Showing posts with label liver. Show all posts
Showing posts with label liver. Show all posts

Thursday, March 23, 2023

Health Resources and Services Administration (HRSA) Announces Organ Procurement and Transplantation Network Modernization Initiative.

Here's a long awaited HRSA announcement, indicating their intent to modernize the deceased organ procurement and allocation system in the U.S.  It's still a bit short on details, but specifically mentions budget increases. In the future it will apparently issue Requests for Proposals from organizations willing to bid on parts of the transplantation allocation system, including software. (I hope HRSA is also thinking about how organ allocation policies will be revised and kept up to date in the future, including the possibility of experimenting with proposed improvements on a regular basis.)

The press release:

HRSA Announces Organ Procurement and Transplantation Network Modernization Initiative. Initiative includes the release of new organ donor and transplant data; prioritization of modernization of the OPTN IT system; and call for Congress to make specific reforms in the National Organ Transplant Act

"[March 22, 2023] Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced a Modernization Initiative that includes several actions to strengthen accountability and transparency in the Organ Procurement and Transplantation Network (OPTN):

"Data dashboards detailing individual transplant center and organ procurement organization data on organ retrieval, waitlist outcomes, and transplants, and demographic data on organ donation and transplant;

"Modernization of the OPTN IT system in line with industry-leading standards, improving OPTN governance, and increasing transparency and accountability in the system to better serve the needs of patients and families;

"HRSA’s intent to issue contract solicitations for multiple awards to manage the OPTN in order to foster competition and ensure OPTN Board of Directors’ independence;

"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; and,

"A request to Congress included in the Fiscal Year 2024 Budget to update the nearly 40-year-old National Organ Transplant Act to take actions such as:

"Removing the appropriations cap on the OPTN contract(s) to allow HRSA to better allocate resources and,

"Expanding the pool of eligible contract entities to enhance performance and innovation through increased competition.

“Every day, patients and families across the United States rely on the Organ Procurement and Transplantation Network to save the lives of their loved ones who experience organ failure,” said Carole Johnson, HRSA Administrator. “At HRSA, our stewardship and oversight of this vital work is a top priority. That is why we are taking action to both bring greater transparency to the system and to reform and modernize the OPTN. The individuals and families that depend on this life-saving work deserve no less.”


"Today, HRSA is posting on its web site at Organ Donation and Transplantation (hrsa.gov) a new data dashboard to share de-identified information on organ donors, organ procurement, transplant waitlists, and transplant recipients. Patients, families, clinicians, researchers, and others can use this data to inform decision-making as well as process improvements. Today’s launch is an initial data set, which HRSA intends to refine over time and update regularly.

"This announcement also includes a plan to strengthen accountability, equity, and performance in the organ donation and transplantation system. This iterative plan will specifically focus on five key areas: technology; data transparency; governance; operations; and quality improvement and innovation. In implementing this plan, HRSA intends to issue contract solicitations for multiple awards to manage and improve the OPTN. HRSA also intends to further the OPTN Board of Directors’ independence through the contracting process and the use of multiple contracts. Ensuring robust competition in every industry is a key priority of the Biden-Harris Administration and will help meet the OPTN Modernization Initiative’s goals of promoting innovation and the best quality of service for patients.

"Finally, the President’s Budget for Fiscal Year 2024 would more than double HRSA’s budget for organ-related work, including OPTN contracting and the implementation of the modernization initiative, to total $67 million. In addition, the Budget requests statutory changes to the National Organ Transplant Act to remove the decades old ceiling on the amount of appropriated funding that can be awarded to the statutorily required vendor(s) for the OPTN. It also requests that Congress expand the pool of eligible contract entities to enhance performance and innovation through increased competition, particularly with respect to information technology vendors.

"HRSA recognizes that while modernization work is complex, the integrity of the organ matching process is paramount and cannot be disrupted. That is why HRSA’s work will be guided by and centered around several key priorities, including the urgent needs of the more than 100,000 individuals and their families awaiting transplant; the 24/7 life-saving nature of the system; and patient safety and health. HRSA intends to engage with a wide and diverse group of stakeholders early and often to ensure a human-centered design approach that reflects pressing areas of need and ensuring experiences by system users like patients are addressed first. As a part of this commitment, HRSA has created an OPTN Modernization Website at OPTN Modernization (hrsa.gov) to keep stakeholders informed about the Modernization Initiative and provide regular progress updates."

************

Here's a related story in the NY Times:

U.S. Organ Transplant System, Troubled by Long Wait Times, Faces an Overhaul. The Biden administration announced a plan to modernize how patients are matched to organs, seeking to shorten wait times, address racial inequities and reduce deaths.  By Sheryl Gay Stolberg

"The Biden administration announced on Wednesday that it would seek to break up the network that has long run the nation’s organ transplant system, as part of a broader modernization effort intended to shorten wait times, address racial inequities and reduce the number of patients who die while waiting.

