Safety and efficacy of DEM-TACE performed with drug-eluting microspheres smaller than 300μm in patients with HCC and TIPS

Aim:Safety and efficacy evidence of drug-eluting-microspheres trans-arterial chemoembolization(DEM-TACE)in patients with hepatocellular carcinoma(HCC)and trans-jugular intrahepatic portosystemic shunt(TIPS)is lacking.The aim of this retrospective study was to report the safety and efficacy of DEM-TACE procedures performed with microspheres smaller than 300μm in patients with HCC and TIPS in a high-volume transplant center.Methods:Embolization was standardized by initiating DEM-TACE with microspheres smaller than 100μm,and if stasis was not achieved,adjunctive embolization with 100-300 or 200μm microspheres was administered.With regards to efficacy,the oncological response was evaluated and categorized according to mRECIST criteria at 1,3-6,9-12,and 15-18 months.Reporting the safety profile,detailed laboratory analysis was performed before,at 36-48 h,and 30-60 days after the procedure.Adverse events(AEs)were recorded;post-embolic syndrome was defined as the onset of fever/nausea/pain after the procedure.Late onset hepatobiliary complications were evaluated by follow-up imaging with computed tomography or magnetic resonance(CT/MR).Results:From December 2007 to November 2020,17 HCC patients(25 HCC nodules)with patent TIPS underwent 20 DEM-TACE.Embolization was performed only with microspheres smaller than 100μm in 3/20 DEM-TACE(15%);adjunctive embolization with 100-300 or 200μm microspheres was required in 17/20 DEMTACE(85%).Reported early AEs were post-embolic syndrome(9/20;45%)all of grade 1-2,late AEs were asymptomatic acute liver bile duct injury(2/20;10%),and in one case we observed hepatic abscess(1/20;5%)resulting in death due to sepsis.With regards to efficacy,the oncological response was evaluated and categorized according to mRECIST criteria.Complete response(CR)at 1,3-6,9-12,and 15-18 months was 52%,50%,50%,and 50%,respectively.Objective response(CR+partial response)at 1,3-6,9-12,and 15-18 months was 95%,71%,70%,and 50%,respectively.Conclusion:DEM-TACE with drug-eluting-microspheres smaller than 300μm can be performed in appropriately selected patients with TIPS.