In draft recommendationsⁱ published today the National Institute for Health and Care Excellence (NICE) has clearly defined which implantable cardiac devices are clinically and cost effective options for thousands of people with life-threatening irregular heartbeats (arrhythmias) or heart failure.

The draft guidance is an update of existing NICE guidance on the use of implantable cardioverter defibrillators (ICDs) in people who have arrhythmias that originate in the ventricles, the lower chambers of the heart (ventricular arrhythmias). It also updates existing NICE guidance on cardiac resynchronisation therapy for people with heart failure.

Arrhythmia describes a condition caused by an abnormality in the heart muscle or in the electrical conduction system of the heart which causes the heart to beat irregularly or at a faster or slower pace than normal. Ventricular arrhythmias are most common in people with underlying heart disease. They can happen suddenly and unexpectedly, and can cause sudden death. Over 50,000 people die suddenly each year in England from heart problems caused by ‘fast' arrhythmias in the ventricles (conditions called ventricular tachycardia or ventricular fibrillation).

People who survive a life-threatening ventricular arrhythmia are at high risk of further arrhythmias and are usually treated with an ICD. An ICD is a small battery powered device that is put into the upper chest below the left shoulder. Leads from the device go through a vein into the heart to control the rate (pace) of the heartbeat, continually sense for an irregular heartbeat, and deliver a small electric shock to return the heartbeat to its normal rhythm (defibrillate) if necessary.

Heart failure is a complex condition that reduces the heart's ability to function efficiently as a pump. One cause of heart failure is left ventricular systolic dysfunction (LVSD) where the left ventricle starts pumping out of time with the rest of the heart. LVSD is associated with a reduced left ventricular ejection fraction (LVEF)ⁱⁱ. People with heart failure also have an increased risk of developing life threatening ventricular arrhythmias and sudden cardiac death is the most common cause of death in people with mild to moderate heart failure.

The aim of cardiac resynchronisation therapy (CRT- also known as cardiac resynchronisation pacemaker [CRT-P]) is to improve the heart's pumping efficiency by bringing the pumping action of the heart chambers back in time with each other. Another type of CRT, called CRT-D combines CRT-P and ICD devices in order to both defibrillate the heart internally in an acute arrhythmic event and improve the heart's pumping efficiency.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "The Committee heard that patients who survive a cardiac arrest, or who have a higher risk of sudden death due to ventricular arrhythmia, live in constant fear of death. Anti-arrhythmic drugs are often not effective, can have unpleasant side-effects and sometimes need frequent dose adjustments which can be demanding for patients and lead to missing doses, taking the wrong dose or overdose. 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. Implantable devices therefore represent an important option for both the treatment and prevention of potentially life threatening arrhythmias and heart failure.

"The recommendations in our original guidance on ICDs for people who have survived an episode of ventricular tachycardia or ventricular fibrillation and for people with specific cardiac conditions, did not need to be updated, as there was no new evidence. Therefore the updated recommendations in this draft guidance, which are based on a new, and comprehensive analysis of all major clinical trials, relate only to people at risk of sudden cardiac death because of heart failure. As a result we have been able to clearly define which of the different devices is a clinically and cost effective treatment option for people who are at risk of sudden cardiac death because of left ventricular dysfunction. We welcome comments on these draft recommendations as part of the consultation."

This is draft guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

Ends

For further information, please contact the NICE press office on 0845 003 7782 / pressoffice@nice.org.uk or out of hours on 07775 583 813.

Notes to Editors

References

1. The draft recommendations are available at: /proxy/?sourceUrl=http%3a%2f%2fguidance.nice.org.uk%2fTAG%2f288

2. The amount of oxygen rich blood that is pumped out of the left ventricle per heartbeat. It is used to measure how well the heart is working. A normal LVEF is 50-70%.

About the draft guidance

1. The draft guidance on implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure is available from the NICE website. Consultation on the draft guidance closes on 27 January 2014.

