Fact checked byRichard Smith

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July 14, 2023
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Overhaul of ‘calcified’ US organ transplant system can expand donor pool, save lives

Fact checked byRichard Smith

Key takeaways:

  • Many patients on the waitlist for a heart transplant die before receiving one.
  • The federal government is leading a public-private partnership to improve the organ transplant system.

Editor's Note: This is part 3 of a three-part Healio Exclusive series on developments and challenges in heart transplantation. Part 1 can be viewed here. Part 2 can be viewed here.

Despite an expanded availability of donor hearts, there remains a shortage of available donor organs for people in need of transplantation, and many experts point to widespread inefficiencies with the U.S. organ transplant system.

Graphical depiction of source quote presented in the article

The heart transplant waitlist is dynamic and has approximately 3,300 patients, according to data from the United Network for Organ Sharing (UNOS).

“In 2022, we completed about 4,100 transplants. We expect that number to grow by about 5% annually; however, that means some people who are wait-listed will never receive a transplant,” Stuart Knechtle, MD, professor of surgery and director of Duke Transplant Center, told Healio. “Approximately 10% to 15% of patients are withdrawn from the transplant list or die before they can receive a transplant.”

Efforts underway

In March, the Biden administration announced a plan to overhaul the country’s organ transplant system. The Health Resources and Services Administration (HRSA), part of HHS, said it will focus on accountability by seeking more contracts to operate the Organ Procurement and Transplantation Network and by sharing data more transparently.

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Data were derived from HHS. HRSA announces Organ Procurement and Transplantation Network modernization initiative. Available at: www.hhs.gov/about/news/2023/03/22/hrsa-announces-organ-procurement-transplantation-network-modernization-initiative.html. Published March 22, 2023. Accessed May 10, 2023.

As part of the update, HRSA has added a new data dashboard on its website to share de-identified information on organ donors, organ procurement, transplant wait lists and transplant recipients.

In a viewpoint article published in January in the American Journal of Transplantation, Knechtle suggested the data management approach of the Organ Procurement and Transplantation Network — which has been criticized due to long wait lists and the number of deaths among those waiting for transplant — be replaced with a patient-centric, omnichannel network in which all donor and recipient data exist in a single longitudinal record that can be used by all applications.

“The information platform that governs and oversees the system of organ transplant is a computer system developed in the 1980s. Frankly, computer systems built in the 1980s don’t need to be improved, they need to be replaced,” Knechtle said. “This platform was designed on the idea of a list, just like a list on a sheet of paper. That is not the optimal method for allocating organs from donors to recipients. The current system gives each center 1 hour to accept or refuse an organ. The problem with that is it just adds more wait time for those further down the list, as the organ gets worse.”

Knechtle said allocating organs should be as quick and efficient as ordering an Uber or a package from Amazon — and that the technology to make that happen is readily available.

“The American public is used to extremely efficient systems,” Knechtle said. “During COVID, we all became used to ordering retail items on Amazon, which is a magnificent computerized system of retail. We expect things to happen quickly. They can, with good systems. We should be using current technologies. Instead, UNOS, a noncompetitive system, becomes calcified and does not adapt. We are grateful HRSA decided to address this and are providing funding for this. That competition will bring in industry partnerships with academic transplant centers. Through a public-private partnership, we think we can bring tremendous improvement to the system, which is what people deserve.”

‘Many of these hearts could have been used’

Seth Hollander

Equally as important in pediatric heart transplant is to utilize available donor organs, according to Seth Hollander, MD, pediatric cardiologist and medical director of heart transplantation at Stanford Medicine Children’s Health.

“One of the most striking and disappointing statistics in my field is that for 50% of families that offer their child’s heart for organ donation, more than half are being rejected by the transplant center and that heart is not being utilized,” Hollander said. “Many of these hearts could have been used had the system been more equipped to incentivize a ‘yes’ answer rather than a ‘no’ answer.”

