Here’s my already-submitted public comment to OPTN on their proposed policy for living kidney donor follow-up. The deadline for comment is December 23rd, so there’s still time to compose and submit your own.
The purpose of this missive is to respond to the proposed policy to establish minimum requirements for living kidney donor follow-up.
Nearly 60 years after the first LKD transplant, there have been no randomized controlled trials to determine the testing required for the evaluation of living kidney donors(1). Transplant programs have little data to guide them in deciding which donors are unacceptable, or which characteristics are associated with kidney disease or poor psychosocial outcomes after donation(2) . Published studies are either single center, susceptible to selection bias and small sample sizes, or compare living donors the general public, an incorrect cohort(3) .
Meanwhile, over the past 30 years, living kidney donors have gotten older, increased in pre-donation BMI, and decreased in pre-donation GFR(4). All are independent risk factors for cardiovascular and kidney disease, but we have no data to know how any or all of these variables affect a living donor’s short or long-term well-being.
In 2000, all transplant centers were required to report one year of living donor follow-up to OPTN, extended to two years in 2006. Over a decade later, more than 30% of living donors are still reported “lost” by one year(5), and transplant centers are given credit for forms containing nothing more than a date and an alive or dead status. Not once has OPTN penalized a transplant center for noncompliance.
Proposed policy 294 falls short of the 2000 mandate, and is even more deficient of the transplant industry’s real responsibility to living donors. Like the proposed evaluation policy, it ignores the living donor’s psychosocial status, and it provides no quality controls in terms of the LKD’s preparedness for surgery or life with one kidney. It concentrates solely on specific surgical aspects of living donation, and provides enough variation in reporting to make future analysis difficult. As stated in Proposed Policy 293, standardization can improve post-donation outcomes for living donors. So why the continued resistance?
Transplant centers have been given ten-plus years to comply with living donor follow-up, and for the past three they’ve been provided with notices detailing their deficiencies and inadequacies. Why give them another two or three years to implement a policy they should already be following? When punitive measures are not explicitly stated in the new policy (and none have ever been implemented), what motivation do transplant centers have to improve their behavior?
The transplant industry relies on autonomy or willingness to justify the morality of living donation. But living donors rely on the transplant industry to protect and care for them. This responsibility includes creating and enforcing policies based on clinical data, not supposition or opinion, and offering transparency about personnel and hospital performance, and patient risks and consequences.
Transplants recipients have a comprehensive and long-term registry. So do bone marrow donors. Meanwhile, despite international, medical and ethical calls for a living donor registry(6), living donors have been given the equivalent of a box of band-aids. A prospective LKD who refuses to agree to follow-up is not an excuse; they simply shouldn’t be taken to the operating room. Safety and public trust must be prioritized above obtaining a kidney for a recipient, or protecting surgeons or facilities from lawsuits.
For nearly sixty years, living donors have been told the equivalent of “We have no idea how this will affect you, but trust us, you’ll be fine”. It is no way to treat heroes. And neither is this inadequate policy.
(1) Joint Societies Consensus Document on the Evaluation of the LKD, 2011.
(2) Mandelbrot, DA. et al. The Medical Evaluation of LKDs: A Survey of US Transplant Centers. American Journal of Trans 2007; 7: 2333–2343
(3) Ommen, ES. Medical Risks in LKDs: Absence of Proof Is Not Proof of Absence. Clin J Am Soc Nephrol 1: 885–895, 2006
(4) Poggio, ED et al. Demographic & clinical characteristics associated with glomerular filtration rates in LKDs. Kidney Int. 2009 May ; 75(10): 1079–1087.
(5) Klein, et al. Organ Donation and Utilization in the United States: 1999-2008. American Journal of Trans 2010; 10 (Pt 2): 973–986.
(6) Consensus Statement on the Live Organ Donor 2000
-Vastag, B. LD Transplants Reexamined: Experts Cite Growing Concerns About Safety of Donors, 2003
-International Forum on the Care of the LD, 2005
-Lainie Friedman Ross, Mark Siegler, J. Richard Thistlethwaite, Jr. 2007
-Shokeir, AA. Open Vs Laparoscopic Live Donor Nephrectomy: A Focus on the Safety of Donors and the Need for a Donor Registry. 2007
-Emara, M. et al. in 2008
-Ommen ES et al. When Good Intentions are not Enough: Obtaining Follow-up Data on Living Kidney Donors. 2011