United Network for Organ Sharing (UNOS) and other groups have been diligently investigating the rising trend of organ non-use to identify root causes and develop effective solutions. As is the case with most elements of organ donation and transplant, the issue is complex and demands multi-faceted solutions from all stakeholders in the donation and transplant system.

As of March 2022, 25% of deceased donor kidneys recovered for transplant, were not ultimately transplanted.  Any organ not transplanted represents a loss, both for the selfless donor’s family and the waiting patient. We are called to honor the gift of life, and that commitment includes not only identifying the issue as to why this occurs, but also seeking substantive solutions to address it. We owe our patients and donor families nothing less.

To date, the most commonly reported reason for a donor organ to go unused is that the list of best-fit candidates on the waitlist was exhausted. In other words, every surgical team representing a patient declined the organ offer until there were no patients remaining on the list who were a match. Independent research suggests that registered transplant candidates who died in need of an organ had received a median of 16 organ offers while waitlisted.

Understanding Organ Non-Use

In order to fully grasp the complexities surrounding organ non-use, one must first understand the organ-matching process: Organ Procurement Organizations (OPOs) recover organs from deceased donors; UNOS, operating under contract with the federal government  in its role as the nation’s transplant system, matches them to the most compatible and medically urgent transplant candidates; the organs are then offered in descending order based on allocation rules to the hospital transplant programs where those candidates are registered. The decision to accept the organ offer ultimately rests with the matched candidates and their medical teams.

At UNOS, we have observed that the rate of organ non-use has been increasing for years, even as donation and transplant rates have also risen.

There are numerous reasons why some organs would be deemed medically unsuitable for transplantation to specific patients, such as organ biopsy findings that could lead to limited organ function or to complications post-surgery.  As a result, there is and will likely remain a degree of non-use based entirely on patient safety and anticipated outcomes. More than any other part of the transplant system, the medical teams at transplant programs have the most comprehensive understanding of their patients’ needs and what organs have the highest chances of resulting in successful transplants. They understand that no two organs are of equal quality. Organs from younger, healthier donors are much more likely to be accepted for transplant than organs recovered from donors who are older or who had health complications prior to their passing. Moreover, there have been annual increases in the successful recovery of organs from donors who experienced circulatory death rather than brain death (DCD donors).  Organs from these donors present greater challenges for successful use by medical teams accepting these organs for appropriate recipients.

These medically complex organs can often be used to save lives, but they nonetheless go unused. Despite this, recent medical innovations and practices have allowed more of these organs to be safely recovered, enabling more transplant surgeries to be performed every year. Although we have these enhanced capabilities thanks to many system-wide advancements, a non-use rate of zero would suggest that OPOs are either failing to recover or purposefully avoiding organs that may be more complex but remain perfectly safe for transplant.

Finding Solutions

Working in collaboration with members of the donation and transplantation community and experts in other fields, UNOS is pursuing a variety of innovative strategies to improve organ acceptance rates at hospitals – to get them to say “yes” on organ offers more easily. UNOS is doing this to save more lives both in its role as the nation’s transplant system – or Organ Procurement and Transplantation Network (OPTN) – and as the mission-driven nonprofit committed to continuously improving the system for the patients who rely on us.

This includes working to improve transportation options for donor organs, as every effort should be made to optimize their timely and efficient delivery.

A vital part of the solution is the need to streamline the acceptance of organ offers by transplant programs. A congressionally requested report by the National Academies of Sciences, Engineering, and Medicine (NASEM) emphasizes the importance of making it easier and quicker for transplant centers to accept to organ offers. In line with this goal, UNOS is leading OPTN collaborative efforts to enhance screening and offer processes for OPOs and transplant programs.

Other relevant UNOS and OPTN projects underway include:

• Offer Filters, a multi-criteria data tool that provides insight to kidney transplant programs on their offer acceptance habits and allows them to filter out offers that they historically do not accept. Such offers could then be presented earlier to other centers who would be more willing to use those organs for transplant, thereby saving time in the offer process and lowering the risk of non-use. More than half of the kidney transplant centers in the nation have elected to use offer filters since UNOS introduced them in January 2022.
• Predictive Analytics, another tool offered to kidney transplant programs that – at the time of an organ offer – leverages data and statistics-based modeling to predict when the transplant candidate in-question could receive the next organ offer as well as their likelihood of survival during that time without a transplant. During a pilot phase, participating programs showed a 2.9 percentage point increase in offer acceptance compared to the previous period while control centers did not show an increase.
• A new image study viewer provides increased image quality in the national donor image sharing hub that enables healthcare providers to quickly access vital information about potential donors and make better informed decisions when considering organ offers.
• A UNOS-developed travel application helps OPOs select the most efficient options for shipping organs on commercial flights. It aggregates real-time flight schedules, driving directions and critical logistics data like cargo hours to give pilot program users a comprehensive look at an organ’s projected travel time and path. The tool is expected to be available to all organ procurement organizations this year.   

