Bioethics Discussion Blog: Does Donation After Cardiac Death (DCD) Break the Dead Donor Rule?

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Sunday, August 31, 2008

Does Donation After Cardiac Death (DCD) Break the Dead Donor Rule?

Alex Tang wrote me a question in my "My Opinion is.." ethics Google Knol which I subsequently answered. Specifically with regard to "donation after cardiac death" (DCD), I thought that his concern that "doctors are allowing the patient to die so that organ harvesting can take place" needs to be responded to. I feel visitors to this bioethics blog should also read Alex's concern and my answer, so I have copied the texts below. In addition, I have included the following link to the New England Journal of Medicine Video Round Table discussion of the issue regarding organ donation after cardiac death with Atul Gawande as moderator and discussants, ethicists George Annas, Arthur Caplan and Robert Truog. ..Maurice.


Here is the question:
Cardiac Death and Organ Harvesting
The normal procedure for organ harvesting is from patients who has been certified brain death. In the United States, the Uniform Determination of Death Act (UDDA) set two criteria for death; (1) sustained irreversible of circulatory and respiratory function, and (2) all function of the brain including the brain stem is considered non-existent.

In recent years, there is a movement to harvest organs when the heart stops but brain function is still present. This is usually in patients that are severely ill and are going to die. This is termed "Non-Heart-Beating" or "Cardiac Death" organ donation. The University of Pittsburgh Medical Centre allocated 2 minutes after the heart stops before organ harvesting can begin. There is some uncertainty about this and the Institute of Medicine (IOM) extended the time to 5 minutes. However there have been documented cases of "autoresuscitation" i.e. the heart restarts after 10 minutes of no heart beats. The University of Zurich allows 10 minutes. This is a scary development because doctors are allowing patients to die so that organ harvesting can take place.

Dr Mark M Boucek reported the first heart transplants in three children after cardiac failure rather than brain death in August 14, 2008 issue of the New England Journal of Medicine. The transplants were done in Denver's Children Hospital in Denver. The time between the heart stops and organ harvesting is...75 seconds.

This is a scary development because the ends has justified the means. While it cannot be denied that there is a need for human organs, these organs must be harvested from patients who are already brain dead, not those allowed to die.

What do you think? Alex Tang


Here is my answer:
The moment of death for legal purposes has always been pronounced by a person who has the legal responsibility and capacity to pronounce death. It should be the same (and is the same) whether organs are to be procured or not. The pronouncement of death of a patient in whom no attempt will be made for cardio-vascular-pulmonary resuscitation should occur when it is known by clinical experience that full return of non-assisted cardio-vacular-pulmonary system function spontaneously is unlikely or if it should occur the period of anoxia of the brain would be long enough to cause brain function to meet brain death criteria. The pronouncement of death can also be made in a patient who may still have cardio-vascular system function but meets the clinical criteria for brain death. The pronouncement of death, if not by neurologic criteria, was made not because the heart was "dead" but because of the permanent pathophysiologic failure of the cardio-vascular-pulmonary system, no longer providing oxygen or other substances to the brain and the other body organs and with no intention to attempt artificial resusitation. I believe it should be clarified that The Dead Donor Rule (that the patient should be dead at the time the organs are removed) is satisfied by a legal pronouncement of death, There is no other way to define death since it is known that the cells throughout the human body don't all die at the same instant. There is nothing inconsistent with the Dead Donor Rule that the donated heart has resumed beating in the recipient. This event is not pertinent to the pronouncement of death of the donor since it was the entire cardio-vascular-pulmonary physiologic system that "died" and not the heart.. Patients have the ethical and legal right to voluntarily withdraw unwanted life support and the legal right to give permission for their organs to be removed for donation when the patient is pronounced dead. I would disagree that "doctors are allowing patients to die so that organ harvesting can take place" since the physicians, supported by the law and ethics, are following the requests of the patient. As long as society maintains strict attention regarding the validity of these patient permissions, the act of organ procurement for transplant is an ethical and humanistic procedure. ..Maurice.

14 Comments:

At Monday, September 01, 2008 6:30:00 PM, Blogger TC said...

I'd like to go a little further with your comment that "physicians, supported by the law and ethics, are following the request of the patient."

Everyday in ICU's around the country, people are taken off of life support and allowed to die, either at the request of family or because of the patient's own wishes as written in a living will. They are taken off the ventilator, given pain/anxiety medication so that they do not feel the effects of hypoxia and allowed to let nature take it's course.

