Iliocaval Skip Stent Reconstruction Technique for Chronic Bilateral Iliocaval Venous Occlusion

PurposeTo report safety and efficacy of a skip stent technique using nitinol stents in patients with chronic bilateral iliocaval venous occlusions.Materials and MethodsA retrospective analysis of 48 consecutive patients (32 men; mean age, 40.7 years; age range, 18–68 years) with chronic bilateral iliocaval obstructions treated using a nonoverlapping stent technique was conducted at a single center. None of the patients had May-Thurner syndrome. Iliocaval confluence was treated by deploying a nitinol stent in inferior vena cava (IVC) and a nitinol stent in each common iliac vein close to the caval stent. Patency of stents was assessed by duplex US at 2 weeks, 3 months, and 6 months and yearly thereafter.ResultsRecanalization and stent reconstruction was technically successful in 47 (98%) patients. The sinus-XL venous stent was used to treat IVC (95 [100%]). Common iliac and external iliac veins were treated with sinus-Venous and VENOVO stents (80 [83%] and 16 [17%] limbs, respectively). External iliac and common femoral veins were treated with sinus-Venous and VENOVO stents (83 [92%] and 7 [18%] limbs, respectively). Early thrombosis (< 30 days) of the iliac vein with stent occurred in 2 limbs. Cumulative primary, assisted primary, and secondary patency rates at 30 months were 74%, 83%, and 97%.ConclusionsFindings of this study suggest that leaving a skipped lesion at the level of iliocaval confluence may not adversely affect stent patency. Patency rates were comparable with other reported techniques of stent reconstruction at the level of iliocaval confluence.     

Treatment of Arm Swelling in Hemodialysis Patients with Ipsilateral Arteriovenous Access and Central Vein Stenosis: Conversion to the Hemodialysis Reliable Outflow Graft versus Stent Deployment

PurposeTo compare outcomes after conversion of arteriovenous (AV) access to Hemodialysis Reliable Outflow (HeRO) graft vs stent deployment in patients with arm swelling owing to ipsilateral central vein stenosis.Materials and MethodsThis single-center retrospective study comprised 48 patients (19 men, mean age 58 y) with arm swelling ipsilateral to AV access and central vein stenosis over a 13-year period who had clinical follow-up and without prior central stents. Twenty-one patients underwent placement of a HeRO graft with anastomosis of the HeRO graft to the existing graft or fistula, and 27 patients underwent central venous stent deployment. Symptomatic improvement in arm swelling and access patency rates after intervention were ascertained from medical records.ResultsImprovement in swelling within 1 month after HeRO conversion and stent deployment was found in 95% and 89%, respectively (P = .62). Swelling eventually recurred in 16 patients (59%) treated with stents compared with 1 patient (5%) who underwent HeRO conversion (P < .001). Primary access patency was statistically significantly longer after HeRO conversions than stent deployments, with 6- and 12-month primary patency rates of 89% and 72% vs 47% and 11% (P < .001). HeRO conversions also resulted in longer 6- and 12-month secondary access patency rates (95% and 95% vs 79% and 58%, P = .006). Mean number of interventions per 1,000 access days to maintain secondary patency was 2.7 for the HeRO group vs 6.3 for the stent group.ConclusionsAlthough stent deployment and HeRO graft conversion are effective for alleviating arm swelling in the short term in patients receiving hemodialysis with clinically significant arm swelling and functioning AV access, the HeRO graft has more durable results.     

