NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

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1 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of percutaneous endoscopic laser lumbar discectomy Symptomatic lumbar disc prolapse occurs when a disc at the lower end of the back bursts and pushes against spinal nerves. This may cause pain in the back or legs, and weakness and numbness in the legs. The aim of a percutaneous endoscopic laser lumbar discectomy is to remove the part of the disc that is pushing against the spinal nerve root. A small cut is made in the skin and a small flexible camera inserted though the cut to enable use of special equipment including a laser to heat and destroy some of the disc and remove its protruding part. Introduction The National Institute for Health and Clinical Excellence (NICE) has prepared this overview to help members of the Interventional Procedures Advisory Committee (IPAC) make recommendations about the safety and efficacy of an interventional procedure. It is based on a rapid review of the medical literature and specialist opinion. It should not be regarded as a definitive assessment of the procedure. Date prepared This overview was prepared in November Procedure name Percutaneous endoscopic laser lumbar discectomy Specialty societies British Orthopaedic Association Society of British Neurological Surgeons Page 1 of 16

2 Description Indications and current treatment Symptomatic lumbar disc herniation occurs when a portion of the intervertebral disc protrudes into the spinal canal. The herniation is caused by the nucleus pulposus protruding through a tear in the surrounding annulus fibrosus. A disc prolapse occurs where the annulus fibrosus becomes stretched or ruptures, resulting in an extruded disc. The protruding part of the disc may then compress one or more nerve roots, resulting in pain, numbness or weakness in the leg. In more severe cases, there may be leg weakness and bladder dysfunction. If left untreated serious neurological sequelae may occur. In most cases symptoms caused by lumbar disc prolapse settle spontaneously. However, for some patients surgery (occasionally as an emergency, for instance for cauda equina or painful foot drop) is indicated to help prevent or minimise permanent neurological damage, or to help control severe pain that is likely to persist for several weeks. Conservative treatments include the use of analgesics, non-steroidal anti-inflammatory medicines, and physical therapy. Epidural injections of corticosteroid can also be used. Surgery to remove disc material is considered if there is nerve compression or persistent symptoms that are unresponsive to conservative treatment. Surgical techniques include open-repair procedures and minimally invasive alternatives using percutaneous approaches. Different surgical or interventional procedure techniques can be used. Open surgical decompression using minidiscectomy or microdiscectomy is a treatment option in which a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed. A number of endoscopic techniques have been described. The choice of operative technique may be guided by several factors, including the location and size of the disc involved, and presenting signs and symptoms. What the procedure involves The procedure is carried out with the patient under local anaesthesia to enable patient feedback on symptomatic relief, and using endoscopic guidance. The disc is decompressed using endoscopic guidance, by curettes, microforceps and a discotome inserted via a cannula through a small (1 2 cm) retractor port. A laser is used to ablate disc material and then to shrink and contract the disc further (laser thermodiskoplasty). Any debris is removed with the discotome, and the probe and cannula are removed. Page 2 of 16

3 OPCS code TBC List of studies included in the overview This overview is based on approximately 400 patients from three case series 1, 2, 3. Other studies that were considered to be relevant to the procedure but were not included in the main extraction table (table 2) have been listed in appendix A. Efficacy A case series of 300 patients treated by percutaneous endoscopic laser lumber discectomy reported that 67% (186/279) of patients with a central disc prolapse, 67% (8/12) of patients with a lateral herniation, and 0% (0/9) of patient with stenosis and herniated nucleus pulposus were able to return to work and had increased mobility at 6-month follow-up 1. In the same study 32% (90/279), 25% (3/12), and 89% (8/9), respectively, of patients reported a reduced need for pain medication at 6-month follow-up. A case series of 67 patients with prolapsed lumbar discs refractory to conservative treatment reported that the mean Oswestry Disability Index score (a 0 to 100-point scale relating to pain and functional capacity; lower scores indicate less pain and better functional capacity) improved significantly from points at baseline to points at a minimum follow-up of 18 months (p < 0.01) 3. Eighty-eight per cent (59/67) of patients were classified as having an excellent or good result and 3% (2/67) needed narcotic analgesic medication at final follow-up. The mean period before return to work was 6.97 weeks (range 1 to 48 weeks). A case series of 43 patients with recurrent disc herniation following previous conventional open discectomy reported that following percutaneous endoscopic laser lumber discectomy 28% (12/43) of patients were classified as having an excellent outcome using the MacNab criteria (a four-grade classification based on pain and functional capacity) at a mean follow-up of 31 months 2. Outcome was good in 53% (23/43) of patients, fair in 14% (6/43), and poor in 5% (2/43). Patients younger than 40 years at baseline (p = 0.036) and those who had symptoms for less than 3 months were statistically more likely to achieve an excellent or good outcome following surgery (p = 0.028). Safety Across the three case series a subsequent operation was needed in 2% (5/300) 1, 2% (1/43) 2, and 4% (3/67) 3 of patients. One case series of 300 patients reported sympathetic mediated pain within 7 days of discharge in 5% (15/300) of patients 1. However, there were no signs of causalgia or sympathetic dystrophy. In the same series psoas haematoma occurred in < 1% (1/300) of patients, which resolved after 5 days of steroid medication. Page 3 of 16

