Clinical Significance of the Initial and Best Responses after Chemoembolization in the Treatment of Intermediate-Stage Hepatocellular Carcinoma with Preserved Liver Function

PurposeTo evaluate the clinical implications of initial and best responses during repeated transarterial chemoembolization procedures for hepatocellular carcinoma (HCC).Materials and MethodsThis study included 726 patients who received a diagnosis of intermediate-stage HCC with Child-Pugh class A liver function between 2007 and 2016, and who were treated with transarterial chemoembolization as the first-line treatment. Evaluation of treatment response was based on the modified response evaluation criteria in solid tumors. Overall survival (OS) was compared between response categories after implementation of landmark analysis.ResultsOf the 726 patients, an objective response (complete response [CR] or partial response [PR]) was observed as the initial response in 78.1% of patients. Regarding the best response during the transarterial chemoembolization series, 87.2% of patients were overall responders. The median OS of initial responders (n = 483) was not significantly different from that of subsequent responders at the 1-year landmark (stable disease [SD] after first transarterial chemoembolization but CR or PR after repeated transarterial chemoembolization; n = 61; 46.2 vs 40.1 months, respectively; P = .145). Likewise, the median OS of initial CR patients (n = 326) was not significantly different from that of the subsequent CR group (n = 126) at the 1-year landmark (PR or SD after first transarterial chemoembolization but CR after repeated transarterial chemoembolization; 53.4 vs 46.3 months, respectively; P = .455). Multivariate Cox analyses showed that the objective responses, the initial responses (hazard ratio [HR], 0.638; P = .001), and the best responses (HR, 0.304; P < .001) had the significant prognostic significance for OS.ConclusionsBoth the initial and best responses during repeated transarterial chemoembolization were significantly associated with OS in patients with intermediate-stage HCC and preserved liver function.     

Transarterial Radioembolization versus Transarterial Chemoembolization Plus Percutaneous Ablation for Unresectable,Solitary Hepatocellular Carcinoma of ≥3 cm: A Propensity Score–Matched Study

PurposeTo compare the safety and effectiveness of transarterial radioembolization (TARE) and transarterial chemoembolization with drug-eluting embolic agents combined with percutaneous ablation (transarterial chemoembolization [TACE] + ablation) in the treatment of treatment-naïve, unresectable, solitary hepatocellular carcinoma (HCC) of ≥3 cm.Materials and MethodsTwenty-nine patients with treatment-naïve, unresectable, solitary HCC of ≥3 cm received combined TACE + ablation, and 40 patients received TARE at a single institution. Local tumor response, tumor progression-free survival (PFS), overall survival, need for reintervention, bridge to transplant, and major complications were compared. Clinical variables and outcomes were compared before and after propensity score matching (PSM).ResultsBefore PSM, patients who underwent TARE had a larger tumor size (3.7 vs 5.5 cm; P = .0005) and were older (61.5 vs 69.3 years; P = .0014). After PSM, there was no difference in baseline characteristics between the 2 groups, with the mean tumor sizes measuring 3.9 and 4.1 cm in the TACE + ablation and TARE cohorts, respectively. After PSM (n = 19 in each group), no statistically significant difference was observed in local radiological response (disease control rates, 100% vs 94.7%; P = .31), survival (subdistribution hazard ratio [SHR], 0.71; 95% confidence interval [CI], 0.28–1.80; P = .469), PFS (SHR, 0.61; 95% CI, 0.21–1.71; P = .342), bridge to transplant (21.1% vs 31.6%, P = .46), and major adverse event rates (15.8% vs 10.5%, P = .63) between the 2 groups. The mean total number of locoregional interventions was higher in the TACE + ablation cohort (1.9 vs 1.3 sessions, P = .02), with an earlier median reintervention trend (SHR, 0.61; 95% CI, 0.20–1.32; P = .167).ConclusionsThe present study showed that TARE and the combination of TACE and ablation are comparable in safety and effectiveness for treating treatment-naïve, unresectable, solitary HCC of ≥3 cm.     

Chronic Hepatotoxicity in Patients with Metastatic Neuroendocrine Tumor: Transarterial Chemoembolization versus Transarterial Radioembolization

