Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism.

PURPOSE: To report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). MATERIALS AND METHODS: In a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years. RESULTS: The composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was 0% (n = 126) through 1 year and 2.4% (n = 85) through the second year of follow-up, with 2 new nonfatal cases at 581 and 624 days that were adjudicated as not related to the procedure or device. Two patients (1.6%) developed symptomatic caval thrombosis during the first month and underwent successful interventions without recurrence. No other filter-related symptomatic complications occurred through 2 years. There was no filter tilting, migration, embolization, fracture, or caval perforation and no filter-related deaths through 2 years. Filter bioconversion was successful for 95.7% (110/115) of patients at 6 months, 96.4% (106/110) of patients at 12 months, and 96.5% (82/85) of patients at 24 months. Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms. CONCLUSIONS: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 2 years of follow-up.

Survival Outcomes of Very Small Drug-Eluting Beads Used in Chemoembolization of Unresectable Hepatocellular Carcinoma.

PURPOSE: To assess the safety and efficacy of transarterial chemoembolization using a 75-µm drug-eluting embolic (DEE) in patients with unresectable hepatocellular carcinoma (HCC). MATERIALS AND METHODS: The medical records of 109 patients with a mean age of 64.1 years (range 85-49) treated for unresectable HCC between November 2013 and August 2016 with transarterial chemoembolization using a 75-µm DEE were retrospectively reviewed. Patients who had prior therapy for HCC were excluded. Child-Pugh A patients and Barcelona Clinic Liver Cancer stages A/B patients constituted 68.8% and 65.1% of the patients, respectively. The mean size of the index tumors was 5.8 cm (range 18.5-1.2) with 42 (39%) patients with central tumors around the porta-hepatis region. Portal vein invasion was seen in 10 (9.2%) patients. Tumor response was categorized according to the modified Response Evaluation Criteria in Solid Tumors 1.1, and the toxicity profile was assessed using Common Terminology Criteria for Adverse Events, version 4.03. RESULTS: At 1-month follow-up, complete response, objective response, and disease control was seen in 23%, 66%, and 90%, respectively. The median progression-free survival was 11.2 months. The median overall survival was 25.1 months (33.4 months for Child-Pugh A and 28.2 months for Barcelona Clinic Liver Cancer stages A/B), and transplant-free survival was 21.3 months. The 6-, 12-, and 24-month survivals were 91.7%, 75.5%, and 50.5%, respectively. Grade 3 toxicity was seen in 1.8% of the patients; no grade 4 or 5 toxicity was reported. CONCLUSIONS: Transarterial chemoembolization using 75-µm DEE is safe and efficacious in the treatment of HCC.

One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter.

PURPOSE: To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). MATERIALS AND METHODS: At 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, filter bioconversion, and incidence of PE and filter-related complications through 12 months. RESULTS: Clinical success was achieved in 111 of 114 evaluable patients (97.4%, 95% confidence interval [CI] 92.5%-99.1%). The rate of freedom from new symptomatic PE through 60 days was 100% (n = 129, 95% CI 97.1%-100.0%), and there were no cases of PE through 12 months for either therapeutic or prophylactic indications. Two patients (1.6%) developed symptomatic caval thrombosis during the first month; neither experienced recurrence after successful interventions. There was no filter tilting, migration, embolization, fracture, or caval perforation by the filter, and no filter-related death through 12 months. Filter bioconversion was successful for 95.7% (110/115) at 6 months and for 96.4% (106/110) at 12 months. CONCLUSIONS: The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 12 months of imaging-intense follow-up.

Chemoembolization of Hepatocellular Carcinoma with Extrahepatic Collateral Blood Supply: Anatomic and Technical Considerations.

