Dual-balloon infusion microcatheter for selective drug-eluting bead transarterial chemoembolization: initial feasibility study.

PURPOSE: We aimed to demonstrate feasibility of the use of a dual-balloon infusion microcatheter for segmental/subsegmental drug-eluting bead transarterial chemoembolization (DEB-TACE).

METHODS: Over a 16-month period, 15 segmental and 21 subsegmental DEB-TACE procedures were attempted using a dual-balloon anti-reflux microcatheter (IsoFlow™ microcatheter, Vascular Designs Inc.) in 21 patients (15 males; median age, 61 years; range, 49-82 years) with hepatocellular carcinoma (Barcelona clinic liver cancer stage A [n=4]; B [n=12]; C [n=5]) with one to three tumors, median size of 3.4 cm (1.2-9 cm). Follow-up enhanced computed tomography or magnetic resonance imaging was obtained at one month then subsequently every three months for one year. Technical success was evaluated. Modified RECIST criteria was used for target tumor response assessment. Safety was evaluated by assessing for arterial injury and hepatic injury at the time of the procedure and subsequent evidence of complications and liver toxicity.

RESULTS: In 26 of the procedures, the segmental/subsegmental arteries were thought not to be easily selected with standard microcatheters due to the arterial branches being severely tortuous/angulated or atretic from prior TACE or anti-angiogenic therapy or could not be catheterized. Radiologic response assessment of treated tumors demonstrated 32% complete response, 19% partial response, 34% stable disease, and 15% progressive disease. No complications occurred. The median time to progression for the targeted tumors was 7 months (range, 3-12 months).

CONCLUSION: DEB-TACE, using this dual-balloon anti-reflux infusion microcatheter is feasible and safe.