Showing posts with label deceased donors. Show all posts
Showing posts with label deceased donors. Show all posts

Tuesday, March 19, 2024

The Impact of prioritization on kidney and liver allocation in Israel

   Israel's  Organ Transplantation Law grants some priority on waiting lists for transplants to candidates who are first-degree relatives of deceased organ donors (i.e. whose family has given permission for someone's deceased organ donation) or who previously registered as organ donors themselves. (There's also a tiny priority for relatives of people who signed organ donor cards...)  Here are two papers that looks at the effect of those priorities on kidney and liver transplants, and how they interact with other priorities on waiting lists for Israeli organs.  

The first paper, on kidneys, concludes that the priorities are effective in reducing waiting time to transplant, and suggests that perhaps these priorities should not be so large compared to other existing priorities (e.g. for time on dialysis), or for priorities that could be established, e.g. for highly sensitized patients (who get high priority in the U.S., for example.)

Mor, Eytan, Meitar Bloom, Ronen Ghinea, Roi Anteby, Ronit Pasvolsky-Gutman, Ron Loewenthal, Ido Nachmani, and Tammy Hod. "The Impact of the Donor Card Holder Prioritization Program on Kidney Allocation in Israel." Transplantation (2024): 10-1097.

Abstract

Background: Since 2014, as part of a priority program within the Israeli Transplant Law, additional points were given to waitlisted candidates with donor cards. We assessed the impact on deceased donor kidney allocation.

Methods: This study enrolled all patients older than 18 y who underwent deceased donor kidney transplantation (January 2016–December 2019). Data were obtained from the National HLA Tissue Laboratory registry at the Sheba Medical Center. Patients were grouped by donor card status (ADI group) (not signed, 0 points; relative signed, 0.1 points; patient signed, 2 points; and relative donated, 9 points). The primary outcome was waiting time until kidney transplantation with and without the additional score.

Results: Four hundred forty-four patients underwent kidney transplantation during the study period: 281 (63%) were donor card holders (DCH) and 163 (37%) were not DCH. DCH with extra points waited 68.0 (±47.0) mo on average, compared with 94.6 (±47.3) mo for not DCH (P < 0.001). Donor card signers had a shorter time until transplant in a multivariable model. Without extra points, 145 recipients (32.6%) would have missed organs allocated to higher-scored candidates. Allocation changes occurred in 1 patient because of an additional 0.1 points, in 103 candidates because of an additional 2 points, and in 41 candidates because of an additional 9 points.

Conclusions: Additional DCH scores improved allocation and reduced waiting time for donor card signers and those with donating relatives. To enhance fairness, consideration should be given to reducing the score weight of this social criterion and raising scores for other factors, especially dialysis duration.

##########

There are many fewer liver transplants than kidney transplants, and the effect of priority is less clear:

Ashkenazi, Tamar, Avraham Stoler, and Eytan Mor. "The effect of priority given to donor card holders on the allocation of livers for transplant—evidence from 7 years of the Israeli priority program." Transplantation 106, no. 2 (2022): 299-307.

Abstract

Background. The Israeli Transplant Law grants priority in organ allocation to patients signing a donor card. Liver transplant candidates get additional 2 points on their Model for End Stage Liver Disease score for signing a donor card, 0.1 points for a relative holding a card, and 5 points if a relative donated an organ. We studied the effect of the priority program on waiting list mortality and allocation changes due to priority.

Methods. Using Israeli Transplant data of 531 adult liver transplant candidates with chronic liver disease listed between 2012 and 2018 we compared waitlist mortality and transplant rate of candidates with and without priority. Then we analyzed liver allocations resulting from additional priority points and followed outcome of patients who were skipped in line.

Results. Of the 519 candidates, 294 did not sign a donor card, 82 signed, 140 had a relative sign, and for 3, a relative donated an organ. The rates of waitlist mortality in these 4 groups were 22.4%, 0%, 21.4%, and 0%, respectively, and the transplant rates were 50%, 59.8%, 49.3%, and 100%, respectively. Of the 30 patients who were skipped because of priority, 24 subsequently underwent transplant, 2 are on the waiting list, and 4 died within 0.75, 1.75, 7, and 17 mo.

