Surgical Resection Is Superior to TACE in the Treatment of HCC in a Well Selected Cohort of BCLC-B Elderly Patients-A Retrospective Observational Study.

Hepatocellular carcinoma (HCC) usually develops in cirrhotic liver, with high recurrence rates. However, considering its increasing detection in non-cirrhotic liver, the choice of treatment assumes particular relevance. This study aimed to investigate outcomes of patients among BCLC stages and enrolled for surgical resection (SR) according to a more complex evaluation, to establish its safety and efficacy. A total of 186 selected HCC patients (median age 73.2 yrs), submitted to SR between January 2005 and January 2021, were retrospectively analyzed. Of which, 166 were staged 0, A, B according to the BCLC system, while 20 with a single large tumor (>5 cm) were classified as stage AB. No perioperative mortality was recorded; complications occurred in 48 (25.80%) patients, and all but two were Clavien−Dindo grade I−II. Median follow-up was 9.2 years. Subsequently, 162 recurrent patients (87,1%) were selected for new treatments. Comparable overall survival rates (OS) were observed at 1, 3, 5, and 10 years in 0, A, B and AB stages (p = 0.2). Eventually, the BCLC-B group was matched to 40 BCLC-B patients treated (2015-2021) with TACE. Significant differences in baseline characteristics (p <0.0001) and in OS were observed at 1 and 3 years (p <0.0001); a significant difference was also observed in oncological outcomes, in terms of the absence, residual, or relapse of disease (p <0.05). Surgery might be a valid treatment in HCC for patients affected by chronic liver disease in a condition of compensation, up to BCLC-B stage. Surgical indication for liver resection in case of HCC should be extensively revised.

Balloon-Occluded Transarterial Chemoembolization: In Which Size Range Does It Perform Best? A Comparison of Its Efficacy versus Conventional Transarterial Chemoembolization, Using Propensity Score Matching.

INTRODUCTION: The aim of this multicenter comparison of balloon-occluded transarterial chemoembolization (B-TACE) versus conventional TACE (cTACE) in treating hepatocellular carcinoma (HCC) was to assess in which size range the 2 techniques offered higher complete response (CR) and objective response (OR) rates in a single session, and to evaluate the possibility of using B-TACE to reduce the need for re-treatment. METHODS: 325 patients were retrospectively evaluated: 91 patients in the B-TACE group (22 with cTACE [B-cTACE] and 69 with drug-eluting microsphere TACE [B-DEM-TACE]) and 234 in the cTACE group. The results were compared according to tumor size: (A) <30 mm, (B) 30-50 mm, and (C) >50 mm; OR and CR rates after the first session and the number of TACE re-interventions within a 6-month period were also evaluated using propensity score matching (PSM). RESULTS: The best target ORs were very high (93.2%) and similar between the 2 treatments both before (94.4% for cTACE and 90.1% for B-TACE) and after PSM (94.5% for cTACE and 90.1%; p = 0.405), with slightly better results for the cTACE cohort probably due to better cTACE effectiveness in smaller lesions. In lesions <30 mm, cTACE obtained a slightly higher CR rate than B-TACE (61.9 vs. 56.3%, p = 0.680), whereas in intermediate-sized HCCs (30-50 mm), B-TACE showed a significant superiority in achieving a CR (72.3 vs. 54.1%, respectively; p = 0.047). In larger lesions (>50 mm), cTACE and B-TACE performed equally, with a poor CR rate (22.6 vs. 23.1%, respectively; p = 1.000). These results were additionally confirmed using PSM. The patients treated with B-TACE had a significantly lower re-treatment rate than the cTACE cohort (12.1 vs. 26.9%, respectively; p = 0.005). B-cTACE and B-DEM-TACE demonstrated similar ORs, with a slightly better CR rate for B-cTACE (68.2 vs. 56.5%, respectively; p = 0.456). CONCLUSION: In HCCs of 30-50 mm, B-TACE should be preferred to cTACE, whereas in smaller nodules (<30 mm), cTACE can suffice in achieving a good CR rate. The statistically significant lower re-treatment rate of the B-TACE cohort after a single procedure reduced the risk of complications due to multiple TACE, which could worsen the patient prognosis.

HCC in the Era of Direct-Acting Antiviral Agents (DAAs): Surgical and Other Curative or Palliative Strategies in the Elderly.

