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Living Donation in the News / How to End the Kidney Shortage
« Last post by Clark on Yesterday at 07:47:48 PM »
https://www.cato.org/regulation/spring-2023/how-end-kidney-shortage

How to End the Kidney Shortage
Few if any of these news stories lamenting the kidney shortage or touting hightech breakthroughs mention that we already have a solution to the shortage: compensating kidney donors to induce more supply
SPRING 2023 • REGULATION
By Frank McCormick and Philip J. Held

News stories abound of kind people—relatives, close friends, and even complete strangers—who donate a kidney to someone suffering from kidney failure. These stories usually explain that people whose kidneys have failed must either obtain a transplant, which enables them to live 10–20 years in reasonably good health, or suffer on dialysis for an average of four to five years as their health steadily deteriorates until they die.
Sometimes these stories explain that many kidney failure patients never receive the optimal treatment of a transplant because there is a drastic shortage of transplant kidneys. About 125,000 patients are diagnosed with kidney failure each year, but only about 22,000 receive a transplant. In a 2022 Value in Health article, we estimate that more than 40,000 additional kidney failure patients would be saved from premature death each year if they received kidney transplants.

Recently, there have been news stories about xenotransplantation: the transplanting of animal organs (usually from pigs) into humans. These came after a patient with terminal heart failure received a genetically modified pig heart and lived for two months. That raised the hopes of many that this breakthrough might be extended to kidneys. However, Food and Drug Administration approval for xenotransplant kidneys will not occur for some time (if ever); the data from the first Stage One trial—which is merely the first step toward any approval—won’t be available for at least a decade. It is extremely unlikely that anyone currently suffering from kidney failure will benefit from xenotransplantation.

Few if any of these news stories lamenting the kidney shortage or touting high‐ tech breakthroughs mention that we already have a solution to the shortage: compensating kidney donors to induce more supply. Frustratingly, the U.S. government is obstructing this solution.

NOTA is the problem / Virtually all economists who have studied the issue believe the basic cause of the kidney shortage is a provision in the 1984 National Organ Transplant Act (NOTA): “It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.”

This sentence seems innocuous, but it imposes a price ceiling of near‐ zero on the market for kidneys. Both economic theory and abundant evidence have shown that whenever the government holds the price of a good below the market‐ clearing price, it causes a shortage of that good. Moreover, if the government holds the price far below the market‐ clearing price (our 2022 article estimates that price would be about $80,000 per kidney), then the shortage will be huge: more than 40,000 kidneys per year in the United States alone. For context, that is more deaths than from motor vehicle crashes each year.

Compensation is the solution / To economists, the solution is straight‐ forward: allow kidney donors to be compensated. But this is not at all obvious to most non‐ economists, who fear it would lead to a world in which rich people would buy kidneys from poor people. Steven Levitt, co‐ author of the best‐ selling economics book Freakonomics, put the dichotomy this way in a May 2022 episode of his People I (Mostly) Admire podcast: “This is an interesting issue because it is one every economist agrees that of course we should have a market for kidneys, and virtually every non‐ economist thinks it is crazy.”

Because there are a lot more non‐ economists than economists, that takes the policy option of a completely free market in kidneys off the table. Instead, policymakers must come up with some solution that allows kidney donors to be compensated but addresses the concerns of the public through regulation.

There does seem to be a consensus developing that the government should take on the role of compensating kidney donors, and it should distribute the acquired kidneys to all patients who need one. In a 2018 PLOS One article, we showed that poor people as a group would be much better off if donors are compensated than they are now when compensation is prohibited, mainly because many would‐ be kidney recipients are poor.
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https://onlinelibrary.wiley.com/doi/full/10.1111/ctr.14955?campaign=wolacceptedarticle

Financial, policy, and ethical barriers to the expansion of living donor liver transplant: Meeting report from a living donor liver transplant consensus conference
Clinical Transplantation
Anjana Pillai, Elizabeth C. Verna, et al.
First published: 07 March 2023
https://doi.org/10.1111/ctr.14955

Abstract

Introduction
In October 2021, the American Society of Transplantation (AST) hosted a virtual consensus conference aimed at identifying and addressing barriers to the broader, safe expansion of living donor liver transplantation (LDLT) throughout the United States (US).

