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Donation of organs from patients with severe brain injury who die after cardiac and respiratory arrest after withdrawal of life sustaining treatment, referred to as controlled Donation after circulatory death (cDCD), has been proposed for use in Norway. The proposed method - cDCD using normothermic regional perfusion (NRP) - is one of several methods under the common designation cDCD. Today's method is referred to as "Donation after Brain Death" (DBD), and means that patients with irreversible cessation of brain function are declared dead while still on mechanical ventilation. cDCD will come in addition to DBD. We conducted a health technology assessment of cDCD’s efficacy and safety, and we considered medical, legal and ethical issues raised by the method. Based on this review, our findings are as follows:
Efficacy and safety
We found no convincing difference in organ quality or graft survival after kidney and liver transplantation when comparing cDCD with DBD, because the confidence intervals were wide. We assessed the certainty of the evidence as very low using the GRADE approach mainly because there were few and small studies.
No legal barriers performing organ donation after cDCD have been identified. The professional medical community will ultimately be responsible for specifying and formulating a detailed description of death criteria. The description will be crucial for how the law and accompanying regulations are to be understood. The description may be included in a brief or by including more precise provisions in existing regulations.
A review of the ethical discussion in international academic literature revealed how cDCD has been a subject of debate for many years, particularly in the early phase of establishing the method internationally. Three criteria must be met for cDCD to be ethically sound:
1) The decision to withdraw life-sustaining treatment and the decision to perform organ donation must be separated from each other in a satisfactory way.
2) The premortem interventions must be regarded as very limited.
3) The "Dead Donor Rule" must be adhered to.
A fourth criterion requires an ethically sound process for providing information and obtaining consent.
The ethical review discusses arguments for and against these criteria are discussed. The conclusion is that with some minor modifications to the cDCD procedure, it will be possible to implement cDCD in an ethically sound manner. Our expert panel agreed about many of the underlying premises needed for the method to be considered ethically sound, but there was disagreement about others.
There have been different assessments in the expert panel regarding the death criteria and the interpretation of the wording of law.
If cDCD with normothermic regional perfusion is to be introduced, the expert panel believes that the professional medical community must design a more robust quality assurance concerning the death criteria and update the current cDCD procedure. This will include specific neurological tests to evaluate brain function and documentation of ceased breathing when confirming death. Some in the expert panel also believe that further measurement methods in addition to invasive measurement of blood pressure and heart rate should be used to ensure that cardiac arrest is achieved. The criteria proposed by the professional medical community can be stated in a brief or specified in existing regulations.
Bestillerforum RHF, the commissioning forum of the The National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway, has commissoned the Norwegian Institute of Public Health to conduct a full health technology assessment on "Organ donation using normothermic regional perfusion (NRP) in patients who die of cardiac and respiratory arrest when life-sustaining treatment is withdrawn". The assignment and method were clarified in a special meeting of the Bestillerforum RHF November 26, 2018, where it was confirmed that the assignment applies to patients with severe brain injury and the method is cDCD with normotheric regional perfusion. Organ donation in patients who die of cardiac and respiratory arrest when life-sustaing treatment is withdrawn is referred to as "controlled Donation after Circulatory Death," cDCD. cDCD using normothermic regional perfusion is one of several methods under this common designation. The method is described by Magliocca et al (1), and adapted and reproduced in the cDCD procedure at Oslo University Hospital (OUS) (2). This procedure forms the basis for our health technology assessment.
The health technology assessment includes a systematic review of efficacy and safety. In addition, it includes an assessment and analysis of medical, legal and ethical issues that use of cDCD raises. The primary focus is on the medical, legal and ethical challenges and ambiguities of the definition of death and the death criteria for cardiac and respiratory arrest when life-sustaing treatment is withdrawn.
Organ donation in patients with severe brain injury who die of cardiac and respiratory arrest will come as an addition to today's method, "Donation after Brain Death" (DBD), if introduced.
Delimitation of the assignment
The assignment does not include health economic evaluations or assessment of organizational consequences.
