The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure, in August 2013.
Heart failure is a complex clinical syndrome of symptoms and signs that occurs when the efficiency of the heart as a pump is impaired. It is caused by structural or functional abnormalities of the heart. Pressures rise within the heart and this leads to a rise in pulmonary artery pressure, which can cause pulmonary oedema and breathlessness. Fluid retention by the kidneys also contributes to high cardiac and pulmonary pressures and can produce peripheral oedema.
The most common cause of heart failure in the UK is coronary artery disease. Around 900,000 people in the UK have heart failure. It has a poor prognosis: 30–40% of patients diagnosed with heart failure die within a year – but thereafter the mortality is less than 10% per year. There is evidence of a trend in improved prognosis in the past 10 years. The 6-month mortality rate decreased from 26% in 1995 to 14% in 2005.
Heart failure is often assessed using the New York Heart Association (NYHA) functional classification system; classes I and II describe mild heart failure with no or slight limitation of physical activity, class III describes moderate heart failure with marked limitation of physical activity and class IV describes severe heart failure, when patients are unable to carry out any physical activity without discomfort.Treatment for chronic heart failure involves lifestyle changes such as increased physical activity and dietary restriction of salt and fluids. Pharmacological treatments include angiotensin-converting enzyme inhibitors, beta-blockers, aldosterone antagonists, angiotensin II receptor antagonists, hydralazine in combination with nitrate, and digoxin (see chronic heart failure: management of chronic heart failure in adults in primary and secondary care [NICE guideline CG108]). Diuretics are used for the relief of congestive symptoms, such as breathlessness and leg swelling associated with heart failure. In some patients cardiac resynchronisation therapy is used.
Monitoring of patients with chronic heart failure is done to identify signs of deterioration in order to modify treatment, with the aims of improving their quality of life and avoiding admission to hospital. This monitoring typically includes clinical assessment of functional capacity, fluid status (for example by measuring body weight), cardiac rhythm, and cognitive and nutritional status. Clinical monitoring and treatment in the community, usually by nurses, may reduce the incidence of complications and subsequent hospitalisation.Monitoring pulmonary artery pressure using an implantable device has been proposed as a method of monitoring the severity of heart failure and to provide early detection of worsening cardiac function.
Guidance development process
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.