A leaky heart valve – mitral regurgitation or MR – occurs when the leaflets of the mitral valve do not close properly, allowing blood to flow backwards or regurgitate into the left atrium of the heart. It is the most common type of heart valve insufficiency and can lead to heart failure, which occurs when the heart becomes too weak to pump blood efficiently throughout the body.
Around 900,000 people in Britain are thought to suffer from heart failure and patients on GP heart failure registers have a five-year survival rate of only 58per cent.
The MitraClip procedure is minimally invasive, where the MitraClip device is inserted through a catheter to clip together a portion of the leaflets of the mitral valve. The treatment is designed to reduce MR, which may allow the heart to recover from overwork and improve function, potentially halting the progression of heart failure and enabling patients to live a higher-quality life.
In late-2009, Ken Richardson was diagnosed with cardiomyopathy, a deterioration of the heart muscle usually leading to heart failure. His condition was made worse by MR and he was recommended to undergo a MitraClip procedure as he was not fit enough for open heart surgery.
“I was 74 at the time and extremely unwell; everything was just too much effort,” Ken says. “I was so breathless that every time I tried to do simple chores, like going up stairs, bending down to tie my shoe laces or walking, I had to stop. It was pretty devastating.”
Within 24 hours of the operation I could get up, take a shower, get dressed and walk without difficulty
In 2012, Ken was treated with a MitraClip implant in London’s Royal Brompton Hospital by leading valve expert Dr Olaf Franzen. The results were transformative and immediate.
“Afterwards I felt absolutely fantastic. Within 24 hours of the operation I could get up, take a shower, get dressed and walk without difficulty,” Ken says. “My wife was amazed at my speedy recovery. I had the procedure on the Saturday, I was discharged on the Tuesday and that evening I took my wife and sister-in-law to dinner.”
Since his procedure, Ken has enjoyed a new lease on life, travelling with his wife in their caravan across the UK and Europe. Incredibly, as a result of the success of his MitraClip therapy, he has now been discharged as a patient suffering from heart failure.
“I walk the dog two miles every day now without any fear of getting breathless,” he adds. “The results have been fantastic and I can’t say how chuffed I am to have got it done. You couldn’t find a more grateful guy than me.”
Low hospital re-admission rates are something consultant cardiologist at University College London’s Heart Hospital, Dr Michael Mullen, emphasises as a key advantage in his experience with the MitraClip procedure.
“We have had patients who were admitted two or three times a year with heart failure, but since having MitraClip therapy not only have they felt much better, but they haven’t required any more admissions to hospital,” says Dr Mullen.
He says the main group of patients, who are currently benefiting from the MitraClip procedure in Europe, have functional MR where the underlying problem is another cause, whether it is coronary disease or a genetic abnormality which makes their heart weak. In these patients, the valve itself is normal, but the whole heart has become stretched, so that the valve doesn’t meet in the middle. As a result, when the patient is active and the heart stretches more, they become more breathless and quality of life is limited.
“Those groups of patients rarely get an operation on their valve, because they don’t do that well with surgery,” Dr Mullen says. “This subset of patients are probably the best suited for the MitraClip procedure.”
Availability of MitraClip in the UK has been limited to date, but the NHS is expected to take forward an evaluative commissioning programme giving patients more equitable access to innovative therapies. The “commissioning through evaluation” scheme will help answer vital questions about the cost effectiveness, risk and efficacy of treatment, and is an approach broadly supported by both physicians and the industry as a whole.
Dr Mullen is positive that the NHS commissioning through evaluation programme will enable novel treatments such as MitraClip therapy to be more readily available throughout the UK.
The MitraClip device is being used as a treatment option in many countries in Europe. Significant progress with MitraClip has been made in Germany, Italy, the Netherlands and Switzerland. There have been more than 10,000 patients treated worldwide with MitraClip to date.
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