Categories
Living Donor Risks Living Kidney Donor OPTN

Second Living Kidney Donor Death in 2015

This one occurred last month at UCSF. Little details are known at this time, but the program has been halted temporarily (standard procedure).

Earlier this year, don’t forget, Jamie Donaldson died at Gulf Coast Medical Center.

This makes TWO living kidney donors deaths (within 30 days of surgery) in 2014 and TWO in 2015….. That the public and media knows about, that is.

Why so cynical, you ask?

 

Well, the first articles that emerged about this living donor’s death said:

“According to the Organ Procurement and Transplant Network (OPTN), from 2009-13, four living kidney donor deaths due to medical causes were reported nationwide within the first 30 days of donation, none of which occurred at UCSF.”

 

Read that again: Between 2009-2013

4 kidney donor deaths in 5 years sounds a hell of a lot better than 8 deaths in 7 years, doesn’t it?

More details as I get ’em.

 

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
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.

Categories
Follow-Up Informed Consent Liver Donor Living Kidney Donor OPTN

Latest from OPTN’s Living Donor Committee

OPTN’s Living Donor sent their latest report to OPTN’s Board of Directors a couple of weeks ago. The following are noteworthy highlights:
  

1. After CMS (Medicare) published the Final Rule in 2007, requiring transplant centers to provide prospective living donors with an Independent Donor Advocate, OPTN followed suit by implementing a similar policy.

note: Yes, this is bureaucracy duplication at its finest, but necessary because some transplant centers may choose not to take Medicare/Medicaid patients, in which case, they would not have to abide by CMS policy. However, where it becomes a giant pain in the ass is where CMS requires one thing, eg. the IDA “must not be involved in transplantation activities on a routine basis” where OPTN simply says “not be involved with the potential recipient evaluation”. What policy do you think transplant centers will follow: the lesser of the two? Yeah).
  

UNOS started performing on-site reviews of living kidney donor transplant programs in January 2011. In April 2012, the Committee received a staff summary of findings and impressions on this first year of audits. The findings included the following observations:

– only 2 of 15 members surveyed were fully compliant with all IDA requirements and
– the benefit and need for post-donation follow-up was the most common element not documented by the IDA as being discussed with the potential donor.

This same report identified variability in member IDA protocols addressing training, qualifications, required documentation, IDA function in the evaluation process, and the use of individual IDAs versus donor advocate teams.
For the living donor site surveys completed in 2012, the Membership and Professional Standards Committee (MPSC) determined that 86% of these members had compliance issues related to IDA requirements.

  
You read that right: transplant centers are non-compliant with policies passed in 2007.

So the LD Committee wrote up a policy clarifying the role of the IDA and put it out for public comment in Spring 2013. After reading public comment, they revised the proposed policy and sent it to the Board of Directors in September. The BoD approved them and the new policies go into effect in February, 2014.
 
Note: unfortunately I don’t know the specifics of the revised proposal. The proposal that went up for public comment is available here: http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/proposals.asp
 
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2. The LD Committee wants all prospective living donors registered with the UNOS/OPTN database UNet before surgery. The proposal is up for public comment now: http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/proposals.asp
 
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3. The LD Committee has written a proposal for live liver donor follow-up, which is available for public comment now: http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/proposals.asp
 
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4. They also have proposed minimum requirements for living liver donor informed consent and medical evaluation. Some folks said (in essence): How those few other living organ donors? Shouldn’t they get protection too? So they’ve gone back to the drawing board to compose national standards of care for *all* living donors.
 
Note: Only took ’em nearly 60 years.
 
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5. In case you’re not aware, living donor follow-up and data has been abyssmal, even though the Secretary of Health mandated it in 2000. SRTR, who collects and analyzes all transplant related data (transplant recipients have a 10-year govt funded registry), reported to OPTN’s LD Committee that they have a contractual obligation to report ‘adequacy of follow-up submission’, ‘adverse events’, and ‘laboratory results’ to the public. (Another FYI: OPTN and the transplant industry have very strenuously objected to *any* center-specific information be given to the public. It’s a symptom of the medical industry’s lack of transparency, which has given rise to numerous patients’ rights groups and pending legislation).
  

A subcommittee was assigned to work with the SRTR to recommend what metrics should be reported in the living donor program PSRs. The subcommittee ultimately recommended that the PSRs include “completeness” of living donor follow-up reporting, and adverse events to include re-hospitalization and type of complication. The subcommittee did not support reporting living donor deaths or organ failure for individual centers

Shock me, shock me that the subcommittee wouldn’t want the public to know if living donors died or experienced organ failure (Sorry about the sarcasm, but really, what motive would they have for withholding this information other than to A. protect their own butts and B. keep the flow of living donors going?)
 
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5. And finally, they decided that living liver donors would *not* get wait list priority if they needed a liver transplant in the future. Nice, eh?
   

Read the full report to OPTN’s Board of Directors here: http://optn.transplant.hrsa.gov/CommitteeReports/board_main_LivingDonorCommittee_11_13_2013_16_50.pdf

Categories
Liver Donor Living Donor Research Living Donor Risks

Overview of Living Liver Donation

The article is free and publicly available; I encourage everyone to read it in full.

 

 …any adverse event in an altruistic donor who did not otherwise require an operation is cause for concern. Significant donor morbidity, including death, has been observed, even among the most experienced centers.

 

… it is impossible to make the risk negligible for an operation of such magnitude. Counseling a potential donor with respect to the risks involved in donor hepatectomy is ethically mandated before proceeding with LDLT, but until recently there have been few registry data to allow an estimation of true risk, and the ability to provide truly informed consent continues to be a challenge and deserves further study.

 

Current available data suggest that overall donor mortality after liver donation in the United States and Europe is on the order of 0.2%

I want to note here that A. I’m not sure where they get this statistic (I’m assuming from OPTN data, which is very limited), and B. they are lumping together right and left lobe donors. The left lobe is smaller and used for children; the right is larger and transplanted into adults. The death and complication rate for adult-to-adult living liver donation is much higher than pediatrics (See here).

 

 In studies that have included donors of either the right or left hepatic lobe, the overall complication rate has been approximately 21%. However, in studies including only right hepatic lobe donors, complications rates are higher and have ranged between 38% and 47%

 

Of all donor complications reported by the A2ALL consortium, infections, pleural effusion, biliary leak, and incisional hernia were the most common

 

Most laboratory abnormalities that occur in donors after lobectomy resolve quickly, and 20% of donors have persistently lower platelet counts 2 to 3 years after donation, although the clinical significance of this finding is unknown.

 

Liver failure requiring rescue transplantation is extremely rare; only five cases have been reported in the literature, four of which involved right lobe donors.

“Reported in the literature” because again, the US has no national registry for living donors, and reporting to OPTN has been less than optimal.

 

Finally, the authors report no long-term information on living liver donors’ health and well-being because no one *has* long-term data.

 

 
Paige M. Porret, Kim M. Olthoff* (2013). Current state of living donor liver transplantation Clinical Liver Disease DOI: 10.1002/cld.231