Comparison of Anticoagulation Regimens Following Stent Placement for Nonthrombotic Lower Extremity Venous Disease.

PURPOSE: To determine whether subtherapeutic anticoagulation regimens are noninferior to therapeutic anticoagulation regimens following stent placement for nonthrombotic lower extremity venous disease. MATERIALS AND METHODS: Fifty-one consecutive patients (88% women; mean age, 44 years) who underwent stent placement for nonthrombotic lower extremity venous disease between 2002 and 2016 were retrospectively identified. The patients were divided into 2 cohorts: those who received prophylactic enoxaparin or no anticoagulation (subtherapeutic) after the procedure and those who received therapeutic doses of anticoagulation with enoxaparin, warfarin, and/or rivaroxaban (therapeutic) after the procedure. Baseline demographic characteristics, procedure characteristics, and outcomes were compared between the 2 groups using the Student t test, Fisher exact test, and χ2 test. The subtherapeutic and therapeutic anticoagulation groups did not differ significantly in the baseline demographic characteristics (eg, sex, race, and age) or procedure characteristics (eg, number of stents placed, stent brand, stent diameter, etc). RESULTS: The mean clinical follow-up time was 4.4 years (range, 0-16.3 years). There were no thrombotic adverse events or luminal obstructions due to in-stent restenosis in either group. There were 5 minor bleeding adverse effects in the therapeutic group and no bleeding adverse effects in the subtherapeutic group (P = .051). There were no statistically significant differences in subjective symptom improvement (P = .75). CONCLUSIONS: In this retrospective cohort, the subtherapeutic and therapeutic anticoagulation regimens produced equivalent outcomes in terms of adverse event rates, reintervention rates, and symptomatic improvement, suggesting that therapeutic doses of anticoagulation do not improve outcomes compared with subtherapeutic anticoagulation regimens following nonthrombotic venous stent placement.

Analysis of patent, unstented lower extremity vein segment diameters in 266 patients with venous disease.

OBJECTIVE: The objective of this study was to characterize the average maximum diameters of widely patent lower extremity vein segments in patients with underlying venous disease and the demographic factors that affect these diameters. METHODS: Maximum axial diameters of each deep vein segment from the diaphragm to the knee were measured from computed tomography venography studies for all patients who underwent venous stent placement during a 20-year period at a single quaternary venous referral institution. Limbs containing only widely patent, unstented vein segments without variant anatomy were identified for inclusion. The final analysis involved diameter measurements from 870 imaging studies of 266 patients. Multivariate linear regression was used to identify factors associated with vein segment diameters. RESULTS: Average vein segment diameters ranged from 7.8 mm for the left and right femoral veins to 27.9 mm for the long axis of the suprarenal inferior vena cava. Multivariate linear regression demonstrated that women had larger IVC, common iliac vein, and external iliac vein diameters, whereas men had larger common femoral veins. Laterality, height, weight, and sex also had statistically significant associations with the diameters of select vein segments. CONCLUSIONS: This study provides an estimate of the average diameters of widely patent deep vein segments in the lower extremities from the diaphragm to the knees in patients with underlying venous disease and characterizes covariates that significantly affect vein diameter. These findings may help interventionalists better select devices for endovascular intervention.

Automated Quantitative Imaging Measurements of Disease Severity in Patients with Nonthrombotic Iliac Vein Compression.

PURPOSE: An automated segmentation technique (AST) for computed tomography (CT) venography was developed to quantify measures of disease severity before and after stent placement in patients with left-sided nonthrombotic iliac vein compression. MATERIALS AND METHODS: Twenty-one patients with left-sided nonthrombotic iliac vein compression who underwent venous stent placement were retrospectively identified. Pre- and poststent CT venography studies were quantitatively analyzed using an AST to determine leg volume, skin thickness, and water content of fat. These measures were compared between diseased and nondiseased limbs and between pre- and poststent images, using patients as their own controls. Additionally, patients with and without postthrombotic lesions were compared. RESULTS: The AST detected significantly increased leg volume (12,437 cm3 vs 10,748 cm3, P < .0001), skin thickness (0.531 cm vs 0.508 cm, P < .0001), and water content of fat (8.2% vs 5.0%, P < .0001) in diseased left limbs compared with the contralateral nondiseased limbs, on prestent imaging. After stent placement in the left leg, there was a significant decrease in the water content of fat in the right (4.9% vs 2.7%, P < .0001) and left (8.2% vs 3.2%, P < .0001) legs. There were no significant changes in leg volume or skin thickness in either leg after stent placement. There were no significant differences between patients with or without postthrombotic lesions in their poststent improvement across the 3 measures of disease severity. CONCLUSIONS: ASTs can be used to quantify measures of disease severity and postintervention changes on CT venography for patients with lower extremity venous disease. Further investigation may clarify the clinical benefit of such technologies.

Lower Extremity Venous Stent Placement: A Large Retrospective Single-Center Analysis.