Transarterial chemoembolization (TACE) is considered a standard local-regional treatment for intermediate-stage hepatocellular carcinoma (HCC) and the most common bridging therapy. This treatment is offered to more than 70% of patients who are on the waiting list for liver transplantation in the United States. HCC typically receives its blood supply from the hepatic artery; however, it can recruit a parasitic supply from extrahepatic collateral (EHC) arteries. The development of an EHC arterial blood supply can interfere with the therapeutic efficacy of TACE and result in treatment failure and poor outcome. Cross-sectional imaging-specifically computed tomography and magnetic resonance imaging-has some limitations in depicting the presence or absence of an EHC arterial supply during the pre-TACE evaluation. Catheterization and angiography of every possible EHC artery during a routine TACE procedure would be time consuming and technically challenging and would not always be feasible. Therefore, the prediction of a potential EHC arterial supply on the basis of tumor location before, during, and after TACE is fundamental to achieving optimal therapeutic efficacy. To perform TACE through EHC arteries, special considerations are necessary to avoid potentially serious complications. The authors review the factors influencing the development of an EHC arterial blood supply to HCC and describe a systematic approach to enhance the ability to predict the presence of EHC arteries. They also describe the proper technique for TACE of each EHC artery and how to avoid potential technique-related complications. ©RSNA, 2017.

Adjuvant stereotactic body radiotherapy following transarterial chemoembolization in patients with non-resectable hepatocellular carcinoma tumours of ≥ 3 cm.

OBJECTIVES: The optimal locoregional treatment for non-resectable hepatocellular carcinoma (HCC) of ≥ 3 cm in diameter is unclear. Transarterial chemoembolization (TACE) is the initial intervention most commonly performed, but it rarely eradicates HCC. The purpose of this study was to measure survival in HCC patients treated with adjuvant stereotactic body radiotherapy (SBRT) following TACE. METHODS: A retrospective study of patients with HCC of ≥ 3 cm was conducted. Outcomes in patients treated with TACE alone (n = 124) were compared with outcomes in those treated with TACE + SBRT (n = 37). RESULTS: There were no significant baseline differences between the two groups. The pre-TACE mean number of tumours (P = 0.57), largest tumour size (P = 0.09) and total tumour diameter (P = 0.21) did not differ significantly between the groups. Necrosis of the HCC tumour, measured after the first TACE, did not differ between the groups (P = 0.69). Local recurrence was significantly decreased in the TACE + SBRT group (10.8%) in comparison with the TACE-only group (25.8%) (P = 0.04). After censoring for liver transplantation, overall survival was found to be significantly increased in the TACE + SBRT group compared with the TACE-only group (33 months and 20 months, respectively; P = 0.02). CONCLUSIONS: This retrospective study suggests that in patients with HCC tumours of ≥ 3 cm, treatment with TACE + SBRT provides a survival advantage over treatment with only TACE. Confirmation of this observation requires that the concept be tested in a prospective, randomized clinical trial.

Computed tomography predictors of hepatocellular carcinoma tumour necrosis after chemoembolization.

BACKGROUND: Radiographical features associated with a favourable response to trans-arterial chemoembolization (TACE) are poorly defined for patients with hepatocellular carcinoma (HCC). METHODS: From 2008 to 2012, all first TACE interventions for HCC performed at the University of Alabama at Birmingham (UAB) were retrospectively reviewed. Only patients with a pre-TACE and a post-TACE computed tomography (CT) scan were included in the analyses (n = 115). HCC tumour response to TACE was quantified via the the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. Univariate and multivariable analyses were constructed. RESULTS: The index HCC tumours experienced a > 90% or complete tumour necrosis in 59/115 (51%) of patients after the first TACE intervention. On univariate analysis, smaller tumour size, peripheral tumour location and arterial enhancement were associated with a > 90% or complete tumour necrosis, whereas, only smaller tumour size [odds ratio (OR) 0.62; 95% confidence interval (CI) 0.48, 0.81] and peripheral location (OR 6.91; 95% CI 1.75, 27.29) were significant on multivariable analysis. There was a trend towards improved survival in the patients that experienced a > 90% or complete tumour necrosis (P = 0.08). CONCLUSIONS: Peripherally located smaller HCC tumours are most likely to experience a > 90% or complete tumour necrosis after TACE. Surprisingly, arterial-phase enhancement and portal venous-phase washout were not significantly predictive of TACE-induced tumour necrosis. The TACE response was not statistically associated with improved survival.