Conclusions. The 2 points added to the Model for End Stage Liver Disease score were associated with lower waitlist mortality and higher transplant rate for candidates signing a donor card without significantly affecting access to transplant during allocation. Further research and consideration of optimal policy when granting priority for candidates signing a donor card should continue.

###########

Earlier:

Stoler, Avraham,  Judd B. Kessler, Tamar Ashkenazi, Alvin E. Roth, Jacob Lavee, “Incentivizing Authorization for Deceased Organ Donation with Organ Allocation Priority: the First Five Years,” American Journal of Transplantation, Volume 16, Issue 9, September 2016,  2639–2645.

 Stoler, Avraham, Judd B. Kessler, Tamar Ashkenazi, Alvin E. Roth, Jacob Lavee, “Incentivizing Organ Donor Registrations with Organ Allocation Priority,”, Health Economics, April 2016 Volume: 26   Issue: 4   Pages: 500-510   APR 2017


Thursday, March 7, 2024

Increasing kidney transplants by reducing discards of risky kidneys

 Kidneys from deceased donors are too often discarded. Dr. Joshua Mezrich, a transplant surgeon at U. Wisconsin, writes in Stat about how to reduce the rate at which high risk kidneys are discarded (after being on ice for a long time while being rejected by many patients). He proposes that kidneys that can be identified as high risk even before being recovered from the deceased donor  be offered promptly to patients/transplant centers that have indicated a willingness to take them. It would require transplant centers to keep current blood tests available for patients who are candidates for high risk kidneys (who may be candidates in part because they are far from the front of the waiting list...)

Too many donor organs go to waste. Here’s how to get them into the patients who need them  By Joshua Mezrich, Stat, March 2, 2024 

"So here is the fix. High-risk kidneys should immediately be offered to transplant centers that opt into a high-risk program as an open offer to their wait list rather than to a specific patient, on a rotating schedule with weight put on proximity to the donor hospital. Ideally the offer should be made prior to procurement of the organ, with final acceptance once it is removed and anatomy and biopsy results can be reviewed by the accepting surgeon.

"If the biopsies show significant disease and the function of the kidney would be inadequate for a recipient, the receiving center can request both kidneys for a single patient, termed a dual transplant (which has been shown to have good outcomes). If a center accepts a kidney, it can then choose the patient who will benefit the most from the transplant and has a long predicted wait time for a low-risk transplant, with informed consent. That would entail a discussion with the patient about expectations regarding the quality of the kidney, how long and how well it might work, and how much longer they might need to wait for a lower-risk kidney. The ability to match the kidney to a recipient is important, as high-risk kidneys need to go into patients who can tolerate the slow initial function. Centers that opt into the high-risk program will need to maintain an updated list of informed patients who are predicted to benefit from these kidneys, who can be called in as soon an offer becomes available. For them, taking a chance beats remaining on dialysis.

Tuesday, February 27, 2024

Stanford Impact Labs announces support for kidney exchange in Brazil, India, and the U.S.

 Stanford Impact Labs has announced an investment designed to help the Alliance for Paired Kidney Donation (APKD) increase access to kidney exchange in Brazil, India, and the U.S.  Here are three related web pages...

1. Stanford Impact Labs Invests in Global Collaboration to Increase Access to Kidney Transplants.  $1.5 million over three years will support solutions-focused project led by Stanford’s Dr. Alvin Roth and the Alliance for Paired Kidney Donation (APKD)  by Kate Green Tripp

"Stanford Impact Labs (SIL) is delighted to announce a $1.5 million Stage 3: Amplify Impact investment to support Extending Kidney Exchange, a solutions-focused project established to increase access to lifesaving kidney transplants.

