Multicenter Quantification of Radiation Exposure and Associated Risks for Prostatic Artery Embolization in 1476 Patients.

Background Prostatic artery embolization (PAE) is a safe, minimally invasive angiographic procedure that effectively treats benign prostatic hyperplasia; however, PAE-related patient radiation exposure and associated risks are not completely understood. Purpose To quantify radiation dose and assess radiation-related adverse events in patients who underwent PAE at multiple centers. Materials and Methods This retrospective study included patients undergoing PAE for any indication performed by experienced operators at 10 high-volume international centers from January 2014 to May 2021. Patient characteristics, procedural and radiation dose data, and radiation-related adverse events were collected. Procedural radiation effective doses were calculated by multiplying kerma-area product values by an established conversion factor for abdominopelvic fluoroscopy-guided procedures. Relationships between cumulative air kerma (CAK) or effective dose and patient body mass index (BMI), fluoroscopy time, or radiation field area were assessed with linear regression. Differences in radiation dose stemming from radiopaque prostheses or fluoroscopy unit type were assessed using two-sample t tests and Wilcoxon rank sum tests. Results A total of 1476 patients (mean age, 69.9 years ± 9.0 [SD]) were included, of whom 1345 (91.1%) and 131 (8.9%) underwent the procedure with fixed interventional or mobile fluoroscopy units, respectively. Median procedure effective dose was 17.8 mSv for fixed interventional units and 12.3 mSv for mobile units. CAK and effective dose both correlated positively with BMI (R2 = 0.15 and 0.17; P < .001) and fluoroscopy time (R2 = 0.16 and 0.08; P < .001). No radiation-related 90-day adverse events were reported. Patients with radiopaque implants versus those without implants had higher median CAK (1452 mGy [range, 900-2685 mGy] vs 1177 mGy [range, 700-1959 mGy], respectively; P = .01). Median effective dose was lower for mobile than for fixed interventional systems (12.3 mSv [range, 8.5-22.0 mSv] vs 20.4 mSv [range, 13.8-30.6 mSv], respectively; P < .001). Conclusion Patients who underwent PAE performed with fixed interventional or mobile fluoroscopy units were exposed to a median effective radiation dose of 17.8 mSv or 12.3 mSv, respectively. No radiation-related adverse events at 90 days were reported. © RSNA, 2024 See also the editorial by Mahesh in this issue.

Radioembolization plus Immune Checkpoint Inhibitor Therapy Compared with Radioembolization plus Tyrosine Kinase Inhibitor Therapy for the Treatment of Hepatocellular Carcinoma.

PURPOSE: To investigate if combination therapy with immune checkpoint inhibitor (ICI) and yttrium-90 (90Y) radioembolization results in superior outcomes than those yielded by tyrosine kinase inhibitor (TKI) therapy and 90Y for the treatment of intermediate- to advanced-stage hepatocellular carcinoma (HCC). METHODS: A retrospective review of patients presented at an institutional multidisciplinary liver tumor board between January 1, 2012 and August 1, 2023 was conducted. In total, 44 patients with HCC who underwent 90Y 4 weeks within initiation of ICI or TKI therapy were included. Propensity score matching was conducted to account for baseline demographic differences. Kaplan-Meier analysis was used to compare median progression-free survival (PFS) and overall survival (OS), and univariate statistics identified disease response and control rate differences. Duration of imaging response was defined as number of months between the first scan after therapy and the first scan showing progression as defined by modified Response Evaluation Criteria in Solid Tumors (mRECIST) or immune Response Evaluation Criteria in Solid Tumors (iRECIST). Adverse events were analyzed per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. RESULTS: Patients in the 90Y+ICI therapy group had better objective response rates (ORRs) (89.5% vs 36.8%; P < .001) and disease control rates (DCRs) (94.7% vs 63.2%; P < .001) by mRECIST and iRECIST (ORR: 78.9% vs 36.8%; P < .001; DCR: 94.7% vs 63.2%; P < .001). Median PFS (8.3 vs 4.1 months; P = .37) and OS (15.8 vs 14.3 months; P = .52) were not statistically different. Twelve patients (63.1%) in the 90Y+TKI group did not complete systemic therapy owing to adverse effects compared with 1 patient (5.3%) in the 90Y+ICI group (P < .001). Grade 3/4 adverse events were not statistically different (90Y+TKI: 21.1%; 90Y+ICI: 5.3%; P = .150). CONCLUSIONS: Patients with HCC who received 90Y+ICI had better imaging response and fewer regimen-altering adverse events than those who received 90Y+TKI. No significant combination therapy adverse events were attributable to radioembolization.

