What's Your Perspective?

  • The Value of Upper Extremity, Face, and Uterus Transplantation: A Workshop with the Leading Programs in the U.S. and Funding Institutions

    Andreas TzakisAndreas Tzakis, MD
    Cleveland Clinic

    ASTS, in collaboration with AST, the American Society for Reproductive Medicine (ASRM), and the American Society for Reconstructive Transplantation (ASRT), is organizing a workshop on face, hand, and uterus transplants to take place at the Uniformed Services University on November 8, 2019. Invited are leaders of private and public funding and regulatory organizations. Presentations will be made by the leading active programs in the United States.

    This workshop is a continuum of a symposium convened in Baltimore in 2017. It aims to update our guests on the current state of VCA. Indeed, significant progress has been made since then toward:

    • Establishing the indications
    • Standardizing the procedures
    • Quantifying and presenting the results using common functional dashboards
    • Accumulating more data on cost benefit analysis
    • Collaborating with third party payers to develop reimbursement plans

    VCAs differ in regard to the clinical problems they address, the organs transplanted, and the qualifications and background of the caregivers. Face and hand transplants have a longer history and slow buildup of the experience. Possible candidates nationwide are numbered in the hundreds. Uterus is the most recent. Experience is building more rapidly, and possible candidates are numbered in the thousands.

    Although spotty, coverage of the medical cost has been provided for exceptional cases. These include military service-related injuries as well as with Local Coverage Determinations (LCDs). In general, reimbursement has been an extremely difficult problem.

    One serious obstacle has been the small number of clinical cases performed. Historically, data is sparse and not standardized. Collaboration among centers is highly desirable.

    Abdominal wall transplants, although VCAs, will not be discussed in this workshop because they have been packaged with intestinal or multivisceral transplants.

    The latest addition, uterus transplants, are also very different. They have been segregated from VCAs and are now included with the other solid organs.

    Indeed, the uterus is a solid organ rather than a composite tissue graft. Whereas transplant surgeons play a consulting role in VCAs, in uterus transplants transplant surgeons and gynecologists play a vital role in the development and performance of these procedures.

    The active clinical programs (Baylor Hospital, University of Pennsylvania, and Cleveland Clinic) already share clinical information through regular meetings and conference calls. They have agreed to form a consortium. Sharing will include a database and tissue repositories in order to expedite learning and research as well as training of new staff.

    Pursuing Current Procedural Terminology (CPT) codes for VCAs to enable tracking has been a priority but is a very elaborate process. It has now been reinvigorated thanks to the personal interest of ASTS President Dr. Lloyd Ratner.

    We hope that this workshop will bring face, hand, and uterus transplants closer to acceptance in clinical practice.

    Uterus Transplant: A personal perspective on the occasion of the International State of the Art International meeting in Cleveland (September 6-7, 2019)

    The 2nd Congress of the International Society of Uterus Transplantation is planned to take place in Cleveland on September 6th and 7th, 2019. More than 100 participants are expected to attend. More than 50 uterus transplants and more than 15 babies born as a result worldwide. Lively and informative discussions are eagerly expected.

    My introduction to uterus transplants started when I was a junior staff surgeon at the University of Pittsburgh. A novelist approached me at the direction of Dr T. E. Starzl; his heroine, a renowned transplant surgeon, had to perform a uterus transplant. He did not disclose the plot. The question was: how would she do it?

    I went to my anatomy books and conceived the operation for him. The book was published successfully. I was included in the credits and did not give it a second thought for several years.

    Then, a young woman in her 20’s presented to me at the University of Miami in need of a multivisceral transplant, a transplant which would include all abdominal organs. She had a prior hysterectomy and no children. Would it not be nice to restore everything back to normal?

    A seminal event had just occurred in my own life and made me sensitive: my wife gave birth to our daughter… I will never forget the day our daughter was born. It was a pivotal event, the happiest day of my life, and had an everlasting effect!

