• by Kaoruko Aita
  • Staff writer (This is the first of two articles. The second, on brain death, will appear on Oct. 25.)

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The line between life and death has grown increasingly obscure in the United States, the world’s most active organ-transplant community, as surgeons grapple with a delicate problem: Organs available for transplant may become less viable if pronouncement of a donor’s death is delayed until death is beyond dispute.

In the Philadelphia area earlier this year, a 57-year-old man suffered severe head injuries in a motorcycle accident. He was rushed to a hospital, where doctors soon determined that he had no hope of meaningful recovery, although he did not meet the criteria for brain death.

Told of the diagnosis, the man’s family decided to authorize withdrawal of life support. Doctors then gave them the option of donating his organs after his heart stopped beating. The family agreed. The man suffered cardiac arrest after the respirator was turned off, and surgeons waited just five minutes before removing his kidneys.

“The organ donation took place around 24 hours after the original injury,” said Kenneth Brayman, kidney-transplant surgeon at the University of Pennsylvania Medical Center in Philadelphia, describing this instance of the controversial practice of obtaining organs from so-called non-heart-beating donors, or NHBDs.

Over the past few years, this type of organ procurement has been slowly spreading in the U.S.

However, it is still not practiced at many hospitals, and doctors and medical ethicists are asking some vital questions: Are such donors really dead? What is the condition of their brains at the time of organ procurement? Are they truly insensate when their organs are removed?

Some worry that the practice may violate the U.S. Uniform Anatomical Gift Act, which prohibits the removal of vital organs for donation until after the donor has been declared dead. The “dead donor rule” has long been considered a golden rule in the U.S., as elsewhere, critical to the maintenance of public trust in the organ-transplant system.

Pressure of shortages

Citing a growing donor-shortage crisis, the U.S. transplant community has been actively seeking new sources of transplantable organs in recent years.

With progress in immunology and transplant-surgery techniques, the number of patients on organ waiting lists has outstripped the supply of available organs. In 1998, cadaveric donors numbered 5,798, whereas the number of those on waiting lists totaled 64,373, including 42,392 waiting for kidneys and 12,070 waiting for livers, according to the United Network for Organ Sharing, a private organization contracting with the U.S. government to distribute organs from cadavers.

In reaction, about a dozen transplant programs in the U.S. have begun procuring organs, not only from brain-dead people whose hearts are still beating, but from people whose hearts have stopped beating but who are not technically brain-dead.

Although a sort of NHBD system was used in the U.S. back in the 1970s, when brain-dead donors were not widely available, today’s NHBDs are different in one respect — they are ventilator-dependent.

It has become common in the U.S. to withdraw life support from those who have been determined by doctors to have no hope of meaningful recovery.

“There is now a trend (where) . . . even if an individual does not meet the strict brain-death criteria, we say they have no chance of meaningful recovery,” Brayman said.

The use of ventilator-dependent patients as organ donors has become possible only since it became standard and acceptable medical practice in the U.S. to withdraw life support in such circumstances. If this were done in Japan, the doctors involved would be prosecuted for murder, say Japanese experts.

This variant of the practice is termed controlled NHB donation because of the fact that doctors decide when to withdraw life support. When emergency patients whose hearts have stopped beating are used as donors, they are called uncontrolled NHBDs. No U.S. medical institutions except two hospitals in Washington, D.C. use uncontrolled NHBDs. They are more common in Europe, where controlled NHBDs are not much used. This article discusses only controlled NHBDs.

The Institute of Medicine — the private, nonprofit medical arm of the National Academy of Sciences– has said that the recovery of organs from controlled NHBDs is an important, medically effective and ethically acceptable approach to reducing the gap between the demand for and the available supply of organs, especially kidneys. (Hearts and lungs cannot be procured from such donors because of possible damage after the blood stops circulating.)

However, the IOM also admits that current NHBD protocols vary from one medical institution to another in such key areas as criteria for the declaration of death and predeath medical interventions.

Critical minutes

Unlike brain-dead patients, who make ideal organ donors because their blood circulation is maintained, the organs of those whose hearts have stopped beating deteriorate quickly. After the withdrawal of life support, deterioration begins even before cardiac arrest, during the last moments of life when the blood pressure drops to a certain level, doctors say.

