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NICE calls for better diagnosis and management of common cardiovascular condition

Healthcare guidance body NICE has today (9 March) published draft recommendations on the diagnosis and management of lower limb peripheral arterial disease (PAD). The draft guideline, which is open to public consultation until 24 April, highlights a number of important changes that are needed in order resolve the considerable uncertainty and variations in practice that currently exist in this area and improve outcomes for patients.

Lower limb peripheral arterial disease is a common condition in which there is a blockage or narrowing of the arteries that carry blood to the legs. The main cause is atherosclerosis, which is narrowing of the arteries caused by fatty deposits on the arterial walls. Intermittent claudication is the most common initial symptom of PAD and is the result of the narrowed arteries not delivering adequate blood to leg muscles and so pain comes from the oxygen starved muscles. As well as having a detrimental impact on quality of life, intermittent claudication also indicates that there is an increased risk of heart attack and stroke compared with patients with PAD who do not have the symptom.

The incidence of PAD increases with age and about 20% of people older than 60 have the condition, although only a quarter of these have symptoms. The incidence of peripheral arterial disease is high among people who smoke, people with diabetes, and people with coronary artery disease. Even when asymptomatic, PAD is a marker for an increased risk of potentially preventable cardiovascular events. If PAD becomes symptomatic it can lead to significant impairment of quality of life through limiting mobility and in its more severe manifestations may lead to a condition called critical limb ischaemia, progressing to severe intractable pain, ulceration and gangrene. PAD is the largest single cause of lower limb amputation in the UK.

Treatment options depend on the level of severity and range from changes in life style (for example, smoking cessation, advice to exercise, management of cardiovascular risk factors (for example through taking aspirin and statins) and vasoactive drug treatment such as naftidrofuryl, to endovascular treatments (including balloon angioplasty, endovascular stents and a range of new adjunct or alternative treatments and techniques) and surgical reconstruction to unblock or bypass occluded or narrowed arteries.

Key recommendations in the draft guideline include:

· Offer all people with peripheral arterial disease appropriate information, advice and support in line with NICE guidance on:

- smoking cessation

- diet, weight management and exercise

- lipid modification and statin therapy

- the prevention, diagnosis and management of diabetes

- the prevention, diagnosis and management of high blood pressure

- drug therapy with antiplatelet agents.

· Assess people with suspected peripheral arterial disease by:

- using structured questioning about the symptoms of intermittent claudication and critical limb ischaemia,

- examining the femoral, popliteal and foot pulses,

- measuring the ankle brachial pressure index

· Offer contrast-enhanced magnetic resonance angiography for people with peripheral arterial disease, who need further imaging prior to considering an intervention.

· Offer a supervised exercise programme to all people with intermittent claudication.

· Ensure that all people with critical limb ischaemia are reviewed by a vascular multi-disciplinary team before treatment decisions are made.

· Do not offer major amputation in people with critical limb ischaemia unless all options for revascularisation have been considered by a vascular multi-disciplinary team.

Christine Carson, Programme Director, Centre for Clinical Practice at NICE, said: “Lower limb peripheral arterial disease is not only potentially life-threatening, but the severe pain associated with intermittent claudication and critical limb ischaemia can also have a significant impact on an individual's life, including loss of independence, employment and social activities. However, the management of peripheral arterial disease remains controversial and although effective treatments are available that can improve symptoms and stop disease progression, rapid changes in diagnostic methods, the emergence of new endovascular treatments and organisational changes in the provision of vascular services have resulted in considerable uncertainty and variations in practice across the UK. This draft guideline aims to improve outcomes for patients by clarifying what tests and treatments provide the most clinically and cost effective PAD diagnostic and treatment pathways.”

Stakeholders have until 24 April 2012 to comment on the recommendations in the draft guideline. Organisations can register as stakeholders at any time during the development of the guideline and comments must be submitted via the NICE website. Until the final guideline is published, recommendations could change depending on feedback received during the development of this guideline.

Ends

For more information call the NICE press office on 0845 003 7782 and out of hours on 07775 583 813.

Notes to Editors

About the draft guideline

1. The draft guideline on the diagnosis and management of lower limb peripheral arterial disease is available from the NICE website at: http://guidance.nice.org.uk/CG/Wave23/5 (from Friday 9 March 2012).