PurposeTo compare the manifestations of chronic liver injury following transarterial chemoembolization with those of transarterial radioembolization (TARE) in patients with neuroendocrine tumor (NET).Materials and MethodsThis study consisted of an Institutional Review Board-approved single-institution retrospective analysis of NET patients who received transarterial chemoembolization from 2006 to 2016 and TARE from 2005 to 2014 and survived at least 1 year from the initial treatment. Patients receiving only transarterial chemoembolization (n = 63) or TARE (n = 28) were evaluated for the presence or absence of durable hepatic toxicities occurring at least 6 months after initial treatment. The definitions and grades of liver injury were adapted from Common Terminology Criteria for Adverse Events version 4.0 and were characterized by the presence of laboratory or clinical toxicities of Grade 3 or above.ResultsChronic hepatic toxicity occurred in 14 of 63 transarterial chemoembolization patients (22%) with a total of 26 Grade 3-4 events, in whom elevation of bilirubin was the most common toxicity, compared to 8 of 28 TARE patients (29%) with a total of 16 Grade 3-4 and 2 Grade 5 events, in whom ascites were the most frequent toxicity. There were more laboratory toxicities in the transarterial chemoembolization group (65% vs 38%, P = .11) and fewer Grade 4–5 injuries (6% vs 27% of patients, P = .06). There was also a significantly higher number of patients who experienced intrahepatic progression of disease in the transarterial chemoembolization cohort than in the TARE patients (75% vs 43%, respectively; P = .005).ConclusionsDelayed hepatotoxicity from transarterial chemoembolization and TARE occurred in 22% and 29% of patients, respectively, from 6 months to several years following treatment. Transarterial chemoembolization-related toxicities on average were less severe and manifested primarily as laboratory derangements, compared to TARE toxicities which consisted of clinical hepatic decompensation.     

Prediction of Response of Hepatocellular Carcinoma to Radioembolization: Machine Learning Using Preprocedural Clinical Factors and MR Imaging Radiomics

PurposeTo create and evaluate the ability of machine learning–based models with clinicoradiomic features to predict radiologic response after transarterial radioembolization (TARE).Materials and Methods82 treatment-naïve patients (65 responders and 17 nonresponders; median age: 65 years; interquartile range: 11) who underwent selective TARE were included. Treatment responses were evaluated using the European Association for the Study of the Liver criteria at 3-month follow-up. Laboratory, clinical, and procedural information were collected. Radiomic features were extracted from pretreatment contrast-enhanced T1-weighted magnetic resonance images obtained within 3 months before TARE. Feature selection consisted of intraclass correlation, followed by Pearson correlation analysis and finally, sequential feature selection algorithm. Support vector machine, logistic regression, random forest, and LightGBM models were created with both clinicoradiomic features and clinical features alone. Performance metrics were calculated with a nested 5-fold cross-validation technique. The performances of the models were compared by Wilcoxon signed-rank and Friedman tests.ResultsIn total, 1,128 features were extracted. The feature selection process resulted in 12 features (8 radiomic and 4 clinical features) being included in the final analysis. The area under the receiver operating characteristic curve values from the support vector machine, logistic regression, random forest, and LightGBM models were 0.94, 0.94, 0.88, and 0.92 with clinicoradiomic features and 0.82, 0.83, 0.82, and 0.83 with clinical features alone, respectively. All models exhibited significantly higher performances when radiomic features were included (P = .028, .028, .043, and .028, respectively).ConclusionsBased on clinical and imaging-based information before treatment, machine learning–based clinicoradiomic models demonstrated potential to predict response to TARE.     

Transarterial Radioembolization for Hepatocellular Carcinoma with Major Vascular Invasion: A Nationwide Propensity Score–Matched Analysis with Target Trial Emulation

PurposeTo examine National Cancer Database (NCDB) data to comparatively evaluate overall survival (OS) between patients undergoing transarterial radioembolization (TARE) and those undergoing systemic therapy for hepatocellular carcinoma with major vascular invasion (HCC-MVI).MethodsOne thousand five hundred fourteen patients with HCC-MVI undergoing first-line TARE or systemic therapy were identified from the NCDB. OS was compared using propensity score–matched Cox regression and landmark analysis. Efficacy was also compared within a target trial framework.ResultsTARE usage doubled between 2010 and 2015. Intervals before treatment were longer for TARE than for systemic therapy (mean [median], 66.5 [60] days vs 46.8 (35) days, respectively, P < .0001). In propensity-score–matched and landmark-time–adjusted analyses, TARE was found to be associated with a hazard ratio of 0.74 (95 % CI, 0.60–0.91; P = .005) and median OS of 7.1 months (95 % CI, 5.0–10.5) versus 4.9 months (95 % CI, 3.9–6.5) for systemically treated patients. In an emulated target trial involving 236 patients with unilobular HCC-MVI, a low number of comorbidities, creatinine levels <2.0 mg/dL, bilirubin levels <2.0 mg/dL, and international normalized ratio <1.7, TARE was found to be associated with a hazard ratio of 0.57 (95 % CI, 0.39–0.83; P = .004) and a median OS of 12.9 months (95 % CI, 7.6–19.2) versus 6.5 months (95 % CI, 3.6–11.1) for the systemic therapy arm.ConclusionsIn propensity-score–matched analyses involving pragmatic and target trial HCC-MVI cohorts, TARE was found to be associated with significant survival benefits compared with systemic therapy. Although not a substitute for prospective trials, these findings suggest that the increasing use of TARE for HCC-MVI is accompanied by improved OS. Further trials of TARE in patients with HCC-MVI are needed, especially to compare with newer systemic therapies.     

