Racial and Ethnic Disparities among Participants in Hepatocellular Carcinoma Clinical Studies Evaluating Transarterial Therapies.

PURPOSE: To evaluate the racial and ethnic representation of transarterial therapy for hepatocellular carcinoma (HCC) clinical trials in the United States. MATERIALS AND METHODS: The ClinicalTrials.gov database was examined to identify all completed studies with transarterial therapies for the management of HCC in the United States and extract information about the observed number of participants for each racial and ethnic group (based on the Office of Management and Budget definitions). The expected number of participants was calculated by multiplying the total number of participants in a trial with the U.S.-population HCC-based proportion for each group. The effects of the study phase, funding source, number of centers involved in the study, and the location of the participating center on racial and ethnic distribution were explored. RESULTS: Seventy-nine relevant studies were identified, of which 27 (34.2%) and 18 (22.8%) reported ethnic and race characteristics, respectively. Most study participants were White (81%, 1,591/1,964) by ethnicity and not Hispanic or Latino (93%, 937/1,008) by race. In terms of the observed-to-expected ratios by race and ethnicity in all trials, White and not Hispanic or Latino participants were overrepresented with a ratio of 1.22 (1.10-1.37) and 1.33 (1.26-1.41), respectively, and all other racial and ethnic groups were underrepresented. The enrollment of African Americans and Asian Americans varied by the study phase, and a higher enrollment of African Americans was noted in the National Institutes of Health-funded and multicenter studies (P < .05). CONCLUSIONS: This cross-sectional study demonstrates that in HCC transarterial therapy clinical trials, racial and ethnic minorities were underrepresented and the majority of the studies identified failed to report this demographic information.

Angiographic Revascularization after Bariatric Embolization in a Swine Model.

This study evaluated fundal arteriole angiographic revascularization after embolization with embolic microspheres of 3 different diameters in a swine model (16 swine, 31 arterioles). In the 50-µm group, 7 of 11 (64%) arterioles recanalized completely, 3 of 11 (27%) arterioles recanalized partially, and 1 of 11 (9%) arterioles had collateralization (no recanalization). In the 100- to 300-µm group, 7 of 10 (70%) arterioles recanalized completely and 3 of 10 (30%) arterioles) recanalized partially. In the 300- to 500-µm group, 7 of 10 (70%) arterioles recanalized completely, 1 of 10 (10%) arterioles recanalized partially, and 2 of 10 (20%) arterioles had collateralization. No difference was found between the groups in the degree of recanalization (P = .64). All embolized arterioles exhibited some degree of angiographic revascularization, irrespective of the microsphere size.

Prevalence of and Factors Associated with Arterial Aneurysms in Patients with Hereditary Hemorrhagic Telangiectasia: 17-Year Retrospective Series of 418 Patients.

PURPOSE: To estimate the prevalence of and identify characteristics associated with the presence of aneurysms in a cohort of patients with hereditary hemorrhagic telangiectasia (HHT). MATERIALS AND METHODS: In the study institution's HHT database, 418 patients with a definite HHT diagnosis were identified based on the clinical Curaçao criteria and/or an HHT-associated genetic mutation. Regression modeling was used to evaluate the association between arterial aneurysms and older age, male sex, smoking, alcohol consumption, hypertension, hyperlipidemia, genetic mutations, the presence of arteriovenous malformations (AVMs) unrelated to the aneurysms, and HHT-related genetic mutations. RESULTS: Forty-three (10.3%) patients had at least 1 aneurysm. Sixteen (3.8%) patients had multiple aneurysms. Of the variables analyzed, older age (odds ratio [OR] = 1.02; 95% confidence interval [CI]: 1.0-1.1), the presence of anatomically and flow-unrelated AVMs (OR = 3.2; 95% CI: 1.3-8.0), and the presence of activin A receptor type II-like 1 (ACVRL1) mutation (OR = 4.0; 95% CI: 1.5-10) were associated with the presence of at least 1 aneurysm. CONCLUSIONS: In this cohort of patients with HHT, the prevalence of intracranial and visceral arterial aneurysms was estimated to be 10.3%. Older age, the presence of unrelated AVMs, and the presence of the ACVRL1 mutation were associated with the presence of arterial aneurysms. Further study is required to assess the clinical importance and risk of rupture of aneurysms in patients with HHT.

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.