2. The draft guidance states that:

1.1 Implantable cardioverter defibrillators (ICDs) are recommended as options for:

• 'Secondary prevention', that is, for people who have, in the absence of a treatable cause, with one of the following:
  - survived a cardiac arrest due to either ventricular tachycardia (VT) or ventricular fibrillation or
  
  - spontaneous sustained VT causing syncope or significant haemodynamic compromise or
  
  - sustained VT without syncope or cardiac arrest, and who have an associated reduction in left ventricular ejection fraction (LVEF of less than 35%;no worse than class III of the New York Heart Association functional classification (NYHA) of heart failure).
• 'Primary prevention', that is,for people who:
  
  - have a specific cardiac condition with a high risk of sudden death, including long QT syndrome, hypertrophic cardiomyopathy, Brugada syndrome or arrhythmogenic right ventricular dysplasia (ARVD), or
  
  - have undergone surgical repair of congenital heart disease.
• 'Primary prevention', that is, for people who have left ventricular dysfunction with an LVEFof 35% or less, and who have:
  
  - NYHA class I-II symptoms, and a QRS of 120 -149 milliseconds or
  
  - NYHA class III symptoms, a QRS of 120 -149 milliseconds with no left bundle branch block

1.2 Cardiac resynchronisation therapy with a defibrillator device (CRT-D) or with a pacing device (CRT-P) are recommended as treatment options for people who have left ventricular dysfunction with an LVEF of 35% or less, who have:

• NYHA class I-II symptoms and a QRS of 150 milliseconds or more or
• YHA class III symptoms, a QRS of 120 -149 milliseconds with left bundle branch block or
• NYHA class III symptoms, a QRS of of 150 milliseconds or more without left bundle branch block

1.3 CRT-P is recommended as a treatment option for people with left ventricular dysfunction with an LVEF of 35% or less, who have:

• NYHA class III symptoms, a QRS of 150 milliseconds or more with left bundle branch block or
• NYHA class IV symptoms and a QRS of 120 milliseconds or more.

3. The existing NICE guidance on ICDs and CRT is available on the NICE website.

About arrhythmias

1. The average survival of adults with an out of hospital episode of ventricular arrhythmia has been reported as low as 7%. With appropriate treatment and secondary preventive strategies, recent studies have reported 5 year survival of 69 to 100%.

2. Many patients presenting with arrhythmias with or without symptoms are treated with anti-arrhythmic drug therapy. Anti-arrhythmic drugs are often not effective and need constant titration which can be confusing for patients and lead to missing doses, taking the wrong dose or overdose. Many anti-arrhythmic drugs result in tiredness and inability to perform day to day activities, dependence on carers and consequently increase the risk of depression. Anti-arrhythmic drugs also have many side effects on the thyroid, liver or lungs.

3. Chronic prophylactic anti-arrhythmic drug therapy aims to suppress the development of arrhythmias, but does not terminate an arrhythmia once it is initiated. People who survive a first episode of a life-threatening ventricular arrhythmia are at high risk of further episodes and usually treated with implantable cardioverter defibrillators (ICDs).

4. Risk factors for sudden cardiac death include age, hereditary factors, having high risk of for coronary artery disease, inflammatory markers, hypertension, left ventricular hypertrophy, conduction abnormalities (for example left bundle-branch block), obesity, diabetes and lifestyle factors.

About heart failure

1. Heart failure is a chronic condition predominantly affecting people over the age of 50 years. It is a condition caused by any structural or functional cardiac disorder that impairs the heart's ability to function efficiently as a pump to support circulation. It is characterised by breathlessness, fatigue and fluid retention. About 900,000 people in England and Wales have heart failure, of which at least half have LVSD.

2. Clinically heart failure is classified using the New York Heart Association (NYHA) functional class, ranging from Class I (no limitation of physical activity) to Class IV (symptomatic at rest and discomfort from any physical activity).

3. Heart failure is also classified based on which heart function or which side of the heart is most affected: some patients have heart failure due to left ventricular systolic dysfunction (LVSD) which is associated with a reduced left ventricular ejection fraction (left heart failure or biventricular failure); while others have only right heart failure with a preserved ejection fraction.

4. Management of chronic heart failure in adults in primary and secondary care” initially recommends pharmacological treatment. However, as the condition becomes more severe, cardiac function and symptoms may no longer be controlled by pharmacological treatment and require invasive procedures. Cardiac function and heart failure symptoms may be improved by the implantation of a cardiac rhythm device which can sense and stimulate the atria, right and left ventricles independently.

About NICE

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