The first organ transplantation in Norway from a deceased donor took place in 1964. Loss of global circulation after lasting cardiac and respiratory arrest in comatose patients was then the common criterion of death by donation. Eventually, it became appropriate to donate organs from patients who were on a mechanical ventilator and where the heart was still beating, but who were still declared "brain dead". It therefore became important to prepare clear criteria for death in Norwegian legislation. These criteria were established by the "Law on transplantation, hospital autopsy and delivery of corpses" (1973), the regulation on the definition of death (1977), and the law "Donation and transplantation of organ cells and tissues" (2015).
Death criteria for organ donation - current laws and regulations
In the law of Donation and Transplantation of Organ, Cells and Tissues (transplantasjonslova 2015) confirmation of death is defined as follows:
Translated into English;
- 10. Confirmation of death:
-Extraction, cf. § 3 letter a, from a dead donor cannot occur before death is confirmed by a physician.
-Physicians who confirm death should not be involved in the extraction of organs, cells or tissues or in the transplant procedure.
-If death is confirmed by irreversible cessation of brain functions, the diagnosis must be confirmed by two physicians. One of the physicians should be a relevant specialist.
The first and second paragraphs apply to all donors, the third paragraph applies only when death is ascertained according to the brain death criteria. Specific rules that provides the regulations concerning the definition of death (HOD 2015 and 2016), where it is further specified in § 2:
Translated into English as: "A person is dead when there are clear signs of total brain destruction with complete and irreversible cessation of all functions of the cerebrum, cerebellum and brainstem. Lasting cardiac and respiratory arrest are clear signs of total brain damage. "
The regulation further states that "when respiration and cardiac activity are maintained by artificial means, the following conditions must be met in order to be able to diagnose death by total brain destruction"
- Known intracranial disease process, i.e. disease or skull damage
- Total unconsciousness that is not drug-related or due to cooling (body temperature lower than 33 degrees)
- Cessation of respiration
- Cessation of all brain nerve reflexes
- Objective detection of ceased blood supply to the brain
Before 1973, loss of global circulation after cardiac and respiratory arrest was the common criterion of death for donation. However, once brain death could be selectively verified through specific diagnostics, it became the only criterion used for donation.
The current method of organ donation: Donation after brain death (DBD)
Today's procedure for organ donation is based on a confirmation of death by irreversible cessation of brain function. The clinical death diagnosis is confirmed by radiological evidence that the brain has swollen to produce a brain tamponade, and the brain is without blood supply. In this case, supply of oxygen-rich blood to other organs will be maintained as long as the patient is connected to the mechanical ventilator and the heart beats. Selective loss of blood supply to the brain is one of five criteria for death diagnosis.
Practical implementations of DBD
After severe brain damage due to trauma, oxygen deficiency or brain hemorrhage, treatment is started with an intention to save life and limit injury. Some patients will already show signs of total brain damage upon arrival at the hospital and lack of blood flow through the brain. If the criteria for brain death are met during ongoing treatment, the relatives are informed that the patient is dead, and they are asked for organ donation. In other patients, the brain still has blood supply, but is so damaged that further treatment is futile. In these patients, neuro-intensive treatment of the brain is withdrawn, in order to see if the condition progresses to loss of all brain functions and loss of brain circulation (brain death). If the relatives wish, intensive care can be started or continued for organ donation pending the patient's death from brain injury. In case of suspected brain death, clinical tests of consciousness, brain nerves and the breathing center are performed, as well as objective imaging of the brain to detect repealed cerebral circulation. The time of death is recorded as the time when the last part of the brain death diagnosis is performed, normally the imaging diagnosis. The deceased receives intensive care to maintain good organ function. Removal surgery is performed on the deceased by surgeons from the transplant hospital at the donor hospital, and the removal team takes the organs to the transplant hospital where surgery is performed on recipients.
Method for evaluation: Donation after circulatory death (DCD) – death after lasting cardiac and respiratory arrest when life-sustaing treatment is withdrawn
Despite extensive brain damage, the process of total brain destruction will stop in some patients, and organ donation in the form of DBD will not be accomplished. Patients who may be relevant for cDCD in Norway, and who this health technology assessment address, are individuals with severe brain injury following trauma, hemorrhage or oxygen deficiency where treating physicians consider that life-sustaining treatment will be futile, and that patients are not likely to meet the criteria for death by total brain destruction while respiration and cardiac activity are maintained artificially.
