Here is my third and final public comment for this batch of OPTN’s proposed policies. Deadline is Friday, December 23rd, so you still have time to write and submit your own. In fact, I recommend you do; things will never change unless we make our voice heard.
This missive is in regards to Proposed Policy 293, Informed Consent of the Living Kidney Donor.
It’s understandable why a LKD would seek graft & recipient survival information during evaluation, but of more importance to their well-being is the center’s LIVING DONOR mortality and morbidity stats. OPTN has collected short term data for over ten years(1), records which could easily be shared. Yet they are not. A prospective LKD has a right to know how a program performs and if it is compliant with federal reporting mandates. After all, the purpose of Informed Consent is to protect the patient, not ‘sell’ living donation or hide a transplant program’s flaws.
While the policy advocates ‘semi-quantitative’, ‘data-based estimates’, it is unclear on the details. Telling a potential LKD that 50% of transplanted kidneys survive 15 years may be true, but it is also disingenuous when more specific data is available from USRDS and SRTR.
– It is not enough to say “Current practice is to prioritize prior living donors who become transplant candidates”. It should be explained that prior LKDs are given four-points of LOCAL priority, equivalent to approximately one year of wait-time(2).
– It is inaccurate to define LKD’s surgical risks as “scars, pain, fatigue & other consequences typical of any surgical procedure”. Laparoscopic donor nephrectomies carry unique risks: hernias, nerve damage, testicular swelling requiring surgical intervention, adrenal dysfunction, chylous ascites and pancreatitis(3). Not informing LKDs of such possibilities could delay symptom recognition and timely treatment, resulting in adverse consequences and perhaps lawsuits.
– An LKD should not be told their remaining kidney will ‘grow’ but should be educated on hyperfiltration, hypertrophy, and glomerular hypertension. Do not assume s/he is unable to understand.
The authors admit that LKDs lose 25-40% of their renal function. However, A 10% reduction in GFR has been shown to significantly increase risk of cardiovascular morbidity and death(4). Most patients in the early stages of CKD won’t progress to kidney failure because they’ll die of a heart-related ailment(5). Yet only approximately 30% of transplant professionals discuss cardiovascular issues with potential donors(6). Policy 293 ignores the subject completely.
The proposed change to the Independent Donor Advocate description, that they not be involved with “recipient evaluation or the decision to transplant the recipient” is far from the original “must not be involved in transplantation activities on a routine basis” dictum set forth by CMS Final Rule 2007(7). OPTN has consistently ignored this provision of the IDA, allowing Transplant (or Living Donor) Coordinators to serve in this capacity. The purpose of the IDA is to provide a prospective LD with an advocate who does not financially or otherwise benefit from their donation, and who is not beholden to the transplant center for their livelihood. For Coordinators to assume this role is clearly a conflict of interest.
Because living donors receive no benefit for themselves, their informed consent process must be more rigorous than that of other surgical interventions(8), more closely resembling that of human research subjects. Ethically, it should always err on the side of too much information rather than too little. As a prospective LKD recently pointed out to me, it is impossible to fact-check a transplant center’s living donor pamphlet because of its overwhelming vagueness. If relinquishing a kidney is as safe as the transplant industry insists, there is no reason for subterfuge. Tell the public the truth.
(3) Merlin TL, et al. The safety and efficacy of laparoscopic live donor nephrectomy: Transplantation. 2000 Dec 27;70(12):1659-66.
Vallancien G, et al. Complications of transperitoneal laparoscopic surgery in urology: review of 1,311 procedures at a single center. J Urol. 2002 Jul;168(1):23-6.
Handschin AE, et al. Laparoscopic donor nephrectomy. Br J Surg. 2003 Nov;90(11):1323-32.
Gruters, G. Living Donors: Process, Outcome and Ethical Questions. Work Group paper for the September 2006 meeting of the President’s Council on Bioethics.
(4) Tonelli M. Should CKD be a coronary heart disease risk equivalent? Am J Kidney Dis 2007: 49: 8.
Emara M, Ragheb A, Hassan A, Shoker A. Evidence for a need to mandate kidney transplant living donor registries. Clin Transplant 2008: 22: 525–531.
(5) Brenner, B. Brenner and Rector’s The Kidney, 8th edition. Saunders, 2008.
(6) Housawi, A.A. Transplant Professionals Vary in the Long-Term Medical Risks They Communicate to Potential Living Kidney Donors: an international survey. Nephrol Dial Transplant (2007) 22: 3040–3045.