• May 2020

    COVID-19 forces transplant programs to reassess their approach to transplant allocation decisions

As the COVID-19 (SARS-CoV-2) pandemic has taken hold in the United States, transplant programs have had to prepare to make critical decisions during a time of severely constrained resources. A transition must be made from the traditional “justice versus utility” approach in organ allocation to a more nuanced allocation scheme based on ethical values that drive decisions in times of absolute scarcity. The goal of this new mind-set is to help guide programs in deciding which patients to transplant, which donors to accept, how to minimize risk and how to ensure the best utilization of transplant team members.

“Even though CMS categorized transplant surgeries as the highest acuity that should not be postponed, we all know there is nuance to which transplant patients and procedures truly meet this standard. As resources became limited, our decisions about who to transplant had to be guided by both the practical reality of each center’s capacity, as well as underlying ethical values,” says Anji Wall, MD, PhD, an abdominal transplant surgeon on the medical staff at Baylor University Medical Center, part of Baylor Scott & White Health, and co-author of a recent paper on this topic published online in the American Journal of Transplantation in April.

As described by Dr. Ezekiel Emanuel in the New England Journal of Medicine in March, the four ethical values that guide rationing of absolutely scarce healthcare resources are to maximize benefit, treat people equally, promote and reward instrumental value and prioritize the sickest patients. Rather than abandon the already established ethical principles of justice and utility that direct organ allocation, the additional values described by Dr. Emanuel and colleagues can be an overlay for making decisions that deviate from standard transplant practice due to capacity constraints, risks of COVID-19 transmission and transplant team safety.

Maximizing benefit

Maximizing benefits to transplant patients is a delicate balance in the setting of COVID-19. Just looking at a match run and determining if the donor and recipient pairing is a good combination will not be enough. In the setting of limited resources, transplant surgeons must pivot and think about which patients will truly benefit from transplantation during this pandemic.

Transplant candidates who can quarantine at home until they receive an organ offer, as well as after transplant surgery, have a lower risk of COVID exposure. However, frail patients and those who have decompensated while on the waitlist are usually much more ill and may require hospitalization while waiting. They also have longer ICU times after transplant, placing them at higher risk for COVID-19 exposure. Each donor-recipient scenario will have different considerations when it comes to resource limitations, potential benefits and risks.

“Many transplants, such as a straightforward kidney transplant, are low resource-utilization operations,” Dr. Wall says. “When we receive an appropriate donor offer and if we have the resources available, we believe doing these transplants is a way we can work toward maximizing benefit and avoiding organ discards. The patient benefits from the kidney transplant, but also decreases the potential exposure to COVID-19 because it eliminates the need to go for dialysis.”

For patients in need of a heart or lung transplant, the considerations and ethical balances are far different. The vast majority of status 1 and 2 patients waiting for a heart transplant are in the ICU on life support, such as ECMO or balloon pump. These candidates have a much higher waitlist mortality than kidney transplant candidates. Every day without a heart transplant means these patients could experience device complications, sepsis or fatal arrhythmias.

“In patients with advanced heart failure, we don’t have living donors or the option of long wait times on dialysis. Often, there is just a matter of days to get these patients to transplant,” says Shelley A. Hall, MD, chief of transplant cardiology, mechanical circulatory support and advanced heart failure at Baylor University Medical Center. “We prioritized our status 1, 2 and 3 patients and kept them active on the wait list. Almost all were in the hospital so they were already potentially exposed to COVID-19. For patients with status 4 through 6, we evaluated them each week to make a quality decision whether making them temporarily inactive was safer than transplanting them in the COVID environment.

“In addition to pre-op testing of both donor and recipient, we screened the environment of the donor and cause of death to calculate the exposure risk to COVID-19,” Dr. Hall says. “It is the risk ratio decision we make every day with every donor offer we get, before, during and after the pandemic. With the measures the hospitals are putting in place to protect inpatients from COVID, I believe we have a very safe environment to continue transplants.”

Treat people equally

As programs become more resource constrained, decisions will have to be made about categorically excluding certain groups of patients from transplantation, even if patients are currently active on the transplant waiting list. These decisions that set more stringent criteria about who will be considered for transplantation must be made in a transparent and equitable manner.

“Similar to other U.S. transplant programs, we decided that we would not do living donor transplants until we could ensure safety to the greatest degree possible,” Dr. Wall says. “Now we test donors and recipients for COVID-19 48 hours prior to the operation and provide a safe pathway into the hospital. Patients go directly to pre-op, then the OR and then directly to a non-COVID unit. While no one can guarantee 0% risk of COVID exposure or of conversion to COVID-positive status postoperatively, I think we are doing an excellent job of providing safety for all of our surgical patients.”

Promote and reward instrumental value

The idea of instrumental value can play into transplantation in at least two ways, broadening the scope of consideration beyond the transplant recipient. The first is the instrumental value of the deceased donor who has the potential to save many lives. This is a major societal contribution which should generally be rewarded by prioritizing the utilization of critical care and operating room resources. However, during a surge, there will likely be a living person with a competing need for those same resources. The transplant community must be selective about which donors will truly maximize benefits to recipients and be expedient in donor evaluation and timing to minimize utilization of these scarce resources.

A second consideration in the framework of instrumental value is that of the transplant team members. If transplants cannot be performed during a COVID-19 surge, abdominal and thoracic transplant surgeons can assist their acute care and trauma surgery colleagues who have to continue to operate in the face of the pandemic. However, physicians caring for immunosuppressed transplant patients must not also care for COVID-19 patients, potentially putting immunosuppressed patients at risk. In a surge situation, programs must have a plan for caring for transplant patients while supporting the overall needs of the institutions.

Priority to the sickest patients

A final, more global consideration that must occur as resources become further constrained is how to prioritize the sickest and most vulnerable patients. This value is useful in determining who should be prioritized for vaccines, experimental treatments, ICU beds and ventilators.

“We have to treat patients in a similar way,” Dr. Wall says. “We can’t have a singular vision that all resources must go to COVID patients. We also have very sick patients who could need these resources. U.S. physicians are not used to facing absolutely scarce resource allocation decisions which compounds this challenge. Ultimately, we must be willing to consider what it means to be worst off in a pandemic and make prioritization decisions in light of the larger picture of all patients in need of scarce resources.”

Learn more about Baylor Scott & White Health’s COVID-19 Safe Care Plan at BSWHealth.com/SafeCare.