Results from a United States Investigational Device Study of Adhesive Capsulitis Embolization in the Treatment of Shoulder Pain: The Adhesive Capsulitis Embolization Study

PurposeTo evaluate the safety and efficacy of arterial embolization to relieve shoulder pain secondary to adhesive capsulitis (AC).Materials and MethodsIn total, 20 patients (18 females, 2 males; mean age, 51 years) with AC resistant to >30 days of conservative treatment were enrolled in a multicenter prospective study. Adhesive capsulitis embolization was performed with 75-μm or 200-μm spherical particles. Subjects were assessed before and after the procedure with magnetic resonance imaging, visual analog scale (VAS; 0–100 mm) scores, Single Assessment Numeric Evaluation (SANE; 0–100) scores, and American Shoulder and Elbow Surgeons (ASES; 0–100) scores. Adverse events were recorded at all follow-up time points.ResultsHypervascularity was identified and embolization was technically successful in all patients, with 83 arteries embolized in 20 patients. Baseline VAS, SANE, and ASES scores before the procedure were 89.2 mm, 27.2, and 30.9, respectively. The 1-month (n = 19), 3-month (n = 18), and 6-month (n = 12) follow-ups demonstrated significant improvements. At the 1-month follow-up, VAS score decreased by 31.8 (P = 1.2E?11), SANE score increased by 22.1 (P = 1.8E?8), and ASES score increased by 14.2 (P = 4.3E?5). At the 6-month follow-up, VAS score decreased by 62.1 (P = 7.0E?11), SANE score increased by 55.4 (P = 4.1E?10), and ASES score increased by 44.5 (P = 1.8E?6). Due to the coronavirus pandemic, the study ended early; 6 patients did not complete the 6-month follow-up. No major adverse events were noted.ConclusionsInterim findings suggest that arterial embolization is safe and effective for patients with AC refractory to conservative treatment.     

Yttrium-90 Radioembolization and Concomitant Systemic Gemcitabine,Cisplatin, and Capecitabine as the First-Line Therapy for Locally Advanced Intrahepatic Cholangiocarcinoma

PurposeTo determine the safety and effectiveness of yttrium-90 transarterial radioembolization (TARE) combined with systemic gemcitabine, cisplatin, and capecitabine for the first-line treatment of locally advanced intrahepatic cholangiocarcinoma (iCCA).Materials and MethodsData of 13 patients with treatment-naïve, locally advanced iCCA treated with a downstaging protocol using gemcitabine, cisplatin, TARE, and capecitabine were retrospectively reviewed. Overall survival (OS), local tumor response (modified Response Evaluation Criteria in Solid Tumors), progression-free survival (PFS), technical adverse events, and toxicity were measured.ResultsCalculated from the time of diagnosis, the median OS was 29 months (95% confidence interval [CI], 15 to not reached), with a 1-year OS of 84.6% (95% CI, 52.2%–95.9%) and 2-year OS of 52.9% (95% CI, 20.3%–77.5%). The median OS values were 24 months (95% CI, 8 to not reached) and 21 months (95% CI, 5 to not reached) from the time of initial cycle of chemotherapy and TARE, respectively. Patients who were downstaged to surgery (n = 7, 53.8%) had a more favorable OS (median OS, not reached vs 15 months; P = .0221). Complete and partial radiologic responses were achieved in 5 (38.5%) and 6 (46.2%) patients, respectively. The median PFS was 13 months (95% CI, 12 to not reached). Although no serum toxicity with Grade >2 occurred within 3 months after TARE, 1 patient was no longer a surgical candidate given suboptimal nutrition status despite successful downstage on imaging studies. Two patients required a reduced dose or delay of post-TARE chemotherapy.ConclusionsFirst-line combination therapy with TARE and systemic gemcitabine, cisplatin, and capecitabine is an effective treatment with an acceptable safety profile for iCCA with a high rate of downstaging to resection.     

Socioeconomic and Survival Analysis of Radioembolization in Patients with Intrahepatic Cholangiocarcinoma: A Propensity Score–Adjusted Study