Comparison of 24-Month Clinical Outcomes after Prostatic Artery Embolization in Prostate Glands Larger versus Smaller than 80 mL: A Systematic Review.

PURPOSE: This review was undertaken to compare the clinical outcomes of prostatic artery embolization (PAE) in patients with >80 versus <80 mL prostatic volume (PV) at the 24-month follow-up to determine whether PV predicted the effectiveness or durability of PAE. MATERIALS AND METHODS: The PubMed/MEDLINE database was searched for articles published between 2010 and 2022 using the search term "(prostat∗ artery embolization) AND (long term OR follow-up OR 24-month)." Articles were included if they discussed PAE for benign prostatic hyperplasia (BPH) and reported a minimum follow-up of 24 months. Articles with <10 patients were excluded. A subgroup analysis was performed to evaluate for any difference in clinical outcomes at the 24-month post-PAE follow-up between studies with a mean PV of >80 mL and those with a mean PV of <80 mL. RESULTS: A total of 14 studies with 2,260 patients were included, all of which demonstrated significant reduction in symptoms at the 24-month follow-up after PAE. Four studies were included as part of the >80-mL PV subgroup (n = 467), and 10 studies were included as part of the <80-mL PV subgroup (n = 1,793). There was a statistically significant difference between the mean preprocedural PV (128.5 vs 64.0 mL; P = .015). At the 24-month follow-up, there were no significant differences between groups across any of the compared parameters. The collective incidence of major adverse events reported in the studies within this review was <1%. CONCLUSIONS: PAE is both safe and durable for patients suffering from BPH and can be effective across a wide range of baseline PVs.

Fertility after Transcatheter Arterial Embolization for Obstetric Hemorrhage: An Urban Health Care System Observational Study.

OBJECTIVE: This study aimed to investigate pregnancy rate, pregnancy outcomes, and resumption of menses after transcatheter arterial embolization (TAE) for obstetric hemorrhage (OH). STUDY DESIGN: Sixty-seven patients who underwent TAE for OH from 2006 to 2020 within an urban, multihospital health care system were identified retrospectively. Selected patients were interviewed by phone to complete a survey with a primary outcome of self-reported pregnancy in those seeking pregnancy. Secondary outcomes included pregnancy outcomes and resumption of menses. Univariate testing of association of pregnancy and miscarriage rate with embolic agent was performed using Fisher's exact test. RESULTS: Thirty-three of 50 patients (66%) meeting the inclusion criteria completed the survey on fertility, a median of 47 (range, 13-123) months after TAE for OH. Of the 13 patients who attempted pregnancy, there was a pregnancy rate of 77% and miscarriage rate of 38%. Those who delivered live newborns conceived spontaneously, carried to term, and delivered a healthy newborn via cesarean section at a weight appropriate for gestational age. Thirty (91%) patients resumed menstruation, and the majority with unchanged frequency. Most patients underwent bilateral uterine artery embolization with radial artery access (54%). The most common embolic agents used were gelfoam only (30%) and glue only (24%). There was no statistically significant association between embolic agent and pregnancy or miscarriage rate. CONCLUSION: Spontaneous pregnancy with live birth and resumption of menses can occur in a majority of patients after TAE for OH. KEY POINTS: · Most patients who attempted pregnancy after TAE for OH achieved pregnancy.. · Most patients who became pregnant conceived spontaneously and delivered healthy newborns at term.. · Most patients resumed menstruation after TAE for OH.. · There was no significant association between type of embolic and pregnancy or miscarriage rate..

MR elastography outperforms shear wave elastography for the diagnosis of clinically significant portal hypertension.

