6 January 2015
In a world first, a new replacement heart valve for patients not suitable for open heart surgery, has been implanted at Royal Brompton Hospital. Sixty-eight-year-old, Margaret Mann, had the minimally-invasive procedure to replace a leaking mitral valve after conventional surgery was deemed inappropriate.
Mrs Mann, who lives with her husband Peter, in Burgess Hill, West Sussex, felt that her life was "drifting away" before she was referred to Royal Brompton Hospital. Just weeks after becoming the first patient in the world to have the Tendyne Transcatheter Mitral Valve 1
system implanted, she now feels that the groundbreaking procedure has given her a new lease of life.
The Tendyne device is the first of its kind that is suitable for the treatment of patients with mitral regurgitation, which can cause shortness of breath, tiredness, dizziness and chest pain. Left untreated it can lead to heart failure and death.
The condition occurs when the mitral valve (which separates the upper left heart chamber from the lower left chamber and helps control blood flow through the heart) becomes damaged and fails to close properly. This results in blood flowing backwards, or leaking, through the valve when the heart contracts.
Mrs Mann explained: "For the last three years I’ve been so short of breath that I haven’t even been able to walk very small distances. I was on various medications that helped a little, but none fixed the problem. I didn’t consider myself old enough to be feeling like I was.
"I had heart bypass surgery 21 years ago and I also have COPD (chronic obstructive pulmonary disease), so I think for a long time my symptoms were put down to this. When my heart valve problem was eventually diagnosed, I was told by the consultant at my local hospital that surgery wasn’t an option because it was unlikely I’d survive the operation."
The new Tendyne tissue valve can be placed into the patient’s beating heart without the use of cardiopulmonary bypass, commonly known as a heart-lung machine. It is implanted via a catheter through a small incision between the ribs. During the procedure the novel device can be repositioned, removed or redeployed as necessary.
Mrs Mann added: "I was referred to Royal Brompton Hospital where I was told about the new valve and that I would be the first person in the world to try it. My surgeon, Mr Moat, explained everything to me in detail, so when it came to making a decision I wasn’t actually too anxious. I decided to go ahead as I didn’t have much of a life as it was.
"I’m so pleased that I did, because now I’m more or less able to run up and down the stairs. For the first time ever I’ve been able to have all of the family, including my seven grandchildren, at home for Christmas dinner. Before I had the operation I wouldn’t have been well enough to cope with everybody under the same roof, so Christmas was something I was really looking forward to."
Since carrying out the world’s first procedure for Mrs Mann, Royal Brompton & Harefield NHS Foundation Trust consultant cardiac surgeon, Mr Neil Moat, has successfully implanted the Tendyne device in two other patients for whom surgery was not an option. Both patients, aged 75 and 87, made a rapid recovery and were discharged home with no residual mitral regurgitation.
Mr Moat said: "Whilst mitral valve surgery remains the gold standard for the treatment of severe mitral regurgitation, there are many patients living with the condition who are not suitable for surgery, either because of their age or because they have other serious medical conditions that increase the risks of open heart surgery. When surgery is considered inappropriate, there have been very few options, other than medication, to relieve symptoms.
"Up until now, catheter-based interventions to replace the mitral valve have been limited to a relatively small number of patients, with devices designed to treat ‘secondary’ mitral regurgitation (when a patient’s heart has become enlarged and results in a leaking valve).
"However, very many patients have ‘primary’ mitral regurgitation (when there is something structurally wrong with the mitral valve itself). The Tendyne system can also be used in these patients.
"We are delighted that Mrs Mann has done so well; continuing to improve and feel better almost two months after her procedure. We have now performed the procedure in two other patients, who also report significant improvement in their symptoms after being discharged home.
"If the Tendyne system continues to prove to be successful it could provide a very useful intervention in the treatment of patients with mitral regurgitation, both to improve their quality of life and potentially even extend the lives of patients with complicated mitral valve disease."
. The Tendyne Transcatheter Mitral Valve system is currently not licensed for marketing in the UK. It has been made available under a compassionate use protocol, which, under the Human Medicines Regulations 2012, exempts certain treatments when patients have special clinical needs that cannot be met by current licensed medicinal products.