Now, it will be possible to explore the possibility of transplanting HIV +ve organs into HIV +ve recipients. In fact, we have long had better anti-retroviral therapies (to treat HIV) than anything available for Hepatitis C. Yet the 1988 law had halted all potential progress. But not now! So, let’s move forward…….consider further broadening the breadth of donors (maybe even living donors who are HIV +ve?) and helping a specific subset of transplant candidates. This was/is a win-win for all.
In follow-up of a different transplant, Grzegorz is not a name that will ring bells for most of us. But you will surely recognize the images taken shortly after he received Poland’s first face transplant on May 15, 2013. You will also recall the horrific story of a stone cutting machine causing the trauma that induced his emergent need for that transplant. The terrific follow-up news came today that he has gone home, breathing and eating on his own a mere 11 weeks after the transplant. The report is that he is also speaking, although the words are still a bit difficult to understand. His speech is expected to improve as the nerves regenerate to the muscles in the transplanted face. The process is likely already underway as he is experiencing pins and needles in his cheeks. Although standardized goals and benchmarks have not yet been fully established for face transplants, 1 and 3 year patient and graft survival are likely to be selected. We will surely breathe a collective sigh of relief when Grzegorz meets the first of these, won’t we?
The final follow-up to be reviewed in this posting is not a happy one, but pertains to a story that is likely also familiar to you, the live donor kidney that was inadvertently discarded and wasted in a tragic human error in 2012. Both the live donor and recipient are reportedly well. A transplant did subsequently occur with a different kidney, but the family has now sued the original transplant hospital.
Life goes on. When donation and transplantation are the causes of life going on for recipients we should be especially grateful. Not necessarily mentioning it at every moment of every day……..but at least acknowledging from time to time that life can never be taken for granted. And when someone gives so that one or more recipients may benefit, a beautiful thing has taken place.
This legislation is an important bipartisan effort, supported by multiple medical, patient and social organizations because it represents a potential win-win for everyone. Expansion of the organ donor pool, carefully supervised clinical research with informed consent of the participating subjects, oversight by the government, support of the major transplant organizations, potential reduction of transplant candidate deaths, etc.
Keep tuned to this blog for updates as additional steps happen. It is beginning to look like this legislative action may become real in the not too distant future.
- allocation – algorithm for distribution of a deceased donor organ
- allograft – a donor organ from a non-identical member of the same species (e.g., parent to child)
- autograft – a donor organ from a genetically identical member of the same species (e.g., between clones or identical twins)
- cold ischemia – time between cessation of blood flow to the donor organ and restoration of blood flow during transplantation
- en bloc – organs that remain anatomically connected (e.g., 2 pediatric kidneys still attached to the aorta and vena cava)
- DCD – Donor after Circulatory Death is a deceased organ donor whose death was declared based on cessation of cardiac activity
- deceased donor – a human being whose organs have been removed after death for the purpose of transplantation
- delayed graft function (DGF) – a newly transplanted organ that is alive (receiving blood flow) but has not yet begun to function (e.g., a transplanted kidney that is not yet making urine)
- donor service area (DSA) – the geographic region that is the smallest unit of organ allocation and is served by one OPO
- EPTS (estimated post transplant survival) – a formula based on four medical factors about the transplant candidate (age, time on dialysis, presence of diabetes, history of a prior transplant) that determines the statistical likelihood of survival of a patient in comparison to other patients
- expanded criteria donor (ECD) – a deceased organ donor who meets the UNOS definition of a less than optimal donor because of age, cause of death or medical history. In general, these organs are more vulnerable to all types of transplant related injury than standard criteria organs.
- graft – organ +/- tissue that is transplanted
- KDPI – kidney donor profile index is a numerical measure that combines ten dimensions of information about a donor, including clinical information and demographics, to express the quality of the donor kidney relative to other donors.(optn KDPI source info). Ranging from 1-100%, a value of 75% means that this kidney has a relative risk of failing that is higher than 75% of deceased donor kidneys.
- immunosuppression – pharmacologic or biologic therapy administered to diminish the strength of the response of the immune system
- import – an organ that has been recovered in a different UNOS region or DSA and transported in to the transplant center and patient. Importanting an organ prolongs the cold ischemia period.
- LYFT (life years from transplant) – the statistical quality adjusted survival benefit provided by the transplantation of a given organ to a given recipient
- multi-visceral – a transplant in which more than one abdominal organ is transplanted, usually involving the liver +/- pancreas, duodenum, stomach, small intestine
- NOTA (National Organ Transplant Act) – federal legislation, P.L. 98-507, enacted in 1984 to address the organ donation shortage and to improve organ matching and placement. The act and its amendments establish the national registry for organ matching and call for a transplant network to be operated by a non-profit organization under federal contract.