OBJECTIVES: Portal hypertension (PH) is associated with complications such as ascites and esophageal varices and is typically diagnosed through invasive hepatic venous pressure gradient (HVPG) measurement, which is not widely available. In this study, we aim to assess the diagnostic performance of 2D/3D MR elastography (MRE) and shear wave elastography (SWE) measures of liver and spleen stiffness (LS and SS) and spleen volume, to noninvasively diagnose clinically significant portal hypertension (CSPH) using HVPG measurement as the reference. METHODS: In this prospective study, patients with liver disease underwent 2D/3D MRE and SWE of the liver and spleen, as well as HVPG measurement. The correlation between MRE/SWE measures of LS/SS and spleen volume with HVPG was assessed. ROC analysis was used to determine the utility of MRE, SWE, and spleen volume for diagnosing CSPH. RESULTS: Thirty-six patients (M/F 22/14, mean age 55 ± 14 years) were included. Of the evaluated parameters, 3D MRE SS had the strongest correlation with HVPG (r = 0.686, p < 0.001), followed by 2D MRE SS (r = 0.476, p = 0.004). 3D MRE SS displayed the best performance for diagnosis of CSPH (AUC = 0.911) followed by 2D MRE SS (AUC = 0.845) and 3D MRE LS (AUC = 0.804). SWE SS showed poor performance for diagnosis of CSPH (AUC = 0.583) while spleen volume was a fair predictor (AUC = 0.738). 3D MRE SS was significantly superior to SWE LS/SS (p ≤ 0.021) for the diagnosis of CSPH. CONCLUSION: SS measured with 3D MRE outperforms SWE for the diagnosis of CSPH. SS appears to be a useful biomarker for assessing PH severity. These results need further validation. KEY POINTS: • Spleen stiffness measured with 2D and 3D MR elastography correlates significantly with hepatic venous pressure gradient measurement. • Spleen stiffness measured with 3D MR elastography demonstrates excellent performance for the diagnosis of clinically significant portal hypertension (AUC 0.911). • Spleen stiffness measured with 3D MR elastography outperforms liver and spleen stiffness measured with shear wave elastography for diagnosis of clinically significant portal hypertension.

Survival Analysis Using Albumin-Bilirubin (ALBI) Grade for Patients Treated with Drug-Eluting Embolic Transarterial Chemoembolization for Hepatocellular Carcinoma.

PURPOSE: The albumin-bilirubin (ALBI) grade has been established as an improved predictor of survival in patients with hepatocellular carcinoma (HCC) treated with conventional transarterial chemoembolization and yttrium-90 radioembolization. The purpose of the study was to investigate the utility of ALBI grade in prognosticating outcomes in patients with HCC treated with drug-eluting embolic (DEE) transarterial chemoembolization (TACE). MATERIALS AND METHODS: A single-center retrospective review was performed to compare the efficacy of ALBI grade and Child-Pugh (CP) classification in predicting the survival of patients with HCC receiving DEE-TACE. A total of 303 patients with HCC were identified who had received DEE-TACE without concomitant locoregional therapy within 30 days. Survival analysis was performed using Kaplan-Meier methods and censored for curative therapy. Survival curves were stratified based on the ALBI grade, CP class, Barcelona Clinic Liver Cancer (BCLC) stage, Eastern Cooperative Oncology Group performance status, and presence of ascites. The discriminatory ability of survival curves was calculated by C-Index. RESULTS: Kaplan-Meier survival curves stratified by the ALBI grade produced distinct, nonoverlapping curves (P < .001), showing greater discriminatory ability than the CP classification (C-index = 0.568 and 0.545, respectively). The substratification of the BCLC stage by the ALBI grade yielded greater discriminatory ability than the substratification by the CP classification (C-index = 0.573 and 0.565, respectively). For patients with BCLC stage B, the substratification by the ALBI grade yielded distinct curves, whereas the substratification by the CP classification did not (P = .011 and P = .379, respectively). CONCLUSIONS: ALBI grade showed improved discriminatory ability compared with CP classification in differentiating overall survival among patients with HCC receiving DEE-TACE. Furthermore, ALBI grade was effective in substratifying survival among patients categorized as CP class A and patients with BCLC stage B, whereas CP classification was not effective.

Noninvasive diagnosis of portal hypertension using gadoxetate DCE-MRI of the liver and spleen.