*****************

 Earlier, the Washington Post had a story about how the most recent (current) version of the system  for allocating deceased donors is indeed having some problems, the most serious of which (in my view) is the congestion  involved in placing an organ for transplant. (This congestion involves time in getting an organ accepted, and then transported...)

New liver transplant rules yield winners, losers as wasted organs reach record high. The number of lifesaving liver transplants has plummeted in some Southern and Midwestern states that struggle with higher death rates from liver disease  By Malena Carollo and Ben Tanen

"New rules requiring donated livers to be offered for transplant hundreds of miles away have benefited patients in New York, California and more than a dozen other states at the expense of patients in mostly poorer states with higher death rates from liver disease, a data analysis by The Washington Post and the Markup has found.

"The shift was implemented in 2020 to prioritize the sickest patients on waitlists no matter where they live. While it has succeeded in that goal, it also has borne out the fears of critics who warned the change would reduce the number of surgeries and increase deaths in areas that already lagged behind the nation overall in health-care access.

...

"The new system, called the “acuity circles” policy, has nearly doubled the median distance livers are transported, increased transport costs and coincided with the highest number of wasted livers in nearly a decade, 949 in 2021. That’s 1 in 10 donated livers. The analysis further shows a significant increase in the number of states sending donated livers beyond their own borders. In 2019, before the new policy took effect, 21 states and territories exported a majority of livers they collected. Two years later, 42 did."

Wednesday, December 21, 2022

Paired liver exchange in India

 Here's a report on 2-way liver exchanges conducted at Max Center for Liver and Biliary Sciences, Max Saket Hospital, New Delhi, India, each between two manually matched, non-anonymous patient-donor pairs.

Paired Exchange Living Donor Liver Transplantation: A Nine-year Experience From North India by Agrawal, Dhiraj MD, DM1; Saigal, Sanjiv MD, DM, MRCP, CCST1; Jadaun, Shekhar Singh MD, DM1; Singh, Shweta A. MD, DM1; Agrawal, Shaleen MS, MCh1; Gupta, Subhash MS, MCh1 


"Background: Paired exchange liver transplantation is an evolving strategy to overcome ABO blood group incompatibility and other barriers such as inadequate graft-to-recipient weight ratio and low remnant liver volume in donors. However, for the transplant team to carry 4 major operations simultaneously is a Herculean effort. We analyzed our experience with liver paired exchange (LPE) program over the past 9 y."

...

"Although the basic framework for LPE was adopted from the kidney paired exchange program, LPE or swap LDLT is inherently distinct, more complex, and associated with more technical, logistical, and ethical challenges.11 Both recipient and donor surgeries are long-duration surgeries and must be flawless to ensure minimum morbidity and mortality. The living donor partial hepatectomy is associated with approximately 10 times greater mortality than living donor nephrectomy, and the morbidity ranges from 9% to 24%, depending on the type of hepatectomy performed.12,13

"The logistics involved in a single-center simultaneous LPE are extensive with 4 simultaneous operations: 4 sets of teams of anesthetists, surgeons, nurses, and technicians. The blood bank must be equipped with requirements for major surges. For a single LDLT operation, it is estimated that >18 skilled team members may be needed, and in LPE, this number is doubled. Furthermore, any unanticipated difficulty due to operative anatomical variations may potentially impact both recipients’ outcomes. These constraints limit the LPE to a few high-volume centers.

...

"After the recipients and donors of an incompatible pair showed willingness for LPE, the medical suitability of each donor and recipient pair and the equity of the exchange were confirmed by a multidisciplinary forum comprising transplant hepatologists, transplant surgeons, social workers, and psychiatrists. Once 2-by-2 donor-recipient pairs were successfully matched, the transplant team informed the pairs and arranged a meeting wherein each recipient could meet their intended donor in the presence of the transplant team to discuss any anticipated issues. All participants who participated in the exchange program underwent a thorough psychosocial assessment to minimize the possibility of conflict. Donors have clarified that a poor outcome is possible in any LDLT, and in rare circumstances, their intended recipient can have a poor outcome. Through several in-depth counseling sessions, all 4 parties were independently and jointly informed about the suitability and structure of the exchange, the entire procedure, and the expected results. They were also provided with alternative options such as ABOi transplantation, deceased donor liver transplantation (DDLT), and associated risks and cost-effectiveness. Donors were allowed to opt out at any step during the process, and care was taken to avoid coercion. After the development of basic trust between all 4 participants, informed consent and a confidential agreement were signed. In India, there is a strict legal requirement for LDLT that the donor and recipient should be related to either blood or marriage. However, since LPE is an unrelated, directed donation, special approval was obtained from the ethical committee of the local authority.

...

