Monday, December 2, 2013

A WHOLE LOTTA HOPE

After an organized, well fought, and fully bi-partisan effort, the HOPE (HIV Organ Policy Equity) Act became U.S. law, signed by President Obama on November 21, 2013. This new legislation removes the previously existing legal barrier to all research on the transplantation of HIV-positive organs in humans.  Present at the legislative signing were the President-elect of the American Society of Transplant Surgeons, Dr. Peter Stock and the President of the American Society of Transplantation, Dr. Dan Salomon. As previously noted HIV-positive transplant candidates had been legally prohibited from receiving HIV-positive organs by the Organ Transplant Amendments Act of 1988, even though cautious exploration of this strategy (a logical potential step in expansion of the too small pool of donor organs) was widely supported.

The logic thread is based on successful transplant outcomes with Hepatitis C. With this infectious disease, organs from infected (or potentially infected) donors are transplanted into recipients known to already be infected with the same virus. This clever strategy, while avoiding the transmission of a new disease (since the recipients are already infected with it) and thereby causing a brand new problem at the time of transplantation, is actually a means of successfully expanding the too small pool of deceased donor organs. Of course, the recipients must be informed about the donor's infection and asked for consent in advance - many (but not all) do agree to proceed. Long term results of liver and kidney transplants for previously infected recipients have been equivalent for those receiving either Hepatitis C -ve or +ve organs. And, future results in both circumstances may prove even better with the advent of new, highly effective anti-viral Hepatitis C drugs. So, instead of completely wasting the organs from a Hepatitis C +ve donor, they are ADDED to those effectively transplanted - saving lives.

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.

Thursday, August 1, 2013

WHAT EVER HAPPENED TO DICK CHENEY?

Time can fly, especially for transplant recipients. Remember the buzz and controversy surrounding former Vice President Richard Cheney's heart transplant on March 24, 2012 at the age of 71? That news story essentially quieted down after a few weeks. No-one at the national level seemed to notice when the major transplant landmarks of one year graft and patient survival were happily met 4 months ago. And there has been no celebration of his high level return to political life that has occurred insidiously, with interviews and occasional speechs (Dick Cheney full return to active politics 6/16/13 ) popping up. There has been no attribution of his active lifestyle to either the deceased donor's gift, or to the hard work of the transplant team, in part or in whole. What has happened is quite simple. He has re-engaged in his life. Transplantation, the donor's heart, the amazing anti-rejection medications (which the Vice President must be taking reliably) are combining to restore a man's ability to live his life. Whether his politics match yours or not, he is living up to his own previous standards of outspoken opinions on hot, important topics. This is the magic of transplant. If the VP is lucky (and adheres to medical advice and medications, etc) we won't have particular reason to notice his next benchmarks at 3 years either!

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.

Monday, July 22, 2013

EVEN MORE HOPE !

An earlier post on June 19, 2013 delved deeply into the rationale behind the HOPE Legislation currently in the U.S. Congress to permit cautious exploration of the use of HIV +ve donor organs for transplantation into HIV +ve recipients, along with appropriate observational research. At that time the Senate had unanimously passed the bill but the House of Representatives was just beginning to take action.

Now there is good news that on 7/17/13 the Energy and Commerce Committee of the House of Representative also voted unanimously to pass H.R. 698. Additional co-sponsors have also signed on to Representative Lois Capps' bill - now at a total of 51 (12% of the 435 Representatives). Now we await action from the entire House of Representatives.

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.

Friday, July 19, 2013

TRANSPLANT JARGON EXPLAINED

A GLOSSARY OF TRANSPLANT TERMINOLOGY

  • 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.

Friday, July 12, 2013

AMERICAN LEGISLATORS SLOWLY JOINING THE IMMUNOSUPPRESSIVE DRUG COVERAGE EFFORT

U.S. congressional efforts are slowly in process, seeking to close the ridiculous catch-22 that ensnares kidney transplant recipients 36 months after transplantation. This bureaucratic trap halts Medicare coverage of their expensive immunosuppressive medications but resumes payment for dialysis when the resulting rejection causes the kidney to fail. In two prior postings on this blog; March 7, 2013 and  May 27, 2013 status reports on the Senate and House versions of the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013 were provided.


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.

Monday, July 8, 2013

FACE + HAND TRANSPLANTS : NEW NAME, NEW REGULATORY NICHE

Clinical transplantation has moved forward in leaps and bounds, surpassing the speed of the U.S.  government in addressing regulatory standards for new transplant types. This is neither an irrelevant nor a minor issue and has just been definitively addressed by the Final Rule published in the July 3, 2013 Federal Register. The National Organ Transplant Act (NOTA) originally enacted in 1984 had defined a specific list of transplant organs based on all of the transplant types that were performed in that era. The Organ Procurement and Transplantation Network (OPTN) and United Network for Organ Sharing (UNOS) oversee and regulate those types of organ transplantation with a fully developed set of bylaws for member institutions and policies that determine how transplants are undertaken. These transplants currently include:

ORGAN TRANSPLANTS
Kidney
Liver
Heart
Lung
Pancreas
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:

CELL + TISSUE "IMPLANTS/TRANSPLANTS" 

Bone
Skin
Cornea
Ligaments
Stem cells
Peripheral blood
Cord blood
Oocytes
Semen

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 COMPOSITE ALLOGRAFTS 
  1. Vascularized - requires blood flow by surgical connection
  2. Contains multiple tissue types
  3. Recovered from a human donor as an anatomical/structural unit
  4. Transplanted into a human recipient as an anatomical/structural unit
  5. Minimally manipulated or processed (but may be cut or shaped)
  6. For homologous use (i.e., to be used for the same purpose in the recipient as it was in the donor)
  7. Subject to ischemia and therefore stored only temporarily
  8. 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.

