"I would not encourage people to be a living donor," said Joyce Somsak, a spokeswoman for the division of the federal government that oversees organ transplants, the Health Resources and Services Administration (HRSA) in 2006.

"There aren't a lot of long-term studies on living donation and what the impact is, what's the impact on people's health," she said.(63)

"Long-term medical risk associated with donor nephrectomy cannot be accurately assessed in this country due to the patchwork access to health care afforded donors at this time."(27)

"Accurate long-term outcome data will only be achieved through the creation of a national or international database and/or registry" (122)

What is a Living Donor Registry?

All living organ and tissue donors would be entered into a national database after being approved for donation*, and all manners of their physical and psychosocial health and well-being tracked for the rest of the lives, including all their pre-donation levels.

Currently other patient populations, including transplant recipients and those diagnosed with cancer, are kept in registries. In addition, persons with certain 'implants', such as pacemakers or artificial joints, are tracked in databases to study product safety, longevity and interactions.

(*Steve Jobs and the state of California want to establish a list of healthy people willing to be living donors in the same way one becomes a deceased organ donor. They are simply looking for a pool of organ incubators for would-be recipients, which is not the accepted and official definition of the term 'registry' in this context.)

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Why is a Living Donor Registry Important?

1. Originally, organ transplantation was conducted with organs from newly deceased persons. The live organ transplant was seen as an aberration, and not the rule. NOTA 1984 was intended to provide a national waiting list and database for deceased organ distribution. At the time, it was believed that maximizing the use of deceased organs could meet the needs of would-be recipients. Consequently, no public policies were ever developed for living donors/donation.

However, as organ donation rates reached a plateau (and no, deceased organ donation and procurement in the U.S. have not been maximized), would-be recipients also increased. The transplant industry recognized the benefits of live organs for those recipients and improved the results of anti-rejection medications, so they began emphasizing living donation and the level of living donors rose.

From 2000-2008, living donors comprised 48% of all organ donations. (see www.optn.org data). It is time to respect, protect, treat, and support living donors.

2. Past and current data collection is inadequate and incomplete.

According to OPTN/UNOS in 2004, only 60% of the 6-month follow-up forms are returned, even though one-year follow-ups have been mandatory since 2000.(28)

By 6 months, complications data are 17% incomplete; by 12 months, data is more than 50% incomplete. About one-third of kidney donors were reported as lost to follow-up during the first year post-transplant. (61)

By 6 months, complications data were less than 10% incomplete; by 12 months, data were less than 20% incomplete. A small fraction of liver donors were reported as lost to follow-up during the first year post-transplant.(61)

Out of 167 donors from 1983-1995 at one transplant center, 23 were unlocatable. (4)

Mr. Graham, Executive Director of UNOS, commented that the living donor data collected to date (2008) does not answer all of the questions on long-term complications, pre-donation issues, peri-operative conditions, and financial complications. (61)

A survey of 27 liver donors reported only 60% of self-reported complications documented in the medical records. (127)

2a. But wait - didn't OPTN pass policy in 2006 requiring all transplant centers to report data on living donors' health at the six-month, one-year and two-year post-surgery marks?

Yes, they did. However, at the November 2008 ACOT meeting, Dr. Cooper from OPTN reported that "For one in every five kidney donors in 2006, there were no forms submitted.". (61)

In 2009, a transplant coordinator who wishes to remain anonymous admitted that UNOS/OPTN is giving transplant centers 'credit' for turning in 'incomplete' living donor follow-up forms.

The annual Utilization report issued on 1999-2008 (published in 2010), says: Of the 6732 living donors who donated an organ in 2006, more than 30% were lost to follow-up. There is significant variation among centers in terms of the percentage of donors for whom follow-up data is missing with some centers declaring no available follow-up for 100% of their donors* (107)

And yes, that policy is mandatory, per the Secretary of Health.

*Meaning: the transplant center didn't bother to even try to follow-up with their living donors.

