Comments

OPTN Organ Procurement Organization Committee | 09/25/2024

The OPTN Organ Procurement Organization (OPO) Committee thanks the OPTN Pancreas Transplantation Committee for their efforts on the Pancreas Continuous Distribution proposal.

There are concerns about potential staffing issues due to the limited number of qualified individuals for such positions. A member suggested clarifying in the proposal that the director role is distinct from the primary surgeon/physician role to avoid confusion. 

Region 5 | 09/25/2024

Online feedback showed support for encouraging OPOs to have procurement teams for all abdominal organs, including pancreas, and a member suggested to know the organ acceptance rates for transplant centers. Regarding cultivating strategies and range of skill set for pancreas transplant professionals, attendees suggest workshops, pointed out that fellows need to rotate at high volume centers to gain experience along with increasing training for procurement, and requiring specific hours with identified focus. For how to encourage programs to have dedicated pancreas directors, separate from kidney, in order to influence outcomes and growth of the programs, an attendee suggested a separate FTE efforts for Pancreas Directorship may help. Another thought that having a dedicated director would support growth but explained that that would be allocating a lot of resources for very little gain. Another attendee said they don’t believe a dedicated pancreas director will make a difference unless the transplant center is vested in pancreas transplantation and has the requisite personnel to do so. A member shared that their program has designated pancreas directors. And having the designated pancreas director is helpful because their program receives the necessary attention.

Gift of Life Michigan | 09/24/2024

We generally support the ongoing exploration and refinement of Continuous Distribution of pancreata as proposed by the OPTN Pancreas Committee and commend them for their work.

We defer to transplant experts to help define surgeon and program qualification; however, we think it worth noting that allocation of pancreata is disappointing. We share thousands of offers of donated pancreata through the current allocation system and match-run. Centers often accept, but then decline just prior to recovery. We urge careful consideration of the impact of distance and travel as the Continuous Distribution modeling is explored. In other words, it seems pancreata have the highest chance of acceptance when the recipient center is closer to the donor location.

OPTN Kidney Transplantation Committee | 09/24/2024

The Kidney Committee thanks the OPTN Pancreas Transplantation Committee for their work on this update and the opportunity to comment. Members noted that pancreas medical urgency should include explicit requirements, and that medical urgency exception requests should be reviewed prospectively, with patients receiving priority after the exception is approved. Committee members also noted that hypoglycemic unawareness can be relatively subjective, and noted that guidance and requirements should be objective. Committee members remarked that pancreas utilization can be a challenging topic to model and consider in policy development, particularly with respect to difficulties in pancreas recovery and the need for more widespread expertise in recovery and transplant of pancreata. Members noted that it is important to ensure pancreas utilization is addressed, noting relatively stable waiting list volumes for kidney-pancreas patients. One member pointed out that pancreas transplant volumes may be challenging for smaller pancreas programs. 

Region 3 | 09/24/2024

During the meeting, in-person attendees participated in group discussions. The pancreas group noted that some programs are recovering pancreas for research only. They also commented that there is a need for more experienced pancreas recovery surgeons, adding that having experience requirements by the OPTN would impact their readiness to participate in organ procurement procedures. The group also commented that it would be impractical for OPOs to have pancreas only recovery teams. The group agreed that there should be dedicated pancreas surgical and medical directors. 

OPTN Pediatric Transplantation Committee | 09/24/2024

The Pediatric Transplantation Committee appreciates the opportunity to provide feedback on the Continuous Distribution of Pancreata Update. To enhance fellowship training and cultivate interest in pancreas transplantation, one of our members suggests requiring fellows to assist their local organ procurement organizations with procurement. Some members support including medical criteria in the future pancreas allocation system.

American Nephrology Nurses Association | 09/24/2024

ANNA agrees. We have reviewed the updates and support continuous work on this project.

NATCO | 09/23/2024

NATCO appreciates the opportunity to provide public comment on the update to the Continuous Distribution of Pancreata project and we continue to support the systematic approach to build a framework that best meets the allocation objectives, while both maximizing utilization and promoting equal access for all transplant candidates. OPOs and Transplant Centers must continue to cultivate relationships and demonstrate full commitment throughout the allocation and recovery process to increase utilization of pancreata. NATCO supports the development of a guidance document encompassing procurement and utilization topics that focus on reducing barriers and promoting best practices, such as but certainly not limited to training, recovery logistics, increased usage from DCD, intra-operative surgeon communication, and protecting vasculature for the pancreas. NATCO also supports the development of the pancreas medical urgency attribute outlined in this paper, especially if it is carefully defined and promotes utilization of pancreata for those candidates most in need. In conclusion, NATCO applauds the committee for their holistic approach to develop the CD structure, while continuing to evaluate ways to best mitigate non-use and non-utilization.

