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Purpose: To report response rates (using mRECIST), overall survival (OS), progression-free survival and local tumour recurrence-free survival (LRFS) of balloon-occluded transarterial chemoembolisation (bTACE) for hepatocellular carcinoma (HCC)., Materials and Methods: Patients from five European centres treated with conventional or drug-eluting microsphere bTACE for HCC were included, and patients already lost to follow-up before 12 months were excluded. Possible factors contributing to LRFS and OS were evaluated with Cox proportional hazards models., Results: Seventy-three patients were enrolled. The mean number of nodules per patient was 2.07(± 1.68), and the average maximum diameter of the nodules was 37 ± 19.9 mm. The response of the target lesion at 6 months was complete response (CR) in 58.9%, partial response (PR) in 28.8%, stable disease (SD) in 6.8% and progressive disease (PD) in 5.5%. The median follow-up time was 31 months; at the last follow-up, target tumour response was CR in 49.3%, PR in 12.3%, SD in 5.5% and PD 32.9%. Overall response at the last follow-up was CR in 17.8%, PR in 9.6%, SD 2.7% and PD in 69.9% (for new lesions in 37% of patients). Median OS was not reached; mean overall survival was 50.0 months, while median LRFS was 31.0 months. At uni- and multivariable analysis, only tumour maximum diameter was related to LRFS (hazard ratio [HR] = 1.021; 95% CI 1.004-1.038, P = 0.015)., Conclusions: bTACE demonstrated high efficacy for HCC, with a complete response in 58.9% of patients, a median local recurrence-free survival of 31.0 months and a mean overall survival of 50.0 months., (© 2024. The Author(s).)

Objectives: To demonstrate in vivo redistribution of the blood flow towards HCC's lesions by utilizing two-dimensional perfusion angiography in b-TACE procedures., Material and Methods: In total, 30 patients with 35 HCC nodules treated in the period between January 2019 and November 2021. For each patient, a post-processing software leading to a two-dimensional perfusion angiography was applied on each angiography performed via balloon microcatheter, before and after inflation. On the colour map obtained, reflecting the evolution of contrast intensity change over time, five regions of interests (ROIs) were assessed: one on the tumour (ROI-t), two in the immediate peritumoural healthy liver parenchyma (ROI-ihl) and two in the peripheral healthy liver parenchyma (ROI-phl). The results have been interpreted with a novel in silico model that simulates the hemodynamics of the hepatic arterial system., Results: Among the ROIs drawn inside the same segment of target lesion, the time-to-peak of the ROI-t and of the ROI-ihl have a significantly higher mean value when the balloon was inflated compared with the ROIs obtained with deflated balloon (10.33 ± 3.66 s vs 8.87 ± 2.60 s (p = 0.015) for ROI-t; 10.50 ± 3.65 s vs 9.23 ± 2.70 s (p = 0.047) for ROI-ihl). The in silico model prediction time-to-peak delays when balloon was inflated, match with those observed in vivo. The numerical flow analysis shows how time-to-peak delays are caused by the obstruction of the balloon-occluded artery and the opening of intra-hepatic collateral., Conclusion: The measurements identify predictively the flow redistribution in the hepatic arteries during b-TACE, supporting a proper positioning of the balloon microcatheter., (© 2024. The Author(s).)

