The Transplant Waiting List and Organ Allocation Process

The Transplant Waiting List and Organ Allocation Process
Dixon B. Kaufman, MD, PhD Ray D. Owen Professor Chief, Division of Transplantation Surgical Director, Kidney Transplantation Douglas T. Miller Symposium on Organ Donation and Transplantation Thursday, April 25, 2013

Presentation Objectives:
Gain knowledge of state, regional, and national statistics related to the transplant waiting list and transplantation. Develop an understanding of the complexities surrounding being on the transplant waiting list and the medical reasons why a patient is added to the transplant waiting list. Hear and understand the emotional and physical constraints of being on a transplant waiting list, waiting for the call, and being given a second chance at life.

Waiting List Data and Statistics
UNOS: United Network for Organ Sharing OPTN: Organ Procurement and Transplantation Network National, regional, and state statistics and data can be found via UNOS or directly at the OPTN websites. The next several data slides were created using those websites and should be considered the source of this data. Source: UNOS/OTPD.net, 4/5/13

“The Gap” *Data based on snapshot of the UNOS, OPTN waiting list and transplants on the last day of each year.

Waiting Lists National Regional Local Center

U.S. Waiting List Data and Statistics
Source: UNOS/OTPD.net, 4/5/13

Regional Waiting List Data and Statistics

WI Waiting List Data and Statistics

MI Waiting List Data and Statistics

IL Waiting List Data and Statistics

How long does the typical waitlisted patient wait for a transplant?

UW OTD’s Laura Van Drese: Her Dad’s Story
Laura will share her family’s experience (Dad) with a failing organ, getting wait listed, complexities of being waitlisted, physical and emotional constraints, waiting for the call, and being given a second chance at life.

UW Average Waiting Times
Deceased Donor Kidney Transplants Wait Time by Blood Type (Includes patients transplanted between 7/1/ /30/2012) ABO Average days A AB B O

Necessary Steps to Getting on the Center Waiting List
Your physician must give you a referral Contact a transplant hospital Schedule an appointment for an evaluation and find out if you are a good candidate for transplant If the hospital's transplant team determines that you are a good transplant candidate, they will add you to the national waiting list Source: UNOS.org/TransplantLiving.org, 4/5/13

Evaluation Schedule Evaluation Appointment Further Testing Surgeon
Social Work Certified Dietician Financial Counselor Pre-Transplant Coordinator Further Testing Chest X-ray Blood Work Other

Standard Evaluation Testing
Colonoscopy age >50 Mammogram and Pap Smear Annually PSA age>50 Chest X-ray Dental Clearance Cardiac Testing Vascular Testing

Approval Multi-Disciplinary Committee Review
Significant Coronary Artery Disease Significant Vascular Disease Malignancy Non-Compliance Substance Abuse (Active) Poor Social/Financial Support Insurance Approval

Two Types of Transplantation
Deceased Donor: UNOS Waiting list, UWHC Waiting List Live Donor: can be related or non-related related by blood or marriage non-related directed donation humanitarian non-directed donor donation National Kidney Paired Exchange Program

Waiting: Complexities and Constraints
Medical Preparation stay healthy keep your appts Practical Preparation stay organized phone/ tree pack your bags dependant care transportation plan Educational Preparation learn, read, find a support group Financial Preparation create financial plan talk to your family POA Spiritual Preparation seek spiritual help or counseling. Receiving “the call” ALWAYS answer your phone have directions to transplant center ready Wait times for transplants vary. Not everyone who needs a transplant will get one. Because of the shortage of organs that are suitable for donation, only slightly more than 50% of people on the waiting list will receive an organ within five years. After your evaluation, it's important to prepare for your transplant while you are waiting. Work closely with your transplant team. Keep all scheduled appointments. Build a solid support system of family, friends, clergy, and medical professionals. Let people know what's going on in your life. They can be a tremendous source of support and information. Taking these steps puts you in control.