OBJECTIVES: To assess the performance of gadoxetate dynamic contrast-enhanced (DCE) MRI of the liver and spleen for noninvasive diagnosis of portal hypertension (PH). METHODS: Thirty-five patients (M/F 22/13, mean age 55 years) with chronic liver disease who underwent hepatic venous pressure gradient (HVPG) measurements were prospectively enrolled in this IRB-approved study. All patients underwent multiparametric MRI including gadoxetate DCE-MRI acquisition. Model-based and model-free DCE-MRI analyses were performed. The correlation between DCE-MRI parameters and HVPG was assessed. ROC analysis was employed to determine the diagnostic performance of DCE-MRI parameters alone and in combination for prediction of PH and clinically significant (CS)PH (HVPG > 5 and ≥ 10 mmHg, respectively). RESULTS: Mean HVPG was 7.0 ± 5.0 mmHg (range 0-18 mmHg). Twenty-one (60%) patients had PH, of whom 9 had CSPH. Modeled liver uptake fraction fi and uptake rate ki and model-free parameters liver upslope and uptake were all significantly negatively correlated with HVPG (r range - 0.490 to - 0.398, p value range 0.003-0.018), while spleen interstitial fraction ve was significantly positively correlated with HVPG (r = 0.336, p = 0.048). For PH diagnosis, liver ki showed the best diagnostic performance with an AUC, sensitivity, and specificity of 0.74 (confidence interval (CI) 0.57-0.91), 71.4%, and 78.6%. The combination of liver ki and spleen ve was selected as the best classifier for diagnosis of CSPH with an AUC, sensitivity, and specificity of 0.87 (CI 0.75-0.99), 100%, and 73.1%. CONCLUSIONS: Our results demonstrate the potential utility of hepatocyte uptake parameters and spleen interstitial fraction obtained with gadoxetate DCE-MRI for the diagnosis of PH and CSPH. KEY POINTS: • Liver uptake and spleen interstitial fraction estimates from gadoxetate DCE-MRI are significantly correlated with portal pressure measurements. • Liver uptake rate shows good diagnostic performance for the diagnosis of portal hypertension. • The combination of liver uptake rate with spleen interstitial fraction exhibits excellent diagnostic performance for the diagnosis of clinically significant portal hypertension.

Single-System Experience With Outpatient Transradial Uterine Artery Embolization: Safety, Feasibility, Outcomes, and Early Rates of Return.

OBJECTIVE. The purpose of this study was to assess feasibility and rate of patients returning to the hospital when a same-day discharge protocol is used for patients undergoing transradial uterine artery embolization (UAE) for symptomatic fibroids. MATERIALS AND METHODS. A total of 374 patients who underwent transradial UAE with a same-day discharge protocol between April 2013 and June 2019, with documented follow-up, were included in this single-health-system retrospective study. Angiographic images and procedural reports were reviewed for technical success (defined as bilateral embolization). Electronic medical records were reviewed for patient and fibroid characteristics, adverse events, clinical success (defined as documented improvement in symptoms or patient satisfaction), and unplanned clinic visits, emergency department visits, and readmissions within 30 days of UAE. Univariate and multivariate analyses were used to identify risk factors for unplanned visits. RESULTS. Eight (2.1%) patients required conversion to inpatient stay (mean length of stay, 1.4 days; range, 1-3 days). The median postprocedure observation time was 3.7 hours (range, 1.1-12.5 hours). Technical success was achieved in 94.7% of patients, with 2.4% requiring crossover to the femoral artery for access. Clinical success was achieved in 86.0% of patients, with 6-month reductions in uterus and dominant leiomyoma volume of 30.4% and 42.9%, respectively. Rates of unplanned clinic visits, emergency department visits, and readmissions were 3.2%, 5.1%, and 0.5%, respectively. Patients with submucosal fibroids or pain as an indication for UAE were significantly more likely to have unplanned visits. CONCLUSION. Transradial UAE for symptomatic fibroids can be performed using a same-day discharge protocol with low rates of patients returning to the hospital. Submucosal location and pain as an indication for UAE were predictors of early return.

Relationship of hospital volume on outcomes in patients with acute pulmonary embolism: Analysis of a 70,000 patient database.