Purpose: Digital variance angiography (DVA), a recently developed image processing technology, provided higher contrast-to-noise ratio (CNR) and better image quality (IQ) during lower limb interventions than digital subtraction angiography (DSA). Our aim was to investigate whether this quality improvement can be observed also during liver transarterial chemoembolization (TACE)., Materials and Methods: We retrospectively compared the CNR and IQ parameters of DSA and DVA images from 25 patients (65% male, mean ± SD age: 67.5 ± 11.2 years) underwent TACE intervention at our institute. CNR was calculated on 50 images. IQ of every image set was evaluated by 5 experts using 4-grade Likert scales. Both single image evaluation and paired image comparison were performed in a blinded and randomized manner. The diagnostic value was evaluated based on the possibility to identify lesions and feeding arteries., Results: DVA provided significantly higher CNR (mean CNR DVA /CNR DSA was 1.33). DVA images received significantly higher individual Likert score (mean ± SEM 3.34 ± 0,08 vs. 2.89 ± 0.11, Wilcoxon signed-rank p < 0.001) and proved to be superior also in paired comparisons (median comparison score 1.60 [IQR:2.40], one sample Wilcoxon p < 0.001 compared to equal quality level). DSA could not detect lesion and feeding artery in 28 and 36% of cases, and allowed clear detection only in 22% and 16%, respectively. In contrast, DVA failed only in 8 and 18% and clearly revealed lesions and feeding arteries in 32 and 26%, respectively., Conclusion: In our study, DVA provided higher quality images and better diagnostic insight than DSA; therefore, DVA could represent a useful tool in liver TACE interventions., Level of Evidence: III Non-consecutive study., (© 2023. The Author(s).)

Aim: To report the multicenter retrospective experience on combination of balloon-occluded MWA(b-MWA) followed by balloon-occluded TACE(b-TACE) in patients with liver malignancies > 3 cm, focusing on appearance and volume of necrotic area, safety profile and oncological results., Materials and Methods: Twenty-three patients with liver primary malignancies (hepatocellular carcinoma,HCC = 18; intrahepatic cholangiocarcinoma,iCC = 2) and metastasis (colorectal cancer metastasis = 1;sarcoma metastasis = 1;breast metastasis = 1) were treated. Maximum mean diameter of lesions was 4.4 cm (± 1 cm). Treatments were performed using a single-step approach:b-MWA was performed after balloon-microcatheter inflation, followed by b-TACE (with epirubicin or irinotecan). Necrotic area shape and discrepancy with the expected volume of necrosis suggested by vendor's ablation chart were assessed at post-procedural CT. Complications were categorized according to CIRSE classification. Oncological results at 1 and 3-6 months were evaluated using m-RECIST(HCC) and RECISTv1.1(metastasis/iCC)., Results: Mean volume of necrotic area was 75 cm 3 (± 36). Discrepancy with vendor chart consisted in a medium percentage of volumetric incrementation of necrotic area of 103.2% (± 99.8). Non-spherical shape was observed in 22/23 patients (95.7%). No complications occurred; Post-embolization syndrome occurred in 12/23patients. Complete response and partial response were, respectively, 91, 3% (21/23) and 8.7% (2/23) at 1 month, 85.7% (18/21) and 9.5% (2/21) at 3-6 months. Progression of disease was 4.7% (1/21) at 3-6 months for extra-hepatic progression. Among partial responders, average percentage of tumor volume debulking was 78.8% (± 9.8%)., Conclusion: b-MWA followed by b-TACE in a single-step procedure led to larger necrotic areas than the proposed by vendors ablation chart, non-spherical in shape and corresponded to the vascular segment occluded during ablation. This permitted to safely achieve promising oncological results in patients with > 3 cm tumors., (© 2022. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).)