Personal Constraints: Physical and Emotional
“I was at the top of the liver waiting list, too sick to be home with my family. While at the hospital, my doctor said, ‘you have to eat’, but I couldn’t keep anything down, so they had to put a feeding tube in. Try taking twenty pills a day with a feeding tube down your throat. It was awful.” Lee Belmas, Liver Recipient “My original diagnosis was Type 1 Diabetes. I just assumed I would die at a young age. After my transplant, I felt like the windows of my house blew wide open. I saw brighter colors, a sense of hope, light, and excitement.” Nancy Garde, Kidney/Pancreas Recipient

Allocation: Matching Donor Organs With Transplant Candidates
When a deceased organ donor is identified, a transplant coordinator from an organ procurement organization accesses the UNet system and enters necessary medical information about the donor. The system uses this information to match the medical characteristics of the candidates waiting against those of the donor. The system then generates a ranked list of patients who are suitable to receive each organ. This list is called a "match run." Source: UNOS.org/TransplantLiving.org, 4/5/13 22

“Match Run” Factors affecting ranking may include: tissue match
blood type length of time on the waiting list immune status - sensitization donor organ quality distance between the potential recipient and the donor degree of medical urgency (for heart, liver, lung and intestines) The organ is offered to the transplant team of the first person on the list. Often, the top transplant candidate will not get the organ for one of several reasons. When a patient is selected, he or she must be available, healthy enough to undergo major surgery and willing to be transplanted immediately. Also, a laboratory test to measure compatibility between the donor and potential recipient may be necessary. If the organ is refused for any reason, the transplant hospital of the next patient on the list is contacted. The process continues until a match is made. Once a patient is selected and contacted and all testing is complete, surgery is scheduled and the transplant takes place. Source: UNOS.org/TransplantLiving.org, 4/5/13

Kidney Donor Profile Index (KDPI)
KDPI Variables Donor age Height Weight Ethnicity History of Hypertension History of Diabetes Cause of Death Serum Creatinine HCV Status DCD Status Ten medical factors about the potential donor are used to calculate the Kidney Donor Profile Index (KDPI) score: Age History of diabetes Height Cause of death Weight Serum creatinine (a measure of kidney function) Ethnicity Hepatitis C virus status History of hypertension Whether the donation occurred after circulatory death These factors are used in a clinical formula. A percentage score estimates how long a kidney offer is likely to function when compared with all other offers. A low KDPI percentage indicates likely longer function, and a high percentage indicates likely shorter function. A KDPI of 20 percent, for example, suggests the kidney will likely function longer than 80 percent of available kidneys. Donor age and certain medical facts about the donor are known to affect how long a donated kidney is likely to function. Under current policy definitions, any deceased kidney donor age 60 or older is considered an “extended criteria donor,” as are those between age 50 and 59 who have certain medical history profiles. All other kidney donors are defined as “standard” criteria donors. Currently, kidneys from extended criteria donors are used in patients who are expected not to do well on dialysis over a long period of time. By undergoing transplantation with a kidney from an extended criteria donor, they can be transplanted more rapidly than if they waited a standard criteria donor kidney. Research has shown that the current definitions do not always precisely estimate the length of donor kidney function. Kidneys from some donors currently considered “extended criteria” may function longer than kidneys from some “standard criteria” donors. The Kidney Donor Profile Index provides a more detailed and accurate estimate of kidney longevity from each donor than the current criteria. KDPI would replace the current designations of ECD and SCD. KDPI values now displayed with all organ offers in DonorNet®

Inclusion of Longevity Matching
Current system does not include measure of potential longevity with transplant Longevity matching for some candidates could reduce the need for repeat transplants A major proposed change to the allocation system is that of Longevity Matching which uses a formula called Estimated Post-transplant Survival (EPTS). Unlike the liver allocation system or the lung allocation system, the current kidney allocation system does not have a candidate classification based risk of death while on the waiting list or estimated post-transplant survival. Incorporating a metric like estimated post-transplant survival would allow for better matching of candidates and donated kidneys so that individuals with very long estimated post transplant survival do not receive kidneys with very short expected survival (necessitating a second or third transplant from an already limited donor pool) and vice versa. 25

