Feb. 21, 2003 — Editor's Note: Avoidable medical errors recently highlighted in the press may have tragic consequences, as was the case for 17-year-old Jésica Santillán, who needed heart-lung transplant for restrictive cardiomyopathy. On Feb. 7, she was transplanted with ABO-incompatible organs at Duke University Hospital in Durham, North Carolina. Despite receiving immunosuppressant treatment, she began rejecting the donor organs and was in critical condition, unconscious and requiring life support. On Feb. 10, she had a myocardial infarction, and on Feb. 16 she had a seizure.
After a massive media campaign, a "directed donation" offered the gift of life to the dying girl, providing a well-matched heart and lungs. At 11:30 pm on Wednesday, Feb. 19, Carolina Donor Services (CDS) notified Duke transplant surgeon James Jaggers, MD, who performed the initial surgery, that compatible organs were available. After completing the procedure ensuring compatibility, the surgical team discussed the situation with Jésica's family at about 12:30 am on Thursday, Feb. 20.
Renee McCormick, spokeswoman for a charity that helps pay Jésica's medical bills, told Fox News that doctors said the organs were an "incredibly good match," but that the surgery still had only a 50% chance of success. All went as expected with the second procedure, which Dr. Jaggers began at 6:15 am and completed at 10:15 am on Feb. 20. Significant worsening of brain function was detected less than a day after the second transplant. Jésica was declared brain dead on Feb. 22.
How the mismatch occurred is still unclear. Although Jésica had type O-positive blood, she received type A organs in the Feb. 7 transplant.
According to a statement from the New England Organ Bank (NEOB) in Newton, Massachusetts, which provided the donor organs, "the correct donor blood-type was identified prior to the organ recovery. Further, the correct donor blood-type was provided at the time of the organ recovery to the surgical team from Duke Hospital that came to New England to perform the recovery surgery."
CDS, the organ procurement organization that serves 79 counties of North Carolina and Pennsylvania County in Virginia, also issued a statement that NEOB called CDS early on Feb. 7 with an organ offer. Because the organs came from a local donor, NEOB was considered the host organ procurement organization. CDS' role was to relay information between NEOB and Duke University Medical Center (DUMC).
"NEOB had run a list of patients waiting for transplants using the United Network for Organ Sharing (UNOS) national wait list database, and DUMC had two patients who printed on the match run list," the statement reads. CDS received the donor's blood type and other medical and laboratory information from NEOB, and conveyed it to transplant surgeons at Duke, where the two patients listed as blood type A-positive were waiting for transplants.
Although Duke transplant surgeons declined the organs for both of these patients, one of the Duke surgeons, whose identity is not revealed in the statement, requested that CDS convey to NEOB that they wished to transplant the heart and lungs into a third patient.
"CDS informed NEOB of the Duke surgeon's request for the third patient," according to the statement. "Carolina Donor Services was informed that Duke suspected an incompatible blood match only after the transplant took place."
Why the delay in recognizing the mismatch, despite paperwork appropriately labeling the donor organs with their correct blood type? Because of the limited viability of hearts and lungs after harvesting, the Duke transplant surgeon had begun removing Jésica's organs while the donor organs were en route. When the transplant was nearly complete, routine tests revealed the blood type incompatibility and early signs of acute rejection.
Dr. Jaggers reported to Duke that the mismatch resulted from human error and incorrect assumptions: "Early in the morning of Feb. 7, I received a call from [CDS] and was informed of available organs. I assumed that after providing Jésica's name to the organ procurement organization and after the organs were released to me for Jésica, that the organs were compatible."
Because of the gravity of this error and its consequences, DUMC is conducting an internal review to determine how the mismatch occurred, and it is revising its procedures to prevent similar problems in the future. Before the second transplant, newly instituted safeguards were being implemented, including use of three additional physicians in ensuring organ compatibility, multiple confirmations of donor match by members of the transplant team, and improved communications between Duke and the organ procurement organization.