DCD can be divided into two groups; uncontrolled (uDCD) or controlled (cDCD). Uncontrolled DCD is after unexpected cardiac and respiratory arrest, whereas controlled DCD is after cardiac and respiratory arrest as a result of controlled withdrawal of life-sustaining treatment. This health technology assessment only applies to cDCD using normothermic regional perfusion (NRP), and is based on the cDCD procedure developed at OUS.
Restriction of ischemic damage to organs following global circulatory arrest can be accomplished by two different methods.
- Rapid recovery (RR): After the declaration of death, the deceased is transported to the operating room where organs are cooled and removed as quickly as possible.
- Normothermic regional perfusion (NRP): After the death declaration, a normothermic regional perfusion of abdominal organs is established by means of an external oxygenator (ECMO - a heart-lung machine that uses a filter and a pump that maintains blood circulation in the abdominal organs). Establishment of an aortic occlusion catheter in the upper aortic descendens, at the level of the diaphragm, prevents reperfusion (restoration of oxygen-rich blood flow) to the heart and maintains circulatory arrest in the brain.
Practical implementation of cDCD with normothermic regional perfusion
Prior to withdrawal of treatment, organ donation physicians from OUS insert two thin catheters into the artery and vein of the groin to prepare for insertion of cannulas (thicker tubes) after death has occurred. The cannulas are used for normothermic regional perfusion. Thereafter, the treating physician withdraws treatment by disconnecting the mechanical ventilator and any medications that maintain adequate blood circulation. Medication is given upon signs of discomfort, pain, shortness of breath or stress. The organ donation doctor provides 5000 IU of heparin intravenously to prevent blood from clotting in the organs and in the circuit for normothermic regional perfusion. An observation phase follows awaiting pulselessnes as detected by invasive blood pressure monitoring as loss of pulse measured in the arterial radialis. Cardiac arrest must occur within 90 minutes after withdrawal of life-sustaing treatment if organ donation is to be performed. Pulselessness is observed for five minutes before death is declared by the treating physician. When the patient is declared dead, the surgeon from the removal team inserts cannulae via the catheters already located in the artery and vein in the groin. The cannula is used to establish an external circulation to the abdominal organs until the point of organ removal. An aortic occlusion catheter is installed via the arterial cannula up to the diaphragm level. The aortic occlusion catheter is inserted to prevent recirculation of the heart and brain. Function and location are verified by X-ray. After the family has seen the deceased, the deceased is taken to the operating room for organ removal. The treating physician completes the death certificate.
We have prepared a health technology assessment that contains three domains: 1. Efficacy and safety including medical issues, 2. Law and 3. Ethics.
PICO 1 (P: population, I: intervention, C: comparator and O: outcome): Population: Individuals aged 16 to 60 (or up to 70 years based on individual assessments) with severe brain injury who are in intensive care and who die of cardiac and respiratory arrest when life-sustaing treatment is withdrawn. Intervention: cDCD with normothermic regional perfusion. For all three domains, effect and safety, law and ethics, the population and intervention in PICO 1 are the same. Topics and issues that are considered within law and ethics are described under the respective chapters.
Efficacy, safety and medical issues:
Inclusion criteria, continued:
PICO 1: Outcome: The number of donors, the number of organs (kidneys, pancreas and lungs), and adverse events. Themes highlighted: a) Medical issues related to the diagnosis of death: premortem interventions, detection and assessment of lasting cardiac and respiratory arrest, and autoresuscitation; and b) cDCD guidelines in other countries.
PICO 2: Population: recipient of organs from dead donor. Intervention: cDCD with normothermic regional perfusion. Comparison: DBD or cDCD with rapid recovery. Outcome: Deaths, recipient survival, organ function and graft survival.
We conducted a systematic search for studies with and without control groups on 11.10.2018 and an update search 07.03.2019. The effect estimate was calculated as the risk ratio (RR) for dichotomous outcomes. We assessed the certainty of the evidence with the GRADE approach. The certainty in the evidence, that is, the degree of confidence we have that an effect estimate is close to a true underlying effect, can be considered high, medium, low or very low. For "Medical issues" and "Guidelines for cDCD in other countries", the results are presented descriptively. The publications are collected from the systematic search, consensus reports, guidelines, reference lists in included studies, procedures, and after input from the experts.