"The team, led by Stanford’s Dr. Alvin (Al) Roth, who shared the 2012 Nobel Prize in Economics for his work on market design, and the Alliance for Paired Kidney Donation (APKD) is working in close partnership with organ transplant specialists and medical centers in Brazil, India, and the U.S., including Santa Casa de Misericórdia de Juiz de Fora, the Institute of Kidney Diseases and Research Center and Dr. H L Trivedi Institute of Transplantation Sciences (IKDRC-ITS), and Walter Reed National Military Medical Center.

"Over the course of the next three years, the team aims to increase the number of transplant opportunities available to patients who need them by creating and growing kidney exchange programs in Brazil and India, where millions of people suffer from kidney disease yet exchange is minimal; and explore the effects of initiating donor chains with a deceased donor kidney (DDIC) in the U.S., an approach which could unlock hundreds more transplants each year.

..."

2. How Does Applied Economics Maximize Kidney Transplants? A project aimed at expanding kidney exchange and saving lives puts Nobel Prize-winning matching theory into practice.  by Jenn Brown   (including a video...)

"APKD uses open source software developed by Itai Ashlagi, Professor of Management Science and Engineering at Stanford University, to facilitate the matching process for its NEAD chains, and they currently average 5 non-simultaneous transplants per chain.

3. Extending Kidney Exchange

"In Brazil, our team has launched a kidney exchange program within Santa Casa de Misericórdia de Juiz de Fora and Hospital Clínicas FMUSP in São Paulo and aims to expand to facilitating exchanges between these centers and others with the ultimate goal of kidney exchange transitioning from a research project to an officially approved practice in Brazil.

"In India, our team has deployed kidney matching software and resources for growth to the Institute of Kidney Diseases and Research Center and Dr. HL Trivedi Institute of Transplantation Sciences (IKDRC-ITS) to support kidney exchange programs. We aim to develop an evidence base for potential updates to organ transplantation laws that expand criteria for who can give and receive lifesaving kidneys.

"In the U.S., we are working with Walter Reed National Military Medical Center to test the use of deceased donor-initiated chains (DDIC) so as to generate hundreds of additional life-saving transplants each year that are not currently supported by today's practice of utilizing a deceased donor kidney to save the life of a single person on a transplant waitlist. "


 

Thursday, February 22, 2024

Directed deceased donation of organs for transplant. (Legal in U.S. but not yet in Europe.)

 It is legal in the U.S. for a deceased donor organ for transplant to be directed to a particular recipient, if the recipient is compatible (and otherwise the organs are allocated as in the usual way for nondirected deceased donation.)  Because compatibility is tricky, directed deceased donation (DDD) is rare (but deceased donor kidneys can potentially be used to start a deceased donor initiated chain of kidney exchange).

But in most of Europe, it turns out, DDD isn't legal. (!) Here's a paper by the European Society of Transplantation's European Platform on Ethical, Legal and Psychosocial Aspects of Organ Transplantation. It cautiously argues that maybe this ban is "one thought too many," and that the ban should be lifted so that carefully regulated DDD would be allowed to increase organ donation in Europe and save more lives.

"When is directed deceased donation justified? Practical, ethical, and legal issues," by David Shaw1,2 , Dale Gardiner3, Rutger Ploeg4, Anne Floden5,6, Jessie Cooper7, Alicia Pérez-Blanco8, Tineke Wind9, Lydia Dijkhuizen10, Nichon Jansen10 and Bernadette Haase-Kromwijk10; on behalf of the ESOT ELPAT Working Group on Deceased Donation, Journal of the Intensive Care Society, 2024.

Abstract: This paper explores whether directed deceased organ donation should be permitted, and if so under which conditions. While organ donation and allocation systems must be fair and transparent, might it be “one thought too many” to prevent directed donation within families? We proceed by providing a description of the medical and legal context, followed by identification of the main ethical issues involved in directed donation, and then explore these through a series of hypothetical cases similar to those encountered in practice. Ultimately, we set certain conditions under which directed deceased donation may be ethically acceptable. We restrict our discussion to the allocation of organs to recipients already on the waiting list.