PurposeTo determine whether transarterial radioembolization (TARE) is associated with longer survival of patients with intrahepatic cholangiocarcinoma (ICC) and whether access to TARE is influenced by socioeconomic factors.Materials and MethodsRetrospective review of patients with ICC in the National Cancer Database from 2004 to 2018 was performed with Cox regression analysis to identify predictors of survival. Overall survival (OS) was estimated using the Kaplan-Meier method. Socioeconomic factors were compared between 2 groups using the Wilcoxon rank-sum test and χ² test. Propensity score–matched cohorts were created between patients with ICC who did and did not undergo TARE.ResultsThe number of patients receiving TARE for ICC increased over time from 1 in 2004 to 210 in 2018. Patients in the TARE group were more likely to be White (87.9% vs 84.3%; P = .012) and less likely to be Hispanic/Latino (7.7% vs 11.0%; P = .009). Fewer patients who underwent TARE were uninsured (0.9% vs 2.8%; P = .012). Older age, male sex, non-White race, higher tumor grade size, and stage, earlier year of diagnosis, lack of treatment with surgery or systemic therapy, and presence of lymphatic or vascular invasion exhibited significant associations with decreased survival (P < .05 for all). Patients who underwent TARE had longer survival in both unadjusted and adjusted cohorts, with an OS of 17.5 months (vs 7.2 months in the non-TARE group) after propensity matching.ConclusionsPatients with ICC who had undergone TARE experienced significantly longer survival than that experienced by those who had not after adjusting for measurable confounders. Significant socioeconomic disparities in access to TARE remain.     

Prostatic Artery Embolization Using 100–300-μm Trisacryl Gelatin Microspheres to Treat Lower Urinary Tract Symptoms Attributable to Benign Prostatic Hyperplasia: A Single-Center Outcomes Analysis with Medium-Term Follow-up

PurposeTo report medium-term outcomes of prostatic artery embolization (PAE) using 100–300-μm trisacryl gelatin microspheres to treat lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia (BPH) and to evaluate how cone-beam computed tomography-measured prostate gland volume (PGV), median lobe enlargement (MLE), age, and Charlson Comorbidity Index (CCI) affect these results.Materials and MethodsSeventy-four consecutive patients who underwent PAE from April 2014 through August 2018 were retrospectively reviewed. Patients had International Prostate Symptom Score (IPSS) >12, Quality of Life (QoL) score >2, prostate gland volume (PGV) >40 mL, age older than 45 years, and medical therapy failure. Twelve patients were excluded for bladder pathology or prostate cancer. Patients (n = 62, age = 71.8 ± 9.3 years, CCI = 3.5 ± 1.7, PGV = 174 ± 110 mL) had pre-procedure IPSS = 22.4 ± 5.6, QoL score = 4.4 ± 0.9, and post-void residual (PVR) = 172 ± 144 mL. Post-procedure values were compared to baseline at 1, 3, 6, 12, and 24 months. Associations between outcomes and PGV, MLE, age, and CCI were evaluated. Adverse event recording used Clavien-Dindo classification.ResultsOne month after PAE (n = 37), IPSS improved to 7.6 ± 5.2 (P < .0001) and QoL score improved to 1.7 ± 1.4 (P < .0001). At 3 months (n = 32), improvements continued, with IPSS = 6.4 ± 5.1 (P < .0001), QoL score = 1.2 ± 1.2 (P < .0001), PVR = 53 ± 41 mL (P < .001), and PGV = 73 ± 38 mL (P < .0001). Results were sustained at 6 months (n = 35): IPSS = 6.4 ± 4.1 (P < .0001), QoL score = 1.2 ± 1.2 (P < .0001), PVR = 68 ± 80 mL (P < .0001), PGV = 60 ± 19 mL (P < .001). At 12 months, patients (n = 26) had IPSS = 7.3 ± 5.5 (P < .0001), QoL score = 1.2 ± 0.8 (P <.0001), PVR = 89 ± 117 mL (P < .0001), PGV = 60 ± 48 mL (P < .01). At 24 months, patients (n = 8) had IPSS = 8.0 ± 5.4 (P < .0001), QoL score = 0.7 ± 0.5 (P < .0001), PVR = 91 ± 99mL (P = 0.17), and PGV = 30 ± 5mL (P = .11). Improvements were independent of PGV, MLE, age, and CCI. Two grade II urinary infections occurred.ConclusionsPAE with 100–300-μm microspheres produced sustained substantial improvements in LUTS, PGV, and PVR, which were independent of baseline PGV, MLE, age, or CCI.     

Survival and Toxicities after Yttrium-90 Transarterial Radioembolization of Cholangiocarcinoma in the RESiN Registry

