Wednesday 26 July 2017

‘If this procedure hadn’t been developed, I’d be bedridden the rest of my life’

Sean Malone is one of the first stroke patients in Ireland to benefit from a new medical device invented in Galway

Chef Sean Malone at The Valkenburg Hotel where he works in Ballinrobe, Co Mayo. Sean underwent a revolutionary new treatment after suffering a stroke. Photo: Keith Heneghan / Phocus
Chef Sean Malone at The Valkenburg Hotel where he works in Ballinrobe, Co Mayo. Sean underwent a revolutionary new treatment after suffering a stroke. Photo: Keith Heneghan / Phocus

Gabrielle Monaghan

In the middle of a Thursday night in February, 49-year-old chef Sean Malone got up to go to the bathroom at his Westport home. He didn't make it back to bed.

Rory, Sean's 17-year-old son, woke to the thump of his father falling down the stairs as a result of a seizure, and the barking of the family's fox terrier. Seeing his father unconscious, the quick-thinking teenager immediately rang 999.

An ambulance brought Sean to Mayo General Hospital, 11 miles away in Castlebar, where he was diagnosed with an acute ischaemic stroke - a clot had blocked the blood supply to his brain.

Within a matter of hours, Malone was transferred to Beaumont Hospital, where he became one of the first stroke patients in Ireland to be treated with a tiny new medical device, pioneered by a Galway company.

During a short procedure, Dr John Thornton, a consultant neuroradiologist and the hospital's clinical stroke lead, used the device, called EmboTrap, to grab the blood clot and pull it out.

The consequences of a stroke can last a lifetime: brain tissue deprived of oxygen-bearing blood can die quickly, leaving survivors with long-term difficulties in walking or speaking. But thanks to the kind of revolutionary clot retrieval therapy carried out by Dr Thornton, Sean was out of hospital in a week, and driving and working part-time after six weeks.

Since June, the chef has been working full-time at a restaurant in Ballina.

While Sean will have to take tablets for the rest of his life and has "the usual aches and pains of a 49-year-old", he realises how lucky he is that his condition was effectively reversed by a new era of stroke care.

"I know a couple of men around here who had strokes in the past, didn't get the treatment I got, and are now walking with canes," he says. "If this procedure hadn't been developed, I could quite conceivably be lying on a bed for the rest of my life."

Dr Thornton, who was involved in an international trial at Beaumont to test the effectiveness of clot retrieval therapy, agrees.

"The reality is that someone like Sean, in the absence of stent retrieval therapy, could have been left with a severe disability, like permanent weakness in one side of the body, and possibly unable to speak properly or return to his job."

There are some 30,000 people in Ireland who live with a stroke-related disability, making stroke the country's biggest cause of acquired disability, according to the Irish Heart Foundation (IHF).

Each year, about 10,000 Irish people suffer a stroke and almost 2,000 die - more deaths than breast cancer, prostate cancer and bowel cancer combined.

Despite the terrible toll wreaked by stroke, more people than ever are surviving it, with deaths down by a quarter in the last seven years, an audit carried out by the IHF and the HSE last year found.

In addition, the rate of direct discharge of stroke survivors to nursing homes has halved since the previous audit was conducted in 2008. This is mostly due to the HSE's reorganisation of acute stroke services in Ireland, which increased the number of hospitals with stroke units from one to 21 and raised the rate of thrombolysis, which uses clot-busting drugs, tenfold to 11pc - one of the highest national rates in the world.

The most common form of the disease is ischaemic stroke, which is caused by a blockage - usually a clot - forming in the vessels carrying blood to the brain. This form of stroke accounts for 85pc of all strokes, with haemorrhagic stroke, or bleeding into the brain, making up 15pc.

While drugs that aim to dissolve a blood clot are the traditional treatment for ischaemic stroke, they do have their drawbacks: the treatment can only be administered within four-and-a-half hours of the onset of symptoms, is not suitable for large clots, and carries a risk of brain haemorrhage if given to certain patients.

A more effective treatment is using the newest generation of stent retrievers, like EmboTrap and its rivals, to carry out a thrombectomy. During the procedure, a small tube carrying the EmbroTrap is inserted into the femoral artery near the groin and fed up through the body, under the guidance of X-ray imaging, to the clot's location.

The stent retriever is then expanded to allow the device's flared wings capture the clot and then drag it back through the artery and out a person's leg, thereby quickly clearing the blood vessel and restoring blood flow to the brain.

The procedure can take between 20 minutes and two hours, according to Dr Thornton.

"It's like a keyhole-type surgery," he says. "Clot retrieval therapy is a huge advance in the treatment of ischaemic stroke and has a potentially enormous impact on stroke victims."

EmboTrap was developed by Neuravi, a small medical technology company based in the Galway suburb of Ballybrit, near the racecourse. Neuravi claims EmboTrap can restore blood flow to the brain faster than its competitors' devices and that it helps avoid clot fragmentation, which would cause further damage to the patient.

