P.101: Safety and Efficacy of a Percutaneous Intraportal Islet Transplantation Procedure Using Tract Embolization With Gelatine Foam Pledgets

Abstract

Introduction: Intraportal pancreatic islet transplantation is a minimally invasive procedure to treat patients with diabetes mellitus and unstable glycemic control despite optimal medical treatment. We analysed the safety and efficacy of percutaneous transhepatic intraportal islet transplantation procedures using embolization of the hepatic puncture tract with gelatin foam pledgets. Methods: This was a retrospective, single center study including all allogeneic islet transplantations between 2007 and 2019 at the Leiden University Medical Center. Under local anaesthesia, islets were infused into the main portal vein using a right-sided transhepatic approach. Tract embolization was performed in 51/62 procedures using the Hunter Biopsy Sealing Device. Complications were assessed according to CTCAEv5.0. Stimulated C-peptide during a mixed meal test was measured after 3 months to evaluate efficacy. Results: A total of 62 islet transplants in 38 recipients (female 39.5%; median age 53.2 (IQR 40.8 – 64.0) years) were included. 11 complications occurred in 62 procedures: no CTCAE grade 4 or 5 complications occurred. Bleeding occurred in 3/11 (27.3%) of procedures without tract embolization, compared to 2/51 (3.9%) with tract embolization (p=0.01). 3 of these bleeding episodes comprised grade 3 complications which could be managed conservatively, and 2 bleeding episodes were grade 1 that did not require intervention. More than one puncture attempt was a positive predictor for bleeding (p=0.001) and pain (p=0.002). No portal vein thromboses were encountered.1 biliary puncture (grade 1) and 5 episodes of pain (grade 1 (n=3) and grade 2 (n=2)) occurred. Three months after infusion, stimulated C-peptide was >0.17 nmol/L in 60/62 (97%) transplant recipients. Conclusion: A percutaneous transhepatic procedure using gelatine foam pledgets is a safe and efficacious method to transplant islets into the portal vein. Complications were either self-limiting or could be managed with non-invasive treatment. The vast majority of patients gained endogenous insulin production.