The National Institute for Clinical Excellence is examining balloon angioplasty of systemic to pulmonary arterial shunts 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 angioplasty of systemic to pulmonary arterial shunts.

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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 23 March 2004

Target date for publication of guidance: June 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 angioplasty of systemic to pulmonary arterial shunts appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

The procedure should only be undertaken in specialist cardiac units.

Systemic to pulmonary arterial shunts are surgically created connections between the aorta and a pulmonary artery in children with cyanotic congenital heart disease such as tetralogy of Fallot or tricuspid atresia. They increase the blood supply to the lungs and the arterial oxygen saturation. The procedures are palliative. In some children, definitive surgery may be possible later. The most common type of systemic to pulmonary shunt is known as the Blalock-Taussig shunt.

Systemic to pulmonary shunts may become blocked or narrowed (stenosed) due to scarring or thrombosis. Stenosed systemic to pulmonary shunts may be treated by a repeat surgical systemic to pulmonary shunt operation.

Balloon angioplasty of shunts is a palliative procedure carried out to relieve blockage or narrowing of pulmonary shunts. The procedure involves inserting a catheter into a large blood vessel (usually in the groin), passing it up into the chest under X-ray control and inflating a balloon in the narrowed area. This may avoid the need for a repeat surgical systemic to pulmonary shunt procedure.

The evidence was limited to small uncontrolled case series. All these studies reported increases in mean oxygen saturation, ranging from 5% to 19%. One of the studies reported successful angioplasty (> 20% increase in oxygen saturation) in 91% (42/46) of patients. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors had no concerns regarding the efficacy of this procedure.

Adverse events were poorly reported in the largest study, which was of 46 people. The main adverse events reported in the next largest studies included pulmonary hypertension in 12.5% (1/8) of patients; death due to pneumonia (could not be weaned off ventilator) in 12.5% (1/8) of patients; thrombosed femoral artery in 17% (1/6) of patients; balloon rupture in 17% (1/6) of patients; and severe arterial vasospasm in 17% (1/6) of patients. For more details, refer to the sources of evidence (see Appendix).

Potential adverse events noted by the Specialist Advisors included tearing of the vessel or shunt, death, complete shunt occlusion, rupture, thrombosis, haemorrhage, embolic stroke, and pulmonary embolism.

This procedure is used to treat an uncommon condition in very ill children.

Case selection is very important.

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 angioplasty of systemic to pulmonary arterial shunts, April 2003

Available from: www.nice.org.uk/ip154overview