"In our efforts to identify organs for this desperately ill patient, regrettably, a mistake occurred," William Fulkerson, MD, chief executive officer of Duke University Hospital, says in a news release. "As a result of this tragic event, it is clear to us at Duke that we need to have more robust processes internally and a better understanding of the responsibilities of all partners involved in the organ procurement process."
To help determine what went wrong, how to prevent mismatches from happening again, and what effect this situation will have on organ donation, Medscape's Laurie Barclay interviewed Robert A. Metzger, MD, medical director of transplantation and of the organ procurement agency of Florida Hospital in Orlando.Medscape: What is the internal Duke investigation likely to disclose about how this error occurred?
Dr. Metzger: We still don't know exactly what happened. It's a tragedy, most likely caused by a clerical error, most likely at Duke. One likely scenario is that someone at the Duke transplant center either didn't know the patient's blood type or was confused about the blood type. It appears that the Duke center was contacted about the availability of type-A organs that matched two patients on Duke's list. The surgeons declined the organs for those patients, probably because of reasons like being the wrong size. With heart-double-lung transplants, size of the organs relative to the chest cavity is very important.
But then one of the surgeons asked if he could have the organs for a third patient. Maybe he was at home when he was notified and got confused, thinking the patient was type A and the donor type O, which would have worked, rather than vice versa. Maybe there was a clerical error at Duke, or maybe there was an error on the list that transplant surgeons carry around with patients' blood types.Medscape: Does removal of recipient organs before arrival of donor organs increase the changes of this type of error? Is it possible to wait until the organs arrive?
Dr. Metzger: Usually the team in charge of harvesting recovers the heart, then once they know it's a go, they notify the transplant team so they can prepare the patient right away, because time is so limited. Once the transplant team gets the word, they evacuate the patient's chest cavity and put her on heart bypass while they're waiting for the donor organs to arrive. Usually no cross-match, HLA compatibility testing, or even blood typing is done when the organs arrive -- there just isn't time, as there would be for a kidney transplant. Typically, when the harvest team tells the transplant team that the organs are on their way, they'll confirm verbally what the blood type is, but we don't know whether or not that happened in this case.Medscape: What was the role of the organ procurement organizations in this situation?
Dr. Metzger: Apparently they correctly notified the transplant team at Duke of the donor organ blood type. They filled out paperwork indicating the donor organ blood type, and that paperwork typically accompanies the donor organs.Medscape: How can errors like this be avoided?
Dr. Metzger: The surgeon should have looked at the paperwork before starting the procedure, although at that point, he would have already removed the patient's heart and lungs. After the procedure he's supposed to fill out forms for the organ procurement center commenting on the organ quality and responding to other specific questions, so you'd think he would at least glance at the forms ahead of time.
Duke has said that at least three transplant team members checked the compatibility before the second transplant, so they may have assumed it was a clerical error the first time. Having more people involved to double-check compatibility should reduce errors. The United Network for Organ Sharing is investigating the situation and should have a report out soon, hopefully with suggestions for how to prevent errors like this.Medscape: Please comment on how the mismatch affected Ms. Santillán's chances of survival, both before and after the second transplant.
Dr. Metzger: Because of the critical shortage of donor organs, we sometimes do ABO-incompatible transplants purposely now, a little more frequently than we have in the past, but below the diaphragm rather than above. I had a patient 20 years ago with an ABO-incompatible kidney transplant who did well. In the '70s and '80s, a few mistakes were made, and the patients did okay. But still, there's no question that the mismatch in this case lowered the odds of a good outcome. Once they recognized it, I assume they started appropriate procedures like plasmapheresis and immunoglobulin infusion to minimize hyperacute rejection. If she had a heart attack, it was because the donor heart blood vessels clotted off, so she may have had to be on cardiopulmonary bypass.