Organs must therefore be procured as soon as possible after the declaration of death.

But how soon?

At the University of Pittsburgh Medical Center, one of the world’s leading transplant centers, the protocol says that surgeons should wait two minutes after the donor’s heart has stopped beating before making an incision to procure organs.

But protocols in place at many other medical institutions say it should be five minutes. This accords with the IOM’s first guideline in 1997, which recommends a five-minute interval between cardiopulmonary arrest and declaration of death.

However, a UPMC expert is critical of the guideline.

“I think it is a political statement,” said Michael DeVita, assistant medical director of the medical management division of UPMC Presbyterian Hospital in Pittsburgh, Penn.

“They did it because it would make people feel more comfortable. The report does not say why we have to wait five minutes. There are no data that say five minutes is any better than two minutes.”

Anthony D’Alessandro, associate professor of surgery at the University of Wisconsin Medical School in Madison, agrees with DeVita.

“There is no real data that indicates that five minutes is better than two minutes,” said the transplant surgeon, although, he admitted, surgeons wait four and five minutes at his institution.

Richard Freeman, associate professor of surgery at Tufts University School of Medicine and a transplant surgeon at the New England Medical Center in Boston, Mass., also questioned the belief that two minutes was too short. However, he added, “why push it? I do not think organ viability changes that much between two minutes, four minutes and 10 minutes. Why not be able to have a little extra margin of error?”

The UPMC waits two minutes because of the phenomenon of autoresuscitation — spontaneous restoration of heart function after the heart has stopped beating, according to Freeman.

“When somebody has cardiac arrest, how long do you have to wait until you feel for sure the person will not resuscitate on his own without any intervention? Two minutes is probably OK, but I would say four minutes or five minutes are better, because then you are absolutely sure that the brain has been deprived of oxygen for that long,” Freeman said.

In its second report on NHB donation, issued earlier this year, the IOM recommends that experts address the conditions under which cardiac autoresuscitation might occur and after what interval.

The U.S. Uniform Determination of Death Act says an individual can be declared dead 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. However, the practice of NHB donation seems to have changed the meaning of irreversibility to irreversibility by autoresuscitation.

In some NHBD cases, cessation of heart function could be reversed with standard emergency-room treatment, but this does not happen because either the donors or their surrogates have decided to refuse further care. It seems a significant change, but one that has happened almost insidiously.

Do they feel anything?

Some experts have questioned whether the brains of NHBDs are dead at the time of procurement. If there is residual brain activity, is there any possibility that patients experience some sensations when their organs are removed?

DeVita of UPMC says that there are sufficient data to show that when circulation stops, neurological function stops within 11 seconds.

“It does not stop irreversibly, but it stops. In fact, if the blood pressure is low enough, neurological function can stop,” DeVita said. “If you say the person may feel something (after two minutes’ asystole, or lack of heartbeat), I reject that absolutely.”

Other doctors agree. “I do not think the brain is destroyed at the moment procurement starts,” said James Bernat, professor of neurology at Dartmouth-Hitchock Medical Center in Levanon, N.H. “But (patients) are unconscious, certainly. So there cannot be any suffering.”

D’Alessandro said that five minutes after a patient registers no pulse or respiration, he or she probably has not progressed to brain death.

“But the patient is certainly not conscious or aware. It’s not been proved, but you can ascertain from what happens to the brain in two to five minutes that there is no consciousness in normal situations,” he said.

Freeman also rebuts the possibility, saying, “There have been a lot of experiments that say the brain function ceases after four minutes of being deprived of oxygen. The nerves probably do function, but there is no perception in the brain,” he said.

But, he added, “It is a sort of philosophical question. If the nerves are conducting the signals of pain to the brain, but there is no perception of pain, is there pain or no pain? I do not know the answer to that question.”

Bernat supports the idea of NHB donation, even though he is not satisfied that such donors are unequivocally dead at the moment procurement begins.

From the viewpoint of public policy, he said, it is important to expand the number of organ donors, and many people want to be donors.

“If (donors’) hearts have stopped for five minutes, and (doctors) know they are not going to start again (on their own), as far as the public is concerned, that is dead enough for the purpose of organ transplantation,” Bernat said. “I would be willing to overlook some technical quibbles about whether they are dead at that moment (for that purpose).”

