Transplantation DirectPub Date : 2026-03-19eCollection Date: 2026-04-01DOI: 10.1097/TXD.0000000000001902
Jérôme Duisit, Edward Geissler, Patrik Lassus, Hatem Amer
{"title":"<i>Transplantation Direct</i>: The Official Journal of the International Society of Vascularized Composite Allotransplantation.","authors":"Jérôme Duisit, Edward Geissler, Patrik Lassus, Hatem Amer","doi":"10.1097/TXD.0000000000001902","DOIUrl":"10.1097/TXD.0000000000001902","url":null,"abstract":"","PeriodicalId":23225,"journal":{"name":"Transplantation Direct","volume":"12 4","pages":"e1902"},"PeriodicalIF":2.2,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13004227/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147499787","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Transplantation DirectPub Date : 2026-03-19eCollection Date: 2026-04-01DOI: 10.1097/TXD.0000000000001917
Emmanuella O Ajenu, Manuela Lopera Higuita, Alexandra Tchir, Rohil Jain, Ehab Hafiz, Bradley W Ellis, Mehmet Toner, Basak E Uygun, Korkut Uygun, Shannon N Tessier
{"title":"Reduction in Red Blood Cell Lysis by Polymer Intervention During Rodent Liver Normothermic Machine Perfusion.","authors":"Emmanuella O Ajenu, Manuela Lopera Higuita, Alexandra Tchir, Rohil Jain, Ehab Hafiz, Bradley W Ellis, Mehmet Toner, Basak E Uygun, Korkut Uygun, Shannon N Tessier","doi":"10.1097/TXD.0000000000001917","DOIUrl":"10.1097/TXD.0000000000001917","url":null,"abstract":"<p><strong>Background: </strong>Normothermic machine perfusion (NMP) has emerged as a promising strategy to improve the preservation and utilization of donor livers, particularly from extended criteria donors and those donated after circulatory death. Despite its advantages, hemolysis remains a major challenge, leading to free hemoglobin release, oxidative stress, and endothelial injury, ultimately affecting graft viability. This study evaluated the use of poloxamer 188 (P188) and Ficoll PM70 as membrane-stabilizing agents to mitigate hemolysis in rodent liver NMP models. We assessed their effects on red blood cell (RBC) stability and grafts during machine perfusion in both a model of donation after brain death and a model of warm ischemia injury.</p><p><strong>Methods: </strong>Rat livers were subjected to NMP with RBC-based perfusates containing P188 and/or Ficoll PM70, or an untreated control. Hemolysis was measured using a NanoDrop spectrophotometer to quantify the free hemoglobin concentration. Hemodynamic stability, liver injury markers, and histological analysis were analyzed to determine the overall graft viability.</p><p><strong>Results: </strong>Treatment with P188 or Ficoll PM70 significantly reduced circulating free hemoglobin in donation after brain death livers, minimizing hemolysis. Similarly, the combination of P188 and Ficoll PM70 significantly reduced hemolysis in warm ischemia livers and showed preserved liver sinusoidal endothelial cells. However, the reduction in hemolysis did not result in improved parameters measured during <i>ex vivo</i> machine perfusion.</p><p><strong>Conclusions: </strong>The use of Poloxamer 188 and Ficoll PM70 in NMP shows promise in reducing RBC hemolysis without compromising perfusion hemodynamics. Additionally, both polymers demonstrated improved preservation of liver sinusoidal endothelial cells, as evidenced by histological analysis. However, some findings suggest that P188 may induce the release of proinflammatory cytokines in the perfusate. Overall, these findings highlight the potential of P188 and PM70 in enhancing NMP protocols for liver transplantation, though further studies are necessary to confirm their efficacy and safety before clinical translation.</p>","PeriodicalId":23225,"journal":{"name":"Transplantation Direct","volume":"12 4","pages":"e1917"},"PeriodicalIF":2.2,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13004231/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147499771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Transplantation DirectPub Date : 2026-03-17eCollection Date: 2026-04-01DOI: 10.1097/TXD.0000000000001914