"The persistent shortage of organs available for transplantation demands fair and objective allocation of the scarce available organs, based on preset transparent and regulated criteria. In most European countries, organs from deceased donors are allocated to patients on the organ waiting list by national Competent Authorities.3 The current worldwide norm is that organs donated after death are considered as an unconditional gift to the patients on the transplant waiting list according to the allocation system. This implies that donors (prior to their death), or their family members (after it), cannot determine to whom the available organs will be assigned, nor exclude any potential recipients.

...

"In a few countries, like the United States, United Kingdom, Japan, and recently Australia, directed deceased donation is possible in restricted cases, since national legislation does not prohibit it. In living donation however, directed donation is permitted in many countries, even when there is no genetic or emotional relationship between the donor and the intended recipient. This inconsistency between the living donation- and deceased donation system has been noted.4

"This paper explores whether directed deceased donation should be allowed, and if so under which conditions.

...

"The main argument against DDD is that this violates the  basic principle of an altruistic, unconditional gift to society; allowing DDD may turn out to be a “slippery slope” in the direction of conditional donation and discrimination against particular patient groups. Conditional donation could also reduce public support for the transplantation system, since it could reduce transparency and fairness of the system.

...

"What, then, are the conditions for ethical DDD at the present time?

1. DDD under strict conditions should not be prohibited by legislation or policy.

2. There must be evidence that the donor wanted or would have been willing to direct the organ to a particular family member or close friend.

3. The donor/family should generally not be able to  insist on only donating the organ intended for DDD; where other organs are transplantable there should be a willingness to donate other organs (at least one) to patients on the waiting list to preserve the societal altruistic aspect of donation and diminish the overall effect on the waiting list.

4. DDD should proceed only if there is no patient on the waiting list in extremely urgent need of an organ transplantation to avoid imminent death.

5. DDD should proceed only if there is a reasonable chance of successful transplantation.

6. The intended recipient should be on the waiting list or be under assessment for being included.

"If these conditions are met, the medical team should do their best to facilitate the wishes of the deceased patient and his/her family by enabling DDD to take place. Letting deceased donors direct their organs to loved ones under carefully controlled conditions could further enhance trust in organ donation and transplantation systems, and hence willingness to become a donor."

Sunday, January 28, 2024

Experiments for organ allocation (an idea whose time may be coming)

 Experiments to improve how deceased donor organs are allocated to waiting patients seem like a good idea...

OPTN Task Force sets goal of achieving 60K transplants by 2026Jan 26, 2024 

“we need to move quicker, be more responsive, and deliver results for the patients we serve,” said Dianne LaPointe Rudow, DNP, president of the OPTN Board of Directors. “The reality is that while the number of transplants continues to grow, so does the non-use of available organs and allocations of organs out of the intended sequence of offers.

...

"The need is clear. In the case of kidneys, the most transplanted organ, the number of kidneys recovered from deceased donors increased by 56 percent between 2018 to 2023. Yet the number of kidney transplants only increased by 44 percent, meaning that approximately one quarter of kidneys recovered were not transplanted.

...

"Under a proposed variance for expedited placement, currently out for public comment, the task force intends to develop a series of rapid, small-scale tests of innovative organ placement approaches and assess their outcomes to evaluate whether they could be incorporated into future OPTN policies. The task force also has committed to prioritizing studies that evaluate potential frameworks for allocating hard-to-place organs to increase the number of transplants and lower non-use rates."

Monday, January 22, 2024

Reporting and misreporting from Organ Procurement Organizations (OPOs)

 Because there are shortages of organs for transplant, it is important to measure how successful Organ Procurement Organizations (OPOs) are at recovering and transplanting organs.  But sometimes definitions can get in the way, and this was the case in islet transplants from deceased donors, into patients with diabetes.  Pancreatic islets are the cells that produce insulin, and it was (and I think still is) regarded as an experimental procedure to transplant islets from a deceased donor's pancreas, rather than the whole pancreas.  So islet transplantation was classified as a research activity.

