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82


Regarding normothermic regional perfusion: Arguing by insistence is not a strong argument [Letter]

Parent, Brendan; Caplan, Arthur; Moazami, Nader; Montgomery, Robert A
PMID: 35352473
ISSN: 1600-6143
CID: 5201132

Results of Two Cases of Pig-to-Human Kidney Xenotransplantation [Case Report]

Montgomery, Robert A; Stern, Jeffrey M; Lonze, Bonnie E; Tatapudi, Vasishta S; Mangiola, Massimo; Wu, Ming; Weldon, Elaina; Lawson, Nikki; Deterville, Cecilia; Dieter, Rebecca A; Sullivan, Brigitte; Boulton, Gabriella; Parent, Brendan; Piper, Greta; Sommer, Philip; Cawthon, Samantha; Duggan, Erin; Ayares, David; Dandro, Amy; Fazio-Kroll, Ana; Kokkinaki, Maria; Burdorf, Lars; Lorber, Marc; Boeke, Jef D; Pass, Harvey; Keating, Brendan; Griesemer, Adam; Ali, Nicole M; Mehta, Sapna A; Stewart, Zoe A
BACKGROUND:Xenografts from genetically modified pigs have become one of the most promising solutions to the dearth of human organs available for transplantation. The challenge in this model has been hyperacute rejection. To avoid this, pigs have been bred with a knockout of the alpha-1,3-galactosyltransferase gene and with subcapsular autologous thymic tissue. METHODS:We transplanted kidneys from these genetically modified pigs into two brain-dead human recipients whose circulatory and respiratory activity was maintained on ventilators for the duration of the study. We performed serial biopsies and monitored the urine output and kinetic estimated glomerular filtration rate (eGFR) to assess renal function and xenograft rejection. RESULTS:in Recipient 2. In both recipients, the creatinine level, which had been at a steady state, decreased after implantation of the xenograft, from 1.97 to 0.82 mg per deciliter in Recipient 1 and from 1.10 to 0.57 mg per deciliter in Recipient 2. The transplanted kidneys remained pink and well-perfused, continuing to make urine throughout the study. Biopsies that were performed at 6, 24, 48, and 54 hours revealed no signs of hyperacute or antibody-mediated rejection. Hourly urine output with the xenograft was more than double the output with the native kidneys. CONCLUSIONS:Genetically modified kidney xenografts from pigs remained viable and functioning in brain-dead human recipients for 54 hours, without signs of hyperacute rejection. (Funded by Lung Biotechnology.).
PMID: 35584156
ISSN: 1533-4406
CID: 5230812

Response to American College of Physician's statement on the ethics of transplant after normothermic regional perfusion

Parent, Brendan; Caplan, Arthur; Moazami, Nader; Montgomery, Robert A
This paper responds to the position statement released by the American College of Physicians (ACP) entitled "Ethics, Determination of Death, and Organ Transplantation in Normothermic Regional Perfusion (NRP) with Controlled Donation after Circulatory Determination of Death (cDCD): American College of Physicians Statement of Concern." The ACP's statement engages with critical ethical issues surrounding cDCD NRP, but several of their conclusions are flawed. Contrary to the statement, the practice respects the dead donor rule and the legal definition of death while honoring the wishes of the deceased and their loved ones to help save the lives of those in need of organ transplants. cDCD NRP is well established in many countries, it can enhance trust in medical practice and organ donation, and will increase the availability of optimal organs for life-saving transplants.
PMID: 35072337
ISSN: 1600-6143
CID: 5152512

The Moral Necessity to Increase Access to HCV+ Transplants With Early Treatment for HCV Naive Patients

Richter, Benjamin I; Parent, Brendan; Lonze, Bonnie E
PMID: 34342960
ISSN: 1534-6080
CID: 5081582

First Report of Xenotransplantation from a Pig to Human Recipient [Meeting Abstract]

Stern, J; Tatapudi, V; Lonze, B; Stewart, Z; Mangiola, M; Wu, M; Mehta, S; Weldon, E; Dieter, R; Lawson, N; Griesemer, A; Parent, B; Piper, G; Sommer, P; Cawthon, S; Sullivan, B; Ali, N; Montgomery, R
ORIGINAL:0015582
ISSN: 1600-6143
CID: 5231032

Assessing Trustworthy AI in times of COVID-19. Deep Learning for predicting a multi-regional score conveying the degree of lung compromise in COVID-19 patients

