Iran Kidney sellers younger, have higher GFR & lower Quality of Life than donors

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http://onlinelibrary.wiley.com/doi/10.1111/ajt.12488/abstract

Comparison of Health Status and Quality of Life of Related Versus Paid Unrelated Living Kidney Donors
M. K. Fallahzadeh1,2,3, L. Jafari1, J. Roozbeh1, N. Singh2,3, H. Shokouh-Amiri2, S. Behzadi1, G. A. Rais-Jalali1, M. Salehipour1, S. A. Malekhosseini1, M. M. Sagheb1,*
DOI: 10.1111/ajt.12488
American Journal of Transplantation
Early View (Online Version of Record published before inclusion in an issue)

Abstract
The aim of this cross-sectional study was to assess the health status and quality of life (QOL) of paid unrelated versus related living kidney donors postdonation at Shiraz Transplant Center in Iran. We invited all donors (n = 580, 347 paid unrelated, 233 related) who underwent donor nephrectomy at our center from 2004 to 2010 to participate in a health survey and physical examination. Of 580 donors, 144 consented to participate; participation of paid unrelated donors was significantly lower than related (52/347 vs. 92/233; p < 0.001). Participants underwent a complete physical examination, QOL assessment (using a 36-item short form health survey [SF-36] questionnaire) and laboratory work-up. The paid unrelated donors compared with related donors were younger (34.2 ± 7.2 vs. 40.7 ± 9.7 years, p < 0.001), had shorter time since donation (2.9 ± 1.6 vs. 3.8 ± 2 years, p = 0.004), had higher estimated GFR (72.6 ± 22 vs. 63.8 ± 15.3 mL/min/1.73 m2, p = 0.006) and had a higher percentage of patients with microalbuminuria (35% vs. 0%, p < 0.001). Additionally, general health and social functioning scores among paid unrelated donors were significantly lower (p < 0.001 and p = 0.02, respectively) than related donors. Other SF-36 scores, although lower in paid unrelated donors, did not reach statistical significance. Iranian paid unrelated donors have lower QOL and higher incidence of microalbuminuria compared with related donors.

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Where There Is Smoke There Is Fire: The Iranian System of Paid Donation
E. J. Gordon1, J. S. Gill2,*
DOI: 10.1111/ajt.12486
American Journal of Transplantation
Early View (Online Version of Record published before inclusion in an issue)

Nearly 30 years after its introduction, the Iranian model remains an enigma to the Western transplant community. Established in 1988, the government-funded, compensated living unrelated kidney donor program was Iran's answer for its urgent transplantation needs. The modest fixed sum (currently about $400 US dollars) provided by the government was intended as a reward rather than as a payment for the donated kidney. The real incentive for those who have submitted to nephrectomy was a supplementary payment negotiated directly between the recipient and living donor (typically in the amount of $10 000 US dollars). Putative oversight by a not-for-profit organization maintains a buyer's market by providing a back-up donor in the event that a recipient and potential donor cannot agree on a price. The government pays for all transplant-related expenses and provides the donor with medical coverage for 1 year after the nephrectomy. It is worth noting that such depictions of the Iranian model have been contested as disingenuous by members of the Iranian transplant community [1]. Accordingly, one must interpret any analyses of the Iranian model with caution.

Predictably, critics of commercialization have opposed the program primarily out of concerns of exploitation and disrespect for human integrity [2, 3]. Aside from such opposition, the model fails to meet many of the proposed standards for a regulated system of organ sales, including nondirected donations, provisions to ensure long-term donor follow-up, and access to health care [4]. Despite the facilitation of tens of thousands of transplants, the lack of public reporting and transparency have precluded acceptance of the Iranian model as a solution to the organ shortage internationally, and have fueled questions about the integrity of the program.