Predictors of repeat transarterial chemoembolization in the treatment of hepatocellular carcinoma.

OBJECTIVES: Repeat transarterial chemoembolization (TACE) is a common intervention performed for hepatocellular carcinoma (HCC). The aim of this study was to identify predictors of the need for repeat TACE. METHODS: Between 2008 and 2012, data on patient and tumour variables were collected for 262 patients treated with a first TACE procedure for HCC. The decision to perform repeat TACE procedures was made at the completion of the first TACE or after follow-up imaging demonstrated the subtotal treatment of HCC tumours. RESULTS: Repeat TACE was performed in 67 of 262 (25.6%) patients. Necrosis of HCC, measured after the first TACE, was lower in patients who subsequently received repeat TACE (P = 0.042). On multivariable analysis, total tumour diameter of >5 cm [odds ratio (OR) 2.76, 95% confidence interval (CI) 1.45-5.25; P = 0.002] and increasing age (OR 1.04/year, 95% CI 1.00-1.07; P = 0.030) were predictive of the need for repeat TACE. Measures of liver function and TACE approach (selective versus non-selective) were not predictive of repeat TACE. Median survival did not differ significantly between patients who did (median survival: 21.1 months) and did not (median survival: 26.1 months) receive a repeat TACE procedure (P = 0.574). CONCLUSIONS: The requirement for repeat TACE is associated with older age, increased HCC tumour burden and subtotal TACE-induced HCC necrosis. Importantly, repeat TACE was not associated with reduced survival.

Chemoembolization outcomes for hepatocellular carcinoma in cirrhotic patients with compromised liver function.

BACKGROUND: Transarterial chemoembolization (TACE) is recommended as a treatment for unresectable hepatocellular carcinoma (HCC) in patients with normal underlying liver function. The efficacy of TACE in cirrhotic patients with compromised liver function is unknown. METHODS: All 'first' TACE interventions for HCC performed at a single institution from 2008 to 2012 were retrospectively reviewed (n = 190). Liver function was quantified via the Child's score. Tumour necrosis after TACE was quantified via the mRECIST criteria. RESULTS: The 'first' TACE procedures of 100 Child's A and 90 Child's B/C cirrhotic patients were evaluated. As expected, the lab-model for end-stage liver disease (MELD) score was significantly higher in the Child's B/C group. Although the number of tumours were similar between the groups, both the size of the largest tumour and the total tumour diameter were greater in the Child's A group. There were no significant differences in post-TACE tumour necrosis between groups. The median survival after TACE was significantly longer in the Child's A compared with Child's B/C patients (21.9 versus 13.7 months, P = 0.03). CONCLUSIONS: TACE appears to be equally efficacious in cirrhotic patients regardless of their Child's classification based upon equivalent mRECIST measures of tumour necrosis. However, inferior survival after TACE was observed in the Child's B/C group.

A phase I clinical trial of Ad5/3-Δ24, a novel serotype-chimeric, infectivity-enhanced, conditionally-replicative adenovirus (CRAd), in patients with recurrent ovarian cancer.