Endovascular Treatment of Malignant Superior Vena Cava Syndrome through Upper-Limb Access: A Comparison between Venous-Dedicated and Conventional Stents

PurposeTo retrospectively evaluate the technical and clinical outcomes of superior vena cava (SVC) stent placement through upper-limb venous access in malignant SVC syndrome (SVCS) and compare the efficacy of different nitinol stent types.Materials and MethodsBetween 2006 and 2018, 156 patients (132 male; mean age, 62 y; age range, 33–81 y) underwent SVC stent placement for malignant obstructions through upper-limb venous access with 1 of 3 types of nitinol stent: 1 venous-dedicated (Sinus-XL stent) and 2 non–venous-dedicated (E-Luminexx Vascular Stent and Protégé GPS). Cases of common femoral vein access or non-nitinol stents were excluded from further analysis. The mean duration of follow-up was 8 mo.ResultsTechnical success was achieved in 99.3% of cases. One patient died during the procedure as a result of cardiac tamponade. Balloon predilation was performed in 10 patients and postdilation in 126. Mean procedural time was 34.4 min (range, 18–80 min). Overall survival rates were 92.3%, 57.3%, and 26.8%, and overall primary patency rates were 94.5%, 84.8% and 79.6%, at 1, 6, and 12 mo, respectively. There were no statistically significant differences in primary patency rates between venous- and non–venous-dedicated stents or among different Stanford SVCS grading groups (P > .05).ConclusionsSVC stent placement through an upper-limb approach is a safe, fast, and effective technique. There is no evident benefit of venous-dedicated vs non–venous-dedicated stents in the treatment of malignant SVCS.     

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

PurposeAn 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 MethodsTwenty-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.ResultsThe 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.ConclusionsASTs 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.     

Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry

PurposeTo analyze the first 250 patients from the prospective, multicenter, industry-sponsored ClotTriever Outcomes (CLOUT) registry, assessing the safety and effectiveness of mechanical thrombectomy for acute, subacute, and chronic deep vein thrombosis (DVT).Materials and MethodsReal-world patients with lower extremity DVT were treated with the ClotTriever System (Inari Medical, Irvine, California). Adjuvant venoplasty, stent placement, or both were performed at the physician’s discretion. Thrombus chronicity was determined by visual inspection of removed thrombus, categorizing patients into acute, subacute, and chronic subgroups. Serious adverse events (SAEs) were assessed through 30 days. Clinical and quality-of-life (QoL) outcomes are reported through 6 months.ResultsThrombus chronicity was designated for 244 of the 250 patients (acute, 32.8%; subacute, 34.8%; chronic, 32.4%) encompassing 254 treated limbs. Complete or near-complete (≥75%) thrombus removal was achieved in 90.8%, 81.9%, and 83.8% of the limbs with acute, subacute, and chronic thrombus, respectively. No fibrinolytics were administered, and 243 (99.6%) procedures were single sessions. One (0.4%) patient in the subacute group experienced a device-related SAE, a fatal pulmonary embolism. On comparing baseline and 6-month data, improvements were demonstrated in median Villalta scores (acute, from 10 to 1; subacute, from 9 to 1; chronic, from 10 to 3; for all, P < .0001) and mean EuroQol group 5-dimension (EQ-5D) self-report questionnaire scores (acute, 0.58 to 0.89; subacute, 0.65 to 0.87; chronic, 0.58 to 0.88; for all, P < .0001). There were no significant differences in outcomes across the subgroups.ConclusionsMechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, subacute, and chronic DVT.     

Utilization of and Outcomes Associated with Intravascular Ultrasound during Deep Venous Stent Placement among Medicare Beneficiaries

