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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

 

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Informed Consent Living Donor Research Living Donor Risks Living Kidney Donor

Living Kidney Donation’s Medical Risks Are Unknown, says Segev

Dr. Dorry Segev is a transplant surgeon and researcher at Johns Hopkins with many living kidney donation publications on his resume. At the American Society of Transplant Surgeons Winter Symposium 2015, he gave a presentation entitled “Long-Term Living Donor Outcomes; When to Say No“.

If you have an extra 20  minutes, I suggest sitting down and watching the video, which contains Segev’s audio and powerpoint slides. He discusses the study he authored in 2010, which has been dissected ad nauseum, and a more recent study he co-authored with Muzzale, which stated that living kidney donors have an 8-11x increased risk of end-stage renal disease as compared to their well-matched, two-kidneyed counterparts.

 

If you’re only interested in the good parts (aka the reason behind the blog post headline), confine yourself to the first minute and a half, wherein Segev says:

 

“We do about 6,000 of these a year, and we still have actually very little understanding of the medical risks.”

“The old school was we just told people, ‘Your risk of ESRD after donation is no higher than that of the general population.’ I mean that’s completely stupid.  That’s like basically saying, ‘Compared to obese, hypertensive, poor health behavior America, you won’t be that bad.  We don’t know how bad you’ll be, but don’t worry, it’s no higher than the general population.’  But we use this as sort of like this reassurance to donors.  I mean it’s completely scientifically stupid.”

“To quote the past ASTS past president Goran Klintmalm …’This is bullshit.'”

 

Can we please, pause for a minute and soak this in?

For 60 years, the transplant industry has been telling the public that living donation is safe, minimal risk, nothing to be concerned about, no danger here, etc. etc. etc. to infinity and beyond. They’ve separated us from other populations who have kidneys removed, claiming that we’re “different” because we’re “healthier”, and that even though people with isolated renal tumors should only undergo partial nephrectomies to preserve their nephrons, living donors are apparently some unique species with super-special nephrons that don’t need saving…..

It’s just so – ridiculous.

And now we have the first admission that it’s total bullshit.

 

Unlike the grandstanding that took place when Segev published his “living donors don’t die earlier” study in 2010 (which didn’t really say that, by the way; that’s just what the *media* claimed it said), this profound revelation won’t even be a blip on the media’s radar screen. Because who, outside of the transplant industry, pays attention to what’s said at these stuffy, boring conferences? Hell, half of the transplant industry probably skips it too.  While I wish I could say they’ll stop lying to potential kidney donors (and the media, and the public) and admit that yes, there is risk to donating, and no, we don’t know what that is, I know better. After all, this is the same industry that ignored repeated letters from the FDA about not using the Hemolock clip, which resulted in multiple living kidney donors deaths and injuries. Too many of them, too often, refuse to let facts get in the way of their opinion.

I guess we’ll have to do it for them. Bookmark this post. Anytime you see an article, or a post on a forum/group that perpetuates the myths, just send them this.

And let me know what happens.