Methods
A multidisciplinary group of LDLT experts convened to address issues related to financial implications on the donor, transplant center crisis management, regulatory and oversight policies, and ethical considerations by assessing the relative significance of issues in preventing LDLT growth, with proposed strategies to overcome barriers.

Results
Living liver donors endure multiple obstacles including financial instability, loss of job security, and potential morbidity. These concerns, along with other center, state, and federal specific policies can be perceived as significant barriers to expanding LDLT. Donor safety is of paramount importance to the transplant community; however, regulatory and oversight policies aimed at ensuring donor safety can be viewed as ambiguous and complicated leading to time-consuming evaluations that may deter donor motivation and program expansion.

Conclusion
Transplant programs need to establish appropriate crisis management plans to mitigate potential negative donor outcomes and ensure program viability and stability. Finally, ethical aspects, including informed consent for high-risk recipients and use of non-directed donors, can be perceived as additional barriers to expanding LDLT.
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https://onlinelibrary.wiley.com/doi/full/10.1111/ctr.14946?campaign=wolearlyview

The real unmet need: A multifactorial approach for identifying sensitized kidney candidates with low access to transplant
Clinical Transplantation
Angela Q. Maldonado, Keighly Bradbrook, Kristoffer Sjöholm, Christian Kjellman, Joshua Lee, Darren Stewart
First published: 26 February 2023
https://doi.org/10.1111/ctr.14946

Abstract

Background
At the start of 2020, the kidney waiting list consisted of 2526 candidates with a calculated panel reactive antibody (CPRA) of 99.9% or greater, a cohort demonstrated in published research to have meaningfully lower than average access to transplantation even under the revised kidney allocation system (KAS).

Methods
This was a retrospective analysis of US kidney registrations using data from the OPTN [Reference (https://optn.transplant.hrsa.gov/data/about-data/)]. The period-prevalent study cohort consisted of US kidney-alone registrations who waited at least 1 day between April 1, 2016, when HLA DQ-Alpha and DP-Beta unacceptable antigen data became available in OPTN data collection, to December 31, 2019. Poisson rate regression was used to model deceased donor kidney transplant rates per active year waiting and using an offset term to account for differential at-risk periods. Median time to transplant was estimated for each IRR group using the Kaplan–Meier method. Sensitivity analyses were included to address geographic variation in supply-to-demand ratios and differences in dialysis time or waiting time.

Results
In this study, we found 1597 additional sensitized (CPRA 50–<99.9%) candidates with meaningfully lower than average access to transplant when simultaneously taking into account CPRA and other factors. In combination with CPRA, candidate blood type, Estimated Post-Transplant Survival Score (EPTS), and presence of other antibody specificities beyond those in the current, 5-locus CPRA were found to influence the likelihood of transplant.

Conclusion
In total, this suggests approximately 4100 sensitized candidates are on the waiting list who represent a community of disadvantaged patients who may benefit from progressive therapies and interventions to facilitate incompatible transplantation. Though associated with higher risks, such interventions may nevertheless be more attractive than remaining on dialysis with the associated accumulation of mortality risk over time.
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https://onlinelibrary.wiley.com/doi/abs/10.1111/ctr.14954?campaign=wolearlyview

Living donor liver transplant candidate and donor selection and engagement: Meeting report from the living donor liver transplant consensus conference
Clinical Transplantation
Michelle T. Jesse, Whitney E. Jackson, et al.
First published: 09 March 2023
https://doi.org/10.1111/ctr.14954

Abstract

Introduction
Living donor liver transplantation (LDLT) is a promising option for mitigating the deceased donor organ shortage and reducing waitlist mortality. Despite excellent outcomes and data supporting expanding candidate indications for LDLT, broader uptake throughout the United States has yet to occur.

Methods
In response to this, the American Society of Transplantation hosted a virtual consensus conference (October 18–19, 2021), bringing together relevant experts with the aim of identifying barriers to broader implementation and making recommendations regarding strategies to address these barriers. In this report, we summarize the findings relevant to the selection and engagement of both the LDLT candidate and living donor. Utilizing a modified Delphi approach, barrier and strategy statements were developed, refined, and voted on for overall barrier importance and potential impact and feasibility of the strategy to address said barrier.

