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ICS 2012 Report – The world’s first fully implantable artificial heart has been designed three decades after the world’s first human heart transplant

Written by | 31 Oct 2012 | All Medical News

by Edel O’Connell reporting on the presentation by Professor Alain Carpentier.

Professor Alain Carpentier of the Hopital Europeen Georges Pompidou, Paris, France.

“When we address the topic of a total artificial heart the first thing we are asked is ‘do we really need it? The answer is yes- first of all we have the challenge of end stage heart failure which effects millions of people in the US and Europe- with a 45pc mortality at one year. Heart transplantation is the answer to face these challenges but as we all know there is a major lack of transplants available in the Europe and the wider world,” said Prof Carpentier.

“There is no question that since we don’t have enough heart transplants available there is a legitimate need for something similar to the heart transplantation to be developed,” he added.

The eminent professor has worked on the prototype for a total artificial heart in complete secrecy for more than 15 years, initially in conjunction with laboratories at Matra, a French engineering firm which merged into EADS (European Defence and Aerospace company) in 2000.

Thirty years after the world’s first human heart transplant (HT), a life-size artificial heart designed by one of Europe’s most renowned surgeons and scientists could save the lives of thousands.

Prof Carpentier  told the 63rd annual ICS meeting that the device is covered in specially treated tissue to avoid rejection by the body’s immune system and particularly the formation of blood clots.

Thanks to the latest electronic sensor technology used in guided missiles, the heart also can respond instantly to changes in blood pressure and flow, and adapt the heart beat rate accordingly.

“If you showed the electrocardiogram to a cardiologist he would think it was a human heart, but it isn’t. It’s prosthesis,’ said its creator, Professor Alain Carpentier, the renowned French surgeon-scientist, from the Pompidou European Hospital in Paris.

“The total artificial heart concept I created has several particularities, contrary to pre existing devices. We have two separate ventricles and integrated electronics The advantage of human heart transplantation is fitting is not an issue, so we had to overcome how to integrate and miniaturise all the materials needed for an artificial heart. With the latest technology you can develop an artificial heart which fits the available space. The current size of the artificial heart is a little larger than a normal heart but still it can fit. Because of the technology we can simulate an operation first to see whether the device will fit a patient or not,” he said.

The commercialisation of the entirely artificial heart is the realisation of a life-long dream for Alain Carpentier, and the headstone of a career that made him the most famous cardiologist in France.

A world authority in artificial heart valves, Prof Carpentier used his expertise to overcome the problem of blood clots — the main stumbling block in other attempts to build an artificial heart.

He managed this by using specially sterilised ‘bio prosthetic’ pig cartilage and by replicating the exact same blood flow — or haemodynamics — of the human heart that reduce blood clot risks.

“The aim of this heart is to allow patients to go from an impossible life — where they can do just a few steps from bed to armchair — to a normal social life. They will even be able to run,” he predicts.

The design of the Carmat artificial heart, protected by 10 global patents, offers numerous advantages over existing alternatives from rival laboratories in the USA or Asia.

A renewed hope and quality of life for hundreds of thousands of patients suffering in the aftermath of a massive heart attack, or with late-stage heart failure, and those for whom standard drug therapy, ventricular assistance or heart transplant have failed or are not possible.

The Carmat heart is designed for much greater durability than earlier devices, with a projected lifetime of about five years, or 230 million heart beats.

Weighing around one kilogram, the only external part of the man-made organ is its battery, which has a five-hour charge life.

The engineers are working on a fuel cell which could provide 16 hours of independence.

Prof Carpentier said the new heart is necessary, given the chronic shortage of heart donors and growing heart patient waiting lists.

Heart disease is among the world’s biggest killers, claiming 17 million lives per year (some 100 000 deaths per year in Europe and North America alone).

The prototype has cost about €55 million and already the groundbreaking organ has been successfully implanted in calves.

The first clinical trial will involve implanting the hearts into patients and monitoring them for 180 days to measure short-term safety and efficiency; the second trial should include 22 patients including six from the first trial, to test for longer term use.

The cost of the operation is expected to be roughly equivalent to that of a  heart transplant, but follow-up care, which adds up to €50, 000 per year for patients with transplanted
human hearts, will be significantly reduced as the artificial hearts are expected to require fewer doctor visits, re-hospitalisations, and drugs.

The artificial heart developed by Carmat, has been financed by Truffle Capital, a venture capital firm, which holds almost 32percent of the equity. EADS holds almost 30percent. Carmat has also received €33 million in subsidies from a French government innovation fund.

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