Together, these innovations can be applied to the overall organ donation and transplant ecosystem to ensure that donor organs are being offered to the right transplant candidates at the right time.

Equally important to the sophisticated transplant tools are the professionals who use them. Ongoing collaborations within the organ donation and transplant community are underway to emphasize and encourage collective action. A national collaborative led by UNOS was initiated in January, uniting experts from more than 80 leading transplant programs across the country, with the specific goal of increasing organ offer acceptance rates. The goal of the collaborative is to share effective practices with the community and increase system efficiencies. The long-term results can help inform innovative solutions to organ non-use.  However, we must not become complacent: continued investment in research and education is essential to saving lives and honoring selfless donors and their families.

Forward Together

The issue of organ non-use demands immediate attention and united action. Each organ donation represents a precious opportunity to save a life, and it is a tragic loss when a donor’s generosity does not result in another life saved. The entire organ donation and transplant community must redouble our commitment to maximizing the gift of life. Collaboration among all stakeholders – including UNOS, OPOs, transplant programs, Congress and government regulators – is essential. We must continue to hold ourselves accountable, foster innovation, and strive to overcome challenges to arrive at a system that works better for every patient in need.

By embracing innovative solutions, such as leveraging new technology to improve organ offer processes, expanding the criteria for suitable organs, and enhancing allocation methods, we strive to unlock the full potential of organ transplantation. Further public education and awareness campaigns are vital to dispel myths, misconceptions, and stigmas surrounding transplantation and organ donation.

Together, we have the power to transform the lives of countless individuals awaiting a second chance. The time for action is now. Let us maximize the gift of life and bring hope to those in need.

The post Unlocking the Full Potential of Organ Transplants appeared first on Medika Life.

The United States has an effective, inclusive and diverse transplant system that saves thousands of lives every year. It has taken decades to get us to this point, made possible due to the gifts of generous donors and their courageous families and the meticulous coordination that takes place every day between patients, physicians, hospitals, organ procurement professionals and volunteers.

As the Chief Medical Officer at United Network for Organ Sharing (UNOS) and the former medical director of major university-based kidney and transplant programs, I have the unique experience of knowing what this lifesaving system looks like up close.

What is UNOS?

UNOS powers the nation’s organ donation and transplant system. We hold the federal contract to serve as the Organ Procurement and Transplantation Network (OPTN), established by Congress in 1986, which also requires that a private, nonprofit organization oversee the transplant system, with decision-making authority given to patients and medical professionals.

UNOS built, maintains and upgrades the nation’s computerized national waitlists of organ transplant candidates. We also built the secure technological infrastructure that makes it possible to offer donor organs to patients in need. In collaboration with transplant professionals and many other stakeholders, we establish policies that allocate organs to waitlisted patients. Patients, physicians, surgeons and others discuss and develop policies in an effort to allocate donor organs equitably and efficiently. Finally, we work with transplant centers and organ procurement organizations to drive improvements and bolster performance.

This extensive national infrastructure and the people who power it are committed on a single purpose: to ensure that patients can receive the gift of life from a generous organ donor.

The Generous Donor

Organ donors are most commonly patients in hospitals who, due to severe injury or illness, have been declared brain dead but whose organs may remain viable for transplant. It’s important to remember that less than 1% of people die in a way that makes organ donation possible.

Physicians exhaust every available option to save a patient’s life. However, if the patient passes away, other lives may be saved through organ donation. At that point, the hospital contacts their local Organ Procurement Organization (OPO), one of 56 regional nonprofits that assess, collect and transport donated organs. OPO staff are trained to counsel families during one of the most difficult moments of their lives.

If the deceased patient is a registered organ donor, the OPO works with the family so they understand the donation process. If the patient was not registered as an organ donor, the OPO staff will offer the family the option to donate.

We should not underestimate the importance of this decision and the strength and courage required by a family during such an emotional time. This decision is transformational – a single donor can save up to eight lives.

Making the Match

After the OPO confirms donation consent, their staff determine if a deceased donor’s organs are viable for transplant. If so, they enter the patient’s medical information into the UNOS database. It generates a list of best match candidates based on a variety of clinical factors, including blood type, body size, severity of illness, distance from the donor hospital and time on the waitlist. 

Currently, more than 100,000 patients are on the national waiting lists, the majority of whom are waiting for a kidney transplant. Potential transplant recipients are placed on the transplant waiting lists after being referred and evaluated at a transplant hospital.

While popular culture has trained us to think otherwise, no patient has a fixed position on the national waitlist; in fact, a patient’s place on it can change over time. It’s more accurate to think of the waitlist as a pool of candidates, awaiting the organ that best fits their unique genetic and medical profile.

Once the UNOS system has produced a list of candidates who best match the available donor organs, the OPO contacts the transplant hospitals of matched patients, once again using UNOS’ computer systems.

A Race against Time

After an organ has been accepted by the patient and their doctors, time is of the essence; organs can be preserved outside the body for only a short time – often just a few hours. The organs are then respectfully recovered from the generous donor.

