1Radhi Ali Alshehri,1Abdullah Almuharib, 1Abdullah Almuharib, 1Abdulaziz Alshoeabi, 2Abdulhadi Alqahtani, 1Abdulhadi Alqahtani

1Department of Medical Imaging and Interventional Radiology, 2Clinical Research Department, Research Center

Objective(s):

This study aims to evaluate the effectiveness and safety of a novel drug-eluting radiopaque beads (LC Bead LUMI) loaded with Doxorubicin for treatment of HCC and liver metastasis.

Material(s) and Method(s):

This was a retrospective study of the outcomes of first 14 TACE procedures done for treatment of 14 tumors in 12 patients at our center utilizing novel drug-eluting radiopaque beads, between March 2019 and Jun 2021.

Radiological findings were collected pre- and post-treatment for assessment of embolization effectiveness and technical success based on mRECIST and gross necrosis criteria using variables include changes in tumor volume, enhancement pattern, tumor density, visibility of beads within the embolized territory and MRI diffusion.

Evaluation for safety was by observing the complications, mortality, need for prolonged hospital stay and survival rate after the procedure. Data of all patients who subsequently underwent ablation procedures is recorded.

Result(s):

14 TACE procedures were performed for 12 patients having 14 tumors, with a median age of 71.6 years (range 51-79), 7(58.3%) male and 5(41.6%) female, 10/12(83.3%) patients have liver cirrhosis, 13 primary hepatic malignancies – HCC (92.9%) and 1 metastatic lesion from colon cancer (7.1%), median lesion volume was 69.3cm3 (range 0.5-130 cm3). The median early follow-up duration was 58 days and for last follow up was 353 days. Mean post procedure tumor volume was 67cm3 after 58 days average follow up and 33cm3 after 353 days follow up.

The response rate at 2 months average follow up was as following: complete response in 8/14 tumors (57.1%), Partial response in 5/14 (35.7%) and no response in 1 (7.14%) tumor because the beads are delivered outside the tumor. The total response rate including complete and partial response at 3,6 and 12 months follow up was seen in 85.7% of tumors. Local recurrence after complete response observed in 1/8 (12.5%) tumor after 444 days follow up. The technical success was achieved in 92.8% of procedures.

The radiopaque beads were visible on intra-operative and follow-up CT images in all patients (100%).

Complications of CIRSE Grade II or above are zero. One adverse event was noticed after using the standard embolic mixture that contains 75mg of Doxorubicin in 2mL of LUMI beads mixed with only 5mL of contrast. After infusion, high viscosity of the embolic mixture restricted the movement of beads, resulting in proximal arterial embolization leading to segmental infarction and atrophy in 1/14 procedure (7.14%). In the following 13 procedures, this complication was completely avoided by adding 15-20 ml of contrast instead of only 5 ml to embolic mixture.

As a result of this technical change, the beads became able to travel to the distal feeding branches and achieve super-selective embolization.

Mortality at early follow up was zero. 1/12 patients died due to unrelated cardiac arrest after 4 months. All patients with partial response were planned for further treatment.

Result(s):

14 TACE procedures were performed for 12 patients having 14 tumors, with a median age of 71.6 years (range 51-79), 7(58.3%) male and 5(41.6%) female, 10/12(83.3%) patients have liver cirrhosis, 13 primary hepatic malignancies – HCC (92.9%) and 1 metastatic lesion from colon cancer (7.1%), median lesion volume was 69.3cm3 (range 0.5-130 cm3). The median early follow-up duration was 58 days and for last follow up was 353 days. Mean post procedure tumor volume was 67cm3 after 58 days average follow up and 33cm3 after 353 days follow up.

The response rate at 2 months average follow up was as following: complete response in 8/14 tumors (57.1%), Partial response in 5/14 (35.7%) and no response in 1 (7.14%) tumor because the beads are delivered outside the tumor. The total response rate including complete and partial response at 3,6 and 12 months follow up was seen in 85.7% of tumors. Local recurrence after complete response observed in 1/8 (12.5%) tumor after 444 days follow up. The technical success was achieved in 92.8% of procedures.

The radiopaque beads were visible on intra-operative and follow-up CT images in all patients (100%).

Complications of CIRSE Grade II or above are zero. One adverse event was noticed after using the standard embolic mixture that contains 75mg of Doxorubicin in 2mL of LUMI beads mixed with only 5mL of contrast. After infusion, high viscosity of the embolic mixture restricted the movement of beads, resulting in proximal arterial embolization leading to segmental infarction and atrophy in 1/14 procedure (7.14%). In the following 13 procedures, this complication was completely avoided by adding 15-20 ml of contrast instead of only 5 ml to embolic mixture.

As a result of this technical change, the beads became able to travel to the distal feeding branches and achieve super-selective embolization.

Mortality at early follow up was zero. 1/12 patients died due to unrelated cardiac arrest after 4 months. All patients with partial response were planned for further treatment.