PurposeTo evaluate temporal trends, practice variation, and associated outcomes with the use of intravascular ultrasound (US) during deep venous stent placement among Medicare beneficiaries.Materials and MethodsAll lower extremity deep venous stent placement procedures performed between January 1, 2017, and December 31, 2019 among Medicare beneficiaries were included. Temporal trends in intravascular US use were stratified by procedural setting and physician specialty. The primary outcome was a composite of 12-month all-cause mortality, all-cause hospitalization, or repeat target vessel intervention. The secondary outcome was a composite of 12-month stent thrombosis, embolization, or restenosis.ResultsAmong the 20,984 deep venous interventions performed during the study period, 15,184 (72.4%) utilized intravascular US. Moderate growth in intravascular US use was observed during the study period in all clinical settings. There was a variation in the use of intravascular US among all operators (median, 77.3% of cases; interquartile range, 20.0%–99.2%). In weighted analyses, intravascular US use during deep venous stent placement was associated with a lower risk of both the primary (adjusted hazard ratio, 0.72; 95% confidence interval [CI], 0.69–0.76; P < .001) and secondary (adjusted hazard ratio, 0.32; 95% CI, 0.27–0.39; P < .001) composite end points.ConclusionsIntravascular US is frequently used during deep venous stent placement among Medicare beneficiaries, with further increase in use from 2017 to 2019. The utilization of intravascular US as part of a procedural strategy was associated with a lower cumulative incidence of adverse outcomes after the procedure, including venous stent thrombosis and embolization.     

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

PurposeTo determine whether subtherapeutic anticoagulation regimens are noninferior to therapeutic anticoagulation regimens following stent placement for nonthrombotic lower extremity venous disease.Materials and MethodsFifty-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).ResultsThe 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).ConclusionsIn 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.     

Midterm and Long-Term Outcomes following Dedicated Endovenous Nitinol Stent Placement for Symptomatic Iliofemoral Venous Obstruction: Three- to 5-Year Results of the VIRTUS Study

PurposeTo assess the midterm patency and long-term safety of placement of a dedicated venous stent (Vici Venous Stent System) for the treatment of venous lesions of the iliofemoral outflow tract.Materials and MethodsPatients with unilateral obstructive disease of the iliofemoral veins and a Clinical, Etiological, Anatomical, Pathophysiological class of 3 or higher or a Venous Clinical Severity Score of 2 or greater were enrolled in this prospective, multicenter, single-arm study at 23 sites in the United States and Europe. The patients were followed up for 36 months after the index procedure for the assessment of patency and up to 60 months for the assessment of safety. The clinical outcomes in 11 patients with a stent fracture were assessed.ResultsA total of 200 patients enrolled in 2 cohorts (ie, feasibility cohort, n = 30; pivotal cohort, n = 170) were combined for this analysis. The overall 36-month primary patency rate was 71.7% (86/120), and the 36-month primary patency rate was 96.4% (27/28) for the nonthrombotic group and 64.1% (59/92) for the postthrombotic group. The freedom from major adverse events was 81.2% (53/65) through 60 months. The 60-month Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) was 84.3%. In 9 of the 11 patients who had a stent fracture (1 patient with nonthrombotic etiology and 10 patients with postthrombotic etiology) identified at 12 months, the stents extended into the common femoral vein. The TVR rates and clinical outcomes were similar between patients with and without a stent fracture.ConclusionsThe results of the VIRTUS study demonstrated good midterm patency and long-term safety following the placement of a dedicated venous stent for iliofemoral obstruction.     

No Advantage of Expanded Polytetrafluoroethylene and Fluorinated Ethylene Propylene–Covered Stents over Uncovered Nitinol Stents for Percutaneous Palliation of Malignant Infrahilar Biliary Obstruction: Results of a Single-Center Prospective Randomized Trial

PurposeTo prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction.Materials and MethodsAfter failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene–covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared.ResultsThree patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178–438 d) for covered and 442 d (95% CI, 172–712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68–124 d) with covered stents and 75 days (95% CI, 42–108 d) with uncovered stents (P = .6).ConclusionsIn malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.     