Wednesday, July 3, 2013

KIDNEY TRIAGE BECOMING MORE SEVERE

Acknowledging reality, the Board of Directors of the United Network for Organ Sharing (UNOS)  accepted recommended changes to the allocation policy for deceased donor kidneys throughout the U.S. at its meeting on June 24-25, 2013. This policy determines how a specific kidney is offered to a specific waiting patient by defining how the UNOS computer generates the specific list in response to availability of a donor.  In the context of the extraordinary discrepancy between people waiting and the number of organs available, several fundamental problems are intended to be improved with the amended policy (see below).

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.

Monday, June 24, 2013

NO GUARANTEE WITH THIS ORGAN

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.

Wednesday, June 19, 2013

HOPE - A LEGISLATIVE ACT NEEDED IN TRANSPLANTATION

U.S. federal law currently prohibits the transplantation of organs from HIV positive donors - a hold over from an early stage in the HIV era. But today many believe that cautious exploration of the safety of using HIV +ve donor organs for HIV +ve recipients may be a reasonable strategy to expansion of the critically limited organ donor pool. Similar approachs are used (with informed consent from the recipients) for patients and donors infected with the hepatitis B and C viruses, with favorable outcomes.  There was therefore substantial cause for preliminary celebration on June 17, 2013 when the U.S. Senate unanimously approved the HIV Organ Policy Act (HOPE Act; S. 330).

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.

Saturday, June 15, 2013

FUNDAMENTALS OF ORGAN DONATION

Pathways through which people may become organ and tissue donors can be confusing. Pathways to consent for donation (for yourself) while still alive thereby authorizing action upon your own wishes should no longer be confusing.

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.

Wednesday, June 12, 2013

NO POLITICS, ONLY GOOD THOUGHTS FOR A RECIPIENT + GRATITUDE TO A DONOR

If an ABCnews report is accurate, Sarah, the young protagonist  in the lung allocation controversy is about to have her chance. Apparently, someone has died and given the gift of life with the lungs being allocated to Sarah.

This no time for politics. Best wishes to Sarah and her surgical team. Deep gratitude to the donor and his/her family. Their generosity cannot be described in words.

PROFESSIONAL RESPONSE TO PLEAS + DIRECTIVES FOR LUNG TRANSPLANT ACCESS

Challenged by the public, the legal system, and by recognition of the validity of concerns about possible unfairness to pediatric patients in need of lung transplants, the transplant community has responded rapidly. On Monday, June 10, 2013 the 16 member Executive Committee (and invited guests) of the  United Network for Organ Sharing/ Organ Procurement and Transplantation Network (OPTN) convened a meeting by conference call to review data, policies, and input from various sources pertaining to the allocation of organs for lung candidates age 11 or younger. The meeting agenda included:
  • Statement from the American Society of Transplant Surgeons + American Society of Transplantation
  • Letter from the House of Representatives' Doctors' Caucus
  • Letter from Senator Robert Casey 
  • Statement from Stephen Harvey, Esquire (attorney for the family of a critically ill pediatric lung candidate) 
  • Comments from 3 other Committees (Ethics, Thoracic and Pediatrics) 
  • Correspondence with Secretary Sebelius of HHS
  • UNOS data about lung transplantation
  • Current lung allocation policy
The outcome was a unanimous vote to effect an immediate change to policy  Policy 3.7.6.4 (Lung Candidates with Exceptional Cases) to permit transplant centers to request prospective review and additional listing (for adult lungs) of pediatric cases age 11 or younger from the Lung Review Board. This policy change will expire on July 1, 2014 pending reconsideration by the entire UNOS/OPTN Board of Directors and additional study and recommendations of the Policy from relevant Committees.

This is an example of the system and the transplant community at its finest. A data driven, comprehensive review with input from all stakeholders. Transparency in the processes defined and executed as outlined, and fully shared with the public (follow the links above). Making the best possible judgement while simultaneously acknowledging the tragedies to befall those receiving the short ends of allocation straws.

But, it would be so wrong to celebrate a process when the lives of dying patients are at stake. This system does not serve them all. It cannot unless we become more successful in addressing the organ shortage. Register now to be an organ and tissue donor. Become an effective ambassador for this cause and these patients. Join our team.

Monday, June 10, 2013

JUDICIAL INTRUSION INTO ORGAN TRANSPLANTATION?

Desperate transplant candidates and families caught in the vast organ shortage in the U.S. should not be criticized for turning over every rock in search of a life-saving organ. But they can not all be winners who receive an organ within the allocation system. The discrepancy between supply and demand is simply too great. (register now to donate) This system of distribution has been devised over years, by multi-disciplinary teams of highly knowledgeable stakeholders (including patients and families) through transparent and democratic processes (Organ Procurement and Transplantation Network Policies). It is imperfect but iterative. Improvements are made. When a gap is identified within this incredibly complex set of policies, a process is followed to fix it. When an unfairness is perceived, a similar process of debate is initiated. Action - or not - is taken. Unilateral decisions that effect multiple patients are not made by individuals, any of whom has an intrinsic bias of one sort or another.



A recent bypass of this set of checks and balances was created when a Federal judge temporarily ordered the Secretary of Health and Human Services to alter the allocation scheme for an individual patient's benefit (temporary restraining order).  This precedent has already generated legal action from at least one other patient seeking similar protection. One can only imagine the potential legal responses from the candidates who may be disadvantaged as a result of the relative advantage afforded to the original plaintiff/claimant. After all, this is a zero sum circumstance in which one patient's benefit comes only at another patient's loss.