PurposeTo report outcomes in patients with intrahepatic cholangiocarcinoma treated with yttrium-90 resin microspheres (transarterial radioembolization [TARE]) from a multicenter, prospective observational registry.Materials and MethodsNinety-five patients (median age, 67 years [interquartile range {IQR}, 59–74]; 50 men) were treated in 27 centers between July 2015 and August 2020. Baseline demographic characteristics included imaging findings, performance status, and previous systemic or locoregional treatments. Dosimetry method was tracked. Overall survival (OS) and progression-free survival were calculated using the Kaplan-Meier method. The best imaging response was calculated using the Response Evaluation Criteria in Solid Tumors v1.1. Grade ≥3 toxicities were assessed using Common Terminology Criteria for Adverse Events v5. Cox regression analysis was performed.ResultsFifty-two of 86 (60%) patients had multifocal tumors, and 24/89 (27%) had extrahepatic tumors. The median index tumor diameter was 7.0 cm (IQR, 4.9–10 cm). The activity calculation method was reported in 59/95 (62%) patients, with body surface area being the most frequently used method (45/59, 76%). Median OS for the cohort was 14 months (95% confidence interval, 12–22). OS at 3, 6, 12, and 24 months was 94%, 80%, 63%, and 34%, respectively. Median OS was longer in patients without cirrhosis (19.1 vs 12.2 months, P = .05). Cirrhosis, previous chemotherapy (OS, 19.1 vs 10.6 months for treatment-naïve; P = .07), and imaging response at 6 months (OS, 16.4 vs 9.5 months for no response; P = .06) underwent regression analysis. Imaging response predicted OS at regression (hazard ratio, 0.39; P = .008). Grade 3–4 bilirubin toxicities were noted in 5 of 72 (7%) patients. Grade 3 albumin toxicity was noted in 1 of 72 (1.4%) patients.ConclusionsObjective response at 6 months predicted longer OS after TARE for intrahepatic cholangiocarcinoma. The incidence of liver function toxicity was <10%.     

A Rat Model of Frozen Shoulder Demonstrating the Effect of Transcatheter Arterial Embolization on Angiography,Histopathology, and Physical Activity

PurposeTo assess the angiographic findings and the effects of transcatheter arterial embolization on physical activity and histopathology using a frozen shoulder rat model.Materials and MethodsFirst, the angiographic and histopathologic findings of rats in which the shoulder was immobilized with molding plaster for 6 weeks (n = 4) were compared to control rats with normal non-immobilized shoulders (n = 4). Next, a total of 16 frozen shoulder rats were divided into 2 groups. In the transcatheter arterial embolization group (n = 8), imipenem/cilastatin was injected into the left thoracoacromial artery. The changes of physical activity before and after procedures were evaluated and compared with a saline-injected control group (n = 8). Histopathologic findings were also compared between the 2 groups.ResultsAngiography revealed abnormal shoulder staining in all of the rats with a frozen shoulder. On histopathology, the numbers of microvessels and mononuclear inflammatory cells in the synovial membrane of the joint capsule were significantly higher compared with the control rats (both P = .03). In the transcatheter arterial embolization group, the running distance and speed were improved (P = .03 and P = .01, respectively), whereas there were no significant differences in the control group. The number of microvessels and mononuclear inflammatory cells in the transcatheter arterial embolization group were significantly lower than the control group (P = .002 and P = .001, respectively).ConclusionsThe rat frozen shoulder model revealed the development of neovascularization. Transcatheter arterial embolization decreased the number of blood vessels and inflammatory changes in the frozen shoulder and increased the moving distance and speed of the rats.     

Thermal Ablation and Transarterial Chemoembolization are Characterized by Changing Dynamics of Circulating MicroRNAs

PurposeTo determine whether the levels of circulating microRNAs (miRNAs) are altered in patients undergoing thermal ablation and chemoembolization and whether these changes are predictive of a clinical outcome.Material and MethodsThis prospective study consisted of 43 patients diagnosed with hepatocellular carcinoma (n = 15) and intrahepatic colorectal cancer metastases (n = 28) treated with thermal ablation (n = 23; radiofrequency [n = 6] or microwave [n = 19]), chemoembolization using drug-eluting embolics (n = 18), or both (n = 2). Four blood samples (immediately before the intervention and 60–90 minutes, 24 hours, and 7 days after the intervention) were taken to measure the plasma concentrations of miRNAs related to hypoxia (miR-21 and miR-210), liver injury (miR-122), epithelial–mesenchymal transition (miR-200a), and apoptosis (miR-34a) using miRNA-specific TaqMan assays and quantitative real-time polymerase chain reaction. Tumor burden and treatment response at 3 months were evaluated using the modified response evaluation criteria in solid tumors. The miRNA results were compared with clinical outcomes (Mann-Whitney U test, Wilcoxon matched-pair test).ResultsDynamic changes in the circulating miRNA levels were observed following both the interventions. For thermal ablation, significant increases in miR-21, miR-210, miR-122, miR-200a, and miR-34a concentrations peaked 60–90 minutes after the intervention (P < .01). However, for transarterial chemoembolization, maximum increases in the miRNA concentrations were observed at 24 hours after the intervention for miR-21, miR-210, miR-122, miR-200a, and miR-34a (P < .05). The increased concentrations of the circulating miRNAs were followed by a subsequent decline to baseline by 7 days. For the thermal ablation (but not chemoembolization) patients, elevations in the miR-210 and miR-200a levels were associated with early progressive disease at 3 months (P = .040 and P = .012, respectively).ConclusionsIncreased but dynamic levels of circulating miRNAs are present following interventional oncologic procedures and may prove useful as biomarkers for the monitoring of clinical outcomes.     

