So preliminary trial results look good – it could be that the next phase will go forward too. The artificial heart of French pioneer Carmat shows several device failures but overcomes major side effects of former gadgets, such as thromboembolism or haemorrhage.
Heart failure is the world’s leading cause of death. In Europe alone, 15 million patients live with it, and the number is constantly growing. About 100 000 of them have end-stage heart failure, which means their only hope are heart transplants, but there are never enough. Specifically, only 4000 transplants are performed each year.
Carmat aims at providing a medical alternative for these patients that is no longer dependent from organ donation: A fully independent artificial heart. The first artificial heart was invented more than 70 years old. During the 70 years since, major setbacks include thromboembolism and haemorrhage. One way Carpentier’s group tackles these difficulties is by using bio-prosthetic materials.
Patient 1: A “rapid recovery of their respiratory and circulatory functions” but two-and-a-half months after the transplantation a device failure occurred and the patient passed away.
Patient 2: Survived nine months. Patient developed renal failure and pericardial effusion and died of multi-organ failure after a motor failure caused the cardiac output became too low.
Patient 3: Received the artificial heart on April 8th and is now living at home.
Despite the apparent flaws in this technology, the study represents a first success for the project. The bio-prosthetic material wasn’t rejected and didn’t lead to hemolysis or thromboembolism. Indeed, the data collected hinted at the formation of a thromboresistant layer on the surface of the artificial heart from patient 1.
“Before proof of concept, we already have substantial confidence in the confirmation of the advantages of the Carmat heart”, states Carpentier. “Its acquired hemocompatibility and the pulsatile way it operates make it possible to minimize the formation of blood clots, which are the main problem other ventricular assist devices face.”
In total, four patients will get the artificial heart in this feasibility study. If they survive for at least 30 days and their vital organs recover functionally, Carmat will initiate a larger study to get its artificial heart to the market.