The OPO arranges to transport the donated organ to the transplant hospital. Once the medical team transplants the organ, a life can be saved, quality of life can be improved and a donor’s legacy can be honored. Recovery from a transplant differs from patient to patient, but each include life-long medications and lifestyle changes.

This complex, lifesaving process, with its many moving parts and medical, logistical and geographic requirements, happens every day. It is successfully replicated across the country seven days a week, 24 hours a day, 365 days a year.

A Lifesaving Goal

We are proud of the results. We have now surpassed over 1 million transplants in the United States since the nation’s first successful transplant in 1954. In 2022 alone, over 42,800 transplants were performed – more than any other year. Our transplant system continues to set lifesaving records thanks to generous donors, their courageous families and the hard work and dedication of those who make up this diverse and thriving national system.

Understanding how the system works, the people who make it possible, the lives saved and the donors honored is essential to advancing our shared goal of driving continuous system improvement to save as many lives as possible.

The post Behind the Complex Balancing Act to Save Lives Every Day appeared first on Medika Life.

Just transplanting an animal’s organ into a human will not work. The person’s immune mechanisms will immediately reject the transplanted organ. So, what is to be done? The key is to genetically engineer the animal to produce organs that are less likely to be rejected. In the last 20 years, there’s been substantial progress on the research front to produce genetically modified pigs. Why pigs? Pig organs are about the same size as human organs but also share many physiologic similarities.

Recent technologies, including CRISPR, have allowed more possibilities to genetically engineer the pig’s genome. A few specific genes have been identified that are critical. Some were modified and some inactivated, called “knocked out.” It’s not just a matter of changing the pig’s genetics, but it’s also having a very specific anti-rejection drug combination. This includes the standard drugs used to prevent rejection of human organs and a specially designed monoclonal antibody against a part of the immune system called CD 40. This monoclonal antibody has been found to be essential and critical to the successful transplantation of a heart in the nonhuman primate model with animals maintained without rejection for upwards of 900 days.

In September 2021, a xenograft kidney from a genetically engineered pig was placed in a brain-dead patient still on life support. It was observed for 58 hours at the New York University Langone Hospital Center with the family’s permission to study for evidence of function and rejection. As a result, the surgical and research team, led by Dr. Robert Montgomery, himself a donor heart transplant recipient, were able to obtain critical information about the pig organ after transplantation. “Whole-body donation after death for the purpose of breakthrough studies represents a new pathway that allows an individual’s altruism to be realized after brain death declaration in circumstances in which their organs or tissues are not suitable for transplant.”

On Friday, January 7, Bartley Griffith, MD, Muhammad Mohiuddin, MD, and an extensive team of multi-specialties successfully implanted a genetically modified pig heart obtained from the Revivicor company. Revivicor created the genetically modified pig and hence the heart to the investigators’ specifications. This included modifying ten genes with three knocked out that lead to antibody development and one knocked out that controls the pig organs’ growth. The patient will also receive various anti-rejection drugs plus the monoclonal antibody aimed at CD40.

The patient, a 57-year-old man, was on life support and not eligible for a human donor organ. His projected lifespan was in days to weeks. He understood the risks of the procedure and that it was a first-time human experiment. But as he said before surgery, “It was either die or do this transplant. I want to live. I know it’s a shot in the dark, but it’s my last choice… I look forward to getting out of bed after I recover.”

The Food and Drug Administration (FDA,) having reviewed the research data, authorized the procedure “for compassionate use” on New Year’s Eve. As of Tuesday, January 12, the patient was doing well with no evidence of rejection. Only time will tell if he will make a full recovery and have his pig heart perform for many years.

Dr. Griffith is a cardiovascular surgeon with years of experience in transplanting human hearts and lungs. He has been working on xenotransplantation for over a decade. Dr. Mohiuddin joined with Dr. Griffith at the University of Maryland School of Medicine and Medical Center about five years ago to further pursue his research from the National Institutes of Health. He and colleagues developed the initial techniques to prevent rejection by gene modifications and anti-rejection drugs.

Together Griffith and Mohiuddin established the Xenotransplantation Center with Griffith as clinical director and Mohiuddin as scientific director. But, of course, there is a large team, not just the two of them. The Center investigators received a $15.7 million sponsored research grant to evaluate Revivicor genetically-modified pig hearts in further baboon studies. Last week’s surgery was the current culmination of those studies with a first in human heart xenotransplantation.

A new dawn has likely arrived for organ transplantation. But, of course, this was only the first patient. It remains to be seen how effective it will be in this man or how effective it will be in others treated with other genetically engineered pig organs like kidneys, pancreas, or lungs. But without question, it’s an exciting time with transplant-waiting individuals having a new potential on the horizon for returning to a reasonably normal life.

Stephen C Schimpff, MD, MACP, is a quasi-retired internist, professor of medicine, former CEO of the University of Maryland Medical Center, and author of Longevity Decoded — The 7 Keys to Healthy Aging and his co-authored book with Dr. Harry Oken BOOM — Boost Our Own Metabolism

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