The CARMAT total artificial heart.

Abstract

Research into the subject of total artificial heart (TAH) began in the USA in 1963 under the impetus of the American Congress; however, it soon hit the snags of haemocompatibility, autoadjustment of operation to the patient’s physiological needs, miniaturization, portable energy and reliability in the long run. Michael DeBakey was the first to use an external heart pump successfully in a patient as a left ventricular bypass pump in 1966. The first TAH, called Liotta-Heart, was implanted by Denton Cooley in 1969 in Houston, TX, USA. The 47-year old male recipient was bridged for 65 h until heart transplantation was possible. This first TAH was developed by the Argentinian surgeon Domingo Liotta who was hired at Baylor College of Medicine in Houston, Texas as Director of the Artificial Heart Program by Michael DeBakey in 1961 and returned to his homeland later. Finally it remained unclear how many Liotta-TAHs were implanted. The next TAH, called Jarvik-7, was implanted in 1982 to a retired dentist. The patient survived 112 days. The Jarvik-7 heart led to a remarkable reaction in the media. Meanwhile the original Jarvik-7 heart was further developed, named CardioWest and finally placed on the market under the name Syncardia TAH. The Syncardia TAH has two pneumatically driven ventricles, separated from each other and with two mechanical valves each. It was originally implanted mainly in Europe (France and then Germany). In 2004, the device was approved by the FDA as a bridge to transplant, allowing several US centres to implant the device. Owing to the introduction of portable drivers in 2010, patients could now be discharged home and the utilization of the Syncardia TAH increased. Over 30 years, more than 1300 were implanted. The company received a humanitarian device exemption to test its TAH for destination therapy in 2012, but has not yet begun clinical trials for this indication. The patient who lived the longest time on the Syncardia TAH was successfully bridged to heart transplantation after 4 years of support. The Syncardia TAH has ventricles of 70 ml, which does not fit in smaller women and adolescent patients. Meanwhile, Syncardia started to develop a smaller version with 50 ml ventricles. The AbioCor® TAH was developed by the company AbioMed. It was the world’s first fully implantable and completely self-contained artificial heart. The internal battery is charged by a transcutaneous energy transfer (TET) system. A 71-year old man survived for 17 months with the AbioCor TAH. A feasibility study in fourteen patients and the end-point of 60-day survival led to an initial rejection by the FDA circulatory system devices advisory panel. In 2006, the FDA approved the AbioCor TAH as a humanitarian use device because of its limited market for patients ineligible for transplantation. The device has since been implanted according to our knowledge in one case (2009).