PURPOSE: To study short-term and long-term outcomes of lower extremity venous stents placed at a single center and to characterize changes in vein diameter achieved by stent placement. MATERIALS AND METHODS: A database of all patients who received lower extremity venous stents between 1996 and 2018 revealed 1,094 stents were placed in 406 patients (172 men, 234 women; median age, 49 y) in 513 limbs, including patients with iliocaval stents (9.4% acute thrombosis, 65.3% chronic thrombosis, 25.3% nonthrombotic lesions). Primary, primary assisted, and secondary patency rates were assessed for lower extremity venous stents at 1, 3, and 5 years using Kaplan-Meier analyses and summary statistics. Subset analyses and Cox regression were performed to identify risk factors for patency loss. Vein diameters and Villalta scores before and up to 12 months after stent placement were compared. Complication and mortality rates were calculated. RESULTS: Primary, primary assisted, and secondary patency rates at 5 years were 57.3%, 77.2%, and 80.9% by Kaplan-Meier methods and 78.6%, 90.3%, and 92.8% by summary statistics. Median follow-up was 199 days (interquartile range, 35.2-712.0 d). Patency rates for the subset of patients (n = 46) with ≥ 5 years of follow-up (mean ± SD 9.1 y ± 3.4) were nearly identical to cohort patency rates at 5 years. Patients with inferior vena cava stent placement (hazard ratio 2.11, P < .0001) or acute thrombosis (hazard ratio 3.65, P < .0001) during the index procedure had significantly increased risk of losing primary patency status. Vein diameters were significantly greater after stent placement. There were no instances of stent fracture, migration, or structural deformities. In patients with chronic deep vein thrombosis, Villalta scores significantly decreased after stent placement (from 15.7 to 7.4, P < .0001). Perioperative mortality was < 1%, and major perioperative complication rate was 3.7%. CONCLUSIONS: Cavo-ilio-femoral stent placement for venous occlusive disease achieves improvement of vein disease severity scores, increase in treated vein diameters, and satisfactory long-term patency rates.

Inferior Vena Cava Atresia: Characterisation of Risk Factors, Treatment, and Outcomes.

PURPOSE: To characterise (1) the risk factors associated with inferior vena cava (IVC) atresia, (2) the radiographic and clinical presentations of deep vein thrombosis (DVT) in patients with IVC atresia, and (3) the treatment and outcome of DVT in patients with IVC atresia. METHODS: The electronic medical record was systematically reviewed for thrombotic risk factors in patients who presented with lower-extremity DVT (n = 409) at a single centre between 1996 and 2017. Patients with IVC atresia were identified based on imaging and chart review. Differences in demographics and thrombotic risk factors between patients with and without IVC atresia were statistically assessed. Extent and chronicity of DVT on imaging, clinical presentation, treatment, and outcomes were evaluated for all patients with IVC atresia. RESULTS: 4.2% of DVT patients (17/409) were found to have IVC atresia; mean age at diagnosis was 25.5 ± 9.4 years. The rate of heritable thrombophilia was significantly higher in patients with IVC atresia compared to patients without IVC atresia (52.9% vs. 17.9%, p < 0.0001). There were bilateral DVT in 70.6% of IVC atresia patients; DVT was chronic in 41.2% and acute on chronic in 58.8%. Pre-intervention Villalta scores were 13.9 ± 9.8 in the left limb and 8.5 ± 7.0 in the right limb. DVT in IVC atresia patients was typically treated with catheter-directed thrombolysis followed by stent placement, achieving complete or partial symptom resolution in 78.6% of cases. CONCLUSION: Thrombotic risk factors such as heritable thrombophilia are associated with IVC atresia. IVC atresia patients can experience high burdens of lower-extremity thrombotic disease at a young age which benefit from endovascular treatment. LEVEL OF EVIDENCE: Level 4.

Toward Data-Driven Learning Healthcare Systems in Interventional Radiology: Implementation to Evaluate Venous Stent Patency.

We developed a code and data-driven system (learning healthcare system) for gleaning actionable clinical insight from interventional radiology (IR) data. To this end, we constructed a workflow for the collection, processing and analysis of electronic health record (EHR), imaging, and cancer registry data for a cohort of interventional radiology patients seen in the IR Clinic at our institution over a more than 20-year period. As part of this pipeline, we created a database in REDCap (VITAL) to store raw data, as collected by a team of clinical investigators and the Data Coordinating Center at our university. We developed a single, universal pre-processing codebank for our VITAL data in R; in addition, we also wrote widely extendable and easily modifiable analysis code in R that presents results from summary statistics, statistical tests, visualizations, Kaplan-Meier analyses, and Cox proportional hazard modeling, among other analysis techniques. We present our findings for a test case of supra versus infra-inguinal ligament stenting. The developed pre-processing and analysis pipelines were memory and speed-efficient, with both pipelines running in less than 2 min. Three different supra-inguinal ligament veins had a statistically significant improvement in vein diameters post-stenting versus pre-stenting, while no infra-inguinal ligament veins had a statistically significant improvement (due either to an insufficient sample size or a non-significant p value). However, infra-inguinal ligament stenting was not associated with worse restenosis or patency outcomes in either a univariate (summary-statistics and Kaplan-Meier based) or multivariate (Cox proportional hazard model based) analysis.