Similar uninformed meddling in the transplant field on behalf of a patient came from a Mississipi judge who granted parole to one female prisoner with kidney failure on the condition that her similarly paroled sister donate a kidney to her. Unfortunately, neither had been accepted by a transplant program and both were declined because of obesity.

Legal intrusion into medical arenas as complex as the area of pre-transplant organ allocation +/or transplantation is not likely to facilitate better regulations, more transplants or a fairer system. The only actions that can effectively do so are successful efforts to diminish the organ shortage by individuals who register to donate and organizations that make broad efforts to support donation.

Caution is warranted to avoid generating chaos similar to a crowd surging to find a space on a lifeboat. While all involved are undoubtedly well intentioned, it may be most appropriate to consult knowledgeable persons in the transplant field prior to taking actions that may have far reaching consequences.

Thursday, June 6, 2013

COMPELLING PATIENT WITH A POIGNANT STORY

The moving story describes a person desperately in need of an organ transplant(s) that may not happen in sufficient time to avert death. We learn that  (first name) (last name)  is ____ years old. He/she has failure of the (heart, intestine, kidneys, liver, lung, pancreas - circle all that apply) caused by ___________(fill in disease name).  He/she is a mother/father/daughter/son/sister/brother/husband/wife/other  (circle all that apply). When healthier, his/her time was spent in work/study/other for ____________. The primary reason that (first name) wants to be transplanted is to "_________________" (use patient's own words). Others want him/her to receive an organ(s) so that ________________.  He/she has been waiting on the list since (fill in month or year, whichever sounds more compelling) but is losing hope.

This bare boned, generic outline of a person dying from organ failure and hoping to benefit from a life saving organ transplant describes virtually all of the patients actually waiting for organs.

It may seem callous to distill a real person's desperate hope for transplantation into such a brief, apparently generic story as simple as the one that was sketched out above. Indeed, each of the >118,000 people waiting for organ transplants in the U.S. and thousands of others around the world does have a unique lifestory to tell that is truly heart wrenching when fully appreciated. Each is a real human being with a life partially lived but also partly unfulfilled. Each wishes to live longer. Some will. Some won't. When the details of that human being's life are stripped away from the relevant story outline leaving the virtually naked transplant candidate waiting in line without accoutrements, it becomes more feasible to assess the legitimacy of that person's claim to transplantation. But how to do that?

The only reasonable way to decide who will be winners is to have a transparent system of rules that applies to everyone and cannot be altered because one person's story is related in an especially compelling manner.
This system will necessarily seem harsh and unfair to the losers. It will probably also seem harsh but fair to the winners. And this system is administered by computer, not human beings.

It should not be forgotten that this is a "zero sum" situation. When one  patient with a poignant story wins, another deserving, compelling patient loses - and dies. Each is represented by a transplant team fully invested in their survival. They may even be listed at the same transplant center. In that case the same transplant team (real people with real feelings) deals with both the joy of caring for a surviving patient and the sorrow of caring for a non-survivor.

The only reasonable outcome is for every reader, for everyone who cares about one or more of these patients, and for every person who understands that some day they too may be telling their own story in the hope of being a winner, to work earnestly addressing the organ shortage. Register to be an organ and tissue donor now......tell your family.......and ask others to do the same.

Friday, May 31, 2013

RESPONSIBLE JOURNALISM WANTED: DEAD OR ALIVE - NOT BOTH

Determining that a human being has died is not an arbitrary process. It does not happen solely on the assessment(s) of untrained observers. And importantly, it does not necessarily follow the temporary absence of a beating heart. If it did, the majority of surviving heart bypass patients would be considered to have died and been resuscitated. Cessation of the heart beat (and motion of the heart) is necessary (for most patients) during that operation so that the vein graft can be safely sutured to the blocked coronary artery. The accurate interpretation of those events is that the heart has been arrested, blood has been circulated to the brain (and rest of the body) by the heart-lung bypass machine while the vein graft is delicately connected, the heart has been restarted (with an electric shock) and the patient has awoken following a standard procedure. The patient was alive throughout.

Journalists reporting about deaths or near-deaths must understand and adhere to these fundamental concepts to avoid misleading the public. Use of the terms "death" and "clinical death" must be reserved for specifically defined circumstances, not casually applied for dramatic effect. Unfortunately, in their zeal to report a recent heart-warming and highly emotive story, both FOXNews and CNN made errors that should not be expected from them. It appears that a pregnant woman suffered a sudden cardiac arrest, was supported with CPR by co-workers, had her heart restarted with a defibrillator, was taken to a hospital where an emergency C-section was performed, had a pacemaker inserted and is alive 3 months later. A wonderful story of skill and resuscitation. The problem is that both news agencies reported that the woman died and came back to life!  In contrast, it seems clear that she had never met the clinical definition of death - fortunately.

If highly reputable reporters cannot distinguish life from death - or do succumb to the temptation of sensationalist reporting without honoring an obligation for accuracy about use of those terms - how can we expect the average person to comprehend the end-of-life scenarios in which organ donation becomes possible? Such high profile stories seek and do grasp the public's attention, perhaps seeding subconscious beliefs about an inability to truly identify death or recognize a potential for resuscitation. Such subtle misleading messaging may be quite harmful to trust and to organ and tissue donation even if that was unintended.

Consistency (and integrity) in all communications about the definition of death is essential to promote the type of public trust in the medical system that will save lives when consent is granted for organ and tissue donation. Subliminal messaging evolved from publicized stories of miraculous recoveries from death, when death did not actually take place, is counter-productive and costs lives. If you come across other egregious examples of inaccurate reporting, please post a Comment on this blog. Shining the bright light of publicity on these unfortunate stories may help to reduce their frequency.

