Hypothermic Oxygenated Perfusion (HOPE) in Donation after Circulatory Death (DCD) for Adult Heart Transplantation Patients

Cardiac hypothermic oxygenated machine perfusion (HOPE) including the XVIVO Heart Assist Transport (XHAT), its disposable unit XVIVO Heart Assist Transport Perfusion Set (XHATPS), and supplemented XVIVO heart solution. Following procurement of a DCD donor heart, the heart will undergo ex vivo hypothermic oxygenated machine perfusion (HOPE) during preservation and transport. HOPE continuously circulates an oxygenated preservation solution through the donor heart at 8 degrees Celsius, with the aim of reducing ischaemic injury, maintaining myocardial viability, extending preservation time, and improving post-transplant graft function. The intervention is being evaluated as an alternative preservation strategy to prolonged normothermic machine perfusion currently used in Direct Procurement and Perfusion (DPP). The XHAT will be operated by the heart transplant team with expertise in donor heart preservation this will include the 1) Cardiothoracic transplant surgeons experienced in DCD heart procurement and transplantation and 2) Perfusionists trained in the operation and management of ex vivo organ perfusion systems All personnel involved will be appropriately credentialed and trained in the use of the HOPE preservation system and transplantation procedures. The HOPE system is already being used routinely in a DBD (donation after brain death) donor setting and the training is done regularly by those already credentialed with the aide of XVIVO using training kits and assisting during procurements. Following DCD donor heart procurement, the donor heart is connected to the XHAT. The heart is perfused with oxygenated preservation solution at 8 degrees Celsius during transport to the transplant centre. The duration of HOPE will be 2 hours at minimum, and may exceed 8 hours if necessary. The preserved donor heart is subsequently implanted into the recipient according to standard heart transplantation procedures. The XHAT will be used once per donor heart during the period between procurement and transplantation. HOPE is applied continuously throughout the donor heart preservation and transport period. The XHAT will be primed by the procuring surgeon and perfusionist from the transplant recipient hospital, in a controlled environment such as an operating room, pump room or operative prep room. The procuring surgeon will place the donor heart into the XHAT system. The Perfusionist will then travel with the donor heart inside the XHAT system from the donor hospital to the recipient hospital. The duration of perfusion will vary depending on the donor-to-recipient transport and implantation time, with the technique intended to facilitate preservation times longer than those achievable with conventional cold static storage. As this is a device-based organ preservation intervention, adherence will be monitored through: - Documentation of donor heart procurement and preservation procedures. - Continuous monitoring and recording of perfusion parameters during HOPE. - Review of device logs and perfusion records by the study team. - Compliance with the study protocol and standard operating procedures for donor heart preservation and transplantation.