The TOPOS study.

Background: We aimed to study the long-term safety and efficacy of oblique venous stents for post-thrombotic syndrome (PTS) with iliac vein compression. Patients and methods: In the multinational, prospective, single-arm TOPOS study, PTS patients scheduled for endovascular therapy with the sinus-Obliquus® stent and optional distal extension with the sinus-Venous® or sinus-XL Flex® stent were enrolled at eight European vascular centres between October 2016 and December 2020. The primary outcome was primary stent patency at 24 months, and secondary outcomes included the clinical course of PTS (Villalta score, revised Venous Clinical Severity Score [rVCSS], Visual Analog Scale [VAS] of pain), quality of life changes (Chronic Venous Insufficiency Quality of Life Questionnaire, CIVIQ-20), and device-related complications. Results: We enrolled 60 patients (mean age 46±15 years, 68% women, 13% active ulcers): 80% required stent extension (70% below the inguinal ligament). The primary patency rate at 24 months was 80.7% (95%CI 68.1-90.0%); it was higher in patients without vs. those with stent extension (90.9% vs. 78.3%, p=.01). Compared to baseline, the Villalta, rVCSS, pain VAS, and CIVIQ-20 decreased by a median of 8 (interquartile range (IQR): 4-11), 5 (IQR: 3-7), 3 (IQR: 2-5), and 17 (IQR: 6-22) points, respectively; p<.001 for all parameters. Overall, 9 events of acute stent occlusion, 4 symptomatic stent stenosis, and 1 pulmonary embolism occurred. We did not observe major bleeding events or contralateral thrombosis. Conclusions: Endovascular treatment with the oblique stent and optional stent extension was safe and resulted in high patency rates at 24 months. The reduction in PTS severity was substantial and persisted over 2-year follow-up.

Three-Year Outcomes of the Abre Venous Self-Expanding Stent System in Patients with Symptomatic Iliofemoral Venous Outflow Obstruction.

PURPOSE: To report 36-month outcomes and subgroup analysis of the ABRE study evaluating the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction disease. METHODS: The ABRE study was a prospective, multicenter, nonrandomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5 years [SD ± 15.9], 66.5% women) with symptomatic iliofemoral venous outflow obstruction at 24 global sites. Outcomes assessed through 36 months included patency, major adverse events, stent migration, stent fracture, and quality-of-life changes. Adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. RESULTS: Primary, primary-assisted, and secondary patency through 36 months by Kaplan-Meier estimates were 81.6%, 84.8%, and 86.3%, respectively. The cumulative incidence of major adverse events through 36 months was 10.2%, mainly driven by 12 thrombosis events. Subgroup analyses demonstrated a primary patency of 76.5% in the acute deep vein thrombosis group, 70.4% in the postthrombotic syndrome group, and 97.1% in the nonthrombotic iliac vein lesion group through 36 months. The overall mean lesion length was 112.4 mm (SD ± 66.1). There were no stent fractures or migrations in this study. Quality of life and venous functional assessments demonstrated significant improvements from baseline to 36 months across all patient subsets. CONCLUSIONS: Results from the ABRE study demonstrated sustained patency with a good safety profile after implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.

Quality of Life after Venous Stenting for Post-thrombotic Syndrome and the Effect of Inflow Disease.

