Organ Donation After Cardiac Death

There was a time when organ donation after cardiac (or circulatory) death ("DCD") was controversial. Then it wasn't (at least not as much). We may be returning to that earlier time once more.

DCD protocols were developed as a way of obtaining transplantable organs without waiting for brain death to occur. Considering the 103,000+ backlog of transplant candidates on national waiting lists, DCD seemed like an innovative way to increase the supply of organs.

The protocol called for taking away life-support, waiting for spontaneous respirations and cardiac function to stop, waiting a little longer to ensure that the donor's heart didn't spontaneously restart ("autoresuscitation), and declaring death. All of these steps take place in an operating room where a transplant team is ready to remove the decedent's organs while they are still relatively "fresh."

Criticisms were mostly focused on the waiting periods, which -- if too short -- might result in taking vital organs from a patient who wasn't really dead. With the encouragement of the transplant field's regulatory body -- the United Network for Organ Sharing (UNOS) -- the practice has established a solid footing and currently accounts for 43% of deceased donors, 7,200 donors in total.

If there's a problem with DCD, it is the persistent reports of DCD donors being declared dead and turning out not to be. As recently as this week, The New York Times ran a long story with the striking headline, "Doctors Were Preparing to Remove Their Organs. Then They Woke Up". Experts say that if the protocol is carried out properly, this should never happen. So what's the explanation? The agency that oversees the federal Organ Procurement and Transplant Network is the Health Resources and Services Administration (HRSA), which conducted a review of cases in Kentucky. As reported by the Times: 

Now, a federal investigation has found that officials at the nonprofit in charge of coordinating organ donations in Kentucky ignored signs of growing alertness not only in that patient but also in dozens of other potential donors.

The investigation examined about 350 cases in Kentucky over the past four years in which plans to remove organs were ultimately canceled. It found that in 73 instances, officials should have considered stopping sooner because the patients had high or improving levels of consciousness.

The results of that investigation has led HHS to start a process of "reforming" the OPTN:

[HHS] announced a major initiative to begin reforming the organ transplant system following an investigation by its Health Resources and Services Administration (HRSA) that revealed disturbing practices by a major organ procurement organization.“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” Secretary Kennedy said. “The organ procurement organizations that coordinate access to transplants will be held accountable. The entire system must be fixed to ensure that every potential donor’s life is treated with the sanctity it deserves.”

The headline of this press release is apparently intended to alarm: HHS Finds Systemic Disregard for Sanctity of Life in Organ Transplant System (boldface in original). The question this leaves open is whether HHS is going to adopt measures to ensure compliance with the existing DCD protocol or take steps to scrap DCD altogether. (Wait until RFK, Jr. is told about Nomothermic Regional Perfusion!) Stay tuned . . . .

New study endorses harvesting hearts after declaration of cardiopulmonary death

There's an Associated Press article in this morning's Dallas Morning News describing a multicenter study involving the transplantation of hearts taken out of donors who were not brain dead but had been declared dead after irreversible cessation of cardiac and circulatory function (DCD/DCCD).

Certain solid organs have been transplanted after DCD for decades. The protocol for harvesting involves the following steps:

• moving the patient to the operating room (usually from an ICU);
• stopping all life-supporting measures;
• waiting for a fixed period of time for the heart to stop beating (usually 60-90 minutes);
• if the heart stops, waiting another period of time (usually 5 minutes) to see if the heart will autoresuscitate;
• if autoresuscitation doesn't occur, death is declared and organ harvesting (usually kidneys, liver, and pancreas).

The DCD procedure was designed to shorten the warm ischemic time from when cardiopulmonary function ceases and the harvested organ can be restored to function in the recipient's body. Even with that innovation, though, hearts were not considered for transplantation because of their extreme fragility.

As described by the AP, however, the results of a multicenter study over a number of years establishes that the six-month survival rate after DCD (94%) was slightly better that the survival rate for heart transplants after brain death (90%). So what has changed? As reported by the AP:

Now doctors can remove those hearts and put them in a machine [a "heart-in-a-box" device invented by TransMedics, the sponsor of the study] that “reanimates” them, pumping through blood and nutrients as they’re transported –- and demonstrating if they work OK before the planned transplant.

I am all for increasing the supply of donor hearts, and this is a very interesting development.  I am wondering, however, how to square the transplantation of a viable heart with the cardiopulmonary criterion of death. The statutory standard of "irreversible cessation of all cardiopulmonary function" will  now need to be understood as “irreversible in the donor’s body but not necessarily in the body of the recipient of the heart.” That begs the question, which has applied to DCD from the beginning, why has cardiopulmonary ceased (because we took away the donor’s life support) and why is the cessation irreversible (because we didn’t try to reverse it). Once we actually try to restore cardiac function (“reanimating” the heart in a “heart-in-a-box” device), some hearts are restored and do at least as well in the recipient’s body as a heart from a brain-dead patient. 

Are we comfortable with this slightly altered version of "irreversible cessation"? Should we be? The so-called "dead donor rule" (DDR) forbids killing a patient for organs or removing organs needed to sustain life from a living patient. So far, we have avoided the slippery slope of removing organs from patients who are almost dead or "as good as dead." How certain are we that this new approach to DCD heart transplantation satisfies the DDR?