Plugging a hole in the heart with an umbrella-like device can significantly reduce the risk of stroke, new studies show.
Yet the procedure is not readily available to NHS patients as funding was cut last year, a decision stroke experts want reversed.
One in four of us is born with a hole in the wall between the two upper chambers of the heart, known as a patent foramen ovale (PFO). Often it doesn’t cause symptoms, but it can increase the risk of having a stroke.
Demand: One in four of us is born with a hole in the wall between the two upper chambers of the heart, known as a patent foramen ovale (PFO)
Now a study shows closing the hole can reduce the chance of another stroke by nearly 80 per cent. NHS England had paid for the £10,000 procedure since 2014. It stopped funding it last year — and is evaluating whether to finance the operation in future.
But in the wake of the new data, presented at the recent European Stroke Organisation conference in Prague, specialists called for funding to be immediately reinstated.
‘The NHS has withdrawn funding for this procedure but that will now need to be reconsidered urgently given the evidence for a long-term benefit,’ says Dr Richard Perry, a consultant neurologist at University College London Hospitals NHS Foundation Trust.
Around 150,000 Britons have a stroke each year, in 95 per cent of cases due to the blood supply to the brain being blocked by a clot, known as an ischaemic stroke.
The majority of ischaemic strokes are the result of heart disease and a build-up of fatty deposits (plaque) on artery walls. These can break off and travel in blood vessels to the brain where they block blood supply.
But in a third of ischaemic stroke cases, there’s no obvious cause.
Treatment after a stroke includes anti-clotting drugs, but research suggests these aren’t good enough, and people who have a stroke are still six times more likely to have another. This suggests there must be another cause and some doctors say a hole in the heart — a PFO — may be to blame.
Studies show that in patients who have had a cryptogenic stroke (with no known cause) the prevalence of PFO is more than 40 per cent, compared with 20 per cent in the general population.
Risks: NHS England stopped funding the procedure, which costs £10,000 each, last year — and is evaluating whether to finance the operation in future
All babies have a PFO in the womb. The hole allows oxygenated blood to bypass the lungs on its way from the mother’s placenta to the organs.
At birth, when the lungs take over the function of oxygenating the blood, this is no longer needed and the PFO closes. But in one in four cases the hole remains. Most people with a PFO will never have symptoms. But the hole opens when there is pressure on the chest, such as a sneeze or cough.
Normally blood travels out of the right side of the heart to the lungs, which filter out debris and clots, before it goes back to the heart on the left side and is pumped out to the organs.
But in a PFO patient, when the hole opens, unfiltered blood is able to travel through the heart into the bloodstream, raising the risk of stroke.
The new procedure uses a tiny implant that looks like two umbrellas to seal the hole. First, doctors make a small incision in the right side of the groin and under X-ray guidance insert a wire through blood vessels to the heart. A thin tube is pushed on top of the wire into the heart and the umbrella is fed through.
Once it reaches the PFO, one side of the device is pushed through so there’s one ‘umbrella’ on each side.
Then doctors open up the flaps so they cover the hole from each side, and clamp them together. The device is biodegradable and partially absorbed as tissue grows over, healing the hole.
Current advice says there’s not enough evidence to judge whether the benefits made financial sense for the NHS, but doctors say the new research changes that.
The two new studies — known as REDUCE and CLOSE — looked at sealing the hole to prevent a second stroke. After 3.4 years there was a 76.6 per cent reduction in a second stroke in patients with the umbrella fitted.
‘The results are groundbreaking,’ said Dr Scott Kasner, a neurologist at the University of Pennsylvania, who led the research.
‘Until now, there hasn’t been a study of a PFO closure device that showed statistically significant reduction in stroke recurrence.’