Extracorporeal Support for Emergent (Uncontrolled) Donation Following Cardiac Dea

描述（由申请人提供）：心源性死亡后紧急（不受控）捐献的体外支持简介：用于移植的供体器官有限，导致对心源性死亡后捐献（DCD）供体的兴趣增加。然而，不受控制或紧急DCD（eDCD）的使用受到后勤困难的限制，并且除了极少数例外情况外，尚未使用。eDCD涉及从复苏失败后死亡的患者身上获取器官。在许多情况下，患者遭受致命的创伤性损伤或意外的心脏骤停。复苏是尝试，直到它被认为是徒劳的重建循环，一个决定，是由医生在急诊科或重症监护病房。为了限制可移植器官的热缺血损伤，有必要在宣布死亡后立即对腹部器官进行原位保存。自2000年10月以来，密歇根大学在宣布受控DCD供体死亡后使用了常温体外支持（ECS）。捐赠者的腹部器官恢复正常功能，并保持直到它们以半选择性的方式获得，类似于脑死亡后捐赠（DBD）。我们对36例对照DCD供体使用了ECS-DCD，结果67例肾脏、19例肝脏和6例胰腺被用于移植。与不使用ECS的快速恢复DCD相比，ECS-DCD导致每个供体（OTPD）移植的器官数量更多，肾脏DGF率降低（8%），肝脏受体和移植物存活率与DBD供体相似。我们最近对1，049名受试者进行了一项具有全国代表性的调查，并询问了他们对器官捐赠的偏好，这些器官捐赠描述了脑死亡，心源性死亡后的受控捐赠和心源性死亡后的紧急捐赠。令我们惊讶的是，受试者更愿意在受控和紧急心脏死亡的情况下而不是脑死亡的情况下捐赠。这些结果表明，公众实际上更支持DCD，包括紧急，比DBD。在过去的一年里，密歇根大学已经制定了使用ECS辅助紧急（不受控制）DCD捐赠的协议。该方案是与移植中心和急诊科共同制定的，并已由密歇根州生命礼物组织、密歇根大学成人伦理委员会和密歇根州生命礼物组织捐赠者家庭顾问审查和批准。在密歇根大学急诊科复苏失败的潜在捐赠者（来自捐赠者登记处或家庭）将在宣布死亡后接受股动脉和静脉插管。将开始体外支持以恢复腹部器官的灌注。将主动脉闭塞球囊置于腹腔上方位置，以防止冠状动脉或脑血管再灌注。腹部器官将在手术室进行采购，并以标准方式分配。在18个月期间，45名患者在密歇根大学急诊科接受CPR/ACLS。其中，84%死于艾德，可能是潜在的紧急DCD供体。在排除不合格的潜在供体（年龄> 60岁，恶性肿瘤，多系统器官衰竭和HIV感染）后，大约17名患者被确定为可能的紧急DCD供体，使密歇根大学的供体库增加了52%。在未来两年，预计将实现以下具体目标：1.与对照DCD和DBD相比，确定紧急DCD的供体数量和OTPD。2.比较紧急DCD供体与对照DCD和DBD供体移植的肾脏（第1年）和肝脏和肾脏（第2年）的结局。3.比较潜在供体家庭对紧急DCD、控制DCD和DBD的看法和态度。结论：基于初步观察，我们预计eDCD会导致a）器官供体数量显著增加，B）与DBD和对照DCD相比，肾移植存活率相似，以及c）与DBD相比，供体家庭对eDCD的接受程度相似或更高。如果ECS-eDCD被捐赠者家庭很好地接受，并导致可接受的移植后结果，我们将在整个生命的礼物密歇根州捐赠者服务区扩大其使用，以研究足够大的人口，以支持制定国家计划。 公共卫生相关性：用于移植的供体器官的有限可用性导致对使用心源性死亡（DCD）供体后的捐赠的兴趣增加，或者与定义为缺乏流向大脑的血液的死亡（脑死亡后的捐赠）相比，心脏停止后的捐赠。由于后勤困难，很少从急诊室心脏骤停后死亡的人身上获得器官进行移植。本项目提出研究一种新的方法，在自愿捐赠者被宣布死亡后，使用类似于心肺旁路的技术灌注器官，以保存腹部器官用于移植，并允许以更容易的方式获得器官。

DESCRIPTION (provided by applicant): Extracorporeal Support for Emergent (Uncontrolled) Donation Following Cardiac Death Introduction: The limited availability of donor organs for transplantation has led to an increased interest in the use of donation following cardiac death (DCD) donors. However, uncontrolled or emergent DCD (eDCD) use has been limited by logistical difficulties and, with rare exception, has not been utilized. eDCD involves procuring organs from a patient who dies following unsuccessful resuscitative efforts. In many situations, patients have suffered either fatal traumatic injury or unexpected cardiac arrest. Resuscitation is attempted until it is deemed futile in reestablishing circulation, a determination that is made by physicians within an emergency department or intensive care unit. In order to limit warm ischemic damage to transplantable organs, it is necessary to provide immediate in situ preservation of abdominal organs soon after death has been declared. Since October 2000, the University of Michigan has utilized normothermic extracorporeal support (ECS) after death has been declared for controlled DCD donors. The donor abdominal organs are restored to normal function and maintained until they are procured in a semi-elective fashion, similar to donation following brain death (DBD). We have used ECS-DCD for 36 controlled DCD donors, resulting in 67 kidneys, 19 livers, and 6 pancreata taken for transplantation. Compared to rapid recovery DCD without the use of ECS, ECS-DCD resulted in a greater number of organs transplanted per donor (OTPD), decreased kidney DGF rates (8%) and liver recipient and graft survival rates similar to DBD donors. We recently conducted a nationally representative survey of 1,049 subjects and asked their preference for organ donation given scenarios describing brain death, controlled donation following