Monday, May 27, 2013

UPDATE: SIGNIFICANT CONGRESSIONAL PROGRESS ON IMMUNOSUPPRESSION CATCH-22

Progress in Congress is exciting. Slow progress is better than none. The awful immunosuppressive drug Catch-22 that limits Medicare coverage of the anti-rejection drugs for renal transplant recipients to (80%) for 36 months, jeopardizing both the kidneys and patients if they can't afford the medications and resulting in a return to expensive dialysis - which is again supported by Medicare, has been approached with new bi-partisan legislation in Congress. Since my blog post of March 7, 2013 the mate bill to Senate Bill S323, HR 1428 has been introduced by Representative Burgess (R-TX ) on April 9, 2013 and was sent to both the House Ways and Means Committee and the Health Sub-Committee of the House Energy and Commerce Committee.
Multiple new sponsors have "signed on" to each of the two bills currently sitting in their respective House and Senate committees. In congressional/political language this is highly significant progress.

New supporters of Senator Durbin's Senate Bill S323 include Udall (D-NM), Wicker (R-MS), Gillibrand (D-NY) and Whitehouse (D-RI). This brings the number of co-sponsors to 9, and the percentage of senators clearly supporting the bill to 10%.

HR 1428, the House version of the Comprehensive Immunosuppressive Drug Coverage Act for Kidney Transplant Patients Act of 2013 now has a total of 45 co-sponsors. Newest supporters include Johnson (R-OH), Latham (R-IA), Lofgren (D-CA), Posey (R-FL), Roby (R-AL), Tierney (D-MA), Schock (R-IL), Smith (D-WA), Levin (D-MI), Payne (D-NJ), Gosar (R-AZ), Lipinski (D-IL), Moore (D-WI), Braley (D-IA), Ellison (D-MI), Schwartz (D-PA), Bonner (R-AL), Connolly (D-VA), Hurt (R-VA), Lowey (D-NY), Courtney (D-CT), Pingree (D-ME), Owens (D-NY). Together with Burgess, the original sponsor, that makes 46/435, 11% of representatives clearly supporting the bill in the House.

As stakeholders and constituents who are eager to support this bill (to change the Catch-22 and save these kidneys and patients) our action steps are to make our voices heard. Phone calls and/or e-mails to our own politicians WILL be noticed if they come in sufficient numbers. Constituents' opinions do matter to politicians. Follow the steps outlined here to be heard. I can report e-mailing my own representative, Dan Maffei (D-NY) but receiving no response. To coordinate with the posting of this blog, I will reach out to him again. Let us know in the Comments section of this blog what your experience is!


Thursday, May 23, 2013

NOW A LIFE IS SAVED WITH AN EMERGENCY FACE TRANSPLANT IN POLAND

What happens when the center of your face and skull are suddenly destroyed by a machine meant to cut stone.......and you don't die. Amazingly, Grzegorz was kept alive by healthcare teams in Poland for three weeks but had no ability to speak or breathe independently. The raw surfaces that had been grotesquely cut left him vulnerable to infections of the bone, central nervous system, throat, bloodstream, etc. By reports, his medical condition was deteriorating, as one would expect. How could he live this way for long? His Polish doctors arrived at a dramatic solution - one they felt technically prepared to perform though it had never before been attempted or accomplished. An emergency face transplant  was necessary to save his life. And they succeeded, at least in the early phase. The transplant was one week ago. So far, so good! And now there is a short term survivor. Thanks to their expertise and hard work......and thanks to the gift of the deceased donor.

Within a few years of the very first face transplant having been performed, world citizens are almost insensitive to the magnitude of the evolutionary steps we are so rapidly witnessing. Yeah, just another face transplant - what's the big deal?! Well, the big deal in this situation is truly enormous. First, the concept of successful face transplantation had already been established.  When Grzegorz was in need, the procedure had already been developed and was in his surgeon's repertoire. Though the Polish team had not performed a previous face transplant, they had prepared as best they could on the basis of the limited, collective world experience. No one could have completed their own "learning curve" for this procedure yet since fewer than 30 cases have been performed worldwide. This is what innovative and bold surgeons do best. We must find ways to promote, not suppress these tendencies in surgeons when they are appropriate. Look at the result!

Whether Grzegorz lives (as we all fervently hope) or dies, it seems that this face transplant was really his only chance. Without having reviewed his records (which I have not) it seems that what distinguished his injury from the other face transplant recipients was the depth of the wound and exposure of the protective layers of the brain. These features were probably why his team felt that infection(s) would inevitably cause his demise if covering to the portals for micro-organisms could not be established. And those infectious critters were in plentiful supply because of the simultaneous injuries to the respiratory and oropharyngeal pathways, each of which harbor abundant quantities. The desperately required covering was the bone and soft tissue of the face that was transplanted. Could a face be found and transplanted before irreversible and lethal infection set in? This is what we are all waiting to learn. Was the patient's life still salvageable? Was the gamble worth it?






Friday, May 17, 2013

IS FOCUSING ON "PATIENT SURVIVAL" REALLY IN OUR PATIENTS' BEST INTERESTS?

