NICE 2002/050
Issued: 4 October 2002


PRESS RELEASE

NICE issues guidance in two specialist areas to improve choice and care for NHS patients in England and Wales

 

In its latest two guidance documents, the National Institute for Clinical Excellence has today recommended:

  • that patients with end-stage kidney failure, who are suitable for home dialysis should be offered the choice between receiving their haemodialysis at home or in a hospital/satellite unit; no matter where they live in England and Wales and

  • that ultrasound devices [the two-dimensional (2-D) imaging type] should be made available to assist NHS clinicians when they are inserting central venous catheters. Patients need central venous catheters in a variety of situations - for example, when they are undergoing cancer treatment, kidney dialysis, or major surgery; or when they require emergency treatment when admitted to A&E or intensive therapy units.

In order that they can deliver these effective options to patients across England and Wales, NHS hospitals and care providers will have to purchase new equipment and review the services supporting its use. NICE has advised the Department of Health that in areas where this is not current practice it is likely to take longer than 3 months to put this into practice. This is important as earlier this year the Secretary of State for Health directed the NHS that it should normally fund NICE guidance within three months of it being issued. The Department of Health and the Welsh Assembly Government have acted on NICE's advice and will exempt these two sets of guidance from the effect of the three month Direction.

In the case of the home haemodialysis guidance, this will also give the NHS the opportunity to take into account the forthcoming Renal National Service Framework.

Andrea Sutcliffe, Planning and Resources Director and Executive Lead commented on the haemodialysis guidance, "Home vs. hospital haemodialysis has long been a subject for debate within the NHS. Whilst the evidence suggests that haemodialysis at home is as effective as that in hospital and that home treatment is likely to be more cost effective; data from the 2001 UK Renal Registry Review showed that was a wide variation in availability of home haemodialysis depending on which centre was providing care. For some patients the benefits of having their haemodialysis at home are significant, added to the fact that they do not need to travel to a hospital, the flexibility of deciding when a haemodialysis session will be held and how long means that they can plan their treatment around their life, and not their life around the treatment".

"However it is important to recognise that the decision to have home haemodialysis is complex and that it should be an informed choice which is made by both the patient and their carers. Not everyone who is clinically suitable will want haemodialysis at home - for example some may not able to maintain the equipment, whilst others will want the support of specialist staff in a hospital or satellite unit to deal a problem should it arise. Today's guidance is clear haemodialysis at home is a clinically and cost effective option and suitable patients should be allowed to make the choice that suits them best."

Anne-Toni Rodgers, Corporate Affairs Director and Executive Lead commented on the second guidance: "Placing central venous catheters is a common procedure, nearly 4,000 catheters per week are inserted in a wide range of settings, by a diverse group of clinicians. It involves inserting a needle into the vein and traditionally clinicians insert the needle by using their knowledge of body structure and by feeling for the pulse in the artery that lies close to the vein. This is known as the Landmark method and whilst experienced operators can achieve relatively high success rates with few complications, the failure rates for initial CVC insertion have been reported as high as 35% and there are a number of complications that can be associated with it, including: puncturing an artery instead of a vein, puncturing the wall of the cavity that surrounds the lungs, causing injury to a nerve or having to make several attempts at inserting the catheter, which can delay treatment and cause tissue damage. The risks and the consequences of complications differ substantially across different patient groups depending on the patient's body structure, the circumstances in which the procedure is carried out and what illnesses or injuries the patient has."

"2-D imaging ultrasound machines display an image of the vein and the tissues surrounding it, on a screen and help the clinician guide the needle into the vein. The independent Appraisal Committee that advises NICE found that there was clear evidence that using these devices to assist in placing the catheters is effective for patients and cost effective for the NHS. However because there will always be occasions when ultrasound equipment is not available - for example, during an emergency outside of a hospital setting - we have recommended that clinicians maintain their ability to use the landmark method and that it should be taught alongside the 2-D ultrasound-guided technique".

ENDS

Notes for Editors:

For further information contact: Lucy Betterton 020 7766 9161 or 07747 865 562

This press release summarises the NICE guidance. It should be read in conjunction with the full guidance document . Copies of the full guidance and supporting documentation will be available on the NICE web site www.nice.org.uk from 12pm (lunchtime) on 4 October 2002.

Home versus hospital haemodialysis:

1. All suitable patients should be offered the choice between home haemodialysis or haemodialysis in a hospital/satellite unit.
   
2.

In general, patients suitable for home haemodialysis will be those who:

  • have the ability and motivation to learn to carry out the process and the commitment to maintain treatment
  • are stable on dialysis
  • are free of complications and significant concomitant disease that would render home haemodialysis unsuitable or unsafe
  • have good functioning vascular access
  • have a carer who has (or carers who have) also made an informed decision to assist with the haemodialysis unless the individual is able to manage on his or her own
  • have suitable space and facilities or an area that could be adapted within their home environment
3. Patients currently treated in hospital who are potentially suitable for home haemodialysis on clinical grounds, but who have not previously been offered a choice, should be reassessed and informed about their dialysis options.

   
4. Patients performing haemodialysis at home and their carers will require initial training and an accessible and responsive support service. The support service should offer the possibility of respite hospital/satellite unit dialysis as required.
   
End-stage renal failure (ESRF) and haemodialysis
   
5. End-stage renal failure is the result of progressive disease of the kidneys leading to irreversible loss of function. Patients with ESRF are unable to excrete waste products and toxins normally and are likely to experience clinical symptoms as a result. Other complications can include anaemia, hypertension, oedema and acidosis.
   
6. When renal function reaches the point where the kidneys are deemed to be unable to support life in the longer term, renal replacement therapy (RRT), which includes haemodialysis, is required.
   