Although these patients can be organ donors, the question of organ donation is not(or should not) be brought up for discussion until after the patient's or family's wishes are known. Their decision should be made without donation being a factor of consideration. As far as I know, this is the policy of every OPO in the country.

 
At Monday, September 01, 2008 7:28:00 PM, Blogger Maurice Bernstein, M.D. said...

TC, my point was to counter the argument "doctors are allowing patients to die so that organ harvesting can take place". Organ harvesting is taking place after death because of the ethical and legal permission of the patient and/or surrogate. But I want to make it clear when and how the decisions are taking place.

It is uniform standard hospital policy and OPO policy that physicians are not to introduce the subject of organ donation prior to the time of the patient/surrogate's decision to terminate life support or when death by neurologic criteria is not yet pronounced. All discussions about the option of organ procurement is made by a OPO trained representative and not the healthcare providers and representative's discussion with the patient/surrogate or family is not made prior to the patient/surrogates decision to terminate life-support. In the case of the brain dead patient, life support is automatically removed because the patient is legally dead. In the case of the patient who is not brain dead (alive) but requests that life-support be removed, the physician does write the order to do so whether or not the patient/surrogate has requested organ donation. It is clearly understood by all involved that organ donation should never be offered or considered an option to make a decision to remove life-support. ..Maurice.

 
At Monday, September 01, 2008 9:07:00 PM, Blogger Alex Tang said...

Hi Maurice,

Thank you for your well reasoned response to my question. However my point is not that "doctors are allowing patients to die so that organ harvesting can take place" which by the way will make a sensation headline.

It is a moving of the goal post of the definition of death and the death donor rule. As far as the definition of death goes, the absence of barin function is a required criteria.

While I agree with you and TC that in the case of willing donors and in non-productive treatment modalities based on the 'clinical experience' of the doctors it is reasonable to withdraw treatment. However I do feel that one should at least wait for death to occur, i.e. no higher brain function before harvesting the organs.

In the report I mentioned, the time taken to harvest the ogran after the heart stops is 75 seconds! Coventional medical wisdom will say in 75 seconds the brain is still alive. This is what concerns me. TC is right that organ donation should not be brought up until the family's wishes are known. In these three cases, the family wishes are known well beforehand.

My argument is that doctors should wait for the patient to die first i.e. satisfy the death criteria before harvesting organs.

 
At Monday, September 01, 2008 11:11:00 PM, Blogger Maurice Bernstein, M.D. said...

Alex, I also think that 75 seconds may be too short.If it is not too short, as based on objective evidence, that no spontaneous resumption of cardio-vascular-respiratory physiologic function can occur and that there is irreversible loss of brain function beyond 75 seconds, I think it is still too short from simply acceptance by the public. In my local community hospital, our policy for DCD requires us to wait the more generally accepted 5 minutes (that's 300 seconds) before pronouncing death.

However, that pronouncement should mark the sign that the Dead Donor Rule is then met. Again, I think that permanent loss of all cardio-vascular-respiratory function and no attempt to artificially substitute for that loss of function in the donor, irrespective of whether the heart can be restarted in the recipient should be considered as death. Remember, even "auto-resusitation" of a heart after cardiac arrest will require intensive medical support simply to maintain circulation and lung function (which has been requested by the patient not to be performed). And then, by that time, the whole brain death has occurred and by that criteria the patient is dead.

Let's hope that some day, through methods that never will depend on organ donation from live or dead patients, failing organs can be revitalized or replaced by tissues or organs created in a laboratory, the law and ethics of what we are debating about today will be moot. ..Maurice.

 
At Tuesday, September 02, 2008 10:39:00 AM, Anonymous TT said...

Interesting topic!

To quote the original post:
"In the United States, the Uniform Determination of Death Act (UDDA) set two criteria for death; (1) sustained irreversible of circulatory and respiratory function, and (2) all function of the brain including the brain stem is considered non-existent."

That's a pretty unequivocal statement. Clearly both criteria must be met. The terms "all function" and "non-existent" are unambiguous. It doesn't say anything about loss of brain function - the requirement is absence of any brain function, including the brain stem.

So to me, the question seems to be how long does it take after the cessation of cardiovascular function for this to occur? I don't know what that period is, but I'm pretty sure it's longer than 75 seconds. Given that victims of heart attack & drowning can be successfully revived with little or no brain damage if CPR is started within the first few minutes, it's probably at least double that.