- opo (organ procurement organization) – a private, non-profit organization responsible for increasing donor registration in the assigned donor service area and for coordinating the donation process in the service area hospitals.
- OPTN (organ procurement and transplantation network) – established by the U.S. congress when it enacted the National Organ Transplant Act (NOTA), this is a unified transplant network to be operated by a private, non-profit organization under federal contract.
- rejection – recognition and attack of the transplanted organ and tissue by the host’s immune system
- standard criteria donor (SCD) – a deceased organ donor who does not meet the UNOS definition of an expanded criteria donor. In general, these organs are most likely to function promptly after transplantation, and most likely to continue functioning for may years.
- SRTR (Scientific Registry of Transplant Recipients) – the primary source of transplant data in the U.S., containing information from 1988 and later. These data are developed from mandatory transplant center reports and are used by multiple regulatory agencies and researchers.
- tolerance – a host’s immune system’s failure to recognize and respond to a specific donor’s organ (or other stimulus) while retaining all other functions
- Thrombosis – the condition of blood clot blocking flow through a blood vessel
- UNOS (United Network for Organ Sharing) – the private, non-profit organization that manages the nation’s organ transplant system under contract with the federal government.
- VCA (vascularized composite allograft) -multiple tissues such as muscle, bone, nerve and skin that are transplanted as a functional unit and require the surgical attachment of blood vessels (e.g., a hand or face).
- xenograft – a donor organ from a member of a different species (e.g., pig to human)
If you don’t see the term you were seeking, please ask for an explanation by submitting a COMMENT.
Today’s report is that additional co-sponsors have “signed on” to each bill. The Senate bill, initially introduced by Senator Durbin from Illinois, now has 11 co-sponsors. This means that 12/100 Senators, or 12% have committed to supporting the bill. Another 88 to go! Are your Senators on board? Use this Senate link to check whether both of your Senators have “signed on”. If they have not, please give them a phone call……or send them an e-mail. Ask them to sign on to S.323 (the formal # for this bill in the Senate).
The current status in the House of Representatives is that 67 members have “signed on” to co-sponsor Representative Michael Burgess’ original bill. This makes a total of 68/435, or 16% who have committed to supporting the bill. Use this House link to determine whether your Representative is on the list and, if not, contact him/her. Ask for support of H.R. 1428.
Together we can make a difference. Legislators DO respond to their constituents. If we make it very clear that this Catch-22 is unacceptable, that we insist on change, and that we hold our own politicians accountable, we can be the agents of change. Take a few moments to take the simple steps outlined above. And, pass the link for this blog to someone else who will help make the change. We do have this power. You have this power. Please use it.
Intestine (any part of the intestinal tract)
In contrast, human cells or tissue for transplantation are under the regulatory jurisdiction of the Food and Drug Administration (FDA) under Section 361 of the Public Health Service Act and 21 CFR parts 1270 and 1271. Examples (not inclusive) of Cell and Tissue “Implants/Transplants” include:
Face, hand, larynx, and abdominal wall transplants are all examples of transplants that did not clearly fit into either of the two pre-existing categories. Agreeing with advocates within the transplant community, the Secretary of Health and Human Services issued this Final Rule that has formally created a new category of Vascularized Composite Allografts (VCA), (allograft = transplant between non-identical members of the same species) that is defined based on functions below (ischemia is a period of interrupted blood, see below):
- Vascularized – requires blood flow by surgical connection
- Contains multiple tissue types
- Recovered from a human donor as an anatomical/structural unit
- Transplanted into a human recipient as an anatomical/structural unit
- Minimally manipulated or processed (but may be cut or shaped)
- For homologous use (i.e., to be used for the same purpose in the recipient as it was in the donor)
- Subject to ischemia and therefore stored only temporarily
- Subject to allograft rejection and generally requiring immunosuppression
The Final Rule also clearly stipulates that VCA transplants fall under the jurisdiction of the OPTN/UNOS, not the FDA. Major implications of this definition are that VCA transplants may only be performed at OPTN member institutions in good standing. New policies specifically applicable to VCA transplants clearly need to be developed by the OPTN/UNOS.
Because of the unique issues pertaining to donor consent for these specific transplant types, wherein donor identification may be retained (e.g., fingerprints and facial identifiers), the Final Rule implies that donor specific consent should be undertaken on a case-by-case basis. This is the current ad hoc practice. But new issues of allocation will arise if the number of transplants begins to grow substantially. For example, there is no other transplant type in which skin color may be relevant!
Overall, a new field of medicine is currently developing at a very rapid pace. This one step is an important one. It will be challenging and exciting as others are made. Stay tuned.