Hepatocellular carcinoma (HCC) accounts for 75-85% of primary liver malignancies, and elderlies have the highest incidence rates. Direct-acting antiviral agents (DAAs) have shown satisfying results in terms of HCV sustained viral response (SVR). However, data regarding HCC risk post-DAA-SVR is still conflicting. This study aims to consider HCC onset in moderate underlying liver disease. We conducted a retrospective study on 227 chronically infected patients (cHCV), treated with DAAs. Patients were divided into three groups: "de novo occurrent HCC", "recurrent HCC", and "without HCC". Fifty-six patients aged <65 years (yDAA) were studied separately. HCC patients aged ≥65 years (DAA-HCC) were compared to a historical group of 100 elderly HCC patients, treated with peginterferon (Peg-IFN) ± ribavirin antiviral agents, non-SVR (hHCC). The HCC prevalence in DAA patients was 32.75%: "de novo occurrent'' 18.13% and "recurrent'' 14.62%, despite 42.85% of them having no fibrosis to mild or moderate fibrosis (F0-F1-F2). yDAA showed 5.36% "de novo occurrent" HCC. Curative procedure rates were compared between DAA-HCC and hHCC at the first and at recurrent presentation (22 (39.29%) vs. 72 (72%); 17 (30.36%) vs. 70 (70%), respectively (p < 0.001)). No significant difference was found in 3-year OS (p = 0.6). However, in cause-specific mortality analysis, HCC-related death was higher in the DAA-treated group, whereas cirrhosis-related death was more common in the historical group (p = 0.0288), considering together the two causes of death. A more accurate patient stratification according to multifactorial and new diagnostic investigations identifying HCC risk might allow an improvement in management and access to curative therapies.

Low serum magnesium concentration is associated with the presence of viable hepatocellular carcinoma tissue in cirrhotic patients.

This study aimed to ascertain, for the first time, whether serum magnesium (Mg) concentration is affected by the presence of hepatocellular carcinoma (HCC). We retrospectively enrolled consecutive cirrhotic patients with a diagnosis of HCC (n = 130) or without subsequent evidence of HCC during surveillance (n = 161). Serum levels of Mg were significantly (P < 0.001) lower in patients with HCC than in those without (median [interquartile range]: 1.80 [1.62-1.90] mg/dl vs. 1.90 [1.72-2.08] mg/dl). On multivariate logistic regression, low serum Mg was associated with the presence of HCC (OR 0.047, 95% CI 0.015-0.164; P < 0.0001), independently from factors that can influence magnesaemia and HCC development. In a subset of 94 patients with HCC, a linear mixed effects model adjusted for confounders showed that serum Mg at diagnosis of HCC was lower than before diagnosis of the tumor (ß = 0.117, 95% CI 0.039-0.194, P = 0.0035) and compared to after locoregional treatment of HCC (ß = 0.079, 95% CI 0.010-0.149, P = 0.0259), with two thirds of patients experiencing these changes of serum Mg over time. We hypothesize that most HCCs, like other cancers, may be avid for Mg and behave like a Mg trap, disturbing the body's Mg balance and resulting in lowering of serum Mg levels.

Preoperative Multiparametric Ultrasound and Fine Needle Aspiration Cytology evaluation of parotid gland tumors: which is the best technique?

AIMS: To evaluate the pre-surgical diagnostic value of Multiparametric Ultrasound (MPUS) and Fine Needle Aspiration Cytology (FNAC) in differentiating parotid gland tumors, comparing the results with histology. MATERIALS AND METHODS: The study enrolled 84 patients with parotid gland lesions surgically treated in a single tertiary center and evaluated by MPUS. Each patient underwent FNAC. Histological examination was considered the gold standard. RESULTS: Histology identified 62 benign tumors and 22 malignancies. In the differential diagnosis between malignant and benign lesions, B-mode Ultrasound (US), Color-Doppler US, Contrast-Enhanced US (CEUS), Elastography (USE) and FNAC showed the following values of sensitivity: 82%, 81%, 86%, 77%, 73% respectively; specificity: 97%, 61%, 95%, 71%, 97% respectively; PPV: 90%, 43%, 86%, 50%, 89% respectively; NPV: 93%, 90%, 95%, 88%, 91% respectively; and accuracy: 89%, 71%, 90%, 78%, 84% re-spectively. CONCLUSIONS: CEUS proved to be a valid and accurate method for identifying malignant tumors of parotid gland; the combination of B-mode US with CEUS showed similar diagnostic accuracy, but better sensitivity than CEUS taken alone. USE did not improve the diagnostic performance of the B-mode US, alone or in association with CEUS; however, it revealed the highest diagnostic accuracy in the differentiation between benign lesions. FNAC demonstrated lower values in comparison with CEUS and with USE. Therefore, according to our study, MPUS could be proposed as a valid alternative to FNAC.

