New Clinical Trial Investigates The Possiblity To Extend The Viability Of Heart Transplant
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New Clinical Trial Investigates The Possiblity To Extend The Viability Of Heart Transplant
A new technology called the Organ Care System is undergoing clinical trials in the United States. The technology aims to increase the time a human heart remains viable between transplants by using a device that combines software, fluid dynamics and preservative solutions to avoid ischemia.
“Because the device completely prevents ischemia during transport, the organ maintains normal energy stores, so that organs transplanted using the device will be in better condition at the time of transplant,” said Dr. Bruce Rosengard, surgical director of cardiac transplantation at Massachusetts General Hospital in Boston.
Current transplantation methods are based on the addition of a saline solution and the use of ice in order to keep the heart viable. Doing so only allows a transplantation window of three, maybe four hours, before the heart is no longer useful to a new patient.
The new system will offer patients that need a heart transplant the possibility to receive a compatible heart from someone situated at a greater distance, thus increasing the chances to find a compatible heart. European surgeons were able to transplant a viable heart after as many as eight hours after the heart has been introduced into the new device.
The purpose of the clinical trial undergoing in the United States is to determine the 30-day survivability rates of patients that receive the heart after using the new device. European studies show that the 30-day survivability rate was almost 97 percent, based on a study on 138 transplanted patients. The current trial includes 9 country-wide hospitals whilst being led by the Heart Transplant Program from UCLA. The trial is expected to be complete by the end of 2012, after 50 percent of the 128 patients will have received a heart that has been kept viable with the help of the new device.
Organ Care System
To the present day, surgeons refuse to transplant almost 70 percent of the available donated hearts because they fear it is not the best heart their patients can receive. If the FDA approves the use of the Organ Care System, the number of rejected hearts could drop significantly due to the fact that the heart is kept in a more natural environment.
But the use of the new system offers more than just increased viability: “Its use in Europe is proving to be highly sensitive in identifying hearts with underlying pathology, such as cocaine scarring, that makes them unsuitable,” said Tamer Khayal, TransMedics' vice president of clinical development, the company that developed the system.
Also, this new technology could perhaps allow the resuscitation of a heart that suffered slight damage from brain death. This possibility might become reality, as transplant surgeon Ayyaz Ali managed to resuscitate animal hearts that have stopped beating. Another option would be the treatment of severely damaged hearts through the aid of gene therapy, cellular therapy and even drug therapy.
In the future, the new Organ Care System could also be used to increase the viability of other organs, already being used to aid the transplantation of human lungs, whilst prototypes for liver and kidney systems are already in development.