Positive relationships between volume and outcome have been seen in several surgical and medical conditions, resulting in more centralized and specialized care structures. Currently, there is a scarcity of literature involving the volume-outcome relationship in pulmonary embolism (PE). Using a state-wide dataset that encapsulates all non-federal admissions in New York State, we performed a retrospective cohort study on admitted patients with a diagnosis of PE. A total of 70,443 cases were separated into volume groups stratified by hospital quartile. Continuous and categorical variables were compared between cohorts. Multivariable regression analysis was conducted to assess predictors of 1-year mortality, 30-day all-cause readmission, 30-day PE-related readmission, length of stay, and total charges. Of the 205 facilities that were included, 128 (62%) were labeled low volume, 39 (19%) medium volume, 23 (11%) high volume, and 15 (7%) very high volume. Multivariable analysis showed that very high volume was associated with decreased 30-day PE-related readmission (OR 0.64; 95% CI, 0.55 to 0.73), decreased 30-day all-cause readmission (OR 0.84; 95% CI, 0.79 to 0.89), decreased 1-year mortality (OR 0.85; 95% CI, 0.80 to 0.91), decreased total charges (OR 0.96; 95% CI, 0.94 to 0.98), and decreased length of stay (OR 0.94; 95% CI, 0.92 to 0.96). In summary, facilities with higher volumes of acute PE were found to have less 30-day PE-related readmissions, less all-cause readmissions, shorter length of stay, decreased 1-year mortality, and decreased total charges.

Safety and feasibility of transradial infrainguinal peripheral arterial disease interventions.

OBJECTIVE: Transradial access (TRA) has traditionally been favored for coronary interventions. Tools with up to 200 cm length now allow operators to treat infrainguinal peripheral arterial disease (PAD) using TRA. This study aims to assess the safety and feasibility of TRA infrainguinal interventions. METHODS: Patients with infrainguinal PAD who underwent intervention via TRA from July 2013 through June 2019 were retrospectively reviewed. Exclusion criteria included Barbeau D waveform, a radial artery diameter of greater than 2 mm, radial artery occlusion, Raynaud syndrome, or peripheral vasculitis. Procedural success (adequate inline flow to the foot), TRA alone failure (crossover or use of an additional access site), clinical success (defined as improvement in ankle brachial index, clinical symptoms, or wound healing) and adverse events were recorded from procedure notes and follow-up visits. RESULTS: Thirty-six procedures were attempted using TRA in 32 patients (mean age, 65.8 years; range, 29-86; 22 male, 14 female) with mean height of 65.8 inches (range, 59.0-72.0 inches) and a body mass index of 28.7 (range, 19.1-43.9). Preprocedure Rutherford classification (II/III/IV/V/VI) was 8/15/2/7/4, respectively. The left radial artery was used for 35 of 36 procedures (97.2%). Treated vessels included the common femoral (n = 4), superficial femoral (n = 25), deep femoral (n = 1), popliteal (n = 10), tibioperoneal trunk (n = 2), tibial (n = 4), and plantar (n = 1) arteries. Interventions included angioplasty (n = 32, 100%), atherectomy (n = 8, 25%), and stenting (n = 13, 41%). Procedural success was 100%, the TRA alone failure rate was 11.1%, and clinical success was 89.3%. The median follow-up was 286.5 days (range, 0-919 days). Adverse events included radial artery pseudoaneurysm (n = 1), access site hematoma/bleeding (n = 3), radial artery occlusion (n = 1), groin hematoma (n = 1), popliteal artery dissection treated with stenting (n = 2), and a small superficial femoral artery perforation (n = 1) treated with prolonged balloon tamponade. No patients experienced signs of cerebrovascular events or distal embolism. CONCLUSIONS: TRA is a useful option for treating patients with PAD; however, several limitations still exist.

Splenic T1ρ as a noninvasive biomarker for portal hypertension.