Purpose: The purpose of this study was to evaluate in vivo the role of the micro-balloon by comparing trans-arterial chemoembolization (DEB-TACE) and selective internal radiotherapy (SIRT) procedures performed with and without balloon micro-catheter (b-DEB-TACE and DEB-TACE/SIRT and b-SIRT) for the treatment of hepatocellular carcinoma (HCC)., Methods: The impact of a balloon micro-catheter on trans-arterial loco-regional treatment was analyzed using non-enhanced post-procedural cone-beam CT (Ne-CBCT) by comparing the attenuation values in the embolized area and the surrounding liver tissue before and after DEB-TACE versus b-DEB-TACE and by comparing 2D/3D dosimetry in single-photon emission computed tomography after SIRT versus b-SIRT, and by comparing the histological count of the beads following orthotopic liver transplantation in the DEB-TACE versus b-DEB-TACE subgroup., Results: We treated 84 HCC patients using trans-arterial loco-regional therapy. Fifty-three patients (26 DEB-TACE and 27 b-DEB-TACE) were analyzed in the TACE group. Contrast, signal-to-noise ratio, and contrast-to-noise ratio were all significantly higher in b-DEB-TACE subgroup than DEB-TACE (182.33 HU [CI95% 160.3-273.5] vs. 124 HU [CI95% 80.6-163.6]; 8.3 [CI95% 5.7-10.1] vs. 4.5 [CI95% 3.7-6.0]; 6.9 [CI95% 4.3-7.8] vs. 3.1 [CI95% 2.2-5.0] p < 0.05). Thirty-one patients (24 SIRT and 7 b-SIRT) were analyzed in the SIRT group. 2D dosimetry profile evaluation showed an activity intensity peak significantly higher in the b-SIRT than in the SIRT subgroup (987.5 ± 393.8 vs. 567.7 ± 302.2, p = 0.005). Regarding 3D dose analysis, the mean dose administered to the treated lesions was significantly higher in the b-SIRT than in the SIRT group (151.6 Gy ± 53.2 vs. 100.1 Gy ± 43.4, p = 0.01). In histological explanted liver analysis, there was a trend for higher intra-tumoral localization of embolic microspheres for b-DEB-TACE in comparison with DEB-TACE., Conclusions: Due to the use of three different methods, the results of this study demonstrate in vivo, a better embolization profile of oncological intra-arterial interventions performed with balloon micro-catheter regardless of the embolic agent employed., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).)

This CIRSE Standards of Practice document is aimed at interventional radiologists and provides best practices for performing transarterial chemoembolisation. It has been developed by an expert writing group under the guidance of the CIRSE Standards of Practice Committee. It will encompass all technical details reflecting European practice of different TACE procedures (Lp-TACE, DEM-TACE, DSM-TACE, b-TACE) as well as revising the existing literature on the various clinical indications (HCC, mCRC, ICC, NET). Finally, new frontiers of development will also be discussed., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).)

Purpose: The aim of this retrospective multicentric study was to compare the tumour response rates of Balloon-occluded Transarterial Chemoembolisation (B-TACE) to non-B-TACE using propensity score matching (PSM) in patients with hepatocellular carcinoma and to investigate the clinical benefit, such as lower rates of TACE re-intervention achieved using B-TACE., Material and Methods: The B-TACE procedures (n = 96 patients) were compared with a control group of non-B-TACE treatments (n = 434 pts), performed with conventional (cTACE) or drug-eluting microspheres TACE (DEM-TACE). Data were collected from six European centres from 2015 to 2019. Objective responses (OR) and complete response (CR) rates after the first session and the number of TACE re-interventions were evaluated using PSM (91 patients per arm)., Results: The best target OR after PSM were similar for both B-TACE and non-B-TACE (90.1% and 86.8%, p = 0.644); however, CR at 1-6 months was significantly higher for B-TACE (59.3% vs. 41.8%, p = 0.026). Patients treated with B-TACE had a significantly lower retreatment rate during the first 6 months (9.9%% vs. 22.0%, p = 0.041). Post-embolisation syndrome (PES) rates were 8.8% in non-B-TACE and 41.8% in B-TACE (p < 0.001), with no significant differences between groups regarding major adverse events., Conclusion: B-TACE is safe and effective, achieving higher CR rates than non-B-TACE. Patients undergoing B-TACE had a significantly lower retreatment rate within the first 6 months but higher PES rates., Level of Evidence Iii: Level 3, retrospective study.