OBJECTIVE: The conditionally replicative adenovirus Ad5/3-Δ24 has a type-3 knob incorporated into the type-5 fiber that facilitates enhanced ovarian cancer infectivity. Preclinical studies have shown that Ad5/3-Δ24 achieves significant oncolysis and anti-tumor activity in ovarian cancer models. The purpose of this study was to evaluate in a phase I trial the feasibility and safety of intraperitoneal (IP) Ad5/3-Δ24 in recurrent ovarian cancer patients. METHODS: Eligible patients were treated with IP Ad5/3-Δ24 for 3 consecutive days in one of three dose cohorts ranging 1 × 10(10)-1 × 10(12)vp. Toxicity was assessed utilizing CTC grading and efficacy with RECIST. Ascites, serum, and other samples were obtained to evaluate gene transfer, generation of wildtype virus, viral shedding, and antibody response. RESULTS: Nine of 10 patients completed treatment per protocol. A total of 15 vector-related adverse events were experienced in 5 patients. These events included fever or chills, nausea, fatigue, and myalgia. All were grades 1-2 in nature, transient, and medically managed. Of the 8 treated patients evaluable for response, six patients had stable disease and 2 patients had progressive disease. Three patients had decreased CA-125 from pretreatment levels one month after treatment. Ancillary biologic studies indicated Ad5/3-Δ24 replication in patients in the higher dose cohorts. All patients experienced an anti-adenoviral neutralizing antibody effect. CONCLUSIONS: This study suggests the feasibility and safety of a serotype chimeric infectivity-enhanced CRAd, Ad5/3-Δ24, as a potential therapeutic option for recurrent ovarian cancer patients.

Outcomes of transjugular intrahepatic portosystemic shunt using 12 mm diameter polytetrafluoroethylene covered stents in cirrhotic patients with portal hypertension.

PURPOSE We aimed to evaluate the safety and efficacy of 12 mm diameter polytetrafluoroethylene (PTFE)- covered stents for the creation of transjugular intrahepatic portosystemic shunt (TIPS) in cir- rhotic patients with portal hypertension complicated by variceal bleeding and volume-overload. METHODS This retrospective study included 360 patients who had TIPS created between January 2004 and December 2017 using 12 mm diameter PTFE-covered stents. Demographic data, model for end- stage liver disease (MELD) score, etiology of cirrhosis, and Charlson comorbidity index were recorded. Symptoms of hepatic encephalopathy (HE), variceal re-bleeding, improvement in vol- ume-overload, TIPS revisions and the need for intervention, and overall survival were assessed. RESULTS The mean age of the patients was 56.8 ± 9.9 years, and the technical success rate was 99.4%. The rates of improvement of volume-overload post-TIPS were 59.5%, 69.8%, and 81.7% at 3, 6, and 12 months, respectively. About 93.3% of patients were free from paracentesis or thoracentesis at 12 months. The rates of re-bleeding post-TIPS were 4%, 12%, and 12.9% at 3, 6, and 12 months, respectively. The rate of TIPS revision at 12 months was 6.5%. Percentage of patients with any symptoms of HE were 34.4%, 42.9%, and 49.5% at 3, 6, and 12 months, respectively. All HE were appropriately medically managed and no patients required a TIPS reduction. CONCLUSION TIPS placement using 12 mm PTFE-covered stents is efficacious in cirrhotic patients with portal hypertension complicated by variceal bleeding or refractory volume-overload, with an accept- able safety profile.

Treatment of acute inferior vena cava and iliac vein thrombosis with pharmacomechanical thrombectomy using simultaneously operating "kissing" Trellis-8 thrombolysis catheters.

PURPOSE: To present a new endovascular technique for treating acute large thrombus burden in the iliocaval venous system. TECHNIQUE: This method is demonstrated in a 62-year-old man with end-stage renal disease on hemodialysis who had a nonfunctioning right femoral dialysis catheter that was placed 3 month earlier. After catheter removal, venography demonstrated significant thrombus in the inferior vena cava (IVC) and both iliac veins. The patient was treated successfully using two simultaneously operating Trellis-8 thrombolysis catheters placed side-by-side in the IVC and both iliac veins in a "kissing" configuration. CONCLUSION: This technique was able to effectively debulk acute large thrombus burden in the iliocaval system in a single session and preserve the patient's available hemodialysis access. The technique has the potential to minimize morbidity, duration of hospital stay, and overall cost of treatment.

