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Editor’s note: this Viewpoint is based on excerpts from an article prepared by the authors on behalf of the executive committee of the American Society of Transplant Surgeons, which includes Kenneth Andreoni, MD; Ginny L. Baumgardner, MD, PhD, FACS; William Chapman, MD, FACS; A. Osama Gaber, MD; James F. Markmann, MD, PhD; Elizabeth A. Pomfret, MD, PhD; Henry B. Randall, MD, MBA, FACS, FAST; and Debra Sudan, MD.
The American Society of Transplant Surgeons is a medical specialty society representing more than 1,900 professionals dedicated to excellence in transplantation surgery. Our mission is to advance the art and science of transplant surgery through patient care, research, education and advocacy.
We agree with Barry Massa and the AOPO that OPOs and transplant centers are not fully aligned in outcome measurements. OPOs are driven by the number of organs recovered regardless of the eventual function of the organs, and transplant centers are judged by actual patient outcomes.
It is difficult if not impossible to assume as stated in this Viewpoint that 62% of unused donated kidneys would have been “viable” for a good clinical outcome if transplanted. An acceptable organ for transplant to an individual patient is a complex decision that takes many factors into consideration. Some patients cannot safely tolerate a donated kidney that may not function soon after transplant. Other donated kidneys have anatomical complexities that are not appropriate for many patients due to the patient’s vascular disease and may be too risky for any patient to receive.
Opportunities
The shortage of organs for transplant has long motivated transplant professionals to explore surgical innovations, pursue multiple avenues of research and develop a variety of clinical strategies to enhance access to transplantation. Efforts to increase living donor kidney transplant through education, reduction of disincentives, expansion of paired kidney donation and altruistic non-directed donation are examples of ongoing strategies. Technological advances with machine perfusion offer unprecedented opportunities to extend the acceptable length of time for organ preservation. Furthermore, these technologies have the potential to facilitate more reliable assessment of organ function especially for the increasing proportion of organs that are at risk of poor or nonfunction.
Donor, recipient risk
We believe all stakeholders in the transplant community are dedicated to best practices for organ donation, procurement and transplantation recipient outcomes. Each time a transplant occurs there is great opportunity for benefiting quality and quantity of life, but there are also intrinsic perioperative surgical risks and risks associated with primary nonfunction or poor organ function that impact short-term and long-term patient morbidity and mortality.
For each transplant that occurs, complex decision-making must occur to assess the risks associated with each organ and deceased donor condition and each recipient’s condition and readiness for transplant at the time of organ availability. Information from the OPOs is transmitted at many time points following the initial organ offer about multiple factors impacting the recipient transplant outcome, including the initial intraoperative organ assessment by the procurement surgeon, post-procurement anatomy, potential biopsy results, potential machine perfusion characteristics and logistics associated with organ retrieval and transportation that impact donor organ quality and function.
Regulations
Layered onto these complex medical decisions are continual perturbations to the process initiated by new federal policies and changes in procedures. Each policy change, such as wider geographical sharing of deceased donor kidneys, has added new challenges for the transplant community, resulting in longer cold ischemia times that increase the risk that organs will encounter delayed graft function, will have reduced function or perhaps not function at all.
Unintended consequences of this new allocation policy include increased strain on the transplant workforce capacity, increased organ procurement costs and increased time associated with organ placement. With the numerous changes in allocation policy in the last decade, it is often not possible to understand the impact of each individual intervention on system-level outcomes, such as organ acceptance and utilization.
Surgeons also have the challenge of transplanting organs in more complex patients and working with more medically complex donors. Some aspects of recipient risks at the time of initial transplant evaluation may increase while candidates are on the waitlist, thus increasing the chance of an adverse surgical outcome or reduced longevity of graft and/or patient survival.
This occurs in a system that initiates regulatory actions and threatens transplant center viability when outcomes are flagged for lower “observed to expected” outcomes.
Organ nonuse
The nonuse of potential donor organs that has been highlighted as an area for system improvement certainly requires evaluation and strategies to mitigate any modifiable impediments. The ASTS has previously commented in response to the CMS request for information (RFI) on Health and Safety Requirements for Transplant Programs, OPOs and end-stage renal disease facilities.
Excerpted from the ASTS response to this RFI is the following:
“At the same time, it is important to keep in mind both that significant progress has been made in organ utilization and that there are limits to the extent to which organ nonuse can be eliminated. ... Despite this progress, there are several significant limitations on the degree to which organ nonuse can or should be reduced or eliminated. The raison d’être of OPOs and transplant programs dictate their slightly different approaches to high-risk organs. The OPOs’ mission is to maximize procurement of potentially transplantable organs, while transplant programs are tasked with critical, life or death decisions regarding the actual suitability of those organs for uniquely individual potential candidates.
OPOs being aggressive at recovering organs from all potentially suitable donors (ie, casting a large net), will increase organ transplant but will naturally incur higher nonuse rates. Transplant programs are cognizant of the huge cost of transplanting an organ that fails to work adequately (morbidity and mortality for that recipient, costs to payers, and further strain on the organ supply as that recipient then reenters the candidate pool). Therefore, to at least some extent, some organ discard is a predictable and an unsurprising consequence of the different roles played by OPOs and transplant programs.”
The ASTS stresses the approach to optimizing donor organ acceptance and use must take into account the entire transplant ecosystem. Preoperative determination of deceased donor suitability, donor management, organ assessment and procurement surgery, post-procurement placement factors, including efficient and reliable transportation, recipient medical condition and readiness for transplant and transplant center resources impact organ acceptance and use. The assumption that there is a formula or percentage of procured organs that can serve as a national performance metric has yet to be validated under one set of conditions, let alone conditions that are unique to individual communities and are evolving in response to new policies and procedures.
Assignment of arbitrary OPO and transplant center performance metrics that are associated with potential decertification or financial penalties have the potential to silo stakeholders and stifle cooperation. Successful minimization of organ nonuse will require a comprehensive approach that incentivizes collaboration, cooperation, trust, research and mutual learning.
The ASTS has continually emphasized that the true intent of our national transplant system should be to increase the donation and transplantation opportunities for all patients and their families. The federal government and private insurers have steadfastly refused to create a reasonable bar of outcome metrics and have instead focused on attempting to drive transplant center behavior by redefining metrics and comparing transplant centers to each other – therefore, almost always, some centers must lose even if the benefit of transplant at the relatively “poorest performing” transplant center is a major advantage in survival and quality of life for recipient patients.
More effort and resources should be focused on optimizing communication and cooperation between donor hospitals and OPOs, and between OPOs and transplant centers to allow this complex series of events to become more efficient and lead to more transplant opportunities. Our system now needs to focus on realignment of goals, priorities and removal of disincentives that will permit the transplant centers, OPOs and other stakeholders to work together more seamlessly despite the increasing complexities of transplantation.
- References:
- American Society for Transplant Surgeons procedural standards for deceased donor organ recovery. https://asts.org/docs/default-source/public-comments/procedural-standards-for-deceased-donor-organ-recovery---approved-jan.-2022.pdf.
- https://asts.org/docs/default-source/regulatory/asts-response-to-hrsa-oamp-rfi-on-the-optn-may-9-2022.pdf.
- Surgical standards for surgeons performing deceased donor organ procurements for transplantation. https://asts.org/advocacy/surgical-standards-for-surgeons-performing-deceased-donor-organ-procurements.
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- Kenneth Andreoni, MD, is a professor of surgery and surgical director of renal transplant at Thomas Jefferson University Health System. He can be reached at asts@asts.org.
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