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Ethical Considerations Informed Consent Living Donor Research Living Donor Risks Living Kidney Donor

Living Kidney Donors Over the Age of 55

The authors retrospectively analyzed 482 cases of living related kidney donation and transplantation. “The cases were divided into 2 groups by donor age > or =55 years (aged donor group, 136 cases) and <55 years (young donor group, 346 cases).”

“(eGFR) was lower in the aged donor group compared with in the young donor group. After transplant, the mean eGFR of the graft in the recipient was also lower in the aged donor group than in the young donor group.”

“Compared with the young donor group, in the aged donor group incidence of proteinuria and 24-hour urinary protein were significantly higher. However, the incidence of delayed graft function was not significantly different between the 2 groups. We found that aged kidney grafts had no significant effect on long-term patient and graft survivals.”

 

It’s not surprising the authors focused on the recipients’ results far more than the donors’. While I am hesitant about any study that aims to say “Yes! Let’s use living human beings as medical supply!”, this topic is an important one.

According to the USRDS, the average age of end-stage renal disease onset in the U.S. is 64.4 years old. Meanwhile, the average age of a living kidney donor in the U.S. is 40/41 years old.

 

As the U.S. population continues to age, the prevalence of ESRD will increase, as will the so-called “need” for donor kidneys. But…

  1. Family sizes are smaller, resulting in fewer potential biologically related donors (All the current emphasis on “altruistic” or “good samaritan” or non-related donors makes more sense now, doesn’t it?)
  2. Median age in the U.S. is increasing (Median = midpoint, where 50% are below and 50% are above)
  3. The U.S. population is suffering from obesity, diabetes, heart disease, etc., which reduces the pool of potential living donors.
  4. The longer a person  lives with one kidney (aka reduced kidney function), the higher their risk of long-term repercussions, cardiovascular disease and death, and renal failure.
  5. GFR declines naturally as we age, so an older recipient wouldn’t require the same post-transplant GFR as someone much younger.

 

So, with all that in mind, the use of “older” (over 55yoa) living kidney donors – IF THEY ARE IN REALLY, REALLY GOOD HEALTH AND FULLY INFORMED – makes sense. Transplant algorithms are designed to maximize efficiency, and it’s inefficient to give a recipient expected to live another 10 years a kidney predicted to survive 40 years. More so, the entire justification of living kidney donation is predicated on the idea of the benefit to the recipient outweighing the harm to the donor*, and that simply isn’t the case if the recipient receives 5 years of life while the donor is denied 30 years of full renal function (and all that it implies: adrenal, potassium, vitamin D, etc).

 

Of course, I also believe that every person who financially benefits from living donation should have to donate – put your money where your mouth is and all that – but for now, I’ll make do with incremental steps toward justice.

 

Cheng, K., Huang, Z., Ye, Q., Ming, Y., Zhao, Y., Liu, L., Zhang, S., Chen, Z., & Wang, Q. (2015). Midterm Outcome of Living-Related Kidney Transplantation From Aged Donors: A Single-Center Experience Transplantation Proceedings, 47 (6), 1736-1740 DOI: 10.1016/j.transproceed.2015.06.016

 

 

* I disagree with this justification, btw; I think it’s total bullshit and inaccurate and dismissive of living donors as separate from their recipients, but that is a subject for another day.

Categories
Follow-Up Liver Donor Living Donor Protections Living Donor Research Living Kidney Donor Psychosocial Risks

Living Donor Psychosocial Evaluations Are Inadequate

Seven European researchers, on behalf of the ELPAT Paychological Care for Living Donors and Recipients Working Group “performed a systematic literature review of guidelines, consensus statements, and protocols on the content and process of psychosocial screening of living kidney and liver donor candidatesThirty-four publications were identified, including seven guidelines, six consensus statements, and 21 protocols or programs.”

“Across 34 publications, 197 different psychosocial factors were identified that can be clustered into 42 psychosocial domains”. According to the researchers, this “broad spectrum” suggests that the transplant industry has no clear definition of what factors need to be identified and/or addressed.There was also a lot of discrepancy in terminology (e.g., psychological well-being, psychosocial stability, psychopathology) “and in the level of detail provided in defining each criterion: some authors only addressed broad “umbrella” terms, like psychiatric disorders, whereas others specified these (e.g., mood disorders (depression, anxiety), personality disorder (schizophrenia, borderline)). Moreover, some authors just listed factors without any clarification, whereas others provided detailed descriptions, together with examples from clinical practice. For example, Leo et al. explained why employment status is important, as employers are a principal source of economic support by providing sick leave or vacation time during postsurgical recovery.”