4 Injury to the thecal sac with cerebrospinal fluid leakage was reported in 3% (2/67) of patients in one case series. However open repair was not needed 3. The rate of transient dysaesthesia in patients following percutaneous endoscopic laser lumber discectomy was reported as 5% (2/43) 2 and 13% (9/67) 3 in two case series. Sequelae were not described in the series of 43 patients but in series of 67 patients the dysaesthesia had resolved in all patients within 1 month of the procedure. Literature review Rapid review of literature The medical literature was searched to identify studies and reviews relevant to percutaneous endoscopic laser lumbar discectomy. Searches were conducted of the following databases, covering the period from their commencement to 10 June 2008: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language restriction was applied to the searches (see appendix C for details of search strategy). The following selection criteria (table 1) were applied to the abstracts identified by the literature search. Where selection criteria could not be determined from the abstracts the full paper was retrieved. Table 1 Inclusion criteria for identification of relevant studies Characteristic Publication type Patient Intervention/test Outcome Language Criteria Clinical studies were included. Emphasis was placed on identifying good quality studies. Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, or a laboratory or animal study. Conference abstracts were also excluded because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature. Patients with symptomatic lumbar disc herniation. Percutaneous endoscopic laser discectomy. Articles were retrieved if the abstract contained information relevant to the safety and/or efficacy. Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base. Existing assessments of this procedure There were no published assessments from other organisations identified at the time of the literature search. Page 4 of 16

5 Related NICE guidance Below is a list of NICE guidance related to this procedure. Appendix B gives details of the recommendations made in each piece of guidance listed. Interventional procedures Automated percutaneous mechanical lumbar discectomy. NICE interventional procedures guidance 141 (2005). Available from Endoscopic laser foraminoplasty. NICE interventional procedures guidance 31 (2003). Available from Laser lumbar discectomy. NICE interventional procedures guidance 27 (2003). Available from Page 5 of 16

6 Table 2 Summary of key efficacy and safety findings on percutaneous endoscopic laser lumbar discectomy Abbreviations used: CT, computed tomography; ODI, Oswestry Disability Index; MRI, magnetic resonance imaging; IV, intravenous; RF, radiofrequency; VAS, Visual Analogue Scale. Study details Key efficacy findings Key safety findings Comments Savitz MH (1998) 1 Functional mobility Complications The study period was 6 years but Outcome Central Lateral Stenosis and Reoperations were needed in 2% the dates are not described. Study type: case series prolapse herniation herniated (5/300) of patients. Four patients were n = 279 n = 12 nucleus operated on using laminotomy, and pulposus one underwent decompressive This is a retrospective study. Country: USA n = 9 laminectomy. Reasons for reoperation were not described. Study period: not reported n = 300 (n = 340 discs) Study population: patients with herniated lumbar discs. Diagnosed with CT, MRI, or myelography. Up to 50% prolapse of the spinal canal n = 279; extremely lateral disc herniation n = 12. Age: range 16 to 81 years Sex: 56% men. Levels with disease L2-3, to L5-S. Inclusion criteria: not reported Technique: a unilateral monoportal, endoscopic/fluoroscopic method using a Ho:YAG laser for disc vaporisation; 5 to 10 pulses per second, with saline irrigation. Systemic and topic antibiotics, and IV anti-inflammatory medication. Return to work and increased mobility Reduced pain medication 67% (186/279) 32% (90/279) 67% (8/12) 25% (3/12) 0% (0/9) 89% (8/9) Psoas haematoma occurred in < 1% (1/300) of patients, with pain radiating to the groin and weakness in the proximal musculature of the thigh. This resolved after a 5-day course of steroids. Sympathetic mediated pain within 7 days of discharge occurred in 5% (15/300) of patients. Signs of causalgia or reflex sympathetic dystrophy were absent. Twelve patients were successfully treated with lumbar sympathetic blocks, and symptoms resolved in three patients treated by non-steroidal antiinflammatory drugs alone. Patients were recruited from three participating centres. The number of clinicians undertaking the procedures is not described. Few baseline clinical characteristics are described. The efficacy outcome measures are not well described. Follow-up: 6 months (median) Conflict of interest: not reported Page 6 of 16