Kathryn Manning, Robert Freercks, Mogamat Razeen Davids, Berzelius Klein-Motsumi, Andrew D Redd, Jason Ensor, Lungiswa Mtingi-Nkonzombi, Elmi Muller
{"title":"Transplantation Improves Patient Survival in a PD-first Program in South Africa.","authors":"Kathryn Manning, Robert Freercks, Mogamat Razeen Davids, Berzelius Klein-Motsumi, Andrew D Redd, Jason Ensor, Lungiswa Mtingi-Nkonzombi, Elmi Muller","doi":"10.1097/TXD.0000000000001914","DOIUrl":"10.1097/TXD.0000000000001914","url":null,"abstract":"<p><strong>Background: </strong>There are limited data on kidney replacement therapy (KRT) allocation and outcomes in patients in kidney failure (KF) who access public healthcare in South Africa.</p><p><strong>Methods: </strong>This retrospective cohort study included patients referred for KRT at the time of KF diagnosis. Incident KF cases were identified between 2012 and 2020, followed from referral until death, kidney transplantation, or continued waitlisting at study end (December 31, 2023). Descriptive analyses and comparisons were performed between KRT allocation and outcomes. Time-to-event analyses employed competing risk models to estimate cumulative incidence functions, whereas Kaplan-Meier methods were applied to calculate survival probabilities.</p><p><strong>Results: </strong>Overall, 761 patients were referred with KF, of which 598 (79%) were untreated and presumed to have died. Untreated patients were either not considered at referral (n = 432), or not accepted at KRT committee meeting (n = 175) because of policy-driven factors. Of those presented to the KRT committee (n = 338), 48% (n = 163) were accepted onto the dialysis program and waitlisted for transplantation. Accepted patients were younger and had greater medical stability and socioeconomic circumstances compared with non-accepted patients. Only 21% (n = 34) of patients initiated on dialysis were transplanted. At 5 y post-KRT initiation, there was a greater probability of dying on the waitlist compared with receiving a transplant (cumulative incidence function 35% [95% CI, 27-42] versus 18% [95% CI, 13-25]), and post-transplantation survival was significantly greater than pre-transplant survival (100% versus 61% [95% CI, 53-69]).</p><p><strong>Conclusions: </strong>Our study findings align with the challenges of providing dialysis and transplantation in a lower- to middle-income setting where patients were most often precluded from KRT because of poorly controlled comorbidities or a lack of unit capacity. There was a clear survival advantage in patients who were transplanted over those who remained on dialysis; however, transplant services remain limited.</p>","PeriodicalId":23225,"journal":{"name":"Transplantation Direct","volume":"12 4","pages":"e1914"},"PeriodicalIF":2.2,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12999133/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147487432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Transplantation DirectPub Date : 2026-03-17eCollection Date: 2026-04-01DOI: 10.1097/TXD.0000000000001915
Elmi Muller
{"title":"Bridging the Treatment Gap in Kidney Failure Through Transplantation-A Model for Africa and Beyond.","authors":"Elmi Muller","doi":"10.1097/TXD.0000000000001915","DOIUrl":"10.1097/TXD.0000000000001915","url":null,"abstract":"","PeriodicalId":23225,"journal":{"name":"Transplantation Direct","volume":"12 4","pages":"e1915"},"PeriodicalIF":2.2,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12999117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147487482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Transplantation DirectPub Date : 2026-03-17eCollection Date: 2026-04-01DOI: 10.1097/TXD.0000000000001920
Lisa-Maria Rosenthal, Luisa M Müller, Michaela M Freitag, Regina Stegherr, Mustafa Yigitbasi, Frank Konietschke, Oliver Miera, Titus Kühne, Felix Berger, Katharina R L Schmitt, Katja Weiss, Danne Friederike, Fatima I Lunze
