Safety profile of sequential small caliber drug eluting bead chemoembolization (DEB-TACE): results in 237 patients

Purpose: To record complications of DEB-TACE performed with DC Bead of diameters 100-300 and 300-500 μm loaded with doxorubicin. Materials and Methods: Included are 237 patients treated with sequential DEB-TACE (3 sessions/6 month f-u). National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0) were used to categorize complications. Results: Results are reported on intention to treat. There were no periprocedural deaths. Thirty day mortality was 1.26% with same overall grade 5 complications, notably one periprocedural sepsis and 2 liver abscesses. One liver abscess was treated conservatively (considered Grade 2 complication). Grade 4 complications resulted in 1.68% (4/237) (irreversible liver failure that led to the discontinuation of TACE). Grade 2 liver function deterioration developed in 10 pts (4.2%) that led to protocol abortion in 1.68%. Cholocystitis was documented with ultrasound in 2.95 to 5.06% across the three sessions (all grade 2 complications). Pleural effusion was observed in 2.1 to 2.95% across treatments (only one was a grade 3 complication requiring drainage; 0.42%). There was 1 patient who developed laboratory pancreatitis (0.42%) and 1 limited GI bleeding not related to varices (0.42%). Overall Post Embolization Syndrome (PES) classified as grade 1 or 2 complication was observed in 60.75 to 85.65% across treatments – the lower rates achieved after routine preventive administration of non-steroidal analgesics for 5 days post treatment. Conclusion: This study shows that: 1) DEB TACE is safe with fewer complications compared to reported rates of conventional TACE, and 2) small calibres are safe and do not result in increased complication rates.