cardiac death, and emergent donation following cardiac death. To our surprise, subjects were much more willing to donate in the setting of both controlled and emergent cardiac death rather than brain death. These results suggest that the general public is actually more supportive of DCD, including emergent, than DBD. Over the past year, the University of Michigan has developed protocols for the use of ECS-assisted emergent (uncontrolled) DCD donation. This protocol has been developed in conjunction with the Transplant Center and the Emergency Department and has been reviewed and approved by Gift of Life Michigan, the University of Michigan Adult Ethics Committee, and the Gift of Life Michigan Donor Family Counsel. Consenting potential donors (either from donor registry or family) who fail resuscitative efforts in the University of Michigan Emergency Department will undergo cannulation of the femoral artery and vein after pronouncement of death. Extracorporeal support will be initiated to restore perfusion to abdominal organs. An aortic occlusion balloon will be placed in a supraceliac position to prevent reperfusion of the coronary or cerebral vasculature. Abdominal organs will then be procured in the operating room and allocated in a standard fashion. During an 18 month period, 45 patients received CPR/ACLS in the Emergency Department at the University of Michigan. Of these, 84% died in the ED and may have been potential emergent DCD donors. After excluding ineligible potential donors (age > 60 years, malignancy, multisystem organ failure, and HIV infection), approximately 17 patients were identified as likely emergent DCD donors, increasing the donor pool at the University of Michigan by 52%. Over the next 2 years, the following specific aims are expected to be achieved: 1. To determine the number of donors and OTPD for emergent DCD when compared to controlled DCD and DBD. 2. To compare the outcomes of kidneys (year 1) and livers and kidneys (year 2) transplanted from emergent DCD donors when compared to controlled DCD and DBD donors. 3. To compare perceptions and attitudes of potential donor families to emergent DCD, controlled DCD, and DBD. Conclusions: Based on preliminary observations, we expect to find that eDCD results in a) a significant increase in the number of organ donors, b) similar rates of kidney graft survival compared to DBD and controlled DCD, and c) similar or greater acceptance of eDCD when compared to DBD by donor families. If ECS-eDCD is well accepted by donor families and results in acceptable posttransplant outcomes, we would then expand its use throughout the Gift of Life Michigan donor service area to study a large enough population to support developing a national program. PUBLIC HEALTH RELEVANCE: The limited availability of donor organs for transplantation has led to an increased interest in the use of donation following cardiac death (DCD) donors, or donation after the heart has stopped compared to death defined as lack of blood flow to the brain (donation following brain death). Because of logistic difficulties, obtaining organs for transplant from people who die after cardiac arrest in an emergency room is rarely performed. This project proposes to study a new method of perfusing organs using a technique similar to heart-lung bypass after a consenting donor is declared dead to preserve abdominal organs for transplant and allow procuring them to occur in an easier fashion.