Updated advice on non-invasive heart op now available
Today (28 March), the National Institute for Health and Care Excellence (NICE) has updated its guidance for the NHS on a procedure which avoids open heart surgery to replace a diseased heart valve. This could benefit certain people who have aortic stenosis; a potentially fatal condition in which the aortic valve becomes narrowed, making blood flow more difficult.
The procedure, called transcatheter aortic valve implantation (TAVI) involves replacing the narrowed aortic valve with an artificial one, which is inserted into the patient's heart through a catheter. This is an alternative to open-heart surgery (surgical aortic valve replacement, SAVR) in which the aortic valve is replaced by opening up the chest.
The guidance published today updates and replaces previous guidance from 2008. The main updates are recommendations on the use of TAVI for people who would be considered unsuitable for open heart surgery (e.g. because of poor health) and on when to consider TAVI as an option for people who could have the more invasive option instead. NICE did not advise on the use of TAVI for these patient groups in 2008 because there was insufficient evidence at the time. Specifically, the new guidance advises the following for people with aortic stenosis:
- If open-heart surgery is not an option (e.g. because of poor health): Specialists could consider performing TAVI routinely, providing that they ensure these patients understand what would be involved and agree to the treatment before giving their consent, and that they monitor the results. NICE calls this “normal arrangements” for clinical governance, consent and audit. NICE did not include recommendations for this group in 2008.
- If open-heart surgery is an option, but would carry a high risk of serious complications or death: This is the only group of patients that NICE's 2008 guidance focused on. NICE still advises specialists to consider TAVI as a treatment option providing they take extra steps for governance, consent, and data collection or research; including for patients to be made fully aware of its uncertainties and risks before giving their consent, and for there to be “special arrangements” in place for monitoring what happens to patient in the long-term after the procedure. Also, the updated guidance encourages specialists to enter suitable patients in the UK TAVI Trial, a research study led by the University of Leicester.
- If open-heart surgery is an option and would not have a high risk of serious complications: Specialists should only consider performing TAVI as part of a structured clinical trial. This is because there is not enough evidence to show that TAVI works better than the open-heart method for this group. NICE did not include recommendations for this group in 2008.
Professor Bruce Campbell, Chair of the independent committee that develops NICE's interventional procedures guidance said: "Current evidence on the safety of TAVI for aortic stenosis shows there are serious but well-recognised complications associated with it. Considering TAVI as a treatment option means balancing these issues against the risk of serious complications if the patients were to have the open heart surgery to replace their narrowed aortic valves. Possible benefits of TAVI could include fewer complications for patients who are at high risk from open heart surgery, quicker recovery and fewer readmissions to hospital. TAVI seems to work well in the short term, with good results for patients during the first year.
"However, NICE recognises that TAVI is a technically challenging procedure and so advises it should only be performed by clinical teams with special expertise in interventional cardiology. NICE also encourages further research, through the UK TAVI Trial and the UK Central Cardiac Audit Database, so that more can be learnt about its place in treating patients who would be suitable for surgical aortic valve replacement. Also, we would like to know how well the aortic valves inserted by TAVI work in the long term."
NICE does not consider cost in this type of guidance. NHS bodies continue to decide locally whether or not to offer the procedure.
Also, this type of NICE guidance does not evaluate the health technologies that may be used in the procedures (e.g. specific brands of artificial aortic valves): the guidance investigates the safety and efficacy of the procedure only.
Notes to Editors
1. The guidance will be available from 00.01, Wednesday 28 March 2012 at: www.nice.org.uk/IPG421. This includes a version written for patients and other members of the public, detailing a summary of the guidance and questions that they could ask their doctor about the procedure. Embargoed copies are available on request from the NICE press office.
2. Aortic stenosis reportedly affects 2-7% of those aged over 65 years. It is more common in men than women. The most common cause is the build up of calcium deposits with age. Other causes include rheumatic fever, congenital heart abnormalities, valve infection (endocarditis) and tissue abnormalities above or just below the valve.
3. In a study of 358 patients with aortic stenosis, 21% had died after 1 year of TAVI, compared to 45% of patients who had open-heart surgery (SAVR).
4. NICE's Interventional Procedures guidance applies to NHS healthcare settings in England, Northern Ireland, Scotland and Wales. The guidance makes recommendations on the safety of a procedure and how well it works. For further information, please read the factsheet: www.nice.org.uk/mediacentre/factsheets/InterventionalProcedures.jsp
5. In addition to the updated guidance on TAVI, NICE has published the following interventional procedures guidance on treating aortic stenosis:
- Percutaneous fetal balloon valvuloplasty for aortic stenosis - www.nice.org.ukIPG175
- Balloon valvuloplasty for aortic valve stenosis in adults and children - www.nice.org.uk/IPG78
1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
2. NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS
3. NICE produces standards for patient care:
- quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
- Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
This page was last updated: 28 March 2012