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Advocacy Living Donor Protections Living Donor Research Living Donor Risks Living Kidney Donor OPTN

OPTN Standards For Transplant Surgeons Are Too Low

This excerpt pretty much says it all:

The learning curve [of a surgeon specializing in laparoscopic donor nephrectomy], defined by decreased operating time, averaged 35 cases.

Improved intra-operative, patient, and recipient outcomes were observed for centers performing ?50 LDNs annually.

The United Network of Organ Sharing [UNOS; in this case used as a synonym for OPTN] requires 15 cases as surgeon or assistant to be certified as the primary LDN surgeon. This falls below the described learning curve for LDN.

 

 

Raque, J., Billeter, A., Lucich, E., Marvin, M., & Sutton, E. (2015). Training techniques in laparoscopic donor nephrectomy: a systematic review Clinical Transplantation, 29 (10), 893-903 DOI: 10.1111/ctr.12592

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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
Advocacy Living Donor Protections Living Donor Research Living Kidney Donor

How to Eliminate Some Living Donation Related Costs

Note: Typical with most recently published studies, I’m only able to see the abstract for this one.

 

Authors collected info from 194 living kidney donors enrolled in the KDOC study.

“Most LKDs (n=187, 96%) reported one or more direct costs, including ground transportation (80%), healthcare (24%), lodging (17%) and air transportation (14%)…..Higher total costs were significantly associated with longer distance traveled to the transplant center”

 

As I’ve discussed at length, not only is it not medically necessary for a potential living kidney donor to have their procedure at the same transplant center as their recipient, it can also be detrimental for the kidney donor’s care, recovery and treatment. Transplant centers prefer both parties to be at the same hospital because –

A. It’s convenient for them.

B. Variations in how transplant centers evaluate potential living donors results in a quality control issue. Transplant center 1 might miss something that transplant center 2 deems exclusionary, etc

C. Transplant centers are paid by the procedure, so having folks at different hospitals splits the revenue pie.

D. If the kidney donor and transplant recipient live in different states, there can be insurance and billing conflicts and issues.

 

How to fix the problem (for the living donor, at least):

1. Put *all* treatment for ESRD and kidney failure under Medicare (this would delight private insurance companies btw), or at minimum, have Medicare assume all healthcare expenses if the prospective living donor and would-be recipient reside in different states to circumvent the state insurance regulation obstacles.

2. Completely standardize the living donor evaluation and selection process.

3. Require insurance companies or transplant centers to pay for the living donor’s travel and lodging expenses. (This, however, would still leave the LKD at risk. S/he must return home at some point and could need further treatment)

 

“Few LKDs reported receiving financial support from the transplant candidate (6%), transplant candidate’s family (3%), a nonprofit organization (3%), the National Living Donor Assistance Center (7%), or transplant center (3%).”

Donation is an act of generosity, which causes the prospective LKD to bear the burden (in this case financial) by themselves. Transplant candidates (aka would-be recipients) are taught, in a million subtle ways, to passively accept the sacrifice a donor is making on their behalf. Maybe we need to change the dialogue from one of recipient entitlement to one of recipient responsibility? Rather than expecting the government (NLDAC) or a nonprofit to help with living donation related expenses, transplant candidates should be prepared to assume these costs. If a would-be recipient is unable or unwilling to do, s/he could continue on dialysis and wait until a deceased donor organ becomes available.

If this idea offends your sense of fairness (Poor people won’t get living donor kidneys!), I hear you, but it’s also the reality of how our healthcare system works in general. If someone can’t afford a treatment or medication, that person can’t have that treatment or medication. Is that unfair? Certainly. But then again, one could argue, so is asking another person to act as your medical supply.

 
Rodrigue, J., Schold, J., Morrissey, P., Whiting, J., Vella, J., Kayler, L., Katz, D., Jones, J., Kaplan, B., Fleishman, A., Pavlakis, M., Mandelbrot, D., & , . (2015). Predonation Direct and Indirect Costs Incurred by Adults Who Donated a Kidney: Findings From the KDOC Study American Journal of Transplantation DOI: 10.1111/ajt.13286

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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

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Advocacy Ethical Considerations Living Donor Protections Living Donor Risks Living Kidney Donor OPTN Psychosocial Risks

Living Donor Dies at Erie County Medical Center

Here are the facts:

ECMC is suspending its living kidney transplant program following the death of a donor from an illegal drug overdose.

Doctors successfully transplanted the organ to a family member in the spring of 2013. Six months later, the donor died.

ECMC decided, with consultation with the United Network for Organ Sharing, the non-profit organization that regulates live organ donations, to temporarily suspend the program until mid-July 2014.

The hospital released the following statement:

“ECMC proactively decided to temporarily suspend living donor recoveries. The ECMC transplant program otherwise continues unaffected and ECMC fully expects that the living donor program will be reinstated by mid-July 2014. In the meantime, the transplant program will fully support and guide any potential living organ donor and recipient in the alternatives available to them.”

 

If that were the end of it, this would be a short post. But it’s not. At least two news stations, WIVB and WGRZ, managed to make this tragedy all about the recipients. Here is the missive I sent to both these reporters (the version below went to Brown at WGRZ; I altered the wording regarding Laurie and Chase for Ms. Kingston):

 

As a living kidney donor and living donor activist, I read the news of ECMC’s living donor death with great sadness. My sorrow, however, became dismay when I realized your story’s only concern was the temporary cessation of transplants. As if the donor’s death were nothing more than an afterthought.

The first living kidney donor transplant occurred in 1954, yet a psycho-social evaluation was not required for potential living donors until 2007 (CMS Final Rule). But it wasn’t until last year, under pressure from HRSA at DHHS, that the policy specified details.

Currently, a transplant center must obtain the prospective living donor’s history of “smoking, alcohol, and drug use, abuse, and dependency”.

They must also screen for “any psychosocial issues, including mental health issues that might complicate the living donor’s recovery and could be identified as potential risks for poor psychosocial outcome”.

And finally, a transplant center is supposed to exclude or reject any potential living donor with a “diagnosable psychiatric condition requiring treatment before donation, including any evidence of suicidality”.

But here’s the reality:

  • Approximately, 30% of U.S. living donors experience depression, anxiety, anger, grief and/or PTSD post-donation.
  • One-third of living kidney donors’ psychological and distress scores worsened one and three months following donation. (Taghavi 2001).
  • 15% of kidney donors are on antidepressants three months after donation (McCune)
  • 2% of donors had a Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) psychiatric diagnosis preoperatively, however, 15% had an Axis I disorder at 12 months. (Smith et. al. 2004).

All of these findings well exceed the community sample range of 2 to 9% for major depression as reported in the DSM-IV.

Transplant centers are not specifically required to offer structured aftercare or support services to living donors, and in fact, not a single center does. Yet it’s been determined by multiple studies that a lack of support contributes to these issues, and early counseling may alleviate suffering.

ECMC determined this living donor to be healthy, both physically *and* psychologically. Yet six months later, s/he is dead. This is a patient safety failure of massive proportions. Instead of lamenting the delay, Laurie and Chase should be grateful; this investigation just might save her life.

Because after all, we’re more than medical supply. Living donors are people too.

 

Note: In 2007, OPTN’s Living Donor Committee proposed comprehensive standards for living donor evaluation, selection and treatment. These policies were violently rejected by the “membership” (aka the transplant centers). I bring it up because the proposed policy contained an appendix with a detailed rationale for interviewing a “Donor Support Person” (spouse, significant other, parent, friend, etc) during the living donor evaluation AND an inventory of questions for a POST-donation psychosocial interview of the living donor.