Before the second transplant, the doctors said she had about a 50-50 chance of the surgery being a success. Apparently she's now is in relatively stable condition with decent heart function, so she's doing better than I thought she would. It's a tough operation under the best of circumstances. If she got good organs, she may have a good chance. But her chances are less than they would have been without the mismatch happening first. Not because of any enhanced rejection, but because of her generally debilitated state, which may have included kidney failure.Medscape: What effect will this error have on public perception of organ donation and of transplantation programs overall?
Dr. Metzger: Hopefully it won't have a significant impact, at least not negatively, on the donor side. In Orlando, at least, we haven't seen any significant backlash. As someone said, I think it was Marilyn Monroe, there is no such thing as bad publicity. In some ways it's helpful when situations like this come to light, because the public sometimes thinks that transplants are a cakewalk. This helps them have a more realistic view that there can be problems. I'm heading up a transplant support group tonight, so it's a shame you're not talking with me about this tomorrow.Medscape: Do you think that media coverage of this situation may in fact highlight the need for more organ donors? Or would potential donors be discouraged that the first set of organs was wasted?
Dr. Metzger: I wish I knew how we could increase the number of organ donors. After intensive public relations campaigns last year, the number of organ donors increased by only 1.9%. As I like to say, the givers are giving, it's the nongivers we need to work on. On the positive side of this situation, the intensive media coverage may have helped this girl get a directed donation from someone who might not have been a donor otherwise. On the negative side, the first set of organs worsened the medical condition of this patient, and they never made it to someone who could have used them. There are only about 200 people right now on the list for heart-double lung. Still, if there was a suitable match in terms of blood type compatibility and size, this error caused those organs to be wasted.
Not having enough people signed up to be organ donors if they die suddenly is a real problem. The organ shortage makes us rely more and more on living donors, which is disturbing, because we're putting them in harm's way. Financial incentives are not acceptable in the U.S., although they are elsewhere in the world. Iran and Kuwait have solved the kidney waiting list problem by paying living donors to donate kidneys. In most of the Third World where dialysis is not available, patients with kidney failure have to receive transplants or else they die.
Some countries have presumed consent, a system in which people have to deliberately opt out of being organ donors. This has worked well in Spain, possibly in Belgium, but not likely in the U.S. Debate is ongoing, but as someone said, Americans are not used to being subjects, as many Europeans are; we view ourselves as individuals. So we don't like someone telling us what to do. Only 10% to 15% in the U.S. are in favor of presumed consent.
The federal government did a direct mailing on organ donation a couple of times, enclosing information with tax forms. We've done direct mailings to specific corporations, encouraging them to give out organ donor cards to all their employees, but that ends up being pretty expensive. We try to get people to sign up at public events.Medscape: How can individuals who want to help sign up to be organ donors?
Dr. Metzger: Just sign an organ donor card and tell your family. You can get the card at transplant centers, organ donation networks, hospitals, and motor vehicle bureaus. Most organ procurement organizations will shy away from organ donation if the family objects, so it's important to tell your relatives ahead of time. These organizations feel they have responsibility for three groups of patients: the recipient, the donor, and the donor's family, so they don't want to step on the family's toes. On the other hand, it's their responsibility to adhere to the individual's wishes. Really it's just like a will.Medscape: How bad is the organ shortage in the U.S.?
Dr. Metzger: In the U.S., there are now about 80,000 individuals on the waiting list for organs of any type, and 54,000 waiting for kidneys. About 5% on the waiting list for kidneys die before they get a transplant. So it's really not a waiting list, it's a waiting-to-die list. Maybe we're all attuned to waiting in our culture — we wait at the supermarket checkout, we wait in line at the bank, we especially wait at airports. So we don't see the urgency in organ donation — we think that someone else will take care of people on that list; it doesn't have to be me.
Reviewed by Gary D. Vogin, MD
Medscape Medical News © 2003
Cite this: Laurie Barclay. ABO Incompatibility in Heart-Lung Transplant: An Expert Interview With Robert A. Metzger, MD - Medscape - Feb 21, 2003.