Regulation of transplant centers and OPO's

I'll be speaking this morning on regulation of transplantation at the 2020 Winter meetings of the American Society of Transplant Surgeons in Miami.

I'll be in a  Special Invited Presidential Session: Transplantation Metrics Roundtable     Moderators:Lloyd Ratner, MD, MPH Timothy Pruett, MD

Transplantation Metrics Roundtable
Time	End Time	Presentation	Speaker	Moderators
10:05 AM	10:20 AM	Welcome and Introduction	Lloyd Ratner, MD, MPH	Lloyd Ratner, MD, MPH Tim Pruett, MD
10:20 AM	10:35 AM	Introductory Presentation from Dr. Pruett	Tim Pruett, MD
10:35 AM	10:50 AM	Introductory Presentation from Dr. Roth	Al Roth, PhD
10:50 AM	12:00 PM	Transplantation Metrics Roundtable Discussion	All panelists (listed below)

Panel Participants

Paul Conway – Chair of Policy and Global Affairs and Immediate Past President of AAKP

Alexandra Glazier – CEO of New England Donor Services

Rick Hasz, BS, MFS, CPTC – Vice President of Clinical Services for the Gift of Life Donor Program

Maryl Johnson, MD – President of UNOS and Professor of Medicine, Heart Failure & Heart Transplantation at University of Wisconsin

Richard Knight, MBA – President of AAKP

Kevin Longino – CEO of the National Kidney Foundation (NKF)

Jean Moody-Williams, RN, MPP – Deputy Director of the Center for Clinical Standards and Quality at Centers for Medicare and Medicaid Services (CMS)

Ken Moritsugu, MD, MPH, FACPM – Rear Admiral, U.S. Public Health Service (Retired) and Acting Surgeon General of the United States in 2002 and from 2006–2007

Alvin Roth – Professor of Economics at Stanford University and awarded the 2012 Nobel Memorial Prize in Economics

The title of my talk (which Alex Chan and I prepared) is:
Performance Metrics and Regulation of Transplantation

Transplantation interviews Dr Lloyd Ratner

It's gated, but here's a link.
Lloyd E. Ratner, MD, MPH: Professor of Surgery and Director of Renal & Pancreatic Transplantation at Columbia University, and Treasurer of the American Society of Transplant Surgeons

Some interesting bits:

"

Transplantation: Together with a team at Johns Hopkins, you have been the first to perform laparoscopic donor nephrectomies. Would you mind sharing aspects of your personal journey leading to this surgical success with us?

LR: When first introduced in 1995, laparoscopic live donor nephrectomy was a novel, radical, and controversial concept. However, there was an antecedent history of about 10 years, which I witnessed. When I was a general surgery resident at Long Island Jewish Hospital, the Chairman of Urology and pioneer of endourology, Dr. Arthur Smith, was the first person to propose a minimally invasive nephrectomy for disease. Smith’s idea was to place a percutaneous nephrostomy tube into the kidney and allow a tract to form. Then, when the tract was sufficiently fibrosed, he proposed that a Resect-o-scope (like that used for TURPs or TURBTs) be passed through the tract and the kidney be resected from the inside out. Jerry Weinberg, a GU resident who worked with Smith eventually published the first experimental series of minimally invasive nephrectomies in a large animal model. In that series, Weinberg and Smith thrombosed the renal vessels radiologically, then fragmented the kidney with ultrasound, and finally removed the fragments laparoscopically.

During my transplant fellowship at Washington University, Ralph Clayman, with the assistance of his fellow Lou Kavoussi, performed the first laparoscopic nephrectomy for disease. In that first case, Clayman had the renal vessels thrombosed by interventional radiology followed by a laparoscopic nephrectomy. This initial case took approximately 12 hours. However, within 1 year, Clayman had reduced the operating time to approximately 4 hours, no longer requiring radiologic thrombosis of the renal vessels.

As part of a faculty position that I took subsequently at Johns Hopkins University, I directed a satellite renal transplant program at Bayview Medical Center (formerly Baltimore City Hospital). Together with Lou Kavoussi, the newly recruited Chief of Urology, we decided to perform laparoscopic live donor nephrectomies. Our goal was to remove logistical and financial disincentives to living kidney donation by reducing pain, length of stay, and recovery while improving cosmesis. In the mean time, Clayman’s group demonstrated in a large animal model that laparoscopically procured kidneys could be successfully transplanted. Finally, after identifying the right patients, Kavoussi and I performed the first laparoscopic donor nephrectomy in February 1995. The donor went home on postoperative day 1 and was back to work as a welder within 2 weeks. The recipient was discharged after an uneventful hospitalization with a creatinine of 0.8 mg/dL. From there, dissemination and adoption of the laparoscopic donor nephrectomy operation was largely patient driven.

