Extracorporeal Support for Emergent (Uncontrolled) Donation Following Cardiac Dea

描述(由申请人提供)：心脏死亡后紧急(非控制)捐献的体外支持：可用于移植的捐献器官有限，导致人们对心脏死亡(DCD)捐赠者使用捐赠的兴趣增加。然而，不受控制的或紧急使用的DCD(EDCD)一直受到后勤困难的限制，除极少数例外外，尚未得到利用。EDCD涉及从因复苏失败而死亡的患者身上获得器官。在许多情况下，患者要么遭受致命的创伤，要么遭受意外的心脏骤停。复苏被尝试，直到被认为在重建循环方面是徒劳的，这是由急诊科或重症监护病房的医生做出的决定。为了限制热缺血对可移植器官的损害，有必要在宣布死亡后立即提供腹部器官的原位保存。自2000年10月以来，密歇根大学一直在为受控DCD捐赠者宣布死亡后使用常温体外支持(ECS)。捐赠者的腹部器官恢复正常功能并保持，直到以半选择性的方式获得它们，类似于脑死亡(DBD)后的捐赠。我们对36例受控DCD供者使用ECS-DCD，结果移植了67个肾脏，19个肝脏和6个胰腺。与不使用ECS的快速恢复DCD相比，ECS-DCD导致了更多的器官移植(OTPD)，降低了肾脏DGF的发生率(8%)，以及与DBD供者相似的肝脏受体和移植物存活率。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，询问了他们在描述脑死亡、心脏死亡后受控捐赠和心脏死亡后紧急捐赠的情景下对器官捐赠的偏好。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捐献，而不是脑死亡。这些结果表明，公众实际上比DBD更支持DCD，包括Emerent。在过去的一年里，密歇根大学已经制定了使用ECS协助的紧急(非受控)DCD捐赠的协议。该方案是与移植中心和急诊科联合开发的，并已由密歇根生命赠与组织、密歇根大学成人伦理委员会和密歇根生命赠与捐赠者家庭顾问审查和批准。同意的潜在捐赠者(来自捐赠者登记或家人)如果在密歇根大学急诊科的复苏努力失败，将在宣布死亡后接受股动静脉插管。将启动体外支持以恢复腹部器官的灌流。主动脉闭塞气囊将被放置在腹膜上位置，以防止冠状动脉或脑血管系统的再灌注。然后，腹部器官将在手术室获得并以标准方式分配。在18个月的时间里，45名患者在密歇根大学急诊科接受了CPR/ACLS治疗。在这些人中，84%死于急诊室，可能是潜在的DCD捐赠者。在排除了不符合条件的潜在捐献者(年龄60岁、恶性肿瘤、多系统器官衰竭和艾滋病毒感染)后，大约17名患者被确定为可能的紧急DCD捐赠者，密歇根大学的捐赠者池增加了52%。在接下来的两年里，预计将实现以下具体目标：1.确定与对照DCD和DBD相比，紧急DCD的捐赠者数量和OTPD。2.比较急诊DCD供者肾移植(第1年)和肝肾移植(第2年)与对照DCD和DBD供者移植的结果。3.比较潜在供者家庭对新发DCD、受控DCD和DBD的看法和态度。结论：根据初步观察，我们期望发现EDCD导致a)器官供者数量显著增加，b)与DBD和对照DCD相比，肾移植存活率相似，以及c)与DBD相比，供者家庭对EDCD的接受度相似或更高。如果ECS-EDCD被捐赠者家庭很好地接受，并取得了可接受的移植后结果，我们将在密歇根州生命礼物捐赠者服务区扩大其使用范围，以研究足够多的人口，以支持制定国家计划。 公共卫生相关性：可用于移植的捐献器官有限，这导致人们对使用心脏死亡(DCD)捐赠者的捐赠，或心脏停止后捐赠的兴趣增加，而死亡的定义是缺乏血液流入大脑(脑死亡后捐赠)。由于后勤方面的困难，从在急诊室心脏骤停后死亡的人身上获取器官进行移植的做法很少。该项目建议研究一种新的方法，在自愿的捐赠者被宣布死亡后，使用类似于心肺搭桥的技术来灌流器官，以保存腹部器官以供移植，并允许以更容易的方式获取它们。

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.