7. Without treatment, ESRF is fatal. With treatment, the 1-year-survival figures for newly diagnosed patients under 65 years and those aged 65 and above are 86% and 66%, respectively. Timely patient referral so that management in the pre-dialysis phase can be optimised, including planning of vascular access, can improve patient outcomes.
   
8. Haemodialysis, or renal replacement therapy (RRT) is a method of removing waste products from the body. The patient is connected to a dialysis machine containing a semi-permeable membrane. The patient's blood is passed into the machine and excess salts and water in the blood pass across the semi-permeable membrane into dialysis fluid. The waste products are retained within the dialysis fluid. A number of different types of haemodialysis machine are currently available. The process can also vary depending on the use of different equipment, dialysis fluids and the frequency and duration of sessions. The most usual haemodialysis prescription is for 4 hours given three times per week.
   
9.

Haemodialysis can be undertaken in different places like any of the following.

  • Hospitals - these are usually specialist units. A renal physician and a team of specialised nursing staff are on call at all times.
  • Satellite units - these centres tend to be in smaller district general hospitals and have a reduced level of medical cover compared with specialist units. Satellite units are always linked to specialist units.
  • Patients' homes - the same equipment and consumables are used in the home as are used for hospital haemodialysis.
10. Home haemodialysis is associated with the same potential complications as hospital haemodialysis, such as low blood pressure, air embolus or blood loss.
   
11. In 2000, an estimated 5350 patients in England and Wales started some form of RRT (derived from an estimated annual rate of 89 per million of the population), and the total number of patients on dialysis increased by 5%.
   

12.

 Across different health authorities, the numbers of people receiving dialysis varied from 329 to 693 per million of the population. Afro-Caribbeans and Asians from the Indian subcontinent have a higher incidence of renal failure and are three to four times more likely to be treated for ESRF.
   
13. The numbers of patients requiring RRT are predicted to continue rising. Since home haemodialysis is at least as effective as and less costly than hospital or satellite unit haemodialysis, increasing the numbers of patients treated at home would enable more patients to be treated with a smaller increase in budget.
   
14. In addition, maximising the numbers of patients able to undertake home haemodialysis would enable hospital haemodialysis resources to be used for those patients for whom no other options are available.
   
15. The majority of renal units in England and Wales already provide some level of home haemodialysis service. However, data from the 2001 UK Renal Registry show that there is wide variation between centres in the numbers of patients on home dialysis with a small number of centres having up to 15% of all their dialysis patients receiving home haemodialysis.
   
16. Making the assumption that 10% to 15% of dialysis patients, given the choice, would opt for home haemodialysis, expansion of the services to support home haemodialysis will be required.
   
17. A complete service to support home haemodialysis will include an assessment team that ascertains the most appropriate form of treatment from both a clinical and a social perspective, initial training for both patient and carer(s) and ongoing technical and medical support.
   
Ultrasonic locating devices
   
18. The NICE guidance recommends the use of 2-D imaging ultrasound guidance as the preferred method for inserting CVCs into the internal jugular vein in adults and children in elective (non-emergency) situations.
   
19. The NICE guidance also recommends that the use of these devices should be considered in most clinical circumstances where CVC insertion is necessary either electively or in an emergency situation.
   
20. All those involved in placing CVCs using 2-D imaging ultrasound guidance should undertake appropriate training.
   
21. The guidance does not recommend the use of audio-guided Doppler ultrasound guidance for CVC insertion.
   
22. A central venous catheters (CVC) is a tube that is inserted into the vein. They are inserted for a number of reasons including the delivery of blood products, drugs, and nutrition, cardiac pacemaker placement and haemodialysis.
   
23. CVC insertion has traditionally been done by puncturing a central vein (most commonly the internal jugular vein (neck), the subclavian vein (beneath the collar bone), the femoral vein (leg) and the upper limb veins) and passing the needle along the anticipated line of the vein by using surface anatomical landmarks and by knowing the expected location of the vein to its companion artery. This method is known as the "landmark method".
   
24. The most common complications associated with CVC insertion are puncturing an artery instead of a vein, puncturing the wall of the pleural cavity that surrounds the lungs, causing injury to a nerve or having to make several attempts at inserting the catheter, which can delay treatment.
   
25. Two types of ultrasound device are now available to help the clinician guide the needle into the vein. Two-dimensional (2-D) imaging ultrasound devices which use high frequency radio waves to produce an image of the vein and the tissues surrounding it, and audio-guided Doppler ultrasound devices which emit a sound when they detect a vein.
   
26. The advantages of using ultrasound locating devices for placing CVCs include the identification of the precise position of the target vein and the detection of anatomical variants and of thrombosis within the vessel, together with the avoidance of inadvertent arterial puncture. Ultrasound guidance therefore has the potential to reduce the incidence of complications related to initial venous puncture, which is the first stage of CVC insertion.
   
Information on NICE
   
27. NICE is the independent organisation responsible for providing national guidance on treatments and care for those using the NHS in England and Wales.
   
28. Health professionals are expected to take NICE guidance fully into account when exercising their clinical judgement for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
   
29. Appraisals are a review of clinical and economic evidence leading to recommendations on the appropriate use of new and existing medicines and treatments Each appraisal takes an average 12 months to complete and involves the manufacturers of the technology, groups that represent patients/carers and healthcare professionals.
   
30. To date NICE has issued 47 technology appraisal guidance.Some of these guidance have been cost saving, others required investment to implement. The estimated cost of implementing is about £600million.
   
31. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. The Institute supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.
   
32. Topics for the NICE work programme are selected by the Department of Health and the National Assembly for Wales. NICE advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, audit tools are produced for use in the clinical setting.