Brayman is not so sure.

“I guess it is kind of similar to determining how much pain medicine to use on neonates (newborns). . . . Everybody who does organ procurement has some experiences and some episodes that make it a little uncomfortable,” he said.

Jeffrey Burns, intensive-care specialist at Children’s Hospital in Boston, pointed out that the question of whether a donor’s brain is organically dead is of particular concern in the case of pediatric patients.

“The pediatric brain is known to be more plastic, meaning that you can survive periods of ischemia (cessation of blood supply) longer than adult brains. Are they insensate when organs are harvested?”

Medical professionals at his hospital have examined the Pittsburgh protocol and others nationwide, and have agreed that they will not use the NHBD organ-procurement method, at least for the time being, he said.

In its recent report, the IOM recommended that “statistically valid observational studies of patients after the cessation of cardiopulmonary function be undertaken to assess the degree and permanence of loss of brain function in whole or in part.”

Hastening death?

Another controversial NHBD-related issue is the use of vasodilator on the potential donor before the ventilator is turned off. The substance is of no benefit to the donor patient but is reportedly useful in keeping organs viable by preventing spasms.

In an April 1997 episode of CBS’ “60 Minutes,” it was alleged that use of the vasodilator phentolamin hastened the death of NHBD candidates by rapidly lowering blood pressure. Consequently, many hospitals nationwide are cautious about using the drug.

Freeman, of Tufts and the New England Medical Center, where the vasodilator is not used, said, “There is a lot of evidence that says it is necessary. . . . Meanwhile, there are a lot of unfounded concerns that it hastens the death of donor patients. I am not so sure that it is absolutely necessary, either,” he said.

In explaining why the NEMC does not use the vasodilator, Freeman said that he and his colleagues did not want to add any controversial element to their NHBD protocol that may make hospital staffers reluctant to participate.

“It is not so much on medical grounds, but on perception grounds, how nurses and anesthesiologists perceive the use of the drug,” he said.

However, the substance has been regularly given to all cadaveric organ donors, both heart-beating and non-heart-beating, at the University of Wisconsin Medical Center, D’Alessandro said.

“In our experience, even though it may cause a small, transient drop in blood pressure, (blood pressure) always comes back within two to three minutes, as opposed to the (allegations),” the doctor said.

“The substance does not speed up the death. It was bad journalism by ’60 Minutes.’ We have never had a patient have cardiac arrest because of the drug. We are very comfortable using the medication,” he said.

The IOM’s second report says that the substance can be used on a case-by-case basis.

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said medical professionals in the field should work out a standardized protocol: “The whole area is troubling because there has never been a consensus about what NHBDs are and about how to deal with them.

“If you look at the protocols at Pittsburgh, Wisconsin and other places, some wait for two minutes or more, some use a certain drug to preserve organs and some do not, some use anesthesia and some do not. That’s a mess. You cannot be using a homemade definition of death,” Caplan said.

Caplan, who does not oppose NHB donation, said the current situation confuses the public. “It would be nice to have some clear-cut rules,” he said. “There should be a national or an international meeting to get consensus on NHBDs.”

Setting is important

Another variation in NHBD protocols concerns the place where the ventilator should be turned off: in the intensive-care unit or in the operating room?

Freeman said that at the New England Medical Center, the ventilator is turned off in the ICU. “Our protocol does not allow the declaration of death of donor candidates in the OR; it has to be done in the ICU so that their families can stay with them,” he said.

According to Freeman, some staffers at NEMC did not want to have the letting-go process take place in the OR, with surgeons waiting for a donor.

He also pointed out that withdrawing life support in the ICU prevents “awkward moments” when a donor candidate does not expire within a certain interval of time.

“In some cases, patients do not die (within the anticipated time). Then we would have to move the patient back to the ICU. That could be very awkward,” he said.

The NHBD protocol at NEMC says organs can only be taken from a donor who has stopped breathing on his or her own within an hour of the ventilator being turned off.

“Some patients keep breathing much longer than you expect after the removal of the ventilator. They may go for two to three hours or more. They could not be organ donors in that situation (because of organ deterioration due to protracted weak circulation),” Freeman said.

Howard Nathan, president of Gift of Life, an organ-procurement organization based in Philadelphia, said, “In four cases, patients did not die within an hour and did not become donors. They were taken back to the ICU to wait for their hearts to stop. . . . It’s eerie.”