Healthcare stakeholders are "buzzing" about the QUALITY of healthcare - rightfully so. As in other arenas, excellence is easily recognized and can be magnificent but is difficult to achieve. A central issue in the ongoing discussion is how to measure and describe points along the Quality spectrum with sufficient accuracy for patients, payers and providers themselves to make decisions based on the results.  How do we deliver care? When do we deliver care (is it timely?)? Are  the outcomes of care are what they should be?  Even whether end of life care was compassionate and competent are some of the questions being asked. In the field of transplantation, even the most basic outcome measure - Patient Survival 1 Year Following Transplantation -  already in use by United Network for Organ Sharing (UNOS)  and Center for Medicare and Medicaid Services (CMS) (and virtually all healthcare payers) to determine whether or not transplant centers meet regulatory expectations, has multiple imperfections as a quality measure.

Let's examine why use of the 1 Year Patient Survival measure to assess the quality of care at a specific transplant center is so tricky. If an imaginary center called the "Chimera Center" has a 1 Year Patient Survival for liver transplants of 100%, it would appear to be doing an excellent job, right? In fact, to achieve that rate, the Chimera team may have turned down patients that were quite sick and, they feared, had too high a likelihood of not surviving the transplant. But, at least some of these patients would likely have been considered acceptable candidates at other transplant centers, and were therefore being denied access to transplantation. Similarly, the Chimera team may have been too "selective" about which organs they accepted for transplantation - again denying patients adequate access to transplantation.

The (mythical) Chimera team that appears to deliver outstanding quality liver transplantation might also be loathe to participate in clinical trials of new drugs or therapies for their patients because of potential adverse impact on their center's patient survival rates. So, unfortunately, the regulatory focus on patient survival rates tends to impede clinical research that may offer advances in transplantation.

If the Chimera Center's most recent 1 Year Patient Survival rate was significantly below the expected rate, any of the factors discussed above may have been responsible. However, it is also possible that the transplants were not well performed, the care during the first post-transplant year was sub-optimal, or there was a combination of both issues. Regardless, changes would be required within the Center's approaches. But, now the Center will have difficulty persuading payers to allow subsequent transplants to be performed at Chimera. This negative selection bias will drive away the best quality patients (however that is measured) and tend to leave the sickest patients for transplantation at Chimera. The Center will therefore be facing a major uphill battle to re-establish a good 1 Year Patient Survival Rate even if all of the appropriate changes have been implemented. Local patients will still have limited access to transplantation because of the challenges of traveling to remote centers and the issues facing Chimera.

This issue of clinical data measurement is front and center in the field of clinical transplantation. The annual American Transplant Congress is about to begin in Seattle, Washington. Stay tuned for updates on this and other topics in subsequent posts.




Monday, May 6, 2013

TISSUE ENGINEERED KIDNEYS + TRACHEA ARE NEW ON THE BLOCK

Tissue engineers strive to construct whole organs for clinical reconstruction or transplantation from components that did not naturally co-exist or may not even be natural. The world has been in a bit of a tizzy because of two different and unrelated advances that became public within two weeks in April, 2013. In the first, kidneys whose cells were removed but whose microscopic infrastructures were kept intact, were reconstituted with two types of cells (epithelial and endothelial). The kidneys (from rats) exhibited some function both in the laboratory and when transplanted (small amounts of urine in rats). In the second, a 32 month old child whose own trachea did not develop, received the world's first bioartificial trachea  engineered from an artificial nanofiber scaffold and stem cells taken from her own bone marrow. In both cases tissue engineers have accomplished incredible feats.



Just imagine the sequences that could result. Rat kidneys that function after transplantation might lead to the ability to engineer human kidneys following the same principles. Suddenly, there might be a way to help the 100,000 people currently waiting for deceased donor kidneys in the U.S. Others who dared not even dream of trying to qualify for a transplant might now do so.

Clinical success with the bioartificial trachea is even more stunning. Direct application of translational science in a living person. Since the living cellular component is her own, there is no expectation of rejection. No need for immunosuppressive medications. What a win-win situation! How many other ways can you imagine using bioengineered body components to fill in missing body parts caused by congenital defects, disease or trauma? Perhaps now the cause for excitement is clear.

We should also take particular note of the timing of these two announcements. Unlikely that serendipity is involved. Maturation of multiple skills, technologies, concepts and prior developments in a field often combine to make a ripe environment for talented researchers to work in - a sort of perfect scientific storm. These leaps forward could probably not have occurred twenty years ago. But today, the time is right. Let's hope that other exciting announcements follow.

Thursday, May 2, 2013

WHY TRANSPLANT A UTERUS?

Roughly half of humanity does just fine without a uterus. The rest of us only experience function during a minor (approximately 12 -48 years of age) portion of our life cycle. While even those years of uterine function remain essential for the survival of our species (despite the amazing reproductive technologies available today), they are not for the individual's survival. For this reason, a uterus- of which there has been one publicly known successful transplant survivor to date - falls into the category of "Quality of Life" transplants. Different from the other organs in that category - the hand, face and larynx-, this is the first vascularized (with a specific reattached blood supply) organ transplant of any type that is intended to be temporary. What a mind boggling concept! It seems that the patient and transplant team expect to stop the anti-rejection medications and remove the uterus following the conclusion of child bearing. Quite logical actually. Why keep a woman on immunosuppression one moment longer than necessary?

Still, this new area raises revolutionary questions.
  • Does it make sense to try to control the immune system's response with potent drugs that can cause life threatening infections and cancers just for a few years and to hope for recovery of that system through withdrawal of the medications and (presumably) the uterus? 
  • Will the immune system recover back to baseline? Are experiences with failed kidney transplantation an appropriate model?
  • Are there long-term consequences for the patient? 
  • Who should pay for the privilege of this non-life saving transplant?
  •  Are there really enough resources available to support widespread use of a therapy that is not required and may indeed be harmful? 
  • If not, and it will only be available to wealthy individuals, should they be permitted to engage the nation's network of donor identification and the organ allocation system in order to find the needed uterus? 
  • If not through that means, how will they find a uterus?
  • Is it reasonable to intentionally expose a helpless fetus to development while receiving immunosuppressants? To the unknown impact of growth within a transplanted uterus? Who should consent for that fetus?
  • Since all nerves to the uterus were cut when it was removed from the donor will the patient/recipient feel contractions (!)?

