In this nonrandomized, single arm, multicenter trial a total of 36 patients were transplanted with donor hearts preserved using HOPE with the XVIVO Heart Assist Transport. Each center completed one or two standard preservation time cases, followed by long preservation time cases. The mean preservation time for the long preservation time cases was 414 minutes, the longest being 8 hours and 47 minutes. 26 hearts were transported for a distance longer than 1000 km, and four of them longer than 3000 km. Thirty-day survival was 100%. One long preservation time recipient developed severe right ventricular primary graft dysfunction, and two developed severe secondary graft dysfunction (one with standard preservation time and one with long preservation time). Thirty-day survival with HOPE was superior compared to historical data from the International Society of Heart and Lung Transplantation (ISHLT) Registry where a strong relationship between mortality and increasing ischemic time was affirmed. HOPE using the XVIVO Heart Assist Transport provides effective preservation up to preservation times of nearly 9 hours, allowing retrieval from remote geographic locations.
“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.”
McGiffin et al, 2023
J Heart Lung Transplant / 2023 / doi: 10.1016/j.healun.2023.10.020
The XVIVO Heart Technology is not regulatory approved on any market and its safety and efficacy has not been established.
The XVIVO Heart Technology is not commercially available.