    Indeed, I don’t know anything more valuable to my wife and I than our daughter. The thought of adding a uterus to my patient’s multivisceral transplant was insistent. Prudence prevailed and I abandoned the thought for this particular patient. It would be too much risk for an unknown procedure. But what about doing a uterus transplant for patients who could not have children because of lack of a functioning uterus?

    I had to study it.

    Having resolved the anatomical considerations, at least in theory, I had to study the immunology of the uterus, particularly because of its role in the tolerance of the offspring by the mother.

    There were 3 volunteers on the team, eager to participate in the studies: Werviston (Tom) DeFaria, Akin Tekin, and Takis Tryfonopoulos, all surgeons with passion for research. We obtained mini swines, which Dr. David Sachs was kind enough to provide. We designed a heterotopic variant of the operation in order to study the uterus, rejection, its treatment, and the longevity of the graft. The feasibility, at least in animals, was demonstrated.

    By good fortune, while working on the mini swine model, I received an Honorary Degree from the University of Gothenburg in Sweden, home of my good friend Michael Olausson and also Mats Brannstrom, the Chairman of Gynecology who was working diligently with his team, including Michael, on uterus transplants. They were ahead of us!

    It was the beginning of a collaboration that took us to Nairobi, Kenya, and Homestead, Florida, for experiments on primates and then to Gothenburg for the first clinical trial at the Sahlgrenska University Hospital.

    This was a great inspiration, particularly because at that time I was relocating to the Cleveland Clinic, an institution with an excellent record in transplant research and an exceptionally good gynecological program led by Dr. Tommaso Falcone.

    Dr. Falcone expressed some skepticism in the beginning. It took a visit to Gothenburg and meeting the recipients of the transplants to persuade him. It was clear that this was an operation that these women really wanted in their quest to have their own children. Once persuaded, Falcone and his team were perfect partners.

    Contrary to most other programs, our preference for these transplants has been that they should be performed with uteri from deceased donors in order to avoid any risk to a living donor.

    We performed our first uterus transplant on February 24, 2016. It was the first attempt in the U.S., which unfortunately failed due to a fungal infection which caused a rupture of one of the arterial anastomoses.

    As a result, there was a very elaborate review of our trial.

    In the meantime, the excellent team at Baylor Hospital in Dallas, Texas, led by Drs. Testa and Klintmalm, with the assistance of Drs. Michael Olausson and Liza Johannesson of the Gothenburg team, performed the first successful uterus transplants in the U.S., which resulted in the births of 2 healthy babies. These were the first babies in the U.S. born from transplanted uteruses.

    We resumed our program as soon as all necessary precautions were taken to avoid another infection. We have now performed an additional 6 transplants, 5 of them successful. One of them resulted in the delivery of a beautiful, healthy baby this July.

    That baby was the first born from a deceased donor in the U.S. and second in the world, confirming the efficacy of this approach.

    Uterus transplantation is evolving rapidly, even in today’s heavily regulated environment. We hope it will be a valuable option to the many women who cannot have children simply because one non-vital part of their body is missing.

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  • Searching for What Defines a Good Outcome After Transplantation

    robert montgomeryRobert A. Montgomery, MD, DPhil, FACS
    NYU Langone Transplant Institute, NYU Langone Health

    Three weeks before my heart transplant in September 2018, I was lecturing at a transplant meeting in Matera, Italy. It was there that I suffered 4 ventricular tachycardic arrests, one after the other.  The next morning, I signed myself out of the tiny hospital in Matera against medical advice with an IV in my arm and boarded a commercial flight back to the U.S. accompanied by a friend who carried a fist full of pre-loaded resuscitation syringes, compliments of the worried Italian doctors. I was rapidly evaluated and admitted to the NYU intensive care unit to wait for a new heart. I had an RO1 grant due the day after my transplant. My first call after my surgeon offered me a new heart at 4 a.m. on September 20th was to my co-PI letting him know he and our staff would have to get the grant across the finish line.

