%) were lower in the laser group; these were not compared statistically. The percentage of patients with overall good/excellent outcomes was found to be similar in the two groups (85.7% vs. 83.8%) at the 2-year assessment; quantitative outcome measures were not reported.  While these reported result appear promising, as noted above, retrospective reviews are considered in evidence-based review methodology to be lower levels of evidence.  In addition, calculations of statistical significance were not reported, quantitative measures were not reported, only percentages and the treatments were not provided simultaneously.  Similarly, in a nonrandomized, noncontrolled case series, Morelet and colleagues reported an 83.1% success rate at one year following percutaneous laser disc decompression. (15) This reported success rate is misleading because it is based only on 59 patients. Had intention to treat calculation been appropriately conducted, 100 of the initial 149 patients would have been considered treatment failures and the success rate would have been 33%. The authors also reported that 45 (30.2%) of the initial 149 patients chose traditional surgical procedure after laser decompression. 

In a 2007 meta-analysis, Goupille and colleagues concluded that “although the concept of laser disc nucleotomy is appealing, this treatment cannot be considered validated for disc herniation-associated radiculopathy resistant to medical treatment”. (16) They cited the lack of consensus regarding technique, that methodology and conclusions of published studies are questionable, and absence of a controlled study. One recent study of laser disc decompression was identified.  Ishiwata and colleagues investigated the clinical results of their magnetic resonance guided percutaneous laser disc decompression practice with reference t the site of the needle tip in the disc. They divided the disc on axial image into 4 quadrants and 3 concentric zones and evaluated clinical results by MacNab’s criteria in each subdivided area 6 months after the procedure. The authors report an overall success rate of 68.8% in their series of 32 patients, and conclude that targeting certain zones seems to result in better outcomes. (17)

Coblation (DISC Nucleoplasty™)

DISC nucleoplasty™ is a relatively new technology with minimal published literature, and no controlled trials. Singh and colleagues reported clinical outcome data from an uncontrolled case series of 67 patients with contained disc herniation who underwent DISC nucleoplasty™.  (18) While improvement was reported in about 60% of patients at 12 months, interpretation of the data is extremely limited due to the lack of a control group.  Several small, non-randomized case series with short term follow-up were published.  (19-23) For example, Ahn and colleagues reported on the outcomes of a case series of 43 consecutive patients who underwent laser disc decompression for recurrent herniation.  While the authors considered this an effective treatment, the lack of a control group limits interpretation of this data.

The original policy statement referred to the treatment of low back pain.  This policy statement is revised to eliminate this limitation, such that the investigational status would also apply to the cervical vertebrae. Two case series described laser disc decompression of the cervical discs.  (24,25) Once again, the lack of a control group limits interpretation. One controlled study in which 50 patients were treated with DISC nucleoplasty™ for cervical disc compression reported promising outcomes.  (26) This trial compared outcomes of DISC nucleoplasty™ to a control group receiving conservative management.  The authors state that patients were randomized; however, the method of randomization is not reported and patients were not blinded.  Outcomes were reported for 60 days only.  Based on short follow-up and methodologic flaws, conclusions concerning the effectiveness of DISC nucleoplasty™ in the treatment of cervical disc compression cannot be made.

Recent literature consists of uncontrolled trials from outside of the United States. One prospective study assessed outcomes in 52 consecutive patients treated with radiofrequency nucleoplasty. (27) Included in the study were patients less than 60 years of age with radicular pain that was resistant to at least three months of conservative treatment.  Also required was magnetic resonance imaging evidence of small and medium-sized herniated discs (< 6mm) that correlated with the patient’s symptoms. Patients with a disc height of less than 50% of adjacent discs, severe degenerated or fractured disc material, or evidence of extruded disc herniation were excluded. Independent assessment at two weeks, six months, and one year (94% follow-up) found a decrease in visual analogue scale (VAS) pain scores from 7.5 to 2.1, a change from 42 to 21 on the Oswestry Disability Index, and a reduction or complete stopping of use of analgesics in 94% of patients.