Yet another typical day in donation and transplantation. A real life situation that could not have been imagined if one had tried. Never a boring day. Trying to achieve equity. Failing to do so because of the resource shortfall. Ethical twists and turns. Learning something every single day.

Those who have never faced infertility issues may not fully understand the strength of the drive for procreation which must be the motivation for a uterine transplant. Among the amazing range of available reproductive technologies, none quite match up to this one. The closest, the use of a gestational surrogate to carry your pregnancy is still not the equivalent of carrying your  own pregnancy, to feeling life within your body, or to delivering your own child. The patient's interest in this transplant is quite understandable. Whether the investigators should perform it when more standard approaches would likely produce a baby with greater certainty is the key, new question on the table.

Thus far, the world has been notified that a first pregnancy has occurred through in vitro fertilization (IVF) and is six weeks along. This patient was also the world's first successful recipient of a uterus transplant. Since then a Swedish team has performed 2 successful mother-to-daughter uterus transplants. Despite the questions and reservations that come to mind, this incredible step in the science and medicine of transplantation now involves a real woman (her name is Derya Sert) and her fetus (with an audible heartbeat). It will be a privilege to provide subsequent comments on even more progress as they share their experiences with the world.



Sunday, April 28, 2013

CITIZEN ACTION NEEDED TO HELP KIDNEY PATIENTS - AGAIN

U.S. kidney transplant patients are caught in a political/fiscal Catch-22 that leads to cessation of Medicare coverage for their anti-rejection medications at approximately $10,000 to 20,000 per year, 36 months after transplantation. A proven outcome for some patients has been failure of the transplant with a return to expensive dialysis - again paid for by Medicare, this time at an approximate cost of $70,000 per year. Ridiculous, right?

http://www.govtrack.us/congress/bills/113/hr1428#
Ironically, this dilemma fits well into the mutual history of kidney disease and Medicare. We now take Medicare coverage of dialysis for granted. But it was an individual citizen's definitive and courageous act that helped establish that new entitlement forty years ago. Shep Glazer, a 43 year old husband, father and salesman, supported by the precursor organization to today's American Association of Kidney Patients,  and other stakeholders, opted to be openly dialyzed on the floor of the Ways and Means Committee, stunning everyone on November 4, 1972.  His "excellent testimony" made the point. Chronic kidney failure was adopted into the Medicare program in October 1972.

It appears that Congress may now finally be committed to fixing this medication coverage problem.  Another step has just been taken on the legislative pathway, but a few major ones are still required (make it out of House and Senate Committees, approval by House, approval by Senate, negotiation + agreement by House + Senate members, Presidential signature). Kudos to Representative Michael Burgess from Texas who introduced the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013  
into the House of Representatives on April 9, 2013. The House Bill was referred directly to the House Ways and Means Committee on the same day and matches the Senate Bill previously introduced on February 13, 2013 by Senators Durbin and Cochran. Both would remove the medication coverage cliff awaiting patients at 36 months following kidney transplantation.

Noted clearly on the government website is the low percentage of bills that make it out of Committees for consideration by the entire House or Senate; only 13% of House bills and 1% of Senate bills succeed to the next procedural step. If our dual immunosuppressive bills don't make it out of their respective committees, they will be "dead" and the Catch-22 will continue. This is where your help is needed - really. We must help push these bills out of committee for consideration by the entire legislative bodies.

Politicians respond to their constituents, especially when significant numbers of citizens make the effort to respectfully express an opinion through the system. To date, it appears that only 35/435 Representatives have signed on as co-sponsors of the Burgess bill, and 5/100 Senators have signed on as co-sponsors of the Durbin bill. Many of our legislators need to hear directly from us about these bills.

Spend some time now confirming the identity and contact information for your own Senators and Representative.   If your politician has already "signed on" to the appropriate bill (the Senate bill for a Senator, the House bill for a Representative), call or e-mail to say; "Thank- you for signing on to the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013".  If the individual has NOT YET signed on, indicate that you believe that signing on is important - and why.

Special effort should come from constituents who live in the districts and states of the House Ways and Means and Senate Finance Committee members. They include:



You will be joining an important and proud tradition of citizen voices shaping Congressional action. Shep Glazer's personal action was considered "excellent testimony" and made a real difference. Your personal phone calls and e-mails will be too.

Wednesday, April 24, 2013

< SIX DEGREES OF TRANSPLANT

Organ donation and transplantation have steadily become so intertwined with the cultures of the developed world that it is difficult NOT to find connections to our own lives. Just this weekend while spending time away with family, I personally fell upon two different and poignant true life transplant tales.

In the first, the woman arranging the new lease on my daughter's (a college freshman) first apartment was unusually helpful - almost motherly in her patient approach. We had established an easy working relationship on the prior day when I scouted the building ahead of my daughter. Despite being kind, her thoroughness and professionalism had provided me with confidence and reassurance that my daughter would be in a well run facility. I was therefore stunned when her placid face and smooth toned voice changed suddenly as she looked at my responses to the form on which I promised to back up my daughter's credit. The words she spoke made no sense; "I pray for you every day", she said.  I did not understand the sudden appearance of tears either. But then she asked; "Are you really a transplant surgeon?" and her story spilled out.