"The 17 pairs of LPE donations included 34 directed living donors with a median age of 38.5 y (19–51 y), of which 27 were females. All donors were first-degree relatives of the recipients and included 18 spouses, 11 children, and 5 siblings. 

...

"ABO-incompatible donor-recipient pairs are encouraged to visit our center regularly, and as this is a common problem, not surprisingly, they are often able to meet another ABOi pair at the center. Furthermore, our coordinators have the telephone numbers of recipients looking for paired exchanges, and they facilitate such pairs to speak to each other on the phone. Once they show willingness to participate in the paired exchange program, their papers are submitted to the government-appointed authorization committee for clearance. Theoretically, in LPE donations, there is a potential for emotional disconnect, as opposed to ABO-incompatible LDLT. Interestingly, in our series of 34 transplants, the donor felt that they had donated to their own recipient, and on follow-up, all 4 participants seemed to have developed great emotional bonding.

"At our center, >75% of donors are first-degree relatives as “nonnear relatives” find very difficult to get governmental clearance. LPE is a transplantation between unrelated people and is, therefore, liable for exploitation. However, The Transplant Act has built in safety features as it allows only “first degree relatives” to be considered for paired exchange and also bars the organ exchanges between Indian and foreigners.

...

"It is possible that, in the future, transplant centers in India will act in tandem, and we will be able to operate pairs at 2 different centers. However, under the existing hospital-based government-appointed authorization committee, this may not be feasible unless a central clearing agency is set up."

Saturday, November 12, 2022

Deceased donor organ discards on weekends, in the the Annals of Transplantation

 Hospital resources and physician incentives can be stressed on weekends, and there is historical evidence that organ discards are higher on weekends.  Here's a study suggesting that is still a thing.

Yamamoto, T., A. Shah, M. Fruscione, S. Kimura, N. Elias, H. Yeh, T. Kawai, and J. F. Markmann.  Revisiting the "Weekend Effect" on Adult and Pediatric Liver and Kidney Offer Acceptance. Annals of Transplantation. 2022 Nov;27:e937825. DOI: 10.12659/aot.937825. PMID: 36329622.

"BACKGROUND: Weekends can impose resource and manpower constraints on hospitals. Studies using data from prior allocation schemas showed increased adult organ discards on weekends. We examined the impact of day of the week on adult and pediatric organ acceptance using contemporary data.

"MATERIAL AND METHODS: Retrospective analysis of UNOS-PTR match-run data of all offers for potential kidney and liver transplant from 1/1/2016 to 7/1/2021 were examined to study the rate at which initial offers were declined depending on day of the week. Risk factors for decline were also evaluated.

"RESULTS: Of the total initial adult/pediatric liver and kidney offers, the fewest offers occurred on Mondays and Sundays. The decline rate for adult/pediatric kidneys was highest on Saturdays and lowest on Tuesdays. The decline rate for adult livers was highest on Saturday and lowest on Wednesday. In contrast, the decline rate for pediatric livers was highest on Tuesdays and lowest on Wednesdays. Independent risk factors from multivariate analysis of the adult/pediatric kidney and liver decline rate were analyzed. The weekend offer remains an independent risk factor for adult kidney and liver offer declines, but for pediatric offers, these were not significant independent risk factors.

"CONCLUSIONS: Although allocation systems have changed, and the availability of kidneys and livers have increased in the USA over the past 5 years, the weekend effect remains significant for adult liver and kidney offers for declines. Interestingly, the weekend effect was not seen for pediatric liver and kidney offers.

Sunday, March 13, 2022

Nondirected living liver donation in the U.S.

Nondirected kidney donation has been important in U.S. kidney transplants for some time.  Here's a report observing that nondirected living liver donation is picking up.

 Herbst, Leyla R. BA1; Herrick-Reynolds, Kayleigh MD1,2; Bowles Zeiser, Laura ScM1; López, Julia I. BA1; Kernodle, Amber MD, MPH1; Asamoah-Mensah, Awura1; Purnell, Tanjala MPH, PhD2; Segev, Dorry L. MD, PhD1,3,4; Massie, Allan B. PhD, MHS1,3; King, Elizabeth MD, PhD1; Garonzik-Wang, Jacqueline MD, PhD1; Cameron, Andrew M. MD, PhD1 The Landscape of Nondirected Living Liver Donation in the United States, Transplantation: March 2, 2022 - doi: 10.1097/TP.0000000000004065 

"Living donor liver transplants (LDLTs) including those from nondirected donors (NDDs) have increased during the past decade

...

"NDDs increased from 1 (0.4% of LDLTs) in 2002 to 58 (12% of LDLTs) in 2020. Of 150 transplant centers, 35 performed at least 1 NDD transplant.

...

"Liver NDD transplants continue to expand but remain concentrated at a few centers. Graft distribution favors female adults and pediatric patients with biliary atresia. Racial inequities in adult or pediatric center-level NDD graft distribution were not observed."

