EVIDENCE BASED INSIGHT
Increasing Access to Transplantation: Lessons from the United States
September 21, 2020 • 5 min read
Expanding access to renal transplantation is a global healthcare goal. The limited progress being made in the United States illustrates that meaningful change requires a comprehensive approach. Decreasing roadblocks to transplantation, better educating patients, and actively encouraging kidney donation have all contributed to reducing the time dialysis patients spend on the transplant waitlist. Yet with only one in seven dialysis patients currently considered a good transplant candidate, Fresenius Medical Care and Fresenius Medical Care Foundation have launched a number of initiatives to further improve transplantation rates and kidney donation.
Renal replacement therapy is one of the miracles of 20th century medicine. Dialysis has changed a disease with 100 percent mortality into a treatable chronic condition with a survival rate of many years. Renal transplantation provides even greater survival benefit as well as a return to normal lifestyle not achievable with dialysis.
Yet, while dialysis is readily available for nearly 550,000 patients at more than 7,000 clinics in the United States, only 22,000 transplants were performed in 2018. In response to this fact, the Executive Order on Advancing American Kidney Health was issued by President Trump on July 10, 2019, calling for better prevention of chronic kidney disease (CKD), increased patient choice of therapies, and increased access to renal transplantation. Efforts to increase kidney transplantation require an understanding of the process and development of methods to decrease roadblocks.
Kidneys become available for transplant in three ways. The most common is a donation at the time of death with the prior direction of the decedent. Organ procurement organizations (OPOs) are independent nonprofit organizations responsible for the collection, matching, and delivery of these kidneys. Another way is when living relatives of end-stage kidney disease (ESKD) patients donate one of their two kidneys, if they have compatible blood and tissue types. There is little, if any, impact on the relative’s subsequent health. The third way is the donation of a kidney by a person unrelated to the patient, a previously rare but increasingly frequent event.
The process of kidney transplantation begins with an evaluation and discussion to determine a patient’s interest in and suitability for the procedure. Most often, the patient’s nephrologist and dialysis clinic staff handle appointment scheduling at one of approximately 240 certified US kidney transplant centers. Necessary evaluation includes tissue typing and tests to rule out malignancy, serious heart disease, infection, and other contraindications for transplant. If deceased donor transplantation is planned, the patient then joins a waiting list. If a living donor is available, this individual will have similar testing as well as psychological evaluation. Not only does each of these steps introduce a potential blocking event for transplant, but the median wait time for a kidney now exceeds 1,500 days.
The percentage of dialysis patients who were wait-listed for a kidney transplant declined between 2016 and 2017, to a new low of less than 14 percent (Figure 1).1 Changes to the kidney allocation system in December 2014 are probably responsible for this downturn, as the incentive for early listing was eliminated. In the new system, patients are credited for time since dialysis initiation rather than time since first wait-listed. Nevertheless, the question remains whether only one in seven dialysis patients is a good candidate for kidney transplants. There are disparities in waitlisting prevalence, including differences between metropolitan areas and the collection of small towns and rural areas, as well as differences among the states. These discrepancies suggest that access to kidney transplantation is variable.
Figure 1 | National wait-listing prevalence has declined
Against this backdrop, data from the United States Renal Data System show that kidney transplantation has continued to increase. There were approximately 15,000 deceased donor transplants in 2017, a new high in this century. The number of living donor transplants remained slightly below 6,000, although there have been steady increases in both unrelated directed altruistic donation and paired exchange (programs allowing incompatible recipients to receive a better matched kidney) in recent years. The increase in overdose-related deaths in the general population may be contributing to this increase, as motor vehicle deaths have continued to decline.
