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Informed Consent Living Donor Misinformation Living Donor Protections Living Donor Research Living Donor Risks Living Kidney Donor Registry

Kidney Donors’ Risk of End-stage Renal Disease – AGAIN

Recently, a media blitz heralded the arrival of an end-stage renal disease prediction calculator for potential living kidney donors, backed up by a prestigious publication in the New England Journal of Medicine. I glanced at the study, noticed that it used the “woefully incomplete” and “useless” OPTN database, and it only pulled living kidney donors from 2005 onward. Which is not good.

You see, OPTN has been collecting (inefficiently) identifying information (aka social security number) on living donors since 1993. The Secretary of Health mandated one year of follow-up on all living donors in 2000. In addition, prior studies indicate that living kidney donors who progress to kidney failure will do so 17-20 years post-donation. These facts led me to believe that the researchers were more interested in minimizing the risk of ESRD for LKDs rather than warning us of our true probability.

And since I have written about this very topic many, MANY times in the past 7 years, I have no inclination to rehash myself. Fortunately, Steiner did much of the work for me in his editorial commentary on the published paper.

However, a recent 7.6-year study in the United States showed that the incidence of ESRD was 8 times as high among donors as among well-selected nondonor controls.2 A similar 15.2-year study in Norway showed that the risk was 11 times as high.3 The magnitude of these relative risks has been debated, but when predonation risks of ESRD are multiplied by the relative risk of donation, significantly greater absolute postdonation risks are predicted. However, the absolute rates of ESRD were low in both studies, which reinforced the prevailing “low risk” characterization of donation..

To translate a smidge: Two prior studies (which I’ve written about here) have found that living kidney donors have an 8-11x increased risk of kidney failure as compared to their healthy, matched, two-kidneyed cohort. But the pro-living donation advocates don’t like using those numbers because they’re – well – scary. Instead, they squawk about “absolute” risk, meaning that even if donating raises the chance of an individual LKD progressing to kidney failure, the incidence of ESRD in living kidney donors is low so – you  know – don’t worry too much about it.
 
For example (and I’m pulling these numbers out of the air here), say there’s a 4 in 100 chance of developing a type of cancer, but that eating garbanzo beans increases that risk 50%. Yikes, right? In ‘absolute’ terms, that’s still only a 6 in 100 risk, which is like ‘meh’, bring on the garbanzos!

But if we were talking about smoking? If the same numbers applied, would you pick up the habit? Hmmm…

[Note: see this nice explanation of these statistical maneuvers here]
 
 
He goes on to say that the low estimates in the prior studies “may well have been underestimated” (In other words, the true risk is higher). Why?

…approximately 90% of cases occur after 44 years of age, and half the cases occur after 64 years of age.5,6 Many diseases that will cause ESRD in later life will not be present in young candidates, and screening will not detect them.

 
 
He uses diabetes, which accounts for nearly half the kidney failure currently seen in the US, as an example:

Currently, postdonation diabetes is poorly predicted in donor candidates, even with the use of focused, traditional criteria8 rather than the nonspecific risk factors used in the current study. Furthermore, ESRD would not have developed in any patient with classically progressing diabetic nephropathy during the study interval.

  1. The researchers included generic risk factors which have limited applicability. When I was being evaluated as a living kidney donor, I asked the nephrologist about my recipient’s expected graft survival. He stammered and said “the average graft survival is…”. Well, I didn’t want to know the “average” of every recipient under all circumstances, I wanted to know specifically about my sister. Potential living kidney donors feel the same way about their own kidney health too.
  2. The six-plus years this study captured is simply NOT ENOUGH TIME to know the true incidence, prevalence and risk of end-stage renal disease for kidney donors. Following them for such a short period results in a gross underestimation of disease progression.

It also allows the transplant industry to keep reassuring the public about living donation’s safety, all while emphasizing the need for living donor organs. They appear to actually care about living donor safety and well-being,when recent and distant history shows they clearly do not.

Unfortunately, I think that’s the point.
 
 
Grams ME, Sang Y, Levey AS, Matsushita K, Ballew S, Chang AR, Chow EK, Kasiske BL, Kovesdy CP, Nadkarni GN, Shalev V, Segev DL, Coresh J, Lentine KL, Garg AX, & Chronic Kidney Disease Prognosis Consortium (2015). Kidney-Failure Risk Projection for the Living Kidney-Donor Candidate. The New England journal of medicine PMID: 26544982

 

Steiner, R. (2015). The Risks of Living Kidney Donation New England Journal of Medicine DOI: 10.1056/NEJMe1513891

 

Categories
Advocacy Living Donor Misinformation Living Kidney Donor

About Kelly Ripa’s Living Kidney Donor Remark

My twitter comments (yes, I miscounted):

KR1 KR2 KR3 KR4 KR5 KR6 KR7 KR8 KR9

 

 

Categories
Advocacy Informed Consent Living Donor Misinformation Living Kidney Donor

Open Letter to Luis Fabregas

Last month, Luis Fabregas from the Pittsburgh Tribune penned this article about the implementation of OPTN’s newest living donor evaluation requirements. I sent Mr. Fabregas my thoughts on his article, but he declined to respond. Here’s what I wrote:

 

Luis,

I’ve been following your articles on transplant related issues for a number of years. While I appreciate everything you’ve done to bring attention to these issues, I feel this last article really soft-pedaled the situation.