Endovascular Venous Stenosis and Thrombosis Large Animal Model: Angiographic,Histological, and Biomechanical Characterizations

PurposeTo characterize an ovine endovascular radiofrequency (RF) ablation-based venous stenosis and thrombosis model for studying venous biomechanics and response to intervention.Materials and MethodsUnilateral short-segment (n = 2) or long-segment (n = 6) iliac vein stenoses were created in 8 adult sheep using an endovenous RF ablation technique. Angiographic assessment was performed at baseline, immediately after venous stenosis creation, and after 2-week (n = 6) or 3-month (n = 2) survival. Stenosed iliac veins and the contralateral healthy controls were harvested for histological and biomechanical assessment.ResultsAt follow-up, the short-segment RF ablation group showed stable stenosis without occlusion. The long-segment group showed complete venous occlusion/thrombosis with the formation of collateral veins. Stenosed veins showed significant wall thickening (0.28 vs 0.16 mm, P = .0175) and confluent collagen deposition compared with the healthy controls. Subacute nonadherent thrombi were apparent at 2 weeks, which were replaced by fibrous luminal obliteration with channels of recanalization at 3 months. Stenosed veins demonstrated increased longitudinal stiffness (448.5 ± 5.4 vs 314.6 ± 1.5 kPa, P < .0001) and decreased circumferential stiffness (140.8 ± 2.6 vs 246.0 ± 1.6 kPa, P < .0001) compared with the healthy controls.ConclusionEndovenous RF ablation is a reliable technique for creating venous stenosis and thrombosis in a large animal model with histological and biomechanical attributes similar to those seen in humans. This platform can facilitate understanding of venous biomechanics and testing of venous-specific devices and interventions.     

Multicenter Evaluation of Survival and Toxicities of Hepatocellular Carcinoma following Radioembolization: Analysis of the RESiN Registry

PurposeTo determine overall survival (OS), progression-free survival (PFS), and toxicity in patients with hepatocellular carcinoma (HCC) in a multicenter, real-world data registry using transarterial radioembolization (TARE) with resin microspheres.Materials and MethodsA total of 448 patients with HCC were treated at 36 centers between 2015 and 2019. Treatment history, baseline laboratory and imaging, and treatment goal were assessed. OS and PFS were stratified using Barcelona Clinic Liver Cancer (BCLC) and Child-Pugh (CP) classifications. Kaplan-Meier analyses compared OS and PFS with 95% confidence intervals. Transplants were tracked. Toxicities were assessed using Common Terminology Criteria for Adverse Events v5. Cox proportional hazard of baseline demographics assessed factors affecting survival.ResultsPrior chemoembolization and systemic therapy were used in 107 (26%) and 68 (16%) patients, respectively. Using the BCLC staging system, 66 patients (19%) were BCLC A and 202, 51, and 26 were BCLC B, C, and D, respectively. Median OS for patients with BCLC A disease was not achieved at 30 months. Median OS for patients with BCLC B, C, and D disease were 19.5, 13.6, and 11.5 months, respectively (P = .0006). Median PFS for patients with BCLC A, B, C, and D were 19.8, 10.0, 6.3, and 5.9 months, respectively (P = .003). Twenty patients underwent transplantation, representing 14 of 43 (33%) and 6 of 28 (21%) patients who underwent bridging and downstaging therapy, respectively. Common Grade 3 toxicities were encephalopathy (11/448, 2.5%), hyperbilirubinemia (10/448, 2.2%), and ascites (9/448, 2.0%). Factors predicting longer survival included CP A (χ² = 4.2, P = .04) and BCLC A (χ² = 5.2, P = .02).ConclusionsIn a frequently pretreated patient cohort with disease burden in 81% beyond the Milan criteria, TARE with resin microspheres provided OS comparable to other studies in this multicenter registry.     

Single-Center Retrospective Comparative Analysis of Transradial,Transbrachial, and Transfemoral Approach for Mesenteric Arterial Procedures

PurposeTo assess feasibility and safety of transradial access (TRA) compared with transfemoral access (TFA) and transbrachial access (TBA) for mesenteric arterial endovascular procedures.Materials and MethodsA retrospective cohort analysis was performed including all consecutive patients who underwent a mesenteric arterial procedure in a tertiary referral center between May 2012 and February 2018. Exclusion criteria were absence of data and lost to follow-up within 24 hours after the procedure. During the study period, 103 patients underwent 148 mesenteric arterial procedures (TBA, n = 52; TFA, n = 39; TRA, n = 57). Mean patient age was 64.3 years ± 13.3, and 91 patients (62%) were women. Primary outcomes were vascular access specified technical success rate and access site complication rate, as reported in hospital records.ResultsTechnical success rate specified for the vascular access technique did not differ between the 3 approaches (TBA 96%, TFA 87%, TRA 91%; TRA vs TBA, P = .295; TBA vs TFA, P = .112; TRA vs TFA, P = .524), and overall access site complication rate was not different between the 3 approaches (TBA 42%, TFA 23%, TRA 35%; TRA vs TBA, P = .439; TBA vs TFA, P = .055; TRA vs TFA, P = .208). However, more major access site complications were reported for TBA than for TRA or TFA (TBA 17%, TFA 3%, TRA 2%; TRA vs TBA, P = .005; TBA vs TFA, P = .026; TRA vs TFA, P = .785).ConclusionsTRA is a safe and feasible approach for mesenteric arterial procedures comparable to TFA, but with a significantly lower major access site complication rate than TBA.     

