The National Institute for Clinical Excellence is examining laser or radiofrequency valvotomy for pulmonary atresia with intact interventricular septum 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 laser or radiofrequency valvotomy for pulmonary atresia with intact interventricular septum.

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• The Advisory Committee will then prepare draft guidance, which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 24 February 2004

Target date for publication of guidance: May 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 or radiofrequency valvotomy for pulmonary atresia with intact interventricular septum does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

Clinicians wishing to undertake laser or radiofrequency valvotomy for pulmonary atresia 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 should 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 laser or radiofrequency valvotomy for pulmonary atresia. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. The Institute may review the procedure upon publication of further evidence.

Laser or radiofrequency valvotomy is used to treat pulmonary atresia, a congenital malformation of the pulmonary valve in which the valve orifice is obstructed and all the blood leaves the heart through the aortic valve. Babies with this condition survive only for the first few days of life while the normal foetal shunts between left and right circulations remain patent. Without an operation in that period to open the pulmonary valve or to make a permanent shunt between the aorta and the pulmonary arteries, the condition is fatal.

Standard treatments for pulmonary atresia include open surgical valvotomy and the Fontan procedure (open surgical creation of a right ventricular bypass by directly connecting either the right atrium or the superior or inferior vena cavae and the pulmonary artery).

Laser or radiofrequency valvotomy is a minimally invasive cardiac catheterisation procedure which involves creating an opening in the blocked pulmonary valve. It is often followed by balloon angioplasty. It avoids open surgery but some children will later need a permanent shunt procedure.

The evidence was limited to one small non-randomised comparative study and three small uncontrolled studies. The success rate of the procedure varied between 75% (9/12) and 93% (14/15). The success rate of surgical valvotomy was not reported in the comparative study. For more details, refer to the sources of evidence (see Appendix).

One Specialist Advisor commented that proper patient selection was important in order to achieve good clinical outcomes.

In the comparative study, the death rate for patients who underwent radiofrequency valvotomy was 16% (3/19), compared with 29% (4/14) for patients who underwent surgical valvotomy. Among the non-comparative studies that reported deaths, the death rate ranged from 20% (3/15) to 50% (6/12). Other complications reported in the studies were perforation of pulmonary artery in 33% (4/12) and 11% (2/18) of patients, and perforation of the right ventricular outflow tract in 17% (3/18) of patients. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors considered the main risks of the procedure to be death, perforation of the heart, cardiac tamponade, cardiac or pulmonary artery perforation/rupture, arrhythmias, infection and multi-organ failure.

This procedure has become established as a life-saving measure for severely ill neonates, and clinical trial data are very limited

.The procedure should only be performed in a specialist unit where paediatric cardiac surgery is available.

The Department of Health runs the UK Central Cardiac Audit Database (UKCCAD) on all patients undergoing paediatric cardiovascular interventions.

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

• Interventional Procedure Overview of laser/radiofrequency valvotomy for pulmonary atresia with intact interventricular septum , March 2003

Available from: www.nice.org.uk/ip147overview