Understanding NICE guidance
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Understanding NICE guidance

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    Understanding NICE guidance Understanding NICE guidance Document Transcript

    • Issue date July 2009 Understanding NICE guidance Information for people who use NHS services Using abdominal keyhole surgery to implant a breathing muscle ‘pacemaker’ NICE ‘interventional This leaflet is about when and how abdominal keyhole surgery can be procedures used in the NHS to insert a breathing muscle ‘pacemaker’ in people guidance’ advises with neurological conditions (including people with spinal cord injury as the NHS on when and how new well as those with diseases of the nervous system) who cannot breathe procedures can be without help. It explains guidance (advice) from NICE (the National used in clinical Institute for Health and Clinical Excellence). practice. 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. NICE has produced this guidance because the procedure is quite new. This means that there is not a lot of information yet about how well it works, how safe it is and which patients will benefit most from it. This leaflet 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 neurological conditions or the procedure in detail – a member of your healthcare team should also give you full information and advice about these. The leaflet includes some questions you may want to ask Information about NICE interventional procedure guidance 307 1
    • your doctor to help you reach a decision. Some sources of further information and support are on page 7. Information about NICE interventional procedure guidance 307 2
    • What has NICE said? Although there is evidence to say that this procedure is safe, there are still uncertainties about how well it works. If a doctor wants to use this procedure, they should make sure that extra steps are taken to explain the uncertainty about how well it works, as well as the potential risks of the procedure. This should happen before the patient agrees (or doesn’t agree) to the procedure. The patient should be given this leaflet and other written information as part of the discussion. There should also be special arrangements for monitoring what happens to the person after the procedure. A team of experienced, specialist doctors should decide who might be suitable for this procedure. It should only be done by a team of specialist doctors including keyhole (known as laparoscopic) surgeons and neurophysiologists (specialists in nerve function) with specific training in the procedure. NICE has encouraged further research into this procedure. NICE may review the procedure if more evidence becomes available. Other comments from NICE It was also noted that the technology for this procedure is still developing. Information about NICE interventional procedure guidance 307 2
    • Abdominal keyhole surgery to implant a breathing muscle pacemaker This procedure may The medical name for this procedure is ‘intramuscular diaphragm not be the only stimulation for ventilator-dependent chronic respiratory failure due to possible treatment for patients with neurological disease’. The procedure is not described in detail here – neurological please talk to your doctor for a full description. disease who cannot Some patients with neurological conditions (including spinal cord injury breathe without help. Your and neurological diseases) lose the ability to breathe without help healthcare team (called chronic respiratory failure) and need a breathing machine (a should talk to you ventilator) to help them. Many will need a tube in the windpipe; others about whether it is suitable for you may use face mask. An alternative may be possible if the nerves (called and about any other the phrenic nerves) to the breathing muscle (the diaphragm) still work. treatment options The nerves can be stimulated with a device similar to a heart available. pacemaker, which allows the patient to breathe without a ventilator. This is called phrenic nerve stimulation. Intramuscular diaphragm stimulation is a new alternative to phrenic nerve stimulation that involves abdominal keyhole surgery. A small cut is made to the abdomen under a general anaesthetic and electrodes are inserted into the diaphragm. The electrodes are connected to a battery-operated pacemaker. Electric pulses make the muscles contract, moving the chest up and down in the same way that it would in normal breathing and allowing air to flow in and out of the lungs. Initially, the person may only be able to breathe using the system for a few minutes. However, using it gradually for longer periods strengthens the muscles, and eventually the patient can breathe without a ventilator for some or all of the time. Information about NICE interventional procedure guidance 307 3
    • What does this mean for me? If your doctor has offered you abdominal keyhole surgery to implant a breathing muscle pacemaker, he or she should tell you that NICE has decided that although the procedure is safe, there are uncertainties about how well it works. 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 leaflet, and have the opportunity to discuss it with your doctor before making your decision. NICE has also decided that more information is needed about this procedure. 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. Information about NICE interventional procedure guidance 307 4
    • 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 operation? Summary of possible benefits and risks You might decide to Some of the benefits and risks seen in the studies considered by NICE have this are briefly described below. NICE looked at 8 studies on this procedure. procedure, to have a different How well does the procedure work? procedure, or not to In one study of 26 patients with spinal cord injuries, all had the system have a procedure at all. implanted successfully. By an average of 142 days after the operation, 25 patients were able to breathe using only the pacemaker for periods of 24 hours, and by the end of the study, 14 patients were using it all the time. In another study, it was successfully implanted in 5 out of 6 patients. A study of 50 patients with spinal cord injuries found that, following the procedure, 49 patients had an increase in the amount of air inhaled and exhaled at each breath (the medical name for this is tidal volume). It also reported that 44 patients could manage at least 4 hours of continuous use 2 years after the operation. Information about NICE interventional procedure guidance 307 5
    • One study looked at patients with a progressive neurological disease called amyotrophic lateral sclerosis. The study showed that the deterioration in the maximum amount of air the patients could exhale (called the forced vital capacity) slowed down 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 the main success factors were breathing and time spent without a ventilator, quality of life, being able to talk and smell, and long-term survival. Risks and possible problems In the study of 6 patients, 1 had air in the chest cavity, causing the lung to collapse (called a pneumothorax), 1 had a wound infection and formation of lumpy tissue where the skin was cut, 1 had shoulder pain during maximum stimulation of the pacemaker and another had an occasional problem with inhaling food when eating. In the study of 50 patients, 21 had carbon dioxide in the chest cavity (called capnothorax) following 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, in theory, possible problems could include infection, technical failure, tiring of muscles, muscle pain, abnormal heart beat, problems with heart pacemakers and problems during magnetic resonance imaging scans. Information about NICE interventional procedure guidance 307 6
    • More information about neurological disease NHS Choices (www.nhs.uk) 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. Information about NICE interventional procedure guidance 307 7
    • 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 www.nice.org.uk/aboutguidance This leaflet is about ‘Intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure due to neurological disease’. This leaflet and the full guidance aimed at healthcare professionals are available at www.nice.org.uk/IPG307 You can order printed copies of this leaflet from NICE publications (phone 0845 003 7783 or email publications@nice.org.uk and quote reference N1907). 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 booklet in their own information about this procedure. Information about NICE interventional procedure guidance 307 8
    • National Institute for Health and Clinical Excellence MidCity Place, 71 High Holborn, London, WC1V 6NA; www.nice.org.uk ISBN 1-84629-998-5 N1907 1P Jul 09 © National Institute for Health and Clinical Excellence, 2009. All rights reserved. This material may be freely reproduced for educational and not-for-profit 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 307 9