7 Abbreviations used: CT, computed tomography; ODI, Oswestry Disability Index; MRI, magnetic resonance imaging; IV, intravenous; RF, radiofrequency; VAS, Visual Analogue Scale. Study details Key efficacy findings Key safety findings Comments Choi G (2006) 3 Pain Complications Study type: case series Country: South Korea Study period: March 2002 to November 2002 n = 67 Study population: patients with prolapsed lumbar discs (level L5-S1) Age = 44 years (mean) Sex = 66% male Inclusion criteria: unilateral radiating leg pain refractive to trial of conservative modalities, confirmation by radiological assessment, no previous history of lumbar surgery at the same level. Technique: under conscious sedation. A monoportal endoscopic method using a Ho:YAG laser and RF probe for removal of prolapsed material and annulus vaporisation with saline irrigation. Single suture closure. Discharge on the same or next day with systemic antibiotics. Follow-up: 18 months minimum Patients with an improvement of 4 points on the VAS for leg pain were considered as having a favourable result; an improvement of 3 or less points was rated as a poor outcome. Baseline 18 months p VAS leg pain 7.89 ± ± 1.96 ODI ± ± 7.7 not reported < % (59/67) of patients showed good or excellent results at the final follow-up point. 3% (2/67) of patients needed narcotic analgesic medication at final follow-up. Operative parameters The endoscopic procedure was completed in 97% (65/67) of patients without conversion to open surgery. MRI assessment showed that 90% (60/67) of patients had near total disc removal. The mean hospital length of stay was 12 hours (range 4 to 48 hours). Functional mobility The mean period before return to work was 6.97 weeks (range 1 to 48 weeks). 3% (2/67) of patients needed conversion to an open procedure, one because of substantial bleeding from the large epidural vessels, and one because the patient was very anxious and uncooperative. 1% (1/67) of patients needed repeat interlaminar surgery at the same level on the contralateral side because of the movement of a free disc fragment causing sciatica at 1-day follow-up. A second patient who had residual disc material seen on MRI (no further details provided) needed open surgery at 2-month follow-up. 1% (1/67) of patients developed recurrent herniations on the same side and needed open lumbar microdiscectomy. 3% (2/67) of patients had an injured thecal sac with cerebrospinal fluid leakage. Open repair was not needed and management was by increased patient hydration. Transient dysaesthesia in the leg (different from shooting radicular pain at baseline) was reported in 13% (9/67) of patients. This resolved in all patients by 1-month follow-up. There were no reports of infection or neural deficit. Retrospective follow-up was by telephone interview at a minimum of 18-month follow-up. The patient accrual method or case selection was not reported. Loss to follow-up is not described. VAS parameters are not described. No objective outcome measures are reported. The ODI scale is assessed by a questionnaire that rates 10 parameters of pain and functional capacity, with scores ranging from 0 (best) to 100 (worst). The authors state that two patients had neural injury during the initial part of the learning curve. The initial 10 operations needed the supervision of an experienced surgeon. Conflict of interest: not reported Page 7 of 16

