Medical Policy Title: Lumbar Discectomy- ARBenefits Approval: <Date>

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1 Medical Policy Title: Lumbar Discectomy- ARBenefits Approval: <Date> Percutaneous, Manual, Automated or Laser Effective Date: 01/01/2012 Document: ARB0275 Revision Date: Code(s): Aspiration or decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method, single or multiple levels, lumbar (eg, manual or automated percutaneous discectomy, percutaneous laser discectomy) Public Statement: Administered by: Manual percutaneous lumbar discectomy (PLD) uses cutting forceps to remove nuclear material from within the disk annulus. The automated percutaneous lumbar discectomy (APLD) uses a specially designed probe to excise small pieces of the nucleus, which is removed by aspiration. Results from PLD and APLD have varied widely, and there is not consistent scientific evidence that this technique improves health outcomes. Medical Policy Statement: Percutaneous discectomy, manual, automated or by laser, in the lumbar, thoracic or cervical spine is considered investigational and is not covered. Background: Manual PLD was developed in Japan in 1975, with a reported success rate of 70% immediately, and 72% at 14 years (reported 1989). Subsequently, a percutaneous PLD method which coupled the instrumentation from the manual approach with an endoscope, was developed. Onik, et. al., reported in 1990 an uncontrolled study of 506 patients who had APLD. These patients had undergone conservative care for a mean of 11.6 months, and the subgroup considered to be ideal for APLD was 75%. The AMA Diagnostic and Therapeutic Technology Assessment reviewed PLD in 1989 Page 1 of 7

2 and found that it was investigational. A re-review was done in 1991 because two large prospective (non-randomized) studies had been published, and the technique was diffusing rapidly into the community setting. The panel concluded that the technique was safe, but there remained a question as to the effectiveness. Although some authors report a very high rate of success with APLD, others report poor results, with many patients requiring subsequent open discectomy. While the better outcome of some surgeons may be attributable to better surgical technique and more experience, there is considerable concern that use of subjective outcome measures and unblinded evaluation of patients, may inflate the success rates reported in these studies. A 2000 Cochrane report (Gibson, 2003) concluded, Three trials of percutaneous discectomy provided moderate evidence that it produces poorer clinical outcomes than standard discectomy or chymopapain. For example, Chatterjee reported on the results of a study that randomized 71 patients with lumbar disc herniation to undergo either percutaneous discectomy or lumbar microdiscectomy (Chatterjee, 1995). A successful outcome was reported in only 29% of those undergoing percutaneous discectomy compared to 80% in the microdiscectomy group. The trial was halted early due to this inferior outcome. In a 1993 randomized study, Revel and colleagues compared the outcomes of percutaneous discectomy to chymopapain injection in 141 patients with disk herniation and sciatica (Revel, 1993). Treatment was considered successful in 61% of patients in the chymopapain group compared to 44% in the percutaneous discectomy group. Another trial cited in the Cochrane review, Mayer et. al., is not applicable since the technique used modified forceps in addition to a suction probe (Mayer, 1993). Finally, the last trial cited in the Cochrane review, Hermantin et. al., provided insufficient data to allow detailed analysis of results (Hermantin, 1999). The only additional controlled study published since the 2000 Cochrane review was the results of the LAPDOG study, a randomized trial designed to compare percutaneous and open discectomy in patients with lumbar disc herniation (Haines, 2002). This trial was designed to recruit 330 patients, but only was able to recruit 36 patients, for reasons that were not readily apparent to the authors. Of the evaluable 27 patients, 41% of the percutaneous discectomy patients and 40% of the conventional discectomy patients were assessed as having successful outcomes at 6 months. The authors concluded that this trial was unable to enroll sufficient numbers of patients to reach a definitive conclusion. The authors state, It is difficult to understand the remarkable persistence of percutaneous discectomy in the face of a virtually complete lack of scientific support for its effectiveness in treated lumbar disc herniation. All of the trials reviewed above focused on lumbar disc herniation. There were no clinical trials of percutaneous discectomy of cervical or thoracic disc herniation. Gibson and Waddel published an updated Cochrane review of surgical interventions for lumbar disc prolapse, concluding that there is insufficient evidence on percutaneous discectomy techniques to draw firm conclusions. A task force of the American Society Page 2 of 7

