Elderly and frail patients for whom open heart surgery would carry too great a risk are set to benefit from a new, less invasive procedure to repair a faulty heart valve.
Up to 400 patients per year will benefit from the innovative new treatment after it was approved for use in the NHS by NICE, the National Institute for Health and Care Excellence. Patients who have the operation should live longer and enjoy a better quality of life.
Until now the only option for patients needing a ‘mitral valve repair’ was open heart surgery, which is considered too risky for some older and frail patients. The new procedure – which can repair the mitral valve without the need for a major operation – will now be more widely available across the NHS in England after the draft recommendations from NICE gave it the green light.
With the patient under a general anaesthetic, a surgeon uses ultrasound to pass a stainless steel clip through a vein in the groin into the mitral valve inside the heart. The clip is then attached to the flaps of the mitral valve to help it close more completely. The aim is to improve symptoms and quality of life and in most cases the patient can be sent home after an overnight stay in hospital.
Under the NICE guidelines, only patients whose risk from a conventional ‘open heart procedure’ is too high should be considered for the new procedure, which must be undertaken by an experienced teams working in specialist centres. Data on patient outcomes must also be collected and carefully analysed.
Professor Kevin Harris, from NICE, said: “This innovative procedure can reduce the symptoms of heart failure and improve quality of life. The latest evidence was reviewed by a NICE committee which concluded that the procedure worked well enough and was safe enough to be offered to those too old or too sick to have their mitral valve repaired through open heart surgery. The procedure has the potential to improve their symptoms and to extend their lives.”
When the mitral valve does not close properly it allows blood to flow back the wrong way. The heart must work harder to pump blood around the body, which can lead to heart failure, causing breathlessness and extreme fatigue. Approving the procedure will help patients who otherwise could only have treatment to manage and support the condition, rather than surgical intervention to resolve it.
As part of the safeguards put in place around the new procedure, it can only take place at specialist centres which have fast access to both cardiac and vascular surgical support (in case of complications requiring emergency treatment). Only clinicians with specialist training and supervision by an experienced mentor for at least the first 20 procedures will be allowed to carry out the procedure.
Dr Dan Blackman, of the British Cardiovascular Intervention Society, said: “This NICE guidance will be warmly welcomed by patients and specialists. Mitral regurgitation causes breathlessness, hospitalisation and reduces life expectancy.
“Unfortunately, many patients are not fit enough to undergo open-heart surgery and until now these patients have had no effective alternative treatment. We hope that the endorsement of the procedure by NICE will soon lead to it being routinely available across the NHS.”
Around 1.5 million people in the UK aged 65 or over are thought to have heart valve disease, including aortic stenosis and mitral regurgitation, and estimates suggest this will double by 2046 and rise to 3.3 million in 2056, due to an ageing population.