The National Institute for Clinical Excellence is examining balloon valvuloplasty for aortic 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 valvuloplasty for aortic 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• The Advisory Committee will then prepare draft guidance, which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.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: 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 valvuloplasty for aortic 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.

Provisional recommendations for use in infants and children:

• critical aortic stenosis is a very rare indication for the procedure in this patient group, but the data on safety and efficacy are adequate
• the procedure is usually used palliatively, until the child is old enough to have valve replacement
• the procedure should be performed in a tertiary centre by a multi-disciplinary team
• patients who have undergone the procedure should be entered on to the UK Central Cardiac Audit Database (UKCCAD).

Provisional recommendations for use in adults:

• the evidence shows that the procedure's efficacy is usually short-lived
• the procedure should only be used for patients unsuitable for surgery
• patients who have undergone the procedure should be entered on to the UK Central Cardiac Audit Database (UKCCAD).

Balloon valvuloplasty is used to treat aortic valve stenosis (narrowing), which may be congenital, or may develop later in life as a result of rheumatic fever, or calcium build-up on the valve that occurs in some people as part of the aging process. The narrowing of the aortic valve causes the pressure in the left ventricle to increase. In order to continue to pump blood through this narrowed area, the left ventricle must pump harder, causing thickening (hypertrophy) of the left ventricular muscle. Symptoms include angina, shortness of breath or fainting on exertion, and palpitations. This condition may eventually lead to heart failure.

Standard treatment involves open chest surgery to perform a valvotomy, or to replace the valve.

Balloon valvuloplasty involves inserting a catheter into a large blood vessel, and passing it into the narrowed valve under X-ray control. A balloon is then inflated to dilate the aortic valve orifice. This can prevent the need for open chest surgery.

The evidence was limited to non-randomised controlled studies and case series studies. One of the studies that looked at 110 neonates found the mean reduction in systolic gradient to be 65% for the balloon valvuloplasty group, compared with 41% for the open surgery group. A study of adults over the age of 75 found the mean gradient decrease to be 24 mmHg for the balloon valvuloplasty group, and 55 mmHg for the surgery group. In another study, in which 80% (539/674) of patients were considered inappropriate for valve replacement due to age or other disease, the mean pressure gradient was reduced by 26 mmHg, but follow-up was only reported for 5 weeks. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors noted that in adults, surgery was generally the first choice of procedure, but balloon valvuloplasty was useful when surgery was contraindicated.

The comparative study of neonates found aortic regurgitation rates of 18% (15/82) in the balloon valvuloplasty group compared with 3% (1/28) in the open surgery group. In this study, immediate major complications were reported in 4% (3/82) of the balloon valvuloplasty group and 0% (0/28) of the open surgery group. However, the two groups in this study differed in their baseline characteristics. The comparative study of patients over 75 showed the death rate in the postoperative and follow-up periods to be 59% (27/46) in the balloon valvuloplasty group and 22% (5/23) in the open surgery group. However, the mean follow-up intervals differed between the groups (22 months for balloon valvuloplasty and 28 months for surgery). 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 myocardial infarction, stroke, aortic valve disruption or regurgitation, myocardial rupture or perforation, mitral valve damage, arterial damage or occlusion, and arrhythmia.

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

• Interventional procedure overview on balloon valvuloplasty for aortic valve stenosis, March 2003.

Available from: www.nice.org.uk/ip141overview