Tuesday, September 28, 2021

Liver transplantation in the Middle East

 Here's a chapter on transplantation in a book about liver cancer.  The countries in the Middle East that can do liver transplants can also transplant kidneys, with living donors being the majority of donors across the region.

Liver Transplantation in the Middle East by Sezai Yilmaz,  In: Carr B.I. (eds) Liver Cancer in the Middle East. Springer, Cham. https://doi.org/10.1007/978-3-030-78737-0_12

It contains some interesting summaries by country.  Here is the summary of the transplant situation in the UAE (about which I expect to be able to say more soon).

"6 LT in the United Arab Emirates

"The United Arab Emirates (UAE) is an Arabian Gulf country located at the southeast end of the Arabian Peninsula with a population of about 9.3 million. It has made great strides in healthcare over the past several years and has among the highest life expectancy in the region. However, one of the key lacking areas of medical care in the country was the availability of solid organ transplantation. Collaborative efforts began a few years ago aiming to establish thoracic and abdominal solid organ transplantation from deceased donors in addition to continued development of the existing program on kidney transplantation from living donors. The UAE played an important role in efforts leading up to the declaration of Istanbul on organ trafficking and transplant tourism in 2008, the groundwork for which was laid in a steering committee meeting organized by the Transplantation Society and the International Society of Nephrology in Dubai in December 2007. This landmark declaration helped establish a framework of ethical principles to guide the practice of transplantation worldwide. The legal definition of brain death in the UAE was confirmed in May 2017, paving the way for deceased donor organ transplantation [42].

"The Cleveland Clinic Foundation was instrumental in the accelerated path to establishment of a multi-organ transplant center at Cleveland Clinic Abu Dhabi. Cleveland Clinic Abu Dhabi, which began clinical operations in early 2015, was established as a partnership between Mubadala Healthcare, Abu Dhabi, and Cleveland Clinic Foundation in Cleveland, Ohio. A meticulous and thoughtful collaborative approach, which began with identifying key operational needs, resulted in the establishment of transplant services within 2.5 years with the establishment of Cleveland Clinic Abu Dhabi. The first multi-organ procurement and transplant from a brain-dead donor in the UAE occurred at Al Qassimi Hospital in Sharjah on July 15, 2017 [42]. Also noteworthy was a regional organ sharing agreement with SCOT that enabled the utilization of deceased donor grafts for potential recipients in Saudi Arabia while awaiting full operational readiness for thoracic and LT at Cleveland Clinic Abu Dhabi. The overall organ donation rate remains low in terms of the number of organs recovered (3.66) and transplanted (3.57) per donor.

"Shortage of deceased donors remains one of the primary challenges facing the transplant community in the UAE. This mandated establishment of LDLT to complement ongoing efforts to improve DDLT. An extensive collaborative effort, with Cleveland Clinic’s main campus in Cleveland, Ohio, resulted in the first successful LDLT in the UAE on July 29, 2018. Since that time, an additional 13 LDLTs were performed (overall: four right lobe and ten left lobe grafts) over the past year and a half [42]."

Wednesday, July 14, 2021

Increasing living donor liver transplantation: liver exchange and other options

 Here's an early online paper from the journal Liver Transplantation.

Can living donor liver transplant in the United States reach its potential?  by Alyson Kaplan, Russell Rosenblatt, Benjamin Samstein, Robert S. Brown Jr., 

First published: 26 June 2021 https://doi.org/10.1002/lt.26220   

Abstract: Living donor liver transplantation (LDLT) is a vital tool to address the growing organ shortage in the United States caused by increasing numbers of patients diagnosed with end-stage liver disease. LDLT still only makes up a very small proportion of all liver transplants performed each year, but there are many innovations taking place in the field that may increase its acceptance amongst both transplant programs and patients. These innovations include ways to improve access to LDLT, such as through non-directed donation, paired exchange, transplant chains, transplant of ABO-incompatible donors, and transplant in high MELD patients. Surgical innovations, such as laparoscopic donor hepatectomy, robotic hepatectomy and portal flow modulation, are also increasingly being implemented. Policy changes, including decreasing the financial burden associated with LDLT, may make it a more feasible option for a wider range of patients. Lastly, center-level behavior, such as ensuring surgical expertise and providing culturally competent education, will help towards LDLT expansion. While it is challenging to know which of these innovations will take hold, we are already seeing LDLT numbers improve within the last two years.

Sunday, June 2, 2019

A third life for a transplanted liver in Hong Kong

The South China Morning Post has the story, of a transplanted liver that survived its recipient and was successfully transplanted into a second recipient following the death of the first recipient (11 years after receiving the transplant):

World first as Hong Kong surgeons transplant single liver into second patient
World-first procedure sees organ transplanted 11 years ago successfully given to another patient

"Hong Kong surgeons have performed a double world first with a transplant from one Hepatitis B sufferer to another of a liver that had already been transplanted once 11 years ago.
Bodybuilder Wong Wan-shing, 37, received the graft at Queen Mary Hospital from a 60-year-old donor identified only as Mr So, who died of a stroke on October 1."