Percutaneous Cystic Duct Interventions and Drain Internalization for Calculous Cholecystitis in Patients Ineligible for Surgery

PurposeTo evaluate the feasibility, effectiveness, and outcomes of percutaneous cholecystostomy drain internalization in patients with calculous cholecystitis who were not surgical candidates.Materials and MethodsPercutaneous cystic duct interventions were attempted in 17 patients (with the intent to place dual cholecystoduodenal stents) who were deemed unfit for surgery and had previously undergone percutaneous cholecystostomies for acute calculous cholecystitis. Baseline demographics, technical success, time from percutaneous cholecystostomy to internalization (dual cholecystoduodenal stent placement), stent patency duration, and adverse event rates were evaluated.ResultsFifteen (88%) of 17 procedures to cross the cystic duct were technically successful. Of these 17 patients, 13 (76%) underwent successful placement of dual cholecystoduodenal stents. Two of these 13 patients (who had successful dual cholecystoduodenal stent placement) needed repeat percutaneous cholecystostomy drains (1 patient had stent migration leading to recurrent cholecystitis, and the other had a perihepatic biloma). The 1-year patency rate was 77% (95% CI, 47%–100%).ConclusionsDual cholecystoduodenal stent placement in nonsurgical patients is a technically feasible treatment option with the goal to remove percutaneous cholecystostomy drains.     

Stent Graft Placement for the Treatment of Hepatic Artery Injury in Patients with Cancer: Primary Patency and Clinical Outcomes

PurposeTo evaluate the safety, primary patency, and clinical outcomes of hepatic artery stent graft (SG) placement for vascular injuries.Materials and MethodsPatients treated with hepatic arterial SG placement for vascular injuries between September 2018 and September 2021 were reviewed. Data on demographic characteristics, indication, stent graft characteristics, antiplatelet/anticoagulant use, clinical success rate, complications, and type of follow-up imaging were collected. Follow-up images were reviewed by 2 independent reviewers to assess primary patency. A time-to-event analysis was performed. The median duration of stent graft patency was estimated using Kaplan-Meier curves. A Cox proportional hazard model was used to evaluate factors related to stent graft patency.ResultsThirty-five patients were treated with hepatic arterial SG placement, 11 for postoperative bleeds and 24 for hepatic artery infusion pump catheter–related complications. Clinical success was achieved in 32 (91%) patients (95% CI, 77–98). The median primary patency was 87 days (95% CI, 73–293). Stent grafts of ≥6-mm diameter retained patency for a longer duration than that with stent grafts of smaller diameters (6 mm vs 5 mm; hazard ratio, 0.35; 95% CI, 0.14–0.88; P = .026; and 7+ mm vs 5 mm; hazard ratio, 0.27; 95% CI, 0.09–0.83; P = .023). Anticoagulation/antiplatelet regimen was not associated with increased stent graft patency duration (P > .05). Only minor complications were reported in 2 (5.7%) patients.ConclusionsStent grafts can be used safely and effectively to treat injuries of the hepatic artery. Stent graft diameters of ≥6 mm seem to provide more durable patency.     

Evaluation of Technical Success,Efficacy, and Safety of Portomesenteric Venous Intervention following Nontransplant Hepatobiliary or Pancreatic Surgery

PurposeTo evaluate technical success, efficacy and safety of portomesenteric venous (PMV) intervention for PMV stenosis or occlusion following nontransplant hepatobiliary or pancreatic (HPB) surgery.Materials and MethodsA retrospective review identified 42 patients (mean age 60 y) with PMV stenosis (n = 33; 79%) or occlusion (n = 9; 21%) who underwent attempted PMV intervention following HPB surgery between June 1, 2011, and April 1, 2018. Main outcomes were technical success, primary patency rates, and complications. Technical success was compared by venous pathology and primary PMV patency based on anticoagulation status after the procedure using Fisher exact test. Rates of primary patency by stent group were estimated using Kaplan-Meier method.ResultsTechnical success was 91% (n = 38/42) and significantly higher in patients with stenosis (n = 33/33; 100%) vs occlusion (n = 5/9; 56%) (P = .001). Primary presenting symptom resolved in 28 (87%) patients, including 6 (100%) patients with gastrointestinal bleeding. At mean imaging follow-up of 8.6 months ± 8.8, primary stent patency was 76%. There was no significant difference in primary stent patency based on anticoagulation status after the procedure (P = .48). There were 2 (4.8%) periprocedural complications.ConclusionsPortomesenteric venoplasty and stent placement following nontransplant HPB surgery is safe with a high rate of technical success if performed before chronic occlusion.     