Background: To compare oncological results and safety profile of balloon micro-catheter trans-arterial chemoembolization (b-TACE) and drug-eluting-microsphere (DEM-TACE) in patients with hepatocellular-carcinoma (HCC)., Methods: This is a case-control, retrospective, single-center study. Between January-2015/March-2019, 149 patients (131 males [87.9%]) with 226 HCC were treated, 22 patients (35 HCC; 19 [86.4%] males) with b-TACE and 127 with DEM-TACE (191 HCC, 112 [88.2%] males). Embolization protocol was standardized (sequential 100 ± 25 and 200 ± 25 μm microspheres). Results were evaluated by modified-response-evaluation-criteria-in-solid-tumor [mRECIST] at 1, 3-6 and 9-12 months and time to recurrence after complete response [TTR] at 1 years. Cox's regression weighted with tumor dimensions was performed. Adverse events (AEs) were recorded., Results: mRECIST oncological response at all time points (1, 3-6 and 9-12 months) for both treatments were similar, with the exception of Objective response rate at 9-12 months. Objective response at 1 and 3-6 months between b-TACE vs DEM-TACE [23/35 (65.7%) vs 119/191 (62.3%), 21/29 (72.4%) vs 78/136 (57.4%) (p > 0.05), respectively]. On the contrary, at 9-12 months, it was significantly higher in b-TACE subgroup than DEM-TACE (15/19 [78.9%] vs 48/89 [53.9%], p = 0.05). TTR for complete response at 1 year had a better trend for b-TACE vs DEM-TACE (278.0 days [196.0-342.0] vs 219.0 days [161.0-238.0], OR 0.68 [0.4-1.0], p = 0.10). The use of balloon micro-catheter reduced the relative risk of the event of recurrence by 0.63 [CI95% 0.38-1.04]; p = 0.07). No significant differences were found in AEs rate., Conclusion: b-TACE showed a trend of better oncological response over DEM-TACE with and longer TTR with a similar adverse events rate, in patients presenting with larger tumors.

Purpose: This study was directed to compare diagnostic accuracy of dual-phase cone beam computed tomography (DP-CBCT) vs pre-procedural second line imaging modality (SLIM [multidetector computed tomography and magnetic resonance imaging]) to detect and characterize hepatocellular carcinoma (HCC) in cirrhotic patients with indication for trans-arterial chemoembolization (TACE)., Methods: This is a single centre, retrospective, and observational study. Exclusion criteria were not-assisted DP-CBCT TACE, and unavailable follow-up SLIM. We evaluated 280 consecutive patients (January/2015-Febraury/2019). Seventy-two patients were eligible. Three radiologists in consensus reviewed: pre-procedural SLIM, DP-CBCT, and SLIM at follow-up, with 4 months of interval between each reading. Hyper-vascular foci (HVF) were detected and characterized. Diameter was recorded. Radiological behaviour, according to LI-RADS criteria, of HFV throughout follow-up time was the reference standard. Diagnostic accuracy was calculated for pre-procedural SLIM and DP-CBCT and evaluated through receiver operating characteristic curve. HVF only visible on DP-CBCT (defined as occult) were analysed. Tumour diameters were compared., Results: Median time between pre-procedural SLIM and DP-CBCT and between DP-CBCT and definitive radiological diagnosis of HVF were 46.0 days (95%CI 36.5-55.0) and 30.5 days (95%CI 29.0-33.0), respectively. DP-CBCT had a better diagnostic performance than pre-examination SLIM (sensitivity 99%vs78%; specificity 89%vs85%; PPV 99%vs99%; NPV 92%vs30%; and accuracy 94%vs79%). DP-CBCT diagnosed 63 occult HVF. Occult HCC were 54/243 (22.2%). Six were occult angiomas. Three were false positive. Mean diameter was significantly higher in DP-CBCT vs pre-procedural SLIM (+7.5% [95%CI 3.7-11.3], p < 0.05)., Conclusions: DP-CBCT has a better diagnostic accuracy and NPV than pre-procedural SLIM in cirrhotic patients with indication for TACE., Competing Interests: Declaration of Competing Interest All authors have participated in (a) conception and design, or analysis and interpretation of the data; (b) drafting the article or revising it critically for important intellectual content; and (c) approval of the final version. This manuscript has not been submitted to, nor is under review at, another journal or other publishing venue. The authors have no affiliation with any organization with