The world’s most advanced artificial heart was implanted for the first time in a human patient this week in France. According to the French company that designed and developed this technology, Carmat, the procedure has gone according to plan so far, with the prosthesis providing appropriate blood flow while the patient is awake and talking in the intensive care unit.
“We are delighted with this first implant, although it is premature to draw conclusions given that a single implant has been performed and that we are in the early postoperative phase,” Marcello Conviti, CEO of Carmat, commented in a statement.
Last September, Carmat gained French approval to implant their artificial heart device in four patients who were suffering from terminal heart failure and had a limited amount of time to live, Reuters reported. At the time, the company had already gotten the go-ahead in Belgium, Poland, Slovenia, and Saudi Arabia.
The heart prosthesis has four cavities that are arranged similarly to the chambers of a human heart with two on the right and two on the left. Each of these four cavities are separated into two spaces by a flexible biomembrane made of bovine tissue; one space is for blood and the other is for a so-called actioning fluid. Two motor pumps alternately suck and inject the actioning fluid into the cavities to mimic heart muscle contractions, inducing the blood to flow in a timed manner and in the correct direction. Sensors are built into the system so that blood flow can adjust to a patient’s physical demands.
The technical aspects of the Carmat device were developed by the European Areonautic Defense and Space Company, which is the parent company of the aircraft manufacturer, Airbus. The inventor of the world’s most ubiquitous replacement heart valve, Professor Alain Carpentier, provided the medical know-how in developing the gadget.
The implant weighs approximately 2 lbs. and costs as much as a top-of-the-line Aston Martin sports car; between $190,000 and $250,000, according to Reuters. The device will be more often used on men because they suffer from heart failure more than women and because the innovative implant weighs almost three times that of a healthy heart. Yet Conviti conveyed to Reuters about the possibility of producing smaller versions that would be more suitable for people who wouldn't be able to handle the dimensions of the current implant, which is relevant not only to women but also to countries that have smaller average body sizes.
Carmat describes artificial hearts as “the only credible response for all cases of end-stage heart failure,” and identified the public health crisis stemming from heart disease being the world’s leading cause of death. According to a World Health Organization (WHO) estimate, ischemic heart disease killed 7 million people in 2011, which is 48 percent of the total number of deaths caused by the world's top ten leading klllers.
The company plans to conduct clinical trials that are split into two successive phases. The first stage involves testing the safety of the prosthesis on four end-stage patients with success hinging on a patient surviving for 30 days or eventually getting an actual heart transplant. The subsequent phase will involve around 20 patients who will undergo a more detailed assessment. In addition to survival, the patients’ level of functional improvement, organ rehabilitation, quality of life, and comfort will be scrutinized. After six months of collecting data — and nothing goes disastrously wrong — the company will go through another regulatory phase before it can begin marketing its bioprosthetic heart. Conviti told Reuters in November that Carmat hoped to finish human trials of the heart by the end of next year and to obtain approval to market them in the EU by early 2015.