The Effects of Protrusion into the Outflow Vein on Outcomes of Stent Grafts Used to Treat Cephalic Arch Stenoses in Dysfunctional Brachiocephalic Fistulae

PurposeTo assess long-term patency rates of cephalic arch stent grafts in brachiocephalic fistulae and the importance of device position.Materials and MethodsThis retrospective study reviewed 152 patients with dysfunctional brachiocephalic fistulae and cephalic arch stenosis treated with stent grafts (Viabahn; W. L. Gore) at a single tertiary center between 2012 and 2021. The median age was 67.5 years (range, 25–91 years), and the median follow-up period was 637 days (range, 3–3,368 days). A grading system of protrusion was applied: (a) Grade 0, no protrusion; (b) Grade 1, perpendicular; and (c) Grade 2, in-line protrusion. Subsequent fistulograms were available in 133 (88%) of the 152 patients and were assessed for central vein stenosis within 10 mm of the stent graft. Clinical records were assessed for sequelae of stent graft protrusion. Stent graft primary and cumulative circuit patencies were calculated using the Kaplan-Meier method.ResultsProtrusion was documented in 106 (70%) stent grafts—56 Grade 1 and 50 Grade 2. Central vein stenosis was seen in 1 (2%) case of no protrusion (Grade 0) and 38 (40%) cases of protrusion (P < .0001). There was no significant difference in stenosis between Grade 1 and 2 protrusion (P = .15). No adverse clinical sequelae occurred in 147 (97%) patients. Eight patients had a new access subsequently formed in the same arm, and 3 of these 8 patients developed symptoms due to the previous stent graft protrusion (all Grade 2). The primary patency rates of the stent-grafts at 6 and 12 months were 73% and 50%, respectively. The cumulative access circuit patency rates at 1, 2, and 5 years were 84%, 72%, and 54%, respectively.ConclusionsThis study demonstrated that protrusion of a cephalic arch stent graft into the central vein is safe and only clinically relevant when a subsequent ipsilateral access is created.     

Transjugular Intrahepatic Portosystemic Shunt and Thrombectomy (TIPS-Thrombectomy) for Symptomatic Acute Noncirrhotic Portal Vein Thrombosis

PurposeTo report the safety and effectiveness of transjugular intrahepatic portosystemic shunt and mechanical thrombectomy (TIPS-thrombectomy) for symptomatic acute noncirrhotic portal vein thrombosis (NC-PVT).Materials and MethodsPatients with acute NC-PVT who underwent TIPS-thrombectomy between 2014 and 2021 at a single academic medical center were retrospectively reviewed. Thirty-two patients were included (men, 56%; median age, 51 years [range, 39–62 years]). The causes for PVT included idiopathic (n = 12), prothrombotic disorders (n = 11), postsurgical sequelae (n = 6), pancreatitis (n = 2), and Budd-Chiari syndrome (n = 1). The indications for TIPS-thrombectomy included refractory abdominal pain (n = 14), intestinal venous ischemia (n = 9), ascites (n = 4), high-risk varices (n = 3), and variceal bleeding (n = 2). Variables studied included patient, disease, and procedure characteristics. Patients were monitored over the course of 1-year follow-up.ResultsSuccessful recanalization of occluded portal venous vessels occurred in all 32 patients (100%). Compared with pretreatment patency, recanalization with TIPS-thrombectomy resulted in an increase in patent veins (main portal vein [28% vs 97%, P < .001], superior mesenteric vein [13% vs 94%, P < .001], and splenic vein [66% vs 91%, P < .001]). Three procedure-related adverse events occurred (Society of Interventional Radiology grade 2 moderate). Hepatic encephalopathy developed in 1 (3%) of 32 patients after TIPS placement. At 1-year follow-up, return of symptoms occurred in 3 (9%) of 32 patients: (a) ascites (n = 1), (b) variceal bleeding (n = 1), and (c) intestinal venous ischemia (n = 1). The intention-to-treat 1-year portal vein and TIPS primary and secondary patency rates were 78% (25/32) and 100% (32/32), respectively. Seven patients required additional procedures, and the 1-year mortality rate was 3% (1/32).ConclusionsTIPS-thrombectomy is a safe and effective method for treating patients with symptomatic acute NC-PVT.     