Percutaneous spine biopsy under cone beam computed tomography guidance for spondylodiscitis: Time is diagnosis.

BACKGROUND AND PURPOSE: Percutaneous spine biopsies for spondylodiscitis have been long discussed due to the low microbiologic yield. This retrospective study evaluated factors of cone beam computed tomography-guided spine biopsies that may affect microbiologic yield. METHODS: We retrospectively reviewed percutaneous spine biopsies under cone beam computed tomography for spondylodiscitis performed from January 2015-December 2020. Clinical and technical features such as the time from initial symptoms to biopsy, level biopsied, biopsy needle type/gauge, technical approach, radiation dose, technical success and microbiologic yield were recorded. Pre-procedure magnetic resonance imaging findings were also recorded such as the number of vertebral bodies involved, and disc morphology. Univariate logistic regression analysis and Receiver operating characteristic analysis were performed to assess any relationship between relevant factors and positive cultures. RESULTS: A total of 50 patients underwent cone beam computed tomography-guided biopsies for spondylodiscitis, with resulted positive cultures in 18 patients (36%). The mean time from the initial referral of spinal symptoms to procedure in the positive culture group was the most influential finding for positive cultures (odds ratio 56.3, p < 0.001). Among magnetic resonance imaging findings, thin or degenerated intervertebral disc was a negative factor for positive cultures (odds ratio 0.09, p = 0.006). Univariate analysis showed that percutaneous approach (transpedicular vs posterolateral/interlaminar) needle size (11-13 g vs 16-18G, odds ratio 1.2, p = 0.7) and site of biopsy (disc vs bone vs disc plus endplate) did not significantly affect the microbiologic yield of spine biopsy. CONCLUSION: Percutaneous cone beam computed tomography-guided biopsy for spondylodiscitis is a reliable and safe technique and its microbiologic yield may increase if biopsy is performed within the acute phase of infection.

Retrospective European Multicentric Evaluation of Selective Transarterial Chemoembolisation with and without Balloon-Occlusion in Patients with Hepatocellular Carcinoma: A Propensity Score Matched Analysis.

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.

Use of Phil Embolic Agent for Bleeding in Non-Neurological Interventions.

OBJECTIVE: To evaluate the safety and efficacy of the Phil liquid embolic agent in non-neurological embolization procedures. M&M: Thirty-five patients with a mean age of 62.5 years underwent percutaneous embolization using Phil for the treatment of visceral arterial bleedings in 20/35 patients (including three gluteal, one bladder, two superior mesenteric, three epigastric, one deep femoral, five internal iliac, four intercostal, and one lingual arteries), splanchnic pseudoaneurysms in 11/35 patients (including three hepatic, five splenic, and three renal arteries), pancreatic bleeding metastasis in 1/35 patient, and gastric bleeding varices in 3/35 patients. Phil is composed of a non-adhesive copolymer dissolved in DMSO (Anhydrous Dimethyl Sulfoxide) with different viscosity. Procedures were performed slowly under continuous fluoroscopic guidance to avoid embolization of non-target vessels. RESULTS: Clinical success was obtained with a single intervention in 34 cases (97.15%), while a repeated procedure was required in one case (2.85%). No technical complications nor non-target embolization occurred. A case of post-embolic syndrome was noted (2.85%) in one patient. DMSO administration-related pain was successfully controlled by medical therapy. CONCLUSION: Phil can be considered a safe and effective embolic agent for the treatment of non-neurologic bleeding.

Balloon occluded TACE (B-TACE) vs DEM-TACE for HCC: a single center retrospective case control 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.

Uncommon presentation of allergic bronchopulmonary aspergillosis during the COVID-19 lockdown: a case report.