Thursday, March 1, 2018

A liver for a kidney?

One consequence of the growth of kidney exchange is that there is more discussion of novel modes of exchange. Here's an article forthcoming in the American Journal of Transplantation that cautiously discusses the ethical issues that would be involved in a kidney-liver exchange.  I found the most interesting of the issues discussed to be those surrounding the excuse that medical teams give to prospective donors who don't really want to donate: they say e.g. that the kidney isn't suitable, or that the donor's kidney function isn't sufficient to allow him/her to donate. So the article discusses how this might pressure a reluctant donor if the question "but how about his/her liver"? could be asked...

The main case being discussed of course is one in which two lives could be saved by an exchange of donors, as in kidney exchange (or liver exchange, as has been employed a bit in Asia...).

(Incidentally, the article is written in the future hypothetical, but I wouldn't be shocked to hear that somewhere in the U.S. one such exchange has already taken place.)

New in the AJT:

A Liver for a kidney: Ethics of trans-organ paired exchange

Authors

  • Accepted manuscript online: 
  • DOI: 10.1111/ajt.14690
  • American Journal of Transplantation (forthcoming)
  • Abstract
  • Living donation provides important access to organ transplantation, which is the optimal therapy for patients with end-stage liver or kidney failure. Paired exchanges have facilitated thousands of kidney transplants and enable transplantation when the donor and recipient are incompatible. However, frequently willing and otherwise healthy donors have contraindications to donation of the organ that their recipient needs. Trans-organ paired exchanges would enable a donor associated with a kidney recipient to donate a lobe of liver and a donor associated with a liver recipient to donate a kidney. This paper explores some of the ethical concerns that trans-organ exchange might encounter including unbalanced donor risks, the validity of informed consent, and effects on deceased organ donation.

Wednesday, February 28, 2018

Liver exchange: prospects and challenges

Might liver exchange be attempted in the U.S.?  (Maybe at Penn?). Here's a forthcoming article that considers how the challenges would be similar and different from the development of kidney exchange.

Liver Paired Exchange: Can the Liver Emulate the Kidney?
by Ashish Mishra, Alexis Lo, Grace S. Lee, Benjamin Samstein, Peter S. Yoo, Matthew H. Levine, David S. Goldberg, Abraham Shaked, Kim M. Olthoff, Peter L. Abt
Liver Transplantation, Accepted manuscript online: 10 February 2018

Abstract: Kidney paired exchange (KPE) constitutes 12 percent of all living donor kidney transplants in the United States. The success of KPE programs has prompted many in the liver transplant community to consider the possibility of liver paired exchange (LPE). Though the idea seems promising, the application has been limited to a handful of centers in Asia.  In this manuscript we consider the indications, logistical issues, and ethics for establishing a LPE program in the United States with reference to the principles and advances developed from experience with KPE. 

Saturday, December 17, 2016

The politics (and incentives) of liver transplants

From the LA Times: California has long wait lists for liver transplants, but not for the reasons you think

"About 7,000 people get a liver transplant each year in the United States, while 17,000 remain on waiting lists at transplant centers. Who should get a lifesaving transplant has always been a complex calculation. But it has blown up into a vicious political struggle that played out most recently at a meeting of the organization governing the nation’s transplant network.

"The benefits of liver transplants are astounding. Patients just weeks from death can have their lives extended significantly, even indefinitely. Given the limited number of donor livers, in 2000 Congress established what’s called “the Final Rule” to guide the medical community in how to allocate them fairly. The Final Rule compels the transplant community to allocate donor organs based on best medical judgment, best use of the organs and avoidance of futile transplants. It also notes that a patient’s chance of getting a transplant should not be affected by where he or she lives.

"Balancing these various guidelines has always been tricky. But what has emerged — and is now the point of contention — is a marked geographic disparity in how sick a patient must be before rising to the top of a transplant list. For example, waiting lists at California transplant centers are significantly longer (and therefore patients in California get a lot sicker before possibly receiving transplants) compared with waiting lists in Oregon. That’s unfair to the Californians who need liver transplants, right?

"Acting on this assumption, the national board of the Organ Procurement and Transplantation Network / United Network for Organ Sharing, or OPTN/UNOS, proposed new boundaries for the nation’s transplant regions. The aim was to have regions with shorter, less-sick waiting lists share the limited supply of donor livers with regions that have longer, more-sick waiting lists. The new map was recently offered for public comment and a regional advisory vote.

"Eight of the 11 regions came out against it — because longer waitlists aren’t necessarily a sign of greater need.

