INSIGHTS

UNOS Chief Medical Officer David Klassen, M.D., discusses perfusion-driven advances and remaining challenges

Normothermic perfusion continues to show promise as an innovation that will help increase the number of donor organs available for transplant. With perfusion, circulation and normal body temperature and function are maintained for the organ, making it possible both to evaluate the organ and potentially to limit the impact of ischemic time. However, cost, technology and training considerations remain barriers to widespread implementation. UNOS Chief Medical Officer Dr. David Klassen discusses recent developments in the field.

Explore issues in normothermic perfusion with a curated reading list

Q. Where is perfusion having the most impact right now in organ transplantation?

We’re seeing a steady increase in the number of organs being perfused. In 2022, more than 1,100 transplanted donor livers, hearts and lungs were perfused. Between 2018 and 2022, there was an almost five-fold increase in perfused livers transplanted, from fewer than 100 to nearly 500.

Perhaps the most important recent development is perfusion for DCD (donation after circulatory death) heart transplantation. Because the heart is particularly vulnerable to warm ischemic injury, increasing the number of successful DCD heart transplants was really dependent on perfusion technologies. A third of all donors are DCD donors, and potentially a significant number could be heart donors; one study estimated that widespread adoption of DCD heart transplant could lead to 300 more adult heart transplants annually.  UNOS data show that the number of DCD hearts perfused and transplanted has gone from 0 in 2018 to 199 in 2022.

“Perhaps the most important recent development is perfusion for DCD (donation after circulatory death) heart transplantation.”

David Klassen, M.D., Chief Medical Officer

Q. Are there other significant new developments?

In addition to ex-vivo machine perfusion, normothermic regional perfusion (NRP) for recovery of organs from DCD donors is now spreading fairly widely, and is also helping to increase the number of DCD hearts available for transplant. (See Normothermic Regional Perfusion: A reading list.) With NRP, cardiopulmonary bypass or ECMO is used to restore circulation and enable perfusion of DCD organs prior to recovery. Because these technologies are already in use in most ICUs, there is no new technology to acquire or learn to use, as there is with ex-vivo machines. Also with NRP, separate perfusion devices for each organ aren’t needed, as abdominal and thoracic organs can be perfused before recovery with this process.

Q. What barriers remain to greater use of perfusion?

At the present time cost remains the most significant limiting factor for either type of perfusion. It’s expensive, and questions have yet to be resolved about when it is most appropriate to use perfusion,  who pays for it, and how those costs are reimbursed.  Whether cost will limit the use of perfusion to larger and better-resourced transplant centers or OPOs remains to be seen.

Implementation of these technologies is also logistically complex.   It takes time and effort for new technologies and procedures like these to be widely incorporated.

Finally, more data are needed to firmly determine whether perfusion leads to better patient outcomes. Research so far indicates generally equal outcomes when compared with non-perfused organs.  Despite these questions perfusion is enabling increased use of expanded criteria and DCD organs, including those that previously might not have been considered viable for transplant.

Read more

Will organ perfusion transform transplantation?

The hypothermic option: Organ Recovery Systems

David Klassen, M.D., on technology making more organs available

Matthew Hartwig, M.D., on increasing lung utilization

Game changers: At the forefront of organ perfusion technology

In focus: Lung and liver perfusion on the rise

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Implemented in 2015 , the HIV Organ Policy Equity (HOPE) Act has given more than 350 living with HIV an opportunity to receive a lifesaving transplant from an HIV-positive donor.

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United Network for Organ Sharing (UNOS) today announced that CEO Brian Shepard will depart the organization at the end of September, following the completion of his contract. Shepard’s 10-year tenure as UNOS CEO was marked by groundbreaking progress in the U.S. organ donation and transplantation system.

Maureen McBride, Ph.D., UNOS’ chief operating officer, will assume the role of interim CEO beginning Oct. 1 while UNOS conducts a national search for Shepard’s successor. McBride has been with the organization since 1995. She served as director of research until 2014, when she accepted her current role as COO.

A commitment to improving the system

During his tenure, Shepard presided over the adoption of innovative policies, lifesaving improvements and record increases in both organ donation and transplant, including 2021, when the national system conducted more than 41,000 transplants in a single year, a global record. These and other advancements have positioned UNOS to drive the next phase of system progress, from increasing equity in transplant to adopting cutting-edge technologies, to collaborative improvement, further strengthening the nation’s high performing system and saving more lives.

“As UNOS CEO, Brian was a constant and courageous advocate for increasing equity in our national donation and transplantation system,” said Jerry McCauley, M.D., vice-president of the UNOS Board of Directors and incoming president. “His leadership has resulted in marked improvements in access to transplant for patients of color and those who have been historically marginalized. I am proud to have worked alongside Brian as a member of the UNOS board and am excited to build upon the foundation he has laid to further advance our mission and save even more lives.”