{"title":"Less Invasive Acute Rejection Surveillance After Pediatric Heart Transplantation: Experiences From a Low-intensity Biopsy Center.","authors":"Lisa-Maria Rosenthal, Luisa M Müller, Michaela M Freitag, Regina Stegherr, Mustafa Yigitbasi, Frank Konietschke, Oliver Miera, Titus Kühne, Felix Berger, Katharina R L Schmitt, Katja Weiss, Danne Friederike, Fatima I Lunze","doi":"10.1097/TXD.0000000000001920","DOIUrl":"10.1097/TXD.0000000000001920","url":null,"abstract":"<p><strong>Background: </strong>Acute rejection remains a leading cause of morbidity and mortality early after pediatric heart transplantation (HT). Current guidelines recommend only endomyocardial biopsies (EMB) as reliable for rejection surveillance. We purposed to explore clinical outcomes of less invasive rejection surveillance in a low-intensity biopsy center in pediatric heart recipients.</p><p><strong>Methods: </strong>We retrospectively analyzed data from 46 pediatric heart recipients (median age 5.7 y; interquartile range [IQR], 2.5-8.0) discharged between 2011 and 2021. Clinical and echocardiographic evaluations were performed frequently, whereas protocol-based routine EMB were scheduled only at 1 and 2 y post-HT. Additional biopsies were performed if new-onset symptoms and/or a decline in graft function, as assessed by echocardiography, including tissue Doppler imaging (TDI)-derived velocities, were detected.</p><p><strong>Results: </strong>Graft survival was not compromised by less invasive surveillance with 97.8% at 1 y and 95.7% at 2 y post-HT. A total of 680 echocardiograms (median 15 per recipient; IQR, 13-17) and 140 biopsies (median 3 per recipient; IQR, 2-4) were analyzed. Acute rejection (4 acute cellular rejection and 8 antibody-mediated rejection) was found in 8.5% of the EMB. None of the protocol-based routine EMB of asymptomatic patients revealed rejection. Absence of a reduction in TDI-derived left ventricular and interventricular septal systolic velocities, combined with clinical evaluation, correlated with nonrejection.</p><p><strong>Conclusions: </strong>Combining frequent clinical follow-up with echocardiographic assessment using TDI as a less invasive method of rejection surveillance did not compromise long-term clinical outcomes. Validated in larger pediatric cohorts, it could save invasive biopsies, reducing the risk of biopsy-related complications and medical costs.</p>","PeriodicalId":23225,"journal":{"name":"Transplantation Direct","volume":"12 4","pages":"e1920"},"PeriodicalIF":2.2,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12999153/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147487488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Transplantation DirectPub Date : 2026-03-13eCollection Date: 2026-04-01DOI: 10.1097/TXD.0000000000001927
Peter J Altshuler, Garrett R Roll, Simon N Chu, Allison C Zheng, Helena L Record, Hamza Hasan, Chris E Freise, Seiji Yamaguchi, John P Roberts, Shareef M Syed
{"title":"Portal Vein Thrombectomy in Liver Transplantation for Patients With Calcified Portal Vein Thrombosis: An Extensive Case Series.","authors":"Peter J Altshuler, Garrett R Roll, Simon N Chu, Allison C Zheng, Helena L Record, Hamza Hasan, Chris E Freise, Seiji Yamaguchi, John P Roberts, Shareef M Syed","doi":"10.1097/TXD.0000000000001927","DOIUrl":"10.1097/TXD.0000000000001927","url":null,"abstract":"","PeriodicalId":23225,"journal":{"name":"Transplantation Direct","volume":"12 4","pages":"e1927"},"PeriodicalIF":2.2,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12991697/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147475185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Transplantation DirectPub Date : 2026-03-13eCollection Date: 2026-04-01DOI: 10.1097/TXD.0000000000001918
Amit Banga, Vincent Valentine, Vidya Rao, Anishka Kappalayil, Brandon Guenthart, John W MacArthur, Gundeep S Dhillon