Endovascular Management of Neurofibromatosis Type I-Associated Vasculopathy: A Case Series and Brief Review of the Literature.

PURPOSE: Neurofibromatosis type 1 (NF1) is an autosomal-dominant disorder found in approximately 1 of every 3000 individuals. Neurofibromatosis type 1 can have vascular manifestations including aneurysms, stenoses, and arteriovenous malformations. The purpose of this article is to describe the clinical manifestations of NF1 vasculopathy, discuss therapeutic options, and highlight endovascular therapies from our institutional experience. MATERIALS AND METHODS: The radiology information system was searched for cases of NF1. Cases with vasculopathy managed with endovascular therapies were included. Demographics, clinical histories, procedural details, and outcomes were recorded. A review of the literature for the management strategies of NF1 vasculopathy was performed. RESULTS: Two pediatric patients with NF1 were identified, both of whom presented with hypertension found to be secondary to renal artery stenosis. One of the patients also had infrarenal aortic narrowing. Both patients were successfully treated with balloon angioplasty, resulting in improved blood pressures. The review of the literature identified case series of pharmacologic, surgical, and endovascular therapies, although, endovascular therapies appear to be preferred due to lower morbidity and mortality. CONCLUSIONS: NF1 vasculopathy is a rare condition that most often presents with hypertension due to renal artery stenosis. In these situations, endovascular management is the preferred approach.

Occlusion time for Amplatzer vascular plug in the management of pulmonary arteriovenous malformations.

OBJECTIVE: The occlusion time, that is, the interval between device deployment and complete occlusion of the vessel, associated with the use of embolic devices influences the risk of embolic complications caused by small clots that can form over the surface of a device and break away. The purpose of our study was to determine the time for an Amplatzer vascular plug to bring about percutaneous transcatheter occlusion of a pulmonary arteriovenous malformation (PAVM). MATERIALS AND METHODS: We retrospectively studied the occlusion times of Amplatzer vascular plugs in the management of 12 PAVMs. We recorded the number, location, type (simple or complex), and diameter and number of feeding arteries of PAVMs; the number and size of devices needed to occlude each PAVM; and the occlusion time for each PAVM. The occlusion time is the time interval from device placement to complete occlusion of the PAVM. Occlusion time was determined by recording the time between acquisition of the first angiographic image after deployment of the device and the angiogram that showed total occlusion of the PAVM. The relevant literature on the subject was reviewed. RESULTS: All PAVMs managed were supplied by a single feeding artery. The average diameter of the feeding arteries was 4.8 mm (range, 3.0-11.2 mm). All PAVMs were occluded by deployment of a single Amplatzer vascular plug. Vascular plug sizes ranged from 4 to 16 mm. The mean occlusion time was 3 minutes 20 seconds (range, 1 minute 49 seconds-5 minutes 16 seconds). There were no immediate complications, including air embolism and thromboembolism. CONCLUSION: The occlusion time determined in our study and the need to place only one Amplatzer vascular plug in each feeding artery to achieve complete occlusion in most cases suggest that the device is safe for management of PAVM with no increased risk of systemic embolization. The use of the Amplatzer vascular plug for PAVM embolization is a relatively recent development. Long-term follow-up studies are needed to assess recanalization rates, radiation exposure rates, and risk of device migration.

Fluoroscopic and sonographic guidance to place peritoneal catheters: how we do it.

OBJECTIVE: The purpose of this article is to detail a percutaneous approach to placing peritoneal catheters using sonographic and fluoroscopic guidance. Fluoroscopic-assisted placement of these catheters has been previously described in the literature. We emphasize the use of additional sonographic guidance, including color Doppler sonography, to determine the safest puncture site and to guide the initial needle puncture to avoid bowel perforation and injury to the epigastric artery. CONCLUSION: Imaging-guided-that is, sonography plus fluoroscopy-percutaneous placement of peritoneal catheters is a safe, minimally invasive, and effective alternative to blind or open surgical placement. The use of sonographic guidance together with fluoroscopic assistance makes placement of peritoneal catheters a safer and effective alternative to blind or open surgical placement.

