Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months.

OBJECTIVE: To determine the safety and effectiveness of vena cava filters (VCFs). METHODS: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. RESULTS: VCFs were implanted in 1421 patients. Of these, 1019 (71.7%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6%). One hundred twenty-six (8.9%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4%) patients' computed tomography scans available to the core laboratory, and of which only 3 (0.2%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5%), including DVT (80 events in 74 patients [5.2%]), PE (23 events in 23 patients [1.6%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1%]). No PE occurred in patients following prophylactic placement. CONCLUSIONS: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months.

OBJECTIVE: To determine the safety and effectiveness of vena cava filters (VCFs). METHODS: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. RESULTS: VCFs were implanted in 1421 patients. Of these, 1019 (71.7%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6%). One hundred twenty-six (8.9%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4%) patients' computed tomography scans available to the core laboratory, and of which only 3 (0.2%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5%), including DVT (80 events in 74 patients [5.2%]), PE (23 events in 23 patients [1.6%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1%]). No PE occurred in patients following prophylactic placement. CONCLUSIONS: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.

Outcomes and toxicity following Yttrium-90 radioembolization for hepatic metastases from neuroendocrine tumors-a single-institution experience.

BACKGROUND: The prognosis of patients with hepatic metastases from neuroendocrine tumors (NET) is generally good, and radioembolization with Yttrium-90 microspheres is a locoregional therapy that is used in efforts to improve hepatic disease control and survival. This study aims to describe the survival outcomes and toxicities associated with radioembolization for hepatic-predominant metastatic NET in a large single-institution cohort. METHODS: A total of 59 patients underwent radioembolization for metastatic NET with hepatic predominant disease at a single academic center. Patient outcomes were analyzed by Kaplan-Meier survival analysis and toxicities were detailed and described. Ten patients within the cohort underwent post-treatment dosimetric analysis using PET-MRI and normal liver dosimetry was correlated with hepatic fibrosis and toxicity. RESULTS: Median overall survival from time of radioembolization in the patient cohort was 31 months, and the 1- and 2-year overall survival was 80.4% and 65.6% respectively. Median hepatic progression-free survival and overall progression-free survival were 18 and 13 months, respectively. Three patients died of hepatic failure that was possibly therapy-related. Ten patients underwent evaluation of post-treatment dosimetry following radioembolization. In patients who did not develop hepatotoxicity or hepatic fibrosis, mean dose to normal liver was 25.4 Gy, while the mean liver dose in patients who experienced toxicity (hepatic fibrosis in n=2 and death from hepatic failure in n=1) was 59.1 Gy. CONCLUSIONS: Overall survival following radioembolization for hepatic metastases from NET is excellent; however, deaths that are potentially treatment-related have been observed. Preliminary data regarding dose to normal liver is suggestive of a relation between dosimetry and toxicity, however further work is required to further elucidate the mechanism, correlation with dosimetry, as well as additional patient and tumor factors that may predispose these patients to toxicity.

Predictors of Survival after Yttrium-90 Radioembolization for Colorectal Cancer Liver Metastases.

PURPOSE: To identify clinical parameters that are prognostic for improved overall survival (OS) after yttrium-90 radioembolization (RE) in patients with liver metastases from colorectal cancer (CRC). MATERIALS AND METHODS: A total of 131 patients who underwent RE for liver metastases from CRC, treated at 2 academic centers, were reviewed. Twenty-one baseline pretreatment clinical factors were analyzed in relation to OS by the Kaplan-Meier method along with log-rank tests and univariate and multivariate Cox regression analyses. RESULTS: The median OS from first RE procedure was 10.7 months (95% confidence interval [CI], 9.4-12.7 months). Several pretreatment factors, including lower carcinoembryonic antigen (CEA; ≤20 ng/mL), lower aspartate transaminase (AST; ≤40 IU/L), neutrophil-lymphocyte ratio (NLR) <5, and absence of extrahepatic disease at baseline were associated with significantly improved OS after RE, compared with high CEA (>20 ng/mL), high AST (>40 IU/L), NLR ≥5, and extrahepatic metastases (P values of <.001, <.001, .0001, and .04, respectively). On multivariate analysis, higher CEA, higher AST, NLR ≥5, extrahepatic disease, and larger volume of liver metastases remained independently associated with risk of death (hazard ratios of 1.63, 2.06, 2.22, 1.48, and 1.02, respectively). CONCLUSIONS: The prognosis of patients with metastases from CRC is impacted by a complex set of clinical parameters. This analysis of pretreatment factors identified lower AST, lower CEA, lower NLR, and lower tumor burden (intra- or extrahepatic) to be independently associated with higher survival after hepatic RE. Optimal selection of patients with CRC liver metastases may improve survival rates after administration of yttrium-90.