A key change involves implementation of the Kidney Donor Profile Index (KDPI) as a measure of the risk of kidney failure after transplantation, with 100% being the worst and 1% the best possible values. An organ with a KDPI of 20% is more likely to function than 80% of transplanted kidneys – pretty darned good. Since one would not like to transplant an organ that is likely to fail, the KDPI is used as a direct measure of donor kidney quality.
Waiting candidates are stratified into 4 groups based on the KDPI and a second formula, the estimated post-transplant survival (EPTS). This not-so-subtle means of including the candidate’s statistical life expectancy following transplantation is a major step in the allocation scheme, taken in order to maximize the number of life years for the kidney following transplantation (LYFT). It is based on the candidate age, length of time on dialysis, prior transplantation and presence of diabetes. However, the new policy amendment will incorporate the EPTS to advantage just those 20% of candidates with the best likely survival.
Now, combining the KDPI and EPTS will lead to the 20% of best KDPI organs being matched to pediatric patients and adult patients with the best EPTS. Pediatric patients are still given an advantage for organs with a KDPI up to 35%. Between KDPI of 35-85% adult recipients are addressed by the standard allocation factors already in effect. Above 85% broad sharing (beyond local areas) will be undertaken promptly in order to avoid discarding potentially transplantable organs.
These changes have been neither reactive nor rapid, but have followed years of debate and formal procedure that included opportunities for input from all stakeholders. Nonetheless, the starkness of including some healthier candidates while excluding sicker ones from access to the best kidneys, is not lost on anyone involved. This “cherry-picking” of transplant candidates is a deeply distasteful but necessary response to the lack of sufficient resources. Please take a moment to register your opinion about these changes by answering the poll at the bottom right of this webpage – thanks.
Any donated human organ or tissue may harbor an unwanted, undiscovered or unrecognized infection, malignancy or other disease. With the transplant, irregardless of the best intentions and most up to date testing, that disease is donated too and may cause serious illness(even death) in a recipient. To minimize this risk, to allow assessment of the risk, and to facilitate informed judgement about whether or not to proceed……in advance of the transplant….. are the objectives. But risk cannot be completely eliminated.
The U.S. Centers for Disease Control and Prevention (CDC) has just issued long awaited guidelines for use in preventing the transmission of Hepatitis B (hep B), Hepatitis C (hep C) and HIV through organ transplantation. They are based on currently available evidence and expert opinions, and formally update guidelines last published in 1994. An essential difference between organ donation and blood or tissue donation led to the restriction of these new guidelines only to the former field. In organ donation transplantation must proceed within hours of the procurement of the donated material that might bear infection. In contrast, both blood and tissue are typically recovered, processed and stored for a longer period of time varying from multiple days to even months or longer. During that interval definitive testing and further risk reduction can clearly be performed.
This rapid time frame within which results of any laboratory testing must be available so that organ procurement and transplantation are not unduly delayed defines different ground rules than in most medical scenarios. For example, only a few labs throughout the country perform the most specialized testing (nucleic acid testing -NAT) for Hep B, Hep C and HIV with 24/7/365 availability and rapid turn around. Blood samples are typically sent by courier to one of these labs when testing of a deceased donor is required. Of course, these steps do increase the cost of transplantation.
A practical approach was, by necessity, taken by the U.S. Public Health Service in developing the guidelines. For example, if one of the test results indicates the presence of Hep B, Hep C or HIV when the virus is really not present (a false positive result), the inappropriate exclusion of the organ donor would be a serious consequence costing one or more lives. The need to balance the potential benefit to be gained from a successful transplant, with the statistical risk of using the possibly infected organ is acknowledged in the guidelines. Thus, it might be reasonable to use a liver from a donor who is suspected of having a false positive test if the liver candidate is at death’s door and no other organs are available. But, it would not be reasonable to use the same donor’s tissue without clarification of the possible infection.
Wisely, these guidelines also delve deeply into the important issue of involving the patient or family (if the patient is unable) through education when transplantation is only a concept, and through full informed consent when the detailed risks and benefits are known. This is a codification of the timing and content of informed consent similar to other approaches in this tightly regulated field.
Behavioral factors that increase the donor’s risk of infection with Hep B, Hep C or HIV include sex with an infected person in the preceding 12 months, male-male sex within the preceding 12 months, people who have had sex with a person in exchange for money or drugs in the preceding 12 months, people who have had sex with a person who injected drugs in the preceding 12 months, a child < 18 months born to an infected or at risk mother, a child who has been breastfed within the preceding 12 months by an infected or at risk mother, people who injected drugs in the preceding 12 months, people in lockup, jail, prison or a juvenile correctional facility > 72 hours in the preceding 12 months, and people newly diagnosed with a sexually transmitted disease in the preceding 12 months.
