Intralesional photocoagulation of subcutaneous congenital vascular disorders The National Institute for Clinical Excellence is examining intralesional photocoagulation of subcutaneous congenital vascular disorders and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. 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 intralesional photocoagulation of subcutaneous congenital vascular disorders.

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

• comments on the preliminary recommendation
• the identification of factual inaccuracies
• additional relevant evidence.

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• The Advisory Committee will then prepare draft guidance, which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

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: 27 April 2004

Target date for publication of guidance: July 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 intralesional photocoagulation of subcutaneous congenital vascular disorders does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

Clinicians wishing to undertake intralesional photocoagulation of subcutaneous congenital vascular disorders should take the following action.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. Use of the Institute's Information for the Public is recommended.
• Audit and review clinical outcomes of all patients having intralesional photocoagulation of subcutaneous congenital vascular disorders.

Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. The Institute is not undertaking further investigation at present.

Intralesional photocoagulation is a laser treatment for people with congenital abnormalities of the blood vessels of the skin (including haemangiomas, port wine stains and arteriovenous malformations). Often these abnormalities require no treatment, as they may resolve spontaneously or cause only mild cosmetic problems.

Laser treatment is often recommended for lesions near the eyes or orifices, or if lesions bleed, ulcerate or become infected. However, external laser treatment of these vascular abnormalities may not be effective, because the laser beam does not penetrate far beneath the skin.

Intralesional photocoagulation involves inserting a laser fibre into the lesion to deliver the light deep within it. More than one treatment may be needed.

The evidence was limited to small case series studies. The largest study, which only included children, reported that following intralesional photocoagulation, 46% (46/100) of patients had a greater than 90% reduction in the size of the lesion and the other 54% (54/100) had a 50-90% reduction in the size of the lesion. In this study, 76% (76/100) of patients had a subsequent surgical resection and reconstruction. In another study of patients with periorbital haemangiomas, 83% (19/23) of patients had a 50% or greater reduction in the size of the lesion within 8 months. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted that use of the procedure in the UK was very limited.

The following complications were reported in the identified studies: ulceration 17% (4/23) to 25% (3/12); continued gradual bleeding requiring surgical control 8% (1/12); scar contracture needing surgical revision 8% (1/12); infection 4% (1/23); residual weakness of branches of the facial nerve 2% (2/100); requirement for transfusion during treatment 2% (2/100); and small burns 2% (2/100). For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors listed the main potential adverse events as ulceration, nerve injury, tissue necrosis, scarring, contracture, and arteriovenous fistula formation.

There is uncertainty about the aims of the procedure and how efficacy should be measured. The procedure is effective in terms of 'shrinking' the lesion.

There is particular uncertainty in the literature about the severity and consequences of ulceration and scarring caused by the procedure.

Facial nerve damage is an important potential complication.

The relationship with surgery is uncertain in some of the studies; the procedure may be used as an adjunct to surgery.

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• Interventional procedure overview of intralesional photocoagulation of subcutaneous congenital vascular disorders, June 2003

Available from: www.nice.org.uk/ip085overview