I had been right in my assessment of her maternal nature. Her own daughter was a transplant recipient, having received her father's kidney 30 years ago at the age of 8. The family had traveled to the U.S. seeking the transplant that was unavailable at home. Tragically, the donor/father/husband was murdered by terrorists back at home a few years later. Subsequent successful life led to the young transplant recipient's natural desire for procreation which carried risk for the potential mother and her kidney. So, the woman/leasing agent became a surrogate mother for her own grandchild, to protect their daughter and the transplant. Years later the kidney still functions well, the daughter works full time as a professional and is the mother of a successful young person. Now I believed this woman's description of her daily prayer for all transplant surgeons.

Secretly hoping that my daughter was as moved by this woman as I was, I returned to find my young niece back at home. Again amazed, I listened while she recounted the adventures of a classmate who had recently missed many weeks of school because of a live donor kidney transplant. Now she was happy that he was back most of the time, except for doctor's visits. He was even well enough to join her in physical education activities approximately 50% of the class time!


Either I have the same type of powerful, natural attractant for people connected to transplantation + donation that I do for mosquitoes, or these fields of medicine/translational science have had enormous impact on society. The facts clearly support this success. Just in kidney transplantation, recent data show growth to an incredible number of prevalent (currently alive with a functioning transplant) patients just in the U.S. of 179,000 patients in 2010. (By the way, note that only 15,000 recipients were alive in the era of the leasing agent daughter's transplant - a rare and marvelous success story stoked by the support of her mother/gestational carrier.) There is no simple means of equivalent, accurate tracking for patients with other types of transplants.

My own experience in speaking to audiences about these topics is that roughly 25% will raise hands to indicate that they have personal contact with these worlds. Still more subjective confirmation that it would take less than 6 degrees to connect most of us to transplant. Would that just as many people will join organ registries, especially during this April - Donate Life month. I WILL love to fall upon and recount even more dramatic - and true - stories yet to come.

I am currently grateful to the leasing agent for permitting me to share her story with you.






Thursday, April 18, 2013

Transplants Bridge Divides

A 16 year old Pakistani girl received an urgent live donor liver transplant in India two months ago. Previously an Israeli suicide bombing victim donated a kidney to a Palestinian woman. Conversely, a Palestinian man's heart now circulates the blood through an Israeli man's body. All of these cases illustrate how organ transplantation can move individuals and their surrounding peoples to bridge epic political divides so that the right thing happens. Tragedy morphs into triumph.

Such beautiful selflessness is sometimes seen even within families suffering the serious pain of separation. When Richard Leakey, the renowned paleoanthropologist and conservationist needed a kidney transplant in 1979, his brother Philip donated an organ that then functioned for 26 years. Philip interrupted his own political campaign for the Kenyan parliament to undergo the procedure, indicating that, "There is a strong family bond" according to People magazine. Less emphasized than that act of heroism (every live donor is a true hero) was the fact that the two brothers barely spoke during 20 years despite the transplant, according to the Philadelphia Inquirer in 1995.

Behind closed doors, those of us privileged to work in this field often participate in similar stories in which an act of live or deceased organ donation and the subsequent transplant accomplish a connection that had seemed virtually unimaginable or reestablish a bond that had seemed unbreakable. These moments are spectacular even for we crusty old healthcare veterans - good exposed beneath tough outer human shells. Neither contrived nor fictitious, the moments are glorious.

Every plain vanilla case of donation and transplantation is glorious too. When reduced to the smallest scale, every live donor has accepted personal risk to save the life of another, regardless of who the donor is. Any deceased donor's organs and/or tissues have been gifted to save or better the lives of others, without qualification by demographics. Each recipient has gained a priceless opportunity to remodel or extend life without entitlement, no matter where the organ originated.

Failure to appreciate the magnificence of what is indeed now taken for granted is a mistake. If it takes "bridging" transplants to help  refocus on the amazing altruistic potential  that does lie inside us all, then more of these stories must be told. Perhaps some who would not otherwise have done so will be moved to register to become organ donors. After all, if Palestinians and Israelis, Pakistanis and Indians can help each other, can't we all do so? And again, let us not overshadow the everyday tales of donation and transplantation that are equally compelling if perhaps somewhat less dramatic.

Sunday, April 14, 2013

Now the US Will Use Prisoners' Organs Too!

News stories of "donated" organs from executed Chinese prisoners being transplanted have horrified the transplant community because of concern about the lack of donor consent and other corollary ethical issues. Now comes news from the first of our fifty states to have torn down legal obstacles to the same practice. On March 28th, Utah's governor Gary Herbert signed legislation, H.B. 26, that expressly permits prisoners to make anatomical gifts if the inmate dies while in the custody of the Department of Corrections. Death row inmates are not excluded. With passage of the bill, the names of 247 inmates who expectantly signed organ donation documents have been added to the state donor registry according to JoNel Aleccia, writing for NBC news.

Pro arguments for the use of prisoners' organs include the desperate need for more organs to stem 18 deaths per day on the U.S. wait list for transplants. And why should commitment of a crime serious enough to land a person in jail necessarily imply an inability to give informed consent for organ (and tissue) donation? Should inmates really be denied the right to make one or more altruistic acts upon their death? Is the notion of reforming a human's ability to behave honorably a complete lost cause?

Con arguments abound as well. Today, we would consider any prisoners' organs to fall within the definition of "CDC high risk" because of the increased prevalence of HIV infection. Would a jury and judge feel more at ease sentencing a defendant to death knowing that organ donation was already checked off on the driver's license?