Gift of Life, which had 24 NHBDs last year, is the most active OPO in the U.S. in terms of the total number of cadaveric donors and the number of donors per capita, he said.

However, D’Alessandro said that at the University of Wisconsin Medical Center life support is also withdrawn in the OR because the liver and pancreas do not tolerate warm ischemia — lack of oxygen to tissues and organs after circulation stops — as long as the kidney does.

“If you procure only kidneys from NHBDs, it is OK to withdraw care in the ICU and then go to the OR,” said D’Alessandro, whose transplant unit is the only one in the U.S. that regularly procures livers and pancreases as well as kidneys from NHBDs. “Anybody who deals with NHBDs has to tell the family and people in the OR that about 10 percent of the NHBD candidates will continue to have spontaneous respiration (for hours). At our institution, we wait for one hour for the liver (and) up to two hours for the kidney, but after that, if the patient still has respiration, then the patient has to go back to the ward.

“We have educated OR and ICU staff about the possibility, and everyone has understood that. We also tell families that can happen because it is very hard to predict who will continue to have respiration and who will not.

“Right now, we think anybody who is considering donating a liver or pancreas in a controlled NHB-donation situation should be done in the OR to minimize warm ischemia and maximize the functions of organs. So it is not awkward here,” D’Alessandro said.

However, Gail Van Norman, former assistant professor of anesthesiology at the University of Washington in Seattle, Wash., said withdrawing life-support in the OR entails pressure that may eventually make doctors cross a line they do not want to cross.

“Suppose the donor candidates live for a while in the OR, do you still stand around the patient waiting for the organs, knife in hand? There is going to be a natural pressure to hasten things, and say ‘Let’s do something to bring about death a little quicker,’ and the longer a life persists, the heavier pressure there would be,” Norman said.

“I worry that that would bring about the mind-set that we can go ahead and end the patient’s life to take their organs. Once we cross the line, we would be talking about something totally different from taking dead people’s organs, we are taking live people’s organs, killing people,” she said.

Where does this road lead?

Stuart Youngner, a leading U.S. bioethicist, believes that controlled NHB donation is close to linking organ procurement with active euthanasia.

“That is Jack Kevorkian’s true wish,” he said, referring to the book “Prescription Medicide,” by the Michigan pathologist who was jailed for assisting end-stage patients to die. In the book, Kevorkian says that death is a very bad thing, and no death should occur without something good coming out of it.

“(Kevorkian) wants to establish a system in which people who want to die can give their body parts to others or can offer themselves for experiments. It is an extreme utilitarian view,” Youngner said.

“It seems to me that turning off the ventilator in such an orchestrated, controlled way, and linking it with organ transplantation, is at least emotionally and symbolically very close (to Kevorkian’s idea),” said Youngner, professor of medicine, psychiatry and biomedical ethics at Case Western Reserve University and director of the clinical ethics program at University Hospitals of Cleveland, Ohio.

According to Burns, of Boston’s Children’s Hospital, there is already considerable variation in the end-of-life care offered to both pediatric and adult patients in institutions nationwide.

Doctors should not be too zealous in procuring organs, he said: “I worry that these protocols are potentially prone to abuse. You have to draw a boundary so that offenses and abuses do not happen.”

It is widely thought that the problem of organ shortage will not be solved unless new technologies, such as organ generation from stem cells and xenotransplants, become available to provide transplantable organs as they are needed.

If this does not happen, Caplan predicts what the future might look like.

“Here is the way to get more organs,” he said. “Hook all patients in ICU up to life support. They can be organ donors when life support is withdrawn.” This takes the debate into the area of whether medicine is starting to “manage” death, bringing it forward so as to obtain much-needed organs.

It would not be a big step for the Pittsburgh doctors, Caplan said. “They would say, ‘We have NHBDs, why don’t we just take anybody who has had a stroke or something . . . and put them on (life support)? That is something I can imagine being done.”

He expressed the concern that if doctors reach the point of manipulating the dying process to that extent for utilitarian purposes, they will start treating people as things — mere organ farms.

“People should be reminded that ethical values are still important. It seems to me really violating some important principles if you go those routes,” Caplan said.

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