OPTN Comment due 12/23/11: #10: Living Donor Medical Evaluation

[Donna Luebke]

Bill,

I support a living donor group would be incorporated into any process involving living donation.  I do not see UNOS as providing the leadership since have already had over 8 years with no results.  The ACOT Living Donor Subcommittee (past group) was much appreciated and I found had leadership which I did not see during my UNOS years.  Not sure who will continue their work moving forward.  

Living donors who work in transplant are few.  No U.S. surgeon has joined our ranks even though they want more of the public to step up and donate.  A collective voice of living donors not involved in transplantation as their work would be more powerful.  Those who work in transplant can join this group.

thanks Bill--keep us posted as move forward.  Have to start somewhere.  For sure we support these proposals in spirit but not its results.  Many of us have provided a laundry list of suggestions.  

[Michael]

Comments from Jane Zill:

Regarding: Proposal to Establish Requirements for the Medical Evaluation of Living Kidney Donors

Donors with family histories of genetic renal disease are not included in Exhibit A which lists Considerations for Relative Contraindications to Living Donation.  This is a serious omission by the Committee and does not reflect to the characteristics of a group of donors who progress to ESRD or do not sustain an acceptable GFR, and are therefore subject to co-morbidities associated with decreased renal function.

Family genetic diseases such as polycystic kidney disease, Alport syndrome, sickle cell trait, and thin basement membrane disease should be considered as a relative contraindication of donation.  Additionally, donors with these family histories are require more scrupulous evaluation, follow-up, and informed consent.
Regarding Alport sydrome, for example, there is a body of literature warning against the use of donors with this particular medical history, yet this it totally unacknowledged in these proposed guidelines for medical evaluation or the attached exhibit.

 “Living Kidney Donor Transplantation from Relatives with Mild Urinary Abnormalities in Alport syndrome: Long-term, risk, benefit, and outcome,” Nephrology Dialysis Transplantation 2009 24(5):1626-1630; doi:10.1093/ndt/gfn635
 http://ndt.oxfordjournals.org/content/22/6/1499.full
 http://www.alportsyndrome.org/IPNA/Rheault/

The clinical importance of nephron mass has been increasingly recognized as significant for recipients and donors.  Those with more nephron mass sustain greater kidney function.   It is estimated that individual endowment of nephrons can have great variability, “among 37 normal Danish adults, the average Nglom was 617,000 per kidney (range 331,000 to 1,424,000).37 Kidney weight was also proportional to Nglom.37”  Low birth weight is considered a surrogate marker for nephron mass.   (V. A. Luyckx., B.M. Brenner (2010), “The Clinical Importance of Nephron Mass.”  J Am Soc of Nephrology 21: 898 -910, 2010)  Yet, this simple and objective measure of the donor is not included in the medical evaluation.   Given the national interest in KPD and emerging trends in  transplant tourism, donors from impoverished areas in which malnutrition and low birth weight may be common, may be a particularly vulnerable group, yet they are individuals most likely to be pressured by poverty to consider selling an organ.

Assessment of depression and other psychiatric disorders should be objectively assessed in the psychosocial evaluation.  In the DONOR meta-analysis, which combined the results of 51 studies, symptoms of depression and anxiety were present in 23% of donors. Among studies that used the Beck inventory, 31% of donors were classified as depressed and 19% as excessively tearful. The number of donors with serious psychiatric symptoms varied from 6-33% (Clemens, K. K., H. Thiessen-Philbrook, et al (2006) “Psychosocial Health of Living Kidney Donors; a systematic review.” Am J Transplant 6 (12): 2965-77) Among donors whose recipients had adverse outcomes, 50% felt negative about donating and transplantation in general, 5% felt guilty or developed markedly increased hostility, 11% had periods of suicidal ideation, and 5% sought and went to counseling. (Clemens, K. K., N. Boudville, et all. (2011) “The long-term quality of life of living kidney donors: a systematic review.” Am J Transplant 11 (3): 463-9 
The DSM-IV states,“ the number of prior episodes predicts the likelihood of developing a subsequent Major Depressive Episode….. …About 5% to 10% of individuals with Major Depressive Disorder, Single Episode, subsequently develop a Manic Episode (pages 341-342).

“In addition, depression is increasingly recognized as a risk factor for a variety of illnesses - whether as a consequence, an exacerbation, or a cause.  In medical settings, those with Major Depressive Disorder have more pain, physical illness, and decreased physical, social, and role functioning" (DSM –IV, p. 340.)

The presence of psychiatric conditions, treated or untreated, needs careful, objective assessment before donation and should be considered a relative contraindication to donation.

For all donors, data collection and medical evaluation should be melded into one coherent program because data collection of living donors should begin at time zero. Electronic medical evaluation forms should be linked to donor follow-up forms.  However, this would require designation of specific tests, assessments, and check lists, whether they be laboratory or objective psychological assessments.   Specificity in tests and protocols are resisted by the transplant community due to concern that they would increase litigation and limit autonomy in medical judgment.   However, without this level of specificity, it is unlikely that a standardized assessment for potential kidney donors will ever be developed.
 
Submitted by Jane Zill, L.I.C.S.W.
Living Kidney Donor, 1991
Living Donor Committee, OPTN 2007-2009
Living Donor Data Task Force, OPTN 2008
Jane Zill, L.I.C.S.W.