The ability to replace a worn-out aortic valve without the trauma of open-heart surgery will return quality of life to the elderly.
In May 2012, the first procedures with a new replacement aortic valve were conducted in three hospitals in Australia. This replacement aortic valve can be implanted without open-heart surgery, is fully repositionable and can be opened and closed for adjustment after implantation.
The new device, known as the Lotus, was inserted into the groin on the end of a wire. From there it was passed up the femoral artery and into the heart. It could then be repositioned – and even removed and replaced – during the procedure.
The cardiac team supervised by Professor of Cardiology Ian Meredith, director of MonashHeart, inserted the new valve into the hearts of 11 elderly women who were too frail for open-heart surgery but suffered from life-threatening aortic stenosis. This degrading and narrowing of the main heart valve, which causes it to fail to open properly, is a common condition of ageing. Without surgery, the sufferer is left weak and breathless and with significantly reduced life expectancy.
The first insertion of a replacement heart valve through the groin was performed in France 10 years ago and had become more common by 2008, but the procedure had only an 80 per cent success rate. Professor Meredith says that with one shot at getting the valve into the right place in the great rush of blood every time the heart beat, it was “a bit hit and miss … like constructing a building on the edge of Niagara Falls”.
Doing the identical procedure using the new Lotus valve is akin to building this Niagara Falls hut with precision. The device opens up like a lotus flower once it is in place in the heart.
“You have the ability to perfectly control its landing,” Professor Meredith says. “You can open it up gently while watching on a screen. And if you get it wrong, you can wind it down and move it back or forward a little bit.”
All 11 participants in the trial, which was conducted at MonashHeart Monash Medical Centre, Melbourne’s St Vincent’s Hospital and Adelaide’s Royal Adelaide Hospital, achieved outstanding results – an improvement on the previous success rate.
While the device, which was developed by US start-up company Sadra Medical, represents the culmination of painstakingly finessed medical engineering, it did not come with a practical user’s guide.
Professor Meredith and his team prepared for the procedures with nine arduous months of night and weekend sessions, finetuning the mechanisms for a procedure he describes as “safely walking into that minefield and safely walking out”.
They practised using computer simulations and followed up with numerous simulated procedures on full-sized silicone models of human bodies, in which water flowed through anatomically perfect blood vessels, all reproduced from CT scan modelling.
The interventional cardiologist also produced a demonstration DVD for other cardiologists and surgeons that explains all the fine details of inserting the Lotus valve in a human heart.
“That was the commitment I sold to Sadra – that we would have an unwavering commitment to perfection in working out how to do this,” says Professor Meredith, who is now engaged in the second stage of trials for the device. These will involve 120 patients in 12 medical institutions in the UK, France and Germany, and four in Australia – MonashHeart Monash Medical Centre, St Vincent’s Hospital, the Royal Adelaide Hospital and Brisbane’s Prince Charles Hospital.
An important update is the arrival of a larger Lotus valve. The first Australian patients to have the procedure were all slightly built women, under 60 kilograms, but this larger valve means that average-sized males can now also have the surgery.
In mid-December 2012, Professor Meredith spent a day in Paris meeting all the European doctors who would conduct the procedures for the trial. In January 2013, he began an eight-week stint in the French capital, from where he commuted to the UK, French and German hospitals to co-supervise 80 to 90 procedures, the first of which took place at the Clinique Pasteur hospital in Toulouse, France.
Another trial of 1000 patients across Europe, the US, Australia and Asia will follow. Provided they succeed, the device should be widely available within two years.
Surgical auditions
Professor Meredith’s campaign for MonashHeart staff to perform this life-saving procedure began five years ago.
He first laid eyes on the Lotus in 2008, when Sadra Medical representatives arrived in Washington, DC, for that year’s Transcatheter Cardiovascular Therapeutics conference. It is an annual meeting attended by the who’s who of interventional cardiovascular medicine, as well as the companies that manufacture medical equipment for them. Sadra Medical was there to talk to venture capitalists who might back its invention and to meet the directors of the world’s top teaching and research institutions, all of whom it knew would be keen to compete for the chance to test the device.
Professor Meredith’s record was more than enough to earn him a meeting with Sadra Medical. Trained at the Brigham and Women’s Hospital, Massachusetts, and Harvard Medical School in the US before arriving at Monash University, he has performed close to 10,000 cardiac procedures and written or co-written more than 150 papers. Among more than 30 international, multi-centre, randomised trials, he has led the world’s first ‘in-human’ trials of new drug-eluting stents.
“I was determined to get this and bring it to Australia,” Professor Meredith says.
During the recruitment process for the first patients on whom the valve would be trialled, Professor Meredith found himself repeatedly awed by the courage of patients who were ready to undergo a procedure by a cardiologist who, in the case of patient number one, had never performed this procedure on a human being.
“A lot of people, especially when they are older, have a great sense of wanting to contribute,” he says.
The new valve has the potential to be a lifesaver for the many thousands of elderly people who need to have their heart valves replaced. In the past, such patients could not have such a procedure because they were too frail to endure open-heart surgery. For them, the Lotus offers real hope.