BACKGROUND: During the ongoing pandemic of coronavirus disease 2019 (COVID-19), lockdown periods have changed the way that people and communities live, work and interact. CASE PRESENTATION: This case report describes an uncommon but important presentation of allergic bronchopulmonary aspergillosis (ABPA) in a previously healthy male, who decided to live in the basement of his house when Italy entered a nationwide lockdown during the COVID-19 pandemic. As high resolution computed tomography (HRCT) of the chest on admission showed diffuse miliary nodules, a miliary tuberculosis was initially suspected. However, further investigations provided a diagnosis of unusual presentation of ABPA. CONCLUSIONS: This case highlights the importance of maintaining awareness of Aspergillus-associated respiratory disorders during the COVID-19 pandemic, especially because lifestyle changes associated with home isolation carry an increased risk of exposure to mold spores present in some indoor environments.

Current assessment and management of endoleaks after advanced EVAR: new devices, new endoleaks?

INTRODUCTION: In recent years there has been an increasing application of advanced EVAR techniques to tackle complex clinical and anatomical scenarios. In a bid to overcome the limitations of the traditional stent-grafts, newer EVAR endografts and techniques have been developed and introduced into clinical practice, permitting endovascular management of difficult infrarenal, juxta-renal and thoracoabdominal aneurysms for which previously there was no endovascular solution. As a consequence, we are now confronted with unique patterns of endoleak requiring customized clinical-radiological assessment and treatment. Despite the increasing body of evidence regarding new EVAR techniques and related endoleaks, current guidelines do not specifically address these issues. OBJECTIVES: Our review aims to assess risk factors, development, and management strategies of these endoleaks, in the most recent infrarenal EVAR devices and in more complex fenestrated EVAR (FEVAR) and Chimney EVAR (Ch-EVAR). EXPERT OPINION: Most new devices have demonstrated types of endoleaks that need specific imaging and treatment, as in EVAS, FEVAR, and ChEVAR. Knowledge of specific stent-graft characteristics and the nature of endoleaks associated with the various procedures facilitates the application of relevant useful imaging. In addition, it should aid development of a customized and practically relevant approach to patient management during intervention and follow-up.

Computed Tomography Angiography findings can predict massive bleeding in head and neck tumours.

PURPOSE: The aim of our study was to assess CT angiography findings of head and neck tumours in predicting carotid blow out syndrome (CBS). METHOD: We retrospectively reviewed the records of patients with head and neck cancer who underwent invasive angiography for CBS at our Institution from July 2013-2019. All routine CT angiography scans were assessed for the following findings with a univariate logistic regression analysis: 1) 360 ° involvement of the suspect artery by the tumour; 2) tissue or tumour necrosis, which was defined as an hypodense area with lack of contrast enhancement in the soft tissues of the neck or tumour mass, adjacent to the suspected vessel; 3) calibre reduction of the culprit artery; 5) jugular vein infiltration. T stage was also included in the analysis. RESULTS: A total of 24 patients who underwent routine CT angiogram neck and embolization for CBS were included in this study. Univariate logistic regression showed as 360 ° involvement of target vessel may significantly increase the risk of bleeding (OR 11.6, CI: 1.4-91.5; p = 0.01), along with T stage (OR 14.0, p = 0.03). Tumour necrosis and calibre vessel reduction were quite influential, but not significantly (i.e. tumour necrosis OR 5.0 95 % CI: 0.8-31.0, p = 0.08). Contingency table analysis found 360 ° vessel involvement with the highest sensitivity and PPV in predicting bleeding (87.5 % and 82.35 %, respectively). CONCLUSIONS: CT angiography imaging findings have the potential to identify patients with head and neck cancer at higher risk of bleeding.

Intra-procedural dual phase cone beam computed tomography has a better diagnostic accuracy over pre-procedural MRI and MDCT in detection and characterization of HCC in cirrhotic patients undergoing TACE procedure.

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.

Sequential dual-phase cone-beam CT is able to intra-procedurally predict the one-month treatment outcome of multi-focal HCC, in course of degradable starch microsphere TACE.

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.

Balloon-Occluded Transcatheter Arterial Chemoembolization (b-TACE) for Hepatocellular Carcinoma Performed with Polyethylene-Glycol Epirubicin-Loaded Drug-Eluting Embolics: Safety and Preliminary Results.

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.

Polyethylene Glycol Epirubicin-Loaded Transcatheter Arterial Chemoembolization Procedures Utilizing a Combined Approach with 100 and 200 µm Microspheres: A Promising Alternative to Current Standards.

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.