Clinical studies conducted by Neuravi last year throughout Europe, where the company is rolling out the device to hospitals, showed that treatment with EmboTrap restored significant blood flow in 86pc of patients, with the majority of patients recovering enough to be able to function independently.

The device is at the forefront of the biggest transformation in decades in the treatment of stroke. Last year, a string of studies published in the New England Journal of Medicine gave physicians the first evidence in 20 years that stent retrievers can help people survive and thrive after a stroke.

Thrombectomies, tested in clinical trials at Beaumont and hospitals in Canada, the US and South Korea, showed a 50pc drop in patient death. In many cases, instead of suffering major neurological disability, patients were able to go home and resume their lives.

Dr Thornton says Beaumont Hospital, the first in Ireland to use EmboTrap, has relied on different types of stent retrievers in the treatment of 350 stroke patients since 2010. The number is growing every year, with about 150 patients receiving a thrombectomy at Beaumont last year.

Cork University Hospital also now offers the treatment. The latest generation of stent retrievers are safer and more effective than older devices, which typically resembled corkscrews.

But even modern stent retrievers are not failsafe: attempts at the procedure can reveal that there is already too much damage to the brain, or that it is not possible to retrieve the clot, Dr Thornton says. One of the biggest challenges, though, is getting a stroke victim to a stroke unit on time - international guidelines recommend that thrombectomies are carried out within six hours from the time of the stroke.

"That's very little time for a patient to get to hospital and then get transferred to the hospital where the procedures are performed," Dr Thornton says.

The audit conducted by the IHF and the HSE found that just 29pc of patients are directly admitted to a stroke unit, namely a ward in a hospital, like Beaumont, where stroke patients are cared for by a team of all professionals who specialise in stroke care.

Despite these obstacles, living a long way from the nearest stroke unit doesn't have to be a barrier to receiving clot retrieval therapy.

"Sean Malone lives quite far away from a thrombectomy centre but successfully went through the pathway and was brought to the centre where the thrombectomy is performed," Dr Thornton says. "Even though this development in stroke treatment is still at an early stage, there is a good network for transferring patients."

But, as the old adage goes, prevention is the best cure. Indeed, the vast majority of strokes are entirely preventable, according to research published in The Lancet last month.

The researchers, who analysed data on almost 27,000 people in 32 countries, discovered that 10 controllable risk factors account for 90pc of all strokes worldwide. The study's principal investigators, including Dr Martin O'Donnell, an associate clinical professor at McMaster University in Canada and a professor of translational medicine at HRB-Clinical Research Facility at NUI Galway, examined the different risk factors for stroke and calculated the proportion of strokes which would be cut if the risk factor disappeared.

Eliminating high blood pressure was estimated to reduce risk by nearly 48pc, the findings showed. The number of strokes fell by more than a third if people were physically active, and dropped by almost one fifth if they had good diets. Smoking accounted for 12pc of risk factors, cardiac problems were responsible for 9pc, diabetes made up 4pc, while alcohol intake and stress each accounted for 6pc of the risk factors.

Sean exercised regularly, had low cholesterol, normal blood pressure and had a healthy diet. But his 30-year cigarette habit had put him at increased risk of stroke.

"I'd been smoking since I was a teenager and smoking is a big no-no with stroke," he says.

Sean was also at a greater risk of stroke because of his family history: his brother had a stroke at 47, his sister had one in her 50s, and his father had a series of strokes before dying in his 70s.

The chef finally gave up smoking after leaving hospital, but he still gets nicotine cravings when he wakes up every morning. Only this time, instead of lighting up, he puffs on an electronic cigarette.

Spot the symptoms

How to spot a stroke and what to do: Someone who suffers a stroke cannot always help themselves during the attack, so they rely on any relatives, colleagues or bystanders who witness the stroke to respond quickly.

Irish Heart Foundation (IHF) research in 2009 indicated a startling lack of public awareness of stroke symptoms and found that less than half of Irish adults would ring 999 if they thought they were having a stroke. As a result, the IHF introduced a TV and radio campaign called F.A.S.T., to create a better public understanding of the warning signs and what people can do to help. The acronym, designed to help people remember the signs during an emergency, stands for:

F: Face. Has the person's face drooped on one side? Ask if they can smile. Is the person's smile uneven?

A: Arms. Can they raise both arms and keep them there? Is one arm weak or numb? Does one arm drift downward?

S: Speech. Is their speech slurred? Is the person unable to speak or is their speech difficult to understand? Ask the person to repeat a simple sentence, such as "The sky is blue". Is that sentence repeated correctly?

T: Time. It's time to dial 999 if you see a single one of these signs. Note the time so you can tell medics when the first symptoms appeared. The average stroke destroys two million brain cells a minute, so the quicker a person gets to hospital, the more of their brain can be saved.

Other symptoms of stroke:

• Sudden numbness or weakness in the face, arm, or leg, especially on one side of the body

• Sudden confusion

• Sudden difficulty seeing in one or both eyes

• Suddenly feeling of dizziness, a loss of balance or coordination, or trouble walking

• Suddenly developing a severe headache without any apparent cause

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