a direct or indirect financial interest in the subject matter discussed in the manuscript, (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: To evaluate the prognostic value of sequential dual-phase CBCT (DP-CBCT) imaging performed during degradable starch microsphere TACE (DSM-TACE) session in predicting the HCC's response to treatment, evaluate with modify response evaluation criteria in solid tumours (mRECIST) at 1-month multi-detector CT (MDCT) follow-up., Materials and Methods: Between January and May 2018, 24 patients (68.5 ± 8.5 year [45-85]) with HCC lesions (n = 96 [average 4/patient]) were prospectively enrolled. Imaging assessment included: pre-procedural MDCT, intra-procedural DP-CBCT performed before first and second DSM-TACEs and 1-month follow-up MDCT. Lesions' attenuation/pseudo-attenuation was defined as average value measured on ROIs (HU for MDCT; arbitrary unit called HU* for CBCT). Lesions' attenuation modification was correlated with the post-procedural mRECIST criteria at 1-month MDCT., Results: Eighty-two DSM-TACEs were performed. Lesion's attenuation values were: pre-procedural MDCT arterial phase (AP) 107.00 HU (CI 95% 100.00-115.49), venous phase (VP) 85.00 HU (CI 95% 81.13-91.74); and lesion's pseudo-attenuation were: first CBCT-AP 305.00 HU* (CI 95% 259.77-354.04), CBCT-VP 155.00 HU* (CI 95% 135.00-163.34). For second CBCT were: -AP 210.00 HU* (CI 95% 179.47-228.58), -VP 141.00 HU* (CI 95% 125.47-158.11); and for post-procedural MDCT were: -AP 95.00 HU (CI 95% 81.35-102.00), -VP 83.00 HU (CI 95% 78.00-88.00). ROC curve analysis showed that a higher difference pseudo-attenuation between first and second DP-CBCTs is related to treatment response. The optimal cut-off value of the difference between first and second CBCT-APs to predict complete response, objective response (complete + partial response) and overall disease control (objective response + stable disease) were > 206 HU* (sensitivity 80.0%, specificity 81.7%), > 72 HU* (sensitivity 79.5%, specificity 83.0%) and > - 7 HU* (sensitivity 91.6%, specificity 65.4%), respectively., Conclusions: DP-CBCT can predict intra-procedurally, by assessing lesion pseudo-attenuation modification, the DSM-TACE 1-month treatment outcome.

Purpose: To report technical success, safety profile and oncological results of balloon-occluded transcatheter arterial chemoembolization using a balloon micro-catheter and epirubicin-loaded polyethylene-glycol (PEG) microsphere (100 ± 25 µm and 200 ± 50 µm) in patients with hepatocellular carcinoma (HCC)., Materials and Methods: This is a single-centre, single-arm, retrospective study with 6-month follow-up. Twenty-two patients (Child-Pugh A 68% [15/22], B in 32% [7/22]; age 67.05 ± 14 years) with 29 HCC were treated in 24 procedures. Technical success is defined: ability to place the balloon micro-catheter within the required vascular segment, balloon-occluded arterial stump pressure drops and assessment of microsphere deposition. Laboratory assessment pre/post-procedural and complications were analysed, respectively, according to Common Terminology Criteria for Adverse Events (CTCAEv5) and CIRSE system. Postembolization syndrome (PES) was defined as fever and/or nausea and/or pain onset. Oncological results were evaluated using m-RECIST criteria with CT/MRI imaging at 1 and 3-6 months. In partial responder patients, pre/post-procedural tumour volume was compared., Results: Pre-planned feeder was reached in all cases. Pressure drop average was 51.1 ± 21.6 mmHg. Exclusive target embolization was achieved in 14/24 procedures (58.3%). Laboratory test modifications were all grade 1. 4/24 adverse events occurred (17%): pseudo-aneurysm of the feeder (grade 3), liver abscess (grade 2) and 2 asymptomatic segmentary biliary tree dilatations (grade 2). PES occurred in 8/24 (33%). The complete response at 1 and 3-6 months was 44.8% (13/29) and 52.9% (9/17), respectively. The partial response at 1 and 3-6 months was 55% (16/29) and 4/17 (23.5%), respectively. Among partial responder patients, the average percentage of tumour volume reduction was 64.9 ± 27.3%., Conclusion: Epirubicin-loaded PEG microsphere b-TACE is technically feasible, safe and effective procedure for HCC treatment.