Here are some of the factors covered, from most common to least (From Table 4 in the paper):

  • Motivation-related factors: 73.5%
  • Coercion or Pressure to donate: 67.6%
  • Support before and after donation; 64.7%
  • Donor-recipient relationship: 58.8%
  • Current of Past psychiatric disorders: 50%
  • Competence: 47.1%
  • Financial Issues: 47.1%
  • Coping-related issues: 44.1%
  • Employment-related issues: 44.1%
  • Family-related issues: 41.2%
  • Ambivalence: 38.2%
  • Unrealistic Expectations: 32.4%
  • Cognitive Status: 29.4%
  • Health Behavior (eg. obesity, smoking, exercise): 23.5%
  • Potential Medical Risks and urgency of donation:: 8.8%
  • Health concerns during and after donation: 5.9%

“Most factors were not supported by evidence or were at least not referenced, making it unclear if they indeed predict poor outcomes in donor candidates.”

In layperson’s terms, this means no proof exists that any of the factors the evaluation examines (eg. drug abuse, history of depression] is linked to poor living donor outcomes. What this really means is that the transplant industry hasn’t taken the time to study living donors and quantify exactly how they fare post-donation and which attributes contribute to their well-being.

“Contraindications for donation [aka red flags, or reasons folks shouldn’t donate] were specifically stipulated in 18 papers (52.9%),of which only three indicated whether these were absolute or relative contraindications [‘relative’ meaning: well, maybe they shouldn’t donate, whereas ‘absolute’ means: no, absolutely not], and only one paper indicated that these were evidence-based”

 

Their final conclusion:

“At present, there is no consensus, nor strong evidence or concrete guidance on what to screen for, how to handle identified psychosocial problems, and how to perform the screening, leading to huge variability in screening practices,the risk that important psychosocial factors might be overlooked or that unnecessarily time-consuming and costly procedures are being undertaken.”

Read the whole thing at the link

 

Duerinckx, N., Timmerman, L., Van Gogh, J., van Busschbach, J., Ismail, S., Massey, E., Dobbels, F., & , . (2014). Predonation psychosocial evaluation of living kidney and liver donor candidates: a systematic literature review Transplant International, 27 (1), 2-18 DOI: 10.1111/tri.12154

Categories
Follow-Up Living Donor Research Living Kidney Donor Psychosocial Risks

Living Kidney Donors Decrease in Qualify of Life Measures 10 years Later

ETA: I was able to get the entire article.

 

This is brand new so I can only get the abstract.

A prospective cohort of 100 living kidney donors at the University of Heidelberg were followed for a median of 10 years. [Note: median means mid-point, so half were more than ten and half less than ten. ETA: 2-11 years, per the study]

 

Clinical data was available for 97 donors and QOL [quality of life]  data for 74 donors.

Nine donors died during follow-up of unrelated causes to donation, and one donor was lost to follow-up.

I’m dubious of the claim “unrelated causes” without knowing the actual causes. For example, if a living kidney donor experiences depression, anxiety, etc post-donation and begins self-medicating with alcohol and dies in a alcohol-related accident, isn’t that related to the donation?

Or if a pre-existing mental illness or drug abuse problem goes undetected during evaluation and subsequently causes the person’s death?

Or an LKD that begins behaving in a self-destructive manner because of trauma-related issues?

My gut says that transplant professionals are quick to dismiss things/events/symptoms as “unrelated” because they don’t want to acknowledge the potential harm they’re doing to their living donors.

 

ETA: One donor died after two years of follow-up due to a car accident, one died after four years of
follow-up of metastasized colon cancer, two died after seven years of follow-up of which one due to
metastasized breast cancer and the other of metastasized lung cancer, one died after eight years of
follow-up due to a cerebral vascular incident, one died after nine years of follow-up due to recurrence
of breast cancer, two died after ten years of follow-up of which one to an aspergillus infection during
chemotherapy for acute myeloid leukemia and the other of a cutaneous malignancy, and one died
after 11 years of follow-up due to a ruptured aneurysm of the descending aorta

Jiminey, that’s a lot of cancer.

