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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

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

Immunogenicity after heterologous third dose COVID-19 vaccination in a heart transplant recipient [Letter]

Mehta, Sapna A; Reyentovich, Alex; Montgomery, Robert A; Segev, Dorry L; Gebel, Howard M; Bray, Robert A; Samanovic, Marie I; Cornelius, Amber R; Mulligan, Mark J; Herati, Ramin S
PMID: 35107835
ISSN: 1399-0012
CID: 5153612

Invited commentary

Montgomery, Robert A
PMID: 35166403
ISSN: 1399-3089
CID: 5163392

Hepatitis E virus infection and rejection in kidney transplant recipients

Wasuwanich, Paul; Sirisreetreerux, Pokket; Ingviya, Thammasin; Kraus, Edward S; Brennan, Daniel C; Sue, Paul K; Jackson, Annette M; Oshima, Kiyoko; Philosophe, Benjamin; Montgomery, Robert A; Karnsakul, Wikrom
BACKGROUND:Hepatitis E virus (HEV) infection has been associated with immune-mediated kidney diseases in developing countries. However, its relationship with kidney transplant outcomes has never been studied. We investigated the association between HEV infection and kidney graft rejection among kidney transplant recipients (KTRs). METHODS:We conducted a matched cohort and longitudinal study utilizing banked sera following kidney transplantation during 1988-2012. Studies with evidence of post-transplantation HEV infection were identified by positive ELISA tests (anti-HEV IgM or anti-HEV IgG seroconversion) or positive HEV PCR and matched to KTR controls with negative HEV ELISA and PCR tests in a 1:5 ratio by age, sex, crossmatch status, immunosuppression era, and time of HEV testing. Outcome data collected included time to first kidney graft rejection, transaminases, and glomerular filtration rates. Log-ranked test was used to analyze survival. RESULTS:) but did not reach significance (p = 0.24). CONCLUSION/CONCLUSIONS:Subjects with evidence of post-transplantation HEV infection demonstrated earlier kidney graft rejection compared to controls.
PMID: 34923120
ISSN: 1878-5492
CID: 5108642

Outcomes at 3 years post-transplant in imlifidase-desensitized kidney transplant patients

Kjellman, Christian; Maldonado, Angela Q; Sjöholm, Kristoffer; Lonze, Bonnie E; Montgomery, Robert A; Runström, Anna; Lorant, Tomas; Desai, Niraj M; Legendre, Christophe; Lundgren, Torbjörn; von Zur Mühlen, Bengt; Vo, Ashley A; Olsson, Håkan; Jordan, Stanley C
Imlifidase is a cysteine proteinase which specifically cleaves IgG, inhibiting Fc-mediated effector function within hours of administration. Imlifidase converts a positive crossmatch to a potential donor (T cell, B cell, or both), to negative, enabling transplantation to occur between previously HLA incompatible donor-recipient pairs. To date, 39 crossmatch positive patients received imlifidase prior to a kidney transplant in four single-arm, open-label, phase 2 studies. At 3 years, for patients who were AMR+ compared to AMR-, death-censored allograft survival was 93% vs 77%, patient survival was 85% vs 94%, and mean eGFR was 49 ml/min/1.73 m2 vs 61 ml/min/1.73 m2 , respectively. The incidence of AMR was 38% with most episodes occurring within the first month post-transplantation. Sub-analysis of patients deemed highly sensitized with cPRA ≥ 99.9%, and unlikely to be transplanted who received crossmatch-positive, deceased donor transplants had similar rates of patient survival, graft survival, and eGFR but a higher rate of AMR. These data demonstrate that outcomes and safety up to 3 years in recipients of imlifidase-enabled allografts is comparable to outcomes in other highly sensitized patients undergoing HLA-incompatible transplantation. Thus, imlifidase is a potent option to facilitate transplantation among patients who have a significant immunologic barrier to successful kidney transplantation. Clinical Trial: (NCT02790437), EudraCT Number: 2016-002064-13.
PMID: 34236770
ISSN: 1600-6143
CID: 4951052

Dynamic prediction of renal survival among deeply phenotyped kidney transplant recipients using artificial intelligence: an observational, international, multicohort study