For any transplant that involved an increased risk of transmission of Hep B, Hep C or HIV, surveillance testing of the recipient for the first year is recommended. If infection does occur, treatment can be initiated as early as possible with the intent of staving off serious illness.
Today, these are the most common severe viral infections that concern transplant recipients. But previously, similar donor transmitted infection with the cytomegalovirus (CMV) and the Epstein Barr virus (EBV) were also highly problematic, at times even causing fatalities. Now these infections are much more manageable because of the anti-viral medications available for use.
If all of these details seem frightening, the real statistic that new (de novo) Hep B, Hep C or HIV infection through transplantation is very rare should be reassuring. The newly available document has simply formalized screening practices that have already become routine at many transplant programs for the protection of patients. Patients are entitled to be familiar with any unusual risks posed by the specific donor whose organ they are being offered (if they are so fortunate). Patients should feel empowered to ask about unusual issues with their donor (if they have not already been informed, which should happen).
Remember that the only way to have no risk at all is to have no transplant. If a transplant does happen, the human donor’s organ has been assessed with a risk/benefit ratio tailored to the specific recipient who should have been informed and should have intentionally opted to proceed. Of course, the transplant team would not typically offer an organ that they did not consider acceptable for that patient. But, in the end, it must be the patient (and/or the family) who agrees to go ahead.
This legislation directs the Department of Health and Human Services (DHHS) and the Organ Procurement and Transplantation Network (OPTN) to develop and institute standards for the use of HIV positive organs in HIV positive recipients if ongoing research warrants. The Secretary of DHHS is also directed to : (1) review annually the results of scientific research in conjunction with the Network to determine whether they warrant revision of quality standards relating to donated HIV-infected organs and to the safety of cross-strain transplantation; and the Network, if the review so warrants, is directed to revise its standards in a way that ensures the changes will not reduce the safety of organ transplantation.
This legislation has been referred back to the House of Representatives and is now in the House Committee on 1) the Judiciary and 2) Energy and Commerce. It was initially introduced by Representative Lois Capps (California) as H.R. 698 and now has 30 co-sponsors. Why not check to see whether your Representative has yet joined as a co-sponsor? If not, call or e-mail his/her office or website to indicate your support. This bill does have bipartisan and bicameral (both houses of Congress) support. Let’s help stimulate our politicians to take a logical step forward to solve the organ shortage, even if it is a small one. Every bit helps.
A live donor may give a kidney, partial liver, partial lung, partial intestine, or partial pancreas.
A deceased donor may give one or both lungs, a heart, a liver (or 2 pieces of a liver for 2 different recipients), a pancreas, a small intestine, two kidneys, a face, two hands, tissue for up to 50 different recipients.
Organs will not be recovered (procured) for donation unless death has been declared by a physician who has no connection to the organ donation team.
Death may be legally declared on the basis of two different criteria. In the first pathway to organ donation, brain death has occurred and has been formally declared. Very specific criteria must be met including: a body temperature of >96.8 degrees, exclusion of drug intoxication or poisoning, absence of spontaneous breathing, absence of movement or responsiveness (except for reflexes), absence of brainstem activity.
Not all individuals with severe neurologic injury will end up with death of the brain. Today, many of us have advised our families or healthcare proxies that we would not like to be maintained in vegetative or moribund states. Families are legally and socially supported in decisions to withdraw supportive care in these circumstances. Following such a decision, a family may be approached about organ donation with the following question: “If your loved one dies within one hour of the withdrawal of support (for example, after the breathing tube has been removed) and a physician who is separate from the organ donation team declares that death has occurred because circulation has stopped, can the organs be rapidly removed for the purpose of organ donation? This is donation after circulatory death (DCD).
When support has been withdrawn from a person with consent for DCD but death does not happen within 60 minutes, organ donation does not occur. The individual will still be expected to die but the focus remains comfort care. No organ recovery takes place because death has not occurred within the timeframe necessary for the organs to remain transplantable.
Brain death is not a natural state. Since a brain dead person does not breathe spontaneously, the heart and other organs (except for the brain whose cells are dead) are kept functional because the person is kept on a ventilator that artificially delivers oxygen into the lungs. However, this is NOT life support because the human being has already died. Thus, 2 references to “life support” in USA TODAY’s 6/15/13 should have been edited. They can still be amended.
The pathway to consenting for organ donation is no longer ambiguous. Each state has its own donor registry. Enrollment now represents legal consent for donation and removes a potentially difficult decision from being your family’s responsibility in the case of your death (at a very difficult and vulnerable time). If you really want to be a donor, please take this step. Only 45% of eligible donors in this country have done so thus far even though 90% of people say they believe organ donation is the right thing to do. Let’s do better.