    Within days of my transplant, I began making decisions and doing academic and administrative work from my hospital bed. I would meet with my assistant each day and we would go over essential items that needed to be acted upon. I was 10 days in the hospital and upon discharge began a routine that would continue for the next 2 months: blood draws, heart biopsies, doctors’ appointments, and cardiac rehabilitation were scheduled early in the morning, followed by meetings, rounds, writing, emails, administrative and academic work until about 2 p.m. I was privileged to be able to get my blood draws in my office, avoiding having to line up at the phlebotomy lab door at 7 a.m. next to my patients. The transplant clinic and cardiac catheterization suite were a few floors above my office and the rehab gym was a few blocks down the road. Mid-afternoon I would go home and rest. Just before Thanksgiving I began working full days. A month later, I was seeing patients in clinic. My nurse practitioners and doctors stopped by my office to check on me and answered my texts at all hours of the day and night.

    This is hardly the typical story of a transplant patient, with one exception. I am now 8 months out from my transplant and I am still unable to operate, the part of my job that, in my mind, defines my career. This is not because I am debilitated; on the contrary, I am stronger and more fit than I have been in 20 years. It is not because I have had rejection episodes or complications.  My post-transplant course has been relatively smooth. I am not doing an essential part of my job because I am experiencing a side effect that almost all of our patients have to deal with but rarely talk about: a tacrolimus tremor.

    My administration and colleagues have been very understanding, certainly far more so than our typical patient’s bosses and co-workers. Well, actually, the inconvenient truth is that most transplant patients do not have bosses or co-workers because only a minority of them actually return to work after their transplant. For kidney transplant patients who were not working before their transplant, there is a 92-94% certainty that they will not return to the work force, and yet I used to smile at them at a follow up visit and say, “now, go back to a normal life.”1 They will go back to life and that is an immeasurable gift, but only for a minority of patients will that life be “normal.”

    I remember doing a second kidney transplant for a woman in her 20’s who was highly sensitized. She had been ill most of her life, in and out of hospitals and on dialysis. With a lot of help she had managed to finish high school. After her successful transplant, which involved a complex desensitization protocol, I triumphantly asked her what she was going to do with her new life. She told me she was going to enroll in college in the fall and become a nurse. Just before Thanksgiving, I saw her at a follow-up appointment and asked how it was going. She cast her gaze downward and said, “Not so good, Dr. Montgomery. I had to withdraw from school.” She began to cry, “No one ever expected anything from me and now everyone thinks I should be able to do anything. I have been so depressed.” Upon further discussion, it became clear that her dialysis days had been largely replaced by doctors’ appointments and blood draws, and although she felt better, she had never really needed to develop good time management skills. Many of our patients have been developmentally stunted by chronic disease and have somewhat chaotic lives as a result, and when their transplant happens they are ill-equipped to jump back in.

    For the purpose of measuring the quality of a transplant center, the Centers for Medicare and Medicaid (CMS) define a successful transplant as one in which the patient is alive with a functioning graft at 1 year. The United Network for Organ Sharing (UNOS) and the payers have adopted CMS metrics. Before the CMS final rule, I think transplant physicians and surgeons felt that “saving a patient’s life” by finding them a suitable allograft and getting them out of the hospital was success. We did liver transplants for patients who had a predicted one-year survival rate of < 70%. We took risks on organs and patients’ diseases that we would not consider doing now that our actions can put programs and hospitals at risk of decertification. We spend a lot of time adjusting the risk needle to satisfy CMS’s definition of success. We have all done the fireman’s carry of a patient with a failing allograft or a flickering life force across the one-year finish line. I think most of us could agree that this type of effort does not feel very satisfying and is not the success that we had hoped for.

