A percutaneous approach for the treatment of clinically significant mitral regurgitation has demonstrated success in the first UK patients who have undergone the procedure. The first three cases of percutaneous mitral valve repair in the UK were performed in November 2008 in the Castle Hill Hospital, Hull. Recently, the percutaneous repair has also been performed in London.
Because the procedure does not require opening of the chest or a heart lung machine, it has the advantage of avoiding potential serious complications from open heart surgery, and typically requires only a short hospital stay. The procedure helps reduce symptoms of mitral regurgitation, improves heart function while preserving surgical options for the future in most patients.
The technology for the procedure, the MitraClip system (Evalve), received CE mark last year and is the only technology for percutaneous mitral repair commercially available in Europe for patients with functional or degenerative mitral regurgitation.
“This technology is cutting edge and may transform the way many of our patients receive heart surgery,” said Dr Farqad Alamgir, who led the team in Hull. “The MitraClip therapy reduces many of the risks and trauma currently associated with open heart surgery. Patients now have a second option which may not require them to have surgery. I believe the MitraClip system will not only play a key role for nonsurgical mitral regurgitation patients, but should also be considered as a therapy for select surgical candidates.” All three patients treated in Hull reported relief of symptoms at four months. The group was also the first in the world to perform angioplasty simultaneously with mitral valve repair on beating heart.
In London, one patient was treated in February with MitraClip by Drs Christopher Baker and Mike Bellamy at the Imperial College Healthcare NHS Trust. “The patient has done very well. The patient was someone with severe symptomatic mitral regurgitation and not thought to be fit to undergo a conventional procedure. The regurgitation was reduced from grade four, the most severe, to grade one, which is mild,” said Baker.
Approximately 500 patients have been treated with the MitraClip system worldwide. In Europe, 11 implanting hospital in five countries (Germany, Italy, UK, Switzerland, and The Netherlands) have treated 100 patients with the device.
Percutaneous mitral valve repair is done under general anaesthetic, via the right femoral vein, with a 24 French device. The Evalve system consists of three subsystems: a steerable guide catheter, a clip delivery system, and the MitraClip device. The first part of the procedure consists of a transseptal puncture and the introduction of a wire across the septum into a pulmonary vein. The septal puncture is done under transesophageal echocardiogram control and is aimed to be very superior and posterior, explains Baker. “It is very high up and towards the back of the atrium, so it gives you enough room to move within it.” A super stiff wire is used to guide the guide catheter across the septum. The clip is introduced, guided by the echocardiogram. “You can choose precisely where on the valve you want to place the clip. It is possible to close the clip and look at the effect of that position on the degree of regurgitation using echo scans before releasing it. If it’s not optimal, you can release the valve leaflets and choose a better position. In our first case, our initial position was not as good as it needed to be, and we then tried several other positions before we were happy,” said Baker.
When the leak has been reduced adequately, the clip is deployed and the final result assessed. About 25% of the cases use two clips.
“The interesting thing is that you see the real time haemodynamic effect of reducing regurgitation. Our patient’s blood pressure, which was between 90mmHg and 100mmHg, as soon as we clipped the valve, would climb to 130mmHg and 140mmHg.”
According to Baker, a patient without major comorbidities would be able to go home on the following day after the procedure. “Our patient is being followed carefully,” he said. Follow-up will is being done at one, three, six and 12 months.
Baker said that the disadvantage is that not every patient or valve is suitable for the procedure.
The percutaneous repair was based on an open heart surgical technique introduced by Dr Ottavio Alfieri, in Milan, Italy, which involves fastening the leaflets together where the valve leaks using suture.