BACKGROUND: There is a need for noninvasive methods for the diagnosis and monitoring of portal hypertension (PH). PURPOSE: To 1) assess the correlation of liver and spleen T1 and T1ρ measurements with portal pressures in patients with chronic liver disease, and 2) to compare the diagnostic performance of the relaxation parameters with radiological assessment of PH. STUDY TYPE: Prospective. SUBJECTS: Twenty-five patients (M/F 16/9, mean age 56 years, range 21-78 years) undergoing portal pressure (hepatic venous pressure gradient [HVPG]) measurements. FIELD STRENGTH/SEQUENCE: 1.5T abdominal MRI scan, including T1ρ and T1 mapping. ASSESSMENT: Liver and spleen T1ρ and T1 , radiological PH score, and (normalized) spleen length were evaluated. STATISTICAL TESTS: Spearman correlation of all MRI parameters with HVPG was assessed. The diagnostic performance of the assessed parameters for prediction of PH (HVPG ≥5 mmHg) and clinically significant PH (CSPH, HVPG ≥10 mmHg) was determined by receiver operating characteristic (ROC) analysis. RESULTS: The mean HVPG measurement was 7.8 ± 5.3 mmHg (PH, n = 18 [72%] including CSPH, n = 9 [36%]). PH score, (normalized) spleen length and spleen T1ρ significantly correlated with HVPG, with the strongest correlation found for spleen T1ρ (r = 0.613, P = 0.001). Spleen T1ρ was the only parameter that showed significant diagnostic performance for assessment of PH (area under the curve [AUC] 0.817, P = 0.015) and CSPH (AUC = 0.778, P = 0.024). Normalized spleen length also showed significant diagnostic performance for prediction of CSPH, with a slightly lower AUC (= 0.764, P = 0.031). The radiological PH score, T1ρ and T1 of the liver and T1 of the spleen, did not show significant diagnostic performance for assessment of CSPH (P > 0.075). DATA CONCLUSION: Spleen T1ρ showed a significant correlation with portal pressure and showed improved diagnostic performance for prediction of CSPH compared to radiological assessment. These initial results need confirmation in a larger cohort. LEVEL OF EVIDENCE: 1 Technical Efficacy Stage: 2 J. Magn. Reson. Imaging 2020;52:787-794.

Use of 70- to 150-µm Radiopaque Spherical Embolics for Prostatic Artery Embolization.

This retrospective report describes treatment of 21 patients who underwent prostatic artery embolization using 70- to 150-µm radiopaque microspheres for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Seventeen patients (81%) received successful bilateral prostatic artery embolization. At a mean follow-up of 42 days (range, 25-59 days), patients showed improvement in International Prostate Symptom Score (n = 11; mean = 10.6; P = .001), quality of life score (n = 17; mean = 2.0; P = .02), and International Index of Erectile Function (n = 17; mean = 9.3; P = .01). The mean prostate volume reduction was 28 mL (16.2%; P = .003). Nontarget embolization occurred twice, resulting in 1 minor adverse event of hematospermia.

Effect of Median Lobe Enlargement on Early Prostatic Artery Embolization Outcomes.

PURPOSE: To evaluate outcomes after prostatic artery embolization (PAE) in patients with severe intravesical prostatic protrusion (IPP). MATERIALS AND METHODS: This 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. RESULTS: No 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). CONCLUSIONS: There were no significant differences in early outcomes in PAE between patients with severe and nonsevere IPP.

Inline Balloon Occlusion-Assisted Delivery of Ethylene Vinyl Alcohol Copolymer for Peripheral Arterial Applications: A Multicenter Case Series.

PURPOSE: To assess the feasibility, safety, and efficacy of balloon-assisted delivery of ethylene vinyl alcohol copolymer (EVOH) for a range of peripheral arterial applications. MATERIALS AND METHODS: Six academic medical centers entered retrospective data on 46 consecutive patients (27 men, 19 women; ages, 11-94 y; mean age, 50.3 y) who underwent 60 balloon-assisted EVOH procedures. The cohort was restricted to procedures involving peripheral, nonneural arteries 1-5.5 mm in diameter. Clinical indications included a wide range of vascular pathologic conditions (most commonly arteriovenous malformations [n = 20], renal angiomyolipomas [n = 8], and acute hemorrhage [n = 9]) and targeted visceral and musculoskeletal peripheral arteries. Data collected included sex, age, clinical indication, arterial pathology, arteries embolized, type of occlusion balloon microcatheter, type and concentration of EVOH agent, effectiveness as an embolic backstop, vessels protected, adequacy of EVOH cast penetration, catheter extraction, nontarget embolization, and complications. RESULTS: Balloon occlusion prevented EVOH reflux in 59 of 60 procedures (98.3%). Nontarget EVOH embolization occurred in 2 procedures (3.3%). Adequate EVOH cast penetration and complete filling of the target pathologic structure were seen in 57 of 60 procedures (95%). Balloon deflation and uneventful extraction occurred in all procedures; small EVOH fragments detached into target arteries in 2 cases. One major (1.7%) and 2 minor (3.3%) complications occurred. CONCLUSIONS: Balloon-assisted EVOH embolization of peripheral arteries is feasible, safe, effective, and versatile. The primary advantage of balloon-assisted EVOH embolization is the ability to apply more injection pressure to advance the EVOH cast assertively into the pathologic structure(s).