    What do your patients think? Until I started asking them this question a few months ago, I had no idea. I assumed they had the same definition as I did, being alive and free of the pain and perils of debilitating end stage organ disease. I knew quality of life measurements showed that the patients were better off than before the transplant, but for most patients things could hardly have gotten worse. I think we need to begin to explore this question beyond what can be discovered with quality of life indices. To do this we need a better understanding of the burden of disease and of transplantation. The restoration of health, happiness, and productivity should be the goal, but not just for one year. We need to get insurers and regulators more interested in outcomes that patients consider to be important. It is going to take resources and buy-in from all the stake holders.  

    And what about innovative therapy like desensitization or xenotransplantation? The more desperate patients feel, the more risk they are willing to take. What are the limits of risk?  Based on primate studies, the best we can expect from xenograft survival in the early human trials will be about 1-2 years and much of that time could be spent in the hospital. Which groups of patients might consider a one- or two-year dialysis hiatus a meaningful outcome that they would be willing to put their lives on the line for? These are questions we need to find out.

    I spoke to a woman the other day at a kidney event who donated to her 60-year-old father five years ago. I asked how he was doing. She smiled and said his creatinine was 1.0. I said, “That’s great. You must be very proud and happy.” She replied that she was, but that he shook so much that he could no longer take care of himself and she had had to move in with him. I asked if they had discussed this with his doctor. “Yes, but he said it was just a side effect of the medication and not Parkinson’s,” was her reply. “I don’t want to complain. I am just glad he is alive.”

    With all the resources and knowledge I have at my disposal – my brightest colleagues ready to discuss my problem with me at meetings or on the phone and my ability to read and process key studies in the literature, travel to centers using innovative immunosuppression protocols, and weigh the risks of trying them – I have no doubt that I will be back in the operating room soon.  Barring a lightning strike, I will return to the life I had hoped for. I am an exception and my story in no way mirrors most — in fact, it acts as an important contrast to the journey of many of our patients. This awareness compels me to ask them questions I never did before and the answers I get are pretty shocking. Everyone who has a stake in transplantation should want their patients to more fully actualize the potential of the miracles we enable. Being awestruck that these folks are still alive and walking around is no longer an acceptable metric for success. We can do better. 

    References:

    1. Tzvetanov I, D'Amico G, Walczak D, Jeon H, Garcia-Roca R, Oberholzer J, Benedetti E.High rate of unemployment after kidney transplantation: analysis of the United network for organ sharing database.Transplant Proc. 2014 Jun;46(5):1290-4.
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  • A Commentary: The Evolving Role of the Advanced Practice Provider in Transplant

    Jennifer M. Sharp, MSJennifer M. Sharp, MS
    Nurse Practitioner
    University of Michigan

    When I began my advanced practice career, nurse practitioners (NPs) had been around for some time. The first nurse practitioner program was developed at the University of Colorado in 1965 by Loretta Ford and Dr. Henry Silver. The program was focused on pediatrics, and historically, most NPs were employed in primary care specialties. NPs were able to add to the provider work force in physician offices, increasing the number of patients able to be seen and followed by any given practice. Over time NPs began to develop individual niches and opened independent clinics with the supervision of a physician. The role evolved further as the industry was able to see that both physician assistants and NPs, now collectively termed Advanced Practice Providers (APPs), were able to expand care capabilities in more focused areas of medicine, such as acute care, surgery and critical care. Nurse practitioner schools began to develop acute care programs and other specialized programs for broadening the scope of APPs into hospital settings and subspecialty practices. Regulations were developed to better define the role of APPs and to take on issues of training and certification that naturally coincided with this expansion of APP practice environments.

    While the addition of APPs to the medical workforce was a positive change for health care in general, there were a lot of murky waters to tread. While many physicians were on board with this expanding venture, others were unsure and unclear as to what APPs were supposed to be doing. What can they do? What are the liabilities? What is the difference between nurse practitioners and physician assistants? What is their scope of practice? How do they fit in on our team? What is the benefit of working with an APP? The uncertainty of answers to these questions led to confusion that likely contributed to underutilized APPs, decreased job satisfaction, and confused employers and team members.