The specific legal issue considered in this health technology assessment primarily concerns whether the described method for cDCD can be implemented within the existing framework provided by the law and related regulations. Questions that arose during our investigations have revolved around issues related to (1) the life-sustaining withdrawal process, (2) the definition of death, and (3) questions related to information and consent (detailed in the ethics chapter).
The section on legal aspects of organ donation from a deceased donor is written according to the standard legal method. It is based on ordinary legal sources: relevant legal text with regulations and preparatory work. In addition, we have used information from the legislative history for the Transplant law of 1973. The work did not present any methodological difficulties or disagreements, as the legal basis is simple and clear.
We have examined most of the written ethics literature in the field and identified what seem to be the most important ethical issues concerning this method based on the number and content of articles. These questions can be formulated roughly as follows:
- Does the cDCD increase the risk that decisions to withdraw life-sustaining treatment are affected by the prospect of donation?
- Are pre-mortem interventions in cDCD ethically justifiable?
- Is the donor in the cDCD really dead (that is - is the Dead Donor Rule adhered to?)?
- Does cDCD need a whole new consent practice?
We have addressed these issues by giving voice to different views and different positions. The ethical evaluation is partly a descriptive representation of the opinions of others: partly a careful weighting of different views and positions of the ethical experts in the expert group, based on their professional judgment, as well as critical input from all members of the expert group.
Efficacy and safety
We found no convincing evidence in favor of either cDCD using normothermic regional perfusion or DBD in organ quality for kidney, and graft survival for kidney and liver because of the imprecision (wide 95% confidence interval). For organ quality of liver we also found no convincing evidence in favor of either cDCD and DBD, and very few recipients (n = 11) were examined. For transplantation of pancreas and lungs, the data is very sparse. Two studies suggest that lung transplantation can be performed in parallell with transplantation of abdominal organs using normothermic regional perfusion. We found significantly fewer complications for liver transplants and greater graft survival for cDCD with the use of normothermic regional perfusion compared with cDCD with the use of rapid recovery.
We consider the certainty of the evidence as very low for the comparison of organ quality and graft survival using cDCD with normothermic regional perfusion relative to DBD, and low for a similar comparison between cDCD with normothermic regional perfusion and cDCD rapid recovery. For the comparison between cDCD with normothermic regional perfusion and DBD, the results were downgraded mainly because few recipients and studies were included.
In summary, the pre-mortem interventions are believed to be of insufficient scope to inflict unnecessary pain on the patient or to hasten death.
Detection and assessment of lasting cardiac and respiratory arrest
According to Bernat et al (2010), an inserted artery catheter that measures arterial blood pressure will be sensitive and specific enough to determine cardiac arrest. No additional documentation was found. The exact duration of ceased blood circulation to the brain prior to achieving irreversible cessation of all brain functions is not known. In several countries, five minutes has been considered long enough to confirm the time of death and to consider this as "lasting," given a number of assumptions. A working group under the auspices of the WHO, has defined death and death criteria as follows: «Death is the permanent loss of capacity for consciousness and all brainstem functions. This may result from permanent cessation of circulation or catastrophic brain injury. In the context of death determination, “permanent” refers to loss of function that cannot resume spontaneously or will not be restored through intervention» (Shemie 2014). The WHO working group thus considers that loss of capacity for consciousness and loss of all brainstem functions are sufficient to declare a person dead. The assumptions are that the patient has a permanent cessation of global circulation, spontaneous re-establishment of circulation (autoresuscitation) is not possible, and cardio pulmonary resuscitation will not be performed (by an intervention).
cDCD guidelines in other countries:
cDCD is performed in eleven countries in Europe, including Sweden in which they are now reaching the final stages in the project of evaluating the method. Eight countries have a five minute no touch period, two countries have ten minutes and one country (Italy) 20 minutes. Eight countries use arterial pressure measurement to detect pulselessness (as the proposal is in Norway), and only two countries use ceased pulsatile pressure as the only confirmation of death diagnosis. A number of countries also have additional criteria in the form of specific neurological tests to confirm death. These criteria are defined by "Academy of Medical Royal Collages, United Kingdom 2008" as:
- Lack of pupillary reflex on light stimulation
- Lack of corneal reflex
- Lack of motor response to supra-orbital pressure
In § 10 (see above - "Death criteria ...") the law states that death can be determined in several ways. The wording in § 10, subsection 3 states that "If ..." death is confirmed after cessation of brain functions, .... The wording thus indicates that there are several ways to confirm death. The legislative history states that the provision is intended to capture both "deaths resulting from brain death, and deaths where the cardiac and respiratory functions have ceased, ...". Beyond this, the provision of the law does not say anything about how death can be determined.