Region 11 | 09/23/2024

The in-person attendee group emphasized the need for ASTS to offer a pancreas procurement workshop to enhance surgeon training. The in person attendee group also advocated for dedicated pancreas transplant directors, separate from kidney directors, noting improved efficiency in identifying suitable pancreas candidates when these roles were separated at their center. The importance of balancing pancreas and intestine allocation was also highlighted. Virtual attendees suggested profiling pancreas transplant success stories to cultivate interest, and emphasized the importance of vascular and trauma surgery skills for organ procurement. The in-person attendee group also discussed the potential impact of OPOs having procurement teams for all abdominal organs, with some suggesting it could increase usage but noting potential financial challenges. Opinions varied on the influence of dedicated pancreas directors, with one virtual attendee doubting significant impact, while another suggested it could improve focus on surgical nuances and post-transplant complication monitoring.

OPTN Transplant Coordinators Committee | 09/23/2024

The OPTN Transplant Coordinators Committee thanks the OPTN Pancreas Transplantation Committee for updating them on their continuous distribution work. The Committee agrees that more training is needed for pancreas procurement, as the pancreas is a very delicate organ to procure.

To increase pancreas utilization, the Committee suggests:

1. Having 1 or 2 specialists in each region who can be resources for pancreas procurements.
2. Instead of requiring a dedicated pancreas program director (due to low volume), having a lead surgeon with pancreas transplant experience to serve as a "pancreas champion" at programs and centers.

The Committee also recommends the Pancreas Committee review, in collaboration with the Scientific Registry of Transplant Recipients (SRTR), post-transplant survival metrics as well as the current graft failure definition. 

American Society for Histocompatibility and Immunogenetics (ASHI) | 09/20/2024

The American Society for Histocompatibility and Immunogenetics (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on this update. ASHI continues to be supportive of prioritizing the attributes of candidate biology for transplant access, especially of the highly sensitized patient population.

Region 10 | 09/20/2024

The discussion centered on strategies to enhance pancreas transplant programs and improve outcomes. A key point is the role of training programs in driving innovative strategies, particularly the potential benefits and challenges of appointing dedicated pancreas directors. While having a dedicated director could focus more attention on pancreas transplants, there is concern that such positions might be used as steppingstones to other roles, which would require institutional support to be truly effective. The group also discussed the small size of the waiting pool for pancreas transplants and whether enough is being done to identify and funnel appropriate candidates. The potential reimbursement for islet transplants was noted as a factor that could increase interest in the field. With advancements in diabetes technology providing good quality of life for many patients, there is a question about whether pancreas transplants are justified, given the risks associated with immunosuppression. The suggestion was made to consider a more regional approach to pancreas transplantation due to the limited number of specialists. Logistics around the recovery and distribution of pancreata are challenging because of the lack of expertise, and these logistics need to be carefully considered. The need for a clear definition of medical urgency was also highlighted, along with the role of ASTS and the OPTN in monitoring procurement processes carried out by OPOs and their staff. Reducing cold ischemic time was mentioned as a factor that could help increase pancreas offers. There was recognition that while it is helpful for transplant programs to receive organs with varied anatomy or surgical damage, this also encourages programs to procure organs themselves to ensure they meet their standards. Engaging with the community, referring doctors, and endocrinologists, as well as developing specific criteria for Type 2 diabetes mellitus, were suggested as ways to improve patient selection and engagement. Some felt that additional overhead, such as increased coordination and logistics for pancreas transplants, may not be practical for most hospitals. While some participants were unsure about the need for certain changes, the overall focus remained on finding effective ways to enhance pancreas transplant practices, with a specific emphasis on collaboration, logistics, and training.

Association of Organ Procurement Organizations | 09/20/2024

As stated in our previous comment on proposed policies related to the continuous distribution of organs, based on current data, AOPO supports the ongoing efforts of the OPTN to implement the continuous distribution of pancreata.