A variety of initiatives have been launched at Fresenius Kidney Care (FKC) and Fresenius Medical Care North America (FMCNA) to improve patient access to transplantation. Within the FKC electronic health record (eCube Clinicals), the transplantation workflow and documentation of referral to a transplant center have been modified to include more clinical detail and better visibility to reasons for non-referral. Since patient refusal is a major barrier to transplant, educational counseling delivered by social workers and other members of the intradisciplinary care team is expanding emphasis on transplantation as a modality option. Recognizing “Percentage of Prevalent Patients Waitlisted (PPPW)” as a new metric within the Medicare Quality Improvement Program, the FKC Clinical Quality Score (the internal quality reporting program for FKC clinics) will display “Transplant Waitlist” in 2020, showing the percent of eligible patients < 75 years of age on the transplant waitlist as gathered from the Transplant Assessment in eCube Clinicals (Figure 2).2
Figure 2 | Large variation in wait-listing prevalence among the states
While kidney donations from living relatives are widely known and specifically sought when patients undergo evaluation, unrelated or “altruistic” donation is less publicized and occurs infrequently. The recently established Fresenius Medical Care Foundation has recognized an opportunity to increase altruistic donation by partnering with Donate Life America (DLA) to create a national registry of individuals willing to donate a kidney.
Further, with Fresenius Medical Care Foundation support, DLA will distribute saliva testing kits to rapidly determine suitability and match donor tissue type with potential kidney recipients. Additionally, FMCNA has provided funding to the National Kidney Foundation’s “Big Ask, Big Give” initiative to help educate patients and families about living donation and suitability as a donor.
Nephrologist leadership and commitment are essential to increase the kidney transplantation rate (Figure 3).3 FMCNA physician education on transplantation is provided through the Medical Office Newsroom, Medical Office Live events, and regular Medical Office communications. New payment models identified in the executive order emphasize the key role of nephrologists in CKD care and appropriate planning for ESKD choices. InterWell, an innovative partnership between FMCNA and nephrologists, is a population management company focused on improving CKD care, increasing home dialysis utilization, and promoting kidney transplantation.
Figure 3 | First-time kidney transplant rates in dialysis patients under 70 years old
Outside of Fresenius Medical Care, significant improvements in the US transplant system are necessary. Under new proposed regulations, OPOs will be required to report deceased donor transplant donation rates and transplantation rates. The quality measure for the transplant programs needs to evolve to eliminate both the excessive denial of transplants to candidates with complicated medical conditions and the refusal to transplant “less than perfect” donated kidneys.
It is clear that progress requires a multifaceted approach to change. Leadership from nephrologists, systemic improvements including new payment models, national campaigns promoting donation, and more in-depth conversations between patients and interdisciplinary care teams are just some of the factors that can help remove excessive barriers to renal replacement therapy.
PARTNERSHIP'S INITIATIVES WILL ENCOURAGE LIVING DONATIONS
The Fresenius Medical Care Foundation has made an investment in two initiatives being launched by Donate Life America (DLA), a nonprofit organization focused on increasing organ transplantation. One initiative is a national, universal living donor kidney registry; the other is the first-ever at-home living donor testing kit. Both will encourage living donations by alleviating wait times for individuals on the kidney transplant waiting list and increasing patient access to living donor transplants.
At-Home Living Donor Testing Kits: Using saliva sample technology, a faster, consumer-friendly screening option has been created to identify and register potential living donors for kidney transplant. The streamlined process helps retain living donor interest by converting testing results to a potential match as quickly and safely as possible.
The National Donate Life Living Donor Registry: This first-of-its kind universal registry will allow the public to register their interest in becoming a living donor, reducing the barriers that currently exist with no clear pathway to express interest. This platform captures preliminary matching results from the at-home testing kits and—in partnership with the United Network for Organ Sharing and transplant programs across the country—allows potential living donors and recipients to find matches nationwide. This new living donor registry is part of the existing secured and trusted National Donate Life Registry, which houses deceased organ, eye, and tissue donor registrations.
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References
- US Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients. OPTN/SRTR 2017 annual data report: kidney. https://srtr.transplant.hrsa.gov/annual_reports/2017/Kidney.aspx.
- Guide to the dialysis facility reports for fiscal year 2019. Table 6 for calendar year 2017. University of Michigan Kidney Epidemiology and Cost Center, July 2018. https:// dialysisdata.org/sites/default/files/content/Methodology/DFRGuide.pdf.
- Guide to the dialysis facility reports for fiscal year 2019. Table 5 data. University of Michigan Kidney Epidemiology and Cost Center, July 2018. https://dialysisdata.org/ sites/default/files/content/Methodology/DFRGuide.pdf.
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