Effectiveness and Safety of Prostatic Artery Embolization for the Treatment of Lower Urinary Tract Symptoms from Benign Prostatic Hyperplasia in Men with Concurrent Localized Prostate Cancer

PurposeTo assess the effectiveness and safety of prostatic artery embolization (PAE) on lower urinary tract symptoms (LUTS) in the setting of localized prostate cancer (PCa).Materials and MethodsThis was a retrospective, single-center, institutional review board-approved study from December 2016 to June 2020 of 21 patients (median age, 72; range, 63–83 years) with moderate LUTS and localized PCa. Clinical effectiveness was evaluated at 6 and 12 weeks using International Prostate Symptom Score (IPSS) and quality of life (QoL) improvement. Seventeen patients were scheduled to receive definitive radiotherapy (RT) after PAE; 13 patients completed RT. Short-term imaging signs of oncologic progression were evaluated at 6 and 12 weeks defined by at least one of the following on magnetic resonance imaging: increased Prostate Imaging-Reporting and Data System score of index lesion(s) to at least 4, new extracapsular extension, seminal vesicle involvement, or pelvic lymphadenopathy. Nonparametric Wilcoxon signed-rank test was used for analysis.ResultsIPSS improved by a median of 12 (n = 19, P < .0001) and 14 (n = 14, P < .0001) at 6 and 12 weeks, respectively. QoL improved by a median of 2 (n = 19, P < .0001) and 3 (n = 3, P < .0001) at 6 and 12 weeks. Prostate volume decreased by a median of 24% (n = 19, P < .0001) and 36% (n = 12, P = .015) at 6 and 12 weeks. No patients demonstrated disease progression at 6 (n = 16) or 12 (n = 8) weeks by imaging. No patients experienced increased prostate-specific antigen after RT, grade ≥3 adverse events, or greater genitourinary toxicity.ConclusionsPAE is effective and safe for the treatment of men with LUTS from benign prostatic hyperplasia in the setting of concomitant, localized, non-obstructive PCa.     

Single-Use versus Reusable Endoscopes for Percutaneous Biliary Endoscopy with Lithotripsy: Technical Metrics,Clinical Outcomes,and Cost Comparison

PurposeTo compare procedure and fluoroscopy time, technical and clinical success, and costs between single-use and reusable endoscopes in patients undergoing percutaneous biliary endoscopy (PBE) with lithotripsy.Material and MethodsThirty-four patients (67 procedures) were retrospectively included in the study. The patients were treated with PBE for gallstone removal from October 24, 2014, to February 12, 2020, using reusable (28 procedures) or single-use (39 procedures) endoscopes. The procedure time, fluoroscopy time, technical success rate (accessing the biliary system and locating the gallstone), clinical success rate (at least partial gallstone removal), complication rate, and cost of use were compared between the procedures.ResultsThe mean (± standard deviation) procedure time was not significantly different between single-use (136 minutes ± 45) and reusable endoscopes (136 minutes ± 51) (P = .47). The mean fluoroscopy time was significantly shorter for single-use endoscopes (11 minutes ± 8.4) than for reusable endoscopes (18 minutes ± 12) (P = .01). When comparing single-use versus reusable endoscopes, the technical success (95% [n = 37] vs 93% [n = 26]) and the clinical success (90% [n = 35] vs 75% [n = 21]) rates were not significantly different (both, P > .05). Only 1 complication was noted in the reusable endoscope group (P = .42). The cost per case was lower for single-use ($1,500) than for reusable ($3,987) endoscope procedures, primarily due to differences in capital costs and repair costs.ConclusionsSingle-use endoscopes offer the potential for lower patient radiation exposure and lower cost per case, which may reduce the financial barriers to offering PBE in interventional radiology practices. The clinical and technical success rates did not differ by endoscope type.     