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Transplantation: Donor nephrectomies were discussed controversially in the 1990s. Can you share early challenges of outcomes and responses of the public, health professionals, and patients with us?

LR: The first manuscript describing the initial case report and technical aspects of the operation was flat-out rejected. After a rebuttal, the manuscript was accepted without revisions. A large portion of the transplant community could not conceive how we could do this laparoscopic operation safely. When we presented our data, people angrily stood up and told us that we were “amoral and that we were going to kill people.” I had nightmares every night for 2 years. ... Transplantation: You have been a pioneer in paired kidney exchanges. How do you envision a further expansion? LR: I believe that kidney-paired donation has not yet reached its maximal potential. The most attention has been paid to optimizing allocation algorithms. However, logistical and financial issues remain important, under-addressed obstacles. These need to be dealt with before we can expect further expansion. Additionally, compatible pair participation in KPD is the most effective way to increase the desperately needed blood group O donors. However, this represents a major paradigm shift, where living donors are converted from a private resource to a shared or public resource. This will take years to gain widespread acceptance. Finally, I think that consideration should be given to using deceased donor organs to kick off living donor chains."

Altruistic donor chain in NY

A news story about a recent non-directed donor kidney exchange chain at Presbyterian Hospital/Columbia University Medical Center caught my eye for several reasons.

There was a wide range of ages of the donors:
"The series of operation on Wednesday and Thursday, which required 10 separate surgical teams and weeks of coordination, was made up of a series of swaps within a group of men and women between the ages of 23 and 68 and with compatible blood types, all motivated by a mix of compassion and commitment to their loved ones."

The senior surgeon, Dr. Lloyd Ratner, is one of the heroes of kidney transplantation, since he did the first laproscopic live donor nephrectomy, which makes it easier for donors to donate, since smaller incisions are involved than with the surgery that had been commonplace before that.

Lily Kuo, the reporter who wrote the story, notes the important role played by the press:
"After every chain that gets some publicity, there's a flood of potential donors contacting kidney exchange networks and individual transplant centers," Alvin Roth, an economics professor at the Harvard Business School said."

NYC police officer receives a kidney through Kidneys for Communities (KFC:)

 Police magazine has the story of an anonymous living kidney donor who wanted his/her kidney to go to a first responder, facilitated by  Kidneys for Communities.

NYPD Officer Received Kidney Transplant with Aid of Nonprofit Group and PBA. Kidneys for Communities' Kidneys for First Responders initiative is designed to improve access to and facilitate living kidney donations by connecting those who want to help first responders with those who are in need of a lifesaving kidney donation.  July 7, 2023

"Kidneys for Communities, a national community-directed living kidney donation program, launched its Kidneys for First Responders initiative with its first kidney transplant recipient, New York City Police Officer Melissa Quinones, with assistance from the Police Benevolent Association of the City of New York.

******

And here's the KFC press release (doesn't that acronym already sound familiar?):

Kidneys for Communities Announces their ‘Kidneys for First Responders’ Initiative

"Kidneys for Communities’ Kidneys for First Responders initiative is designed to improve access to and facilitate living kidney donations by connecting those who want to help first responders with those who are in need of a lifesaving kidney donation"

"As Dr. Lloyd E. Ratner, who performed Quinones’ transplant, affirms, “The community-directed model, now available to interested communities and pioneered by Kidneys for Communities, is a common-sense approach to growing the pool of living kidney transplant donors. As more communities come on board, we expect it will shorten the critical waiting time for transplant recipients and save lives.”."

The first kidney exchange in the U.S., and other accounts of early progress

The Student BMJ (a student run affiliate of the British Medical Journal) has an article interviewing the pioneering surgeons who conducted the first kidney exchange in the U.S., in 2000. (It's gated, but you can register for free.)

Anthony P Monaco and Paul E Morrissey: a pioneering paired kidney exchange
Transplant surgeons Anthony P Monaco and Paul E Morrissey performed the first paired kidney exchange in the United States
By: Prizzi Zarsadias
Published: 24 March 2010, Cite this as: Student BMJ 2010;18:c1562

The article is in interview form. Some highlights:
"When two patients found they were ABO incompatible with their live kidney donors it seemed that a long wait on the organ donor list awaited them. But by coincidence the donors were a match for each other’s recipient. Rather than lose this chance for both patients to receive a live kidney donation Anthony P Monaco and Paul E Morrissey saw an opportunity, and in 2000 they performed the first paired kidney donation in the United States. "

How did the first paired kidney donation come about?
Paul E Morrissey: We knew about paired donation from an experience in Korea. We had encountered articles about paired donation. Then these pairs simultaneously presented to us; it just clicked that we could exchange the donors. I wouldn’t attribute the idea to myself or Dr Monaco but to the entire team. We discussed it with 15 of our doctors and nurses, social workers, and various other people, and we agreed that it would be something that we would propose to the family.

