The first patient in an investigator-initiated heart preservation study using XVIVO’s technology was transplanted during the first quarter of 2021 at The Alfred hospital (Melbourne, Australia). The trial includes Australian and New Zealand transplant centers and is investigating if the novel preservation technology may safely extend the transport time for donor hearts, which is ideally limited to four hours using existing processes.
There are approximately 7,500 heart transplants performed in the world each year, of which the absence of blood flow and oxygen during donor heart transport may translate into poor patient outcomes after transplantation. The time that the donated heart may be stored on ice outside of the body is currently limited to four hours for standard of care. The detrimental effects of a prolonged out-of-body time of the donor heart (> 4 hours) is reflected in an increased rate of complications and impaired survival after transplantation.
XVIVO’s innovative non-ischemic heart preservation method includes a device that supplies the resting heart with continuous perfusion of a proprietary oxygenated solution during transport. A safety study published in Nature Communications in June 2020, showed that the use of this heart technology developed by Professor Stig Steen is a safe method for preservation of human hearts. The Australian investigator driven study will investigate if XVIVO’s novel heart preservation technology can safely extend the time that the donated heart can be outside of the body from the current four hours to up to eight hours.
“It is still very early days in our clinical trial and, while premature to talk about the first transplants, our extensive preclinical research, undertaken with the Critical Care Research Group at Prince Charles Hospital (Brisbane, Australia), demonstrated the potential of this technology,” said Professor David McGiffin, cardiothoracic surgeon and co-principle investigator of the trial alongside Professor David Kaye, heart failure and transplant cardiologist at Alfred Health.
“Lack of donated hearts and the maximum organ transport time is currently limiting the number of patients offered a new heart. If this study can show a safe extension of the time that the donated heart can be transported, this will allow for expansion of heart transplant programs into new geographies, more donor hearts to be safely utilized and eventually more patient given the chance of a transplantation” says Dag Andersson, CEO of XVIVO.
April 19, 2021
Gothenburg
Dag Andersson, CEO
XVIVO Perfusion AB (publ)