The heart transplantation team at Ronald Reagan UCLA Medical Center is conducting Phase II clinical study of TransMedics' experimental organ-preservation system Organ Care System (OCS), which allows donor hearts to continue functioning outside the body during transport.
TransMedics said the OCS consists of a high-tech OCS box into which the heart is placed after removing it from the donor’s body.
Once placed in the box, the donor heart is immediately revived to a beating state, and is perfused with oxygen and nutrient-rich blood, and maintained at an appropriate temperature.
The device also features a monitor which displays how the heart is working during transport.
The current standard of transporting donor heart involves the use of iceboxes, and it requires the restarting of heart once it has been placed inside the recipient.
Principal investigator of the study Abbas Ardehali said the new technology can help better assess the suitability of a potential donor, since the heart can be tested in the device.
The multicentre randomised controlled Phase II study will enroll 128 patients across the US, and will compare the safety and effectiveness of the experimental OCS with the existing icebox method in keeping donor hearts healthy.