Abstract
Heart transplantation is the therapy of choice for selected patients with end-stage heart diseases. Despite its life saving therapeutic potential, heart transplantation is currently facing significant challenges: (i) the number of heart transplantation surgeries has remained static or declined in some geographies; (ii) donor heart utilization has remains limited to approximately 30% of available donors annually; (iii) primary graft dysfunction/failure continues to contribute significantly to post-operative morbidity and mortality after heart transplantation. Despite significant progress in most aspects of heart transplantation (i.e. donor management, operative technique, immunosuppressive regimens, and post-operative care), the technique for donor heart preservation remains cold ischemic storage. Cold ischemic preservation has several clinical and metabolic limitations: (a) It subjects the donor hearts to time-dependent ischemic and subsequent reperfusion injuries that could impair heart function post-transplant. This causes transplanting physicians to only select those hearts most likely to withstand the potential damage associated with cold ischemic preservation. It also imposes significant time and geographical limitations on the heart retrieval process, adversely impacting the utilization of available donor hearts. (b) It lacks any resuscitative capabilities. The brain dead donor milieu is known to adversely affect donor heart function and may lead to refusal of “acceptable” donor hearts and consequently under-utilization of the available donor heart pool. (c) It lacks any ability to evaluate the donor hearts’ metabolic state or function after procurement and during preservation, to determine the suitability of the donor hearts for transplantation. The portable Organ Care System (OCS) Heart technology is the first and only clinical platform to maintain the donor hearts in a warm, beating, near-physiologic state ex-vivo, for transplantation. OCS has several potential clinical advantages: (1) It reduces the time-dependent ischemic injury to the donor hearts during preservation. (2) It allows optimization of donor heart ex-vivo environment, by optimizing oxygen and substrate delivery, while also replenishing key hormones and nutrients that are depleted due to donor brain death. (3) It allows ex-vivo assessment of the donor heart by determining the adequacy of the perfusion, using standard clinical (perfusion pressures, coronary flow and EKG) and chemical parameters (circulating arterial and venous lactate level) to allow physicians to judge the suitability of the organ for transplantation, thus minimizing the risk of transplanting diseased hearts into recipients. The PROCEED study reports the results of the international, multi-center, prospective, randomized non-inferiority trial comparing the clinical outcomes of patients undergoing heart transplantation with donor hearts preserved on OCS vs. standard of care cold ischemic preservation.
Published Version
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