Catheter insertion of a new aortic valve to treat aortic stenosis

Transcription

1 Issue date March 2012 Understanding NICE guidance Information for people who use NHS services NICE interventional procedures guidance advises the NHS on when and how new procedures can be used in clinical practice. Catheter insertion of a new aortic valve to treat aortic stenosis This document is about when and how catheter insertion of a new aortic valve (a procedure called transcatheter aortic valve implantation or TAVI for short) can be used in the NHS to treat people with aortic stenosis. It explains guidance (advice) from NICE (the National Institute for Health and Clinical Excellence). Interventional procedures guidance makes recommendations on the safety of a procedure and how well it works. An interventional procedure is a test, treatment or surgery that involves a cut or puncture of the skin, or an endoscope to look inside the body, or energy sources such as X-rays, heat or ultrasound. The guidance does not cover whether or not the NHS should fund a procedure. Decisions about funding are taken by local NHS bodies (primary care trusts and hospital trusts) after considering how well the procedure works and whether it represents value for money for the NHS. This document is written to help people who have been offered this procedure to decide whether to agree (consent) to it or not. It does not describe aortic stenosis or the procedure in detail a member of your healthcare team should also give you full information and advice about these. The document includes some questions you may want to ask your doctor to help you reach a decision. Some sources of further information and support are on page 9. Information about NICE interventional procedure guidance 421 1

2 What has NICE said? Current evidence on the safety of transcatheter aortic valve implantation for aortic stenosis shows that there are serious but well-recognised complications associated with it. Evidence on how well the procedure works shows that it is more suited to some groups of patients than others. Whether the procedure is appropriate for an individual patient depends on their risk of serious complications if they were to have open heart surgery to replace their aortic valve. For patients with aortic stenosis who cannot have open heart surgery because of poor health or technical difficulties, transcatheter aortic valve implantation can be offered routinely as a treatment option provided that doctors are sure that the patient understands what is involved and agrees to the treatment, and the results of the procedure are monitored. If open heart surgery is an option for patients with aortic stenosis, but carries a high risk of serious complications, NICE has recommended that extra steps are taken for these patients when transcatheter aortic valve implantation is being offered. Before the patient agrees (or doesn t agree) to the procedure, the uncertainty about how well it works and how safe it is compared with open heart surgery should be explained to them. The patient should be given this document and other written information as part of the discussion. There should also be special arrangements for monitoring what happens to the patient after the procedure, including their long-term health. For patients in whom open heart surgery is an option, without a high risk of serious complications, there is not enough evidence to be certain how well transcatheter aortic valve implantation works compared with open heart surgery. For this reason, NICE has said that this procedure should only be carried out in these patients as part of a research study (also called a clinical trial). Information about NICE interventional procedure guidance 421 2

3 What has NICE said? A team of healthcare professionals who are experienced in managing aortic stenosis should decide which patients should be offered transcatheter aortic valve implantation. The team should include a heart surgeon, a specialist in heart procedures using catheters (known as an interventional cardiologist), a heart anaesthetist and an expert in cardiac imaging. NICE has also said that this is a difficult procedure. It should only be carried out by clinicians with special expertise/training in carrying out complex heart procedures using catheters. The procedure should be carried out in units with specialists in heart and blood vessel surgery available in case emergency treatment is needed. NICE has encouraged doctors to consider asking patients to take part in the UK TAVI trial ( a UK based research study (called a clinical trial) looking at this procedure.nice is asking doctors to send information about everyone who has the procedure and what happens to them afterwards to UK Central Cardiac Audit Database ( so that the safety of the procedure and/or how well it works can be checked over time. Information about NICE interventional procedure guidance 421 3