The divide is deep. Antagonists have split into camps (“Liver Alliance” versus “Coalition for Organ Distribution Equity”), hired lobbyists and collected their congressional representatives. Given the uproar, it was not surprising that the OPTN/UNOS board of directors declined to vote on the controversial proposal at its national meeting in St. Louis last week. Nevertheleess, there’s a feeling of urgency that something must be done, so it’s entirely possible the board will soon enact the redistribution proposal — perhaps with minor modifications — despite present objections.
...
"Transplant waiting lists also get distorted by intense competition in populous regions where there are more liver transplant centers — a largely ignored issue. With money and prestige at stake, centers are motivated to perform more liver transplants. The simplest way to accomplish that is to put very ill patients on the transplant list, because when a donor organ becomes available, the center with the sickest listed patient in that region gets the organ.

Unfortunately, this encourages centers to list sicker patients over those who have the best chance of long, high-quality lives post-transplant.
...
"Rates of organ donation, by the way, do not explain the wait-list problem: California has some of the highest donation rates in the country, while New York persistently ranks at the bottom. Everyone agrees on the need to increase donations — but just redistributing livers will not significantly change the number of transplants or lives saved.

"Still, the disparity between the wait lists causes endless teeth-grinding in the transplant community.

"There is no question that wait lists are abhorrently long in some places, but OPTN/UNOS’ redistribution proposal misses the larger point: What is it about our transplant system that has created this situation? How can we make changes to keep the wait lists at more reasonable levels?

"Matters of healthcare access, while important, are beyond the control of OPTN/UNOS and the transplant community. Within grasp, however, is a simple solution: Lower the number of patients on transplant lists. Such a move would not affect the number of transplants (every available liver would still be transplanted), but it would reduce the delay and degree of illness for those on the wait lists. This is, of course, simple to say, but difficult to implement given how our current system incentivizes transplant centers to get as many patients on their lists as possible.

"To create a fairer balance between the haves and have-nots, though, both factions in the liver debate need to understand (and agree on) who the haves and have-nots actually are. Without consensus on that, we risk missing the big picture: increasing the health, happiness and well-being of more people with liver disease."

Dr. Willscott E. Naugler is an associate professor and medical director of liver transplantation at Oregon Health & Science University in Portland. He also serves as the Region 6 (Pacific Northwest) regional representative to the UNOS Liver and Intestine Committee."

Monday, August 22, 2016

Quality control of transplant centers, and the choice of who to transplant (and which organs to accept)

Transplant centers are regulated by measures such as their one-year graft-survival rate, so they feel pressure not to transplant patients, or organs, that have too high a risk to meet the required measure of success.

Here's a recent paper from the Journal of the American College of Surgeons that discusses some of the consequences:

Background

The central tenet of liver transplant organ allocation is to prioritize the sickest patients first. However, a 2007 Centers for Medicare and Medicaid Services regulatory policy, Conditions of Participation (COP), which mandates publically reported transplant center performance assessment and outcomes-based auditing, critically altered waitlist management and clinical decision making. We examine the extent to which COP implementation is associated with increased removal of the “sickest” patients from the liver transplant waitlist.

Study Design

This study included 90,765 adult (aged 18 years and older) deceased donor liver transplant candidates listed at 102 transplant centers from April 2002 through December 2012 (Scientific Registry of Transplant Recipients). We quantified the effect of COP implementation on trends in waitlist removal due to illness severity and 1-year post-transplant mortality using interrupted time series segmented Poisson regression analysis.

Results

We observed increasing trends in delisting due to illness severity in the setting of comparable demographic and clinical characteristics. Delisting abruptly increased by 16% at the time of COP implementation, and likelihood of being delisted continued to increase by 3% per quarter thereafter, without attenuation (p < 0.001). Results remained consistent after stratifying on key variables (ie, Model for End-Stage Liver Disease and age). The COP did not significantly impact 1-year post-transplant mortality (p = 0.38).

Conclusions

Although the 2007 Centers for Medicare and Medicaid Services COP policy was a quality initiative designed to improve patient outcomes, in reality, it failed to show beneficial effects in the liver transplant population. Patients who could potentially benefit from transplantation are increasingly being denied this lifesaving procedure while transplant mortality rates remain unaffected. Policy makers and clinicians should strive to balance candidate and recipient needs from a population-benefit perspective when designing performance metrics and during clinical decision making for patients on the waitlist.
It drew this headline in the news:
Hospitals are throwing out organs and denying transplants to meet federal standards

Wednesday, June 10, 2015

Liver transplant waiting times and MELD scores around the country (and a calculator you can use)

Here's a story in the Wisconsin State Journal: Access to liver transplants unequal in Wisconsin, nation . (Link to a liver calculator at bottom, by transplant center, etc.)

"Access to liver transplants varies in Wisconsin and around the country, with relatively healthy patients getting organs in some places while sicker patients elsewhere deteriorate or die on the waiting list.