Following living donors for only two years provides no information on long-term consequences, such as hypertension, diabetes, and kidney dysfunction and failure. The living donors who have been added to the UNOS waiting list since 1993 averaged 17 years post-donation when kidney failure occurred.

In addition, there is a paucity of research and knowledge regarding living donors' psychological and emotional well-being. Current data collection policies do not include any mental health information. In act, the follow-up form is incredibly generic and non-standard. It only regards those complications requiring rehospitalization to be important, and provides a simple blank line for 'write-in' comments. This has resulted in a unusable and un-analyzable data. (examples of actual information reported to UNOS as reasons for readmission: nernia repair, backache, complications due to donation)

3. There are currently 200+ transplant centers across the U.S. Current law and policies give them great latitude in the evaluation, treatment and follow-up of their living donors. These differences will affect the validity and reliability of any future data, research or studies. (Comparing apples to oranges, so to speak)

In addition, the transplant community has begun using what they call "Expanded Criteria" donors (older, lower pre-surgical GFR, etc) on which no data has been collected.

4. Transplant centers are rated and compensated by their recipient outcomes and have no obligation (legal) or motivation (legal or financial) to provide their living donors with aftercare. In fact, many transplant centers will refer a donor with a post-surgical complication or complaint to their primary care physician so they will not have to document the issue and report it with their statistics.

Dr. Matthew Cooper, a transplant surgeon at the University of Maryland Medical Center and OPTN Living Donor Committee Chair,  felt that centers do not report the donors with complications.  The centers may not know about complications or may minimize them. Living donors tend to be uncomfortable going back if they have a complication, which skewed the numbers. He felt that donors might be more honest if their responses did not go to the centers. (61)

Gil Thiel brought to attention the potential of underreporting donor complications because of the hesitation of the transplant physicians to reveal them either to the hospital center, future donors, or insurance carriers.(38)

The International Liver Transplantation Society's 13th Annual International Congress (2007) states: "One of the key problems with examining living donor morbidity and mortality is the under-documentation or lack of direct reporting of complications by the transplant centers, leading to a dearth of hard data on which to base transplant decisions and to an to inability to provide potential donors with true informed consent."

"Specialty societies may not have enough clout to regulate the actions of surgeons and transplantation programs."(110) And right now, UNOS membership is made up primarily of transplant centers, surgeons, Organ Procurement Organizations, and Histocompatibility Laboratories (359/396 members). Who or what is keeping them in check?.

5. Both short-term and long-term living donor studies are sporadic and rife with qualitative issues.

The short- and long-term health and social impacts of donor nephrectomy remain relatively undefined, owing in part to the paucity of long-term follow-up studies.(14,30,37). (From American Journal of Transplantation 2006; 6: 2548–2555.)

While it is known that some American donors eventually develop CKD (chronic kidney disease) themselves, long-term medical risk associated with donor nephrectomy cannot be accurately assessed in this country due to the patchwork access to health care afforded donors at this time.(27)

6. The collection of mortality, morbidity, and complication data is ill-defined and non-standard.

A registry would provide a comprehensive and longitudinal database of living donors: demographics and risk factors at the time of donation, post-op complications, mental health difficulties (anxiety, depression, PTSD), long-term health changes, financial and other psychosocial issues related to living donation (lost wages, inability to procure health insurance, job loss, etc). This data could be used to identify risk factors related to transplant outcome, donor psychosocial and physical complication rate, and the long-term ramifications of living donation on the donor. Ultimately, this information can be used to more thoroughly protect, evaluate, treat, and support living donors, minimizing risks and detrimental outcomes.

The Swiss organ living donor health registry was initiated in 1993. A donor registry has existed in the Netherlands since 1998. In Australia and New Zealand, the Anzdata Living Donor Kidney Registry was established in 1997. In 1997 the Norwegian National Hospital Donor Registry was established.(95)

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Who has called for a Living Donor Registry?

Who hasn't?

- Consensus Statement on the Live Organ Donor, 2000 (65)

"The rationale...includes concern for donor well-being, limitations of current knowledge regarding the long-term consequences of donation, the potential to evaluate the impact of in criteria for donor eligibility on the outcome of donors..."