    My Center, My Story

    I started in transplant as a bedside nurse, first at the Johns Hopkins Hospital (JHH), then at University of Michigan Health System (UMHS). After completing my training as a nurse practitioner, I transitioned to transplant surgery. I emailed Dr. Jeffrey Punch, then the Chief of the Division of Transplant Surgery and the director of the UMHS Transplant Center, more than once. I even encountered his wife (also a physician leader at UMHS) in an elevator, at which time I promptly explained who I was and why her husband needed to hire me. The possibility of working as a NP in the transplant program was a very unique opportunity. It was a natural evolution for me but somewhat confusing for those around me. I was a little bit like a transplant unicorn. I had lots of bedside nursing experience with the transplant population, which was hard to find at the time, but I was now a mid-level provider (which was what we used to be called) able to use that knowledge and experience in a more in-depth manner on the transplant team. The team did not have an inpatient nurse practitioner. Dr. Punch probably thought: “This woman has emailed me repeatedly and confronted my wife in the elevator; maybe I should hire her. She seems persistent. But what do I do with her? What’s an acute care nurse practitioner? How do we train her? Do we let the existing PAs train her?” These were legitimate questions plaguing program directors who were hiring APPs at the time. In our program, I worked alongside my fellow “MLPs” and learned the job. There were 4 of us (3 PAs and me) working with the inpatient team coordinating discharges and other tasks. We also completed H&Ps for kidney patients and saw post-operative liver transplant patients in clinic two days a week. Our center volume was 250 kidneys and 90 livers a year in the abdominal transplant programs at that time.

    Fast forward to 2018: our transplant surgery team at Michigan Medicine is now 7 APPs (2 PAs and 5 NPs). We function in the outpatient and inpatient setting alike. Collectively and via self-management, we take day call for the inpatient kidney service, oversee the junior residents who take day call for the inpatient liver service, cover 3-4 clinics each day for post-operative kidney/pancreas and liver patients, and see all pre-operative living donor kidney and liver patients prior to surgery. We are making clinical judgments and providing care in the acute setting as well as directing and following through with plans of care in the outpatient arena. We run daily multidisciplinary rounds and collaborate independently with all departments. We act on behalf of our faculty in matters of patient care when they are not available. Our role in coordinating care for the post-operative liver transplant patients has been studied and shown to improve care coordination and contribute to decreased length of stay.

    In addition to patient care, we serve on transplant center and hospital committees. We have been able to grow our group and retain talented providers. We collaborate with faculty on best practices regularly. We are involved in research, attending and speaking at national conferences. Additionally, some of us have been able to independently develop significant quality improvement interventions that have been implemented for the benefit of patients. We participate fully in the education and training of surgical residents, medical students, and NP students both in inpatient and outpatient care settings. We also play a critical role in orienting the ASTS transplant surgery fellows to our program each year.

    How and Why Did This Happen?

    The answer to these questions is complex. We know our patients have become older and sicker. Their needs have grown. Their time waiting for organ transplantation has increased. The manpower needed to manage these patients is increasing. In addition, the Accreditation Council for Graduate Medical Education work hour restrictions instituted in July 2011 have limited the amount of time residents spend in the hospital caring for patients. These issues combined have created a growing need for additional providers to meet the needs of the transplant patient population. Responsibilities have grown to meet the needs of patients, including daily clinic expansion, increasingly complex outpatient management, and maintaining the necessary continuity for successful patient outcomes and patient safety. The role of the APP has evolved in that we are able to manage, and we have gained a more autonomous role in directing, the care of transplant patients in both inpatient and outpatient settings. We provide an aspect of care continuity that is unique and have grown into a large, invaluable part of the transplant team to our faculty, fellows and patients.

    Is This Model Successful?