Evaluation of a Novel Spun Polytetrafluoroethylene Stent Graft in an Ovine External Iliac Artery Model

PurposeTo evaluate the patency, cellular response, and thrombogenicity of a novel vascular stent graft.Materials and MethodsTest stent grafts, incorporating luminal spun polytetrafluoroethylene and a nonpermeable fluoropolymer layer, and control stent grafts, constructed of permeable expanded polytetrafluoroethylene, were implanted in the external iliac arteries of 14 adult sheep with a median weight of 73.4 kg ranging from 60.6–86.8 kg for 30 (n = 4), 90 (n = 4), and 180 (n = 6) days. Angiographic patency and percent diameter stenosis (%DS) were assessed at termination. Excised stent grafts were fixed and stained for histopathologic analysis, including neointimal coverage (NC) assessment.ResultsTest and control device migration occurred in 1 animal, resulting in test device thrombosis. Both devices were excluded from analysis. Mean %DS in test and control implants was 4.6% and 8.2% (P = .563), 2.0% and 10.9% (P = .363), and 2.1% and 10.3% (P = .009) at 30, 90, and 180 days, respectively. Median NC scores at 30, 90, and 180 days were significantly lower in middle test device sections (P < .05). Proximal and distal test and control sections exhibited similar median NC scores at all time periods (P > .05). When present, test and control devices exhibited no neointimal detachment from the graft surface. Except for the migrated test device, no thrombus was observed. Transgraft cellular migration was absent in test devices but present in control devices with tissue accumulation around the stent struts.ConclusionsTest and control devices demonstrated excellent patency in an ovine model. Compared to the control, test devices exhibited significantly lower %DS values at 180 days and significantly lower mid-device NC scores at 30, 90, and 180 days.     

Effect of Median Lobe Enlargement on Early Prostatic Artery Embolization Outcomes

PurposeTo evaluate outcomes after prostatic artery embolization (PAE) in patients with severe intravesical prostatic protrusion (IPP).Materials and MethodsThis was a retrospective, single health system, 2-hospital study from April 2015 to December 2018 of 54 patients who underwent elective PAE procedures (age mean 67.5 years; standard deviation [SD] 8.5). The cohort had a mean ellipsoid prostate volume of 100.1 cm³ (SD 56.7), a mean baseline International Prostate Symptom Score (IPSS) of 18.7 (SD 8.2), a mean baseline quality of life (QOL) score of 4.1 (SD 1.4), and a median follow-up of 38 days (range 10–656 days). Outcomes including IPSS and QOL score reduction (where a lower QOL score indicates an improvement in QOL), and clinical success were compared between severe (≥10 mm) and nonsevere (<10 mm) IPP patients. A linear regression model was used to examine the impact of IPP on these outcomes.ResultsNo significant differences in patient characteristics were found between nonsevere (n = 17) and severe (n = 37) IPP patients. Both cohorts showed IPSS reduction (nonsevere 6.0, P = .0397; severe 8.2, P < .0001) and QOL score reduction (nonsevere 1.0, P = .102; severe 2.0, P < .0001). No significant differences in IPSS or QOL score reduction were found between the cohorts (P = .431 and P = .127). Linear regression found that baseline IPP was not a significant contributor to the outcomes (IPSS: R² = .5, P < .0001; IPP: P = .702; QOL: R² = .5, P = .0003; IPP: P = .108).ConclusionsThere were no significant differences in early outcomes in PAE between patients with severe and nonsevere IPP.     

Percutaneous Access of the Modified Hutson Loop for Retrograde Cholangiography,Endoscopy, and Biliary Interventions

PurposeThe purpose of this study was to present the institutional experience of performing endoscopy, cholangiography, and biliary interventions through the modified Hutson loop by interventional radiology.Materials and MethodsA total of 61 of 64 modified Hutson loop access procedures were successful. This single-center retrospective study included 61 successful procedures of biliary interventions using existing modified Hutson loops (surgically affixed subcutaneous jejunal limb adjacent to biliary anastomosis or anastomoses) for diagnostic or therapeutic purposes in 21 patients. Seventeen of 21 patients (81%) had undergone liver transplantation. Indications included biliary strictures (n = 18) and biliary leaks (n = 3). The clinical success and complications were evaluated.ResultsThere were 3 of 26 modified Hutson loop retrograde biliary intervention failures (12%) before introduction of endoscopy and no failures (0 of 38 [0%]) subsequently (P = .06). Endoscopy or cholangioscopy was performed in 19 procedures by interventional radiologists. Retrograde biliary interventions included diagnostic cholangiography (n = 26), cholangioplasty (n = 25), stent placement (n = 29), stent retrieval (n = 25), and biliary drainage catheter placement (n = 5). No procedure-related mortality occurred. There was 1 major complication (duodenal perforation) (1.6%) and 12 minor complications (19%). In the 9 patients undergoing therapeutic interventions for biliary strictures, there was a significant decrease in median alkaline phosphatase (288.5 to 174.5 U/L; P = .03). There was a trend toward decrease in median bilirubin levels (1.7 to 1 mg/dL; P = .06) at 1 month post-intervention.ConclusionsThe modified Hutson loop provided interventional radiologists a safe and effective alternative access to manage biliary complications in patients with biliary-enteric anastomoses. Introduction of the endoscope in interventional radiology has improved the success rate of these procedures.