The National Institute for Clinical Excellence is examining balloon angioplasty or stenting for coarctation or recoarctation of the aorta 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 or stenting for coarctation or recoarctation of the aorta.

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• The Advisory Committee will then prepare draft guidance, which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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 or stenting for coarctation or recoarctation of the aorta 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 be performed by a multidisciplinary team in specialist centres with cardiac surgery facilities.

Patients should be entered into the UK Central Cardiac Audit Database (UKCCAD).

Aortic coarctation is a congenital narrowing of part of the aorta, most commonly the aortic arch, usually close to the origin of the left subclavian artery. This results in high blood pressure in the upper body and arms and low blood pressure in the legs.

Standard treatment for native coarctation and recoarctation (see 2.2.1) involves open chest surgery. The type of surgery used depends on the anatomy of the lesion and preference of the surgeon, but may include resection of the coarctation site and end-to-end anastomosis repair, patch aortoplasty, left subclavian flap angioplasty and bypass graft repair.

Balloon angioplasty of aortic coarctation is a minimally invasive procedure that involves inserting a catheter into a large blood vessel, usually in the groin, and passing it up to the area of narrowing under X-ray control. A balloon is then inflated within the narrowing. A stent (a small tube) may be placed within the narrowing to keep it dilated. Balloon angioplasty and stenting may be carried out as a first treatment (in 'native' coarctation) or if previous surgical or angioplastic treatment fails and coarctation recurs ('recoarctation').

One small randomised controlled trial (RCT) was identified, along with a non-randomised comparative study and several case series studies. The RCT reported an 86% reduction in peak systolic pressure gradient in both the balloon angioplasty group and the surgery group. A non-randomised study comparing balloon angioplasty with and without stent placement reported a reduction in peak systolic gradient of 83% in the angioplasty alone group and 96% in the angioplasty with stent group. This was statistically significant (p < 0.001). For more details, refer to the sources of evidence (see Appendix).

One Specialist Advisor noted that results could be improved by concomitant stenting; another considered residual stenosis to be an efficacy concern.

In the RCT, the main complications reported were aneurysm in 20% (4/20) of the angioplasty group and 0% (0/16) of the surgery group; diminished pulse (in the leg through which angioplasty was performed) in 10% (2/20) of the angioplasty group and 0% (0/16) of the surgery group; bleeding in 5% (1/20) of the angioplasty group and 13% (2/16) of the surgery group; and hypertension in 5% (1/20) of the angioplasty group and 0% (0/16) of the surgery group. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors considered the main potential adverse effects of the procedure to be death, aortic rupture, aneurysm, femoral artery damage, neurological damage, and stroke. One Advisor noted that there were possible safety concerns if the procedure was being done for recoarctation after previous patch repair, but not for other types of surgery.

There were no data on use of the technique in neonates and infants because these patients are usually treated surgically.

The alternative to this procedure is major 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 balloon angioplasty or stenting for coarctation or recoarctation of the aorta, April 2003

Available from: www.nice.org.uk/ip142overview