4 This procedure may not be the only possible treatment for aortic stenosis. Your healthcare team should talk to you about whether it is suitable for you and about any other treatment options available. Catheter insertion of a new aortic valve to treat aortic stenosis The medical name for this procedure is Transcatheter aortic valve implantation. This is sometimes referred to as TAVI. The procedure is not described in detail here please talk to your doctor for a full description. Stenosis means narrowing, and in aortic stenosis, the aortic valve in the heart has become narrow. Normally, this valve lets blood flow forward and out of the heart to the rest of the body, and stops it from flowing backwards into the heart. When the valve becomes narrowed, it doesn t open properly, so blood can t flow so easily out of the heart. This puts strain on the heart muscle. People with aortic stenosis may have chest pain, feel breathless and dizzy, and may faint. Some people develop heart failure, or may die suddenly. An artificial valve may be inserted to replace the narrowed aortic valve. The standard operation for aortic stenosis is known as surgical aortic valve replacement. This involves opening the chest (open heart surgery) and putting the patient onto a heart and lung machine (heart lung bypass). The valve can then be replaced. Transcatheter aortic valve implantation aims to provide a less invasive alternative to open heart surgery to treat aortic stenosis. In this procedure the new valve is inserted through a catheter (thin tube) into the heart, with the patient under general anaesthesia or using local anaesthesia with sedation. The new valve is positioned within the existing aortic valve. The catheter is normally inserted into the body through a large blood vessel, usually in the groin (known as the transfemoral approach). Sometimes the valve is inserted directly into the heart through a small cut in the chest (known as the transapical approach). The risk and complications are higher in patients who have the valve inserted by the transapical approach. However, this is usually Information about NICE interventional procedure guidance 421 4

5 because the transfemoral approach is not suitable for the patient because of complicating factors such as arterial disease. What does this mean for me? If you are not well enough, or your heart and vessels are not suitable for, aortic valve replacement by open heart surgery, but your doctor thinks that transcatheter aortic valve implantation is a suitable treatment option for you, he or she should make sure you understand the benefits and risks before asking you to agree to it. If open heart surgery is an option for you, but carries a high risk of serious complications, your doctor should tell you that the benefits and risks of transcatheter aortic valve implantation compared with open heart surgery are uncertain. This does not mean that the procedure should not be done, but that your doctor should fully explain what is involved in having the procedure and discuss the possible benefits and risks with you. You should only be asked if you want to agree to this procedure after this discussion has taken place. You should be given written information, including this document, and have the opportunity to discuss it with your doctor before making your decision. If open heart surgery is an option for you, and doesn t carry a high risk of serious complications, your doctor can only offer you transcatheter aortic valve implantation as part of a research study (also called a clinical trial). Your doctor may ask you if details of your procedure can be used to help collect more information about this procedure. Your doctor will give you more information about this. You may want to ask the questions below What does the procedure involve? What are the benefits I might get? How good are my chances of getting those benefits? Could having the procedure make me feel worse? Are there alternative procedures? What are the risks of the procedure? Are the risks minor or serious? How likely are they to happen? What care will I need after the procedure? What happens if something goes wrong? What may happen if I don t have the procedure? Information about NICE interventional procedure guidance 421 5

6 You might decide to have this procedure, to have a different procedure, or not to have a procedure at all. Summary of possible benefits and risks Some of the benefits and risks seen in the studies considered by NICE are briefly described below. NICE looked at 8 studies on this procedure and a review of 84 studies. How well does the procedure work? Two studies (one including 1038 patients and the other 870) found that 94% (956 of 1019 procedures) and 97% of procedures were successful (exact numbers were not given in one study). In the study of 1038 patients, 69% of patients who had the procedure through a small cut in the chest and 78% of patients who had the procedure through a large blood vessel in the groin had mild or no symptoms 1 year after the procedure (exact numbers were not given). In another study, which included 358 patients, 75% of patients who had the procedure had no or mild symptoms 1 year after the procedure, compared with 42% who had standard therapy (including drug treatment; the exact numbers of patients were not given). In a study of 699 patients who were well enough for open heart surgery, but for whom it carried a high risk of serious complications, 18% of patients who had the procedure and 16% who had open heart surgery needed to be readmitted to hospital within 1 year (exact numbers were not given). One study asked 99 patients to complete a quality of life questionnaire both before and after the procedure. The results of the questionnaire showed that the physical health of these patients had improved 3 months after having the procedure. In the study of 358 patients who were not well enough for open heart surgery, after 1 year 21% of patients who had the procedure had died because of heart or blood vessel problems compared with 45% of Information about NICE interventional procedure guidance 421 6