Allahabadi, Himanshi; Amann, Julia; Balot, Isabelle; Beretta, Andrea; Binkley, Charles; Bozenhard, Jonas; Bruneault, Frederick; Brusseau, James; Candemir, Sema; Alessandro, Luca; Fieux, Genevieve; Chakraborty, Subrata; Cherciu, Nicoleta; Cociancig, Christina; Coffee, Megan; Ek, Irene; Espinosa-Leal, Leonardo; Farina, Davide; Fieux-Castagnet, Genevieve; Frauenfelder, Thomas; Gallucci, Alessio; Giuliani, Guya; Golda, Adam; van Halem, Irmhild; Hildt, Elisabeth; Holm, Sune; Kararigas, Georgios; Krier, Sebastien A; Kuhne, Ulrich; Lizzi, Francesca; Madai, Vince I; Markus, Aniek F; Masis, Serg; Wiinblad, Emilie; Mureddu, Francesco; Neri, Emanuele; Osika, Walter; Ozols, Matiss; Panigutti, Cecilia; Parent, Brendan; Pratesi, Francesca; Moreno-Sanchez, Pedro A; Sartor, Giovanni; Savardi, Mattia; Signoroni, Alberto; Sormunen, Hanna; Spezzatti, Andy; Srivastava, Adarsh; Stephansen, Annette F; Bee, Lau; Jahan, Jesmin; Tuominen, Jarno; Umbrello, Steven; Vaccher, Filippo; Vetter,, Dennis; Westerlund, Magnus; Wurth, Renee; Zicari, Roberto V;
ORIGINAL:0015725
ISSN: 2637-6415
CID: 5286152

Addressing ethical confusion in deceased donation and transplantation research: the need for dedicated guidance

Martin, Dominique E; Cronin, Antonia J; Dalle Ave, Anne; van Haren, Frank M P; Locke, Jayme E; MiƱambres, Eduardo; Oniscu, Gabriel C; Parent, Brendan
Innovative research in deceased donation and transplantation often presents ethical challenges for researchers and those responsible for ethical governance of research. These challenges have been recognized as potential barriers to the conduct of research. We review the literature to identify and describe ethical considerations that may cause confusion or uncertainty in the context of research involving potential deceased donors or deceased donor transplantation. We normatively examine these considerations and discuss their implications for the ethical conduct of research. In addition to the complexities of research involving critically ill, dying or recently deceased individuals, uncertainty may arise regarding the ethical status of various individuals who may be involved in research aimed at improving availability and outcomes of organ transplantation. Consequently, routine ethical guidelines for clinical research may fail to provide clear guidance with regards to the design, conduct and governance of some deceased donation or transplantation studies. Ethical uncertainty may result in delays or barriers to research, or neglect of important ethical considerations. Specific ethical guidance is needed to support research in deceased donation and transplantation as the ethical considerations that arise in the design and conduct of such research may not be addressed in the existing guidelines for human research.
PMID: 34516693
ISSN: 1432-2277
CID: 5061322

Legal Foundation for Crisis Clinical DNR Orders [Editorial]

Parent, Brendan; Rivera-Agosto, Jorge L; Walsh, B Corbett
PMCID:8061152
PMID: 33886029
ISSN: 1525-1497
CID: 4873712

Ethical considerations regarding COVID-19 vaccination for transplant candidates and recipients

Parent, Brendan; Caplan, Arthur; Mehta, Sapna A
Solid organ transplant (SOT) candidates and recipients were not included in the COVID-19 vaccine trials that have justified vaccine administration to millions worldwide and will be critical to ending the pandemic. The risks of COVID-19 for SOT candidates and recipients combined with data about this population's response to other vaccines has led to transplant centers recommending vaccination for their candidates and recipients in accordance with guidance from major transplant organizations. Relevant ethics considerations include: weighing the low risk of vaccination causing transplant complications against potentially limited antibody response of vaccines for transplant recipients; the equitable distribution of vaccines among vulnerable populations; the duty to steward and respect organs as limited resources; the duty to support vaccination; and patient autonomy. Vaccinated transplant patients and candidates should also consider participating in research studies to better understand the efficacy and potential long-term risks in this patient population. There are difficult scenarios, like timing transplant after second vaccine dose, when to administer the second dose to a partially vaccinated candidate who gets an organ match, whether to vaccinate a recent transplant recipient with low exposure risk and which vaccine to use. Here we provide ethics considerations for vaccinating different groups within the transplant population.
PMID: 34241923
ISSN: 1399-0012
CID: 4950372

Mistrust and inconsistency during COVID-19: considerations for resource allocation guidelines that prioritise healthcare workers

Cheung, Alexander T M; Parent, Brendan
As the USA contends with another surge in COVID-19 cases, hospitals may soon need to answer the unresolved question of who lives and dies when ventilator demand exceeds supply. Although most triage policies in the USA have seemingly converged on the use of clinical need and benefit as primary criteria for prioritisation, significant differences exist between institutions in how to assign priority to patients with identical medical prognoses: the so-called 'tie-breaker' situations. In particular, one's status as a frontline healthcare worker (HCW) has been a proposed criterion for prioritisation in the event of a tie. This article outlines two major grounds for reconsidering HCW prioritisation. The first recognises trust as an indispensable element of clinical care and mistrust as a hindrance to any public health strategy against the virus, thus raising concerns about the outward appearance of favouritism. The second considers the ways in which proponents of HCW prioritisation deviate from the very 'ethics frameworks' that often preface triage policies and serve to guide resource allocation-a rhetorical strategy that may undermine the very ethical foundations on which triage policies stand. By appealing to trust and consistency, we re-examine existing arguments in favour of HCW prioritisation and provide a more tenable justification for adjudicating on tie-breaker events during crisis standards of care.
PMID: 33106381
ISSN: 1473-4257
CID: 4660372