8 Abbreviations used: CT, computed tomography; ODI, Oswestry Disability Index; MRI, magnetic resonance imaging; IV, intravenous; RF, radiofrequency; VAS, Visual Analogue Scale. Study details Key efficacy findings Key safety findings Comments Ahn Y (2004) 2 Functional mobility Complications Study type: case series Country: South Korea Study period: not reported Study population: patients with recurrent disc herniation following conventional open discectomy. Age = 46 years (mean) Sex = 74% male. Pain-free interval since open surgery = 63 months (mean). n = 43 (L3-L4: n = 2; L4-L5: n = 35; L5-S1: n = 6) Inclusion criteria: previous open discectomy; recurrent radicular pain at the same level after a minimum of 6 months pain-free; refractive to extensive conservative therapy. Technique: Local anaesthetic. A posterolateral endoscopic method using a Ho:YAG laser and removal of herniated disc and fibrotic scar tissue. Single suture closure. Discharge within 24 hours if no postoperative complications. Follow-up: 31 months (mean) Conflict of interest: none 28% (12/43) of patients were classified as having an excellent outcome using the MacNab criteria, 53% (23/43) had a good outcome, 14% (6/43) fair, and 5% (2/43) poor. Patients younger than 40 years were more likely to have an excellent or good outcome (p = 0.036), as were patients who had had symptoms less than 3 months (p = 0.028). Operative parameters The mean surgical time was 51 minutes (range 25 minutes to 100 minutes). One of the two patients who were rated as having a poor outcome needed further surgery (open microdiscectomy) because of incomplete decompression. The other was treated by physical therapy and repeated epidurals. Transient dysaesthesia occurred in 5% (2/43) of patients within 6 months of surgery. This was a consecutive patient sample. Efficacy outcomes were evaluated using a VAS and the MacNab criteria. This rates the results of operative interventions using a four-point scale: Excellent: no pain or restriction of activity. Good: occasional back or leg pain of sufficient severity to interfere with the patients ability to do normal work or capacity to enjoy themselves in leisure hours. Fair: improved functional capacity, but handicapped by intermittent pain of sufficient severity to curtail or modify work or leisure activities. Poor: no improvement or insufficient improvement to enable an increase in activities; further operative intervention needed. A radiologist blinded to the study undertook all radiological assessments. The authors state that this procedure needs a highly experienced endoscopic surgeon, and that the learning curve is steep. Page 8 of 16

9 Validity and generalisability of the studies Two of the studies were in patients who had not previously undergone back surgery, while one was in patients who had recurrent pain following open discectomy. The intervention varied within and between studies. Some patients were treated at one spinal level and some had treatment at multiple levels. The condition is chronic and has recurring symptoms, but little long-term data are available. Few objective efficacy outcome measures are describe, and the series use several different subjective scales. Specialist Advisers opinions Specialist advice was sought from consultants who have been nominated or ratified by their Specialist Society or Royal College. The advice received is their individual opinion and does not represent the view of the society. Prof D Wardlow (British Association of Spinal Surgeons), Mr P Sell (British Association of Spinal Surgeons), Mr T Germon (British Association of Spinal Surgeons). One adviser considered endoscopic procedures with the use of laser or coblation to be unproven and have a higher complication rate. The key efficacy outcomes for this procedure include pain relief, pain recurrence, hospital length of stay, and return to work. The procedure is likely to be undertaken by neurosurgeons and orthopaedic surgeons. Specialist involvement in case selection and specialist training is required for new percutaneous procedures. The key comparator procedures are mini open discetomy or microdiscectomy None of the Specialist Advisers has undertaken the procedure. Theoretical adverse events with this procedure may include higher risk of nerve or dural injury because of the poor visual field and disorientation, and higher probability of missed fragments because of the small visual field. Page 9 of 16

10 One Specialist Adviser noted that this the uptake of this procedure is likely to be low. One Specialist Advisor stated that if there is good evidence that is it better than microdiscectomy it vould be very popular. Issues for consideration by IPAC Percutaneous endoscopic laser thoracic discectomy (NICE interventional procedures guidance 61) was published in June An updated literature search showed that there are no new data on thoracic discectomy. However the committee is now going to consider this procedure and also endoscopic laser cervical discectomy. Page 10 of 16

11 References 1 Savitz MH, Doughty H, and Burns P (1998) Percutaneous lumbar discectomy with a working endoscope and laser assistance. Neurosurgical Focus 4: e Ahn Y, Lee SH, Park WM et al. (2004) Percutaneous endoscopic lumbar discectomy for recurrent disc herniation: surgical technique, outcome, and prognostic factors of 43 consecutive cases. Spine 29: E326 E Choi G, Lee SH, Raiturker PP et al. (2006) Percutaneous endoscopic interlaminar discectomy for intracanalicular disc herniations at L5-S1 using a rigid working channel endoscope. Neurosurgery 58: Suppl. 1. ONS Page 11 of 16

12 Appendix A: Additional papers on percutaneous endoscopic laser lumbar discectomy There were no additional papers identified. Page 12 of 16

