National Institute for Health and Clinical Excellence (NICE)
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NICE guidance set to increase the number of patients receiving life-saving cardiac resynchronisation therapy to treat heart failure
The National Institute for Health and Clinical Excellence (NICE) has recently launched guidance on the use of cardiac resynchronisation therapy (CRT) – potentially life-saving heart pacing devices for the treatment of people with heart failure. The guidance also provides additional treatment options for some groups of people covered in NICE’s guidance on implantable cardioverter defibrillators (ICDs) published in 2006.
Heart failure is a complex syndrome that can result from any structural or functional cardiac disorder that impairs the heart’s ability to function efficiently as a pump. In a healthy heart, the lower chambers (ventricles) pump at the same time and in synchrony with the upper chambers (atria). This appraisal considered the treatment of people with heart failure caused by left ventricular systolic dysfunction – the failure of the left ventricle to pump in synchrony with some or all of the other chambers of the heart.
The aim of CRT (also known as biventricular pacing) is to improve the heart’s pumping efficiency by resynchronising the pumping action of the chambers.
The NICE guidance recommends which groups of people should be considered for CRT as follows:
• Cardiac resynchronisation therapy with a pacing device (CRT-P) is recommended as a treatment option for people with heart failure who fulfil all the following criteria.
– They are currently experiencing or have recently experienced New York Heart Association (NYHA) class III–IV symptoms.
– They are in sinus rhythm:
i. either with a QRS duration of 150 ms or longer estimated by standard electrocardiogram (ECG)
ii. or with a QRS duration of 120–149 ms estimated by ECG and mechanical dyssynchrony that is confirmed by echocardiography.
– They have a left ventricular ejection fraction of 35% or less.
– They are receiving optimal pharmacological therapy.
• Cardiac resynchronisation therapy with a defibrillator device (CRT-D) may be considered for people who fulfil the criteria for implantation of a CRT-P device as above and who also separately fulfil the criteria for the use of an implantable cardioverter defibrillator (ICD) device as recommended in NICE technology appraisal guidance 95.
Around 3% of people aged 65–74 years have heart failure and this increases to about 7% of those aged 75–84 years, and to just over 14% in those aged 85 years and older. The prevalence of heart failure in the UK is 40 per 1000 in men and 30 per 1000 in women. Heart failure has a poor prognosis, with about 40% of patients dying within 1 year of diagnosis. More severely ill patients are more likely to die because of pump failure (congestive heart failure), while those with less severe heart failure are more likely to experience sudden cardiac death.
Gillian Leng, Implementation Systems Director and Executive Lead for the appraisal, said: “This guidance provides an important option for the treatment of heart failure. Heart failure, particularly of the severity covered by this guidance, can be both distressing and have a significant negative impact on a person’s quality of life. CRT has been shown to improve both the length and quality of life of patients with heart failure by improving the function of the heart and by alleviating some of its symptoms, such as breathlessness, reduced exercise tolerance and fatigue.”
Because implementation of this guidance will require an increase in the number of cardiologists and clinical staff who are trained in CRT, and in the number of implantation centres, the Department of Health has agreed to vary the usual three month period that the NHS is required to fund NICE technology appraisal guidance to 18 months.
Notes to Editors
1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance 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 and procedures within the NHS
• clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.