Results
Barriers identified fell into three general categories:
1) awareness, acceptance, and engagement across patients (potential candidates and donors), providers, and institutions,
2) data gaps and lack of standardization in candidate and donor selection, and
3) data gaps regarding post-living liver donation outcomes and resource needs.

Conclusions
Strategies to address barriers included efforts toward education and engagement across populations, rigorous and collaborative research, and institutional commitment and resources.
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https://www.statnews.com/2023/03/22/living-organ-donors-priority-status-transplant-waiting-list/
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[/size]Living kidney donors rely on a promise to protect our future health. We’re scared it will go away
By Martha Gershun
Five years ago, I donated my “spare” kidney at the Mayo Clinic to a woman I read about in the newspaper. Though living with only one kidney has risks, I was not particularly concerned about my own health. The clinic’s medical evaluation was extremely thorough, and I knew their highly conscientious selection committee would not approve me to be a living donor if they were even the slightest bit concerned the procedure would cause me long-term health problems. Furthermore, I was assured at every step of the process that if my remaining kidney should fail or be damaged, I would “go to the top of the transplant waiting list.”
That promise reassured both me and my family that it was safe to move forward with my donation. The day before my surgery, I signed the forms identifying me as a living kidney donor that would go to the United Network for Organ Sharing (UNOS), the national system that distributes deceased donor organs to those in need of a transplant. If my act of altruism put me at future risk, the nurse transplant coordinator assured me, these forms would guarantee my high priority status.
But that guarantee now feels less certain, because UNOS is changing the way deceased donor organs are allocated to those on the transplant waitlist. Under the current UNOS allocation system, put in place in 1996, two groups of people needing a kidney transplant receive absolute priority over otherwise similarly situated candidates: 1) those with very rare blood types, who are extremely hard to match, and 2) prior living donors like me.

In the new “continuous distribution” framework, all attributes will be considered at once, including estimates of medical urgency, projections of post-transplant survival, placement efficiency, and candidate age. While living organ donors will continue to receive extra “points,” no one attribute will decide an organ match. Each candidate’s total score, a calculation based on a weighted average of all attributes, will determine their prioritization for available organs. (Editor’s note: On Wednesday morning, after publication of this article, the Washington Post reported that the U.S. government plans to “overhaul the troubled U.S. organ transplant system, including breaking up the monopoly power of [UNOS,] the nonprofit organization that has run it for the past 37 years.” It’s unclear what this might mean for the new framework.)





The new framework is intended to combat the very real equity issues surrounding the allocation of scarce cadaveric organs available for transplantation. But this change is profoundly unsettling to living kidney donors around the country, prompting us to ask: Will my priority status be preserved?
In 2022, living donors accounted for more than 15% of all transplants in the United States, gifting a portion of their lung, liver, pancreas, or intestines or one of their two kidneys, the most commonly transplanted organ. UNOS is assuring advocates that it is well-aware of the importance that living kidney donors play in the complex system of organ transplantation. A statement issued by UNOS on March 16 affirms: “We wish to assure the community that the OPTN Kidney Transplantation Committee intends for both prior and future living donors to receive the same level of priority for a deceased donor organ in the new framework as they receive in the current allocation system.”

But we cannot be sure until the algorithm for kidney allocation is finalized. Simulated allocation models still need to be run this summer, followed by public comments and a final recommendation to the UNOS Board at its meeting in either December 2023 or June 2024.


Kidney donors’ concern is understandable. On March 9, UNOS’s continuous distribution system went into effect for lungs, the first organ to be migrated to the new framework. Next it will be rolled out for pancreases and kidneys, then livers and intestines, and finally hearts, the only organ that cannot be donated by a living person.
The communication surrounding this first effort did not look great for living donors. (Many people are surprised to learn that you can donate part of your lung. It’s possible, though very rare; only 253 such procedures have ever been done in the U.S., none in the past 10 years.)
In fact, the weights listed for different factors to be considered in the allocation algorithm were initially quite alarming, with prior living donors receiving only 5 points out of 100 (labeled as “5%” on the chart). That’s the same weight as travel efficiency, proximity efficiency, height, blood type, and antigen sensitivity and less than waitlist survival, post-transplant outcomes, biological disadvantages, patient access, pediatric status, and placement efficiency.


