Improving Access To Kidney Transplantation: A Global Perspective
Learning how to successfully expand access to organ transplantation will be for naught unless more organs are procured. In the US, a 15-year regulatory regime requiring transplant centers to achieve a high threshold for patient and graft survival under threat of decertification from Medicare finally came to an end. This regulatory policy likely led to demonstrable risk aversion regarding candidate listing practices and organ acceptance behaviors, possibly contributing to a durable 20% rate of organ discard in the country.20 While not all the discarded kidneys were likely viable, prudent and targeted regulatory reform is needed to encourage transplant surgeons to accept and transplant ostensibly “higher risk” kidneys without risking regulatory or financial jeopardy.
So-called “presumed consent” or “opt-out” policies in Europe, in which consent to organ procurement after brain death is “presumed” for policy purposes, are variably defined and enforced, and have not been shown to improve organ procurement rates compared to the traditional “opt-in” consent model extant in the US.21
One promising avenue is to build on the success of the European Union’s European Senior Program (ESP), which improved access to transplantation for elderly recipients by explicitly allocating kidneys from older donors (which might otherwise have been discarded) to them.22 While expanding the organ pool is an important strategy, it will not be a wholesale panacea: a recent analysis from Europe suggests that extending elderly donors after circulatory death may not routinely confer survival versus maintenance dialysis.23
In addition, identifying key demographic differences in high-KDPI kidneys will be key to learning the right lessons about more aggressive organ procurement. A recent retrospective review of utilization of and outcomes from using high-KDPI kidneys in the UK showed that high-KDPI scores in UK donors were often driven more by advanced age, rather than the combination of advanced age and comorbidities such as hypertension and diabetes.24 Given the limitations of the KDPI score as a predictive tool (the KDPI only has a c-statistic of 0.6 for predicting graft survival), the need for more sophisticated prognostic tools to make distinctions between subcategories of “high risk” kidneys is urgent.25
STEWARDSHIP OF THE “GIFT OF LIFE”: EXTENDING LONG-TERM PATIENT AND GRAFT SURVIVAL
Improving access is also for naught without longevity. In the US, a conﬂagration of quality metrics focused on one-year outcomes, a culturally bound sharp separation of duties between transplant centers and general nephrologists, and a payment model that rewards procedures more than longitudinal care all conspire to make the long-term care of transplant recipients no one’s dedicated responsibility. Given a recent analysis that showed the burden of premature graft failure in the US in 2017 resulted in $1.37 billion of additional costs and a reduction of nearly 30,000 additional quality-of-life years, implementing population health interventions to extend patient and graft survival harmonizes good patient care with return on public investment.26
Happily, there are new potential therapeutic targets for extending allograft survival, including some early data suggesting that sodium glucose co-transporter 2 inhibitors (SGLT-2i) may be of benefit in transplanted patients.27 Providing this end-to-end care for patients across the continuum is integral to the future of integrated patient care models that will be pioneered by Fresenius Medical Care.
To improve access and increase the total number of kidney transplants performed, and to improve access to kidney transplantation for patients around the world, Dr. Hippen and his team will focus on:
- Designing care models to improve communication and care coordination between general nephrologists, dialysis providers, and transplant centers
- Implementing workflow streams to improve the efficiency and timeliness of the multidisciplinary transplant evaluation, while bringing transparency to the process for patients and healthcare providers
- Identifying best practices in organ acceptance processes and patient care models from transplant centers around the world, and developing a toolbox suitable for transplant programs globally
- Integrating kidney transplantation into value-based care arrangements with private payors to improve patient access to transplantation, while reducing healthcare expenditures for public and private payors
- Identifying, codifying, and promulgating novel innovations in organ procurement, including developing freestanding organ procurement centers, exploring new technologies in organ preservation and organ regeneration, and supporting the mission of organ procurement organizations through regulatory and policy reforms
- Identifying pharmaceutical and medical device innovations that render kidney transplantation safer for patients and prolong allograft survival
Meet The Experts
- Hippen BE, Reed AI, Ketchersid T, Maddux FW. Implications of the Advancing American Kidney Health Initiative for kidney transplant centers. Am J Transplant 2020 May;20(5):1244-50. doi: 10.1111/ajt.15619.
- Hippen BE, Maddux FW. Integrating kidney transplantation into value-based care for people with renal failure. Am J Transplant 2018 Jan;18(1):43-52. doi: 10.1111/ajt.14454.
- Sussell J, Silverstein AR, Goutam P, et al. The economic burden of kidney graft failure in the United States. Am J Transplant 2020 May;20(5):1323-33. doi: 10.1111/ajt.15750.
- Ibrahim HN, Murad DN, Knoll GA. Thinking outside the box: novel kidney protective strategies in kidney transplantation. Clin J Am Soc Nephrol 2021 Mar 23:CJN.15070920. doi: 10.2215/CJN.15070920.