    For our center, this model is successful. All seven of us are able to fill in at any time, in any of the areas of responsibility. This is particularly important in transplant, as the daily work volume is unpredictable and highly variable. We continue to review and revise the role as the needs of our patients demand.

    We have been successful in providing care and education by combining the following:

    • Relationships: Getting to know and trust one another; understand preferences, values, and the things that are important to each other; respect each other inside and outside of the office.
    • Time: It has taken years to cultivate these relationships. We have successes and failures, missteps and saves, and go through all of it together, growing professionally and personally, as a cohesive team.
    • Common mission/teamwork: We depend on each other to get to our common goal: excellent, timely, and safe delivery of care to our patients. We all need one another to provide the standard of care we believe in from beginning to end of the patient experience.

    These factors are not often studied or written about. But there is a common thread among transplant teams that provide exceptional care: they work well together. Each member understands that an individual cannot carry out our mission alone. The care we provide is based around the team and the systems in which we operate. APPs enhance this structure of care delivery at Michigan Medicine.

    What Is Next for the Advanced Transplant Provider (ATP)?

    I have described the role of the surgery APP group at Michigan Medicine. However, there are APPs all over the transplant center in every division. The field of transplantation is made up of several teams: medical, surgical, pre, post, and everything in between. APPs on all these teams form another layer of connection. We provide the same underlying network for all the specific organ teams, performing different responsibilities but overall ensuring that all patients have what they need, continuously.

    Nationwide, APPs can be found in different transplant programs in clinic, in the hospital, in outreach, assisting in the operating room, and on procurements—each with different responsibilities in kidney, liver, pancreas, lung, heart, and small bowel organ transplantation. APPs are known to complete morning rounds, write progress notes, perform H&Ps, perform pre-transplant evaluations, oversee waitlist management, participate in transplant protocol development and quality improvement activities, manage post-transplant clinic follow up, coordinate discharge, and take in house and at home call. Currently there are several NP/PA fellowship programs around the nation that developed to intensify and specialize training that is needed in relation to the growing industry as APPs take on more responsibilities in transplant centers around the country and in other areas of health care.

    It is my perspective that the next logical step for the transplant advanced practice provider is to be placed into a dual role, both clinical and administrative. We have proven how versatile we are in our current clinical position. Transplant centers can only benefit from positioning APPs in leadership roles that develop center policy, mission goals, center operational strategies, fiscal development, competitive practices, and center organization.

    Being an ATP has afforded me a vast array of opportunities to grow in my profession. Transplant is a complex field. It has many moving parts. There are many important aspects of care that require extra attention and time. It is clear that the ATP role in transplant centers in today’s healthcare delivery environment is now indispensable. I have heard our role described as many things through the years, some accurate and some not so accurate. The real deal is that it is hard to define this role universally. It is all relative to where you work, what the needs are, and what structural model is utilized at that particular center.

    The field of transplant is very well suited for the APP role. The patients require intuitive, highly skilled, and continuous care. The APP allows the team providing this care to be just that: continuous. When working in tandem with faculty, the role allows for minimal breaks in delivery of quality patient care. I have no doubt that this role will continue to evolve in all parts of healthcare.

    Having said that, the role of an ATP is specific to institution; efforts are still being made for standardization in skill sets, responsibilities, and scope of practice. There are advantages to creating a value-added role from the ground up in a particular patient population at a specific center. However, developing standard responsibilities that can be maintained by the ASTS could certainly be a helpful tool for employers and personnel alike in the ever-changing health care environment.

    In an effort to continue the discussion on this topic, the Communications Committee will be collaborating with the ATP Committee members in coming months to collect job descriptions from ATPs around the country. There are currently 93 ATPs within the ASTS membership. This collaboration will give more insight into the diversity in structural models and current roles throughout the field of transplant. There is every reason to expect that ATPs will continue to play a growing role in the field of transplantation, and the ASTS is poised to help lead that growth.

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