Bowel Penetration by Inferior Vena Cava Filters: Feasibility and Safety of Percutaneous Retrieval.

OBJECTIVE. The purpose of this study was to evaluate the safety and technical feasibility of inferior vena cava filter (IVCF) removal when filter elements penetrate adjacent bowel. MATERIALS AND METHODS. A multicenter retrospective review of IVCF retrievals between 2008 and 2018 was performed. Adult patients with either CT or endoscopic evidence of filter elements penetrating bowel before retrieval were included. Technical success of IVCF retrieval was recorded. Patient records were assessed for immediate, 30-day, and 90-day complications after retrieval. RESULTS. Thirty-nine consecutive adult patients (11 men and 28 women; mean age, 51.2 years; age range, 18-81 years) qualified for inclusion. Filter dwell time was a median of 148 days (range, 32-5395 days). No IVCFs were known to have migrated or caused iliocaval thrombosis. Five IVCFs (12.8%) had more than 15° tilt relative to the inferior vena cava (IVC) before retrieval. Three IVCFs (7.7%) had fractured elements identified at the time of retrieval. Mean international normalized ratio (INR) was 1.24 ± 0.53 (SD), and mean platelet count was 262 ± 139 × 103/µL. Ten patients (25.6%) were on antibiotics at the time of retrieval. All 39 IVCFs were successfully retrieved (technical success = 100%). Two patients experienced minor complications in the immediate postprocedural period, which resulted in a minor complication rate of 5.1%. There were no complications (major or minor) identified in any patient at 30 or 90 days after retrieval. The overall major complication rate was 0%. CONCLUSION. Endovascular retrieval of IVCFs with CT evidence of filter elements that have penetrated adjacent bowel is both safe and technically feasible.

Association Between Gut Hormones and Weight Change After Bariatric Arterial Embolization: Results from the BEAT Obesity Trial.

PURPOSE: To evaluate associations of ghrelin, glucagon-like peptide 1 (GLP-1), and peptide YY 3-36 (PYY3-36) with weight change after bariatric arterial embolization (BAE). MATERIALS AND METHODS: Subgroup analysis of data collected during the BEAT Obesity Trial involving 7 participants with BMI > 40 who were embolized with 300- to 500-µm Embosphere Microspheres. Three participants were characterized as "responders" (top tertile of weight loss at each visit) and 4 as "non-responders" (bottom tertile of weight loss at each visit). Mean ± standard deviation participant age was 44 ± 11 years, and 6 of 7 participants were women. Participants were evaluated at baseline, 2 weeks, and 1, 3, 6, and 12 months after BAE. After fasting, participants consumed a mixed meal test at each visit; blood samples were collected at 0, 15, 30, 60, 120, 180, and 240 min. Study outcome measures were changes in weight from baseline and plasma serum hormone levels. RESULTS: Percentage change in ghrelin decreased significantly in non-responders at 60 and 120 min at 1 and 12 months (estimated difference between 60 vs. 0 min at 1 month: 69% [95% CI - 126%, - 13%]; estimated difference between 120 vs. 0 min at 12 months: - 131% (95% CI - 239%, - 23%]). Responders had significantly lower ghrelin and greater weight loss than non-responders at 6 and 12 months. GLP-1 and PYY3-36 levels did not differ between groups. CONCLUSION: Participants with consistent weight loss throughout follow-up had lower ghrelin than non-responders, supporting decreased ghrelin as a mechanism underlying BAE-induced weight loss. LEVEL OF EVIDENCE I: High-quality randomized trial or prospective study; testing of previously developed diagnostic criteria on consecutive patients; sensible costs and alternatives; values obtained from many studies with multiway sensitivity analyses; systematic review of Level I RCTs and Level I studies.

Does Intraprocedural CT Improve the Success Rate of Adrenal Venous Sampling? A Systematic Review and Meta-Analysis of Data from 809 Patients.

