Purpose:
To evaluate the efficacy of the Surefire Infusion System (SIS) for delivery of DEB-TACE in treatment of HCC.

Materials and Methods:
A retrospective review was performed of all patients who under went DEB-TACE for the treatment of HCC with the SIS in a 12-month period. All patients underwent standard angiogram to identify lesions, and treated with 100μm hydrogel microspheres + 50mg Doxorubicin. Treatment location was chosen to be as selective as possible. Patient outcomes were assessed based on mRECIST criteria on follow up imaging.

Results:
11 patients with 25 separate HCC lesions (mean size, 3.8cm) under went DEB-TACE treatments using SIS. Of the 24 lesions that were treated with SIS, 12 were de-novo lesions and 12 had previously failed to respond to DEB-TACE using a standard end-hole catheter. With SIS, 15 of 24 (62.5%) of the lesions had complete response (CR), 5 of 24 (20.8%) demonstrated partial response (PR), and 4 lesion had stable disease (SD). Six lesions that did not achieve CR in the first treatment were re-treated with the SIS. Of these, 5 (83.3%) achieved CR. No hepatoxicity was observed; and four patients were successfully downstaged to within Milan criteria.

Conclusion:
SIS is a promising tool for delivery of DEB-TACE in treatment of HCC and may lead to improved disease response compared to standard end-hole catheters. In this retrospective study, SIS achieved 83% OR even in lesions that have previously failed DEB-TACE using standard end-hole catheters. A larger, prospective trial is planned to further validate these findings.


Patient Characteristics

Age(year)
59.5 (range 36– 74)

Sex(M/F)
Male: 10
Female: 1

Etiology of Liver Disease
Hepatitis B: 3 (27.3%)
Hepatitis C: 5 (45.5%)
Alcohol Hepatitis: 2 (18.2%)
Nonalcoholic steatohepatitis: 1 (9.1%)

Child-Pugh Classification
A: 9 (81.8%)
B: 2 (18.2%)

Tumor Distribution
Unilobar: 6 (54.4%)
Bilobar: 5 (45.5%)

BCLC Stage
A: 4 (36.4%)
B: 7 (63.6%)


Lesion Characteristics (number of lesions, n=25)

Average Number of Lesions
2.5 (range 1– 6)

Lesion Size Prior to DEB-TACE
3.8cm (range 1.6– 9.0cm)

Viable Lesion Size Prior to First ARM TACE
3.6cm (range 0.8– 9.0cm)