I think Alex's point is well taken, and I feel that to allow doctors to redefine death to their benefit in order speed up of the harvest of organs is wrong. It's slippery slope that I don't think we need to start down......

In my opinion, the most ethical approach is to determine what the worst case scenario is (longest it could take) and make that the benchmark period that must elapse before harvesting of donor organs may begin.

 
At Tuesday, September 02, 2008 11:46:00 AM, Blogger Maurice Bernstein, M.D. said...

TT, the Uniform Determination of Death Act states: " Be it enacted . . . 1. [Determination of Death]. An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. A determination of death must be made in accordance with accepted medical standards..."

I put the word "either" in italics for emphasis. Notice that for the pronouncement of death each criterion is INDEPENDENT of the other. When a patient is pronounced dead by neurologic criteria (criterion #2), the patient's heart and circulation may continue for days or longer as long as the mechanical ventilation and fluid support is maintained. Nevertheless the patient is now legally dead and meets the Dead Donor Rule.

In the case of criterion #1, at the moment when irreversible loss of circulatory and respiratory function is called, the brain may or may not be irreversibly dead. Remember also that it is a fact that the temperature of the brain tissue at the time of circulatory or respiratory arrest affects the brain life and function with cold preserving function. Nevertheless if there is no attempt to resuscitate circulatory and respiratory function, it doesn't change the significance of the criterion.

The only argument I can see regarding organ procurement when criterion #1 is called would be that despite the patient is unconscious (moments after cardiac arrest), the gross appearance of unconsciousness and unresponsiveness doesn't mean the patient can't feel and appreciate pain (a more theoretical argument). Mechanical infusion of a powerful narcotic after pronouncement but before starting procurement might mitigate that argument.

Hopefully, I have explained away your concern about this aspect. ..Maurice.

 
At Tuesday, September 02, 2008 10:38:00 PM, Anonymous TT said...

Dr. Bernstein,

Thank you for posting the corrected text and link - there is a big difference between "and" which is what was stated in the original post, as I referenced, and "either/or".

I still have serious reservations with beginning procurement before the entire brain ceases to function irreversibly.

Regardless of whether or not resuscitation will be attempted, if at any given point in time there is a viable chance that it could restore any function if it was attempted, then by definition the entire brain has not yet ceased to function irreversibly.

The point you bring up about whether an unconscious and unresponsive patient can feel and appreciate pain is an interesting one that I think bears consideration. I question whether the infusion of a powerful narcotic after pronouncement would have much effect, since both the circulatory and respiratory systems would already have ceased to function, and there's no way for the drug to get where it needs to be. For it to work effectively you would probably have to infuse the narcotic before circulation ceased - the problem with this is the narcotic will further depress both the cardiovascular and respiratory systems, in all probability hastening the death of the patient. Now you've potentially gone from passive withdrawal of life support to allow natural death, to taking measures that actively hasten the patient's death.

As I said earlier, to me it's a slippery slope that I'd hate to see us start down. Why not simply wait the few extra minutes to be sure.

Would this affect the viability of some donor organs? Maybe, but to me that is preferable to taking any chance of doing any harm to the donor patient in the process.

Just my $0.02..........

 
At Wednesday, September 03, 2008 8:05:00 AM, Blogger Alex Tang said...

hi Maurice,

Thank you for highlighting the either which is very significant. In Malaysia and Singapore, we are still using the Harvard criteria of brain death.

The only argument I can see regarding organ procurement when criterion #1 is called would be that despite the patient is unconscious (moments after cardiac arrest), the gross appearance of unconsciousness and unresponsiveness doesn't mean the patient can't feel and appreciate pain (a more theoretical argument). Mechanical infusion of a powerful narcotic after pronouncement but before starting procurement might mitigate that argument. Doesn't the fact that a person can feel pain means that he or she is alive?

 
At Wednesday, September 03, 2008 10:52:00 AM, Blogger Maurice Bernstein, M.D. said...

TT, you write "Regardless of whether or not resuscitation will be attempted, if at any given point in time there is a viable chance that it could restore any function if it was attempted, then by definition the entire brain has not yet ceased to function irreversibly." But that's the significance of the "either" in the UDDA. It makes no difference what is the health status of the brain when death by "irreversible cessation of circulatory and respiratory functions" is met. In fact, there would be no way to fully establish that status at that moment. Yes, the health status of the brain is critical when the cardio-vascular-respiratory system is maintained but when death by neurologic criteria is being considered.