Predictors of Clinical Outcomes of Pharmacomechanical Catheter-Directed Thrombolysis for Acute Iliofemoral Deep Vein Thrombosis: Analysis of a Multicenter Randomized Trial

PurposeTo identify the baseline patient characteristics that predict who will benefit from pharmacomechanical catheter-directed thrombolysis (PCDT) of acute iliofemoral deep vein thrombosis (DVT).Materials and MethodsIn the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) multicenter randomized trial, 381 patients with acute iliofemoral DVT underwent PCDT and anticoagulation or anticoagulation alone. The correlations between baseline factors and venous clinical outcomes were evaluated over 24 months using post hoc regression analyses. Interaction terms were examined to evaluate for differential effects by treatment arm.ResultsPatients with clinically severe DVT (higher baseline Villalta score) experienced greater effects of PCDT in improving 24-month venous outcomes, including moderate or severe postthrombotic syndrome (PTS) (odds ratios [ORs] and 95% confidence intervals [CIs] per unit increase in the baseline Villalta scores were as follows: for PCDT, OR, 1.08 [95% CI, 1.01–1.15]; for control, OR, 1.20 [95% CI, 1.12–1.29]; P_interaction = .03), PTS severity (between-arm differences in the Villalta [P_interaction = .004] and Venous Clinical Severity Scale [VCSS] [P_interaction = .002)] scores), and quality of life (between-arm difference in the Venous Insufficiency Epidemiological and Economic Study Quality of Life score; P_interaction = .025). Patients with previous DVT had greater effects of PCDT on 24-month PTS severity than those in patients without previous DVT (mean [95% CI] between-arm difference in the Villalta score, 4.2 [1.56–6.84] vs 0.9 [?0.44 to 2.26], P_interaction = .03; mean [95% CI] between-arm difference in the VCSS score, 2.6 [0.94–4.21] vs 0.3 [?0.58 to 1.14], P_interaction = .02). The effects of PCDT on some but not all outcomes were greater in patients presenting with left-sided DVT (Villalta PTS severity, P_interaction = .04; venous ulcer, P_interaction = .0499) or a noncompressible popliteal vein (PTS, P_interaction = .02). The effects of PCDT did not vary by sex, race, ethnicity, body mass index, symptom duration, hypertension, diabetes, or hypercholesterolemia.ConclusionsIn patients with acute iliofemoral DVT, greater presenting clinical severity (higher baseline Villalta score) and a history of previous DVT predict enhanced benefits from PCDT.     

Prospective,Multicenter Clinical Study of the Covera Vascular Covered Stent in the Treatment of Stenosis at the Graft-Vein Anastomosis of Dysfunctional Hemodialysis Access Grafts

PurposeTo study the use of the self-expanding Covera covered stent for the treatment of stenotic lesions at the venous anastomosis of hemodialysis arteriovenous grafts (AVGs).Materials and MethodsA total of 110 patients with AVG venous anastomotic stenosis of ≥50% and access dysfunction were treated at 14 centers in the United States using percutaneous transluminal angioplasty followed by covered stent placement. The primary end points were 30-day safety and 6-month target lesion primary patency (TLPP). The secondary measures included access circuit primary patency, circuit cumulative patency, and the number of reinterventions through 24 months.ResultsFreedom from a primary safety event at 30 days was 96.4% while the 6-month TLPP rate was 70.3%. Seventy-five patients completed 24-month follow-up (68.2%). The TLPP rates were 54.2% at 365 days and 36.9% at 730 days while the access circuit primary patency rates were 16.7% at 365 days and 7.8% at 730 days (Kaplan-Meier analysis). The access circuit cumulative patency rates were 85.4% at 12 months and 73.6% at 24 months. The number of reinterventions to maintain the patency of the access circuit was 3.6 ± 3.1 at 24 months (1.6 ± 1.9 at the target lesion).ConclusionsUse of the Covera covered stent for hemodialysis graft-vein anastomotic stenosis provided a safe treatment option with a TLPP rate of 70.3% at 6 months and TLPP and cumulative access circuit patency rates of 36.9% and 73.6% at 2 years.     

