Surgeons retrieving organs for transplant just after a donor’s heart stops beating would no longer have to wait at least two minutes to be sure the heart doesn’t spontaneously start beating again under new rules being considered by the group that coordinates organ allocation in the United States.
The organization is also poised to eliminate what many consider a central bulwark protecting patients in such already controversial cases: an explicit ban on even considering anyone for those donations before doctors and family members have independently decided to stop trying to save them.
The proposed changes by the United Network for Organ Sharing, the Richmond nonprofit organization that coordinates organ donation under a contract with the federal government, are part of the first major overhaul of the 2007 guidelines governing “donation after cardiac death,” or DCD, which accounts for a small but growing percentage of donations each year.
Proponents say the changes strengthen the transplant system by aligning the rules with other regulatory bodies and better ensure that the wishes of donors and their loved ones are honored without sacrificing necessary protections.
“The ultimate goal is to facilitate the dying wishes of patients who wish to be donors and save the lives of the 112,000-plus patients who are in need,” said Charles Alexander, the immediate past president of UNOS. “We are always very aware of our public trust.”
Critics, however, say the move heightens the risk that potential donors will be treated more like tissue banks than like sick people deserving every chance to live, or to die peacefully.
“This is another step towards this idea of hovering, hovering, hovering to get more organs,” said Michael A. Grodin, a professor of health law, bioethics and human rights at Boston University. “The bottom line is that they want to do everything they can to increase organ donation.”
The 16-page proposal, which has resurrected the knotty debate over what it means to be dead, was drafted over a year by the 22-member UNOS organ procurement organization committee. It was posted for public comment for about three months, a period that ended June 10. The UNOS board will convene Nov. 14 and 15 in Atlanta to finalize the revisions, which include officially shifting the guidelines from “model elements” to “requirements.”
“We want the process to happen the way it’s supposed to happen to avoid any questions or problems,” Alexander said.
DCD involves surgeons taking organs within minutes of respirators and other forms of life support have being cut off from hospitalized patients who still have at least some brain activity. DCD had been the norm for organ donors before neurological criteria — “brain death” — became the standard in the early 1970s. Since then, most donors have been brain-dead.
But as the number of people needing transplants rose, doctors in the 1990s began reviving what was then called “non-beating heart” donation. DCD has become a growing source of organs as the gap between the number of patients waiting for transplants and the number of available organs has widened. About 6,000 Americans succumb each year while waiting for donated organs.
DCD advocates say the potential donors are unquestionably going to die because everyone involved agrees further treatment is futile. At least the patients and their families should be able to find solace by helping save someone else, this argument says.
Supporters maintain that doctors, nurses and organ bank workers are extremely careful to ensure potential donors are never put in jeopardy.
Critics, however, call DCD ghoulish and raise the specter of transplant surgeons preying on dying patients. Doctors, nurses and bioethicists who hold this view fear the medical system will give up on potential donors in their final days or even possibly speed their deaths by giving them anti-clotting medication or other organ-preserving drugs, which could hasten death.
With the support of the federal government, DCD has slowly crept beyond patients who are in intensive care after suffering severe brain damage — but who are not brain-dead — because of a car accident, a stroke or some other tragedy. One controversial federally funded program in Pittsburgh is exploring obtaining DCD organs while patients are still in the emergency room. Another is investigating using special organ-retrieval ambulances in New York City.
The National Academy of Sciences concluded in 1997 that DCD was ethical as long as tight rules are followed: The decision to withdraw care must be independent of the decision to donate organs, and before removing any organs, surgeons must wait at least five minutes after the heart stops to make sure it doesn’t spontaneously start beating again.
But, hoping to salvage more organs, some hospitals began cutting the waiting time, with many holding off just the two minutes that were incorporated in the existing UNOS guidelines. At Children’s Hospital Colorado in Denver, surgeons tried standing by only 75 seconds before taking hearts from brain-damaged newborn babies to be transplanted into infants who would otherwise die. That ignited an emotional debate about whether a new taboo had been breached. The hospital now waits two minutes.
The rules revision also renames the procedure again, calling it “donation after circulatory death.” That terminology, advocates say, is more accurate, given that the heart might not necessarily be “dead” before “death” can be declared. Cutting circulation is what really causes brain death, they say.
Some bioethicists, however, question whether that change is an attempt to divert attention from the ethically fraught question of what truly constitutes death.
“I think this effort to solve the problem by renaming the process is not successful and is potentially intentionally deceptive,” said Robert M. Veatch, a Georgetown University bioethicist who serves on the UNOS ethics committee.
He said the 31-member committee, meeting in Chicago last week, debated whether DCD patients could really be considered “irreversible” or “permanent” — as the definitions of “circulatory” or “cardiac” death state. Circulation is sometimes restored with chest compressions or other means; in Denver, DCD hearts were transplanted into someone else to start beating again.
“We had a long, heated battle at the meeting,” Veatch said. “It was a remarkably heated battle.”
Others, however, support the name change.
“It was always kind of confusing to say, ‘You have donation after cardiac death,’ because a dead heart can’t be transplanted,” said Arthur L. Caplan, a University of Pennsylvania bioethicist. “It gave the impression that maybe in an odd way the rest of you was alive. I found it almost Edgar Allan Poe-like.”
But Caplan and others are disturbed by the discarding of language that says “the hospital’s primary health care team and the legal next of kin must have decided to withdraw ventilated support or other life-sustaining treatment” before anyone is evaluated as a possible donor.
“This change in policy creates the appearance that the patient is always being evaluated as a possible donor, which I think would make the public uneasy, and rightfully so,” said Leslie Whetstine, a Walsh University associate professor of medical ethics.
UNOS’s Alexander argues that early evaluation lifts the burden of another decision for families whose loved ones turn out to be ineligible for donation and eases the withdrawal of life support for those who can donate.
“We really want to avoid undue delay for families that have gone through a very difficult hospitalization and come to a difficult decision that ongoing treatment is not something the patient would want,” Alexander said. “This is a service to the grieving family.”
But spiking a specific wait-time is fueling alarm that the changes may erode crucial public trust, critics say.
“By this document, every hospital in America can now develop its own definition of ‘dead,’ ” University of Washington bioethicist Gail Van Norman wrote in an e-mail. “And that is profoundly disturbing. . . . We are, it seems, admitting that we are willing to take the chance of procuring organs from someone who is not dead yet.”
But Alexander said that individual hospitals and specialists in emergency medicine are best equipped to determine the right interval.
“The existing recommendations were essentially arbitrary and not based on data,” Alexander said. “What we’ve come to realize is the hospital and the care team in charge of that patient is really the most qualified to make the determination of death.”
Another change would specify certain patients, such as perhaps those with spinal cord injuries, muscular dystrophy and Lou Gehrig’s disease, as potential donors. Some worry that might subtly pressure patients to forgo care. Others say the step was aimed only at making sure those who want to donate and could be candidates are not overlooked.
Said Jim Bowman of the federal government’s Health Resources and Services Administration, which oversees UNOS: “I don’t think this is targeting individuals.”