Li and colleagues reported on a prospective study of 126 patients from China with contained cervical disc herniations who underwent nucleoplasty. Visual analog scores of pain were significantly improved at one, three, six and 12 months follow-up. (28) Two smaller studies also reported statistically significant reduction in pain. Calisaneller and colleagues reported on 29 patients who had lumbar nucleoplasty. Mean pre-operative VAS score was 6.95, and post-operative scores were 2.45, 4.0, and 4.53 at 24 hr, and three and six months respectively. (29) Al-Zain and colleagues reported outcomes for 69 patients for whom 12 month data were available from a cohort of 96 patients who underwent nucleoplasty for back pain and/or radiating pain in the lower extremities. (Seven patients were lost to follow-up, 11 were excluded due to secondary disc sequestration at the treated segment or elsewhere, and data for 8 patients is available only up to 6 months.) Seventy-three percent (73%) of patients improved more than 50% in early post-operative visual analog score; this was reduced to 61% of patients at 6 months and 58% after one year. (30)

Chemonucleolysis as pre-treatment for percutaneous discectomy

A MEDLINE search of the literature returned two published studies in which chymopapain was used as pre-treatment for percutaneous discectomy.  One cadaver study was identified in which chymopapain was used to pre-treat discs prior to automated percutaneous lumbar discectomy; the pretreatment did not result in a higher yield of nucleus material.  (31) One small study involving live patients was identified in which the two procedures were combined to treat cervical spine pathology  (32); however, no clinical studies in live patients were identified in which the combined procedures were investigated as a treatment of lumbar disc herniation.

Clinical Practice Guidelines

Practice Guidelines from the American Society of Interventional Pain Physicians reported moderate evidence for short-term and limited evidence for long-term relief of pain with percutaneous laser discectomy, while evidence is limited for short- or long-term efficacy for radiofrequency disc decompression. (33) The guideline authors note that claims of satisfactory results with fewer serious complications from percutaneous disc decompression remain controversial.

In 2007, the American College of Physicians and American Pain Society Low Back Pain Guidelines Panel clinical practice guidelines for chronic low back pain strongly recommend conservative, nonoperative management of low back pain.  The guidelines do not recommend surgery or minimally invasive surgical procedures. (34)

Summary

Randomized controlled trials in appropriately selected patients are needed to evaluate the efficacy of these treatments in comparison with alternative therapies. An updated search of the MEDLINE database through January 2009 failed to return any clinical studies that would prompt reconsideration of the policy criteria.

