**3. Development of mechanical circulatory support for advanced heart failure in Japan**

Artificial heart development research was carried out in 1957 by Akutsu and Kolff at the Cleveland Clinic [6], and ventricular assist device (VAD) was carried out by Kusserow [7].

Atsumi et al. of the University of Tokyo started research and development of an extracorporeal pulsatile VAD in Japan at about the same time and in 1980 it was clinically applied at Mitsui Memorial Hospital. Subsequently, Takano et al. of the National Cerebral and Cardiovascular Center (NCVC) also developed the other extracorporeal pulsatile Nipro VAD (Nipro Co. Ltd., Osaka, Japan) and it was clinically applied at NCVC in 1982 [8]. Both VADs began clinical trials in 1986 as bridges

## *Heart Transplantation and Mechanical Circulatory Support in Japan – Past, Current and Future… DOI: http://dx.doi.org/10.5772/intechopen.113730*

to recovery (BTR) for acute heart failure or cardiogenic shock, and both were covered by insurance in 1990. In 1992, when this VAD was applied to a 16-year-old boy with dilated cardiomyopathy, VAD for the purpose of a bridge to a heart transplant (BTT) was not covered by insurance. The patient later traveled to the United States and underwent a heart transplant, who is still alive today. A pulsatile flow implantable VAD, the Novacor (World Heart Corp., Oakland, CA) was the first to be reimbursed for BTT purposes in Japan (2004). It took a long time to get approval after the clinical trial, and it was no longer produced in the United States. In 2006, we withdrew from the Japanese market. However, it must not be forgotten that the fact that the implantable VAD was reimbursed by insurance at this time the home management fee was approved, and although the amount was small, the medical fee of this implantable VAD implantation was approved. It was the cornerstone of the current implantable VAD treatment. Moreover, the first heart transplantation under the Japanese Organ Transplant Act was performed on a 47-year-old man supported by a Novacor VAD for more than 4 months [3]. Meanwhile, another implantable VAD, the HeartMate XVE (Thoratec Corp., Pleasanton, CA) has completed clinical trials but has not been reimbursed. Following the reimbursement of this implantable VAD, the Nipro VAD has also been approved for use for BTT purposes.

Around this time, the mainstream changed from pulsatile flow VAD to nonpulsatile flow VAD in Europe and the United States. and was launched in 2008 and was reimbursed in April 2011 in Japan. As a result, the mainstream of VAD in Japan has become non-pulsatile flow implantable VAD [9]. After that, Jarvik 2000(Jarvik Heart, Inc.; New York, NY), HeartMate-II (Thoratec Corp., Pleasanton, CA), and HVAD (HeartWare Inc., Framingham, MA) were reimbursed one after another. As a result, it can be said that implantable VAD treatment can be performed according to the patient's physique, pathology, etc. After introducing the HeartMate 3 (Thoratec Corp.; Pleasanton, CA) for BTT use, HeartMate 3 became the most popularly used VAD for BTT purposes as well as destination therapy (DT) purposes which were reimbursed by insurance in April 2021.

For children, Nipro VAD, HVAD, or Jarvik 2000 can be fitted depending on their physique. Reimbursed, but currently out of production). In April 2015, Berlin Heart EXCOR VAD (Berlin Heart, The Woodland, TX) was reimbursed by insurance, which can be implanted in infants. The implementation of the revised Organ Transplant Act in 2010 made it possible to donate brain-dead organs from children under 15 years of age [5]. Then infantile heart transplantation has started since 2012 and 27 children supported with EXCOR LVAD and one with Biventricular ECOR VAD had transplantation at the end of 2022.
