A biodegradable polymer plug for liver tract embolization after percutaneous or surgical placement of transhepatic...

To evaluate the feasibility of liver tract embolization after transhepatic biliary drainage using a biodegradable polymer plug (IMPEDE-FX, Shape Memorial Medical, Santa Clara, CA, USA).In a retrospective observational study, 15 plug embolizations were performed in 13 patients at risk for tract-related adverse events (AEs). Risk factors included coagulopathy, cirrhosis, central bile duct puncture, previous drain-related bleeding, malignant obstruction, large tract diameter, or multilevel strictures. Clinical and imaging follow-up was performed at 24 hours, 3 months, and 6 months. Primary endpoints were technical and clinical success. Technical success was defined as plug deployment in the intended position. Clinical success was defined as the absence of biliary, infectious, or bleeding AEs. To assess clinically occult bleeding or biliary obstruction, periprocedural hemoglobin, hematocrit, and bilirubin levels were compared. Secondary endpoints were plug migration, plug oversizing, and plug visibility on imaging.The technical success rate was 100%. The clinical success rate was 84.6%. There were no infectious or bleeding AEs. In 2 cases where the persistence of biliary congestion was clinically underestimated prior to drain removal, 2 biliary AEs occurred (2 biliocutaneous fistulas including 1 plug migration within 24 hours; 15.4% SIR grade 3 AEs). The median plug oversizing relative to the diameter of the hepatic tract was substantially lower in unsuccessful cases than in successful cases (27% vs. 86%). The plug was visible on ultrasound and CT. On MRI, no plug-related artifacts occurred.The plug could be an option when a non-permanent, precisely deployable device is desired for tract embolization. Adequate plug-to-tract oversizing and biliary decongestion are essential to achieve durable tract closure. Therefore, the plug seems unsuitable for patients with multilevel strictures where complete drainage of the biliary system is not feasible. · The polymer plug can be precisely delivered within the liver tract.. · Plug-to-tract oversizing and biliary decongestion are essential for durable tract closure.. · The plug appears unsuitable for endoscopically incompletely relievable multilevel biliary strictures.. · Thurner A, Giulia Dalla G, Hartung V et al. A biodegradable polymer plug for liver tract embolization after percutaneous or surgical placement of transhepatic biliary drainage tubes: a feasibility study. Rofo 2025; 197: 1204-1212.