References

1. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.93
2. Choy DSJ. Percutaneous laser disc decompression (PLDD): Twelve years’ experience with 752 procedures in 518 patients. J Clin Laser Med Surg 1998;16(6):325-31
3. Casper GD, Hartman VL, Mullins LL. Results of a clinical trial of the holmium:YAG laser in disc decompression utilizing a side-firing fiber. Laser Surg Med 1996;19(1):90-6
4. Liebler WA. Percutaneous laser disc nucleotomy. Clin Orthop Rel Res 1995;310:58-66
5. Ohnmeiss DD, Guyer RD, Hochschuler SH. Laser disc decompression. The importance of proper patient selection. Spine 1994;19:2054-9
6. Quigley MR. Percutaneous laser discectomy. Neurosurg Clin N Amer 1996;7(1):37-42
7. Gronmeyer DH, Buschcamp H, Braun M et al. Image-guided percutaneous laser disc decompression for herniated lumbar disks: a 4-year follow-up in 200 patients. J Clin Laser Med Surg 2003;21(3):131-8
8. Hellinger J, Stern S, Hellinger S. Nonendoscopic Nd-YAG 1064 nm PLDN in the treatment of thoracic discogenic pain syndrome. J Clin Laser Med Surg 2003;21(2):61-6
9. Sobieraj A, Maksymowicz W, Barczewska, et al. Early results of percutaneous laser disc decompression (PLDD) as a treatment of discopathic lumbar pain. Ortop Tramatol Rehabil 2004;6(3):264-9
10. Maksymowicz W, Barczewska, Sobieraj A, et al. Percutaneous laser lumbar disc decompression – mechanism of action, indications and contraindications.  Ortop Tramatol Rehabil 2004;6(3):314-8
11. Li K, Qin H, Chen J. Clinical application of percutaneous laser disc decompression in the treatment of cervical disc herniation. Zhongguo Xiu Fu Chong Jian Wal Ke Za Zhi 2007;21(5):465-7
12. Gibson JNA, Grant IC, Waddell G. Surgery for lumbar disc prolapse (Cochrane Review). In: The Cochrane Library, Issue 2, 2003. Oxford: Update Software
13. Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev 2007;(2):CD001350
14. Tassi GP. Comparison of results of 500 microdiscectomies and 500 percutaneous laser disc decompression procedures for lumbar disc herniation. Photomed Laser Surg 2006;24(6):694-7
15. Morelet A, Boyer F, Vitry F, et al. Efficacy of percutaneous laser disc decompression for radiculalgia due to lumbar disc hernia (149 patients). Presse Med 2007;36(11 pt 1):1527-35. Abstract only; article in French
16. Goupille P, Mulleman D, Mammou S, et al. Percutaneous laser disc decompression for the treatment of lumbar disc herniation: a review. Semin Arthritis Rheum 2007;37(1):20-30
17. Ishiwata Y, Takada H, Gondo G et al. Magnetic resonance-guided percutaneous laser disk decompression for lumbar disk herniation—relationship between clinical results and location of needle tip. Surg Neurol 2007;68(2):159-63
18. Singh V, Piryani C, Liao K, Neischur S. Percutaneous disc decompression using Coblation (Nucleoplasty™) in the treatment of chronic low back pain. Pain Physician 2002;5(3):250-59
19. Hellinger J, Stern S, Hellinger S. Nonendoscopic Nd-YAG 1064 nm PLDN in the treatment of thoracic discogenic pain syndromes. J Clin Laser Med Sur 2003;21(2):61-66
20. Agarwal S, Bhagwat AS. Ho: YAG laser-assisted lumbar disc decompression: A minimally invasive procedure under local anesthesia. Neurology India 2003;51(1):35-38
21. Knight M, Goswami A. Management of isthmic spondylolisthesis with posterolateral endoscopic foraminal decompression. Spine 2003;28:573-581
22. Cohen SP, Williams S, Kurihara C et al. Nucleoplasty with or without intradiscal electrothermal therapy (IDET) as a treatment for lumbar herniated disc. J Spinal Disord Tech 2005;18(suppl):S119-24
23. Ahn Y, Lee SH, Park WM et al. Percutaneous endoscopic lumbar discectomy for recurrent disc herniation: Surgical technique, outcomes and prognostic factors of 43 consecutive cases. Spine 2004;29(16):E326-32
24. Haufe SM, Mork AR. Complications associated with cervical endoscopic discectomy with the holmium laser. J Clin Laser Med Surg 2004;22(1):57-58
25. Ahn Y, Lee SC, Lee SH et al. Factors predicting excellent outcome of percutaneous cervical discectomy: Analysis of 111 consecutive cases. Neuroradiology 2004;46(5):378-54
26. Nardi PV, Cabezas D, Cesaroni A. Percutaneous cervical nucleoplasty using coblation technology. Clinical results in fifty consecutive cases. Acta Neurochir 2005;92:73-78
27. Mirzai H, Tekin I, Yaman O et al. The results of nucleoplasty in patients with lumbar herniated disc: a prospective clinical study of 52 consecutive patients. Spine J 2007;7(1):88-92
28. Li J, Yan DL, Zhang ZH. Percutaneous cervical nucleoplasty in the treatment of cervical disc herniation. Eur Spine J 2008;17(21):1664-9
29. Calisaneller T, Ozdemir O, Karadeli E et al. Six months post-operative clinical and 24 hour post-operative MRI examinations after nucleoplasty with radiofrequency energy. Acta Neurochir (Wien) 2007;149(5):495-500
30. Al-Zain F, Lemcke J, Killeen T et al. Minimally invasive spinal surgery using nucleoplasty: a 1-year follow-up study. Acta Neurochir (Wien) 2008;150(12):1257-62
31. Pfeiffer M, Schafer T, Griss P et al.  Automated percutaneous lumbar discectomy with and without chymopapain pretreatment versus non-automated discoscopy-monitored percutaneous lumbar discectomy. An experimental study in human cadaver spines.  Arch Orthop Trauma Surg 1990;109(4):211-6
32. Hoogland T, Scheckenbach C.  Low-dose chemonucleolysis combined with percutaneous nucleotomy in herniated cervical disks. J Spinal Disord 1995;8(3):228-32
33. Boswell MV, Trescot AM, Datta S et al; American Society of Interventional Pain Physicians. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007;10(1):7-111.
34. Chou R, Qaseem A, Snow V, et al. Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society. 2007;147(7):478-491

Cross References

Percutaneous Intradiscal Electrothermal Annuloplasty (IDET) and Percutaneous Intradiscal Radiofrequency Thermocoagulation, Regence Medical Policy Manual, Surgery, Policy No. 118

Percutaneous Discectomy, Regence Medical Policy Manual, Surgery, Policy No. 145

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