Removal of blood group A/B antigen in organs by ex vivo and in vivo administration of endo-ß-galactosidase (ABase) for ABO-incompatible transplantation

Kobayashi, Takaaki; Liu, DaGe; Ogawa, Hideoki; Miwa, Yuko; Nagasaka, Takaharu; Maruyama, Shoichi; Li, Yu-Teh; Ōnishi, Akira; Iwamoto, Masao; Kuzuya, Takafumi; Kadomatsu, Kenji; Uchida, Kazuharu; Nakao, Akimasa

doi:10.1016/j.trim.2008.09.007

Cited by 23 publications

(16 citation statements)

References 27 publications

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“…A new strategy that may come into clinics in the future is the reduction of blood group antigen levels in the allograft by ex vivo infusion of endo-beta-galactosidase (32). …”

Section: Future Perspectivesmentioning

confidence: 99%

ABO-Incompatible Kidney Transplantation

et al. 2017

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ABO-incompatible (ABOi) kidney transplantation has long been considered a contraindication to successful kidney transplantation. During the last 25 years, increasing organ shortage enforced the development of strategies to overcome the ABO antibody barrier. In the meantime, ABOi kidney transplantation has become a routine procedure with death-censored graft survival rates comparable to the rates in compatible transplantations. Desensitization is usually achieved by apheresis and B cell-depleting therapies that are accompanied by powerful immunosuppression. Anti-A/B antibodies are aimed to be below a certain threshold at the time of ABOi kidney transplantation and during the first 2 weeks after surgery. Thereafter, even a rebound of anti-A/B antibodies does not appear to harm the kidney transplant, a phenomenon that is called accommodation, but is poorly understood. There is still concern, however, that infectious complications such as viral disease, Pneumocystis jirovecii pneumonia, and severe urinary tract infections are increased after ABOi transplantations. Recent data from the Collaborative Transplant Study show that during the first year after kidney transplantation, one additional patient death from an infectious complication occurs in 100 ABOi kidney transplant recipients. Herein, we review the recent evidence on ABOi kidney transplantation with a focus on desensitization strategies and respective outcomes.

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“…A new strategy that may come into clinics in the future is the reduction of blood group antigen levels in the allograft by ex vivo infusion of endo-beta-galactosidase (32). …”

Section: Future Perspectivesmentioning

confidence: 99%

ABO-Incompatible Kidney Transplantation

et al. 2017

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“…The avoidance of harm via appropriate antiinfective strategies, cancer surveillance and consideration of risk factors for HUS are also important. Although we must proceed cautiously, more will be heard of intentional ABOi LTx—particularly if the emerging technique of ex vivo lung perfusion can be combined with the pretransplant use of Abase , an enzyme to “condition” an incompatible organ by removing A and B antigens.…”

Section: Discussionmentioning

confidence: 99%

Lessons and Insights From ABO-Incompatible Lung Transplantation

Snell

Holmes

Levvey

et al. 2013

American Journal of Transplantation

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With ABO blood group incompatibility (ABOi) between donor and recipient becoming a part of mainstream living-donor renal transplantation, the applicability of ABOi to other areas of transplantation is being reconsidered. Here we present a case of inadvertent ABOi lung retransplantation managed successfully with initial plasmapheresis, antithymocyte globulin and intravenous immunoglobulin; and subsequently with oral cyclophosphamide and sirolimus in addition to tacrolimus and prednisolone. Interestingly, in the setting of solid levels of tacrolimus and sirolimus, the patient developed a fatal thrombotic microangiopathy of uncertain origin subsequent to the cessation of cyclophosphamide at 9 years posttransplant. It is apparent that ABOi lung transplantation can result in surprisingly successful long-term outcomes. Low pretransplant antibody titers likely aid this and, in pediatric neonatal or infant cases, this may not be uncommon. We must proceed cautiously as there are significant risks. Understanding the monitoring, prevention and treatment of lung transplant antibodymediated rejection, while avoiding the long-term complications of overimmunosuppression, will be the keys to the success of future cases.

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“…4 You follow the PICOT format, which serves as the starting point for identification of important key words used in the search process: 5 • Population: heart transplant patients • Intervention: heart transplantation with ex-vivo perfusion • Comparison: heart transplantation with cold storage • Outcome: patient survival and graft survival • Time horizon: 30 days after transplant You then conduct a literature search in PubMed Clinical Queries using the search terms "heart transplantation" AND "ex-vivo perfusion" AND "cold storage," using the "Therapy" and "Broad" filters. You identify 10 articles: 7 ex-vivo human/animal studies, [6][7][8][9][10][11][12] 1 nonrandomized clinical study, 13 1 review 14 and 1 RCT. 15 The RCT addresses your research question and has the benefit of being level-I evidence.…”

Section: Finding the Evidencementioning

confidence: 99%

Users’ guide to the surgical literature: how to assess a noninferiority trial

Thoma

Farrokhyar

Waltho

et al. 2017

CJS

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DISCUSSIONS IN SURGERY • DISCUSSIONS EN CHIRURGIEUsers' guide to the surgical literature: how to assess a noninferiority trial A well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we want to show that a new surgical intervention is superior to a standard one, we analyze data from an RCT to see if the null hypothesis of "no difference" can be rejected (i.e., the 2 surgical interventions have the same effect).1,2 Let's consider a hypothetical RCT that compares laparoscopic to open appendectomy and the outcome meas ured is a pain score based on a Likert scale from 0 to 10. Suppose it was found that the mean pain score following laparoscopic appendectomy was 7 points and that following open appendectomy was 8 points, and that this 1-point difference was statistically significant. Such a result would be uncommon because it would require a large sample size, but let's accept this for now. Although statistically the result is significant, we do not consider this 1-point difference to have clinical relevance. This type of thinking addresses the concept of minimum clinically important difference (MCID), which describes a threshold that might persuade us to change our surgical practice. The meaningful MCID is usually based on the available best evidence derived from previous systematic reviews, pilot/feasibility studies or clinical judgment based on discussion with experts in the field.In another hypothetical RCT, the length of stay (LOS) after laparoscopic appendectomy was observed to be 24 hours versus 30 hours after open appendectomy, with a p < 0.05. It would be meaningless to conclude that the observed difference of 6 hours is the truth without reporting a confidence interval (CI), as a p value alone does not provide information on the degree of uncertainty (variation) applied in measuring the difference in hospital stay. Briefly, a CI provides information regarding the degree of uncertainty associated with the observed difference of 6 hours in hospital stay. It is within the CI that the true difference will likely lie. Let's say that in our hypothetical example the 95% CI for hospitalization time difference of 6 hours was 1-11 hours in favour of the laparoscopic approach. This means we are 95% confident that the true difference lies somewhere between 1 and 11 hours, A well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we want to show that a new surgical intervention is superior to a standard one, we analyze data from an RCT to see if the null hypothesis of "no difference" can be rejected (i.e., the 2 surgical interventions have the same effect). A noninferiority RCT design seeks to determine whether a new intervention is not worse than a prevailing (standard) one within an acceptable margin of risk or benefit, referred to as the "noninferiority margin...

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Removal of blood group A/B antigen in organs by ex vivo and in vivo administration of endo-ß-galactosidase (ABase) for ABO-incompatible transplantation

Cited by 23 publications

References 27 publications

ABO-Incompatible Kidney Transplantation

ABO-Incompatible Kidney Transplantation

Lessons and Insights From ABO-Incompatible Lung Transplantation

Users’ guide to the surgical literature: how to assess a noninferiority trial

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