Development of Research Agenda in Prostate Artery Embolization: Summary of Society of Interventional Radiology Consensus Panel.

PURPOSE: To summarize the Society of Interventional Radiology Foundation's Research Consensus Panel development of a research agenda on prostate artery embolization (PAE). MATERIALS AND METHODS: PAE for the treatment of lower urinary tract symptoms has been shown to be safe and effective in decreasing symptoms and prostate size. Lack of randomized controlled trials (RCTs) on PAE in the United States has prevented inclusion in American Urologic Association guideline recommendations for treatment of lower urinary tract symptoms resulting from benign prostatic hyperplasia. Recognizing the need for well-designed trials, the SIR Foundation funded a Research Consensus Panel to prioritize a research agenda. The panel included interventional radiologists, urologists, SIR Foundation leadership, and industry representatives. The goal of the meeting was to discuss weaknesses with current data and study design for development of US trials to report long-term outcomes data. RESULTS: Final consensus on a research design could not be made because the group was split on 3 research designs: (i) RCT of PAE versus sham with crossover of the sham group. (ii) RCT of PAE versus simple prostatectomy. (iii) RCT of PAE versus holmium laser enucleation of the prostate/thulium laser enucleation of the prostate. The panel recommended a nonindustry-funded registry to obtain real-world data. CONCLUSIONS: Level 1 data are required to be included in the American Urologic Association guidelines for treatment of benign prostatic hyperplasia. Because of concerns with all 3 study designs, the panel did not reach a consensus. Further meetings are planned with the panel to select among these research designs.

Safety and Efficacy of Locoregional Treatment during Immunotherapy with Nivolumab for Hepatocellular Carcinoma: A Retrospective Study of 41 Interventions in 29 Patients.

PURPOSE: To assess the safety of locoregional treatment (LRT) combined with nivolumab for intermediate and advanced hepatocellular carcinoma (HCC). MATERIALS AND METHODS: A single-center retrospective review included 29 patients undergoing 41 LRTs-transarterial chemoembolization or yttrium-90 transarterial radioembolization-60 days before or concurrently with nivolumab. Demographic, clinical, and laboratory values and adverse events were reviewed before and after nivolumab initiation and after each LRT. Treatment response and time to progression were assessed using Modified Response Evaluation Criteria in Solid Tumors. Clinical events, including nivolumab termination, death, and time of last follow-up, were assessed. RESULTS: Over a median nivolumab course of 8.1 months (range, 1.0-30) with a median of 14.2 2-week cycles (range, 1-53), predominantly Child-Pugh A (22/29) patients-12 Barcelona Clinic Liver Cancer (BCLC) B and 17 BCLC C-underwent 20 transarterial chemoembolization and 21 transarterial radioembolization LRTs at a median of 67 days (range, 48-609) after nivolumab initiation. Ten patients underwent multiple LRTs. During a median follow-up of 11.5 months (range, 1.8-35.1), no grade III/IV adverse events attributable to nivolumab were observed. There were five instances of grade III/IV hypoalbuminemia or hyperbilirubinemia within 3 months after LRT. There were no nivolumab-related deaths, and 30-day mortality after LRT was 0%. CONCLUSIONS: LRTs performed concurrently with nivolumab immunotherapy demonstrate an acceptable safety profile in patients with intermediate and advanced HCC.

Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity) Trial: Results at 1 Year.