OBJECTIVE: Patients with PTS experience an impaired quality of life (QoL). We aimed to study QoL in patients stented for post thrombotic syndrome (PTS) and analyze the influence of different parameters. METHODS: Patients stented for PTS after iliofemoral deep vein thrombosis were asked to complete the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36) in this cross-sectional study. All other data were collected retrospectively. Primary endpoints were median CIVIQ-20 and physical (PCS) and mental (MCS) component summary SF-36 scores. The influence of age, sex, and years between the procedure and completion of questionnaire were investigated using a multivariate linear regression model. Wilcoxon signed rank test compared the PCS and MCS with the normative. Effects of inflow from the deep femoral vein (DFV) and/or the femoral vein (FV) on QoL was analyzed in patients with patent stents. RESULTS: The response rate was 70.3% (n = 45/64). Time period (median) from stenting to questionnaire completion was 6.6 years (IQR: 8.0). Most stents were placed unilateral left-sided (73.3%). For patients with patent stents (n = 42) median CIVIQ-20 was 35.5 (IQR: 17.3), higher than the minimum of 20.0 (P < .001). Median PCS of 44.7 (IQR: 14.2) was lower (P < .001), and MCS of 55.9 (IQR: 7.1) higher (P = .001) than the normative (50.0). Time since stenting and sex were not associated with QoL. Age was a significant predictor [standardized coefficient ß = .36, P = .04] for QoL using the CIVIQ-20, but not for the SF-36. Inflow disease did not impact QoL, but patients with occluded stents (n = 3) had poor functioning levels. CONCLUSION: Quality of life is impaired after venous stenting for PTS, particularly physical functioning, among patients with an open stent, but was similar between patients with good and impaired inflow. Patients with a permanent stent occlusion had the lowest QoL.

Pregnancy after iliac vein stenting for pelvic venous insufficiency.

BACKGROUND: The use of iliac vein stenting for the treatment of pelvic pain secondary to pelvic venous insufficiency has significantly increased. In women of childbearing age, the effect of the gravid uterus on stent function and patency is unclear. The purpose of this investigation was to determine the effect of pregnancy on stent patency and reintervention rate in women with iliac vein stents. METHODS: A retrospective chart review and email survey was performed to identify women treated at the Center for Vascular Medicine who were treated with iliac vein stenting and who had subsequent pregnancies. Medical and surgical comorbidities, stent type, location, length, number of stents, reintervention rates, number of pregnancies after stenting, anticoagulation usage during pregnancy, and type of delivery were assessed. RESULTS: From January 2014 to December 2020, 15 women with 16 iliac vein stents and who had 17 subsequent pregnancies were identified. The average age at stenting was 35.3 ± 4.13 years. The average interval between stenting and conception was 350 ± 287 days. Before pregnancy, stent location was in the right common/right external iliac veins in 1 patient and left common/external iliac veins in 14 patients. The average stent diameter and length were 19.6 ± 3 and 79.5 ± 20.3 mm, respectively. Thirteen Boston Scientific Wallstents and three Bard Venovo stents were used before pregnancy. One patient with a Wallstent required a stent extension before pregnancy and one patient had two stents placed at the initial procedure. Two women were pregnant twice after stenting for a total of 17 pregnancies. There were 16 term and 1 premature delivery of single infants. Patients were treated with enoxaparin (Lovenox) for stent-related thrombosis prophylaxis in 11 of 17 pregnancies, 5 had no prophylaxis, and the status of 1 pregnancy is unknown. One asymptomatic patient underwent a stent venoplasty after delivery. CONCLUSIONS: Iliac vein stents tolerate a gravid uterus well. No stents thrombosed during or after pregnancy and none required reintervention secondary to pregnancy-related compression. Anticoagulation with low-molecular-weight heparin should be considered for stent thrombosis prophylaxis. Potential pregnancy should not be considered a contraindication to iliac vein stenting for the treatment of symptomatic pelvic venous insufficiency.

Utility of a Mechanical Thrombectomy Device in Treating Calcified Instent Restenosis Post Iliofemoral Venous Stenting.

Instent restenosis (ISR) following iliofemoral venous stenting is quite common with up to three-quarters of patients developing some degree of ISR. However, only around 16% develop recurrent symptoms impairing their quality-of-life meriting reintervention. The first line of treatment for such ISR involves the use of angioplasty balloons to recreate an adequate flow channel. At times such angioplasty alone is inadequate particularly in the presence of calcified ISR. It is in this setting that the authors decided to explore the utility of a mechanical thrombectomy device to debulk the ISR and thereby help create an adequate flow channel. The successful utilization of such a device in a patient presenting with recurrent, disabling, quality of life impairing symptoms due to ISR represents the focus of this report.

Partial In-Stent Thrombosis After Iliac Vein Stenting in Non-Thrombotic Vein Lesions.