PURPOSE: To perform a systematic review and meta-analysis to quantify the technical success rate of adrenal venous sampling (AVS) with and without intraprocedural computed tomography (CT). METHODS: A systematic search of the Medline, Scopus, EMBASE, and Web of Science databases for comparative studies using intraprocedural CT was undertaken. More than 1,000 records were screened using titles and abstracts. Full texts of 121 studies were reviewed and 14 eligible studies were identified. Nine studies had adequate comparative data and were included in the meta-analysis. RESULTS: A research synthesis was performed and data from 809 patients were pooled in multiple random effect models. Overall success rate of AVS without and with intraprocedural CT was 72.7% (59.3-83.0%) and 92.5% (86.6-95.9), respectively. The addition of intraprocedural CT increased the technical success rate by 19.8% (P < 0.001), with an odds ratio (OR) of 5.5 (3.3-9.2; P < 0.01). In meta-regression, odds of success with intraprocedural CT was associated with younger age (beta: 0.16 ± 0.05; P:0.001), higher body mass index (BMI; beta:0.08 ± 0.03; P:0.002), and higher selectivity index (defined as the ratio of cortisol in the adrenal vein to that in the inferior vena cava; beta:0.35 ± 0.08, P < 0.001). We found a linear inverse association between operator's success without CT and improved success with intraprocedural CT (R2: 0.86). CONCLUSIONS: Intraprocedural CT is not required for every case, but can be performed in difficult cases or when operators' success is limited. The benefit was more pronounced in younger patients with higher BMI, female gender, and with higher selectivity. LEVEL OF EVIDENCE: III Systematic review and meta-analysis of non-randomized clinical trials.

Multidetector CT of blunt traumatic venous injuries in the chest, abdomen, and pelvis.

Venous injuries as a result of blunt trauma are rare. Even though current protocols for multidetector computed tomography (CT) of patients with trauma are designed to evaluate primarily the solid organs and arteries, blunt venous injuries may nevertheless be identified, or at least suspected, on the basis of the multidetector CT findings. Venous injuries are associated with high morbidity and mortality rates. Diagnosis of a possible venous injury is crucial because the physical findings of a venous injury are nonspecific and may be absent. This article aims to make the radiologist aware of various venous injuries caused by blunt trauma and to provide helpful hints to aid in the identification of venous injuries. Multidetector CT technology, in combination with interactive manipulation of the raw dataset, can be useful in the creation of multiplanar reconstructed images and in the identification of a venous injury caused by blunt trauma. Familiarity with direct and indirect signs of venous injuries, as well as with examples of blunt traumatic venous injuries in the chest, abdomen, and pelvis, will help in the diagnosis of these injuries.

Characteristics and Outcomes of Percutaneous Biliary Interventions in the United States.

OBJECTIVE: To explore baseline characteristics, comorbidities, and clinical diagnoses in the prediction of outcomes for inpatient percutaneous biliary interventions in the United States. METHODS: Hospitalizations for percutaneous transhepatic cholangiography and percutaneous biliary drainage were studied using the National Inpatient Sample 2012 to 2015. Associations between baseline characteristics, comorbidities, clinical diagnoses, and outcomes were analyzed using multivariable regression modeling. Regional variations were studied in an exploratory analysis. RESULTS: Hospitalizations for percutaneous biliary interventions had average inpatient mortality of 3.8% ± 0.8% and length of stay of 7.6 ± 0.3 days. Hypertension was the most common comorbidity (50.5% ± 0.8%), and paralysis was associated with the highest inpatient mortality (19.1% ± 5.7%) and length of stay (11.4 ± 1.3 days). Compared with nonmalignant biliary-pancreatic disorders, sepsis was associated with the highest inpatient mortality (6.5% ± 1.1%; adjusted odds ratio [aOR]: 5.2 [3.9-7.0]) and length of stay (9.0 ± 3.0 days; aOR: 2.2 [1.9-2.5]), followed by underlying malignancy (mortality of 5.5% ± 0.6%; aOR: 2.3 [1.7-3.0]; length of stay of 8.3 ± 0.2 days; aOR: 1.6 [1.4-1.8]). The observed associations were independent of baseline characteristics and comorbidities. With regard to regional variations, the Middle Atlantic states had the lengthiest hospital stays (38.8% ± 2.0% >8 days) and the East South Central states had the highest inpatient mortality (6.6% ± 1.6%) while having the highest frequency of malignancy (37.9% ± 3.7%) and the lowest frequency of postoperative cases (15.2% ± 2.4%). CONCLUSION: In addition to baseline characteristics and comorbidities, sepsis and malignancy were determinants of higher mortality and increased length of stay in hospitalizations for percutaneous biliary interventions. We observed significant regional variations in clinical diagnoses and outcomes across the United States.

Inferior Vena Cava Filters: Why, Who, and for How Long?