To encourage this use of deceased donor pancreases, recovery of a pancreas "for research" was counted as a transplant. But some OPO's have heavily gamed this, reporting that they recovered a pancreas when the "research" wasn't connected to transplantation.  That loophole is now being closed.

Here's a January 18 memo from HHS, CMS, Center for Clinical Standards and Quality

Organ Procurement Organization (OPO) Conditions for Coverage – Definition Clarification 



"Background:

"The OPO CfCs are intended to drive improvements in organ procurement and transplantation through, among other provisions, the donor and transplantation outcome measures. OPOs are required to report data related to pancreata procured for research, and this data is incorporated into calculations used to assess compliance with the donor and transplant outcome measures and are used for re-certification purposes. To facilitate accurate reporting of data related to pancreata donors, the term “donor” is defined in CMS regulation to specify that, among other requirements, an individual would be considered a donor even if only the pancreas is procured and is used for research or islet cell transplantation.

"CMS has noted a significant increase in the number of pancreata procured since this definitionwas revised in 2020, raising questions about the interpretation of this definition by OPOs and how this definition is applied to reporting data related to donors of pancreata used for islet cell research. There is a concern that the increase in pancreata procured may not reflect a meaningful increase in pancreata being actually used for islet cell research, and instead may reflect pancreata procured for other purposes. This memo is clarifying that the pancreata must be used for islet cell research. 

...

"In summary, this memo is clarifying that consistent with the Pancreatic Islet Cell Transplantation Act of 2004, only pancreata procured by an OPO and used for islet cell transplantation or research shall be counted"

Monday, January 8, 2024

"Scraping poison off the bone": Transplants in China without organs from executed prisoners

 Following a long period in which the bulk of China's organ transplants used organs from executed prisoners, there have been steady efforts to create a system of voluntary deceased donation comparable to that in most of the world where transplants are done.

Global Times has the latest bit of that evolving story:

China’s organ donation to be more transparent under newly issued rules By Zhao Yusha and Zhang Yuying   Dec 15, 2023

"Chinese Premier Li Qiang has signed a decree of the State Council to unveil rules on human organ donation and transplantation, media reported on Thursday, with Chinese experts noting that the country’s organ donations will be more transparent under the regulation, which reflects great determination in China's organ donation reform. 

The newly issued rules, which will take effect on May 1, 2024, have been refined from the ones on human organ transplantation issued in 2007 to meet the demands of changing situations and ensure the healthy development of the cause, according to the Xinhua News Agency.

The rules strengthen the publicity and guidance of organ donation. Besides, the regulations stipulate that organ donation must adhere to the principles of voluntary and unpaid participation, and the conditions and procedures of donation should be improved based on the Civil Code. 

...

"China’s organ donations will be more transparent under the newly issued rules, Huang Jiefu, chairman of China Human Organ Donation and Transplantation Committee and chair of the China Organ Transplant Development Foundation Advisory Board, told the Global Times on Thursday.

"Huang noted that the revision of the rules shows the great determination in China's organ donation reform, which he described as scraping poison off the bone. “The regulations reflect the importance the Party and country attach to organ donation, which provides a strong legal guarantee for the high-quality development of organ donation cause.” 

"According to the rules, the application management of organ transplantation technologies should be improved to ensure medical quality. Specifically speaking, the rules define the conditions that medical institutions and practicing physicians must possess when engaging in organ transplantation, and require regular evaluation of the clinical application capabilities of relevant technologies in medical institutions. 

...

"In addition, the rules improve related provisions on legal liabilities and strengthen the punishment of malpractice in the field, Xinhua reported.

"Experts said the new rules call for more people to get involved in organ donations and transplants, and it is hoped that China's organ transplantation technology will spread to more countries in the future."

********

Here (in Chinese, but with Google Translate) is the announcement from Xinhua News Agency

李强签署国务院令 公布《人体器官捐献和移植条例》"Li Qiang signed a State Council order announcing the "Regulations on Human Organ Donation and Transplantation"

[The new regulations] "stipulate that patients whose spouses, direct blood relatives and other relatives have donated deceased organs can apply for organ transplantation , priority is given to them under the same conditions. 