Inclusion of Longevity Matching
Four medical factors used to calculate Estimated Post Transplant Survival (EPTS) Age History of diabetes Length of time on dialysis History of a prior transplant Four medical factors about the transplant candidate are used to calculate the Estimated Post-Transplant Survival (EPTS) score: Age History of diabetes Length of time on dialysis History of a prior transplant These factors are also used in a clinical formula. A percentage score estimates how long a candidate is expected to benefit from a functioning kidney when compared to the experience of other recipients over a recent time. A low EPTS percentage indicates likely longer-term survival, and a high percentage indicates shorter likely benefit. An EPTS of 20 percent, for example, suggests that if the candidate is transplanted, he or she would likely survive longer than 80 percent of other recipients. The use of EPTS would not change how the majority of kidney candidates get priority for kidneys – only those expected to need and benefit from a transplant the very longest. This proposal would give first consideration for the 20 percent of kidneys with the best KDPI – those with the longest estimated function – to the 20 percent of candidates estimated by the EPTS to have the longest time to benefit from a transplant. For the remaining 80 percent of transplant candidates, the organ offer process would be much the same as the existing system unless they fall into one of the hard-to-match categories. All candidates are eligible for the “top 20% of kidneys” but they will be offered first to candidates with the longest estimated post transplant survival. Candidates that are not in the top 20% EPTS will still have access to excellent quality kidneys as a kidney with a KDPI score of 25 or even 50% are expected to function very similarly. Organ offers with a KDPI score that suggests shorter length of function will also be offered on a wider geographic basis, so they can be considered for patients who would do better with a transplant than they would on dialysis. It is always up to the individual patient and his or her transplant hospital to decide what organ they would be willing to accept. The KDPI might predict that a given kidney might provide five years of function, less than other kidneys would. But five years of having a functional kidney, and being off dialysis, may be very beneficial for some patients rather than continuing to wait years for an offer. KDPI will not be used in allocation for most candidates. But it is already available as a resource to help clinicians and transplant candidates understand more about kidney offers and make resulting treatment decisions. KDPI provides more detailed information than the current designation of “standard criteria” versus “expanded donor criteria” kidneys. Currently, kidneys designated as “expanded donor criteria” tend to be discarded at a higher rate than “standard criteria” organs, although in some instances the KDPI for some “expanded criteria” organs is better than that of some “standard” kidneys. We hope that through using KDPI to assess offers, utilization of kidneys will improve and allow more people to be transplanted. 26

Proposed Classifications: Very Highly Sensitized
Candidates with CPRA >=98% face immense biological barriers Current policy only prioritizes sensitized candidates at the local level. Proposed policy would give following priority To participate in Regional/National sharing, review & approval of unacceptable antigens will be required Sensitized candidates are known to wait substantially longer than unsensitized candidates, suggesting that more needs to be done to equalize waiting times between these two groups. Additionally, candidates with CPRA greater than 98% see a marked decline in the number of compatible offers received (Figure 9). Due to their level of sensitization, these candidates require access to a larger donor pool in addition to priority within their donation service area. The proposed policy would give national priority to those candidates with CPRA scores of 100%, regional priority to those candidates with CPRA scores of 99% and local priority to candidates with CPRA scores of 98%. CPRA=100% National CPRA=99% Regional CPRA=98% Local

New categories for highly sensitized candidates
Sequence A KDPI <=20% Sequence B KDPI >20% but <35% Sequence C KDPI >=35% but <=85% Sequence D KDPI>85% Highly Sensitized 0-ABDRmm (top 20% EPTS) Prior living donor Local pediatrics Local top 20% EPTS 0-ABDRmm (all) Local (all) Regional pediatrics Regional (top 20%) Regional (all) National pediatrics National (top 20%) National (all) 0-ABDRmm Local adults Regional adults National adults Local Regional National Local + Regional *all categories in Sequence D are limited to adult candidates These highly sensitized candidates would appear in the top category for each sequence, stratified by CPRA score and level of distribution. New categories for highly sensitized candidates