Background Bariatric embolization is a new endovascular procedure to treat patients with obesity. However, the safety and efficacy of bariatric embolization are unknown. Purpose To evaluate the safety and efficacy of bariatric embolization in severely obese adults at up to 12 months after the procedure. Materials and Methods For this prospective study (NCT0216512 on ClinicalTrials.gov ), 20 participants (16 women) aged 27-68 years (mean ± standard deviation, 44 years ± 11) with mean body mass index of 45 ± 4.1 were enrolled at two institutions from June 2014 to February 2018. Transarterial embolization of the gastric fundus was performed using 300- to 500-µm embolic microspheres. Primary end points were 30-day adverse events and weight loss at up to 12 months. Secondary end points at up to 12 months included technical feasibility, health-related quality of life (Short Form-36 Health Survey ([SF-36]), impact of weight on quality of life (IWQOL-Lite), and hunger or appetite using a visual assessment scale. Analysis of outcomes was performed by using one-sample t tests and other exploratory statistics. Results Bariatric embolization was performed successfully for all participants with no major adverse events. Eight participants had a total of 11 minor adverse events. Mean excess weight loss was 8.2% (95% confidence interval [CI]: 6.3%, 10%; P < .001) at 1 month, 11.5% (95% CI: 8.7%, 14%; P < .001) at 3 months, 12.8% (95% CI: 8.3%, 17%; P < .001) at 6 months, and 11.5% (95% CI: 6.8%, 16%; P < .001) at 12 months. From baseline to 12 months, mean SF-36 scores increased (mental component summary, from 46 ± 11 to 50 ± 10, P = .44; physical component summary, from 46 ± 8.0 to 50 ± 9.3, P = .15) and mean IWQOL-Lite scores increased from 57 ± 18 to 77 ± 18 (P < .001). Hunger or appetite decreased for 4 weeks after embolization and increased thereafter, without reaching pre-embolization levels. Conclusion Bariatric embolization is well tolerated in severely obese adults, inducing appetite suppression and weight loss for up to 12 months. Published under a CC BY-NC-ND 4.0 license. Online supplemental material is available for this article.

Balloon-Occluded Transarterial Chemoembolization for the Treatment of Hepatocellular Carcinoma: A Single-Center US Preliminary Experience.

This report describes a single-center experience with balloon-occluded transarterial chemoembolization for liver-directed therapy. A total of 26 patients (11 male, 4 female; mean age, 65 y ± 7) with 28 tumors (mean diameter, 2.7 cm; range, 1.1-5.9 cm) were treated. Technical success rate was 100% (28 of 28 cases), with 1 minor complication of left portal vein thrombosis and small liver infarct. Of the 15 tumors analyzed for response, 60% (9 of 15) exhibited complete response, 33.3% (5 of 15) exhibited partial response, and 6.6% (1 of 15) had stable disease on follow-up. Eight patients exhibited overall progression with a new hepatic lesion and a median time to progression of 7.9 months (range, 5-11 mo).

Endovascular Therapy for Vasculogenic Erectile Dysfunction: A Systematic Review and Meta-Analysis of Arterial and Venous Therapies.

PURPOSE: To systematically review and perform a meta-analysis on the safety and efficacy of endovascular therapy in the treatment of the two most common etiologies of vasculogenic erectile dysfunction (ED): veno-occlusive dysfunction (VOD) and arterial insufficiency (AI). MATERIALS AND METHODS: PubMed, Web of Science, ScienceDirect, and Scopus databases were searched for published English literature regarding endovascular ED treatments. Case series (n ≥ 3) were included. Multiple data points were obtained, including demographic data, etiology, diagnosis method, imaging studies, treatment approach, technical success, clinical success, complications, and follow-up. RESULTS: Sixteen relevant articles were obtained and a total of 212 patients with VOD and 162 with AI were identified. The VOD cohort were treated either percutaneously (60.4%; n = 128) or after surgical exposure of the deep dorsal vein (33.5%, n = 71), or it was unspecified (6.1%; n = 13). The most common embolic used was n-butyl cyanoacrylate (51.9%; n = 109). Meta-analysis found an overall clinical success rate of 59.8% in VOD patients. Complications occurred in 5.2% of patients (n = 11), with 9 considered to be mild and 2 considered to be severe. The AI cohort contained 162 patients most commonly treated via stenting of the internal pudendal artery (40.1%; n = 65). Meta-analysis found an overall clinical success rate of 63.2% in AI patients. Complications occurred in 4.9% of patients (n = 8), with 4 considered to be mild and 4 considered to be severe. CONCLUSIONS: Endovascular therapy for medically refractory ED is safe and may provide a treatment alternative to more invasive surgical management; however, conclusions are limited by the heterogeneity of clinical success definitions among the included studies.