Vena cava filters are implantable devices that are placed to trap thrombus originating in the lower extremities and prevent it from migrating to the lungs. In general, inferior vena cava (IVC) filters are indicated for patients who cannot receive anticoagulation. Other indications for IVC filtration are less clear, and guidelines vary. All patients who have a retrievable IVC filter should be followed, and the removal of the IVC filter should be considered once its indication is lost.

Vena Cava Filter Retrieval with Aorto-Iliac Arterial Strut Penetration.

PURPOSE: To evaluate the safety and technical success of inferior vena cava (IVC) filter retrieval in the setting of aorto-iliac arterial strut penetration. MATERIALS AND METHODS: IVC filter registries from six large United States IVC filter retrieval practices were retrospectively reviewed to identify patients who underwent IVC filter retrieval in the setting of filter strut penetration into the adjacent aorta or iliac artery. Patient demographics, implant duration, indication for placement, IVC filter type, retrieval technique and technical success, adverse events, and post procedural clinical outcomes were identified. Arterial penetration was determined based on pre-procedure CT imaging in all cases. The IVC filter retrieval technique used was at the discretion of the operating physician. RESULTS: Seventeen patients from six US centers who underwent retrieval of an IVC filter with at least one strut penetrating either the aorta or iliac artery were identified. Retrieval technical success rate was 100% (17/17), without any major adverse events. Post-retrieval follow-up ranging from 10 days to 2 years (mean 4.6 months) was available in 12/17 (71%) patients; no delayed adverse events were encountered. CONCLUSIONS: Findings from this series suggest that chronically indwelling IVC filters with aorto-iliac arterial strut penetration may be safely retrieved.

Preoperative Epoxy Embolization Facilitates the Safe and Effective Resection of Venous Malformations in the Hand and Forearm.

BACKGROUND: The standard of care for treatment of low-flow venous malformations (VMs) is percutaneous sclerotherapy. These lesions are seldom surgically resected, especially if the malformation is in an anatomically difficult location. Percutaneous sclerotherapy is safe and effective. However, the drawbacks to sclerotherapy are the need for repeated treatments and risks of skin ulceration, deep venous thrombosis, scarring/contractures, and nerve damage. Surgical resection can be difficult because of intraoperative bleeding, intraoperative lesional decompression, and difficulty in localization. METHODS: We describe our initial experience with 11 patients who underwent surgical resection of VMs located in the hand and forearm after preembolization of 27 total sites using n-butyl-cyanoacrylate or ethylene vinyl alcohol copolymer. RESULTS: Of the 11 patients treated, 5 had focal VMs, 3 had multifocal VMs, and 3 had diffuse VMs throughout the affected extremity. Four of the 5 patients with focal VMs were followed for at least 1 year, and no further treatment was required. All 3 of the patients with diffuse VMs have required ongoing treatment. No major functional impairments were reported, and there were no major procedure-related complications. CONCLUSIONS: Overall, embolization of the malformation before surgical resection facilitated localization, demarcation, and removal of the lesion.

ACR Appropriateness Criteria® Nonvariceal Upper Gastrointestinal Bleeding.

Upper gastrointestinal bleeding (UGIB) remains a significant cause of morbidity and mortality with mortality rates as high as 14%. This document addresses the indications for imaging UGIB that is nonvariceal and unrelated to portal hypertension. The four variants are derived with respect to upper endoscopy. For the first three, it is presumed that upper endoscopy has been performed, with three potential initial outcomes: endoscopy reveals arterial bleeding source, endoscopy confirms UGIB without a clear source, and negative endoscopy. The fourth variant, "postsurgical and traumatic causes of UGIB; endoscopy contraindicated" is considered separately because upper endoscopy is not performed. When endoscopy identifies the presence and location of bleeding but bleeding cannot be controlled endoscopically, catheter-based arteriography with treatment is an appropriate next study. CT angiography (CTA) is comparable with angiography as a diagnostic next step. If endoscopy demonstrates a bleed but the endoscopist cannot identify the bleeding source, angiography or CTA can be typically performed and both are considered appropriate. In the event of an obscure UGIB, angiography and CTA have been shown to be equivalent in identifying the bleeding source; CT enterography may be an alternative to CTA to find an intermittent bleeding source. In the postoperative or traumatic setting when endoscopy is contraindicated, primary angiography, CTA, and CT with intravenous contrast are considered appropriate. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.