Assessment of the Albumin-Bilirubin (ALBI) Grade as a Prognostic Indicator for Hepatocellular Carcinoma Patients Treated With Radioembolization.

OBJECTIVE: As the utility of Child-Pugh (C-P) class is limited by the subjectivity of ascites and encephalopathy, we evaluated a previously established objective method, the albumin-bilirubin (ALBI) grade, as a prognosticator for yttrium-90 radioembolization (RE) treatment for patients with hepatocellular carcinoma (HCC). MATERIALS AND METHODS: A total of 117 patients who received RE for HCC from 2 academic centers were reviewed and stratified by ALBI grade, C-P class, and Barcelona Clinic Liver Cancer stage. The overall survival (OS) according to these 3 criteria was evaluated by Kaplan-Meier survival analysis. The utilities of C-P class and ALBI grade as prognostic indicators were compared using the log-rank test. Multivariate Cox regression analysis was performed to identify additional predictive factors. RESULTS: Patients with ALBI grade 1 (n=49) had superior OS than those with ALBI grade 2 (n=65) (P=0.01). Meanwhile, no significant difference was observed in OS between C-P class A (n=100) and C-P class B (n=14) (P=0.11). For C-P class A patients, the ALBI grade (1 vs. 2) was able to stratify 2 clear and nonoverlapping subgroups with differing OS curves (P=0.03). Multivariate Cox regression test identified alanine transaminase, Barcelona Clinic Liver Cancer stage, and ALBI grade as the strongest prognostic factors for OS (P<0.10). CONCLUSIONS: ALBI grade as a prognosticator has demonstrated clear survival discrimination that is superior to C-P class among HCC patients treated with RE, particularly within the subgroup of C-P class A patients. ALBI grade is useful for clinicians to make decisions as to whether RE should be recommended to patients with HCC.

Balloon occlusion retrograde transvenous obliteration of gastric varices in two non-cirrhotic patients with portal vein thrombosis.

This report describes two non-cirrhotic patients with portal vein thrombosis who underwent successful balloon occlusion retrograde transvenous obliteration (BRTO) of gastric varices with a satisfactory response and no complications. One patient was a 35-year-old female with a history of Crohn's disease, status post-total abdominal colectomy, and portal vein and mesenteric vein thrombosis. The other patient was a 51-year-old female with necrotizing pancreatitis, portal vein thrombosis, and gastric varices. The BRTO procedure was a useful treatment for gastric varices in non-cirrhotic patients with portal vein thrombosis in the presence of a gastrorenal shunt.

From the angio suite to the γ-camera: vascular mapping and 99mTc-MAA hepatic perfusion imaging before liver radioembolization--a comprehensive pictorial review.