How did the patients in the first exchange fare?
PEM: The surgeries were uneventful. One recipient had great kidney function. The second had recurrence of the original disease and a bad acute rejection shortly after the transplant and went back onto dialysis several weeks after the transplant. One outcome was not good. The other patient did fantastically. Any time that a living donation doesn’t work is sad. And in this circumstance, to have had a child make a donation for a parent and to have it work out for the person she donated to but not work out for the parent was sad and unfortunate.

What was the worst case scenario?
PEM: This would be close to it; the success rate for a live kidney donation is in the neighbourhood of 98% or so. This might happen once in every 50. It’s an extremely unusual circumstance for any living donation, and in this setting it adds to the unhappiness. There was a lot of hand holding for the recipient with the failed kidney but also for the donor. There was a lot of follow-up on a longitudinal basis. They are both alive and well today but who knows exactly what emotion they harbour, and I hope that the other patient is enjoying the outcome of her operation.
APM: The worst case scenario for any living transplant would be that the recipient or donor die because of surgery. We haven’t seen that, but that’s the risk in this scenario. We’ve had recipients who have died a week or two later, but that has not happened with swap transplants.
PEM: We inform the patients more of the adverse outcomes. It was, of course, at the forefront of our minds when we proceeded the second time.

During the first exchange did you envisage the technique’s success?
APM: We did not envision it, but we were not surprised that it has grown because it works well. There is a natural evolutionary process to extend it into other situations. We do swaps that involve not just ABO incompatibility; we also swap kidneys between pairs that are incompatible because of HLA antibodies. We are also currently working on a five-way swap.
PEM: The credit obviously goes to countless groups throughout the country that have pushed it forward. In particular the group in our organ procurement organisation, the New England Organ Bank, has really been a leader in taking this forward nationally but at the time that we did this, we didn’t have thoughts about expanding it beyond the reaches of our own programme. I think that they’ll continue to grow out of necessity.

The article begins with these biographical details:
Anthony P Monaco
Peter Medawar professor of transplantation surgery, Harvard University, emeritus director of the Beth Israel Deaconess Harvard Medical Center Transplant Program, and director of the Rhode Island Hospital Transplant Services
Biography—After graduating from Harvard Medical School in 1956 his career has spanned five decades. In that time he has published more than 470 papers and has held the post of editor of Transplantation for 32 years until 2001 and has been the special features editor for the same journal ever since. He is also a trustee of the New England Organ Bank.

Paul E Morrissey
Associate professor of surgery and transplant surgeon at Rhode Island Hospital and assistant medical director for the New England Organ Bank
Biography—Trained at the University of Massachusetts and held residencies and research fellowships at Yale and Harvard Medical Schools. He has been a transplant surgeon at Rhode Island Hospital since 1997 and has been surgical director of the Division of Organ Transplant since 2002. He has been awarded many honours, including the Thomas Murray award from the Rhode Island Organ Donor Awareness Coalition. "

As the article indicates, an earlier exchange had been carried out in S. Korea. Another country that has been active in kidney exchange is Holland, and a recent report of their experience is in the April 2010 issue of the American Journal of Transplantation: "Altruistic Donor Triggered Domino-Paired Kidney Donation for Unsuccessful Couples from the Kidney-Exchange Program" by Roodnat, J. I.; Zuidema, W.; van de Wetering, J.; de Klerk, M.; Erdman, R. A. M.; Massey, E. K.; Hilhorst, M. T.; IJzermans, J. N. M.; Weimar, W.

The New England Program for Kidney Exchange (the institutional descendent of that first U.S. exchange by Monaco and Morrissey) maintains a page listing Kidney Exchange:A Chronology of Scientific Contributions (scroll to the bottom of that page).

While I'm on the subject of important firsts, donating a kidney became much easier with the introduction of laproscopic kidney nephrectomies for donor kidneys (taking the kidney out via a small incision instead of a big one). Here's the article by Lloyd Ratner et al. reporting the first one:

Laparoscopic live donor nephrectomy.
Ratner LE, Ciseck LJ, Moore RG, Cigarroa FG, Kaufman HS, Kavoussi LR., Transplantation. 1995 Nov 15;60(9):1047-9.

