Artificial heart research and present status of clinical application in Japan.

Japan has a long history of research and development of the artificial heart since Atsumi began studying artificial hearts at the University of Tokyo in 1959. Since that time, the University of Tokyo group has been developing different types of artificial hearts, as well as materials, blood pumps, driving mechanisms, and control methods. Other than the University of Tokyo, there are 12 institutes involved in artificial heart research and development in Japan. As for artificial heart clinical application in Japan, four devices were approved by the government; two are domestic, two are imported. Between 1980 and 2004, 697 cases of clinical application of a ventricular assist device (VAD) have been performed, including in 38 pediatric patients under 18 years. Recently, clinical use of percutaneous cardiopulmonary support has been increasing with 600 to 800 cases being performed every year, including in 40 to 60 patients under age 20 years. Although the requirement for clinical use of pediatric VADs is increasing, there is no device, domestic or imported, currently used in Japan; therefore, there is an urgent need for development of a pediatric VAD.