The report by Fallahzadeh et al [5] in this issue of the journal provides a novel glimpse into the Iranian model. The study shares many of the limitations of other studies from Iran, including a small and selected study sample. However, their identification of a difference in microalbuminuria postnephrectomy between paid and unpaid donors fuels concerns that the clinical evaluation of donors may be compromised when donor payments are allowed. Although the absence of prenephrectomy information precludes definitive conclusions, the short time since donation suggests that abnormalities may have been present prior to nephrectomy and accordingly, that the donor clinical evaluation may not have been as thorough as necessary. The potential presence of predonation abnormalities is worth considering given the ethical ramifications. A scrupulous pretransplant evaluation and conservative approach to donor acceptance may be particularly important for paid donors who may be vulnerable to adverse health outcomes for other reasons. Subjecting paid donors to unnecessary harms without sufficient safeguards in place during the evaluation process tips the delicate risk–benefit balance against living donation.

The most plausible alternative explanation for the findings is that the proteinuria was in some way related to the higher level of poverty in the paid donors. There is limited research to suggest a link between poverty and development of proteinuria in living donors. In a cross-sectional study of living related donors from Hyderabad, India, 40% of the 50 donors studied developed microalbuminuria, and 14% developed overt proteinuria (>300 mg/day) after an average of 63 months postdonation [6]. Irrespective of the basis for the observed difference, it is not clear that the Iranian system will financially support the authors' recommendation for long-term follow-up of the individuals who developed microalbuminuria in the study.

Sadly, the risk factors for and clinical significance of proteinuria in living kidney donors remain unclear. The existing literature on this subject is hampered by use of nonstandardized definitions, a paucity of controlled studies, and virtually no information regarding progression over time. Therefore, although it is tempting to criticize the lack of organized donor follow-up in the Iranian model, to do so would be hypocritical [7]. The findings of this study therefore serve as a reminder of our collective responsibility to better understand the long-term consequences of living kidney donation.

The findings of Fallahzadeh et al [5] add to the accumulating literature that there are problems with the existing Iranian model and that the program must evolve. It is clear that the majority of paid donors are poor males, whose quality of life after nephrectomy is lower than that of the general Iranian population, and who are frequently dissatisfied with their decision to undergo nephrectomy [8]. Further, the program has been a contributing factor limiting the advancement of deceased donation and living related donation in Iran. For these reasons, a program that was once justified on the basis of need, may now be a barrier to the advancement of transplantation in Iran. How much harm to living donors' health and quality of life should Iranian transplant centers tolerate? As transplant centers are responsible for ethically sound clinical care, all potential living donors must be assured a high standard of clinical and psychosocial evaluation before the Iranian model can publicize its success.

As Fallahzadeh et al [5] point out, studies have found that few paid unrelated donors undergo follow-up care due to insufficient finances to pay for care, and donors lack knowledge about living donor complications or the need for follow-up care [9, 10]. Accordingly, transplant centers operating within the Iranian model should take extra care to optimally inform donors about the short- and long-term complications of living donation, as well as inform, encourage and enable living donors, particularly donors most at risk—paid unrelated donors—to undergo long-term follow-up care. The government's provision of health insurance to living donors for 1 year is a start toward removing some of the disincentives to donation; however, the recognition of paid donors as a particularly vulnerable group behooves the government to provide long-term follow-up care.

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http://onlinelibrary.wiley.com/doi/10.1111/ajt.12675/full

Perfect Is the Enemy of Good: The Iranian System of Paid Donation
S. M. Khatami1, M. Mahdavi-Mazdeh2,*
DOI: 10.1111/ajt.12675
American Journal of Transplantation
Early View (Online Version of Record published before inclusion in an issue)

To the Editor:

We read the article and editorial titled “Comparison of health status and quality of life of related versus paid unrelated living kidney donors” and “Where there is smoke there is fire: The Iranian system of paid donation.” They tried to shed light on the darker side of living-unrelated donation [1, 2]. As there is no concrete solution for organ shortage, it is the responsibility of experts to discuss different aspects of every possible system to clarify its weaknesses and strengths. We fully agree with the authors that the lack of long-term donor follow-up and the direct method of payment by the recipient in the Iranian model are major weak points [3].

Apart from being for or against this model, there are some points in the articles that need to be elucidated, including the incorrect recipient payment of USD10 000 [2], which is actually not more than USD4000 [1]. To the contrary of what the editorial states, living-unrelated kidney donors (LUKD) not only did not stop the progression of the brain dead donors (BDDs) program but paved the way for infrastructure development. We still need to transfer the identified BDD to an intensive care unit in an academic hospital for further management [4]. What helped Iranian transplant teams to implement the BDDs program was their experience with a high number of LUKD in more than 25 centers. Although the absolute number of kidney transplantations increased from 1421 in 2000 to 2273 in 2011, the 2.2% share of BDD in 2000 increased to 34% in 2011 [3, 5].