"The geographic disparities persist even after a policy two years ago required broader access to patients most in need.

"Policymakers are proposing a more radical change: Dividing the country into four or eight districts for liver sharing instead of the 11 regions and 58 local areas used today.

"Populous states welcome the idea. It would direct livers to “patients in most urgent need, drastically reduce existing geographic disparities in access and, most importantly, save lives,” members of Congress from California, New York and other states wrote to federal officials after the proposal was released last year.

"But congressional representatives mostly from the Midwest and South said the proposal would disadvantage more rural parts of the country. “Areas with high organ donation rates would be disproportionately affected,” they wrote.
...
 "Nationwide, more than 15,000 people await livers, nearly 13,000 of them in active status, meaning they could receive an organ today. About 6,700 people got liver transplants last year.

"Roughly 1,500 people die waiting for livers each year, according to the United Network for Organ Sharing, or UNOS, which runs the transplant system.

"Patients are ranked by medical urgency scores called Model for End-Stage Liver Disease, or MELD. The scores, based on three lab tests, range from 6 for least ill to 40 for gravely ill.

"The sickest patients go to the top of their local waiting lists. But where they rank depends on where they live, as demand for and supply of livers varies around the country.

"Patients getting livers in much of Indiana, Iowa, South Carolina and Tennessee typically have MELD scores of 25 or lower. In parts of California, Massachusetts and New York, the median MELD score at the time of transplant is 33 or higher.

"In Madison’s local area, the median MELD is 28.5. In Milwaukee, it’s 34. In Chicago, it’s 30.

"When the late Apple founder Steve Jobs flew from California to Tennessee for a liver transplant in 2009, he brought attention to one way patients can circumvent the system — by going to places with lower MELD scores and shorter wait times.

"To assist the vast majority of patients who don’t have private jets, Sridhar Tayur launched OrganJet in 2011. The Weston, Massachusetts, company can help people waiting for kidneys or livers get to hospitals in other states in time for transplants, said Tayur, an operations management professor at Carnegie Mellon University in Pittsburgh.

"The cost: $17,000 to $24,000 per flight. So far, about 35 people have signed up for the service but nobody has used it, Tayur said.

He’s trying to get insurance companies to cover the fee. “That would really increase demand,” he said.
...
"Opponents of broader sharing also say more time is needed to gauge the impact of a 2013 policy requiring partial sharing of livers.

The policy, called Share 35, gives livers to patients with MELD scores of 35 or higher throughout each region before local patients with lower scores get them.

A Milwaukee patient with a MELD of 36 gets priority for a Madison donor’s liver over a Madison patient with a MELD of 28, for example. Previously, the Madison patient would have received the liver.

What most irks Madison doctors is something called MELD exception points. Extra points can be given to patients with conditions such as liver cancer, who otherwise have low MELD scores.

Use of exception points varies, with some studies showing more liberal use on the coasts.

“People have gamed the system to have livers sent their way,” said Dr. Tony D’Alessandro, a transplant surgeon at UW Hospital.

Dr. Peter Stock, a transplant director at the University of California, San Francisco, said exception points “are only given if they’re truly, truly needed.”

UNOS is looking at creating a national board to review MELD exceptions, which would replace regional boards used today."
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You can get information about different transplant centers around the country, for patients of different ages, blood types and MELD scores using a calculator from the Scientific Registry of Transplant Recipients (SRTR)
 Liver Transplant Waiting List Outcomes Tool Beta

Sunday, January 25, 2015

Domino liver transplants

At the University of Maryland, a woman who received a liver transplant from a deceased donor was nevertheless able to donate her liver to another patient...The Baltimore Sun has the story.

Rare domino liver transplant saves two lives

"The 52-year-old suffered from a rare genetic disease, familial amyloid polyneuropathy, that caused her liver to produce a protein that travels to other organs and sickens them. She had a stroke after the protein had begun to deposit in her heart, and she also had trouble walking.
?Dzielski underwent a lifesaving liver transplant in October. And although her old liver threatened her life, in the end it saved someone else's.

"During a nearly five-hour procedure at the University of Maryland Medical Center called a domino liver transplant, Dzielski received a liver from a deceased organ donor and then gave her liver to an Owings Mills woman.

"Other than the protein defect, Dzielski's liver was healthy, so it could be transplanted into someone else. But it needed to be an older person who likely wouldn't live long enough for the symptoms of familial amyloid polyneuropathy to appear. It typically takes years for the disease to show, which is why Dzielski didn't have problems until her 50s. In domino procedures, these livers are given to people at least 60 years of age."

Wednesday, February 26, 2014

Boston Globe on 2010 death of live liver donor

The Boston Globe had a story earlier this month recounting the events surrounding the 2010 death of a liver donor (about which they wrote and I blogged at the time: Live Liver donation tragedy).