 

(emphasis mine below)

QOL showed significant clinically relevant decrease of ten-year follow-up scores in SF-36 dimensions of physical function (p<0.001), bodily pain (p=0.001), and general health (p<0.001).

Here’s an explanation of the SF-36.

 

MFI-20 [Multidimensional Fatigue Inventory] scores were significantly higher for general fatigue (p<0.001), physical fatigue (p<0.001), reduced activity (p=0.019), and reduced motivation (p=0.030).

ETA: On average donors did not return to baseline during ten-year follow-up for any dimension of the MFI-
20:

On one hand, this is more confirmation of what many living kidney donors have been experiencing. On the other, it’s a far less rosy picture than the transplant industry would lead the public to believe. What’s even more troubling is that even in the face of these results, the Dutch researchers still conclude “Donor outcomes are excellent ten years post-nephrectomy”.

Exactly how much do we have to be maimed before they stop ignoring us?

 

ETA: I was able to obtain the full article.

 

A big red flag regarding the researchers’ attitudes toward living kidney donors is evident three sentences into the Introduction when they say “While the donor is not the patient, he or she is willingly exposed to harm of the surgical procedure to improve the well-being of another individual.”

Newslfash: Living donors ARE patients. We put ourselves in the care of a medical team (who gets paid!) and we undergo a major surgical procedure to remove an important organ. That, by definition, MAKES US PATIENTS!

 

The LKDs experienced a median 14% loss in eGFR.

18.9% had eGFR between 30-60. More interestingly, the baseline GFR of the 18.8% was significantly lower than those with eGFR >60, a median of 60 and 94 ml/min respectively. I interpreted “baseline” to mean “pre-donation” but it is possible they accepted someone with a GFR of 60 as a living kidney donor?? That seems dangerously low. Granted, kidney function does decline with age,so it’s possible many of these donors were significantly older than the U.S. average of 41?

 

After ten years 35 donors (38%) have lost over 6-34% of their creatinine levels as compared to their
one year follow up. Within this group, creatinine at follow-up was significantly lower when compared to
donors who lost less than the expected five percent of their creatinine, a median of 98.5 and 112.5
ml/min respectively

More on creatinine clearance and relation to kidney function.

 

25.6% developed high blood pressure after ten yearsThese donors had a median eGFR at follow-up of 68.7 ml/min, the median eGFR in the group of donors without hypertension was 79.9 ml/min

 

The researchers continue to categorize these results as “excellent” because they’re comparing kidney donors with the general population. As I’ve discussed many, many times before (and so have many research articles), this is an inappropriate comparison. Living kidney donors are screened for various physical and mental health issues, therefore they skew “healthy” in relation to the general population. If we are suddenly the “general population” post-donation, then our health is being downgraded by the process of donating, and that’s unacceptable. If we’re not, if we’re still considered “healthy”, then we cannot be compared to those who would never be accepted as a donor.

 

Klop, K., Janki, S., Dooper, P., Weimar, W., Ijzermans, J., & Kok, N. (2015). More than a decade after live donor nephrectomy – a prospective cohort study Transplant International DOI: 10.1111/tri.12589

Categories
Living Donor Risks Living Kidney Donor

More on Kidney Donor Jamie Donaldson’s Death

On April 16, 2015, Jamie Donaldson died while donating a kidney to his father, Frank Donaldson, at Gulf Coast Medical Center in Fort Myers, Florida. Per federal guidelines, Gulf Coast’s transplant services were suspended until an investigation is complete.

Liz Freeman, of the Naples Daily News, has been covering this story from the beginning. Below is her latest contribution. The original article can be found here. It, unfortunately, requires one to be a subscriber to see the whole thing. Transcription below.

 

Man who donated kidney to dad died from internal bleeding, autopsy shows

 

John “Jamie” Donaldson bled to death after donating a kidney to his ailing father at Gulf Coast Medical Center this past spring, according to an autopsy report released Wednesday.