{"title":"Donor and Procedural Factors on Early Dialysis Trends After Lung Transplantation in the United States.","authors":"Amit Banga, Vincent Valentine, Vidya Rao, Anishka Kappalayil, Brandon Guenthart, John W MacArthur, Gundeep S Dhillon","doi":"10.1097/TXD.0000000000001918","DOIUrl":"10.1097/TXD.0000000000001918","url":null,"abstract":"<p><strong>Background: </strong>Acute kidney injury requiring dialysis after lung transplantation (LT) is a serious complication associated with poor outcomes. While prior studies have emphasized recipient factors, the effects of donor and procedural variables are less understood.</p><p><strong>Methods: </strong>We analyzed United Network for Organ Sharing registry data on adult LT recipients from 2017 to 2022 (n = 14 999). Multivariable logistic regression identified predictors of early dialysis during the index hospitalization. Kaplan-Meier and Cox regression assessed survival. A subgroup analysis examined 1-y mortality among dialysis recipients.</p><p><strong>Results: </strong>Early dialysis occurred in 8.9% of recipients, with substantial center and regional variability (5.2%-13%). Independent predictors included lower pretransplant estimated glomerular filtration rate, Black race, vascular disease, intensive care unit admission, mechanical ventilation or extracorporeal membrane oxygenation, and lung allocation score >40. Notably, extended criteria donors, donation after circulatory death, bilateral LT, and ischemic time >7 h were donor and procedural variables also independently associated with dialysis need. Early dialysis was associated with longer hospitalization (median 57 versus 18 d; <i>P</i> < 0.001), increased extracorporeal membrane oxygenation use (39.7% versus 6%), a higher incidence of stroke (9% versus 2.1%), and reduced survival (adjusted hazard ratio, 3.85; 95% confidence interval, 3.56-4.17). Among those requiring dialysis, age >65, ischemic time >7 h, and single LT predicted higher 1-y mortality.</p><p><strong>Conclusions: </strong>The incidence of early dialysis after LT has increased by >50% in the past decade. Donor and procedural factors now significantly contribute to dialysis risk and should be integrated into perioperative planning and donor-recipient matching to improve outcomes.</p>","PeriodicalId":23225,"journal":{"name":"Transplantation Direct","volume":"12 4","pages":"e1918"},"PeriodicalIF":2.2,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12991637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147475226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Transplantation DirectPub Date : 2026-03-04eCollection Date: 2026-04-01DOI: 10.1097/TXD.0000000000001929
Thei S Steenvoorden, Juan Miguel Tellez Garcia, Joost W van der Heijden, Frederike Bemelman, Janneke A J Rood, Sandrine Florquin, Alessandra Tammaro, Henri Leuvenink, Liffert Vogt
{"title":"Alkaline Phosphatase Supplementation During Hypothermic and Normothermic Machine Perfusion Improves Metabolic Dysfunction in a Porcine Model of Donor Kidney Preservation.","authors":"Thei S Steenvoorden, Juan Miguel Tellez Garcia, Joost W van der Heijden, Frederike Bemelman, Janneke A J Rood, Sandrine Florquin, Alessandra Tammaro, Henri Leuvenink, Liffert Vogt","doi":"10.1097/TXD.0000000000001929","DOIUrl":"10.1097/TXD.0000000000001929","url":null,"abstract":"<p><strong>Background: </strong>Kidney preservation techniques, such as hypothermic machine perfusion (HMP), improve graft outcomes in deceased-donor kidney transplantation by pausing graft metabolism and ameliorated ischemia-reperfusion injury (IRI) but do not completely eliminate injury. Alkaline phosphatase (ALP) has been postulated to reduce IRI-induced kidney injury through the conversion of extracellular adenosine triphosphate into adenosine. This study aimed to evaluate whether ALP offers protection during deceased-donor kidney storage.</p><p><strong>Methods: </strong>Sixteen abattoir porcine kidneys (8 ALP and 8 with placebo) were procured after euthanization and exposed to 30 min of warm ischemia followed by 24 h of HMP or static cold storage (SCS). Reperfusion was partly simulated by 240 min of normothermic machine perfusion (NMP). Throughout NMP, we obtained functional, biochemical, and histological parameters.