7 patients who had standard therapy. In the study of 870 patients (877 procedures), the survival rate was 79% at 1 year and 74% at 2 years (exact numbers of patients were not given). As well as looking at these studies, NICE also asked expert advisers for their views. These advisers are clinical specialists in this field of medicine. The advisers said that the aims of the procedure are successful placement of the aortic valve, improved blood flow, improved survival and quality of life, and fewer readmissions to hospital. Risks and possible problems In the study of 699 patients who were well enough for open heart surgery, but for whom it carried a high risk of serious complications, 8% of the patients had a stroke or mini-stroke (a temporary stroke) within 1 year of having the procedure. This was compared with 4% of patients who had open heart surgery (exact numbers were not given). The lining of the heart became infected in 2 patients who had the procedure and 3 patients who had open heart surgery. In the same study, similar numbers of patients who had the procedure compared with those who had open heart surgery needed a pacemaker within 1 year (6% compared with 5%). A pacemaker was also needed in 141 out of 867 (16%) patients in the study of 870 patients and in 81 out of 243 (33%) patients in a study of 270 patients. A review of 2375 patients reported fluid or blood accumulating around the heart in 1 10% of patients. Four studies (involving 1038, 699, 175 and 870 patients) reported moderate or severe leaking of blood back through or around the aortic valve after the procedure in 20 out of 1036 (2%) patients, 12% patients (exact numbers were not given), 6 out of 63 (10%) patients and 14% of patients (exact numbers were not given) respectively. Mild leaking was reported in 16 out of 63 (25%) patients in the study of 175 patients. In Information about NICE interventional procedure guidance 421 7

8 the same study, 1 patient needed surgery to insert a new valve because of severe leaking. In two studies (involving 699 and 358 patients) major bleeding within 30 days was reported in 32 of 348 (9%) patients and 30 of 179 (17%) patients who had the procedure, in 67 of 351 (20%) patients who had open heart surgery and in 7 out of 179 (4%) patients who had standard therapy. In the same two studies, 11 out of 348 (3%) patients and 8 out of 179 (5%) patients who had the procedure died because of problems with their heart or blood vessels, compared with 10 out of 351 (3%) patients who had open heart surgery and 3 out of 179 patients (2%) who had standard therapy. In the study of 1038 patients, 88 out of 1038 (9%) died within 30 days of having the procedure. This study also reported a tear in the aorta in 9 of 463 (2%) patients who had the procedure through a large blood vessel in the groin and in 5 out of 575 (less than 1%) patients who had the procedure through a small cut in the chest. A second valve had to be implanted after the procedure in 22 of 1036 (2%) patients because the original valve was not working or was in the wrong position. In the study of 699 patients, 5% required treatment for kidney failure after the procedure compared with 7% after open heart surgery. 15 of 99 (15%) patients in the study of 99 patients had kidney failure after the procedure. As well as looking at these studies, NICE also asked expert advisers for their views. These advisers are clinical specialists in this field of medicine. The advisers said that complications included the valve blocking an artery or causing blood clots. They also said that a possible problem was anaemia caused by breakdown of blood cells on the new heart valve. Information about NICE interventional procedure guidance 421 8

9 More information about aortic stenosis NHS Choices ( may be a good place to find out more. Your local patient advice and liaison service (usually known as PALS) may also be able to give you further information and support. For details of all NICE guidance on aortic stenosis, visit our website at About NICE NICE produces guidance (advice) for the NHS about preventing, diagnosing and treating different medical conditions. The guidance is written by independent experts including healthcare professionals and people representing patients and carers. They consider how well an interventional procedure works and how safe it is, and ask the opinions of expert advisers. Interventional procedures guidance applies to the whole of the NHS in England, Wales, Scotland and Northern Ireland. Staff working in the NHS are expected to follow this guidance. To find out more about NICE, its work and how it reaches decisions, see This document is about Transcatheter aortic valve implantation for aortic stenosis. This document and the full guidance aimed at healthcare professionals are available at guidance.nice.org.uk/ipg421 The NICE website has a screen reader service called Browsealoud, which allows you to listen to our guidance. Click on the Browsealoud logo on the NICE website to use this service. We encourage voluntary organisations, NHS organisations and clinicians to use text from this document in their own information about this procedure. Information about NICE interventional procedure guidance 421 9

10 National Institute for Health and Clinical Excellence Level 1A, City Tower, Piccadilly Plaza, Manchester M1 4BT; ISBN Mar 12 National Institute for Health and Clinical Excellence, All rights reserved. This material may be freely reproduced for educational and not-forprofit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of NICE. Information about NICE interventional procedure guidance