The excessive bleeding was due to failure of a clamp or staple that should have sealed the renal artery stump after the left kidney was removed for the transplant, according to the Lee County Medical Examiner’s Office.

In addition, there was a small cut to the aorta just below the left renal artery but it had been closed by a metallic staple, the report said. The medical examiner said the death was accidental.

The autopsy for the 40-year-old Cape Coral resident sheds light on what went wrong during the April 16 living kidney transplant surgery at Gulf Coast. Donaldson’s death led the hospital to voluntarily halt all kidney transplants involving living donors while a probe was conducted.

Donaldson was donating a kidney to his 69-year-old father, Frank Donaldson, also of Cape Coral, who learned of his son’s death after waking up in the recovery room.

The suspension of transplants for living kidney donations took effect April 21 and is still in place. Other patients and their living donors are in waiting mode or transferring to other transplant programs.

The United Network for Organ Sharing, which operates the nation’s transplant program under contract with the federal government, was notified. The U.S. Department of Health and Human Services, which contracts with UNOS, also has been informed.

Lee Memorial Health System, which runs Gulf Coast, issued a statement Wednesday:

“The autopsy supports our initial assessment that the patient experienced excessive bleeding, which is a rare, but known complication,” hospital spokeswoman Mary Briggs said. “All potential kidney donors go through an extensive medical clearance process, which includes a comprehensive medical and psychosocial evaluation to determine if they are suitable for organ donation. After undergoing this extensive evaluation, Mr. Donaldson was cleared for the kidney donation.

“Our deepest sympathies are with the Donaldson family during this difficult time and to our extraordinary caregivers who are dedicated to healing patients even in the most trying circumstances.”

Frank Donaldson said Wednesday he had not seen the autopsy report.

“I haven’t dealt with Jamie’s situation yet,” he said, using his son’s nickname. “I want to heal myself. Eventually I will. Until then, I have to get myself in decent shape.”

His son’s death after he received a new life without dialysis is not a good feeling, he said.

“No father should bury their child before him,” he said. “No matter what I do, it isn’t going to bring Jamie back.”

The transplant went well and Frank Donaldson goes weekly to his kidney specialists for progress checks, from blood work to adjustments for anti-rejection medications, he said.

The hospital reached out to him early after the transplant but not recently, and he has not spoken with the transplant surgeon. He isn’t surprised by that.

“I’m a tough old dude. I’ve been around a long time. I am pretty patient waiting for someone to talk to us,” he said. “Sometimes a one-on-one can save a lot of grief and costs in court.”

There’s another issue, he said, and that’s the $1 million life insurance policy he paid for in his son’s name in case something went wrong. His son’s wife, Christine Donaldson, is the beneficiary.

The life insurance company sent her a letter refusing to pay the claim, Donaldson said. She is having to deal with that issue now, along with how her three children are coping with the loss of their father, he said.

Categories
Ethical Considerations Follow-Up Informed Consent Living Donor Research Living Kidney Donor Organ Markets

More Bad News For Iranian Kidney Donors – er – Sellers

From Transplant Proceedings:

 

With assistance of the Iranian Kidney Foundation, we accessed the contact information of living donors through the years 2001–2012. We tried to contact donors who have donated at least 2 years before the survey. We interviewed these donors according to a questionnaire that was approved by the ethics committee of the research deputy of Tehran University of Medical Sciences. The collected data were analyzed using the SPSS software version 20.

Results

The contact data of 388 donors were available but we were able to contact only 60 donors. We found that 40% of donors had been informed about the risks and benefits of donation. Also, 11% of donors had not had a full physical examination and in 5% even blood pressure was not measured before donation by the transplantation team. The donors reported that 34% of them had not been educated on how they should follow up their health status and 50% of the donors did not have any follow-up after donation.

 

The most understated conclusion in the history of conclusions:

 

In the Iranian model of transplantation the donors are the neglected victims of renal transplantation and this model should be revised immediately, concerning both the medical and ethical issues.

 

Khatami, M., Nikravan, N., & Alimohammadi, F. (2015). Quality and Quantity of Health Evaluation and the Follow-up of Iranian Living Donors Transplantation Proceedings, 47 (4), 1092-1095 DOI: 10.1016/j.transproceed.2014.11.059