With regard to your question regarding the delivery of narcotic to the brain when the heart is not pumping, of course, an intramuscular injection or pushing the drug by a syringe into a peripheral vein would be fruitless without circulation. However, infusion through the circulatory system by mechanical pump is certainly possible. But as I said the issue of perception of pain in a patient who is grossly unconscious, comatose (not just sleeping) and unresponsive is theoretical or perhaps merely philosophic. ..Maurice.

 
At Friday, September 19, 2008 12:39:00 PM, Anonymous TT said...

This is the url of a blog thread with some interesting information on this subject.

http://mkeamy.typepad.com/anesthesiacaucus/2008/03/mostly-deadis-s.html

It pretty much highlights most of the concerns I have with DCD. It is indeed a slippery slope, and if this process is going to be allowed, then there need to be strict controls, barriers and safeguards.

For example:
1. In order to prevent undue influence, the organ harvest team should not be in the same room with the patient care team nor have any communications with them until death is officially pronounced.
2. No procedures that are not strictly for the benefit of the dying patient should be allowed - any potential benefit for potential recipient(s) should be irrelevant.
3. More research needs to be done as to what time period guarantees irreversible loss of circulatory and respiratory function. Irreversible means "can't be reversed", so whether there is any intent to attempt to reverse the loss of function or not should not be a factor, only that there is no statistical probability for it to succeed were it to be attempted.

 
At Friday, September 19, 2008 7:33:00 PM, Blogger Maurice Bernstein, M.D. said...

TT, I would fully agree with your #1 and #2 requirements. With #3, the Uniform Determination of Death Act includes "irreversible cessation of circulatory and respiratory functions." I consider that "irreversible" means
"can't be reversed either spontaneously without external assistance and that there is no intention to attempt to reverse by any such external assistance." If there was any intent for artificial resuscitation then the issue of when to pronounce death would be premature or if these functions were artificially reestablished would be moot. Therefore, yes, what one needs to establish through research is how long to wait until there is no chance for spontaneous return of circulatory along with respiratory functions. ..Maurice.

 
At Friday, September 19, 2008 11:50:00 PM, Anonymous TT said...

Dr. Bernstein,

Guess we have to agree to disagree.

The universally recognized definition of "irreversible" is "incapable of being reversed", and there is no provision in the Uniform Definition of Death Act modifying or redefining it for the purposes of DCD to include "can't be reversed either spontaneously without external assistance and that there is no intention to attempt to reverse by any such external assistance."

The following URL points to an article at NEJM published in August 2008 that specifically addresses this issue:
http://content.nejm.org/cgi/content/full/359/7/672

The article is copyrighted, so I won't directly quote it here, but will closely paraphrase a couple of points:

1. It's not possible to successfully transplant a heart after irreversible stoppage. If a transplanted heart is restarted, the patient from whom it was procured can't have been dead according to cardiac death criteria. Taking organs organs from a person whose heart not only can be restarted, but has been or will be restarted in another body, is ending a life by organ removal.
2. Whether or not any legal changes are made to the dead donor rule, any successfully transplanted heart can't have come from a patient who was declared dead on the basis of irreversible heart stoppage.

I understand the OPO's desire to make more viable organs available for transplant, but if changes are to be made in the clinical definition of death to help accomplish this, then it needs to be done above board in the light of day, not by sleight of hand or playing fast and loose with interpretation of the current definition. What is, is. If it's to be modified, the correct procedure is to do the research to get the hard data, define the changes to be made based on the research, then enact them legislatively or electorally with full public disclosure and input.

 
At Friday, February 06, 2009 1:53:00 PM, Anonymous Anonymous said...

I do not think harvesting of organs should be allowed in patients who are not both brain dead and cardiac dead. We cannot know for sure when exactly a patient is dead while we are on this side of life. Therefore, it is best to err on the side of caution, especially since greed and hubris are known to be part of the human condition. I understand the great need for organ donation, but succumbing to evil is much more fearful than death.

 
At Tuesday, August 25, 2009 1:41:00 AM, Anonymous Rådgivende ingeniørfirma said...

Cardiac dead donor rule should not be break. Because maybe the person who wants to donate his body parts is his mission after death. It has a consent of the donor that after he died all of the good body parts that can be used by the other person should be given to them. Its a big help to have a body donor. Thank and keep up the good work.

 

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