Fingers showing model of human heart isolated on white background. Male hand holding plastic human heart showing exterior isolated on white background. The hand is showing an upright artificial heart model.This model shows the real size of this vital organ, it is used in high school to teach teens biology and science.

    There is a remedy for heart failure — why hasn’t the NHS adopted it?

    22 May 2017

    For most of us, the tragic events in Syria were shocking. Sarin gas caused the innocent victims’ bodies and lungs to fill with fluid. They gasped for breath, turned blue and then died. The compassionate world rightly condemned their misery. If we could have helped, we certainly would. Yet I know something else that does this. Something far more common and closer to home: heart failure.

    I first witnessed the effect of heart failure with the death of my grandfather. It had a profound impact on me, as little could be done to help in the 1950s. The shiny new NHS did its best — his loyal GP arrived in a black Austin-Healey and helped him on his way with morphine, at home surrounded by his family.

    In Britain there are 150,000 patients with what we call stage 4 heart failure. Of these, 15,000 are under 65 and therefore eligible for a cardiac transplant. Yet very few of these patients actually receive one: just 150 donor hearts are available a year. So we treat one per cent of those eligible. The majority receive palliative care and an early death.

    The first heart transplant was performed in 1967, while I was a medical student. These transplants used to be described as the ‘gold standard’ in treatment for severe heart failure. Yet, given that they apply to less than one per cent of those who need help, that statement is difficult to justify.

    There is another treatment available, used in America and in many European countries, which provides survival equivalent to heart transplantation in selected patients. Yet so far it has not been used as a permanent solution for any patients in the NHS.

    Instead, the treatment — a motorised implant known as a left ventricular assist device (LVAD) — is used as a ‘bridge to transplantation’ in a small number of dying patients pending acquisition of a donor heart. Within weeks or months these hugely expensive devices (engineered to last 20 years or more) are discarded when the diseased heart is removed.

    Moreover, a recent study from Newcastle suggested that some of the supported hearts may have recovered anyway — that actually there was no need for a subsequent transplant.

    The first artificial heart was created in 1969. It was the size of a large melon — the breast bone could not always be closed over it. Nevertheless, Life magazine announced: ‘The Artificial Heart Is Here.’ It soon became clear this machine would never prove patient friendly. That year, the blood pump engineer Robert Jarvik wrote in Scientific American: ‘If the artificial heart is ever to achieve its objective, it must be more than a pump. It must be more than functional, reliable and dependable. It must be forgettable.’

    Jarvik later came up with the answer: a thumb-sized titanium device that would fit inside a patient’s failing heart. It was a high-speed rotary pump that pumped blood continuously rather than with a pulse. Thanks to a chance meeting I worked with him to introduce it to patients. By then, the profession had learnt that it was usually just the diseased left ventricle that needed help, rather than the whole heart. Most right ventricles could continue to cope with the low pressure blood flow to the lungs.

    The Texas Heart Institute first used the device as a bridge to transplant. In Oxford, using charitable funding, we tested it as a permanent alternative. Peter Houghton, 59, was a dying man deemed ‘not fit for a haircut’. Yet he lived for almost eight years and became well known in his quest for others to benefit from the lifesaving technology. Ten per cent of his lifespan was supported by battery-driven LVAD technology and our first effort generated the longest survivor by far with any type of artificial heart. Peter eventually died when a nose bleed caused his single poorly functioning kidney to fail.

    For a while, I continued the LVAD programme in Oxford using charitable monies to treat patients who had been turned down for transplantation. But each American LVAD cost more than £100,000 and, with added hospital costs, the work became a personal liability. It was then that Peter Houghton said that I had to make an affordable British LVAD. I set up a company, Calon Cardio-Technology, with the laser physicist Professor Marc Clement. Stuart McConchie, a highly successful CEO in the field, joined us from America. Our LVAD is currently in the bench testing phase — we hope the first implant in a human patient can be carried out by the end of next year.

    The Food and Drug Administration (FDA) approved the Jarvik device in 2010. In contrast to heart transplants with donor runs in the middle of the night, surgeons could take a pump off the shelf at their time of choosing. An LVAD implanted electively at low risk provided the best symptomatic relief, best prospects for improved longevity and best quality of life for non-transplant eligible patients. In many countries — but not Britain — LVADs are widely used for symptomatic relief even in the elderly. To allow the under-70s to reach a cachectic state, either from shock or kidney and liver failure, without even considering an LVAD could be considered negligent. Yet this is the case in the NHS.

    Some German transplant centres now advocate the use of LVADs primarily for all patients, then the use of a transplant only in the event of a life-threatening complication.

    What, if any, are the arguments against LVADs? Leaving aside cost, the main problem is formation of blood clots on the artificial materials of the device followed by stroke. Second is bleeding as a result of damage to clotting proteins in the blood. And, third, infection may occur where the electric power line leaves the skin. All these problems have been lessened considerably thanks to engineering improvements. They do not occur more frequently than the complications of heart transplantation. At Calon we are working on lessening the complications even further.

    Some might say: ‘Well, Westaby would say all this — he started an LVAD company.’ But it takes an enormous amount of time and effort to begin an initiative like this. Also it takes money. You risk your home, your reputation, and do the work in your spare time. But the goal is worth it. Our blood pump should be the jewel in the British med-tech crown.

    Will NHS patients benefit from our efforts? This debate is currently underway with NHS commissioners who decide which treatments should be funded. Effective drugs for hepatitis C and some cancer drugs are now deemed unaffordable. The same applies to LVADs. Apparently there is an agreement between the National Institute for Clinical Excellence (NICE) and NHS England that even approved and cost-effective treatments with cost implications greater than £20 million (cost of treatment multiplied by number of prospective patients) will not be introduced without protracted debate. But the public must be involved. Transparency is vital for these life and death decisions.

    That leaves the ethical issue. Should heart surgeons be obliged to turn away as patients fill with fluid, gasp for breath and die unnecessarily? It may not be the deliberate use of sarin gas thrust into the public eye by the media, but the suffering is the same. We don’t need a dead person and a donor heart to help — just an LVAD off the shelf. If the NHS cannot provide this, change the system. Doctors must decide who to treat, not grey men in Westminster.