Transplant Expert by Amy L. Friedman, M.D.

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.

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.

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.

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.

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.

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.

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!

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?






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.