ACP: Pump the Brakes on New Organ Procurement Method

Use of a new method of organ procurement that aims to preserve circulation to organs such as the heart and intestine after inducing brain death should be paused, the American College of Physicians (ACP) said in a statement this week.

Though organs remain in short supply, ACP said the proposed method, which has been called normothermic regional perfusion with controlled donation after circulatory determination of death (NRP-cDCD), “appears to violate” the dead-donor rule — that donors cannot be made dead in order to obtain their organs, and that organ retrieval cannot cause death.

“This new method of organ retrieval raises profound ethical questions regarding determination of death, respect for patients, and the ethical obligation to do what is best for patients,” said ACP President George M. Abraham, MD, MPH, in a statement. “Valid ethical arguments — not just assertions — must serve as the foundation for organ transplantation, consistent with U.S. legal and ethical standards for determination of death. Otherwise, public trust and confidence in healthcare and in organ donation — things we need more of — are jeopardized.”

ACP said the name NRP-cDCD “lacks clarity” and does not fully describe what occurs during procurement. “It is more accurately described as organ retrieval after cardiopulmonary arrest and the induction of brain death,” ACP stated.

In general, organ donation occurs after circulatory determination of death or determination of brain death, and ACP said it supports both methods in line with ethical and legal standards.

One way in which circulatory determination of death proceeds, ACP noted, is through planned withdrawal of life-sustaining therapies consistent with patient or family wishes. When a patient’s circulatory and respiratory functions cease, a “hands off” period occurs to confirm the cessation of those functions is irreversible. At that point, death is declared followed by rapid organ retrieval.

That process — controlled circulatory determination of death — has been used successfully for many organs, but rarely for the heart or intestines, ACP said, as these organs are more susceptible to ischemic injury following irreversible cessation of circulation. As a result, there has been interest in developing ways to retrieve organs to minimize such injury, the organization said.

In NRP-cDCD, extracorporeal membrane oxygenation, cardiopulmonary bypass, or other technologies are used after the hands-off period to restore circulation to vital organs or restart the heart. Perfusion is referred to as “regional” primarily because circulation to the brain has been actively excluded, ACP said. And then, according to one protocol the statement cited, “‘standard [determination of brain death] procurement will commence.'”

ACP said the determination of irreversibility — necessary for the certification of death moments before — is “apparently inaccurate” given that circulation is restored.

“It is tragic when a patient dies awaiting a needed organ,” the organization said. “But organ procurement and transplantation must satisfy ethical standards in meeting this need.”

NRP-cDCD raises profound ethical questions including, “the categorical imperative to never use one individual merely as a means to serve the ends of another, no matter how noble or good those ends may be,” ACP said in its statement.

ACP is recommending a pause of the use of NRP-cDCD as well as further professional and public discussion of the practice. It was not immediately clear how often the method is being used.

Current data shows a nationwide wait list of more than 3,500 registrants for hearts, more than 200 for intestines, and more than 117,000 for all organs combined.