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Ventricular Assist Devices / Heart Transplantation

Heart Transplantation

Already a popular treatment in Europe and the United States, heart transplantation is a method of treating patients with severe heart failure that can not be saved by conventional pharmaceutical and surgical treatments. In Japan, in October 1997 the "Organ Transplantation Law" was enacted, and the first heart transplant in Japan was carried out at our hospital on 28th February 1999, 1 year and 4 months later. Since then, although the number of organ donors has increased, there are still very few organs available, and the number of heart transplants is only about 40 per year in the whole of Japan. Currently in Japan, the number of patients waiting for a heart transplant exceeds 500 people, and most of them are using a ventricular assist device (VAD) in the meantime.

After being approved as a heart transplantation facility, our hospital conducted the first heart transplant in Japan on 28th February 1999. The patient had been bedridden for more than a year due to the need for continuous intravenous administration of cardiotonic medicine, and was in such a condition that an external ventricular assist device (VAD) had been necessary for three months preceding the transplant. However, after undergoing the ground-breaking heart transplant, cardiotonic medicine and the VAD were both deemed unnecessary, and nine months after the transplantation, the patient was able to return to work. As of October 2016, over 80 heart transplants had been performed at Osaka University Hospital, making us one of the most experienced facilities in Japan.

 

This kind of treatment can only made possible by the goodwill of the donor and their family. Thanks to this treatment, many patients with severe heart failure have been saved, when they could not possibly have been treated before. Compared to the number of patients needing heart transplantation, the number of people donating organs is still small; nevertheless we expect heart transplantation to become an established treatment in Japan, and help many more people with heart failure in the future.

Heart transplants in Japan

Heart Transplantation in Japan

Osaka University 2018 total: 14 cases Total to 2018: 102 heart transplants + 3 heart-lung transplants

Ventricular Assist Device (VAD) Implantation

The Ventricular Assist Device (VAD) is a mechanical blood pump that sends blood to the body on behalf of the heart, when the heart itself too weak. In Japan, provision of organs for heart transplantation is extremely poor, and it is usually necessary to wait three or four years after the heart transplant has been deemed necessary. While waiting for the transplant, VAD is a proven means to maintain life until the heart transplant can be performed. This is known as a Bridge to Transplantation (BTT). The standard model in the past was an external NIPRO VAD, but since Spring 2011, the use of an implantable VAD has been approved under insurance, and our hospital has equipped over 150 patients with implantable VADs, making us one of the leading facilities in Japan.

Ventricular Assist Device usage at Osaka University

HeartMate II is an axial implantable VAD, which has been used in over 24,000 cases worldwide to date, and became clinically available in Japan in 2013. Jarvik 2000 is an axial flow VAD available under insurance from 2014. Because the pump itself is implanted inside the heart chamber, it is easier to implant in physically small patients. EVAHEART is an implantable VAD developed independently in Japan, which makes use of a centrifugal pump, ensuring long-term durability with its own “cool seal” system, and has high flow rate performance (max. 20 L/min).

Provided by NIPPO / St. Jude Medical Japan Co., Ltd.

Provided by Century Medical, Inc.

「EVAHEART®」Provided by Sun Medical Technology Research Corp.

When using an implantable VAD, there are fewer complications, and it is possible to return home, dramatically improving quality of life while waiting for a heart transplant. Because of its high success rate and convenience, use as a final treatment instead of heart transplantation has been reported overseas for patients who can not receive a transplant, and clinical trials are currently in progress in Japan. This is known as Destination Therapy (DT). Some patients find their cardiac function restored after using VAD for some time, “resting” their heart. Even removal of the VAD is possible for some such patients. This is known as Bridge to Recovery (BTR).

VAD treatment under the “Patient-Directed Treatment Protocol”

Studies on the safety of ventricular assist devices with behind-the-ear connector

This clinical study involves cases of severe heart failure which necessitate a transplant, but in patients who are not otherwise eligible for transplant. The Jarvik 2000 model which is not currently used in Japan (a model where the percutaneous driveline connection is not at the abdomen, but behind the ear) is used as DT.

This research is carried out with the consent of patients under the “Patient-Directed Treatment Protocol. Because this research-stage treatment is not approved for medical insurance coverage, equipment costs fall to the patient (total cost of non-covered portion: ¥16,137,000). However, the costs of examination and non-surgical treatment during the research period are generally covered by health insurance in the same way as any other normal medical treatment.
For details, please consult your doctor or a nearby medical institution.

Ventricular Assist Devices(VAD)and Heart Transplants for Pediatric Patients

Among cardiac conditions that develop in childhood, there is a class of diseases called "cardiomyopathy" that cause cardiac function to deteriorate due to a disease of the heart muscle tissue. Also, there are conditions known as "myocarditis" which cause acute suppression of cardiac function with intense inflammation of the heart muscle, usually as a result of infection or allergic reaction.

If either of these conditions become severe, pharmaceutical treatment may not be sufficient, and heart transplantation may be required.

Cardiomyopathy includes dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and others. In particular, dilated cardiomyopathy often develops in infancy, and it is a disease that often becomes severe, leading to many cases where transplantation is necessary. Restrictive cardiomyopathy is often complicated by pulmonary hypertension, and also presents a high risk of sudden death, but pharmaceutical treatment is difficult, so eligibility for heart transplantation may have to be considered at an early stage.
Since the Organ Transplant Law was revised in 2010, the provision of organs from childhood donors became possible, and the first heart transplants for children began to be carried out. Further, in August 2015, Berlin Heart EXCOR® for children became eligible for insurance coverage, and it became possible to provide cardiac assist therapy as a bridging treatment until heart transplantation.

Our department is a recognized pediatric heart transplant facility, and we have treated a significant number of pediatric patients with cardiac assist therapy and heart transplantation.

For school-age patients, we are employing implantable ventricular assist devices (VADs) to the greatest extent possible, to maximize quality-of-life while awaiting transplant.

As of February 2017, we have handled 10 cases with the Berlin Heart EXCOR®, 9 cases with an implanted VAD, and 2 cases with NIPRO. Since 2010, 11 children have received a heart transplant, and 2 children have, with the support of VAD implants, recovered heart function to the point where the device could be removed, with no need for organ transplantation.

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