National guidelines for donation after cardiac death in China

National guidelines for donation after cardiac death in China

Chinese Society of Organ Transplantation, Chinese Medical Association

Introduction

The fi rst edition ofNational Guidelines for Donation after Cardiac Death (DCD)in China has been implemented for more than one year. During this period, the human organ donation pilot program has made a signif i cant progress. An organ donation system in China has formed[1]and a large amount of clinical data have been collected by organ donation practitioners from over ten regions throughout the country. In addition, the introduction ofChina Categories of Deceased Donors(2011) provides principal guidance on organ donation. In August 2011, experts from the Chinese Society of Organ Transplantation revised the fi rst edition of the guidelines in Hohhot city, under the supervision of the Department of Medical Management, the Ministry of Health. The second edition of the guidelines combines the latest international updates with Chinese experiences of DCD, based on specif i c conditions in China.[2-18]The new edition focuses more on the clinical feasibility and practicality by revising organ donation procedures and key issues such as organ preservation, preparation and evaluation. It further def i nes roles and responsibilities of donor-treating physicians, organ donation coordinators and transplant team. The revision of the guidelines is to standardize and guide the practice of DCD in China.

Purposes

The guidelines for DCD were developed by Chinese Society of Organ Transplantation according to theRegulations on Human Organ Transplantation(2007) and other policies on organ transplantation in China. The purposes of the guidelines are: to provide an ethically justif i able and auditable process that respects the rights of donors; to avoid any potential harm to donors, their family members, recipients, and medical staff; and to make recommendations that are ethically, legally, and medically acceptable in the practice of DCD.

Scope of the guidelines

The guidelines are designed for clinicians and other personnels involved in hospital-based organ donation process. It also provides useful information for patients and professionals responsible for the quality and safety of health care. The guidelines should be followed only upon the time of withdrawing cardio-respiratory support of a patient, who is therefore considered as a potential donor. However, the guidelines are independent of the decision-making of life support termination. They are not suitable for the donation of tissues such as cornea, skin, etc.

Def i nition and categories

Def i nition

DCD, also known as non-heart beating donation, refers to donation after death on the basis of irreversible cessation of circulatory function. Generally speaking, it is not necessary for the patients to fulf i ll the criteria of brain death, def i ned by the irreversible loss of all functions of the entire brain.[19]Brain death in China isdef i ned in Table.[20]

Table.The def i nition of adults' brain death in China

Maastricht categories of DCD

In 1995, four categories of DCD were def i ned in Maastricht International Conference in the Netherland.[23]Category V was added recently. These internationally accepted categories are used to classify potential organ donors based on different clinical situations.

Category I: Dead on arrival.

Category II: Unsuccessful resuscitation.

Category III: Awaiting cardiac arrest.

Category IV: Cardiac arrest while brain death.

Category V: Unexpected cardiac death in a critically ill patient.

China categories of deceased donors

In February 2011, China categories of deceased donors were issued by the Organ Transplantation Committee under the Ministry of Health.

Category I: Donation after brain death (DBD).

Category II: Donation after cardiac death (DCD): same as the Maastricht categories.

Fig.The algorithm of this specif i c category in China.

Category III: Donation after brain death awaiting cardiac arrest (DBCD). The donors meet the criteria of brain death (similar to Maastricht-IV). However, due to the absence of brain death legislation in China, and most of families cannot accept organ removal with a beating heart, the organ should be retrieved only after cardiac arrest under this situation. The algorithm of this specif i c category in China is illustrated (Fig.). The "family" in the present guidelines indicates the spouse, parents, children of the patients, or authorized decision-makers.

Roles and responsibilities of personnel involved in DCD

The following personnels/institutions are typically involved in the DCD process: the donor-treating physicians, organ donation coordinators, organ procurement organizations, and other supporting staffs participating in the operation and anesthetization, as well as the organ donation committees. Representatives of these participants are divided into specif i c workgroups who cooperated with other experts to make the key elements of DCD protocol consistent.

The physicians participate in the whole process of donation except the organ procurement. They 1) identify and evaluate the potential donor; 2) refer the donor information to provincial organ donation committee after decision has been made to withdraw cardio-respiratory support; 3) assist the organ donation coordinators and discuss the donation option with the family; 4) provide end-of-life care, withdraw cardiorespiratory support and declare cardiac death; 5) perform pre-mortem interventions; and 6) perform postcase review and report to organ donation committee.

Organ donation coordinators discuss all DCD related issues with the family and obtain their written consent. These coordinators are trained and certif i ed by Red Cross Society of China.