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With the onset of the COVID-19 pandemic, there is an increased rate of donors testing positive for COVID-19, which generally renders the donors unsuitable for transplantation. Several institutions have started to use COVID-19-positive donor hearts for heart transplantation in recent months and have reported good outcomes, Adam D. DeVore, MD, associate professor of medicine at Duke University School of Medicine and member in the Duke Clinical Research Institute, told Healio. However, in a study published in the Journal of the American College of Cardiology in May, some recipients of hearts from donors with active COVID-19 had an elevated risk for death at 6 months and 1 year. New research also demonstrates donor hearts positive for hepatitis B and C are also acceptable for transplant.

“We can now transplant hearts from donors who are positive for hepatitis C, hepatitis B and COVID-19,” DeVore told Healio. “We are trying every possible avenue to use donor hearts that we could not historically use before.”

Mary Norine Walsh

Healio | Cardiology Today Editorial Board Member Mary Norine Walsh, MD, MACC, medical director of heart failure and transplantation at St. Vincent Heart Center in Indianapolis and past president of the American College of Cardiology, said public awareness of the need for donors is paramount.

“Designating donor status on your driver’s license and making sure your wishes for donation are known to your loved ones is crucial,” Walsh told Healio.

A future of ‘open-ended hope’

Jon Kobashigawa

In a perspective published in the Annals of Cardiothoracic Surgery, Healio | Cardiology Today Editorial Board Member Jon Kobashigawa, MD, director of the advanced heart disease division and of the heart transplant program at the Smidt Heart Institute at Cedars-Sinai, as well as associate director of the institute, wrote that “the future of heart transplant is bright,” with the advent of newer immunosuppressive medications and strategies that may even result in transplant tolerance without immune suppression. The future will also include personalized medicine, where genomics and molecular science could dictate customized treatment for optimal outcomes.

“When I say immune suppression, I mean better tolerance,” Kobashigawa said in an interview. “Can we develop better tolerance with gene editing or with regulatory cells? There are many ways, using thymus or even bone marrow transfusions beforehand. Xenotransplantation is the second parallel arm. Can we get better with that? What happened to that first patient? There was probably antibody rejection and some infection issues.”

Advances in mechanical circulatory support will also improve outcomes for patients, he said.

“That is not quite transplant, but it is an alternative,” Kobashigawa said. “Can we get better? Can we have a tetherless device, something implantable with a rechargeable battery? Then, the patients would have freedom to do whatever they want. These are things that need to be addressed.”

DeVore agreed.

“There will always be a need for transplant, but I am excited about mechanical circulatory support,” DeVore said. “I do think that we will one day in the near future have fully implantable mechanical circulatory devices that require no immune suppression. I look forward to that and it will happen once we address challenges around design and battery technology.”

Hollander said he hopes continued advances will lead to a future where every person listed for a heart transplant will receive one.

“I would like to see a world in which every single waiting list mortality is unexpected and considered a tragedy,” Hollander said. “I would also like to be able to tell my patients and their families that they can have open-ended hope after a transplant. I don’t want anyone to think that when we do a heart transplant, their time is limited; that there is a clock ticking and there is only so much to expect out of life. I want to say to a patient, ‘Your future is wide open.’ Then, we will have made a real difference.”

We want to hear from you:

Healio wants to hear from you: Do you have an experience with UNOS that you would like to share? Share your thoughts with Healio by emailing the author at rschaffer@healio.com or tweeting @CardiologyToday. We will contact you if we wish to publish any part of your story.

References:

For more information:

Adam DeVore, MD, can be reached at adam.devore@duke.edu; Twitter: @_adevore.
Seth Hollander, MD, can be reached at sethh1@stanford.edu; Twitter: @sethhollander.
Stuart Knechtle, MD, can be reached at sstuart.knechtle@duke.edu.
Jon Kobashigawa, MD, can be reached at jon.kobashigawa@cshs.org.
Mary Norine Walsh, MD, MACC, can be reached at macwalsh@iquest.net; Twitter: @minnowwalsh.