...

"Ethical review requirements before organ harvesting will be refined, and the witnessing procedures for harvesting organs from deceased persons will be stipulated. Improve the cadaver organ distribution system, stipulate that the distribution of cadaver organs should meet medical needs, follow the principles of fairness, impartiality, and openness, and distribute uniformly through the distribution system established by the health department of the State Council. It is required to regularly announce the donation and distribution of cadaver organs and accept social supervision.

...

"In addition, relevant provisions on legal liability have been improved, penalties have been increased, and illegal activities in the field of organ donation and transplantation have been severely cracked down on.

  "(Authorized release) Order No. 767 of the State Council of the People's Republic of China

  "(Authorized release) Regulations on Human Organ Donation and Transplantation"


HT: Michelle Miao

Wednesday, January 3, 2024

Pilot projects to speed deceased donor organ allocation

I won't use the word "experiments" for fear of the evil eye, but the OPTN is planning to authorize 'pilot programs' to try to speed the allocation of deceased donor organs. The idea is that after an organ has been rejected numerous times, and has started to be in danger of discard, it can be offered to a transplant center and patient that are likely to accept and transplant it, rather than proceeding to offer it to centers and patients in priority order. This is important, because too much waiting time on ice is one of the chief reasons that organs are rejected and eventually discarded.

Expedited Placement Variance his proposal recommends a new variance related to expedited organ placement and proposes modifying the OPTN’s variance process in order to allow for more rapid studies of potential improvement.

"Proposed changes

"Create a variance to govern pilot projects related to expedited organ placement.

Gives the OPTN Executive Committee authority to develop protocols for expedited organ placement.

This approach will allow the OPTN the ability to rapidly iterate on different protocols.

Update portions of the OPTN’s governance structure regarding variances.

This will allow for a more rapid and iterative approach when creating new variances."

Read the full proposal (PDF)

"The task force intends to conduct multiple iterative pilots or PDSAs with the community to identify effective practices to improve the efficiency of the organ allocation process. (Not all pilots or PDSAs will require a policy variance.) This proposal 1) creates a variance to govern the expedited placement pilots and 2) adjusts the OPTN’s governance of all variances. Additional variances or process improvement projects will focus on other topics to improve the efficiency of the organ allocation process.

"The Committee is issuing this proposal for a thirty-day public comment period, which is shorter than the usual public comment period. This is to allow the variance to take effect sooner than the end of regular public comment but allow the community time to comment on the proposed variance. It also is in line with the public comment periods for emergency and expedited policy changes."

Tuesday, January 2, 2024

What's ahead for U.S. organ allocation in the coming year

 Here's the December announcement from HRSA of their plans for reforming organ procurement and allocation this year.  

Organ Procurement and Transplantation Network (OPTN) Modernization Initiative. HRSA's approach to securing best-in-class expertise and an independent Board of Directors, December 2023 Updates

"At every step of the modernization process, HRSA has been committed to robust competition for the first-ever multi-vendor solicitations for OPTN contracts, and we were pleased that Congress supported our vision for fundamental reform through passage of the bipartisan Securing the U.S Organ Procurement and Transplantation Network Act. For more than a year, we have pursued a fundamental sea change in how the OPTN operates in order to improve the performance, transparency, independence, and accountability of this life-saving system for patients – the first time in the nearly 40-year history of this program that any Administration has advocated for this type of fundamental reform to break up the monopoly. Below is an update on the progress made to date and details regarding next steps. 

...

"A key element of HRSA’s OPTN Modernization Initiative is the President’s Fiscal Year 2024 Budget proposal to more than double investment in organ procurement and transplantation with a $36 million increase over Fiscal Year 2023 for a total of $67 million. In light of the uncertainty regarding full-year appropriations for Fiscal Year 2024, as well as the upcoming holidays and HRSA’s commitment to providing at least 60 days for potential bidders to respond to solicitations, HRSA plans to issue the solicitations in January 2024.

...