Factors Affecting Recurrent Deep Vein Thrombosis after Pharmacomechanical Thrombolysis and Left Iliac Vein Stent Placement in Patients with Iliac Vein Compression Syndrome

PurposeThis study evaluated the factors affecting contralateral and ipsilateral recurrent deep vein thrombosis (DVT) after iliac vein stent placement in patients with iliac vein compression syndrome (IVCS).Materials and MethodsData from 130 patients (95 female patients) who underwent catheter-directed thrombolysis and stent placement for IVCS with left lower leg thrombosis at a single institution were retrospectively analyzed. Mean patient age was 69.0 ± 14.0 years old. Median follow-up was 14 months (range, 3–164 months). Anticoagulation therapy was prescribed for 6 months, followed by lifelong antiplatelet therapy. Multivariate logistic regression analysis was performed to evaluate the factors affecting the development of contralateral and ipsilateral recurrent DVT.ResultsSeven patients (5.4%) developed contralateral DVT (median, 26 months; range, 2–61 months), and 11 patients (8.5%) developed ipsilateral DVT (median, 1 month; range, 0–53 months). Stent location (odds ratio [OR], 11.564; 95% confidence interval [CI], 1.159–115.417) and in-stent thrombosis during follow-up (OR, 15.142; 95% CI, 1.406–163.119) were predictors of recurrent contralateral DVT. Thrombophilia (OR, 47.560; 95% CI, 2.369–954.711), remaining inferior vena cava filter (OR, 30.552; 95% CI, 3.495–267.122), and in-stent thrombosis during follow-up (OR, 82.057; 95% CI, 2.915–2309.848) were predictors of ipsilateral DVT.ConclusionsContralateral DVT occurs late and is associated with extension of the iliac vein stent to the inferior vena cava and in-stent thrombosis. Ipsilateral DVT occurs relatively early and is associated with thrombophilia, remaining inferior vena cava filter, and in-stent thrombosis.     

Stent Diameter,Not Cephalic Arch Anatomy,Predicts Stent Graft Patency in Cephalic Arch Stenosis

PurposeTo investigate the relationship between anatomic factors and primary patency of brachiocephalic arteriovenous fistulae (AVFs) after stent graft (SG) placement for cephalic arch stenosis (CAS).Materials and MethodsThis retrospective study reviewed all cephalic arch SGs placed in brachiocephalic AVFs in a tertiary academic medical center between 2014 and 2017. Sixty-three patients were included in the study. The mean patient age at the time of SG placement was 62.6 years ± 19, and the mean patient follow-up was 1,994 days ± 353. A cohort of patients (n = 31) who underwent brachiocephalic fistulograms for CAS but only received percutaneous transluminal angioplasty (PTA) was the control group. Patient demographic characteristics, AVF anatomy, SG type, and clinical outcomes were reviewed. The duration of primary cephalic arch patency after SG placement was compared with that after previous PTA.ResultsThe median AVF age at the time of data retrieval was 345 days. The primary patency of CAS after SG placement at 6 months, 12 months, and 3 years was 64%, 49.9%, and 23.5%, respectively. Primary cephalic arch patency was significantly associated with the SG diameter (P = .007) but not with cephalic vein–axillary vein junction anatomy, size of feeding artery, or SG length (P > .05). The primary patency of CAS in patients treated with PTA only (n = 31) at 6 months, 12 months, and 3 years was 61%, 35%, and 0%, respectively, which was significantly lower than that in patients treated with SG placement (P = .01).ConclusionsThis study showed that the primary patency of CAS after SG placement was significantly higher than that of PTA-only treatment. Moreover, primary cephalic arch patency after SG placement was significantly associated with the SG diameter.     

