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Case-control evaluation of end-hole microcatheter versus Surefire Infusion System for use during transarterial chemoembolization for hepatocellular carcinoma
JVIR
’
Scientific Session
Wednesday
imaging. Patient outcomes were assessed based on overall survival, successful downstaging and having undergone transplantation. Results: 20 patients with 37 separate HCC lesions underwent 37 SIS-TACE within 6 months from the first SIS-TACE. 11 patients had been previously treated using a standard end-hole catheter. All lesions were treated with 50 mg of Doxorubicin and either 100 micron Oncozene microspheres or 100-300 micron LC beads. Follow up imaging was available for all patients. Six months after initial treatment with SIS and average 1.9 ⫾ 1.1 SIS treatments per patient, 23 (62.2%) of the lesions had complete response (CR), 7 (18.8%) demonstrated partial response (PR) and 4 (10.8%) progressed. Two patients with 3 (8.2%) lesions were transplanted with necrosis between 10-80% on explant pathology. Overall, of the 18 non transplanted patients, 8 (44.5%) had CR, 6 (33.5%) had PR and 4 (22%) progressed. 7 of 20 (35%) patients were outside of Milan criteria prior to treatment and 6 (85.7%) of them were successfully downstaged. At 12 months, follow-up was available in 7 patients with 12 lesions. Three patients (43%) with 4 lesions, including one patient who was down-staged, had undergone transplantation. Transplant explant pathology in these 3 patients demonstrated overall necrosis ranging between 30-100%. In the remaining 4 patients, 3 had stable disease (75%) and 1 (25%) progressed. Of the 8 total lesions, 1 (8.3%) had CR, 2 (16.7%) PR, 2 (16.7%) stable disease and 3 (25%) progressed. The lesions demonstrating progression were all found in a single patient. Conclusions: SIS delivery of DEB-TACE demonstrates promising efficacy for the treatment of HCC in the intermediate and long term. A prospective randomized clinical trial is underway to substantiate these results.
3:09 PM
Abstract No. 363
Case-control evaluation of end-hole microcatheter versus Surefire Infusion System for use during transarterial chemoembolization for hepatocellular carcinoma
Purpose: To compare outcomes of the Surefire Infusion System (SIS) anti-reflux catheter versus end-hole microcatheters (EM) for use during TACE for hepatocellular carcinoma (HCC). Materials: A case-control study was performed on nineteen patients (mean age, 61.3; range 36-74) who underwent TACE for HCC using SIS between 3/2015-8/2016. Nineteen controls (mean age, 61.4; range 46-83) were selected based on similarities in initial total tumor size, location, laterality, Child-Pugh score, and underlying etiology of HCC (Table ). Post-TACE tumor response was assessed on follow-up imaging using mRECIST criteria. The total number of TACE treatments for each patient was recorded. Results: Per lesion, the initial overall response rate post-TACE with SIS and EM was 78.9% and 36.8% (p ¼ 0.008). The initial overall complete response (CR) rate with SIS and EM was 26.3% and 21.1% (p ¼ 1.0). The initial overall partial response (PR) rate with SIS and EM was 52.6% and 15.8% (p ¼ 0.02). The percentage of patients who initially had progressive disease
S157
(PD) with SIS and EM was 0% and 21% (p ¼ 0.13). The total number of TACE treatments received by the SIS and EM groups were 2.3 and 3.1 (p ¼ 0.16). Four and three patients in the SIS and EM groups received liver transplants, respectively. Conclusions: In our case-control series, patients undergoing TACE with SIS demonstrated a statistically significant improvement in disease response rate compared to those undergoing treatment with a standard end-hole microcatheter. A prospective, comparative evaluation is now underway to validate our preliminary findings. Baseline Characteristics of the 38 Patients Surefire
End-hole
Microcatheter Infusion P Value System (n¼ 19) (n¼ 19) Mean number of HCC lesions (range) Mean total size of lesions, cm (range) Mean Child-Pugh