“UNOS is the engine that powers the U.S. donation and transplant system, and we are so lucky to have had Brian Shepard in the driver’s seat for the past decade,” said Matthew Cooper, M.D., president of the UNOS Board of Directors. “During such a pivotal time in our community, Brian took UNOS to the next level, driving accomplishments and championing the work of so many. His is a legacy to be celebrated.”

Prioritizing patients, equity and innovation

Under Shepard’s leadership, UNOS undertook a series of efforts to increase equitable access to transplant, including adopting a new way to distribute donor organs that emphasizes patient need. These new polices have resulted in greater access for the sickest patients.

“These changes to organ distribution weren’t easy or always popular, and it was so important to have Brian centering these discussions,” said David Mulligan, M.D., immediate past president of the UNOS board. “Now that these policies are in place, we can see the positive impact they’re having on patients and families across the country.”

Additionally, Shepard was instrumental in the development of UNOS Labs, an innovation center dedicated to fostering new ideas and encouraging experimentation. Since its founding, UNOS Labs has developed transplant-focused predictive analytics to help doctors decide whether to accept an organ offer for their patient, a GPS tracker for organ shipments, an offer simulator to conduct behavioral science research to improve organ matching, and a high-quality medical image sharing platform.

“The UNOS team is the most incredibly talented and dedicated team I’ve ever had the honor of being a part of,” said Shepard. “I’ve always viewed my job as making their job easier; removing obstacles and watching them run. I’m so proud of what they’ve accomplished and of all of the ongoing efforts that will further improve donation and transplant in the U.S.”

A vision for the future of organ allocation

Over the last several years, Shepard has helped put into place a new allocation policy, called continuous distribution. This innovative approach dissolves rigid boundaries, and is structured so that no single attribute determines whether or not a patient receives a transplant. Importantly, continuous distribution is also designed to allow for more patient engagement in the decision-making process.

“As a three-decade heart transplant survivor who strongly advocates increased involvement for transplant patients in the policy development process, continuous distribution is a game changer,” said Jim Gleason, president of Transplant Recipients International Organization (TRIO). Gleason has engaged with UNOS for more than 25 years and is a two-term former UNOS Board member. “This effort is not only going to help guide patients to the information they need in their transplant journey, it will also give them an active contributor seat at the decision-making table.”

A lasting legacy

“From policymaking to technology, from system-wide improvements to one-on-one interactions, Brian’s leadership has left an indelible mark on UNOS and the wider donation and transplant community,” said Sue Dunn, former CEO of Donor Alliance and a former UNOS board president. “But for me, to see his ongoing commitment to honoring selfless donors, their courageous families, and recognizing the often-thankless work of our OPOs – that is a legacy be proud of.”

“We’ve come such a long way in the last decade,” said Shepard. “While I am honored that the Board asked me to continue to serve as CEO, I felt it was the right time to take the next step. I have worked with so many amazing and dedicated people over the years who made it possible to accomplish all that I originally set out to do as UNOS CEO. Now, as we embark on a new chapter with even more exciting opportunities, I know the UNOS team and the donation and transplant community are in good hands, and I’m excited about the future.”

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The winter 2021 public comment cycle opens Jan. 21 and will close March 23. The Organ Procurement and Transplantation Network (OPTN) is offering six proposals, two requests for feedback, and one white paper for public comment.

Comments and replies will be published here on the OPTN website to promote transparency and trust in the national transplant system. Visitors also have the option to share their posted comments to social media.

We encourage patients, transplant candidates and recipients, living donors, donor families and transplant professionals to learn more about the proposals and provide their valuable feedback to help shape U.S. organ transplant policy.

Items available for public comment:

• 2021-2024 OPTN Strategic Plan
• Calculate Median MELD at Transplant around the Donor Hospital and Update Sorting within Liver Allocation
• Clarify Multi-Organ Allocation Policy
• Develop Measures for Primary Graft Dysfunction in Hearts
• Modify the Deceased Donor Registration (DDR) Form
• Require Notification of Human Leukocyte Antigen (HLA) Typing Changes
• Revise General Considerations in Assessment for Transplant Candidacy
• Update National Liver Review Board Guidance Documents and Policy Clarification
• Update Transplant Program Key Personnel Training and Experience Requirements

Educational resources will be made available January 21 to provide multiple opportunities to learn more about the proposals.

All comments are reviewed and considered by the OPTN Board of Directors before they vote on the proposals to become policy. Learn more about the policy development process here.

Engage in public comment

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This holiday season, organ placement specialists are working around the clock in the UNOS Organ Center to help place lifesaving organs across the country. Here’s their holiday message for everyone touched by transplant. We wish you all a healthy and peaceful New Year!

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Pediatric transplant program components

The Board of Directors of the Organ Procurement and Transplantation Network, at a virtual meeting held Dec. 7, approved pediatric components for 268 heart, kidney, liver, lung and pancreas transplant programs. Effective Dec. 8, any candidate younger than age 18 must be listed at one of these programs unless an exception is made for a very medically urgent heart or liver candidate. The searchable member directory on the OPTN website will display programs with a pediatric component.

