The first operation was performed recently at Papworth Hospital in Cambridgeshire by consultant cardiologist Dr Michael O’Sullivan and his colleague Dr Peter Schofield.
Dr O’Sullivan is the UK Chief Investigator for the EVOLUTION II trial, with Papworth the lead centre, looking at the new procedure for mitral regurgitation. The common disease is where a heart valve leaks, causing blood to wash backwards as the heart valves weaken.
Mitral regurgitation is often treated with open-heart surgery, but this new treatment involves passing the Monarc device, manufactured by Edwards Lifesciences, into the heart minimally invasively through a vein in the neck, while the patient is still awake.
The Monarc device is made of metal nitinol and has two mesh anchors separated by a spring, which is kept open with packing material between the coils. It is passed through a small 5mm incision in the neck, down the jugular vein and into the coronary sinus. The Monarc is anchored in position and left to contract as the packing material dissolves in the blood. Over the following six weeks, the Monarc reshapes the valve and stops the leakage. This leads to a gradual change in the function of the mitral valve, causing a reduction in leakage, and potentially an improvement in patient symptoms and outcome.
As the procedure does not involve major heart surgery, patients mobilise quickly, and can be discharged early after the procedure, usually the next day.
By this summer the procedure had only been performed 60 times around the world and it is still believed to be three years away from widespread use. However, Papworth Hospital stresses that the new procedure may not be suitable for all patients. ‘Whilst it must be emphasised that this is a new technique, and will not be suitable for everyone, the early results with this device have been very promising,’ said Dr O’Sullivan. ‘There is the potential that this will dramatically impact upon the treatment of patients with mitral valve disease and cardiac failure. This new approach is the first type of treatment of its kind and is a brilliant, minimally-invasive way, of helping patients with leaking valves. Open heart surgery is still very effective and suits the majority of patients but it does have its risks and we are always looking to develop new, less invasive procedures.’
Papworth Hospital NHS Foundation Trust, which carried out the UK’s first successful heart transplant in 1979, followed by Europe’s first successful heart and lung transplant in 1984, then the world’s first heart, lung and liver transplant in 1986, became one of the UK’s leading specialist centres for the diagnosis and treatment of heart and lung disease, treating over 20,000 in-patient and day cases and over 30,000 out-patients annually from across the UK.
Papworth is one of three UK centres taking part in this trial. The first patient at Papworth responded well and was able to return home the following day.