</p><p><strong>Results: </strong>Significantly lower urine production accompanied by lower perfusate pCO<sub>2</sub> and higher pH were observed in the ALP group throughout NMP. At the end of NMP, intracellular ATP reserves and oxygen consumption were significantly higher in the ALP-treated group. Metabolomics analysis with principal component analysis demonstrated significant differences between the ALP and placebo groups in glycolysis and mitochondrial metabolites, along with a significantly attenuated rise in perfusate lactate dehydrogenase levels.</p><p><strong>Conclusions: </strong>ALP supplementation during HMP was associated with lower urine production and energetic stress, with a shift toward less metabolic dysfunction and graft injury by the end of NMP. Our findings suggest an improvement in the early metabolic incompetency that characterizes delayed graft function in humans. Further research should elucidate whether these findings result in enhancement of graft functionality after transplantation.</p>","PeriodicalId":23225,"journal":{"name":"Transplantation Direct","volume":"12 4","pages":"e1929"},"PeriodicalIF":2.2,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12962581/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147378665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Transplantation DirectPub Date : 2026-03-04eCollection Date: 2026-04-01DOI: 10.1097/TXD.0000000000001925
Isaac S Alderete, Qimeng Gao, Nihal Aykun, Mohamed Mustafa Diab, Nader Abraham, Siavash Raigani, Brian Shaw, Aparna Rege, Lisa McElroy, Deepak Vikraman, Kadiyala Ravindra, Bradley H Collins, Stuart J Knechtle, Debra L Sudan, Andrew S Barbas
{"title":"Back-to-base Versus In-transit Machine Perfusion in Donation After Circulatory Death Liver Transplantation: Insights From a National Registry.","authors":"Isaac S Alderete, Qimeng Gao, Nihal Aykun, Mohamed Mustafa Diab, Nader Abraham, Siavash Raigani, Brian Shaw, Aparna Rege, Lisa McElroy, Deepak Vikraman, Kadiyala Ravindra, Bradley H Collins, Stuart J Knechtle, Debra L Sudan, Andrew S Barbas","doi":"10.1097/TXD.0000000000001925","DOIUrl":"10.1097/TXD.0000000000001925","url":null,"abstract":"<p><strong>Background: </strong>Normothermic machine perfusion (NMP) improves utilization of extended criteria liver grafts, but the optimal delivery strategy-whether in-transit or back-to-base-remains uncertain.</p><p><strong>Methods: </strong>Adult recipients of donation after circulatory death (DCD) liver transplants between January 1, 2022, and January 1, 2024, were identified using the national transplant database. In-transit NMP was defined as grafts coded as machine perfused; back-to-base NMP was inferred for noncoded grafts with a cold ischemia time of ≥10 h. Baseline characteristics, geographic distribution, and outcomes-including acute rejection, length of stay, and graft survival-were compared. Multivariable Cox regression was used to adjust for dialysis and recipient hospitalization status. A sensitivity analysis was performed, limited to cases with cold ischemia time of ≥10 h across both groups.</p><p><strong>Results: </strong>Among 1217 DCD liver transplants using NMP, 936 (77%) were in-transit and 281 (23%) were back-to-base. In-transit NMP was more commonly used in the Western United States, whereas back-to-base was concentrated in the Midwest and Southeast. In-transit recipients had higher rates of pretransplant dialysis (3.1% versus 0.7%; <i>P</i> < 0.05) and shorter preservation times (14.1 versus 16.0 h; <i>P</i> < 0.05). Median hospital stay was shorter in the in-transit group (8 versus 9 d, <i>P</i> < 0.001). There were no significant differences in acute rejection (<i>P</i> = 0.15) or 1-y graft survival (93.3% versus 90.5%, <i>P</i> = 0.23). In adjusted analysis, back-to-base NMP was not associated with increased graft failure risk (hazard ratio 1.46; 95% confidence interval, 0.90-2.38; <i>P</i> = 0.13). Findings were consistent in the sensitivity analysis (n = 1001).</p><p><strong>Conclusions: </strong>In-transit and back-to-base NMP strategies yield comparable clinical outcomes in DCD liver transplantation. Strategy selection may be guided by logistical infrastructure and center-level expertise without compromising recipient outcomes.</p>","PeriodicalId":23225,"journal":{"name":"Transplantation Direct","volume":"12 4","pages":"e1925"},"PeriodicalIF":2.2,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12962566/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147378579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Transplantation DirectPub Date : 2026-03-04eCollection Date: 2026-04-01DOI: 10.1097/TXD.0000000000001928