Donor’s death shatters family, stuns surgeons: Pure generosity drove Paul Hawks to donate part of his liver to his desperately ill brother-in-law. Then disaster struck, and transplant medicine has had to rethink its rules.
By Liz Kowalczyk    FEBRUARY 02, 2014

Friday, August 24, 2012

Incentives and organ donation in Germany

Bettina Klaus writes:  There is an article about a recent organ donation scandal at the university hospital Goettingen

One of the transplant surgeons there seems to have manipulated patient files (25 cases are currently under investigation) in order to push his patients up on the waiting list. Interestingly his salary depended on the numbers of transplants he did and the article states that under his lead the number of liver transplants at the university hospital Goettingen had significantly increased in 2009 and 2010. 

Here's an English account of that, and organ sales as well: Desperation, Greed and the Global Organ Trade 
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Something similar  to the Goettingen events led to a change in the deceased-donor liver allocation system in the U.S.
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See also http://www.spiegel.de/gesundheit/diagnose/organspende-skandal-goettingen-montgomery-fordert-schaerfere-kontrollen-a-847985.html, for a related story (also in German), which focuses on recent changes in the German transplant and organ donation systems. (HT Rosemarie Nagel)
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And Markus Mobius points to this article (also in German, but the headline is clear): Transplantationsskandal

He writes "The article says that an increasing share of transplants in Germany are now bypassing the waiting list and go straight to in-house patients.
"10 years ago, 9.1% of livers, 8.4% of hearts, 10.6% of lungs and 6.3% of pancreas bypassed the waiting list. Now the shares are 37.1%, 25.8%, 30.3% and 43.7%, respectively. "

Tuesday, July 10, 2012

Living donors' stories

Narrative Inquiry in Bioethics (2, 1, Spring 2012) is devoted to a Narrative Symposium: Living Organ Donation

"As Elisa Gordon notes, the collection of stories represent the experiences of liver and kidney donors; donors whose organ was successfully and unsuccessfully transplanted into a recipient; related and unrelated donors; and donors who had overwhelmingly positive experiences, mixed experiences, and negative experiences. In these stories we read about a wide variety of motives for donation and concerns with the donation experience. We hope that the collection of personal narratives and commentaries by Drs. Dianne LaPointe Rudow and Paul Root Wolpe will lead to a better understanding of the current living donation process as well as improvements in that process for future donors."


Living Organ Donors’ Stories: (Unmet) Expectations about Informed Consent, Outcomes, and Care

pp. 1-6 | DOI: 10.1353/nib.2012.0001

Living Organ Donation

pp. 7-37 | DOI: 10.1353/nib.2012.0002

An Altruistic Living Donor’s Story

pp. 7-10 | DOI: 10.1353/nib.2012.0018

Surgery for the Soul

pp. 10-11 | DOI: 10.1353/nib.2012.0008

Kidney Donation Story

pp. 11-14 | DOI: 10.1353/nib.2012.0010

The Essence of Giving—A Transplant Story

pp. 14-17 | DOI: 10.1353/nib.2012.0012

Love—the Risk Worth Taking

pp. 17-19 | DOI: 10.1353/nib.2012.0014

My Donation Journey

pp. 19-21 | DOI: 10.1353/nib.2012.0016

A Life For A Life: My Gift To My Dad

pp. 21-24 | DOI: 10.1353/nib.2012.0017

Lessons Learned: The Realities of Living Organ Donation

pp. 24-26 | DOI: 10.1353/nib.2012.0007

Sarah’s List Exchange Experience

pp. 26-29 | DOI: 10.1353/nib.2012.0009

Accelerated Living Donation

pp. 29-31 | DOI: 10.1353/nib.2012.0011

Liver Donor Nightmare

pp. 31-34 | DOI: 10.1353/nib.2012.0013

Adrift After Donation

pp. 34-37 | DOI: 10.1353/nib.2012.0015

Personal Narratives: Living Organ Donation (Web Only Content)

Getting Our Child Off Dialysis

p. E1 | DOI: 10.1353/nib.2012.0019

A Living Donor’s Journey

pp. E2-E6 | DOI: 10.1353/nib.2012.0020

The Spare Kidney

pp. E6-E9 | DOI: 10.1353/nib.2012.0021

Living Donors are People Too

pp. E9-E11 | DOI: 10.1353/nib.2012.0022

Gifts and Obligations: The Living Donor as Storyteller

pp. 39-44 | DOI: 10.1353/nib.2012.0003

The Gift of Life—Walking by Faith

pp. E11-E14 | DOI: 10.1353/nib.2012.0023

Journey of an Altruistic, Non–designated Living Donor

pp. E14-E16 | DOI: 10.1353/nib.2012.0024

Experiences of the Live Organ Donor: Lessons Learned Pave the Future

pp. 45-54 | DOI: 10.1353/nib.2012.0004