Heart at Work

“What pushed me to throw myself into this crazy endeavour forty years ago was nothing else than my vocation as a doctor: the overwhelming need to save people on the edge of death,” confides Alain Carpentier. At 84 years old, this surgeon is known for being the crea­tor of the first French artificial heart. Twenty million individuals in Europe and the United States suffer from ter­minal heart failure. They could conti­nue to live for a long time if they could get a transplant. “Sadly, we would need 3,000 transplantable donor hearts per year in France, but we only get around 350. Only an artificial heart can make up for this lack,” says Alain Carpentier.

“Bitten by the research and innovation bug,” he became famous at the end of the sixties for the fabrication of prosthetic heart valves from animal tissue. A suc­cess that prefigured a much larger pro­ject: a 100 % artificial heart. He got to work in the eighties with the help of the Technical Center for Mechanical Indus­try (CETIM). In 1993, his meeting with Jean-Luc Lagardère, then head of the group Matra (the future EADS), would be decisive. From this encounter, an Economic Interest Grouping (GIE) was born. It was dubbed Carmat, a fusion of Carpentier’s name and that of Matra.

A prototype ceaselessly improved

Together, they succeeded in further miniaturizing the onboard computer of the prosthesis which, on arrival, now weighs no more than 900 grams – versus around 300 for the human heart. The integrated microprocessor detects changes in blood pressure at the ventricles – blood’s entrance to the organ – and accordingly modulates the pumps that impulse the cardiac rhythm. The pumps are powered by a battery carried around the patient’s waist. In the current version, there are two batteries, each with a life of four hours. Professor Carpentier says that Carmat is doing everything they can to replace them with fuel cells that would last at least twelve hours. The device sends a signal to avoid the risk of run­ning down the battery. “Today, with mobile phones, having to plug in every eight hours can be perfectly integrated,” notes the professor, “but it wasn’t the case twenty years ago.” A monitoring device at the waist directly links the subject to a hospital that remotely ensures the proper functioning of the device and reacts in case of emergency.

The design of the prosthesis has been the object of special attention. Developed by computer, its form clo­sely imitates that of the human heart. The stakes are high, since it must find its place within an organism in which it must remain for at least five years. Its architecture, texture and the materials from which it is made led to numerous patents between 1999 and 2004. Carmat’s teams of engineers are now reflecting on how to further miniaturize the device, which is cur­rently adapted to the chest cavities of only 70 % of men and 25 % of women. “Today’s model won’t be that of the future,” assures Alain Carpentier.

The dawn of a new era

The prosthesis has already been implanted in four patients between September 2013 and January 2016, during an initial “feasibility” phase. For the French Agency for the Safety of Health Products (ANSM), this phase would determine if the treatment could move beyond the experimental phase. The condition was that at least half of the patients survive one month after the transplant or more. The contract was respected, and the ANSM ended up approving this first step. A second phase, which began in July 2016, fore­sees operating on around twenty indi­viduals in France. If successful, the artificial heart will be declared to meet European standards and will spread beyond the borders of France. This will lead to the publication of important scientific literature and the beginning of a process of industrialization of the prosthesis followed by its commerciali­zation. The selling price is estimated at 160,000 euros. Expensive? Much less than a transplant, which requires expen­sive immunosuppression treatments, and well below the cost of the hospitalization and monitoring of a patient suffering from chronic heart failure,” underlines the professor.

With the announcement, Carmat stock, on the market since 2010, will shoot up, after having fluctuated for years due to uncertainties concerning the results of the experiment. For their part, the Public Investment Bank (BPI) would regain its confidence in the project, granting it new subsidies. “The corporation would then reach eco­nomic equilibrium by finally selling the product of its research,” predicts Alain Carpentier. Today, the artificial heart exists. A scientific feat that takes on a nearly mystical dimension due to the symbolism surrounding the organ. “Is it a progress? Are we entering forbidden territory?” the professor wonders. “As far as I know, no dogma forbids helping others or caring for your neighbor. It is even a duty.”

By Charles Faugeron