Additional detailes about the confirmation of death are given in the regulations of December 21, 2015 no. 1813. Section 2 provides a general provision for the confirmation of death, while section 3 provides detailed conditions for confirming death by total destruction of the brain while breathing and cardiac activity is maintained by artificial means. Death after lasting cardiac and respiratory arrest must therefore be confirmed in accordance with § 2. Confirmation of death (see above). If the conditions in section 2 of the regulation are fulfilled, this is sufficient for confirmation of death according to the Transplantation Act.
When defining the specific content of the death criteria in relation to cDCD, it is, in particular the assessment (or interpretation) of the regulation's wording in section 2 about requirements for "lasting cardiovascular arrest" that must be discussed in this context, more specifically what is needed for the cessation to be "lasting".
Consistent with findings in the legislative history for both the old and new transplantation laws, this question should be resolved by the medical profession, rather than as a matter of law. The problem must be limited to an assessment of how many minutes it takes before cardiac and respiratory arrest can be termed "lasting". Furthermore, a professional standard does not exclude the attachment of other (related) medical assessments to the term, for example, an assessment that the circulatory and respiratory arrest should also be considered "irreversible".
An overall assessment of the legislative text, the regulations and the cited statements from the legislative history together with the other legal history indicates that there is no legal obstacle to cDCD in Norway today.
- Withdrawal of life-sustaing treatment versus donation – difficult to separate?
Ethical concerns have been raised about the independence of decisions on withdrawal of life-sustaining treatment when cDCD may be a possibility. Treating physicians are required by law to judge whether the patient may become a donor (3). In other words, the two simultaneous roles are an intergral part of the law, and a complete separation between the withdrawal and donation process is not possible. However, it is important that the decision to discontinue life-sustaining treatment is not affected by the possibility of donation. While it is possible to find temporary organizational solutions to prevent conflicts of interest in these decisions, ultimately, it is the treating doctor’s professional care, integrity and dedication to their patient that is crucial. The possible conflict of interest is not an argument against allowing cDCD as such, but it does emphasize the need for a robust framework and a high level of ethical awareness around cDCD.
Furthermore, there has been much debate in the international literature whether pre-mortem organ-preserving interventions that do not directly benefit the patient is ethically acceptable. The cDCD procedure from OUS uses pre-mortem interventions, but they are more limited than in other countries. The interventions are not of a significantly different nature than the accepted pre-mortem interventions at DBD. We conclude that the proposed specific pre-mortem interventions can be defended as ethically acceptable.
- The death criteria – is the donor really dead?
Death is absolute and final, but at the same time, the process of death is a gradual process. As a consequence, death declarations are sometimes relative and context-dependent. This means that how we confirm that someone is dead depends on the context. cDCD is relevant for patients with severe brain damage and where there on an independent medical basis has been decided to withdraw life-sustaining treatment. Today, the death definition for organ donation is linked to questions about brain death as described in the regulation. We believe that the cDCD method will be strengthened if it is even more closely linked to the way we confirm brain death.
Five minutes "no touch" seems to be sufficient both empirically and physiologically to prevent the heart from spontaneously restoring circulation. Given the serious diagnosis of the patients and the intention not to perform cardiovascular rescue, we believe that cardiac arrest is an acceptable surrogate for total brain destruction. However, there is no direct evaluation of the cessation of brain function in the OUS cDCD procedure. Such an evaluation would strengthen the method.
- Consent, information and trust – what is changed with cDCD?
In the ethical evaluation, we have identified various arguments that indicate that cDCD, under certain conditions, does not violate the "Dead Donor Rule". We also indicate that pre-mortem interventions, for example inserting thin catheters, or use of 5000 IU Heparin given intravenously, are limited in nature. It would therefore be unreasonable to claim that such procedures deviate from good patient care or that they are essentially different from the practice of DBD. If one is persuaded by these arguments, then it could be argued that there is no necessity to change established consent.