Organ procurement organization is only responsible for organ procurement and must not be involved inother processes.

The role of organ donation committee is to ensure that documentation of death has been correctly completed and all relevant consents have been fully obtained, thus authorizing the initiation of organ procurement according to legislative requirements.

The operating room personnel and anesthetists should offer help in the organ procurement.

Protocol of DCD

Donor selection criteria

Patients considered for DCD should be those who suffered from catastrophic, irreversible neurological injury and/or other organ failures, depending on mechanical ventilation and/or circulatory support with a prognosis of inevitable death. DCD is appropriate if the patient is likely to die within 60 minutes after withdrawal of cardio-respiratory support by the judgment of the treating physician. Evaluation criteria of United Network for Organ Sharing (UNOS)[8,9,22]and University of Wisconsin (UW) assessment tool[23]are recommended for making the judgment. If predictive tests are deemed necessary, the physicians should document any correlated conversation with the family and additional consents in the medical record.

General criteria for organ donors: Patient identity is known. DCD would not be considered if the cause of death needs further investigations, such as death occurs under arrest or detention, in mental health hospital, due to poisoning, being involved in medical dispute, and other abnormal causes.

1) Less than/equal to 65-year-old.

2) No positive HIV infection.

3) No history of drug abuse, intravenous usage of addictive drug, homosexual/bisexual activities, or other high-risk behaviors.

4) No history of malignant melanoma, metastatic or incurable malignancy. However, some patients with early-stage of malignancies or central nervous system tumors that have received successful treatment may be considered.

5) No active and untreated infection of bacteria, virus or fungus.

6) Hemodynamic and oxygenating status is stable.

7) The function of the organs to be donated is basically normal.

After identifying a potential donor, physicians from different specialties should arrange a meeting to discuss carefully and to conf i rm an unavoidable death. The family should clearly understand the patient outcome, and decide to withdraw cardio-respiratory support. The discussion about termination of life support must be clearly separated from the discussion of organ donation.

The treating physicians should evaluate the potential donor after conf i rming the family's decision to stop life support treatment. All data of potential organ donors should be provided to provincial organ donation committee. Provincial organ donation committee will designate organ donation coordinators and organ procurement organization for each case.

Decision-making and informed consent

Organ donation, including DCD, should be considered as a good opportunity to improve the quality of end-of-life care, and therefore should be raised to all potentially suitable patients. All procedures and outcomes should be discussed with the family in detail. If the family agrees with the donation, written consent must be obtained. Documentation of any formal consent and discussion with the family regarding withdrawal of life support treatment and DCD is mandatory. Anyone in the family can decline DCD even if donation is the patient's will.

Some families may independently express the willingness of organ donation prior to the decision to withdraw cardio-respiratory support. If this is the case, the whole issue should be thoroughly documented. Also, conversations with the family during the consent obtaining process should be clearly recorded when the family signs the consent forms with the donation coordinator.

The informed consent for DCD should be reported to and fi led by the organ donation committee which supervises the process of DCD and ensures that the consent complies with the associated legislative requirements. All the documents of DCD should be reported to and fi led in the provincial organ donation off i ce at the fi nal stage.

Donor management

General assessment and pre-mortem interventions should be performed once formal consents have been obtained. General assessment should include the followings: general information of the patient, detailed present history, past history and laboratory results, etc. Pre-mortem interventions protecting the graft should do no harm to the donor and be performed with the consent obtained from the family and the donor if he/ she is conscious. Any pain or distressing symptoms must be managed with analgesia and sedation; interventions hastening the process of death should be avoided. Premortem interventions are not justif i able unless there is adequate scientif i c evidence supporting that these interventions improve organ viability. The use of anypre-mortem intervention should be recorded in detail in the donor management record.[24,25]

Withdrawal of cardio-respiratory support and declaration of death

Organ procurement team should absolutely take no part in the termination of treatment. The family could be allowed to be present at the scene while cardiorespiratory support is withdrawn if they wish to. Any drug that may accelerate death should be avoided.

The time of withdrawing cardio-respiratory support should be recorded. Vital signs of the donor including the heart rate, respiratory rate, blood pressure, oxygen saturation status, and urine output should be monitored and recorded simultaneously. Warm ischemic time def i ned by the interval from the termination of life support to the hypothermic perfusion of the graft should be recorded. It is recommended that the warm ischemic time should not exceed 30 minutes for the liver, and 60 minutes for the kidney, pancreas and lung. Irreversible organ damage occurs beyond this time point and the risk of graft nonfunctioning is highly increased.[26-35]

In the circumstance that death does not occur within the 60 minutes timeframe, DCD should be cancelled; the patient will be given continued end-of-life care in a prearranged location until death.

