Results from a Australian/New Zealand study using XVIVO’s heart technology published
The results of the clinical trial conducted in Australia and New Zealand on XVIVO's heart technology were earlier this week published in the prestigious scientific journal, The Journal of Heart and Lung Transplantation [1]. The study concludes that donor hearts that were previously considered unsuitable for transplantation due to long distances between hospitals may be transplanted with a 100% survival rate at 30-days when transported in XVIVO Heart Assist Transport.
Ice-based, cold static storage, is still used during transport of the vast majority of donor hearts. When the transport time of the heart exceeds 4 hours, the transplanted patient faces an increased risk of severe complications or even death. This risk increases significantly with each additional hour of transport. Still, up to 40% of transplant recipients are exposed to this risk due to the scarcity of donor hearts. The long distances between hospitals will often prevent the use of a donor heart at all, leaving a critically ill person waiting for a new organ.
In the study conducted at five transplant centers across Australia and New Zealand, researchers investigated the use of donor hearts with a projected transport time of 6-8 hours using the XVIVO Heart Assist Transport device. The 36 included patients received donor hearts with a mean transport time of nearly 7 hours, with the longest transport time being 8 hours and 47 minutes. Survival at 30 days after transplant was 100%, with only one patient developing primary graft dysfunction (PGD), which resolved within a week.
“This trial has demonstrated that HOPE preservation can safely allow for transplantation of brain-dead donor hearts with preservation times approaching 9 hours. We believe these findings have transformative implications for the field of heart transplantation including the expansion of available donor pools and for the logistic aspects of transplant surgery. Within Australia and New Zealand, the substantial extension of the safe preservation time will mean that a donor heart in either country should not be declined for geographical reasons, and the same reasoning would apply to the North America and Europe,” says Professor David McGiffin, The Alfred, Melbourne, Australia.
“This publication is a significant milestone in proving the effectiveness of our innovative heart technology. Since the study was initiated, we have been following the progress with great excitement. Today, the technology is currently being utilized in approximately 30 percent of all heart transplants in Australia and New Zealand under special compassionate use permission, i.e. before regulatory approval. This achievement makes us very proud. As I have mentioned many times before, I genuinely believe that XVIVO's heart technology will change the paradigm of heart transplantation, ensuring that patients, regardless of distance, receive the transplantation they desperately need,” says Christoffer Rosenblad, CEO XVIVO.
November 3, 2023
Gothenburg
Christoffer Rosenblad, CEO
XVIVO Perfusion AB (publ)
[1] https://www.jhltonline.org/article/S1053-2498(23)02110-1/fulltext