13 Appendix B: Related NICE guidance for percutaneous endoscopic laser lumbar discectomy Guidance Interventional procedures Recommendations Laser lumbar discectomy. NICE interventional procedures guidance 27 (2003). 1.1 Current evidence on the safety and efficacy of laser lumbar discectomy does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake laser lumbar discectomy should inform the clinical governance leads in their Trusts. They should ensure that patients offered it understand the uncertainty about the procedure s safety and efficacy and should provide them with clear written information. Use of the Institute s Information for the Public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present. Automated percutaneous mechanical lumbar discectomy. NICE interventional procedures guidance 141 (2005). 1.1 Current evidence suggests that there are no major safety concerns associated with automated percutaneous mechanical lumbar discectomy. There is limited evidence of efficacy based on uncontrolled case series of heterogeneous groups of patients, but evidence from small randomised controlled trials shows conflicting results. In view of the uncertainties about the efficacy of the procedure, it should not be used without special arrangements for consent and for audit or research. 1.2 Clinicians wishing to undertake automated percutaneous mechanical lumbar discectomy should take the following actions. Inform the clinical governance leads in their Trusts. Ensure that patients understand the uncertainty about the procedure s efficacy and provide them with clear written information. In addition, use of the Institute s Information for the public is recommended. Audit and review clinical outcomes of all patients having automated mechanical percutaneous lumbar discectomy. The Institute may review the procedure upon publication of further evidence. Endoscopic laser foraminoplasty. NICE interventional procedures guidance 31 (2003). 1.1 Current evidence of the safety and efficacy of endoscopic laser foraminoplasty does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake endoscopic laser foraminoplasty should inform the clinical governance leads in their Page 13 of 16

14 Trusts. They should ensure that patients offered the procedure understand the uncertainty about its safety and efficacy and should provide them with clear written information. Use of the Institute s Information for the Public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit or research. Further research into safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present. Technology appraisals Clinical guidelines Public health guidance There is currently no NICE guidance related to this procedure There is currently no NICE guidance related to this procedure There is currently no NICE guidance related to this procedure Page 14 of 16

15 Appendix C: Literature search for percutaneous endoscopic laser lumbar discectomy Database Date searched Version/files Cochrane Database of 10/06/08 Issue 2, 2008 Systematic Reviews CDSR (Cochrane Library) Database of Abstracts of 10/06/08 N/A Reviews of Effects DARE (CRD website) HTA database (CRD website) 10/06/08 N/A Cochrane Central Database of 10/06/08 Issue 2, 2008 Controlled Trials CENTRAL (Cochrane Library) MEDLINE (Ovid) 10/06/ to May Week MEDLINE In-Process (Ovid) 10/06/08 June 09, 2008 EMBASE (Ovid) 10/06/ to 2008 Week 23 CINAHL (Search 2.0, NLH) 10/06/ to date (via Dialog) BLIC (Dialog DataStar) 10/06/ to date National Research Register 05/06/08 N/A (NRR) Archive UK Clinical Research Network 05/06/08 N/A (UKCRN) Portfolio Database Current Controlled Trials 05/0608 N/A metaregister of Controlled Trials - mrct Clinicaltrials.gov 05/06/08 N/A The following search strategy was used to identify papers in MEDLINE. A similar strategy was used to identify papers in other databases. 1 Diskectomy/ 2 Endoscopy/ 3 1 and 2 4 Diskectomy/ 5 Diskectomy, Percutaneous/ 6 Decompression, Surgical/ 7 (Percutan$ adj5 discectom$).tw. 8 (Percutan$ adj5 diskectom$).tw. 9 (Endoscopic$ adj5 discectom$).tw. 10 (Endoscopic$ adj5 diskectom$).tw. 11 (Posterolateral$ adj5 discectom$).tw. 12 (Posterolateral$ adj5 diskectom$).tw. 13 (Decompress$ adj3 surg$).tw. 14 Microdecompress$.tw. Page 15 of 16

16 15 or/ Lasers/ 17 Laser Therapy/ 18 Laser$.tw. 19 Thermodiskoplast$.tw. 20 Thermodiscoplast$.tw. 21 or/ and Animals/ 24 Humans/ not (23 and 24) not $.ed $.ed $.ed $.ed $.ed $.ed $.ed $.ed $.ed. 36 or/ and 36 Page 16 of 16