In our practice, unrelated donors usually prefer to be anonymous; therefore, they do not give their addresses in detail. But to our surprise the percentage of both groups who have not been accessed because of unavailable contact information was similar in Fallahzadeh et al's study (paid donors: 334/681 [49%] vs. related donors: 280/513 [55%]) [1]. Afterward, 131/233 (56%) of living-related kidney donors responded, which was surprisingly low, as we assumed they would be happy to publicize their altruistic intention [6]. On the whole, 7.6% (52/681) of unrelated and 17.9% (92/513) of related donors participated in the study. The unwillingness of related donors to participate in the study may be due to some level of hidden dissatisfaction. It may raise the possibility of subtle family pressure on donors.

Another important issue in the article was gender as a confounding variable: the male ratio in related versus unrelated donors was 35% and 81%, respectively. We know that the 36-item short-form health survey is a patient-reported survey, and health status scores may differ significantly for males and females. The analysis should be adjusted based on observed baseline incomparability. Moreover, this ratio, based on the national report on gender of donors over a span of 22 years, was 54.1% (1441/2663) in related donations and 84.4% (11827/14009) in unrelated donations [7]. Consequently, the results cannot be generalizable.

The last concern is regarding the number of urine measurements for microalbuminuria assessment. Because of day-to-day and biologic variability, any microalbuminuric patient needs two positive specimens out of three to rule out transient proteinuria, which was not included in the study [1, 2]. So, the clinical significance of the finding may be questionable.

S. M. Khatami1 and M. Mahdavi-Mazdeh2,*
1Nephrology Research Center, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran
2Iranian Tissue Bank and Research Center, Tehran University of Medical Sciences, Tehran, Islamic Republic of Iran
*Corresponding author: Mitra Mahdavi-Mazdeh, mmahdavi@tums.ac.ir

Disclosure
The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.


References
1
Fallahzadeh MK, Jafai L, Roozbeh J, et al. Comparison of health status and quality of life of related versus paid unrelated living kidney donors. Am J Transplant 2013; 13: 3210–3214.
2
Gordon EJ, Gill JS. Where there is smoke there is fire: The Iranian system of paid donation. Am J Transplant 2013; 13: 3063–3064.
3
Mahdavi-Mazdeh M. The Iranian model of living renal transplantation. Kidney Int 2012; 82: 627–634.
4
Nozary Heshmati B, Tavakoli SA, Mahdavi-Mazdeh M, Zahra S. Assessment of brain death of organ donors in Iran. Transpl Int 2010; 23: 7–9.
5
Global Observatory on Donation and Transplantation (GODT) data, produced by the WHO-ONT collaboration. Available at: http://www.transplant-observatory.org. Last updated version 1/7/2014. Accessed February 18, 2014.
6
Danovitch GM, Leichtman AB. Kidney vending: The “Trojan horse” of organ transplantation. Clin J Am Soc Nephrol 2006; 1: 1133–1135.
7
Taheri S, Alavian SM, Einollahi B, Nafar M. Gender bias in Iranian living kidney transplantation program: A national report. Clin Transplant 2010; 24: 528–534.

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http://onlinelibrary.wiley.com/doi/10.1111/ajt.12680/full

Is Proteinuria a Common Finding After Kidney Donation?
B. Einollahi
Article first published online: 2 APR 2014
DOI: 10.1111/ajt.12680
American Journal of Transplantation
Early View (Online Version of Record published before inclusion in an issue)

To the Editor:

I read with great interest the editorial article titled “Where There Is Smoke There Is Fire: The Iranian System of Paid Donation” by Gordon and Gill [1]. This editorial paper focused its message on drawing attention to some ethical aspects of the Iranian model as a solution to the organ shortage.

