A new organ preservation system manufactured by the TransMedics seems promising. It is now into multi-center phase 2 clinical study in US.
It allows donor hearts to continue functioning in a near-physiologic state outside the body during transport. The trial is being led by principal investigator Dr Abbas Ardehali, surgical director of the heart and lung transplantation program at UCLA.
The Organ Care System (OCS), developed by TransMedics, works this way: After a heart is removed from a donor's body, it is placed in a high-tech OCS device and is immediately revived to a beating state, perfused with oxygen and nutrient-rich blood, and maintained at an appropriate temperature. The device also features monitors that display how the heart is functioning during transport.
According to Ardehali, the technology could also improve donor-heart function and could potentially help transplant teams better assess donor hearts — including identifying possible rejection factors that could complicate tissue-matching — since the organs can be tested in the device, over a longer period of time.
In addition, it could help expand the donor pool by allowing donor hearts to be safely transported across longer distances, he said.
When 61-year-old Rob Evans' new donor heart arrived at Ronald Reagan UCLA Medical Center, the organ wasn't frozen on ice inside a cooler, as is typical - the OCS kept the heart warm and beating with oxygen and nutrient-rich blood during its journey from Northern California.
With his new, strong heart beating inside his chest, Evans says he is thankful to the donor family for his gift of life and that he is ready to get back to the things he loves, including riding horses, playing with his grandson, and his work.
UCLA's Heart Transplant Program is leading the nationwide study, which started in 2009. The randomized trial will enroll a total of 128 patients — half whose donor hearts will be transported the traditional way, and half who will receive hearts in the device. To date, UCLA has enrolled nine patients in the phase 2 trial. Columbia University and the Cleveland Clinic are also enrolling patients, and more centers are being added.
"There are not enough donor hearts to help all the patients who are waiting," Ardehali said. "If we can find ways to improve upon our limited supply of hearts, then more lives will be saved."
The OCS clinical trial, called the "Prospective, Randomized, Multicenter Safety and Effectiveness Evaluation of the Organ Care System Device for Cardiac Use" (PROCEED II), is fully designed and sponsored by TransMedics.