OPTN (or UNOS, if you’d like) has had purview over living donor policy since 2005, a responsibility Walter Graham, then UNOS Executive Director, requested. In 2007, the Living Donor Committee proposed a comprehensive living donor evaluation and follow-up policy based on recommendations from the American Society of Transplantation, a review of published literature, and a focus survey of the largest transplant centers. This policy was vehemently rejected by OPTN’s membership (aka transplant centers and others who financially benefit from transplants). For 60 years, the US had *no* standards of living donor evaluation, selection, treatment or follow-up.

The Secretary of Health has required one year of follow-up on all living donors since 2000. OPTN expanded that another year in 2006. Yet transplant centers have willfully not complied with this mandate, and neither CMS, HRSA nor UNOS have held anyone responsible. More than 1/3 of living donors are reported “lost” to follow-up after one year, and OPTN admits that in most cases, no attempt has been made by the transplant center to make contact. <- But recipients are tracked for ten, in a government-funded registry.

It is only because HRSA pressured OPTN for years that OPTN was forced to revisit the issue. They created a committee of transplant-related organizations to produce a consensus document to be used as the basis of the policy (BTW, the consensus document admitted that there is no clinical evidence on the ‘best’ way to evaluate a potential living donor). Yet the final result was a policy that removed any concrete teeth the consensus document contained, and (again) neglected to provide any consequence for noncompliance. This policy is so vague, it actually requires transplant centers to inform rejected potential living donors that they can be evaluated at a different center and accepted, because the other center might have different selection criteria. This is not, in my opinion, the definition of “thorough”.

UNOS/OPTN’s follow-up forms do not include information on mental health. Yet other studies have indicated that 20-30% of living donors experience depression, anxiety, grief, anger, and/or PTSD. Transplant centers are not required, and therefore do not, provide aftercare or support services. People seeking weight loss surgery are given more and longer psychological support than living donors.

Questions such as “Do you regret donating?” or “Would you donate again?” are biased. The vast majority of people donate to people they are emotionally related to. No matter how detrimental the outcome, how many would say they regret trying to help someone they love? More importantly, a lack of regret does not negate the transplant industry’s responsibility to treat living donors with the same care and respect they provide to recipients. And weight loss surgery patients.

Again, I appreciate everything you do. But as a living donor who was harmed, and as a living donor activist that has dealt with countless other wounded living donors, I encourage you to see through OPTN’s pro-donation message.

Sincerely,

Categories
Advocacy Living Donor Misinformation Living Donor Research Living Donor Risks Living Kidney Donor

Shipping Living Donor Kidneys Is Just Fine

It’s not unusual to hear of a potential living kidney donor traveling to their would-be recipient’s transplant center for testing and surgery. While this benefits the transplant center (money & convenience), it can be harmful to the living donor. Some transplant centers discourage living donors from choosing a transplant center closer to their residence, reasoning that it’s “better” for the recipient if ischemic time (the length of time the organ spends outside of the human body) is as short as possible.

But deceased organs are shipped regularly, and now we have an infusion pump to keep blood flowing through the organ while it’s traveling, so…

 

 

57 shipped live donor kidneys were transplanted from 31 institutions in 26 cities. The mean shipping distance was 1,634 miles (range 123-2811) with mean CIT [cold ischemic time] of 12.1 ± 2.8 hours. The incidence of delayed graft function in the shipped cohort was 1.8% (1/57) compared to 0% (0/57) in the non-shipped cohort. The 1-year allograft survival was 98% in both cohorts. There was no significant differences between the mean serum creatinine values or the rates of serum creatinine decline in the immediate post-operative period even after adjusted for gender and differences in recipient and donor BMI.

 

Remember: No one is a better advocate for a living donor than her/himself. Don’t allow anyone to put your care at risk.

 

 

Treat EG, Miller ET, Kwan L, Connor SE, Maliski SL, Hicks EM, Williams KC, Whitted LA, Gritsch HA, McGuire SM, Mone TD, & Veale JL (2014). Outcomes of Shipped Live Donor Kidney Transplants Compared With Traditional Living Donor Kidney Transplants. Transplant international : official journal of the European Society for Organ Transplantation PMID: 25052215

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Living Donor Misinformation Living Donor Research Living Donor Risks Living Kidney Donor

How Not to Define Safety, Transplant Industry

The focus of this Egyptian transplant center study was the 8 living kidney donors who experienced kidney failure, as opposed to their overall 2000 LKDs. In the discussion section, however, the authors talked about *all* the donors, saying that 22% developed hypertension.

Let’s remember, hypertension is second to diabetes in causing kidney failure.

 

Then there’s this statement: “The authors found that the incidence of diabetes mellitus, hypertension, and cardiovascular morbidity among live-kidney donors were lower than those of age- and sex-matched Egyptian general population, and they confirmed the safety of live-kidney donation”.

Living kidney donors are supposed to be HEALTHIER than the general population. They *should* have lower rates of all of those things. The question is not how LKDs’ risk compares to the general population (which includes folks with high risk, who would never be approved to donate), but how it compares to their two-kidneyed risk. In other words, did donating a kidney increased that individual’s risk of those health issues? Overall, does donation increase that population’s* risk?

If the answer is yes, then living kidney donation is not ‘safe’.

 

*Population = living kidney donors.
Wafa EW, Refaie AF, Abbas TM, Fouda MA, Sheashaa HA, Mostafa A, Abo El Ghar MI, & Ghoneim MA (2011). End-stage renal disease among living-kidney donors: single-center experience. Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation, 9 (1), 14-9 PMID: 21605018