Safety and Feasibility of Yttrium-90 Radioembolization for Cirrhosis-Induced Splenomegaly and Thrombocytopenia: Results from an Investigational Device Exemption Study.

Cirrhosis-associated hypersplenism and thrombocytopenia lead to discomfort and bleeding risk, which can complicate necessary medical/procedural management. Current medical therapies are limited in effectiveness, whereas surgical splenectomy and partial splenic embolization are associated with unfavorable adverse event (AE) profiles and other drawbacks. This prospective study evaluated novel yttrium-90 (90Y) splenic transarterial radioembolization (TARE) for cirrhosis-associated hypersplenism and thrombocytopenia. In 7 patients, 90Y splenic TARE was associated with 2 mild AEs, and no moderate/severe AEs. Although significant improvements in platelet counts and splenic volumes were not observed, premature study termination due to enrollment difficulties limited sample size and prevented planned dose escalation beyond 100 Gy. Pre-TARE nuclear medicine lung shunt evaluation and post-TARE 90Y positron emission tomography (PET)/computed tomography (CT) demonstrated shunt fractions <5% and no extrasplenic 90Y deposition, confirming procedural safety and single-session feasibility. Given the demonstrated safety and feasibility as well as theoretical promise of 90Y splenic TARE in this population, future research is warranted.