Modified Classification: Pediatric
Current policy prioritizes donors younger than 35 to candidates listed prior to 18th birthday Proposed policy would Prioritize donors with KDPI scores <35% Eliminate pediatric categories for non 0-ABDR KPDI >85% Provides comparable level of access while streamlining allocation system Candidates who were younger than 18 at the time of registration receive priority ahead of all other local candidates for kidneys from donors younger than 35. This system was designed to expedite transplant for pediatric candidates by providing increased access to organs with longer estimated post-transplant function. The system has been working well and achieving its stated objectives. As the Kidney Transplantation Committee began working to design a kidney allocation system based on KDPI, it asked the Pediatric Transplantation Committee to consider whether the donor age threshold could be converted to KDPI, a more refined measure of donor quality compared to age alone. The purpose of this change would be to maximize system flexibility. After modeling various thresholds, the Pediatric Transplantation Committee recommended that the KDPI threshold be set at With this threshold, SRTR simulation modeling has forecasted that pediatric candidates would maintain the same level of access that is experienced under the current system. Additionally, in the proposed system, pediatric candidates would no longer receive offers for kidneys from donors with KDPI scores greater than 85%. An analysis of OPTN data determined there have been zero transplants of solitary ECD kidneys into pediatric candidates since Removing pediatric candidates from this allocation sequence would streamline system efficiency without harming access for this patient population.

Continued priority pediatric candidates
Sequence A KDPI <=20% Sequence B KDPI >20% but <35% Sequence C KDPI >=35% but <=85% Sequence D KDPI>85% Highly Sensitized 0-ABDRmm (top 20% EPTS) Prior living donor Local pediatrics Local top 20% EPTS 0-ABDRmm (all) Local (all) Regional pediatrics Regional (top 20%) Regional (all) National pediatrics National (top 20%) National (all) 0-ABDRmm Local adults Regional adults National adults Prior living organ donor Local Regional National Local + Regional *all categories in Sequence D are limited to adult candidates Pediatric candidates are categorized in the same manner as in the current system. Continued priority pediatric candidates (now based on KDPI)

Modified Classification: Local + Regional for High KDPI Kidneys
KDPI >85% kidneys would be allocated to a combined local and regional list Would promote broader sharing of kidneys at higher risk of discard DSAs with longer waiting times are more likely to utilize these kidneys than DSAs with shorter waiting times Currently, kidneys from expanded criteria donors are offered first locally and candidates who elect to receive ECD kidneys are rank ordered only according to waiting time. The goal is to expedite placement of these kidneys. Unfortunately, discard rates for ECD kidneys are high and also vary widely across OPOs. Generally, OPOs with longer waiting times tend to procure and transplant more ECD kidneys than OPOs with shorter waiting times. This suggests that demand drives decision making on whether to utilize these kidneys more so than clinical utility. The Committee investigated ways to improve procurement and transplantation rates for kidneys at a high risk of discard. Among the options considered was expanding the distribution area for these kidneys so that these kidneys are offered first to a combined regional and local unit. This proposed approach would make available with less cold ischemic time those kidneys that would be discarded in one OPO due to shorter candidate waiting times but utilized in a neighboring OPO with longer waiting times.

Proposed Regional Sharing
Sequence A KDPI <=20% Sequence B KDPI >20% but <35% Sequence C KDPI >=35% but <=85% Sequence D KDPI>85% Highly Sensitized 0-ABDRmm (top 20% EPTS) Prior living organ donor Local pediatrics Local top 20% EPTS 0-ABDRmm (all) Local (all) Regional pediatrics Regional (top 20%) Regional (all) National pediatrics National (top 20%) National (all) 0-ABDRmm Local adults Regional adults National adults Local Regional National Local + Regional *all categories in Sequence D are limited to adult candidates Proposed Regional Sharing Whereas the current system places ECD kidneys locally and then regionally, the proposed system would combine these two distribution units to expedite placement.