There has been disagreement and discussion about cDCD within the academic setting in both Norway and other countries. The disagreement over what is a good enough definition of death has been central in these discussions. This is a legitimate disagreement, embracing philosophical, ethical, medical, legal and biological issues of a challenging nature. How to inform the public about a professional controversy, while avoiding unnecessary turmoil and distrust, is almost an ethical challenge in itself. Openness is an ideal in our society, and it is crucial that the public has trust that they have access to relevant information during the organ donation process.
In the ethical analysis in this health technology assessment, there is a proposal to make the criteria for circulatory death similar to the already well-established clinical and regulatory criteria for brain death, which can have both an ethical and a practical dimension. There are some differences in the criteria used to confirm death when we compare the cDCD procedure from OUS with similar procedures in other countries. One possibility for further quality assurance of the death diagnosis is to include, after a five minute no-touch period, the neurological tests used in the UK and proposed in Denmark. There is also a suggestion from the expert panel to rely on echocardiography in addition to invasive blood pressure measurement to quality ensure the detection of pulselessness.
Another question that has been highlighted in the expert panel is whether an additional formulation is needed about the concept of "lasting" cardiac and respiratory arrest as described in the law. Whether this can be accomplished via briefs, supervisors, national protocols, guidelines or regulations is outside the mandate of this health technology assessment.
Prerequisites for possible introduction of cDCD
Suggestions for quality assurance of death criteria and death diagnosis:
Challenges inherent in the introduction of such a new method can be remedied if some detailed guidelines on how the law, including regulations, is to be understood. This can be done in a brief or by including precise provisions in existing regulations. Such proposals are outside the mandate of the expert group, but what has been described about the assessment of confirmation of death in the cDCD procedure for the proposed method will provide a good starting point.
In addition to invasive measurement of heart rate and blood pressure, one or more alternative measurement methods could be used to ensure that pulselessness has been achieved:
- Absence of contractility of the heart measured using echocardiography
- Optionally, another measurement method that can ensure that pulselessness is present
In addition, existing procedures for verifying cessation of respiration must be documented in the procedure.
The expert panel proposes that selected neurological tests should be conducted to confirm death / evaluate brain stem and cerebrum function in cDCD. The neurological tests may be similar to the tests described in the English guidelines for cDCD:
- Lack of pupillary reflex on light stimulation
- Lack of corneal reflex
- Lack of motor response to supra-orbital pressure
An update and quality assurance of the cDCD procedure
Efficacy and safety
The results of our included clinical studies suggest, admittedly on a weak basis, that the organ quality after cDCD with normothermic regional perfusion is not significantly different from DBD.
Conclusions from the legal review are that the law does not prevent cDCD, but it is the professional medical community who must prepare specifications of the death criteria and formulate the precise description of them. The description will be central when questions are raised about how the law and regulatory framework should be understood. The description can be included in a brief or by including more precise provisions in existing regulations.
The following criteria must be met to make cDCD ethically sound:
- The decision on withdrawal of life-sustaining treatment and the decision on organ donation must be satisfactorily separated.
- The pre-mortem measures must be regarded as very limited.
- Dead Donor Rule must be adhered to. The "Dead Donor Rule" is a universal rule that states that the donor must be dead before organ withdrawal begins, and that the organ withdrawal must not cause the donor's death.
- An ethically sound consent and information practice.
In the ethical evaluation, arguments for and against these criteria are discussed. The conclusion is that with some minor modifications to the OUS cDCD procedure one will be able to implement cDCD in an ethically sound manner.
The report agrees on many of the underlying premises for the method to be ethically sound. There is also disagreement within the group about some of the premises.
There have been various evaluations in the medical expert panel relating to the death criteria and interpretation of the legal text. If the cDCD with NRP is to be introduced, the expert panel believes that the professional medical community must design a more robust quality assurance of the death criteria and update the current cDCD procedure.
Specific suggestions for the road ahead are:
- Make more detailed descriptions of how the law with regulations is to be understood. This can be done in a brief or by including precise provisions in existing regulations.
- Include specific neurological tests to evaluate brain function when confirming death. The neurological tests may be similar to those described in the English guidelines for cDCD.
- Proposal to include further tests of heart rate and global circulation to quality assure that cardiac arrest is achieved.
- Include documentation of ceased breathing.
- Quality assure and update the entire cDCD procedure.