The National Institute for Clinical Excellence is examining laser lumbar discectomy and will publish guidance on its safety and efficacy to the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about laser lumbar discectomy.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 23 September 2003

Target date for publication of guidance: March 2004

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

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.

Indications

Laser lumbar discectomy is a minimally invasive procedure used to treat prolapsed intervertebral discs. Prolapsed (or herniated) lumbar discs cause backache and sciatica in some patients.

The herniation is a result of a protrusion of the nucleus pulposus through a tear in the surrounding annulus fibrosis. The annulus fibrosis may rupture completely, resulting in an extruded disc, or it may remain intact but stretched, resulting in a contained disc prolapse. This may then compress one or more nerve roots, resulting in pain along the sciatic nerve.

Surgery is considered where there is nerve compression or persistent symptoms that are intractable to conservative treatment. Laser discectomy can be performed where the prolapse is contained. It is one of several minimally invasive surgical techniques, and it can be an alternative to open repair procedures such as open lumbar discectomy or laminectomy.

Laser lumbar discectomy works by vaporising part of a prolapsed disc. A probe is inserted into the disc through a small incision in the patient's back. The needle is inserted through the annulus and into the nucleus pulposus. Laser energy is then delivered through the probe and used to vaporise part of the nucleus pulposus. Several lasers are available for the procedure which differ in absorption, energy requirements, and rate of application. The procedure is performed under local and/or neuroleptic anaesthetic, and using radiographic imaging.

The main benefit of this procedure is short-term pain relief. In a UK study of 348 patients with chronic back pain, 210 (60%) patients reported good or excellent results at 1 year. The validity of these studies was compromised by high rates of loss to follow-up and the lack of long-term data on efficacy outcomes. For more details refer to the Overview (see Appendix A).

The Specialist Advisors had concerns about the efficacy of this procedure. One Advisor thought that most spinal surgeons believed the procedure to be ineffective. Another Advisor felt that the results of laser discectomy were unlikely to be better than conventional treatment. The same Advisor was concerned that operations could often be unnecessary, given that most disc prolapses often resolve without treatment.

Complications reported in the studies included discitis, thermal damage, and soft tissue injury. In one study of 164 patients, 12 (7%) patients reported experiencing postoperative dysaesthesia.

The Specialist Advisors listed the main potential complications as nerve damage, damage to the vertebral endplates and neighbouring structures, and disc-space infection. One Advisor was concerned about the risk of paraplegia.

The Committee noted that different types of laser might produce different effects, and it was concerned about potentially serious complications including nerve damage and paraplegia.

The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.

• Interventional Procedure Overview of Laser Lumbar Discectomy, October 2002