Only after an explanatory conversation with UNOS did I understand this is not as dire as it appears. Since no candidate will ever receive all 100 points, the five-point “bump” for being a prior living donor will, in almost all cases, move the candidate very near the top of the list. But this is complicated math, and no effort has been made to explain the implications to laypeople.
Even worse, in a hypothetical example of the continuous allocation distribution for lungs on the UNOS website, the graph shows a prior living donor dead last on a simulated “match run” of seven people in need of a lung transplant. There is a new disclaimer just added to the website that says “the points shown in the below sample match run were created as examples early in the project development and do not reflect the final points assigned to each part of the score.” This is no way to build trust among critical stakeholders!
In addition to keeping the promise made to all prior living kidney donors, UNOS’s priority protection is vital to encourage people considering living donation in the future — especially altruistic donors not seeking to save the life of a specific friend or family member. It is also important to reassure patients who may be reluctant to accept an organ from a living relative or close friend. Otherwise fewer people will offer organs for donation, causing longer wait times for those on the list.
There are currently more than 104,000 people on the U.S. transplant waiting list. In 2022, 6,465 living donors provided an organ — in most cases, a kidney — that took patients off that list, likely saving those lives and moving everyone else behind them on the list closer to receiving a lifesaving transplant. In the case of kidneys, living donations often last many years longer than deceased donor organs, reducing the need for repeat transplants, thus taking even more pressure off the waitlist.
When I offered my kidney to a stranger, I understood the physical and mental health risks I would be undertaking. I embraced them as the reasonable cost of saving someone else’s life. But I also trusted the transplant system to protect me if I needed a replacement organ in the future. It is imperative that UNOS ensure their new continuous distribution framework affirms the implicit contract our transplant system made with each of us who chose to donate a part of our own body to save the life of someone else.
Martha Gershun is a nonprofit consultant, writer, and community volunteer living in Fairway, Kan. Her book “Kidney to Share” (Cornell University Press, 2021), co-authored with John D. Lantos, M.D., chronicles her experience as a living kidney donor.
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https://www.medscape.com/viewarticle/987909
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[/size]Living Kidney Donors Should Receive Money for Their Costs of Donating


(video)


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http://www.pharmabiz.com/NewsDetails.aspx?aid=157039&sid=2


Western India’s first fully robotic liver donor surgery performed at Jaslok Hospital
Mumbai’s Jaslok Hospital recently achieved a major milestone by performing Western India’s first fully robotic liver donor surgery on 40-year-old Sujata Sahu. Doctors, A S Soin, Kamal Yadav, Amit Rastogi and Pravin Agarwal performed this successful surgery a month ago.[/font][/color][/font][/size] Sujata’s landmark surgery made a life-saving liver transplant possible for her 69 year old father, Panchanan Patra, who was terminally ill with autoimmune related cirrhosis and cancer of the liver. Prior to the transplant, Sujata was very keen to save her father by donating a part of her liver. However, she was worried about the visible scar on the abdomen and pain from the surgery. Dr A S Soin, the lead surgeon and chairman of liver transplantation, said, “Sujata’s anxiety was not uncommon. Many prospective donors hesitate to donate for the same reason. She was relieved when we offered to operate with the fully robotic technique, which leaves no big scar on the abdomen, and the pain is minimal. The robotic approach has revolutionized liver donor surgery. Most of the post-operative pain and wound problems associated with open donor surgery due to abdominal wall trauma are avoided with this technique. In fact, in our experience, robotic surgery has helped to increase the willingness for donation by at least 30%”, added Dr Soin. Dr Pravin Agarwal, senior consultant hepatobiliary and liver transplant surgeon, explained, “Before the transplant, we performed a detailed liver matching and multi-system check to ensure the transplant was safe for both, the donor and the patient. A special Robotic liver surgery 3D-CT scan protocol was followed in preparation for smooth surgery. We proceeded once we found the pair to be suitably matched.” Dr Kamal Yadav, senior robotic transplant surgeon said that the donor operation was accomplished via small 8-10 mm holes in the abdomen, using fine robotic instruments that were controlled on the robotic console by us. When the donor’s partial liver was ready for removal, we retrieved it via a concealed 9 cm incision just above the pubic bone. Compared to the open cut, this incision is much smaller, hidden and does not involve any muscle cutting. This helps in quicker, relatively pain-free recovery for the donor who can return to work and normal activities much sooner than with the open incision. Elaborating on the coordination needed to accomplish the donor and recipient surgeries, Dr. Amit Rastogi, director of liver transplant surgery, said, “Panchanan’s surgery was performed simultaneously in the adjacent operating room, and meticulously synchronized with the donor surgery. We removed the patient’s entire diseased liver, and prepared the abdomen to receive the robotically retrieved hemi-liver. After bench surgery on the donor liver, it was finally transplanted into the recipient. Both procedures took us about 9 hours to complete.” Dr Aabha Nagral, the chief hepatologist at Jaslok, said, “This transplant sets an excellent example for those suffering from liver failure or liver cancer. Currently, we only transplant a fraction of the patients who need it to cure liver failure or hepatocellular cancer. This is because deceased liver donors are scarce and family members are reluctant for living donation as they are fearful of surgery. Young donors are the medically preferred donors, but they are most conscious of scars. Robotic surgery will encourage this group to volunteer to donate more often. Sujata was discharged 6 days and the recipient 12 days after the transplant. Barely a month later, they are well and leading normal lives.” Jitendra Haryan, CEO, Jaslok Hospital said, “It’s great to be the first hospital in Maharashtra to do the robotic liver donor surgery. At Jaslok we strive to provide the best available technology to our patients to improve clinical outcomes and create more awareness about organ donation to save more lives. The Jaslok Hospital & Research Centre is one of the oldest tertiary care, multi-specialty Trust hospitals of the country.[/font][/color]
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https://unos.org/news/unos-welcomes-competitive-bidding-process-for-next-optn-contract/