About peripheral arterial disease

2. Peripheral arterial disease (PAD) is a condition in which there is a blockage or narrowing of in one of the main arteries, most commonly the femoral artery in the thigh, or sometimes the iliac artery in the lower abdomen, that carry blood to the legs and arms. The main cause is atherosclerosis, which is narrowing of the arteries caused by fatty deposits on the arterial walls. Asymptomatic PAD is common in people with diabetes.

3. Intermittent claudication (IC) is a symptom of PAD and is the result of the narrowed arteries not delivering adequate blood to leg muscles and so pain comes from the oxygen starved muscles. Pain is relieved with rest. People with IC have an increased risk of heart attack and stroke compared to people with PAD who do not have IC. In the majority of those with IC, symptoms remain stable but approximately 20% become severe and progressive.

4. The incidence of PAD increases with age and about 20% of people older than 60 have the condition, although only a quarter of these have symptoms. The incidence of peripheral arterial disease is high among people who smoke, people with diabetes, and people with coronary artery disease. Asymptomatic peripheral arterial disease is common in people with diabetes.

5. Many people will have undetected and asymptomatic PAD. In post-mortem studies, there is a significant incidence of such disease that has never led to lifetime symptoms. The development of symptoms will depend both upon the extent of disease and activity levels of the individual.

6. Peripheral arterial disease may progress to critical limb ischaemia (CLI), with constant and intractable pain preventing sleep, often with ulceration or gangrene of the foot. People with CLI are at risk of losing their leg if they don't receive treatment, and a high proportion present for emergency care. Around 1-2% of people with IC eventually undergo amputation, although the risk is higher (about 5%) in people with diabetes.

7. Even in the absence of symptoms, a reduced blood pressure at the ankle (Ankle Brachial Pressure Index or ABPI) - a sign of PAD - is an independent predictor of cardiac and cerebrovascular morbidity and mortality and may help to identify people who would benefit from secondary prevention with aspirin, statins and angiotensin-converting enzyme (ACE) inhibitors. However, treatments for secondary prevention are currently less commonly offered to people with peripheral arterial disease than to those with other cardiac and cerebrovascular risk factors.

8. Self-help measures, including lifestyle changes such as quitting smoking, taking regular exercise and eating a healthy diet, are the most important components in reducing the chance of developing peripheral arterial disease.

9. The management of peripheral arterial disease remains controversial. Treatments include watchful waiting, medical management, exercise training, endovascular treatment and surgical reconstruction.

10. Mild symptoms are generally managed in primary care, with referral to secondary care when symptoms do not resolve or deteriorate. There are a number of treatment options for those with IC. This includes changes in life style (for example, smoking cessation), advice to exercise, management of cardiovascular risk factors (e.g. aspirin, statins) and vasoactive drug treatment (e.g. naftidrofuryl). However, for some people the severe pain that is often associated with intermittent claudication means that their ability to engage in regular exercise, particularly walking, can be severely limited.

11. People with severe symptoms that are inadequately controlled are often referred to secondary care for assessment for endovascular or surgical revascularisation. In recent years there has been a move away from invasive investigation by catheter angiography to non-invasive investigation by duplex ultrasonography, magnetic resonance angiography or computed tomography angiography. Treadmill walking tests and segmental pressures are other commonly used investigations.

12. Endovascular treatments include balloon angioplasty, endovascular stents and a range of new adjunct or alternative treatments and techniques. The new treatments include drug-eluting stents, modified balloons, laser angioplasty, atherectomy, cryotherapy and brachytherapy.

13. Surgical reconstruction may be carried out to unblock or bypass occluded or narrowed arteries. Procedures include aorto-bifemoral, femoro-popliteal and femoro-distal bypass and common femoral endarterectomy. The risks and outcomes of these vary according to the nature of the procedure, the presenting symptoms, comorbidities, and the site and extent of the disease. The current trend is toward less invasive treatment.

14. In 2011 NICE published technology appraisal guidance on cilostazol, naftidrofuryl oxalate, pentoxifylline and inositol nicotinate for peripheral arterial disease (TA223. See: Peripheral arterial disease - cilostazol, naftidrofyryl oxalate, pentoxifylline and inositol nicotinate

About NICE

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

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: 09 March 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.