"A laparoscopic live-donor nephrectomy was performed on a 40-year-old man. The kidney was removed intact via a 9-cm infraumbilical midline incision. Warm ischemia was limited to less than 5 min. Immediately upon revascularization, the allograft produced urine. By the second postoperative day, the recipient's serum creatinine had decreased to 0.7 mg/dl. The donor's postoperative course was uneventful. He experienced minimal discomfort and was discharged home on the first postoperative day. We conclude that laparoscopic donor nephrectomy is feasible. It can be performed without apparent deleterious effects to either the donor or the recipient. The limited discomfort and rapid convalescence enjoyed by our patient indicate that this technique may prove to be advantageous."

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

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• Accepted manuscript online: 14 February 2018 
• 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.

Compatible pairs in kidney exchange

The question of whether compatible patient-donor pairs should be invited to take part in kidney exchange is gaining some exposure with recent articles and news items in the medical literature. The issue is that if kidney exchange is restricted to patients who are incompatible with their live donors, we will be seeing many fewer blood type O donors than are in the general population, so exchanges will be more difficult to find, and there will be fewer transplants than if there weren't such a shortage. (Since O donors don't have a blood type incompatibility with any recipient, most of them will be compatible with their intended recipients; O donors are only incompatible if there is some other, immunological incompatibility.)

Here's a story from the most recent, Feb 2010 Nephrology Times: Dramatic Increase in Transplant Rates Projected if Compatible Pairs Are Included in Kidney Swaps

It follows up on a recent article by Lloyd Ratner, of Columbia University/New York–Presbyterian Hospital, reporting such a three-way exchange (Transplantation, 2010;89:15-22). The story also interviews some of the other pioneering surgeons involved in kidney exchange, including Frank Delmonico, Bob Montgomery and Steve Woodle.

Inviting compatible pairs to participate in exchanges seems like a very good idea indeed. (An early discussion, with simulations to provide quantitative estimates of the effect of including compatible pairs (which is quite large), was reported in Table 1 of:
Roth, Alvin E., Tayfun Sonmez, and M. Utku Unver, "A Kidney Exchange Clearinghouse in New England" American Economic Review, Papers and Proceedings, 95,2, May, 2005, 376-380. )

Kidney paired donation conference: financing kidney exchange

A conference in Philadelphia today will take a look at a so far unresolved aspect of kidney exchange: how to finance it. Since transplantation is far cheaper than dialysis, this shouldn't in principle be a big problem, but there are still lots of kinks to iron out in determining who pays for what. I spoke to a similarly constituted group in Minneapolis in 2007...
Kidney Paired Donation Conference, Philadelphia, Pennsylvania, WEDNESDAY, OCTOBER 27, 2010

8:00 a.m. Welcome and Opening Remarks, Chris Pricco, Chief Operating Officer, Complex Medical
Conditions, OptumHealth Care Solutions

8:05 a.m. Introduction and Conference Overview, Dennis Irwin, MD, National Medical Director, Transplant Solutions, Complex Medical Conditions, OptumHealth Care Solutions

8:15 a.m. Kidney Transplantation: Alternative Donors, Lloyd E. Ratner, MD, New York-Presb - Columbia
Campus

8:35 a.m. The Unmet Need for Kidney Transplantation as Viewed by the National Kidney Foundation,
Bryan Becker, MD, University of Illinois-Chicago

8:55 a.m. The OptumHealth/UnitedHealthcare Experience with End Stage Renal Disease, Kidney
Transplantation and the Unmet Need, F. Gregory Grillo MD, National Medical Director, Kidney
Resource Services, OptumHealth Care Solutions

9:15 a.m. The United Network for Organ Sharing (UNOS) Pilot, Kenneth Andreoni, The Ohio State
University Hospitals

Representation and Overview from UNOS Coordinating Centers

9:45 a.m. Ruthanne L Hanto RN MPH, New England Program for Kidney Exchange

10:00 a.m. Dorry Segev, MD, PhD, Johns Hopkins Hospital

10:15 a.m. Michael Rees, MD, PhD, Alliance for Paired Donation

10:30 a.m. Jeffrey L. Veale MD, Ronald Reagan UCLA Medical Center

Successful Single Center Experience with Paired Kidney Donation

10:45 a.m. John Friedewald, MD, Northwestern University Hospital

11:00 a.m. Adam Bingaman, MD, PhD, Texas Transplant Institute

11:30 a.m. National Kidney Registry, Garet Hil, National Kidney Registry (Invited)

