The National Institute for Clinical Excellence is examining balloon dilatation of pulmonary valve stenosis 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 balloon dilatation of pulmonary valve stenosis.

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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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 balloon dilatation of pulmonary valve stenosis appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

Balloon dilatation of pulmonary valve stenosis should only be performed in a specialist unit where paediatric cardiac surgery is available.

Pulmonary valve stenosis is narrowing of the pulmonary valve in the heart. It is usually congenital. The outflow of blood from the right ventricle of the heart to the lungs is obstructed. Symptoms include shortness of breath, chest pains, fainting and, in some instances, sudden death.

In the past, the standard treatment for pulmonary valve stenosis was open surgical valvotomy.

Outline of the procedure

Balloon dilatation is a minimally invasive transvenous procedure to dilate the pulmonary valve orifice during cardiac catheterisation.

The evidence identified was limited to case series and one historical controlled study. All the studies reported a reduction in the residual pressure gradient across the pulmonary valve. In addition, the studies that reported data with more than 11 months follow-up showed that the reduction in pressure gradient persisted. In a case series of 533 children who received the procedure, an immediate residual gradient of less than 36 mm Hg was reported in 74% (394/533) of patients. No clinical outcomes were reported. For more details, refer to the Sources of evidence (see Appendix).

The Specialist Advisors had no concerns about the efficacy of this procedure, but recommended that it should be carried out only in paediatric cardiology units with special expertise.

Most of the studies identified did not report safety findings in detail. The study that described safety findings in most detail reported the following immediate complications among 811 patients: arrhythmia, 1% (8/811); bleeding from catheter site, 0.9% (7/811); femoral vein thrombosis, 0.6% (5/811); hypoxia, 0.4% (3/811); death, 0.2% (2/811); tricuspid regurgitation, 0.2% (2/811); femoral vein tears, 0.2% (2/811); arterial thrombosis, 0.2% (2/811); cardiac perforation, 0.1% (1/811); and respiratory arrest, 0.1% (1/811) . For more details, refer to the Sources of evidence (see Appendix).

The Specialist Advisors commented that pulmonary regurgitation was common after the procedure, but that the long-term effects of this were unknown. They cited an incidence of less than 1% of both pulmonary artery rupture and death. They considered the risks to be greater in neonates than in older infants and children.

The Advisory Committee noted that this procedure has become established practice on the basis of clinical experience. There is very limited research evidence published.

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 balloon dilatation of pulmonary valve stenosis, March 2003

Available from: www.nice.org.uk/ip140overview