Furthermore, Gordon and Gill [1] said that the Iranian program of kidney transplantation has been a contributing factor limiting the advancement of deceased donation and living-related donation in Iran. However, the annual number of deceased donor kidney transplants rose from less than 1% of all kidney transplants at the end of 2000 to 30% in 2012. Kidney transplantation using deceased donors was initiated in 2002 at Baqiyatallah Transplant Center, the largest kidney transplant unit in Iran with more than 4200 kidney transplants over 20 years, and deceased donor transplantation annual numbers have increased from 0.4% in 2002 to 31% and 50% in 2008 and 2013, respectively. The opposite of the current editorial's opinion [1], the Iran model for living unrelated kidney transplantation did not result in limiting the improvement of deceased donation.

I absolutely agree that the “Iran model” has some deficiencies and of course these problems need to be eliminated. However, the Society for Supporting Dialysis and Transplantation Patients (SSDTP), a charity founded by ESRD patients, has, by facilitating living-unrelated donation, eliminated the waiting list for unrelated kidney transplantation since 1999 [2]. The SSDTP acts as a liaison agency between potential donors and recipients [2]; however, the potential recipients, who would like to receive a kidney from an unrelated donor, still wait at least 6–12 months. If a potential recipient cannot find a deceased donor within this period, the recipient can be introduced to a potential donor who should be in complete health.

Although Gordon and Gill [1] claimed that the clinical evaluation of donors may be compromised when donor payments are allowed, this is not acceptable with the existing very strict donor evaluation program in whole-kidney transplant centers of Iran. The potential donors should be in complete health confirmed by a transplant nephrologist [2]. Moreover, many relative contraindications for living donor selection such as mild hypertension, BMI >35, microalbuminuria >30 mg per day and history of nephrolithiasis are absolutely rejected by our centers.

It is of interest that Gordon and Gill [1] explained some causes of microalbuminuria in living donors after nephrectomy such as inadequate pretransplant evaluation and conditions related to the poverty of unrelated donors. However, most reported data suggest that proteinuria increased in the living kidney donor population, and the prevalence of microalbuminuria in living donors varied from 11.5% to 34% in different studies [3, 4]. In addition, a study showed that 56% of 152 donors developed mild proteinuria (>150 mg/day) [5]. One meta-analysis demonstrated that the average proteinuria was 154 mg/day and concluded that kidney donation results in small increases in urinary protein [6]. The suggested causes of proteinuria postnephrectomy were subclinical hyperfiltration damage of the glomeruli, hypertension and a lower glomerular filtration rate.

Finally, it is generally accepted that all kidney donors should be screened for microalbuminuria at 2- to 3-year intervals postkidney donation because albuminuria has been illustrated as an appropriate indicator of kidney damage in the context of nephrectomy.

B. Einollahi*
Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, IR, Iran
*Corresponding author: Behzad Einollahi, einollahi@numonthly.com

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http://onlinelibrary.wiley.com/doi/10.1111/ajt.12679/full

Reply (Invited Response to 2 Letters re Iran Editorial)
E. J. Gordon1 andJ. S. Gill2,*
Article first published online: 7 APR 2014
DOI: 10.1111/ajt.12679
American Journal of Transplantation
Early View (Online Version of Record published before inclusion in an issue)

To the Editor:

We were pleased to see our concerns regarding the need for increased transparency and reevaluation of the practice of direct payment by the recipient echoed by transplant colleagues in Iran [1, 2]. We are also pleased to learn that Iran is moving forward with developing a deceased donor program and applaud this achievement. We understand that implementation of a paid system of living donation was considered necessary in the absence of infrastructure to support deceased donor transplantation, but are unsure whether this approach enabled the development of a deceased donor program. Although most countries without transplant infrastructure first develop living donor programs out of necessity, payment is not a feature in countries other than Iran. Thus the justification for a paid system is unclear.

Our concern with living donor payment is not with the amount paid. The fairness of a price that maintains a buyer's market in which a backup donor is provided if the amount is unacceptable to the potential donor is problematic. We thank the writer for clarifying the amount of the payment [1] but it is the fairness of this approach, rather than the actual amount, that remains our concern.

Although we agree that reporting of a single measure of proteinuria by Fallahzadeh et al [3] is sub-optimal, the main concern was the difference in proteinuria between paid and unpaid donors in a relatively short time after donation.