Context: The Igls criteria were developed to provide a consensus definition for outcomes of beta-cell replacement therapy in the treatment of diabetes during a January 2017 workshop sponsored by... Show moreContext: The Igls criteria were developed to provide a consensus definition for outcomes of beta-cell replacement therapy in the treatment of diabetes during a January 2017 workshop sponsored by the International Pancreas & Islet Transplant Association (IPITA) and the European Pancreas & Islet Transplant Association. In July 2019, a symposium at the 17th IPITA World Congress was held to examine the Igls criteria after 2 years in clinical practice, including validation against continuous glucose monitoring (CGM)-derived glucose targets, and to propose future refinements that would allow for comparison of outcomes with artificial pancreas system approaches.Evidence acquisition: Utilization of the criteria in various clinical and research settings was illustrated by population as well as individual outcome data of 4 islet and/or pancreas transplant centers. Validation against CGM metrics was conducted in 55 islet transplant recipients followed-up to 10 years from a fifth center.Evidence synthesis: The Igls criteria provided meaningful clinical assessment on an individual patient and treatment group level, allowing for comparison both within and between different beta-cell replacement modalities. Important limitations include the need to account for changes in insulin requirements and C-peptide levels relative to baseline. In islet transplant recipients, CGM glucose time in range improved with each category of increasing beta-cell graft function.Conclusions: Future Igls 2.0 criteria should consider absolute rather than relative levels of insulin use and C-peptide as qualifiers with treatment success based on glucose assessment using CGM metrics on par with assessment of glycated hemoglobin and severe hypoglycemia events. Show less
Complete graft thrombosis is the leading cause of early graft loss following pancreas transplantation. Partial thrombosis is usually subclinical and discovered on routine imaging. Treatment options... Show moreComplete graft thrombosis is the leading cause of early graft loss following pancreas transplantation. Partial thrombosis is usually subclinical and discovered on routine imaging. Treatment options may vary in such cases. We describe the incidence and relevance of partial graft thrombosis in a large transplant center. All consecutive pancreas transplantation at our center (2004-2015) were included in this study. Radiological follow-up, type and quantity of thrombosis prophylaxis, complications and, graft and patient survival were collected. Partial thrombosis and follow-up were also studied. All 230 pancreas transplantations were included in the analysis. Computed tomography was performed in most cases (89.1%). Early graft failure occurred in 23 patients (13/23 due to graft thrombosis, 3/23 bleeding, 1/23 anastomotic leakage, 6/23 secondary to antibody mediated rejection). There was evidence of partial thrombosis in 59 cases (26%), of which the majority was treated with heparin and a vitamin K antagonist with graft preservation in 57/59 patients (97%). Thrombosis is the leading cause of early graft loss following pancreas transplantation. Computed tomography allows for early detection of partial thrombosis, which is usually subclinical. Partial graft thrombosis occurs in about 25% of all cases. In this series, treatment with anticoagulant therapy (heparin and vitamin K antagonist) resulted in graft preservation in almost all cases. Show less