Thousands of people with the heart condition atrial fibrillation, which causes irregular or abnormally fast heart rates, could be saved from strokes, disability or death because of new guidance from NICE.
The update highlights the need to ensure people with atrial fibrillation (AF) are offered the right treatments to reduce their chance of dying from strokes.
Atrial fibrillation happens when abnormal electrical signals fire from the top chambers of the heart (the atria). The chambers contract randomly and override the heart's natural pacemaker. The condition affects around 800,000 people in the UK; but it's thought around 250,000 others may be undiagnosed. Symptoms can include heart palpitations, dizziness, shortness of breath and fatigue.
"Atrial fibrillation is a major cause of stroke because it often leads to the formation of blood clots. We know that AF increases the risk of strokes by up to five times. It's estimated that the condition causes around 12,500 strokes each year." says Professor Mark Baker, NICE's Director of Clinical Practice.
"We also know that that around 7,000 strokes and 2,000 premature deaths could be avoided every year through effective detection and protection with anticoagulant drugs that prevent blood clots forming(i). Unfortunately only half of those who should be getting these drugs, are. This needs to change if we are to reduce the numbers of people with AF who die needlessly or suffer life-changing disability as a result of avoidable strokes."
The causes of atrial fibrillation are not fully understood. It affects more men than women. It is more common as people age - around 1 in 10 people aged over 65 have atrial fibrillation. It is also more common in people with other heart conditions such as high blood pressure or clogged arteries (atherosclerosis).
A report, also published today to coincide with this guidance by a group set up to advise on the implementation of NICE guidance, known as the NICE Implementation Collaborative (NIC)(ii), highlights the steps needed to increase the uptake of anticoagulant drugs(iii).
Until recently the only anticoagulant available to people with AF who were assessed as being at increased risk of stroke was warfarin. Although cheap and effective, warfarin has drawbacks which can make taking it problematic for some people. For example, many foods can interfere with or alter the effects of warfarin, such as green leafy vegetables, as well as alcohol and many medicines.
Also, regular monitoring and dose adjustments to ensure that the drug is working properly - which is often carried out in special clinics - can affect patients' work, social and family life. For example, attending anticoagulant clinics may be particularly difficult for some elderly patients who are housebound or have mobility problems.
Since 2012 a number of drugs belonging to a new generation of oral anticoagulants have been approved by NICE. Known as novel oral anticoagulants (or NOACs), they don't require such regular monitoring and dose adjustments and so represent an attractive option for some people with AF. However, there is evidence that these drugs are not being as widely prescribed as they could.
The new generation of oral anticoagulants are potential lifesavers for some people with AF - particularly those who find it difficult to control their blood clotting with warfarin or those who are intolerant to warfarin. They are also an option for people newly diagnosed with AF who have a higher risk of stroke and for those currently taking aspirin for stroke prevention.
Professor Neal Maskrey, Consultant Clinical Adviser, Medicines and Prescribing Centre, NICE, and member of the NIC NOAC consensus group, said: "Alongside the publication of the NICE guideline there are two novel approaches to support the implementation of the new evidence about stroke prevention for people with AF. The NICE Implementation Collaborative has summarised key aspects of the new guidance around the use of the new generation of oral anticoagulants and recommends ways in which local practices can be adapted to deliver high quality treatment for people with AF."
The guideline makes a strong recommendation that aspirin should not be offered to people with AF solely on account of increased risk of stroke. It used to be thought that aspirin is much safer in the older population because of the increased risk in this patient group of both bleeding and haemorrhagic stroke associated with anticoagulants.
New evidence shows that aspirin is not as effective as anticoagulants at preventing stroke in people with AF who are at increased risk of stroke, and is also not as safe in terms of causing bleeding. Although the risks of anticoagulation also increase with age, the evidence also shows that its benefits outweigh the risks in the vast majority of people with AF.
The guideline also recommends the use of a new tool - the CHA2DS2-VASc - to assess the risk of stroke in people with AF in order to distinguish better between those with a low risk who do not need anticoagulation and those with a higher risk who do.
In addition, NICE has worked with AF experts and patients to produce its first pilot Patient Decision Aid(iv). This is designed to help patients weigh up the possible benefits, harms, advantages and disadvantages of the different options for treatment so that they can better discuss them with a health professional and come to a decision together. The PDA includes a tool for patients to rate what is and isn't important to them in stroke prevention. It also has visual representations of the risks and benefits of the treatments to prevent stroke.
Dr Matthew Fay, a GP and member of the Guideline Development Group, explains: "With more than 10% of over 65 year olds having AF, GPs have to deal with both its identification and management on a regular basis. The NICE guideline builds on the relationship between the patient with AF and their GP, outlining how each patient should have a clear management plan which takes into account their personal preferences and the clinician's view of the evidence that has been clearly laid out in the guideline.
"GPs have evidence-based tools on how to assess the patient's personal stroke risk and their risk of bleeding and how to minimise that risk.
"The guideline incorporates the previous positive appraisals by NICE of the newer anticoagulants apixaban, dabigatran and rivaroxaban, positioning them clearly to enable the GP to support patients in their choice of preventive medication."
Ensuring people with AF are properly assessed and offered the right anticoagulation if they have a higher risk of stroke is just one of a number of important aspects of the management of AF covered by the new guideline.
The guideline also addresses the best ways to slow a person's heart rate or restore or maintain the normal heart rhythm if their symptoms of AF continue once their heart rate has been controlled or if a heart rate-control strategy has not worked.
The chair of the Guideline Development Group, Dr Campbell Cowan, says: "We felt that referring people to a specialist AF service if their symptoms failed to respond to treatment would greatly improve health outcomes through symptom management, timely monitoring, and treatment plans. "The guideline outlines the role of various therapies in the management of AF, including: drug therapy, cardioversion (electric shocks administered under anaesthetic) and ablation (radiofrequency pulses to destroy the area of the heart causing the abnormal heart rate). These treatments are often employed sequentially. For example, a patient might first undergo cardioversion, and then receive drug therapy to help maintain normal rhythm and then be considered for ablation if he or she continues to experience symptomatic arrhythmia.
"There is a concern with such sequential management, that there may be undue delays at each step in the process. Not only does this leave the patient with ongoing troublesome symptoms and uncertainty about further management options, it may reduce the success rate of these further options when they are eventually employed, most particularly the success rate of ablation. "The new guideline makes the important recommendation, that if a particular management step should fail, the patient should be referred back for consideration of more specialised management options within a 4 week period."
The updated guideline highlights that addressing patient concerns and providing them with the knowledge to make informed choices about their condition, whilst time consuming, is good clinical practice and should be the goal for all healthcare professionals. "Giving people with AF a personalised package of care and information will go a long way to ensuring that the treatment they receive is the treatment they need," says Eileen Porter, patient/carer representative on the Guideline Development Group.
"The guideline recommends this package should include up-to-date and comprehensive education and information on areas such as the cause, effects and possible complications of AF. This means that people with AF can be equal partners in their care. It will enable them to be actively involved with their clinician in decision-making about their treatment options and agree the therapies that are best for them."