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.


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!


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?


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.


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.


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.