UNOS welcomes competitive bidding process for next OPTN contract

UNOS supports Health Resources and Services Administration’s (HRSA) plan to introduce additional reforms into the nation’s organ donation and transplantation system. We also stand united with HRSA in our shared goal to get as many donor organs as possible to patients in need while increasing accountability, transparency and oversight.

We welcome a competitive and open bidding process for the next Organ Procurement and Transplantation Network (OPTN) contract to advance our efforts to save as many lives as possible, as equitably as possible. We believe we have the experience and expertise required to best serve the nation’s patients and to help implement HRSA’s proposed initiatives.

Numerous components of HRSA’s plan also align with our new action agenda, which is a list of specific proposals we outlined earlier this year aimed at driving improvement across the system.

We are committed to working with HRSA, U.S. Department of Heath and Human Services (HHS), Congress and others who care about this system so deeply to assist in carrying out these reforms and to do our part to improve how we serve America’s organ donors, transplant patients and their families.
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Living Donation in the News / HRSA's new Organ Transplant Center Data Dashboard
« Last post by Clark on March 24, 2023, 04:42:58 PM »
https://data.hrsa.gov/topics/health-systems/organ-donation

Organ Donation and Transplantation[/size]HRSA’s Health Systems Bureau manages the nation’s Organ Donation and Transplantation program. This program works to extend and enhance the lives of individuals with end-stage organ failure for whom an organ transplant is the most appropriate therapeutic treatment.
[/size]HRSA makes available to the public both data and data visualizations on organ donation and transplantation. The aim of this information is to improve transparency around organ transplantation activities across the nation for the public.
[/size]The presented data are collected through a number of means by the nation’s Organ Procurement and Transplantation Network (OPTN). HRSA encourages viewers of this data to appreciate that these data are complex, and that additional data, information, and context may be necessary to properly address key policy issues around the nation’s organ transplantation systems. HRSA recommends users thoroughly review the important contextual information provided in the "Frequently Asked Questions" document.
[/size]Contact Information: If you have any questions or feedback on how we can improve these dashboards, please email AskDoT@hrsa.gov with the subject ‘OPTN Dashboard.’
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[/size]N.B.: Interesting highlights when choosing "Organ Donation" => "Organ Donor Demographics" => "Living Donors":
[/size]- 36,377 of us in the past six years.
[/size]- Female/male split: 23,130/13,247 or 64%/36%, almost exactly 2:1. This ratio is nearly reversed for the recipients of our gifts every one of these years.
[/size]- Big drop in donor numbers in 2020, understandable, but a huge drop in 2022, no clear reason?
[/size]- Amazingly, 2,308 living donors did so without health insurance.
[/size]  No doubt much more to be discovered.


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