In general, AOPO is hopeful that using this continuous distribution methodology for pancreata moving forward will increase utilization and decrease or eliminate any variations in transplant center organ acceptance rates. As stated in the SRTR Annual Data Report published in 2024, from 2021 to 2022, the number of pancreata recovered with the intent to transplant decreased by 22.1 We hope this allocation change to the continuous distribution model will reverse that trend.

AOPO reaffirms its support for the continuous distribution of pancreata and the need for its continued evaluation. We believe more data collection and analysis will facilitate achieving the policy goals. Initial analysis indicates this allocation model may benefit OPOs without a local pancreas transplant program or a small pancreas transplant program, as they have reported a slight increase in pancreas donation and transplantation. One of the challenges faced by OPOs is the risk of a pancreas being allocated for transplant, only for it to be turned down after recovery by a local surgeon from the accepting center.

AOPO agrees with the goals stated in the document presented for public comment. The most critical goal is to decrease non-use of pancreata.

In closing, we ask that the committee continue to evaluate the use of medical urgency to increase the utilization of pancreata and monitor the impact broader sharing of organs is having on candidates awaiting transplantation and the utilization of donated pancreata.

1. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report. U.S. Department of Health and Human Services, Health Resources and Services Administration; 2024.

Region 7 | 09/17/2024

Virtual attendees emphasized several strategies to enhance pancreas transplantation. One virtual attendee suggested expert-supervised procurement training and programs to educate about the pancreas's importance, especially for people with diabetes. Another virtual attendee noted that encouraging OPOs to have procurement teams for all abdominal organs could prevent unnecessary declines, improve logistics, and reduce the number of teams needed. There was also support for having dedicated pancreas directors separate from kidney programs, as this could ensure more focused attention on pancreas transplants and better organ utilization. One virtual attendee stressed that pancreas transplantation requires intentional effort and time, and separating offer and procurement activities from kidney call could be beneficial.

During the meeting, attendees participated in group discussions and provided the following feedback:

• Participants discussed time to procure pancreata and reliance on other teams. Suggested strengthening pancreas recovery skill sets among OPOs through training.

American Society of Transplant Surgeons | 09/16/2024

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View attachment from American Society of Transplant Surgeons

OPTN Living Donor Committee | 09/13/2024

The OPTN Living Donor Committee thanks the OPTN Pancreas Transplantation Committee for their work on continuous distribution. The Committee strongly supports the prioritization of prior living donors in the pancreas allocation system. Although this prioritization status would apply to only a very small number of individuals, it would have a high impact within the living donor and transplant communities by acknowledging the altruism of living donors, demonstrating the value of reciprocity, and recognizing the need to support living donors. The Committee commends the support of living donor priority as supporting patient access. Ensuring prioritization for prior living donors also maintains confidence in the development of continuous distribution in the organ donation and transplantation system. The Living Donor Committee offers the following as key points to consider for inclusion of prior living donor priority into continuous distribution:

·      Prior living donors should receive priority if they are listed for transplant

·      All prior living donors should receive priority for any organ needed

·      Prior living donor priority should not have a time restriction

·      Prior living donors should not be valued differently based on organ donated

·      Prior living donor priority should not be optional to individual candidates

American Society of Transplantation | 09/12/2024

The American Society of Transplantation (AST) is generally supportive of what is outlined in committee update, “Continuous Distribution of Pancreata Update, Summer 2024.”

The AST supports the medical urgency criteria for pancreas candidates as outlined in the paper. The AST is also entirely supportive of enhancing equity, transparency, and more data analysis to evaluate the feasibility of including utilization and non-use models in pancreas allocation, as reviewed in this update. The AST believes it would be beneficial to focus on those topics highlighted for possible inclusion in a future guidance document on pancreas procurement and utilization. Instead of possible punitive measures for programs with high non-utilization rates, the current focus should be to reduce the numerous barriers that drive pancreata non-utilization. Having expertly trained personnel available within organ procurement organization procurement teams would be a step towards addressing current barriers to successful pancreas procurement. Additionally, encouraging separate pancreas and kidney transplant program directors could positively impact pancreata utilization and outcomes; however, the OPTN should not require this separation to avoid unduly burdening small and medium sized programs that could lead to the closure of some pancreas programs.

The AST also supports increased collaboration with those interested in transplantation at the American Diabetes Association (ADA). As part of this collaboration and acknowledging the significant advancements in medical management of diabetes, the AST suggests developing education about adequate management of diabetes to be provided in parallel with information about pancreas transplant.

