A keyhole surgery procedure for mitral valve disease has been rolled out across the NHS this week after a decade-long delay due to funding struggles.
The procedure, trans-catheter edge-to-edge repair (TEER), takes just 2 hours and is a much less invasive alternative to traditional open-heart surgery, with patients up and about the next day, and able to be discharged soon after.
As with percutaneous repair for aortic stenosis, TEER offers particular hope for patients ineligible for conventional open surgery due to their age or other comorbidities who, left untreated, have a very poor prognosis. The techniques have been widely used in Europe for years, yet the availability of trans-catheter 'keyhole' procedures has been limited in the UK, with substantial variation in access to treatment in different areas.
In 2019, NHS England allowed limited commissioning of the TEER procedure in a small number of specialised centres. Criteria were that TEER be offered only to adults with symptomatic, severe primary degenerative mitral regurgitation who had been assessed as inoperable or at very high risk with conventional surgery, who had a healthy life expectancy of at least 12 months, and in whom reduction of mitral regurgitation would be expected to provide sustained symptom and quality of life benefits.
"It is hugely exciting that TEER is now available across the NHS," said Professor Dan Blackman, interventional cardiologist at Leeds Teaching Hospitals NHS Trust, one of the 20 active centres across the UK that will now be performing the procedure routinely.
"This decision comes after a funding battle which has taken more than 10 years since the initial NHS decision not to fund in 2011," he explained. "It follows a 2-year evaluation to prove its effectiveness, and further delays due to the COVID-19 pandemic in more recent years."
UK Bottom of European League Table
The delay in NHS funding was despite contemporary results of an independent registry showing that the procedure was "associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation, and improvement of clinical symptoms".
It left the UK lagging behind other countries in giving patients access to the TEER procedure. Recent data showed that in Germany 50 times as many TEER procedures were performed annually, and in Switzerland 30 times more, while the UK languished at the bottom of a league table of 15 Western European nations.
TEER uses a system called a MitraClip, a two-armed cobalt-chromium device with a polyester covering that promotes tissue growth between the valve leaflets. The clip system is introduced via venous access and delivered trans-septally into the left atrium under fluoroscopic and trans-oesophageal echocardiography guidance. The clip arms are used to approximate the anterior and posterior leaflets, usually creating a double-orifice mitral valve.
Although there are other techniques, TEER is the most frequently used and researched method for percutaneous mitral valve repair. Clips can be repositioned to obtain optimal reduction, and additional clips may be placed if residual regurgitation persists and if the resultant valve area and trans-mitral gradient will allow.
Procedure is 'Life-Changing and Life-Saving'
"This is a life-changing and life-saving procedure," said Prof Blackman, who is also director of the UK Valve for Life programme. This is a joint initiative between the European Association of Percutaneous Cardiovascular Interventions and the British Cardiovascular Intervention Society, which aims to improve and expand NHS access to minimally invasive key-hole therapies for heart valve disease, including TEER and trans-catheter aortic valve implantation (TAVI). The latter was recommended earlier this month as a way to help reduce the current record backlog of patients waiting for surgical aortic valve replacement on the NHS, having been shown in a study published in May to give results broadly comparable with conventional open surgery.
As with TAVI, most patients experience substantial improvements in symptoms and quality of life following the TEER procedure for mitral valve disease, such as a marked reduction in breathlessness and restoration of the ability to perform everyday tasks such as walking up a flight of stairs, doing housework or simply taking a short walk.
"One of the most dramatic results I have seen was a patient who was in hospital for 11 weeks, and was stuck on the intensive care unit, critically ill. After we performed TEER he was discharged from hospital in just a week. This was a remarkable outcome and highlights just how effective this straightforward procedure can be," said Prof Blackman.
Patients Encouraged to Seek Referral
The new care pathway is expected to be able to achieve similar mitral valve repair procedure rates to other European countries, with each of the 20 active NHS centres performing up to 50 TEER procedures each year based on capacity. Patients withdiagnosed mitral valve disease and mitral regurgitation are being encouraged to seek advice from their cardiology team about referral for the procedure, which will now be available at NHS hospitals across the UK.
The centres are:
- London – Barts, Royal Brompton, Harefield (Hillingdon), King's College, St Thomas's Hospital
- England – Bristol Royal Infirmary, John Radcliffe (Oxford), Papworth (Cambridge), Royal Sussex (Brighton), Queen Elizabeth (Birmingham), North Staffordshire Hospital (Stoke), New Cross Hospital (Wolverhampton), Leeds General Infirmary, Freeman (Newcastle), James Cook University Hospital (Middlesbrough) Wythenshawe (Manchester)
- Wales – University Hospital (Cardiff)
- Scotland – Royal Infirmary (Edinburgh), Golden Jubilee (Glasgow)
- N. Ireland – Royal Victoria Hospital (Belfast)
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