OBJECTIVE: Iliac vein stenting is a safe and efficacious procedure for the correction of iliac vein stenosis. One of its known major complications is complete iliac vein stent thrombosis. However, we have noticed in our practice that a number of patients developed only early partial in-stent (<60%) thrombosis, within the first 30 days. In order to try to learn more about these lesions, we reviewed the data for possible causes of these lesions. MATERIALS/METHODS: From September 2012 to August 2018, we obtained 3518 iliac vein venograms using intravascular ultrasound (IVUS) for patients with venous insufficiency who failed to respond to conservative therapy. Patients were followed up with transcutaneous duplex ultrasound (DUS) every 3 months for the first year and every 6 - 12 months thereafter. Patients were prescribed clopidogrel for 3 months or were told to continue their pre-existing anticoagulants. RESULTS: There were 2234 women and 1284 men who received an iliac vein stent. The mean age was 65.7 ±14 years. Mean follow-up for this cohort was 17 months. Of 74 patients developed a full thrombosis, 38 developed a partial venous thrombosis and 3406 developed no thrombosis. When comparing those who developed a partial thrombus versus those who developed no thrombus/full thrombus, overall age, laterality, CEAP, gender, and whether the patient received clopidogrel prior to the procedure and after the procedure were not found to be statistically significant factors. However, patients with an ASA score of 2 or 3,were found to be at a higher risk of developing a partial thrombus(P = 0.0223) compared to those who had an ASA score of 1 or 4. CEAP Scores and ASA class breakdown can be seen in Table 1 and Table 2, respectively. Of the 38 partial venous thrombosis that developed,18 completely resolved within the first 3 months after the procedure and 20 remained chronic past 3 months after the procedure. Patients with partial venous thrombosis were asymptomatic upon clinical presentation, and none developed post thrombotic syndrome (PTS) or pulmonary embolism (PE). Male gender was associated with partial thrombus resolution(P = 0.0036) CONCLUSIONS: Patients with ASA scores of 2 or 3, seemed to be at a higher risk of developing a partial thrombus when compared to patients with ASA score of 1 or 4. Male gender was associated with partial thrombus resolution. All other factors appear to not be statistically significant in impacting the development of a partial thrombus. This has been the first attempt to look at this new clinical entity.

Female Gender is a Predictor of Lower Iliac Vein Stenting Patency Rates.

BACKGROUND: Iliac venous stenting (IVS) for thrombotic and nonthrombotic venous disease is increasingly used as evidence of the safety, efficacy and durability of these interventions increases. Female gender has been implicated as a predictor of failure in arterial endovascular interventions. We hypothesize that female gender could be predictive of patency rates of iliac vein stenting. METHODS: Consecutive patients who underwent IVS for thrombotic or nonthrombotic venous disease at our institution from 2007 until 2019 were identified and divided into groups based on gender. Operative notes, venograms, and the electronic health record were then queried to obtain operative details, co-morbid conditions, postoperative outcomes and stent patency. Study outcome was long term patency rate. The data was analyzed using chi-square, logistic regression, and Kaplan-Meier analysis as appropriate. RESULTS: A total of 200 consecutive patients (231 limbs) were identified in our retrospective analysis, with a mean age of 48.8 ± 17.3, and BMI of 31.6 ± 8.6. Of those, 119 (59.5%) patients, (131 [56.8%] limbs) were female. Comparisons between the gender groups revealed no difference in age, BMI, or preoperative comorbidities. There was no difference in type of venous disease between male (85% thrombotic, 15% nonthrombotic) and female (84% thrombotic, 16% nonthrombotic), P= 0.830. The male cohort was more likely to present with leg ulceration (17% vs. 4.6%, P = 0.002), and the female cohort was more likely to present with leg edema (98.5% vs. 93.0%, P= 0.03). The male cohort had a higher rate of caval (48% vs. 33.6%, P= 0.027) and infrainguinal stent extension. (11% vs. 6.9%, P= 0.02). Females had a higher rate of left sided stenting (80.9% vs. 66/0%, P= 0.010). There was no difference in the median stent diameter used between the cohorts. Primary patency at 5 years was significantly higher for the male cohort (94.1% vs. 74.4%, P= 0.01) On adjusted multivariable cox regression female gender was a predictor of loss of primary patency within 5 years (HR, 4.04; P= 0.007). CONCLUSIONS: In this single center retrospective analysis of IVS, male patients were found to have better primary stent patency compared to female.