"1. Launching an Independent OPTN Board of Directors

"Current practice: For nearly 40 years, the Board of Directors for the Organ Procurement and Transplantation Network (OPTN) has been comprised of the same individuals who serve as the Board of Directors for the private entity that has held the OPTN contract. No formal requirements existed to protect against conflicts of interest resulting from this shared role.

"Under HRSA’s OPTN Modernization Initiative:

"HRSA will issue a solicitation in January 2024 for independent non-profit organizations to bid on supporting an independent OPTN Board of Directors in order to ensure mission-driven governance, strong conflict of interest policy, and that the system remains a public good not a private asset. The organization awarded the OPTN Board Support Contract will not be awarded any other OPTN contract.

...

"2. Robust Competition for First Ever Multi-Vendor Solicitations to Support Best-in-Class Vendors for OPTN IT, Operations, Communications, Research and Evaluation

"Current practice: Across the nearly 40-year history of the OPTN, all functions of the OPTN have been managed by a single vendor and not competed based on technical expertise in areas like IT or operations. This does not serve patients well and does not allow the system to keep pace with modern technology.  

"Under HRSA’s OPTN Modernization Initiative:

"Phase 1 — Competitive Transition Contracts:

"In January 2024, HRSA will release solicitations open to all non-profit and for-profit organizations for proposals for OPTN work related to information technology management, operations, data analytics/research, and communication.

"These contracts will support the transition from the legacy OPTN system to a modernized system and approach while ensuring uninterrupted access to the organ matching system and related processes in order to support transplantation and prevent unnecessary risk while protecting patients. As such, we refer to them as Competitive Transition Contracts.

...

"Phase 2 — Next Gen Contracts:

"In Summer 2024, HRSA will issue solicitations open to all non-profit and for-profit organizations for proposals for the OPTN Next Gen contracts.

"The Next Gen contracts will prioritize human-centered design practices and will focus on developing a truly modern organ matching technology solution that is highly reliable, secure, and user-friendly."

######

So the plan is to start this month with bids for contracts to manage the transition from the current system to the 'next generation' system, and to follow those in the summer with bids to design the next generation system. (If that seems out of order to you, you're not the only one.)

Tuesday, December 12, 2023

Waiting for HRSA's request for bids to reorganize deceased organ recovery and allocation

Frank McCormick's invaluable email newsletter includes this Bloomberg article on potential bidders who may emerge when HRSA puts out bids to break up the functions that UNOS presently aggregates for managing the deceased donor organ system.  I'm still not at all sure what bids will be forthcoming, especially since the planned request for bids is still quite opaque.

Big Tech, Startups Look to Revamp Troubled Organ Donation System  by Tony Pugh

"Later this fall, the Health Resources and Services Administration plans to solicit bids for the first round of contracts on the OPTN modernization project. The competition will usher in a years-long effort to both stand up new digital technology that better serves the 100,000-plus people on the organ waiting list, while increasing accountability, equity, and efficiency in the way organs are recovered, matched, and transplanted."

Often when I see a short quote broken up into even smaller pieces I worry that it might not accurately represent what was actually said, but this quote is spot on:

When I look at” the current software used to match organs with possible recipients and to send accept-or-refuse offers to transplant surgeons, “it reminds me of the 1980s,” said Nobel Prize-winning Stanford University economist Alvin E. Roth, who studies how kidneys are matched with suitable candidates.


Tuesday, December 5, 2023

Organ & Body Donations: John Oliver

Laugh through the tears with John Oliver:

Friday, August 11, 2023

Freezing (and then carefully warming) donor organs breaks the organ transplant time barrier (for rats, for the time being)

 Here's a note in Nature Reviews Nephrology pointing out the longer term promise of the recent successful freezing, thawing, and transplantation of rat kidneys.

