The overall aim of this proposal is to compare a new state-of-the-art ex-vivo organ preservation method with standard ischemic cold static storage of donor hearts in adult cardiac transplantation. Standard heart preservation before transplantation consists of cold ischemic storage of the heart. Clinical studies has shown that the morbidity and mortality risk increases with extension of the allograft ischemic time over four hours. For each additional hour the mortality risk increase with 25% the first year. This time constrained is costly and results in severe logistical problems, leading to loss of transplantable organs. Initially the study is prospective, single-institution, open-label, non-randomised trial comparing the NIHP method with the conventionally SCS in adult heart transplanted patients at Skane University Hospital, Lund, Sweden. Six patients will be transplanted using the non-ischemic hypothermic cardioplegic perfusion. These will be compared with contemporary control patients transplanted with standard ischemic cold static storage. The results will be analysed and reported. After the initially six patients have been completed, the study will become a single center, prospective, open, blinded endpoint, randomized, controlled clinical trial including 34 patients. The primary end-point is a composite of mortality, primary graft dysfunction (PGD), need for extra corporal support, or acute cellular rejection (ACR) within 30- days post-transplant. PGD and ACR will be accessed blinded.An improved preservation of the transplanted organ will reduce the major limitations for survival in the early post-transplant period such as non-specific graft failure and acute rejection. Furthermore, it will make it possible to increase the donor pool.
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Short-term graft failure
Timeframe: Within 30-days post-transplantation