3 of Interventional Pain Physicians reports that percutaneous disc decompression remains controversial; although all observational studies were positive, the evidence from 4 of 4 randomized published studies was negative (Boswell et al, 2007). Questions also remain about the appropriate patient selection criteria (particularly related to the size and migration of the disc herniation) for this procedure. (Gibson, 2007). Freeman and Mehdian assessed the current evidence for three minimally invasive techniques used to treat discogenic low back pain and radicular pain: electrothermal therapy (IDET), percutaneous discectomy, and Nucleoplasty (Freeman, 2008). They report that trials of automated percutaneous discectomy suggest that clinical outcomes are at best fair and often worse when compared with microdiscectomy. Two systematic reviews published in 2009 were identified, each analyzing the literature for a different device. Hirsch and colleagues reviewed 4 randomized controlled trials (RCTs) and 76 observational studies in their analysis of studies in which the Nucleotome was used (Hirsch, 2009). In two of the RCTs, the comparator was chemonucleolysis. The first, Revel et al, was reviewed in a previous update. The second of these RCTs did not meet Cochrane review criteria for randomized controlled trials. The other two RCTs compared automated percutaneous discectomy with microdiscectomy and also failed to meet study quality criteria. Singh et al. Performed a systematic analysis of studies in which the Dekompressor device was used (Singh, 2009). The authors identified no RCTs. Goupille et al reviewed the literature on laser disc decompression and 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. They cite the lack of consensus regarding technique, the questionable methodology and conclusions of published studies, and the absence of a controlled study in their discussion (Goupille, 2007). One recent study of laser disc decompression was identified. Ishiwata et al investigated the clinical results of their magnetic resonance-guided percutaneous laser disc decompression practice with reference to 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 (Ishiwata, 2007). References: Ahn Y, Lee S-H, et al.(2004) Percutaneous endoscopic lumbar discectomy for recurrent disc herniation: surgical technique, outcome, and prognostic factors of 43 consecutive cases. Spine 2004; 29:e326-e332. Page 3 of 7

4 Automated percutaneous lumbar discectomy. Hayes, Inc 5/12/2006:1-15. Castro WH, Jerosch J, Hepp R, et al.(1992) Restriction of indication for automated percutaneous lumbar discectomy based on computed tomographic discography. Spine 1992; 17: Chatterjee S, Foy PM, Findlay GF.(1995) Report of a controlled clinical trial comparing automated percutaneous discectomy and microdiscectomy in the treatment of contained lumbar disc herniation. Spine 1995; 20: Coverage Issues Manual. Accessed April Eichholz KM, Ryken TC.(2003) Complications of revision spinal surgery. Neurosurg Focus 2003; 15:1-4. FDA.(2000) Center for Devices and Radiological Health Releasable 510(k) search. Accessed April Fiume D, Parziale G, Rinaldi A, et al.(1994) Automated percutaneous discectomy in herniated lumbar discs treatment: experience after the first 200 cases. J Neurosurg Sci 1994; 38: German JW, Foley KT.(2005) Minimal access surgical techniques in the management of the painful lumbar motion segment. Spine 2005; 30 (16S):s52-s59. Gibson JNA, Grant IC, Waddell G.(2000) Surgery for lumbar disc prolapse. Cochrane Database Systematic Reviews 2000; Issue 3. Gibson JNA, Grant IC, Waddell G.(2003) Surgery for lumbar disc prolapse. (Cochrane Review) The Cochrane Library, Issue 2, Gill K, Blumenthal SL.(1993) Automated percutaneous discectomy. Long-term clinical experience with the Nucleotome System. Acta Orthop Scand 1993; Sup; 64: Gilmer HS, Papadopoulos SM, Tuite GF.(1993) Lumbar disk disease: pathophysiology, management and prevention. Am Fam Phys 1993; 47: Goupille P, Mulleman D, Mammou S et al.(2007) Percutaneous laser disc decompression for the treatment of lumbar disc herniation: a review. Semin Arthritis Rheum 2007; 37(1): Grevitt MP, McLaren A, Shackleford IM, et al.(1995) Automated percutaneous lumbar discectomy: an outcome study. J Bone Jt Surg Br 1995; 77: Page 4 of 7