Correlation between Post-Procedure Residual Thrombus and Clinical Outcome in Deep Vein Thrombosis Patients Receiving Pharmacomechanical Thrombolysis in a Multicenter Randomized Trial

PurposeTo evaluate relationships between immediate venographic results and clinical outcomes of pharmacomechanical catheter-directed thrombolysis (PCDT).Materials and MethodsVenograms from 317 patients with acute proximal deep vein thrombosis (DVT) who received PCDT in a multicenter randomized trial were reviewed. Quantitative thrombus resolution was assessed by independent readers using a modified Marder scale. The physician operators recorded their visual assessments of thrombus regression and venous flow. These immediate post-procedure results were correlated with patient outcomes at 1, 12, and 24 months.ResultsPCDT produced substantial thrombus removal (P < .001 for pre-PCDT vs. post-PCDT thrombus scores in all segments). At procedure end, spontaneous venous flow was present in 99% of iliofemoral venous segments and in 89% of femoral–popliteal venous segments. For the overall proximal DVT population, and for the femoral–popliteal DVT subgroup, post-PCDT thrombus volume did not correlate with 1-month or 24-month outcomes. For the iliofemoral DVT subgroup, over 1 and 24 months, symptom severity scores were higher (worse), and venous disease-specific quality of life (QOL) scores were lower (worse) in patients with greater post-PCDT thrombus volume, with the difference reaching statistical significance for the 24-month Villalta post-thrombotic syndrome (PTS) severity score (P = .0098). Post-PCDT thrombus volume did not correlate with 12-month valvular reflux.ConclusionsPCDT successfully removes thrombus in acute proximal DVT. However, the residual thrombus burden at procedure end does not correlate with the occurrence of PTS during the subsequent 24 months. In iliofemoral DVT, lower residual thrombus burden correlates with reduced PTS severity and possibly also with improved venous QOL and fewer early symptoms.     

Endovascular Lymphatic Decompression via Thoracic Duct Stent Placement for Refractory Ascites in Patients with Cirrhosis: A Pilot Study

PurposeTo evaluate the technical and clinical success of endovascular lymphatic decompression via thoracic duct (TD) stent placement in patients with cirrhosis with refractory ascites.Materials and MethodsNine patients (6 men and 3 women; median age, 66 [interquartile range {IQR}, 65–68] years; range, 62–78 years) who underwent TD stent placement for refractory ascites with contraindications for liver transplantation and transjugular intrahepatic portosystemic shunt creation were included in this retrospective study. TD stent placement was performed under local anesthesia using retrograde access from the venous system. Self-expanding stents from 5 to 8 mm in diameter were used and extended into the subclavian vein by approximately 1 cm. Technical (correct positioning of the stent) and clinical success (no more requirement of paracentesis) were evaluated. In addition, the safety of the procedure and TD pressure evolution were evaluated.ResultsThe technical success rate was 100%, and 3 (33%) patients reported clinical success. Five (56%) patients reported 7 minor adverse events (Grade I), among which 2 TD perforations were induced by stent angioplasty, with no clinical manifestation or treatment required. The median TD pressure decreased from 19 mm Hg (IQR, 11–24 mm Hg) at the beginning of the procedure to 6 mm Hg (IQR, 5–11 mm Hg) after TD stent placement. The median survival time after the procedure was 7.1 months.ConclusionsEndovascular lymphatic decompression via TD stent placement is feasible and safe and was effective on ascites in some patients with cirrhosis with refractory ascites.