“This is a key milestone in promoting the safety and efficiency of transplantation for children in need of a transplant,” said David Mulligan, M.D., president of the board. “The requirements were developed carefully to ensure that these programs have highly trained and experienced clinical staff and appropriate facilities to care for the specific needs of pediatric candidates and recipients. The application and review process took place in a staged fashion to allow programs interested in applying to take any needed steps to ensure they would qualify.”

Strategic planning

The board heard an overview of ongoing development of the OPTN Strategic Plan for 2021 through 2024. The OPTN Executive Committee will circulate a draft plan for public comment in January 2021, and a proposed final plan will be presented for board action in June 2021. As currently envisioned, there are four overall strategic goals:

• Increase the number of transplants
• Provide equity in access to transplants
• Promote living donor and transplant recipient safety
• Improve waitlisted patient, living donor, and transplant recipient outcomes

COVID-19 operational actions reviewed, will remain in effect

The board reviewed several operational actions adopted by the OPTN Executive Committee in March and April, 2020, to help members document COVID 19-issues affecting organ donation and transplantation and to help members focus needed resources on essential clinical services. The board agreed to make permanent a requirement for OPTN members to document COVID-19 testing for all potential deceased donors. The board resolved that the following measures will remain in effect, subject to ongoing Executive Committee review for their applicability and effectiveness:

• Updates to transplant candidate data if a transplant hospital is unable to bring a candidate in for updated lab testing due to COVID-19 issues
• Relaxation of certain data submission requirements for follow-up of transplant recipients and living donors
• Modifications to reporting wait time initiation for kidney transplant candidates who are not on dialysis

Other actions

The board took additional actions as follows:

• Approved new and amended OPTN policies to align with recently updated recommendations from the U.S. Public Health Service to assess organ donors and monitor transplant recipients for potential HIV, hepatitis B and hepatitis C infection
• Endorsed a slate of nominees for election to open positions on the board for terms beginning July 1, 2021
• Approved the programming into the UNet^SM system of allocation policy for vascularized composite allografts (VCA)
• Modified data collection requirements for living VCA donors
• Accepted new guidance and updated policy regarding adult heart allocation, to standardize and streamline data reporting for candidates with certain clinical conditions
• Adopted guidance addressing the use of exception requests for pediatric heart candidates
• Approved additional updates to operational processes and guidance for the National Liver Review Board, to clarify guidance and better ensure expert review of exception requests
• Updated the cohort of data used to calculate the lung allocation score
• Amended the OPTN Bylaws to permit all members of the board to vote on the full slate of representatives to the OPTN Executive Committee

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Implementation date:

• Dec. 3: Heart, lung, heart-lung, liver and intestine

At-a-glance

For heart, lung, heart-lung, liver and intestine programs, local donor acceptance criteria in Waitlist℠ have been updated in order to provide additional efficiency in organ allocation. Transplant programs should evaluate their current settings.

Summary of changes

With the transition away from donation service area (DSA) as a unit of allocation, a new framework has been developed to determine what type of offers would be screened using “local” acceptance criteria for a candidate. Because proximity to the donor hospital is a primary factor in the revised allocations, changes have been made to allow the location of the donor hospital in relation to the candidate to be considered when “local” acceptance criteria are applied.  Read additional background information here.

For each organ type, the following new local acceptance criteria will be used to include candidates on the match run:

• Offers to candidates listed at transplant programs within the DSA and/or within 250 NM of the donor hospital:
  • Heart
  • Heart-lung
  • Lung

• Offers to candidates listed at transplant programs within the DSA and/or within 150 NM of the donor hospital:
  • Liver

• Offers to candidates listed at transplant programs within the DSA and/or within 500 NM of the donor hospital:
  • Intestine

Similar changes will be implemented for kidney and pancreas allocation on Dec. 15, when DSA and region are removed from distribution of those organs.

The inclusion of DSA in this definition does not impact the order of the match run as that is established and organized by distance-based allocation definitions within OPTN policy.

What you need to do

Transplant programs for all organ types should evaluate their current “local” acceptance criteria settings for candidates in Waitlist and determine if updates are appropriate based on the revised definition of “local” donor acceptance criteria.

Additional resources

Find professional education on UNOS Connect:

• QLT103D Acceptance Criteria for Distance-based Allocation

In addition, DonorNet® online help documentation has been updated so that transplant programs will have access to the information about how local acceptance criteria is used for offers for all organ types.

Questions?

If you have questions relating to implementation, contact UNOS Customer Service at unethelpdesk@unos.org, or call 1-800-978-4334 from 8 a.m. to 7 p.m. EST.

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This final rule revises the Organ Procurement Organizations (OPOs) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures and increasing competition for open donation service areas (DSAs).