Approaches for safe transarterial chemoembolization of multifocal hepatocellular carcinoma with retrograde flow in a retroportal artery.

We report a case of an 81-year-old woman with multifocal hepatocellular carcinoma who underwent transarterial chemoembolization. The patient had significant superior mesenteric artery (SMA) ostial stenosis, which led to retrograde flow in the retroportal artery to the SMA. The authors adopted several approaches to avoid potential nontarget embolization that might result from the change in the hemodynamics in the hepatoenteric arteries by initially stenting the SMA ostial stenosis as well as the use of the Surefire infusion system and balloon occlusion for delivery of chemoembolization material to tumors in the hepatic lobes. To our knowledge, the collective use of these approaches to avoid potential risks related to SMA ostial stenosis and retrograde flow in a retroportal artery has not been previously described in the literature.

Persistent Pulmonary Arteriovenous Malformations: Percutaneous Embolotherapy.

Pulmonary arteriovenous malformations (PAVM) are an uncommon entity that interventional radiologists may face in their clinical practice. Many of these lesions are treated successfully using endovascular techniques with satisfactory long-term results. However, some PAVMs respond poorly to initial interventional techniques. This article reviews the signs and symptoms of persistent PAVMs, illustrates different imaging modalities used to diagnose these lesions, and outlines mechanisms by which these lesions may persist. The article highlights techniques and embolic agents used for percutaneous transcatheter embolotherapy of persistent PAVMs and discuss the outcomes of these interventions.

Current guidelines for chemoembolization for hepatocellular carcinoma: Room for improvement?

Transarterial chemoembolization (TACE) is the most common oncologic therapy used according to the American Association for the Study of Liver Diseases (AASLD) guidelines established in 2005, revised in 2011. The purpose of this study was to determine how AASLD criteria for the management of hepatocellular carcinoma (HCC) have impacted TACE practice in the community. Clinical, demographic, and cause of death information were collected for patients diagnosed with HCC in the 2012 linkage of the Surveillance, Epidemiology, and End Results Medicare database. Propensity score survival analysis was used to compare survival outcomes in patients whose HCC tumor characteristics were less than, met, or were beyond AASLD criteria. The proportion of patients with HCC receiving TACE who met the AASLD-recommended criteria increased after the 2005 guidelines were published. Up to 17% of patients treated with TACE had tumor characteristics less than the AASLD criteria and were not offered potentially curative therapies. Propensity score matching demonstrated the largest survival advantage in patients with HCC whose tumor characteristics met the AASLD criteria (hazard ratio, 0.42; 95% confidence interval, 0.38-0.47). A significant survival advantage was also observed in patients with HCC whose tumor characteristics exceeded the AASLD criteria. Conclusion: The AASLD criteria successfully identify a population of patients with HCC that maximally benefit from TACE therapy. However, patients with HCC with tumor characteristics beyond the AASLD criteria also appear to receive a significant survival advantage with TACE. Further studies are necessary to improve referral patterns and appropriate use of chemoembolization in the management of unresectable HCC. (Hepatology Communications 2017;1:338-346).

Embolization of congenital intercostobronchial trunk-pulmonary artery fistula using Amplatzer vascular plugs.

We present the case of a 54-year-old male patient diagnosed with a right upper lobe lung cancer and was referred for resection. Positron emission tomography-computed tomography scan showed a prominent vascular structure in the right lung, suspicious for vascular malformation. A computed tomography angiography was done, demonstrating an intercostobronchial trunk-pulmonary artery fistula. There was also non-tapering dilated wandering pulmonary artery coursing through the right lower lung without any abnormal connection with pulmonary veins and were supplying normal lung parenchyma. Amplatzer vascular plugs were used for the treatment of the intercostobronchial trunk-pulmonary artery fistula. Our case highlights these very rare vascular anomalies, and their management.