Raynaud, Marc; Aubert, Olivier; Divard, Gillian; Reese, Peter P; Kamar, Nassim; Yoo, Daniel; Chin, Chen-Shan; Bailly, Élodie; Buchler, Matthias; Ladrière, Marc; Le Quintrec, Moglie; Delahousse, Michel; Juric, Ivana; Basic-Jukic, Nikolina; Crespo, Marta; Silva, Helio Tedesco; Linhares, Kamilla; Ribeiro de Castro, Maria Cristina; Soler Pujol, Gervasio; Empana, Jean-Philippe; Ulloa, Camilo; Akalin, Enver; Böhmig, Georg; Huang, Edmund; Stegall, Mark D; Bentall, Andrew J; Montgomery, Robert A; Jordan, Stanley C; Oberbauer, Rainer; Segev, Dorry L; Friedewald, John J; Jouven, Xavier; Legendre, Christophe; Lefaucheur, Carmen; Loupy, Alexandre
BACKGROUND:Kidney allograft failure is a common cause of end-stage renal disease. We aimed to develop a dynamic artificial intelligence approach to enhance risk stratification for kidney transplant recipients by generating continuously refined predictions of survival using updates of clinical data. METHODS:In this observational study, we used data from adult recipients of kidney transplants from 18 academic transplant centres in Europe, the USA, and South America, and a cohort of patients from six randomised controlled trials. The development cohort comprised patients from four centres in France, with all other patients included in external validation cohorts. To build deeply phenotyped cohorts of transplant recipients, the following data were collected in the development cohort: clinical, histological, immunological variables, and repeated measurements of estimated glomerular filtration rate (eGFR) and proteinuria (measured using the proteinuria to creatininuria ratio). To develop a dynamic prediction system based on these clinical assessments and repeated measurements, we used a Bayesian joint models-an artificial intelligence approach. The prediction performances of the model were assessed via discrimination, through calculation of the area under the receiver operator curve (AUC), and calibration. This study is registered with, NCT04258891. FINDINGS/RESULTS:13 608 patients were included (3774 in the development cohort and 9834 in the external validation cohorts) and contributed 89 328 patient-years of data, and 416 510 eGFR and proteinuria measurements. Bayesian joint models showed that recipient immunological profile, allograft interstitial fibrosis and tubular atrophy, allograft inflammation, and repeated measurements of eGFR and proteinuria were independent risk factors for allograft survival. The final model showed accurate calibration and very high discrimination in the development cohort (overall dynamic AUC 0·857 [95% CI 0·847-0·866]) with a persistent improvement in AUCs for each new repeated measurement (from 0·780 [0·768-0·794] to 0·926 [0·917-0·932]; p<0·0001). The predictive performance was confirmed in the external validation cohorts from Europe (overall AUC 0·845 [0·837-0·854]), the USA (overall AUC 0·820 [0·808-0·831]), South America (overall AUC 0·868 [0·856-0·880]), and the cohort of patients from randomised controlled trials (overall AUC 0·857 [0·840-0·875]). INTERPRETATION/CONCLUSIONS:Because of its dynamic design, this model can be continuously updated and holds value as a bedside tool that could refine the prognostic judgements of clinicians in everyday practice, hence enhancing precision medicine in the transplant setting. FUNDING/BACKGROUND:MSD Avenir, French National Institute for Health and Medical Research, and Bettencourt Schueller Foundation.
PMID: 34756569
ISSN: 2589-7500
CID: 5050482

Clinical and Financial Implications of 2 Treatment Strategies for Donor-derived Hepatitis C Infections

Stewart, Zoe A; Stern, Jeffrey; Ali, Nicole M; Kalia, Harmit S; Khalil, Karen; Jonchhe, Srijana; Weldon, Elaina P; Dieter, Rebecca A; Lewis, Tyler C; Funches, Nur; Crosby, Sudara; Seow, Monique; Berger, Jonathan C; Dagher, Nabil N; Gelb, Bruce E; Watkins, Anthony C; Moazami, Nader; Smith, Deane E; Kon, Zachary N; Chang, Stephanie H; Reyentovich, Alex; Angel, Luis F; Montgomery, Robert A; Lonze, Bonnie E
Transplanting hepatitis C viremic donor organs into hepatitis C virus (HCV)-negative recipients is becoming increasingly common; however, practices for posttransplant direct-acting antiviral (DAA) treatment vary widely. Protracted insurance authorization processes for DAA therapy often lead to treatment delays.
PMID: 34514117
ISSN: 2373-8731
CID: 5067212

Early experience with donation after circulatory death heart transplantation using normothermic regional perfusion in the United States

Smith, Deane E; Kon, Zachary N; Carillo, Julius A; Chen, Stacey; Gidea, Claudia G; Piper, Greta L; Reyentovich, Alex; Montgomery, Robert A; Galloway, Aubrey C; Moazami, Nader
OBJECTIVE:This pilot study sought to evaluate the feasibility of our donation after circulatory death (DCD) heart transplantation protocol using cardiopulmonary bypass (CPB) for normothermic regional reperfusion (NRP). METHODS:Suitable local DCD candidates were transferred to our institution. Life support was withdrawn in the operating room (OR). On declaration of circulatory death, sternotomy was performed, and the aortic arch vessels were ligated. CPB was initiated with left ventricular venting. The heart was reperfused, with correction of any metabolic abnormalities. CPB was weaned, and cardiac function was assessed at 30-minute intervals. If accepted, the heart was procured with cold preservation and transplanted into recipients in a nearby OR. RESULTS:Between January 2020 and January 2021, a total of 8 DCD heart transplants were performed: 6 isolated hearts, 1 heart-lung, and 1 combined heart and kidney. All donor hearts were successfully resuscitated and weaned from CPB without inotropic support. Average lactate and potassium levels decreased from 9.39 ± 1.47 mmol/L to 7.20 ± 0.13 mmol/L and 7.49 ± 1.32 mmol/L to 4.36 ± 0.67 mmol/L, respectively. Post-transplantation, the heart-lung transplant recipient required venoarterial extracorporeal membrane oxygenation for primary lung graft dysfunction but was decannulated on postoperative day 3 and recovered uneventfully. All other recipients required minimal inotropic support without mechanical circulatory support. Survival was 100% with a median follow-up of 304 days (interquartile range, 105-371 days). CONCLUSIONS:DCD heart transplantation outcomes have been excellent. Our DCD protocol is adoptable for more widespread use and will increase donor heart availability in the United States.
PMID: 34728084
ISSN: 1097-685x
CID: 5038042

SARS-CoV-2 Vaccination, Immune Responses, and Antibody Testing in Immunosuppressed Populations: Tip of the Iceberg [Comment]

Woodle, E Steve; Gebel, Howard M; Montgomery, Robert A; Maltzman, Jonathan S
PMID: 34144554
ISSN: 1534-6080
CID: 4995322