Cryopreservation breaks the organ transplant time barrier by Marlon J. A. de Haan & Ton J. Rabelink, in Nature Reviews Nephrology (2023)

"The pressing issue of organ shortages for transplantation is fuelled by the rising incidence of kidney failure and the declining quality of organs from an ageing donor pool. However, the main bottleneck in organ transplantation is time; indeed, the current clinical standard for kidney preservation necessitates immediate transplantation following organ recovery1. This urgency often results in suboptimal matches between donors and recipients. Cryopreservation has emerged as a potential solution to this challenge. Such an approach would enable organs to be preserved in a suspended state for extended periods and ready for transplantation on demand. The prospect of long-term banking of cryopreserved organs holds promise for transforming organ transplantation into an elective procedure, thereby enhancing donor–recipient matching, improving equity in access, optimizing patient preparation, refining transplant tolerance protocols, increasing organ utilization and improving graft and patient survival. However, even though cryopreservation has successfully been used to store human embryos, extending the process to preserve whole organs has remained a scientific aspiration — until now. A study by Han et al. introduces an approach to cryopreservation that seemingly extends the shelf life of organs indefinitely2."

...

"By rapidly cooling rat kidneys to –150°C, Han et al. were able to halt the biological clock of the organs, effectively inducing a glass-like state — a process known as vitrification2 (Fig. 1). Specifically, the researchers perfused a cocktail of cryoprotective agents (CPAs) and iron oxide nanoparticles into the organ’s vasculature, which they followed by rapid cooling to ultralow temperatures to achieve a state of vitrification. This vitrified kidney, with its hard, smooth, glasslike appearance, was then transferred to a –150°C freezer for long-term banking. When these kidneys were later rewarmed and transplanted into nephrectomized recipients, they regained life-sustaining renal function. The rewarming stage poses more challenges to the process of cryopreservation: it requires both speed to avoid ice formation during devitrification and uniformity to prevent thermal stresses and mechanical cracks. Here, the iron oxide nanoparticles had a crucial role. Placing the vitrified kidney in a coil that generates electromagnetic fields activates these nanoparticles, generating heat. This innovative approach enabled rapid rewarming at an impressive rate of approximately 72 °C per minute throughout the entire organ, ensuring uniform warming rather than limiting warming to the organs’ surface. This ground-breaking milestone marks an extraordinary achievement in ‘reviving’ a complex organ like the kidney and is the culmination of decades of research into methods to prevent the destructive formation of ice during the cooling process, minimize toxicity from CPAs, and enable fast and uniform rewarming3.



***********

Recently:

Wednesday, June 28, 2023

Friday, July 21, 2023

The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System: participant statements

 Yesterday's Senate Finance committee hearings on The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System are on video, and the following witness statements (delivered beforehand) are now also available.

If you only have time to read one, I'd recommend clicking on the testimony of Matthew Wadsworth, the President And CEO of the OPO, Life Connection of Ohio.

Witnesses 


  1. LaQuayia Goldring
    Patient
    Louisville , KY
  2. Molly J. McCarthy
    Vice Chair & Region 6 Patient Affairs Committee Representative
    Organ Procurement and Transplantation Network (OPTN)
    Redmond , WA
  3. Matthew Wadsworth
    President And CEO
    Life Connection of Ohio
    Kettering , OH
  4. Raymond J. Lynch, MD, MS, FACS
    Professor Of Surgery And Director Of Transplantation Quality And Outcomes
    Penn State Health Milton S. Hershey Medical Center
    Hershey , PA
  5. Donna R. Cryer, JD
    Founder And CEO
    Global Liver Institute
    Washington , DC
**********

Thursday, July 20, 2023

Senate Finance Subcommittee on Health Care --testimony on organ transplants, going on now

Watch right now or listen later.  UNOS is not popular in the Senate.

 https://www.c-span.org/video/?529461-1/health-advocates-testify-improving-organ-transplant-system

Health Advocates Testify on Improving Organ Transplant System

Patients and health professionals testify on the effectiveness of the organ transplant system before the Senate Finance Subcommittee on Health Care.

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Another set of links:Subcommittee Hearing
Subcommittee on Health CareDate: Thursday, July 20, 2023Time: 10:00 AMLocation: 215 Dirksen Senate Office Building