Removed Classification: Kidney Paybacks
Current payback policy was evaluated and found to be Administratively challenging Unfair in that it affected all candidates in an OPO even if only one center was responsible for accruing debt Ineffective in improving outcomes of recipients Kidney paybacks would no longer be permitted. All payback credits and debts would be eliminated upon the implementation of the revised kidney allocation system. Currently, the kidney allocation system requires an OPO that receives a kidney from another OPO for zero-antigen mismatch or for a combined organ transplant to payback a kidney to the originating OPO from the same blood type. Policy sets requirements for which types of kidneys must be offered as paybacks. From an administrative perspective, the kidney payback system has been fraught with challenges since its implementation. Penalties for exceeding debt thresholds are levied against all transplant programs served by an OPO, even if only one program is responsible for accruing the debt. Several OPOs have reported difficulty in paying down debt because credited OPOs do not accept payback offers. The Kidney Transplantation Committee has spent considerable time hearing complaints about the payback system and has, over the years, adjusted the system to no apparent benefit. Furthermore, the benefit of shipping kidneys purely for administrative purposes is not clear. Payback kidneys tend to have more cold ischemic time than kidneys transplanted locally. For these reasons, the Committee proposes eliminating the kidney payback system entirely. Kidneys that are shared for zero antigen mismatches, for extremely highly sensitized candidates, and for combined organ transplant would no longer incur a payback debt. All payback credits and debts would be eliminated upon the implementation of the revised kidney allocation system. 33

Priority within Classifications

Proposed Changes to Point System
Candidates are rank-ordered according to points within each classification. The current system awards points for zero HLA-DR and one HLA-DR mismatches, for prior living organ donors and for pediatric candidates. These points are not slated to be changed. The Committee is recommending revisions to the points awarded to sensitized candidates, and the points awarded for waiting time. No proposed point changes for Proposed point changes for HLA-DR Prior living organ donors Pediatric candidates Sensitized candidates Waiting time 35

Proposed Point Changes: Sensitization
4 points Proposed Current (CPRA=98,99,100 receive 24.4, 50.09, and points, respectively.) Based on a time-to-offer analysis, the Committee found that that candidates began to experience barriers to transplant starting at a CPRA score of 20% which gradually increased with increasing sensitization until an inflection point at about 95%. Above 95%, waiting time increases more substantially due to the decreasing offer and transplant rate for these candidates. In response to these observations, the following point system, a “sliding scale” based on candidate CPRA was derived via a mathematical transformation of the offer rate patterns shown above. This sliding scale would replace the current 4 points offered only to candidates with CPRA scores greater than or equal to 80%. Current policy: 4 points for CPRA>=80%. No points for moderately sensitized candidates. Proposed policy: sliding scale starting at CPRA>=20% 36

Proposed Point Changes: Waiting Time
Current policy begins waiting time points for adults at registration with: GFR<=20 ml/min Dialysis time Proposed policy would also award waiting time points for dialysis time prior to registration Better recognizes time spent with ESRD as the basis for priority Pre-emptive listing would still be advantageous for 0-ABDR mismatch offers Studies have shown that some minority candidates are less likely than Caucasians to be listed for a kidney transplant either at or before the time they start dialysis. Thus by the time they are listed and start getting waiting time priority for a transplant, their kidney disease is more advanced and they are more likely to experience additional health complications. In some cases, this time gap between dialysis and transplant listing may happen because the potential candidate hasn’t received reliable information about the option of getting a transplant. Under the proposed policy, waiting time priority for all candidates would begin from the time they begin dialysis or meet a medical definition of end-stage kidney failure. This should make transplant waiting times more equivalent in terms of medical need and benefit among all candidates. 37

Simulated Policy Results

Evaluating Potential Policy Changes
Scientific Registry of Transplant Recipients (SRTR) simulates proposed policy changes Kidney-Pancreas Simulated Allocation Model (KPSAM) 50+ KPSAM runs conducted throughout policy development 4 KPSAM runs presented here for comparison <<Review bullet points>> While simulation modeling is immensely useful for evaluating the potential effects of policy changes, it has its limitations. The results presented here can only show what may happen with the current supply of donated kidneys and the candidates currently on the waiting list. The modeling does not take into account any changes in behavior that will likely follow a policy change. Additionally it is more important to look at trends and directions of the results rather than determining whether small percentage changes are remarkably different from one another. For example, a four percent increase in the number of transplants for minority candidates under one simulation run may not be statistically different from a five percent increase—what is important is the increase itself. 39