Legal def i nition of death is irreversible cessation of circulatory and respiratory function. The urgent time constraints in DCD require additional def i nitive proofs of circulatory and respiratory cessation by monitoring and/or conf i rmatory tests. Thus, electrocardiography, intra-arterial monitoring or Doppler examination in rare situations should be utilized to facilitate the determination and subsequent certif i cation of death. These measurements are taken to ensure that the "stand down" period is appropriately adhered, and to assure the physicians and family that the patient is dead. However, the cardiac electronic activity may still exist for a few minutes even the circulation stopped, electrocardiography should not be used alone as the proof of death. Two to 5 minutes of observation should be employed in the diagnosis of death to ensure that the process is irreversible and permanent.

The chief attending physician declares the cardiac death and records the process and time of death (the transplant surgeons and organ procurement organization team should not be present). Once death has been declared, resuscitation should not be applied any more. Re-intubation will be allowed only to prevent inf l ation and secondary lung injury. The organ procurement starts immediately after the declaration of cardiac death.

Family members should leave the scene upon the cardiac death declaration of the donor. Counseling and support should be offered to the family in accordance with the established hospital protocol.

Organ procurement

Once death has been declared, retrieval surgery should be initiated as soon as possible. In order to reduce warm ischemic time to the minimum, all necessary preparations in the operating room should be completed prior to the withdrawal of cardio-respiratory support, and the retrieval team and operating room staff should be ready in advance. All signif i cant time-points must be accurately documented. After operation, the body remains should be disposed properly in a respected manner.

Cold storage for donor organs is performed after retrieval. Hypothermic machine perfusion is recommended for organs suffering prolonged warm ischemia time and other unfavorable conditions.

Factors impacting organ viability should be considered. Donor factors include age, height, weight, cause of death, ICU stay period, treating procedures, etc. Organ factors include ischemic time, adequacy of perfusion, and abnormalities. If necessary, biopsy should be performed. Machine perfusion and microdialysis may be helpful for assessment.

Post-case review

A case review meeting should be organized as soon as possible and a reviewing report should be submitted to the committee of donation and provincial organ donation committee for fi nal documentation.

Conclusions

At present, organ transplantation has become the fi rst option for many end-stage diseases. However, this lifesaving approach is critically restricted by the problem of organ shortage, which could be solved in certain level by the extended use of DCD. The establishment of the national guidelines will enable all DCD-related procedures to be stringently regulated, thus ensuring the appropriate medical practice. On the other hand, it will also protect the patients from unnecessary harms and provide adequate respect to the deceased donors. We believe that the publicity of DCD will promote a better understanding and wider acceptance of organ donation in China.

Competing interest:No benef i ts in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.

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Received March 31, 2012

Accepted after revision February 4, 2013

Yong-Feng Liu, MD, Department of Organ Transplantation, First Aff i liated Hospital, China Medical University, Shenyang 110001, China (Email: yf l iu@mail.cmu.edu.cn)

The guidelines were proposed by the Chinese Society of Organ Transplantation, Chinese Medical Association. The English version was translated from the Chinese version by Xu-Chun Chen, Dong-Hua Cheng, Ying Cheng, Hong Li, Hao Liu, Ting-Ting Liu, Yi-Man Meng, Rui Shi, Haibo Wang and Gang Wu. Others who read the proof of the English version include: Shi Chen, Xiao-Ping Chen, Zhong-Hua Chen, Ke-Feng Dou, Yao-Wen Fu, Xiao-Shun He, Ning Li, Long Liu, Yong-Feng Liu, Cheng-Hong Peng, Zhi-Hai Peng, Jian-Min Qian, Zhong-Yang Shen, Bing-Yi Shi, Jian-Ming Tan, Ye Tian, Xiao-Tong Wu, Wu-Jun Xue, Lu-Nan Yan, Qi-Fa Ye, Li-Xin Yu, Yun-Jin Zang, Shu-Sen Zheng, Ji-Ye Zhu and You-Hua Zhu.

The Chinese version of the guidelines was published in theChinese Journal of Organ Transplantation, 2011;32(12):756-758.

© 2013, Hepatobiliary Pancreat Dis Int. All rights reserved.

10.1016/S1499-3872(13)60038-7