CAST YOUR mind back to November 1989. If you are old enough to remember it, chances are the outstanding event is the fall of the Berlin Wall, writes CLAIRE O’CONNELL
The same month though, Ireland celebrated a less sensational but nonetheless clinically relevant landmark – the first coronary stenting procedures to be carried out here, where medical devices were inserted into arteries to prop them open.
Since then, stenting has spawned innovations, generated industry and resulted in plenty of patients with working arteries, explains Prof Declan Sugrue, consultant cardiologist at the Mater Misericordiae Hospital, who helped to carry out the first such procedures here.
“It’s about less invasive treatments for heart disease,” he says. “That’s a theme that has been gathering momentum for about 25 years in medicine – we have been moving away from making big holes in people to making smaller holes and using more tablets.”
The stent is a small permanent implant which is inserted by feeding a narrow tube through an artery in the leg or wrist under X-ray guidance. An angio- plasty balloon is inflated at the blockage to stretch the narrowed section of the artery, then the balloon is removed and the stent is left in place as a splint to keep the blood vessel open.
Widening a blocked artery from within has now become more commonplace than the cardiac bypass, which involves opening the chest and using a blood vessel from elsewhere in the body to reroute the flow of blood around a blocked stretch of artery, explains Sugrue.
“Right across the developed world, for stenting and angioplasty the numbers of procedures has surpassed the number of coronary bypass procedures,” he says.
However, 20 years ago, stenting technology was still relatively primitive. A US doctor, Richard Schatz, had co-developed a bare metallic device (the Palmaz-Schatz stent) and was travelling the world to teach others how to insert it. A contact in Johnson Johnson, which had the licence to the technology, set up the link between Schatz and Sugrue and the two carried out stenting procedures in Dublin.
“Back then the technology was difficult to work with, very crude,” recalls Sugrue. “We did a couple of cases in November 1989 and we managed to kill nobody and they worked, so we were very pleased with ourselves.”
Since then, stents have been transformed. First the bare metal device was coated with a polymer to help reduce scar tissue building up in the artery and re-narrowing the blood vessel.
Then a huge breakthrough was the drug-eluting stent, which is coated with medication to help reduce inflammation at the site. It’s a platform that has seen many improvements in recent years, according to Sugrue.
“Stents are very unexciting to look at but they are highly engineered and we are now on to the fourth generation of drug-eluting stent, the holy grail, which is a bioabsorbable device – the frame and the drug disappear completely over time,” he says.
Ireland has done well from stent RD and manufacturing – the big international players Medtronic, Abbott Vascular, Johnson Johnson and Boston Scientific all have a presence here – but now there’s a push on to contribute more to clinical trials here, says Sugrue, who will address a conference in Dublin on stenting next month.
“The piece of the circle we haven’t been able to square is the involvement by Irish hospitals and doctors in clinical trials. There are some trials going on but you wouldn’t say we are in the premier league,” he says.
“That’s partly related to the fact that we have been small and poor, and partly because the regulatory processes here – including ethics committees, and the Irish Medicines Board – have been working hard to get up to speed.”
Schatz, now research director of the division of cardiology at the Scripps Clinic in California, agrees that Ireland has an opportunity to improve in clinical trials of stents, but notes that companies zone in on countries where they will get rapid results.
“All the companies are very eager to work overseas, and you have to create a friendly environment that is efficient, fast, fleet-footed, with few barriers and it has got to be economic,” he says.
“A lot has been done in India recently – there are some countries where it is easy for the doctors to put this all together, and in other countries it’s hard.”
But the market is there – about one million stent procedures are carried out in the US each year, and about 8,000 are expected in Ireland this year.
“Stents are not going to go away, they have to be an integral part in treatment of vascular disease in some form or fashion,” says Schatz, will also address next month’s conference.
However, the rise of stents is posing some challenges to the status quo, notes Sugrue, and the question now is how to manage stenting to the benefit of the patient in Ireland.
“It’s absolutely clear that the more of these procedures that an individual or group or hospital does, the better the outcome, so how do we configure services – is it high volume centres or old workhouse model that we have in Ireland of hospitals at the crossroads?” he asks.
Meanwhile, for individual patients, once the stent is in, they should concentrate on keeping the rest of their blood vessels healthy, advises Sugrue.
“The stents are very robust, the recurrence rate with drug-coated stents is about 5 per cent,” he says. “And for most people who have coronary stents implanted and then come back with further trouble, it’s mostly due to new disease in another area of their arteries.
“So it’s not the stented bit you have to worry about, it’s the rest of your arteries, and that’s about medication and lifestyle.”
To celebrate the 20th anniversary of the first stenting procedure in Ireland, the Irish Cardiovascular Alliance and the Irish Medical and Surgical Trade Association will host a conference on Saturday, November 7th at the Royal College of Physicians, Kildare Street, Dublin 2. For more details e-mail admin@imsta.ie.
The bicycle ride that ended up in a life-saving operation
Fourteen years ago, Stan Kevlihan went on a bicycle ride that ended in an emergency trip to hospital. Keen on sport, the psychiatric nurse had taken part in the annual Co-operation North maracycle for several years, and at the age of 48 decided to train for another.
“I had found the maracycle difficult for the past couple of years, but I had decided to give it another go,” he says.
On February 5th, 1995, Kevlihan headed out for a training session cycling from Blanchardstown to Lucan, but he soon felt a pain in his chest. “I went on for another two miles or so, but thought then I had better head for home,” he recalls.
He soon realised he wasn’t going to make it. He sat down at the roadside near a local rugby club, where a driver spotted him and came to his rescue.
At the hospital the doctors discovered that even though Kevlihan was fit, didn’t smoke and had a low-fat diet, one of his coronary arteries had a 90 per cent blockage.
Kevlihan spent the next six weeks in hospital, during which he nearly died. When he was well enough, the doctors implanted a stent into the affected blood vessel. The technology was still new in those days, but Kevlihan grabbed the opportunity to avail of it.
“When I heard there was a treatment, a possibility, I said yes,” he says. “When someone says you have a blocked artery and there’s only one way to fix it, you don’t have a choice.”
The stenting procedure itself, carried out by Prof Declan Sugrue at the Mater, was straightforward, recalls Kevlihan, who was conscious throughout it.
He then underwent cardiac rehabilitation, built back up his strength and took early retirement from his job.