Purpose: To report clinical effectiveness, toxicity profile, and prognostic factors of combined 100 μm ± 25 and 200 μm ± 50 epirubicin-loaded polyethylene glycol (PEG) microsphere drug-eluting embolic transcatheter arterial chemoembolization protocol in patients with hepatocellular carcinoma., Materials and Methods: In this prospective, single-center, single-arm study with 18 months of follow-up, 36 consecutive patients (mean age 69.9 y ± 10.8; 26 men, 10 women; 54 naïve lesions) were treated. Embolization was initiated with 100 μm ± 25 microspheres, and if stasis (10 heart beats) was not achieved, 200 μm ± 50 microspheres were administered. Each syringe (2 mL) of PEG microsphere was loaded with 50 mg of epirubicin. Results were evaluated using Modified Response Evaluation Criteria In Solid Tumors with multidetector computed tomography/magnetic resonance imaging at 1, 3-6, 9-12, and 15-18 months. Toxicity profile was assessed by laboratory testing before and after the procedure. Complications were recorded. Postembolization syndrome (PES) was defined as onset of fever/nausea/pain after the procedure. Patient/lesion characteristics and treatment results were correlated with predicted outcome using regression analysis. Child-Pugh score was A in 86.1% of patients (31/36) and B in 13.9% (5/36)., Results: In 10 of 21 lesions, < 2 cm in diameter (47.5%) stasis was achieved with 100 μm ± 25 microspheres only, whereas all other lesions required adjunctive treatment with 200 μm ± 50 microspheres. Reported adverse events were grade 1 acute liver bile duct injury (3/39 cases, 7.7%) and PES (grade 2; 3/39 cases, 7.7%). Complete response (CR) at 1, 3-6, 9-12, and 15-18 months was 61.1%, 65.5%, 63.63%, and 62.5%. Objective response (CR + partial response) at 1, 3-6, 9-12, and 15-18 months was 83.3%, 65.85%, 63.63%, and 62.5%. No single factor (laboratory testing, etiology, patient status, hepatic status, tumor characteristics, administration protocol) predicted outcomes except for albumin level at baseline for CR (P < .05, odds ratio = 1.09)., Conclusions: The combined microsphere sizing strategy was technically feasible and yielded promising results in terms of effectiveness and toxicity., (Copyright © 2018 SIR. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare image quality and diagnostic performance of cone-beam computed tomography (CT) and multidetector CT in the detection of hypervascular hepatocellular carcinoma (HCC) in patients with cirrhosis undergoing transarterial chemoembolization with drug-eluting embolic agents., Materials and Methods: Fifty-five consecutive patients referred for chemoembolization of hypervascular HCC were prospectively enrolled. Imaging included preprocedural multidetector CT within 1 month before planned treatment, intraprocedural cone-beam CT, and 1-month follow-up multidetector CT. Analysis of image quality was performed with calculations of lesion-to-liver contrast-to-noise ratio (LLCNR) and lesion-to-liver signal-to-noise-ratio (LLSNR). One-month follow-up multidetector CT was considered the reference standard for the detection of HCC nodules., Results: Median LLCNR values were 3.94 (95% confidence interval [CI], 3.06-5.05) for preprocedural multidetector CT and 6.90 (95% CI, 5.17-7.77) for intraprocedural cone-beam CT (P < .0001). Median LLSNR values were 11.53 (95% CI, 9.51-12.44) for preprocedural multidetector CT and 9.36 (95% CI, 8.12-10.39) for intraprocedural cone-beam CT (P < .0104). Preprocedural multidetector CT detected 115 hypervascular nodules with typical HCC behavior, and cone-beam CT detected 15 additional hypervascular nodules that were also visible on 1-month follow-up multidetector CT., Conclusions: Cone-beam CT has a significantly higher diagnostic performance compared with preprocedural multidetector CT in the detection of HCCs and can influence management of patients with cirrhosis by identifying particularly aggressive tumors., (Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.)