1.90 (1–4)
1.79 (1–3)
0.61
5.62 (1.2–10.7)
5.45 (2–10.7)
0.54
A6
A6
0.53
score
3:18 PM
Abstract No. 364
Proof of concept: pressure-directed embolization of hepatic arteries in a porcine model using a temporary occlusion balloon microcatheter S. Rose1, G. Halstead2, I. Newton1, K. Narsinh1; 1UCSD Medical Center, San Diego, CA; 2Embolx, Inc., Sunnyvale, CA Purpose: To test the hypothesis that temporary balloon occlusion of a hepatic artery would permit increased intracompartmental selective delivery of particulate emboli to a targeted intrahepatic arterial collection catheter located within the downstream vascular compartment due to reduced blood pressure distal to the occlusion balloon and subsequent pressure driven redirection of blood flow. Materials: Five Yorkshire pigs underwent transfemoral placement of balloon microcatheters into selected segmental hepatic arteries. A collection catheter was surgically introduced into a downstream hepatic artery branch. Blood pressures at the femoral artery sheath and the collection catheter were obtained with the microcatheter balloon deflated then inflated. In two pigs, hepatic arteriography was performed through the balloon microcatheter when deflated then inflated. Identical quantities of calibrated 250mm and 400mm microspheres were then injected via the balloon microcatheter when deflated, then inflated. Microspheres collected from the intrahepatic collection catheter were counted manually by light microscopy. Results: Inflation of the balloon microcatheter in the segmental hepatic artery resulted in a consistent and significant decrease in blood pressure (range 12–45 mm Hg; Po0.05) in the downstream vascular compartment. Angiographically, fewer segmental hepatic arteries were seen when the balloon was inflated rather than deflated. The number of microspheres selectively delivered to the targeted intrahepatic collection catheter was significantly greater
WEDNESDAY: Scientific Sessions
N. Apseloff1, J. Keung2, T. Caridi2, D. Buckley2, G. Lynskey2, A. Kim2; 1Georgetown University School of Medicine, Washington, DC; 2Georgetown University Hospital, Washington, DC
’
’
Scientific Session
Wednesday
imaging. Patient outcomes were assessed based on overall survival, successful downstaging and having undergone transplantation. Results: 20 patients with 37 separate HCC lesions underwent 37 SIS-TACE within 6 months from the first SIS-TACE. 11 patients had been previously treated using a standard end-hole catheter. All lesions were treated with 50 mg of Doxorubicin and either 100 micron Oncozene microspheres or 100-300 micron LC beads. Follow up imaging was available for all patients. Six months after initial treatment with SIS and average 1.9 ⫾ 1.1 SIS treatments per patient, 23 (62.2%) of the lesions had complete response (CR), 7 (18.8%) demonstrated partial response (PR) and 4 (10.8%) progressed. Two patients with 3 (8.2%) lesions were transplanted with necrosis between 10-80% on explant pathology. Overall, of the 18 non transplanted patients, 8 (44.5%) had CR, 6 (33.5%) had PR and 4 (22%) progressed. 7 of 20 (35%) patients were outside of Milan criteria prior to treatment and 6 (85.7%) of them were successfully downstaged. At 12 months, follow-up was available in 7 patients with 12 lesions. Three patients (43%) with 4 lesions, including one patient who was down-staged, had undergone transplantation. Transplant explant pathology in these 3 patients demonstrated overall necrosis ranging between 30-100%. In the remaining 4 patients, 3 had stable disease (75%) and 1 (25%) progressed. Of the 8 total lesions, 1 (8.3%) had CR, 2 (16.7%) PR, 2 (16.7%) stable disease and 3 (25%) progressed. The lesions demonstrating progression were all found in a single patient. Conclusions: SIS delivery of DEB-TACE demonstrates promising efficacy for the treatment of HCC in the intermediate and long term. A prospective randomized clinical trial is underway to substantiate these results.
