Originally published in Volume 44 Issue 6 of Artificial Organs, 29 April 2020
The first heart transplantation (HTx) in Japan was carried out in Sapporo by Dr. J. Wada 8 months after Dr. C. Barnard performed the world’s first case in Cape Town, South Africa in 1967.1 After the recipient’s death, doubts spread through mass media about the brain death and indication to that patient with valvular disease, which led to demand that the surgeon be tried for murder.2 After this problematic case, organ transplantation from brain-dead donors was not carried out for the next three decades.
After long arguments about organ transplantation from brain-dead donors, and after suffering from another antitransplant action,3 the law allowing donation of the organs under brain death passed the Diet in 1997. HTx under legislation was started smoothly in 1999. However, over the next 10 years, organ donation was very limited because of the stringent law as donations were only possible under the presence of written will of the donor and acceptance from the family. In 2010, the law was revised as accepting the donation without donor’s written will and the number of HTx has increased significantly. The cumulative number of HTx has reached over 500 in 2019. However, HTx itself has been still limited not exceeding over 100 cases per year.
The development of devices for mechanical circulatory support (MCS) started very early in Japan, and two groups, one at the University of Tokyo (UT) and one at the National Cardiovascular Center (NCVC), began to develop extracorporeal ventricular assist devices (VADs) in the 1970s. The UT released the Zeon pump and the NCVC released the Toyobo pump in the 1980s.
Considering the long waiting period for the coming HTx era, efforts to introduce implantable VADs (left ventricular assist devices, LVADs) were conducted starting with pulsatile devices, HeartMate (HM), and Novacor, and then, moved toward the continuous flow LVADs. During the above period, Japanese original LVADs, the EVAHEART and the DuraHeart were developed.
Currently, the national supportive scheme for introducing durable LVADs has progressed under the academic autonomy system, and a significant increase of the newly implanted durable VADs has been over 100 in recent years. However, the indication of such VADs has been limited to bridge use for HTx and destination therapy (DT) has not been started.
In this article, the historical steps of clinical application of advanced therapeutic modalities such as VAD and HTx are reviewed to show how the people involved struggled and worked together.
This review has intended to cover the period from 1980s to mid-2010s when I worked mainly at Osaka University (Professorship was from 1991 to 2005).
2 DEVELOPMENT OF A VENTRICULAR ASSIST DEVICE IN JAPAN
2.1 University of Tokyo project
The UT project, specifically the team led by Prof. Kazuhiko Atsumi who made great contributions in the field of artificial organs, started in the early 1970s.4 The UT project with co-workers Drs. I. Fujimasa, K. Imachi, and S. Nitta (Tohoku University) developed a pneumatic sack-type pulsatile extracorporeal VAD in collaboration with Nippon Zeon Corp. (Tokyo) for the pump and Aishin Seiki Co. (Tokyo) for the driving console in the late 1970s.5 This UT-Zeon VAD (Zeon VAD, Figure 1) was applied in 1980 to a patient with postcardiotomy heart failure at Mitsui Memorial Hospital, Tokyo; this patient was the first to be supported by a VAD in Japan.6 The second application was carried out by Prof. Y. Sezai and his group at Nihon University.7