- Schold JD, Mohan S, Huml A, et al. Failure to advance access to kidney transplantation over two decades in the United States. J Am Soc Nephrol 2021 Feb 11:ASN.2020060888. doi: 10.1681/ASN.2020060888.
- Huml AM, Sedor JR, Poggio E, et al. An opt-out model for kidney transplant referral: the time has come. Am J Transplant 2021 Jan;21(1):32-36. doi: 10.1111/ajt.16129.
- Reese PP, Mohan S, King KL, et al. Racial disparities in preemptive waitlisting and deceased donor kidney transplantation: ethics and solutions. Am J Transplant 2021 Mar;21(3):958-67. doi: 10.1111/ajt.16392.
- Schold et al. Failure to advance access to kidney transplantation over two decades in the United States.
- Bae S, Massie AB, Luo X, et al. Changes in discard rate after the introduction of the Kidney Donor Profile Index (KDPI). Am J Transplant 2016 Jul;16(7):2202-7. doi: 10.1111/ajt.13769.
- Aubert O, Reese PP, Audry B, et al. Disparities in acceptance of deceased donor kidneys between the United States and France and estimated effects of increased US acceptance. JAMA Intern Med 2019 Aug 26;179(10):1365-74. doi: 10.1001/jamainternmed.2019.2322.
- Shroff S, Gill JS. Bold policy changes are needed to meet the need for organ transplantation in India. Am J Transplant 2021 Feb 14. doi: 10.1111/ajt.16537.
- Alexander SI, Clayton PA, Chadban SJ. Organ transplantation in Australia. Transplantation 2017 May;101(5):891-92. doi: 10.1097/TP.0000000000001621.
- Khanal N, Lawton PD, Cass A, McDonald SP. Disparity of access to kidney transplantation by Indigenous and non-Indigenous Australians. Med J Aust 2018 Sep 17;209(6):261-66. doi: 10.5694/mja18.00304. Erratum in: Med J Aust 2018 Dec 10;209(11):475.
- Conway PT, Knight R. Legitimization and incorporation of patient preferences: the arrow that hit the Achilles heel of status quo kidney care. Clin J Am Soc Nephrol 2021 Apr 7;16(4):645-47. doi: 10.2215/CJN.11780720.
- Vanholder R, Domínguez-Gil B, Busic M, et al. Organ donation and transplantation: a multi-stakeholder call to action. Nat Rev Nephrol 2021 May 5:1-15. doi: 10.1038/s41581-021-00425-3.
- Loupy A, Aubert O, Reese PP, et al. Organ procurement and transplantation during the COVID-19 pandemic. Lancet 2020 May 23;395(10237):e95-e96. doi: 10.1016/S0140-6736(20)31040-0.
- ClinicalTrials.gov. COVID-19 pandemic and worldwide organ procurement (COVID). https://clinicaltrials.gov/ct2/show/NCT04416256.
- Doyle M, Subramanian V, Vachharajani N, et al. Organ donor recovery performed at an organ procurement organization-based facility is an effective way to minimize organ recovery costs and increase organ yield. J Am Coll Surg 2016 Apr;222(4):591-600. doi: 10.1016/j.jamcollsurg.2015.12.032.
- Collins KM, Doyle MBM. Revisiting the organ procurement organization-based organ procurement center in the COVID era. Am J Transplant 2020 Nov;20(11):3263-3264. doi: 10.1111/ajt.16124.
- Schold JD, Buccini LD, Poggio ED, et al. Association of candidate removals from the kidney transplant waiting list and center performance oversight. Am J Transplant 2016 Apr;16(4):1276-84. doi: 10.1111/ajt.13594.
- Glazier A, Mone T. Success of opt-in organ donation policy in the United States. JAMA 2019;322(8):719-20. doi: 10.1001/jama.2019.9187.Rose C, Schaeffner E, Frei U, et al. A lifetime of allograft function with kidneys from older donors. J Am Soc Nephrol 2015 Oct;26(10):2483-93. doi: 10.1681/ASN.2014080771.
- Peters-Sengers H, Berger SP, Heemskerk MB, et al. Stretching the limits of renal transplantation in elderly recipients of grafts from elderly deceased donors. J Am Soc Nephrol 2017 Feb;28(2):621-31. doi: 10.1681/ASN.2015080879.
- Ibrahim M, Vece G, Mehew J, et al. An international comparison of deceased donor kidney utilization: what can the United States and the United Kingdom learn from each other? Am J Transplant 2020 May;20(5):1309-22. doi: 10.1111/ajt.15719.
- Organ Procurement and Transplantation Network. “A guide to calculating and interpreting the Kidney Donor Profile Index (KDPI)” (updated March 23, 2020). Available at https://optn.transplant.hrsa.gov/media/1512/guide_to_calculating_ interpreting_kdpi.pdf.
- Sussell et al. The economic burden of kidney graft failure in the United States.
- Ibrahim et al. Thinking outside the box.