The safety and efficacy of haemostasis with a catechol-conjugated, chitosan-based haemostatic dressing versus a chitosan-based haemostatic dressing after transfemoral approach for transcatheter arterial chemoembolization: a randomized controlled trial.

PURPOSE: To compare the haemostatic efficacy (i.e. efficacy to prevent access site complications) of the InnoSEAL haemostatic pad and Clo-Sur PLUS P.A.D. after femoral arterial puncture for transcatheter arterial chemoembolization (TACE). MATERIAL AND METHODS: This randomized controlled trial compared the safety and efficacy of an InnoSEAL haemostatic pad (n = 48) and a Clo-Sur PLUS P.A.D. (n = 52) for haemostasis of arterial puncture sites after TACE with femoral arterial access using a 5-Fr sheath. Primary endpoints were incidence of major (necessitating surgery) and moderate access site complications (ASC) (necessitating blood transfusion/thrombin injection). Secondary endpoints were incidence of minor ASC (no therapy required) and time to haemostasis. RESULTS: No major or moderate ASC was seen with either device. Minor ASC (6.3% [3/48] vs. 19.2% [10/52], p = 0.075) and ecchymosis (classified as minor ASC; 4.2% [2/48] vs. 17.3% [9/52]; p = 0.053, p-value cut-off after Bonferroni correction = 0.025) were less frequently observed with the InnoSEAL haemostatic pad. The time to haemostasis did not differ significantly between the 2 devices (5.6 ± 1.0 vs. 5.3 ± 0.7 minutes; p = 0.118). Multivariable logistic regression analysis showed a lower risk of ASC with the InnoSEAL pad (adjusted OR, 0.174; 95% CI: 0.034-0.890; p = 0.036). CONCLUSIONS: No major ASC was seen with either pad, and no significant difference of minor ASC was observed between 2 pads.

A prediction model for overall survival after transarterial chemoembolization for hepatocellular carcinoma invading the hepatic vein or inferior vena cava.

OBJECTIVES: An effective therapeutic option has not yet been established for hepatocellular carcinoma (HCC) invading the hepatic vein (HV) or inferior vena cava (IVC). This study aimed to determine the therapeutic effect of transarterial chemoembolization (TACE) in HCC patients with HV or IVC invasion, and to build a risk prediction model. METHODS: Data from patients who underwent TACE as a first-line treatment for HCC invading the HV or IVC between 1997 and 2019 were retrospectively evaluated. RESULTS: Data from 296 patients were included (1997-2006 comprised the training cohort, n = 174; 2007-2019 comprised the validation cohort, n = 122). The median post-TACE survival was 7.3 months and an objective tumor response was achieved in 34.1% of patients. Multivariable Cox analysis of the training cohort identified five pretreatment factors (maximal tumor size > 10 cm, infiltrative HCC, combined portal vein invasion, extrahepatic metastasis, and ECOG performance status 1), which were used to create predictive models for overall survival. Median overall survival times in the validation cohort were 14 and 4.2 months for the low (sum of risk score: 0-3)- and high-risk (sum of risk score: 4-7) groups, respectively (p < 0.001). Time-dependent ROC curves for the predictive models for overall survival applied to the validation cohort showed acceptable AUC values (0.723 and 0.667 at 6 months and 1 year). CONCLUSIONS: TACE seems effective for selected patients with HCC invading the HV or IVC. The predictive model may help to identify candidates most likely to benefit from TACE. KEY POINTS: • To develop a risk prediction model for patients with HCC with HV or IVC invasion treated with TACE, five factors were selected from a multivariate Cox regression model for overall survival. • The combination of these factors helped to identify two prognostic categories: low- and high-risk. • The predictive model can help to select candidates who will benefit most from TACE in this patient group.

A Single-Center Retrospective Analysis of Periprocedural Variables Affecting Local Tumor Progression after Radiofrequency Ablation of Colorectal Cancer Liver Metastases.

Background Local tumor progression (LTP) is associated with poorer survival in patients undergoing radiofrequency ablation (RFA) for colorectal liver metastasis (CLM). An algorithmic strategy to predict LTP may help in selection of patients who would benefit most from RFA for CLM. Purpose To estimate local tumor progression-free survival (LTPFS) following RFA of CLM and develop an algorithmic strategy based on clinical variables. Materials and Methods In this retrospective study, between March 2000 and December 2014, patients who underwent percutaneous RFA for CLM were randomly split into development (60%) and internal validation (40%) data sets. Kaplan-Meier method was used to estimate LTPFS and overall survival (OS) rates. Independent factors affecting LTPFS in the development data set were investigated by using multivariable Cox proportional hazard regression analysis. Risk scores were assigned to the risk factors and applied to the validation data set. Results A total of 365 patients (mean age, 60 years ± 11 [standard deviation]; 259 men) with 512 CLMs were evaluated. LTPFS and OS rates were 85% and 92% at 1 year, 73% and 41% at 5 years, 72% and 30% at 10 years, and 72% and 28% at 15 years, respectively. Independent risk factors for LTP included tumor size of 2 cm or greater (hazard ratio [HR], 3.8; 95% CI: 2.3, 6.2; P < .001), subcapsular tumor location (HR, 1.9; 95% CI: 1.1, 3.1; P = .02), and minimal ablative margin of 5 mm or less (HR, 11.7; 95% CI: 4.7, 29.2; P < .001). A prediction model that used the risk factors had areas under the curve of 0.89, 0.92, and 0.90 at 1, 5, and 10 years, respectively, and it showed significantly better areas under the curve when compared with the model using the minimal ablative margin of 5 mm or less alone. Conclusion Radiofrequency ablation provided long-term control of colorectal liver metastases. Although minimal ablative margin of 5 mm or less was the most dominant factor, the multifactorial approach including tumor size and subcapsular location better predicted local tumor progression-free survival. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Soulen and Sofocleous in this issue.

Transarterial chemoembolization vs. radiofrequency ablation for the treatment of single hepatocellular carcinoma 2 cm or smaller.

OBJECTIVES: To compare the effectiveness of transarterial chemoembolization (TACE) and radiofrequency ablation (RFA) for treating small (≤2 cm) hepatocellular carcinomas (HCCs). METHODS: This retrospective study consisted of 287 patients (mean age, 57.1 years; age range, 29-84 years; 221 men, 66 women; 73.5% with HBV; 100% with liver cirrhosis) with Barcelona Clinic Liver Cancer very early-stage HCC (≤2 cm single HCC) who were initially treated with TACE (n=122) or RFA (n=165). The primary study end point was overall patient survival. Secondary study end points were time to progression and tumor response. RESULTS: The RFA and TACE groups were well balanced in terms of baseline variables. The two groups did not differ significantly in overall survival (P=0.079) or major complication (P>0.999) rates. The respective cumulative survival rates at 1, 3, 5, and 8 years were 97.6, 86.7, 74.5, and 60.0% for RFA and 93.4, 75.4, 63.1, and 51.1% for TACE. Their objective tumor regression (complete or partial response) rates were 100% (165/165) and 95.9% (117/122), respectively (P=0.013). The median times to progression for RFA and TACE were 27.0±3.8 (95% confidence intervals (CIs): 19.6-34.4) and 18.0±2.9 (95% CIs: 12.2-23.8) months, respectively. RFA yielded a significantly longer time to progression (P=0.034). CONCLUSIONS: TACE may be a viable alternative treatment for ≤2 cm HCCs when RFA is not feasible.