Preview of Expected Outcomes
New system forecasted to result in: 8,380 additional life years gained annually Improved access for moderately and very highly sensitized candidates Improved access for ethnic minority candidates Comparable levels of kidney transplants at regional/national levels Before we begin, it’s important to see where we’re going. The changes that I am about to describe result in a gain in life years for transplant recipients, as well as improved access for candidates who currently face difficulty receiving a transplant while not disrupting the current geographic distribution of kidneys. 40

KPSAM results by candidate age
The proposed policy continues to allow broad access for candidates who are age 50 and older. Candidates who are 50 or older make up more than 60 percent of the kidney transplant waiting list and currently receive more than 60 percent of deceased donor kidney transplants. 41

KPSAM results by ethnicity
The proposed policy appears to better align transplants with the distribution of candidates on the waiting list based on candidate ethnicity. 42

KPSAM results by CPRA The simulation modeling shows a decrease in transplants for candidates with CPRA scores of 0%. Currently, there is no point incentive for listing unacceptable antigens unless the candidate can achieve a CPRA score of at least 80%. As the proposed point system would start at 20%, the Committee expects that many of these candidates with CPRA scores of 0% actually have some degree of sensitization. The sliding scale point system shows an increase for moderately sensitized candidates with 20-79% CPRA scores, and a small decline for those with CPRA scores over 80%. Based on the time to offer analysis, the current policy of awarding 4 points to candidates with CPRA scores over 80% may have lead to on over-advantage for candidates with CPRA scores between 80% and 90%. The sliding scale corrects this. 43

KPSAM results by CPRA (95-100%)
The Committee initially examined giving national priority to all candidates with CPRA scores of 98% and higher, as shown in Run N3 (the purple bars) above. It was found that national priority resulted in a disproportionate number of transplants for candidates with CPRA scores of 98% and 99%, indicating that the donor pool was too broad. The Committee then revised its approach in Run N4 (the light blue bars above) to give national priority to candidates with 100% CPRA, regional priority to candidates with 99% and local priority to candidates with 98% CPRA. This approach resulted in a distribution of transplants that more closely reflected the waitlist distribution for each CPRA category. 44

Summary New system forecasted to result in:
8,380 additional life years gained annually Improved access for moderately and very highly sensitized candidates Improved access for ethnic minority candidates Comparable levels of kidney transplants at regional/national levels To summarize… <<Read the bullet points>> 45

Participate in Policy Development
Submit comments online: optn.transplant.hrsa.gov Access webinar schedules Download educational materials This and other current public comment proposals are available online on the OPTN website: Before commenting, please read the proposal. It explains in detail the intended goals, alternative approaches that have been considered, and statistical modeling of possible effects of the policy. You may then submit a comment online through the website. Comments will be accepted through Friday, December 14, 2012. Public comment period ends December 14 46

Committee Leadership and Support
John J. Friedewald, MD Committee Chair Richard N. Formica, Jr, MD Committee Vice Chair Ciara J. Samana, MSPH UNOS Committee Liaison

“Connect to Purpose Letter”
UW OTD Services “Connect to Purpose Letter” Wendy, read aloud: Letter from a recipient mother to a donor family: "Our daughter received the most amazing gift of life from your child. She just had her 9 month post transplant check up and everything looks perfect. Absolutely perfect. Our perfect daughter, altered only by her telltale incision from her neck almost to her bellybutton, has a perfect heart to match. And for this we will be forever grateful. She is the happiest child I have ever seen. She has enough happiness in her for herself and her angel heart twin. Sometimes, as she is falling asleep, she folds her hands as if in prayer. I firmly believe she is talking to your child. Not an hour goes by in our day that we don't think of your child and your family. We are forever saddened by your loss and by the choice you had to make that day in June, but are so, so, so very thankful for the gift our daughter has been given, the gift we all have been given."

The Transplant Waiting List and Organ Allocation Process

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