Reality can be unpleasant
Without absolute answers to any of these questions, a practical issue arises. Once an organ recovered from a Utah prisoner organ enters the national UNOS system, it will be allocated to a patient somewhere in the U.S. That patient may be located outside of the state of Utah. Similarly, tissue may be distributed throughout Utah, Idaho, Wyoming or Nevada, according to the Intermountain Donor Services 2012 Annual Report. The anonymity that is intrinsic to both organ and tissue donation systems assures that recipients will not be informed that their anatomic gifts were donated by a prisoner, regardless of their state of residence. Thus, passage of the Utah law implies that the entire U.S.  is now engaged in the practice of using organs from prisoners.

Reality can be unpleasant. The organ shortage is terrible. Commission of a crime serious enough to land a person in prison merits serious punishment. So long as transparency is retained within a system that requires informed consent of donors and recipients, this new law may be an important step forward for inmates and transplant candidates. Utah has dragged the entire U.S. into an ethically challenging arena. The implications must be clarified and openly acknowledged. Alternatives are not readily apparent, especially to those who can expect to die waiting for organs not otherwise available.

Wednesday, April 10, 2013

Every Transplant Surgeon's Learning Curve

Who should be selected to perform a transplant, a surgeon who has performed 100 prior transplants or one with the experience of 500 previous cases? Most of us would indicate that the more experienced surgeon is the obvious choice. We are intrinsically responding to the desire to have a surgeon who has moved farther along or completed his/her learning curve for that transplant. Noone wants to participate in the early portion of a surgeon's learning curve, do they?

Although that is a logical response, it is also unrealistic. Every surgeon - every single surgeon - has had a personal learning curve. The surgeon should still have active mini-curves for new devices and new procedures that are relevant to his/her practice. No surgeon has been pre-loaded with any of the knowledge, skills or judgement that comprise surgical experience. And, how are new surgeons going to be trained, or experienced surgeons going to learn new procedures (think of when the laparoscopic donor nephrectomy was first introduced) without passing through a respective learning curve. The answer is that they won't.

Patients are protected during learning curves through the collective efforts of transplant teams which mitigate (disperse) most of the risks. This is a specialty that still preserves the old fashioned concept of surgical training as a type of apprenticeship. Trainees are guided and supervised day in and day out by the same mentors who come to know them very, very well. These mentors know their strengths and weaknesses and specifically help to hone their skills both in and out of the operating room. Independent responsibility is permitted on a graded basis and is earned based on performance. The senior mentor is physically present, assisting the learning surgeon but also prepared to assume control if necessary - similar to the 2 pilots in a cockpit. This is the system that protects patients. And, it is a major part of why a transplant team is judged on its collective performance, rather than on the individual providers' outcomes.

Notable too is the challenge of determining when the highly experienced but aging surgeon should stop - or be stopped - from personally performing surgery. This sensitive issue is also mitigated through the team approach, allowing valuable experience to still be put to genuine use.

If it is unreasonable to expect that only the most accomplished and senior (but not too senior) transplant surgeon will be operating, what are reasonable expectations? The identities and backgrounds of those surgeons who participate on the team should be made accessible.  But, presence of a specific transplant surgeon at a transplant center does not translate into accessibility for a specific procedure unless it is a live donor transplant. Deceased donor transplants simply are not scheduled in advance. Consequently, the team's on call structure is very important and determines which surgeon(s) will participate. This reality should be clarified at the time of pre-transplant education. The patient should be able to expect to have a surgeon who has progressed far along a relevant learning curve(s) participate in the impending transplant and should feel empowered to ask directly whether or not this is the case.

Comments from patients and other stakeholders on this post are welcome - please participate in the Comment space below.


 

Friday, April 5, 2013

Depression Treatment Linked to Longer Transplant Survival

An elusive goal, the ability to favorably impact LONG TERM survival following liver transplantation has just been reported for the first time from the University of Pittsburgh in the American Journal of Transplantation. Earlier posts have focused on the emergence of a new Quality of Life Era of transplantation because of our ability to predictably overcome routine EARLY surgical and immunological challenges.  Rogal and collaborators now show that adequate depression treatment with medication(s) within the first year after liver transplantation for alcohol related disease is more strongly linked to the patient's survival at ten years than other risk factors. More strongly linked to survival at ten years than how ill the patient was at the time of transplant. More strongly linked to survival at ten years than the absence or presence of Hepatitis C.



Why is this so significant? Because it represents a factor that we may potentially improve to improve survival! The overall ten year survival rate following liver transplantation with a deceased donor organ is only 54%, far from what we would like it to be. Judging (extrapolating) from the 25% of patients in this study who were depressed but inadequately treated, the ability to intervene more favorably in one-quarter of transplant recipients could significantly impact the overall statistic. And forgetting about statistics for a moment, wouldn't it be wonderful to offer better therapy to each of those inadequately treated patients?

The question is how to accomplish the delivery of adequate care of a complex patient within the current healthcare environment? Transplant teams don't routinely deliver primary care for their patients and depend on local providers to do so. While psycho-social personnel are key team members, they usually focus most on the pre-transplant and early post-transplant issues. These new important data highlight a possible need to expand that emphasis or, at least, to improve the linkage and tracking of what is happening locally - consistent with the Accountable Care Organization model. Not easy to accomplish particularly without additional resources. Clearly, we will have to find a way.

If, as I suspect, the finding that the adequacy of depression treatment also extends to a strong linkage with long term survival following kidney and other transplant types, monitoring of the mental health medications and (perhaps) services will also require improved engagement by those respective transplant teams. Wow, a lot to chew on. But, at least we have a direction in which to go so that we can potentially make outcomes better.