3:09 PM
Abstract No. 363
Case-control evaluation of end-hole microcatheter versus Surefire Infusion System for use during transarterial chemoembolization for hepatocellular carcinoma
Purpose: To compare outcomes of the Surefire Infusion System (SIS) anti-reflux catheter versus end-hole microcatheters (EM) for use during TACE for hepatocellular carcinoma (HCC). Materials: A case-control study was performed on nineteen patients (mean age, 61.3; range 36-74) who underwent TACE for HCC using SIS between 3/2015-8/2016. Nineteen controls (mean age, 61.4; range 46-83) were selected based on similarities in initial total tumor size, location, laterality, Child-Pugh score, and underlying etiology of HCC (Table ). Post-TACE tumor response was assessed on follow-up imaging using mRECIST criteria. The total number of TACE treatments for each patient was recorded. Results: Per lesion, the initial overall response rate post-TACE with SIS and EM was 78.9% and 36.8% (p ¼ 0.008). The initial overall complete response (CR) rate with SIS and EM was 26.3% and 21.1% (p ¼ 1.0). The initial overall partial response (PR) rate with SIS and EM was 52.6% and 15.8% (p ¼ 0.02). The percentage of patients who initially had progressive disease
S157
(PD) with SIS and EM was 0% and 21% (p ¼ 0.13). The total number of TACE treatments received by the SIS and EM groups were 2.3 and 3.1 (p ¼ 0.16). Four and three patients in the SIS and EM groups received liver transplants, respectively. Conclusions: In our case-control series, patients undergoing TACE with SIS demonstrated a statistically significant improvement in disease response rate compared to those undergoing treatment with a standard end-hole microcatheter. A prospective, comparative evaluation is now underway to validate our preliminary findings. Baseline Characteristics of the 38 Patients Surefire
End-hole
Microcatheter Infusion P Value System (n¼ 19) (n¼ 19) Mean number of HCC lesions (range) Mean total size of lesions, cm (range) Mean Child-Pugh
1.90 (1–4)
1.79 (1–3)
0.61
5.62 (1.2–10.7)
5.45 (2–10.7)
0.54
A6
A6
0.53
score
3:18 PM
Abstract No. 364
Proof of concept: pressure-directed embolization of hepatic arteries in a porcine model using a temporary occlusion balloon microcatheter S. Rose1, G. Halstead2, I. Newton1, K. Narsinh1; 1UCSD Medical Center, San Diego, CA; 2Embolx, Inc., Sunnyvale, CA Purpose: To test the hypothesis that temporary balloon occlusion of a hepatic artery would permit increased intracompartmental selective delivery of particulate emboli to a targeted intrahepatic arterial collection catheter located within the downstream vascular compartment due to reduced blood pressure distal to the occlusion balloon and subsequent pressure driven redirection of blood flow. Materials: Five Yorkshire pigs underwent transfemoral placement of balloon microcatheters into selected segmental hepatic arteries. A collection catheter was surgically introduced into a downstream hepatic artery branch. Blood pressures at the femoral artery sheath and the collection catheter were obtained with the microcatheter balloon deflated then inflated. In two pigs, hepatic arteriography was performed through the balloon microcatheter when deflated then inflated. Identical quantities of calibrated 250mm and 400mm microspheres were then injected via the balloon microcatheter when deflated, then inflated. Microspheres collected from the intrahepatic collection catheter were counted manually by light microscopy. Results: Inflation of the balloon microcatheter in the segmental hepatic artery resulted in a consistent and significant decrease in blood pressure (range 12–45 mm Hg; Po0.05) in the downstream vascular compartment. Angiographically, fewer segmental hepatic arteries were seen when the balloon was inflated rather than deflated. The number of microspheres selectively delivered to the targeted intrahepatic collection catheter was significantly greater
WEDNESDAY: Scientific Sessions
N. Apseloff1, J. Keung2, T. Caridi2, D. Buckley2, G. Lynskey2, A. Kim2; 1Georgetown University School of Medicine, Washington, DC; 2Georgetown University Hospital, Washington, DC
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