Endovascular mapping and conjoint (99m)Tc-macroaggregated albumin ((99m)Tc-MAA) hepatic perfusion imaging provide essential information before liver radioembolization with (90)Y-loaded microspheres in patients with primary and secondary hepatic malignancies. The aims of this integrated procedure are to determine whether there is a risk for excessive shunting of (90)Y-microspheres to the lungs; to detect extrahepatic perfusion emerging from the injected vascular territory, which might lead to nontargeted radioembolization; to reveal incomplete coverage of the liver parenchyma involved by the tumor, which may be related to anatomic or acquired variants of the arterial vasculature; and to aid in calculation of the (90)Y-microsphere dose to be delivered to the liver. This pictorial essay presents an integrated comprehensive review of the anatomic, angiographic, and nuclear imaging aspects of planned liver radioembolization. The relevant anatomy of the liver, including the standard and the variant arterial vasculature, will be shown using digital subtraction angiography, SPECT/CT, contrast-enhanced CT, and anatomic illustrations. Technical details that will optimize the imaging protocols and important imaging findings will be discussed. From the angio suite to the γ-camera-the goal of this review is to help the reader better understand how the technical details of the angiographic procedure are reflected in the imaging findings of the (99m)Tc-MAA hepatic perfusion study. In addition, the reader should learn to better recognize the pertinent findings and their clinical implications. This knowledge will enable the reader to provide a more useful interpretation of this complex multidisciplinary procedure.

Uteroenteric fistula after uterine artery embolization.

BACKGROUND: Uterine artery embolization is a common procedure for symptomatic leiomyomas and is being used as a less invasive alternative to a hysterectomy. This is a report of an uteroenteric fistula after uterine artery embolization. CASE: A 50-year-old woman developed an uteroenteric fistula that was seen on a computed tomography scan 6 months after she had an uncomplicated uterine artery embolization for symptomatic leiomyomas. She was managed surgically with a hysterectomy and small bowel resection with reanastomosis. CONCLUSION: Uteroenteric fistula can occur as a complication of uterine artery embolization for leiomyoma management.

Nephroureteral stents: principles and techniques.

Nephroureteral stents including antegrade, retrograde, or internal (double-J) stents are routinely placed by interventional radiologists. The purpose of this review is to provide a detailed and comprehensive description of indications, contraindications, technique, and various technical challenges of these procedures. Also pre- and postprocedure management of patients will be discussed including routine follow-up and dealing with potential complications.

Ureteral interventions.

The pelvic course of the ureter with its close proximity to the iliac artery, pelvic viscera, and other structures predispose to fistula formation. Surgical management of lower urinary tract fistulas is difficult and often ineffective. Nonvascular lower urinary tract fistulas can be managed by urinary diversion with percutaneous nephrostomy to allow for fistula healing. If this fails, ureteral embolization can be very effective; however, this should be preceded by careful evaluation and discussion with the patient as this intervention results in irreversible ureteral occlusion necessitating a diverting nephrostomy catheter indefinitely. A ureteroarterial fistula is a distinct entity compared with nonvascular fistulas with a different approach to management; it can be managed by exclusion of the fistula by endovascular placement of a stent graft across the arterial component of the fistula.

Renal artery embolization.

Renal artery embolization (RAE) is an effective minimally invasive alternative procedure for the treatment of a variety of conditions. Since the 1970s when RAE was first developed, technical advances and growing experience have expanded the indications to not only include treatment of conditions such as symptomatic hematuria and palliation for metastatic renal cancer, but also preoperative infarction of renal tumors, treatment of angiomyolipomas, vascular malformations, medical renal disease, and complications following renal transplantation. With the drastically improved morbidity associated with this technique in part due to the introduction of more precise embolic agents and smaller delivery catheters, RAE continues to gain popularity for various urologic conditions. The indications and techniques for renal artery embolization are reviewed in the following sections.

Nephrostolithotomy.

Percutaneous nephrostolithotomy (PCNL) is the treatment of choice for large (>2 cm) renal calculi and staghorn calculi. Percutaneous access into the kidney is often achieved by interventional radiologists, either prior to stone surgery or in conjunction with the urology team. Several basic techniques should be considered in gaining access to the kidney to avoid both intraoperative and postoperative complications. In this article, the authors discuss indications for PCNL, techniques for renal access, complications of PCNL, and management of these complications. They also briefly discuss management of post-operative drainage tube(s).