Region 9 | 09/10/2024

An online comment expressed concern that encouraging OPOs to have procurement teams for all abdominal organs, including pancreas, would delay procurements even more than they are now. Another member noted that currently good quality kidneys are being separated from pancreata due to multi-visceral transplants.

During the meeting, attendees participated in group discussions and provided the following feedback:  

• Pancreas transplants are limited, so utilizing virtual trainings and refresher courses would help increase awareness and experience.  
• The group stated having reliable relationships with OPOs is also key. 
• Having outreach with the endocrinology community would help with having more dedicated pancreas transplant directors.

OPTN Transplant Administrators Committee | 09/04/2024

The OPTN Transplant Administrators Committee appreciates the opportunity to comment on the OPTN Pancreas Committee’s update on Continuous Distribution of Pancreata. The Committee offers the following feedback for consideration:

• The Committee suggests training programs to increase pancreas program provider staffing. 

Overall, the Committee is supportive of the developments on Pancreas Continuous Distribution.

Region 6 | 09/03/2024

During the meeting, in-person attendees participated in group discussions. The pancreas group discussed innovation strategies for fellowship training. While no specific recommendations were provided, it was noted that increased pancreas procurement experience could lead to better facilities and not every surgeon trains at a transplant center with pancreas transplant or procurement. They also encouraged transplant centers to have pancreas medical and surgical directors separate from kidney to focus on specific organ needs and requirements to grow the program. The discussion also highlighted the positive impact of having a dedicated pancreas procurement team at Organ Procurement Organizations (OPOs). It was suggested that encouraging all OPOs to adopt this practice would be beneficial. 

Virtual attendees also provided feedback on key questions. One attendee commented that having individuals that are exclusively on call for pancreas transplantation could be helpful. There was also feedback that while encouraging OPOs to have procurement teams for pancreas would likely increase pancreas procurement, it may also be a burden to bring multiple teams to distant recoveries.

Region 1 | 08/29/2024

One attendee commented that part of the reason their program no longer does pancreas transplants was because their pancreas surgeon felt that oftentimes, how the liver was recovered resulted in damage the pancreas anatomy, so it is highly important to consider issues related to pancreas recovery. Another member said that only efficiency and patient matching should be considered for pancreas continuous distribution, and that the only time a pancreas is transported should be if the list of local candidates is exhausted.

During the meeting, attendees participated in group discussions and provided the following feedback:

· The group agreed there’s need for improved training and dedicated pancreas directors, but ultimately questioned whether it should be a goal to increase the number of pancreas transplants. 

UAMS Medical Center | 08/28/2024

After reviewing the Summer 2024 update to the continuous distribution of pancreata proposal, we appreciate the additional information provided and offer the following feedback. We believe that it is important to standardize the distribution process for simultaneous Kidney/Pancreas transplants. Creating a standardized process will allow all centers/OPOs to communicate effectively during organ allocation. We feel that multiple patient attributes should be evaluated simultaneously, and a composite allocation score should be created to remove the barriers with categorized scoring.

Region 8 | 08/27/2024

During the meeting, attendees participated in group discussions and provided feedback in-person and online, on the following questions:

· For innovative strategies that could be implemented to enhance fellowship training and cultivate greater interest in pancreas transplantation among medical professionals and what range of skills and experiences might contribute to a professional's readiness to participate in organ procurement procedures – attendees suggested the following:

o  Volume, experience, and exposure to pancreas transplants are really important

o  More funding to promote training in pancreas transplants

o  Train at centers that do the procedure

o  Personal mentorship by experienced surgeon

o  Focus on comprehensive skill development, including advanced surgical and blood conservation techniques crucial for patients like Jehovah's Witnesses. (This aligns with the OPTN Ethics Committee's 2021 White Paper encouraging unbiased evaluation.) Fellows should rotate through related specialties, participate in research on bloodless surgery techniques, and engage in simulation-based training for complex scenarios. Cultural competence training should emphasize consistent, transparent criteria application to avoid discrimination. Mentorship programs with surgeons experienced in bloodless transplantation and interdisciplinary collaboration can advance innovative techniques. These strategies ensure a well-rounded skill set addressing diverse patient needs and could increase overall transplant numbers.