5 Haines SJ, Jordan N, et al.(2002) Discectomy strategies for lumbar disc herniation: results of the LAPDOG trial. J Clin Neurosci 2002; 9: Haines SJ, Jordan N, et al.(2002) Discectomy strategies for lumbar disc herniation: study design and implications for clinical research. J Clin Neurosci 2002; 9: Henrikson L, Schmidt V, Eskesen V, et al.(1996) A controlled study of microsurgical versus standard lumbar discectomy. Br J Neurosurg 1996; 10: Hermantin FU, Peters T, Quartararo L, et al.(1999) A prospective, randomized study comparing the results of open discectomy with those of video-assisted arthroscopic microdiscectomy. J Bone Jt Surg 1999; 81-A: Hirsch JA, Singh V, Falco FJ et al.(2009) Automated percutaneous lumbar discectomy for the contained herniated lumbar disc: a systematic assessment of evidence. Pain Physician 2009; 12(3): Accessed December, Ishiwata Y, Takada H, Gondo G et al.(2007) 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): Jattiot F, Fouquet B, Goupille P, et al.(1994) Automated percutaneous discectomy: results in 50 patients. Rev Rhum Engl Ed 1994; 61: Jensen TT, Asmussen K, Berg-Hansen EMB, et al.(1996) First-time operation for lumbar disc herniation with or without free fat transplantation. Spine 1996; 21: Laser Discectomy. Hayes, Inc 6/10/2002:1-17. Le H, Sandhu FA, Fessler RG.(2003) Clinical outcomes after minimal -access surgery for recurrent lumbar disc herniation. Neurosurg Focus 2003; 15:1-4. MacKay MA, Fischgrund JS, Herkowitz HN, et al.(1995) The effect of interposition membrane on the outcome of lumbar laminectomy and discectomy. Spine 1995; 20: Maroon JC.(2002) Current concepts in minimally invasive discectomy. Neurosurgery 2002; 51 (sup 2); Mayer HM, Brock M.(1993) Percutaneous endoscopic discectomy: surgical technique and preliminary results compared to microsurgical discectomy. J Neurosurg 1993; 78: NHS - National Institute for Clinical Evidence.(2003) Laer lumbar discectomy - Page 5 of 7

6 understanding NICE guidenance - information for people considering the purcedure, and for the public. National Institute for Clinical Evidence Decemver, NHS - National Institute for Health and Clinical Excellence.(2005) Automated percutaneous mechanical lumbar discectomy. NHS, November, 2005, Interventional Procedure Guidance 141. North RB, Kidd DH, Piantadosi S.(1995) Spinal cord stimulation versus reoperation for failed back surgery syndrome: a prospective, randomized study design. Acta Neurochir 1995; 64: Petrie JL, Ross JS.(1996) Use of ADCON-L to inhibit postoperative peridural fibrosis and related symptoms following lumbar disc surgery: a preliminary report. Eur Spine J 1996; 5:S Revel M, Payan C, Vallee C, et al.(1993) Automated percutaneous lumbar discectomy versus chemonucleolysis in the treatment of sciatica. A randomized multicenter trial. Spine 1993; 18:1-7. Saal JA.(1996) Natural history and nonoperative treatment of lumbar disc herniation. Spine 1996; 21:2S-9S. Sahlstrand T, Lönntoft M.(1999) A prospective study of preoperative and postoperative sequential magnetic resonance imaging and early clinical outcome in automated percutaneous lumbar discectomy. J Spinal Disord 1999; 12: Schenk B, Brouwer PA, et al.(2006) Percutaneous laser disk decompression: a review of the literature. Am J NeuroRad 2006; 27: Shapiro S.(1995) Long-term follow up of 57 patients undergoing automated percutaneous discectomy. J Neurosurg 1995; 83: Singh V, Benyamin RM, Datta S et al.(2009) Systematic review of percutaneous lumbar mechanical disc decompression utilizing Ddekompressor. Pain Physician 2009; 12(3): Stevenson RC, McCabe CJ, Findlay AM.(1995) An economic evaluation of a clinical trial to compare automated percutaneous lumbar discectomy with microdiscectomy in the treatment of contained lumbar disc herniation. Spine 1995; 20: Teng GJ, Jeffery RF, Guo JH, et al.(1997) Automated percutaneous lumbar discectomy: a prospective multi-institutional study. J Vasc Interv Rad 1997; 8: Tullberg T, Isacson J, Weidenhielm L.(1993) Does microscopic removal of lumbar disc herniation lead to better results than the standard procedure? Results of a one-year randomized study. Spine 1993; 18:24-7. Page 6 of 7

7 Application to Products This policy applies to ARBenefits. Consult ARBenefits Summary Plan Description (SPD) for additional information. Last modified by: Date: Page 7 of 7