Elizabeth Sarmiento, Judith Montanchez, Ikram Ezzahouri, Jose Cifrian, Carlos Ortiz-Bautista, Rosalia Laporta, Carles Bravo, Magdalena Salcedo, Maria Luisa Rodriguez-Ferrero, Jose Gonzalez-Costello, Javier Segovia, Alicia de Pablos, Victor Mora, Piedad Ussetti, Sonia Lopez, Nuria Sabe, Manuel Gomez-Bueno, Iago Sousa, Paula Navas, Pablo Diez-Villanueva, Myriam Aguilar, Ainhoa Fernandez-Yunquera, Fernando Anaya, Patricia Muñoz, Maricela Valerio, Ana Mur, Alba Alarcon, Kristofer Limay, Marcos Lopez-Hoyos, Francisco Lopez, Ana Vionnet, Manuel Serrano, Javier Carbone
{"title":"Evaluation of IVIG for Prevention of Infections Occurring On-study and Treatment of Infection of Solid Organ Recipients With Secondary Antibody Deficiency: A Phase 2 Randomized Clinical Trial.","authors":"Elizabeth Sarmiento, Judith Montanchez, Ikram Ezzahouri, Jose Cifrian, Carlos Ortiz-Bautista, Rosalia Laporta, Carles Bravo, Magdalena Salcedo, Maria Luisa Rodriguez-Ferrero, Jose Gonzalez-Costello, Javier Segovia, Alicia de Pablos, Victor Mora, Piedad Ussetti, Sonia Lopez, Nuria Sabe, Manuel Gomez-Bueno, Iago Sousa, Paula Navas, Pablo Diez-Villanueva, Myriam Aguilar, Ainhoa Fernandez-Yunquera, Fernando Anaya, Patricia Muñoz, Maricela Valerio, Ana Mur, Alba Alarcon, Kristofer Limay, Marcos Lopez-Hoyos, Francisco Lopez, Ana Vionnet, Manuel Serrano, Javier Carbone","doi":"10.1097/TXD.0000000000001928","DOIUrl":"10.1097/TXD.0000000000001928","url":null,"abstract":"<p><strong>Background: </strong>There is a paucity of data to guide the management of posttransplant secondary antibody deficiency (SAD). We aimed to evaluate the role of IVIG in solid organ recipients with SAD.</p><p><strong>Methods: </strong>A phase 2, randomized, multicenter, open-label study of solid organ recipients with severe infection and SAD defined as serum IgG <600 mg/dL. The study evaluated the efficacy of adding a fixed protocol of IVIG early after detection of SAD to standard of care (SOC) for the prevention of infection occurring on-study and the treatment of infections, versus SOC. We also assessed reconstitution of humoral immunity in a substudy. Forty-four transplant recipients were randomized in 6 transplant centers in Spain. The IVIG protocol comprised 2 doses of 15 g (interval 7-15 d) followed by 3 doses of 20 g (interval 15-30 d). The primary endpoint was infection occurring on-study defined as a new severe infection after randomization.</p><p><strong>Results: </strong>Forty-two patients were included in the intention-to-treat analysis (IVIG arm, n = 21 versus non-IVIG arm, n = 21). The rate of infection occurring on-study was lower in patients randomized to receive IVIG versus SOC (23.8% versus 66.7%, Fisher exact test, <i>P</i> = 0.012). The median number of infections occurring on-study was lower in the IVIG group. The median total number of new admissions considered to be related to an infection occurring on-study was significantly lower in IVIG-treated patients. A significant increase in specific anti-cytomegalovirus IgG, anti-varicella zoster IgG, anti-<i>Clostridium difficile</i> toxins A and B IgG, and anti-tetanus toxoid IgG and IgG1 was demonstrated in the IVIG arm.</p><p><strong>Conclusions: </strong>In solid organ recipients with severe infection and SAD, IVIG may reduce infection occurring on-study occurrence versus SOC.</p>","PeriodicalId":23225,"journal":{"name":"Transplantation Direct","volume":"12 4","pages":"e1928"},"PeriodicalIF":2.2,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12962580/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147378600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}