Presented by the OPTN
Jonathan Fridell, MD, FACS
Surgical Director, Pancreas Transplant Program Indiana University Health
Chairman, OPTN/UNOS Pancreas Transplantation Committee
Zoe Stewart, MD, PhD
Surgical Director, Kidney and Living Donor Transplantation University of Iowa Hospital & Clinics
Region 8 Representative, OPTN/UNOS Pancreas Transplantation Committee
Jonathan: Hello, this is Dr. Jonathan Fridell. I am the Chairman of the OPTN/UNOS Pancreas Transplantation Committee. With me today is Dr. Zoe Stewart.
Zoe: Hello, I am Dr. Zoe Stewart and I am the Region 8 Committee representative of the OPTN/UNOS Pancreas Transplantation Committee.
Jonathan: For the next 10 minutes I will interview Zoe about upcoming changes to the pancreas transplantation allocation system and will focus on what you as a provider will need to know to prepare for the changes that are coming.
Jonathan: Zoe, could you start by providing an overview of why there was a need to change the pancreas allocation system?
Zoe: The pancreas is the only organ that does not have a consistent national system for allocation in the context of simultaneous pancreas-kidney, for which I will refer to as SPK, versus a pancreas alone transplantation. Additionally, any changes to the kidney allocation system, such as the possibility for the kidney to follow the pancreas in allocation (i.e. allocating from the pancreas or SPK list before allocating from the kidney list), are not feasible without changes to pancreas allocation.
The Committee was thus challenged to develop a national pancreas allocation system that will be acceptable to the pancreas transplantation community, the kidney transplantation community (adult and pediatric), and other major stakeholders. The system would also need to meet the policy objectives outlined in the OPTN long-range strategic goals and priorities. As part of the new kidney allocation system development, the OPTN/UNOS Kidney Transplantation Committee requested that the Pancreas
Transplantation Committee investigate the development of pancreas allocation policy where the kidney follows the pancreas locally and defines appropriate KP qualifying criteria.
- There is no nationally established allocation practice for patients with diabetes and renal failure. Consequently, waiting time for SPK transplant varies widely across the country because of local or regional allocation decisions.
- Furthermore, current practice does not seek to maximize the utilization of the pancreas. SPKs candidates commonly receive offers after other renal/extra-renal multi-organ transplants, kidney paybacks, and zero mismatch kidney-alone candidates. This allocation order may lead to the discard of grafts declined for pancreas-alone transplants that would likely be transplanted if offered in the context of SPK transplantation.
- Also, there are no specific listing criteria for SPK transplants with respect to renal function necessary to qualify to receive waiting time for a SPK transplant.
Jonathan: Thanks Zoe. So what goals do we hope to achieve with this new system?
Zoe: The goals of the new system are to:
- Reduce geographic inequities of deceased donor pancreas utilization, increase access to transplantation, and change the waiting time calculation.
- It’s also to maximize capacity without adversely affecting adult and pediatric renal transplant candidates; including the age, ethnicity, and gender distribution of recipients, and
- To enhance operations and reduce complexity of programming requirements.
Jonathan: With all these changes, what should providers expect from UNOS with regards to preparing for the new system?
Zoe: In the coming months, transplant programs and their providers will receive instruction on the new polices, training on system enhancements, educational materials for patients, a frequently asked questions resource document, and suggestions for optimizing the discussions with their patients about the newly modified system.
It is the goal of the OPTN/UNOS Pancreas Transplantation Committee to ensure that once the new pancreas allocation system goes live, all transplant professionals - physicians, surgeons, nurses, coordinators, and administrators – will be fully educated on changes to the system.
Starting with this podcast, we hope to make providers aware of the implementation plan so they are prepared for questions from their patients.
Jonathan: That sounds like a very comprehensive approach. In your opinion, what are the overarching changes to the pancreas allocation system?
Zoe: The overarching changes to the pancreas allocation system are:
- That pancreas and SPK candidates will appear on a single match run list;
- Organ Procurement Organizations will be required to offer organs to potential transplant recipients on the combined SPK and pancreas match run list through the local classification before offering organs to candidates on the kidney-alone match run list;
- Local candidates who are allocated a pancreas from the combined list will be allowed to receive a kidney if they meet specific qualifying criteria; and
- Qualifying criteria for a diabetic uremic patient to accrue SPK waiting time are created.
Jonathan: What is the biggest change that organ procurement organizations will experience?
Zoe: After implementation of the new system in 2014, OPOs must allocate organs from the combined SPK and pancreas match run list before allocating organs from the kidney match run list.
OPOs will need to understand how SPK qualifying criteria work and allow the kidney to follow the pancreas only when a candidate is receiving an offer for a combined SPK. In the new system, the kidney cannot be allocated to a candidate based on his or her pancreas-alone listing.
Jonathan: Zoe, you mentioned there are new qualifying criteria for SPK candidates. What are those qualifying criteria?
Zoe: After implementation of the new pancreas allocation system, SPK candidates (who are 18 years or older) will have to meet three new qualifying criteria. The SPK candidate’s qualifying criteria are:
- That the candidate must be registered for a SPK transplant;
- They must also qualify to accrue kidney waiting time; and
- The candidate must be either be:
- On insulin with a c-peptide less than or equal to 2 ng/mL; or
- On insulin with a c-peptide greater than 2 ng/mL and have a BMI less than or equal to 28.
Jonathan: What does this mean for the pancreas and kidney-pancreas transplant programs? Is there anything the programs should do to prepare for these changes?
Zoe: This means that the pancreas and kidney-pancreas transplant programs will have to collect and report whether a SPK candidate is on insulin, and the SPK candidates’ c- peptide value, height, weight, and respective dates the measurements were taken, for all
SPK candidates added to the waiting list after implementation of the new pancreas allocation system.
In preparation, transplant programs should examine whether their candidates are listed for SPK, pancreas-alone, or both and whether these listings still meet the needs of their candidates, particularly in light of the improved access expected for candidates receiving a living donor kidney followed by a pancreas-alone transplant.
In addition, some of new SPK qualifying criteria fields are already available, on the SPK candidate’s registration page in UNetSM. Transplant programs may begin entering SPK qualifying criteria data elements in UNetSM for currently listed patients in order to update the SPK candidates’ records.
After implementation of the new pancreas allocation system transplant programs will need to collect and report these SPK qualifying criteria data on all SPK transplant candidates. Specifically, there will be six new qualifying fields in UNetSM for SPK candidates. The information in these qualifying fields will be used to determine if a SPK candidate qualifies to accrue SPK waiting time. Transplant programs will have to enter information into these fields for when they add SPK candidates after implementation of the new pancreas allocation system.
Jonathan: Zoe, thank you for discussing the upcoming changes to the pancreas allocation system today. If podcast listeners have questions, whom may they contact for answers?
Zoe: Questions about the new pancreas allocation system, policy changes, and the educational items that will be available in the upcoming months should be directed to their UNOS Regional Administrator. Programs may also connect to the OPTN website or Transplant Pro for more information and resources as they become available.