· For encouraging OPOs to have procurement teams for all abdominal organs, including pancreas, impact procurement, attendees suggested the following:

o  Make it more efficient and economical

o  If the surgeons are highly skilled, it would be positive; if not, it would have negative impact

o  Noted support for OPOs having procurement teams

· For encouraging programs to have dedicated pancreas directors, separate from kidney, influence outcomes and growth of the programs, attendees provided the following feedback?

o  A dedicated person that can focus on increasing pancreas transplant would be ideal.

o  There could be a decrease in volume since pancreas transplant is a specialized field. 

Region 4 | 08/19/2024

One attendee strongly advocated for giving priority to prior living donors noting that over the past 25 years, the number of prior living donors who are listed for transplant is very low but has a high impact on promoting trust in the system and is important for how the transplant community connects with the community at large. 

Virtual attendees also provided feedback that education of diabetic specialists could cultivate greater interest in pancreas transplants among medical specialists. Attendees also commented that having dedicated pancreas program directors could improve outcomes and increase transplant. Some attendees commented that encouraging OPOs to have procurement teams for pancreas would be helpful for quicker coordination of procurement with family and donor hospital OR availability.  It would also reduce the risk of flying for the transplant team.  

Region 2 | 08/16/2024

Feedback submitted online emphasized the importance of setting standards to improve the chances of successful transplant outcomes. An attendee, who is a simultaneous kidney and pancreas transplant recipient, expressed a wish that they had been given the option for a pancreas transplant 25 years earlier. This could have potentially prevented complications from Type 1 Diabetes and preserved their kidneys. There was also agreement on the value of metrics and modeling in the Continuous Distribution update. 

During the meeting, attendees participated in group discussions and provided feedback on the following questions: 

• What innovative strategies could be implemented to enhance fellowship training and cultivate greater interest in pancreas transplantation among medical professionals? What range of skills and experiences might contribute to a professional's readiness to participate in organ procurement procedures? 
• The discussion highlighted the rarity of pediatric pancreas transplants, particularly for adolescents who often face challenges in accessing adult programs due to the specialized skills required for pancreas surgeries. The need for adult programs to gain expertise in treating younger patients was emphasized, especially as advancements in diabetes care, such as Dexcom and insulin pumps, are transforming treatment options. Concerns were raised about the future of training for pancreas transplant surgeons, including the potential reduction of required surgical fellowship years and the removal of mandatory transplant rotations, which could impact the quality of training. The idea of utilizing simulation labs to enhance surgical practice and better prepare fellows and donor surgeons for pancreas transplants was proposed. Additionally, it was noted that, with limited pancreas donor resources, it is essential to ensure that all transplant surgeons are adequately trained and qualified. There was some uncertainty expressed about the relevance of pancreas transplants given the advancements in insulin technology, indicating a need for ongoing discussion in the transplant community about these issues. 
• How might encouraging OPOs to have procurement teams for all abdominal organs, including pancreas, impact procurement? 
• The discussion focused on the potential benefits of moving towards local recovery of pancreata from an OPO perspective. Local recovery could improve the training of procurement staff and ensure that centers are more inclined to utilize pancreata, as they would have the capability to procure them directly. This approach aims to control the recovery narrative and reduce declines attributed to inadequate recovery staff or the challenges of traveling long distances for pancreas retrieval. Overall, enhancing local recovery practices could increase the number of available pancreata for transplantation. 
• In what ways might encouraging programs to have dedicated pancreas directors, separate from kidney, influence outcomes and growth of the programs? 
• While there was some skepticism about whether simply appointing a pancreas director would lead to significant improvements, it was noted that having someone solely focused on pancreas transplants could enhance interest and outcomes. Dedicated pancreas directors may not be influenced by the demands of kidney or liver transplants, allowing for a more concentrated effort in this area. It was acknowledged that having specialized staff could improve outcomes, although there are questions about the overall demand for pancreas transplants, especially regarding the inclusion of type 2 diabetics. The conversation also highlighted the high costs associated with pancreas transplantation, raising concerns about the financial feasibility of expanding programs focused solely on pancreas transplants. 

Luke Preczewski | 08/02/2024

I am generally supportive of these efforts, especially resolution of issues related to SPK. Will need to see an actual proposal for this, but the direction is right.
One note: the discussion needs to take into account much more significantly logistic and financial consequences of allocation changes. Past changes have led to a system in which far too many unnecessary flights occur. This has dramatically increased logistic challenges and costs for transplant centers. This trend is not financially or logistically sustainable, and any future changes need to take this seriously.