11:45 a.m. Kidney Paired Donation from the Donor’s Perspective, John Milner, MD, Loyola University
Medical Center

12:00 p.m. The OPO perspective, Speaker TBD

12:15 p.m. Summary of the recent Living Kidney Donor Follow-Up: State of the Art and Future Directions
conference, Alan Leichtman, MD, University of Michigan

12:30 p.m. National Marrow Donor Program (NMDP): 23 Years of Experience in Establishing and
 Managing a Successful Program for Matching Willing Donors to Recipients, Jeffrey W. Chell,
MD, Chief Executive Officer, National Marrow Donor Program

1:30 p.m. Facilitated Discussion, Clifford Goodman, PhD, Vice President, The Lewin Group

4:00 p.m. Closing Remarks

Note: OptumHealth reserves the right to make any necessary changes to this program. Efforts will be made to keep presentations as scheduled. However, unforeseen circumstances may result in the substitution of faculty or content. Last Updated: 10/05/10

An open letter supporting experiments on providing benefits to kidney donors

An open letter to President Obama and Congress calls for pilot studies on the effects of providing benefits to kidney donors.

An Open Letter to President Barack Obama, Secretary of Health and Human Services Sylvia Mathews Burwell, Attorney General Eric Holder and Leaders of Congress


Here are the conclusions, and the list of initiating signers

CONCLUSION

We applaud the President’s declaration that 2014 is a “year of action” when he will use executive powers and the regulatory process to ensure the health and well-being of Americans and end unnecessary health expenditures. As part of this process, we call on the President to take executive action on organ transplantation and initiate pilot studies on benefits to donors.

We call on HHS to develop the necessary regulatory process for conducting such studies and to implement them.

We call on the Attorney General to smooth the way for such pilot programs by recognizing that they are consistent with the intent of the National Organ Transplant Act.

Finally, we call on Congress to pass legislation that allocates the necessary funding for these programs and clears the way for their implementation.

Kidney disease has for too long been neglected by all branches of government. It is time to act.

Initiating signers*:

Nir Eyal, Associate Professor of Global Health and Social Medicine, Harvard Medical School and Harvard University
Julio Frenk, Dean, Harvard School of Public Health, Harvard University
Michele B. Goodwin, Chancellor’s Chair in Law, University of California-Irvine Law School
Lori Gruen, Professor of Philosophy, Feminist, Gender, and Sexuality Studies, and Environmental Studies at Wesleyan University
The Very Reverend Gary R. Hall, Dean, Washington Cathedral
Douglas W. Hanto, Professor of Surgery and Associate Director Vanderbilt Transplant Center, Vanderbuilt University, Tennessee
Frances Kissling, President, The Center for Health, Ethics and Social Policy
Ruth Macklin, Professor of Bioethics, Albert Einstein College of Medicine
Steven Pinker, Johnstone Family Professor, Department of Psychology, Harvard University
Lloyd E. Ratner, Professor of Surgery, Columbia University
Harold T. Shapiro, President Emeritus, Princeton University
Peter Singer, Ira W. DeCamp Professor of Bioethics, Princeton University
Andrew W. Torrance, Professor of Law, University of Kansas and Visiting Scholar MIT Sloan School of Management
Robert D. Truog, Director, Center for Bioethics, Harvard University, Harvard Medical School
Robert M. Veatch, Professor of Medical Ethics at the Kennedy Institute of Ethics, Georgetown University

Together with the long list of other signers, the letter has a lot of support from a diverse group of people, including many transplant professionals who I know and respect. It's a sign that the discussion is changing.

Risk attitudes in transplantation--then and now

Organ transplantation has become much more organized since its early days, for both good and ill.

Today there's a good deal of regulation of transplant centers, which need very high success rates (one year graft survival rates in particular) to remain in the good graces of government and private payers.

It wasn't always so.

Here's a quote from Lloyd Ratner's Message from the ASTS President for November 2019:

"In the transplant world, this [perseverance] is best exemplified by Thomas Starzl’s ceaseless quest to make liver transplantation a reality. Between March 1963 and May 1967, Dr. Starzl performed his first 7 liver transplants at the University of Colorado, all of whom died in the peri-operative period. The longest survivor succumbed after 23 days to “sepsis, bile peritonitis, and liver failure.” Despite this disastrous start, Dr. Starzl persevered. Starzl’s eighth patient, transplanted for hepatocellular carcinoma, lived 400 days before dying from carcinomatosis. By 1990 the programs that Dr. Starzl directed in Pittsburgh would perform 571 liver transplants in a single year and would train many of the world’s leaders in the field."