- Renz & Roberts. Long-term complications of living donor liver transplantation. Liver Transplantation Vol 6, No 6, Suppl 2 (Nov) 2000 pp: S73-S76

- Jacobs SC, et al. "Laparoscopic donor nephrectomy: the University of Maryland 6-year experience". J Urol. 2004 Jan;171(1):47-51.(54)

"There should be a national data registry of donors to measure accurately the immediate impact and the long-term impact on donor health."

- International Forum on the Care of the Living Donor, Amsterdam 2005.

"Comprehensive national registries should be established to determine whether the incidence of medical risk factors and renal dysfunction is different from the general population." (38)

- The International Liver Transplantation Society 13th Annual International Congress (2007) agreed that:

"One of the key problems with examining living donor morbidity and mortality is the under-documentation or lack of direct reporting of complications by the transplant centers, leading to a dearth of hard data on which to base transplant decisions and to an to inability to provide potential donors with true informed consent."

- We Need a Registry of Living Kidney Donors: essay from Bioethics Forum after two studies revealed some living kidney donors end up on the transplant waiting list themselves.

Because of the high incidence of proteinuria and possible changes in bone metabolism inclusion of kidney donors in registries appears worthwhile.(73)

Lainie Friedman Ross (bioethicist, living donor researcher, UNOS committee member), Mark Siegler, and J. Richard Thistlethwaite, Jr., in 2007 after UNOS failed to pass a uniform living donor evaluation policy said in an essay published by The Hastings Center:

The lack of support for a prospective large-scale living donor registry is morally inexcusable.

Emara, M. et al. in 2008:

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Why isn't there a Living Donor Registry already?  

1. The original organ transplantation system was devised around deceased donor organs. Until 2006, no agency or organization had authority to oversee, or develop policies or procedures for living donation. Even now, there is no organization or public policy dedicated to the living donor. It is impossible to simultaneously increase the supply of donor organs while adequately protecting the rights and needs of prospective and current living donors.

2. There's no profit in it. Even though living donors make up almost half of all organ transplants in the U.S., the transplant centers and organizations balk at the expense of a registry. Hospitals charge up to $500,000 for a transplant procedure (64), and receive federal funding based on recipient outcomes so the more transplants, the bigger profits. It can be inferred that the surgeons and transplant centers simply do not see living donors as 'patients' and do not want to take responsibility for them.

The very cynical perspective is that by encouraging living donation, transplant centers are creating another 'class' of patient for themselves, ie. another long-term revenue stream. 

3. Transplant centers and public policy organizations are simply afraid of what a registry will reveal. If anecdotal evidence (that is, personal stories and small studies) are to be believed, there are far more consequences to living donation - physical and psychosocial - than anyone has ever acknowledged. If those risks and consequences are confirmed scientifically, the transplant community will have to stop using terms like "minimal risk" to describe living donation, take responsibility for their living donors by improving evaluation and aftercare procedures, engage in more Informed Consent and worst of all (from their perspective) - the rate of living donation will drop.

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Irony Alert:

The Social Security Act in 1972, Section 1881, provides a Medicare benefit to living kidney donors. Two years later, the Director of SSA ordered transplant centers to violate this law, either billing to a recipient's private insurance or filing all Living Kidney Donor charges under the recipient's Medicare benefit.

If the law had been followed, the public and medical community would now have long-term data on approximately 120,000 living donors. 

Instead, a review of all existing living donor research studies in 2006 found the accumulated literature to be 'subject to selection bias', rife with 'small sample sizes', 'underpowered', and containing a 'paucity of data on cardiovascular risk factors'.

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What To Do

CMS (Medicare/Medicaid) is a government organization responsible to the public. So is HRSA, OPTN, DHHS, ACOT and myriad other acronyms. Each can be contacted privately via email, snail mail, telephone or fax. Contact federal and state legislators, or if one would like to make a more direct impact, their regularly scheduled meetings are open to the public. Attend and be heard.

Still under construction....

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