Common iliac vein stenting for May-Thurner syndrome and subsequent pregnancy.

BACKGROUND: For women with left common iliac vein compression (ie, May-Thurner syndrome) who undergo venous stenting and subsequently become pregnant, concerns have been raised regarding a possible compromise of stent patency due to compression from the gravid uterus and the hypercoagulability induced by pregnancy. Only a small body of literature exists on this subject, and limited management guidelines are available. The present study was designed to evaluate the safety of iliac vein stenting for May-Thurner syndrome (MTS) with subsequent pregnancy. METHODS: Female patients who had undergone common iliac vein stenting at our center who were aged 18 to 45 years and had subsequently become pregnant were identified. A retrospective medical record review of eight eligible patients was conducted, recording the demographics, procedural characteristics, and anticoagulation strategies. The primary outcome evaluated was stent patency. RESULTS: All eight patients had undergone left common iliac vein stenting for MTS. A total of eight stents were placed, and all demonstrated duplex ultrasound patency throughout pregnancy and postpartum. Seven patients delivered healthy pregnancies, and one experienced a stillbirth. The clinical CEAP (clinical, etiologic, anatomic, pathophysiologic) class remained unchanged or improved from pregnancy to postpartum for all patients. The average age at stent placement was 31 ± 5 years, and the average interval from stent placement to pregnancy was 28 ± 19 months. One patient developed nonobstructive deep vein thrombosis (DVT) of the left femoral vein during pregnancy and was treated with therapeutic enoxaparin. The nonobstructive DVT did not compromise the iliac vein stent. Two patients received low-dose aspirin and prophylactic doses of enoxaparin, one for a history of DVT and factor V Leiden and one for a recent history of fertility treatment. The five remaining patients received no anticoagulation, three received low-dose aspirin, and two received no antiplatelet therapy. CONCLUSIONS: Common iliac vein stent patency was not compromised by subsequent pregnancy in our eight patients with MTS. Furthermore, the stents remained patent throughout pregnancy in patients receiving a wide range of anticoagulation and antiplatelet treatments, suggesting that no uniform therapeutic threshold exists and treatment should be individualized. For most patients, low-dose aspirin alone or no treatment was adequate. This could have implications for counseling women who require intervention for MTS and are of child-bearing age.

Effect of body mass index on initial presentation and outcomes after stenting for quality of life-impairing chronic iliofemoral venous obstruction.

OBJECTIVE: The incidence of obesity has been increasing, with recent data indicating that the age-adjusted mean body mass index (BMI) is close to 30 kg/m2 in the United States. Prior studies have raised concerns for an increased incidence of chronic venous insufficiency in the obese population. We aimed to build on current knowledge by assessing the effects of BMI on the initial presentation and outcomes after intravascular ultrasound (IVUS) luminal area-guided stenting in patients presenting with quality of life (QOL)-impairing chronic iliofemoral venous obstruction (CIVO). METHODS: A retrospective analysis of contemporaneously entered electronic medical record data on 464 continuous patients (464 limbs) with initial iliofemoral stents (2014-2017) for QOL-impairing CIVO was performed. The characteristics evaluated and compared included the degree of iliofemoral compression, CEAP (clinical, etiologic, anatomic, pathophysiologic) clinical class, venous clinical severity score (VCSS), grade of swelling (GOS), visual analog scale (VAS) for pain score, ulcer healing, reflux (venous segmental disease score; venous filling index-90), calf pump function (ejection fraction; residual volume fraction), and quality of life (CIVIQ-20 [chronic lower limb venous insufficiency 20-item questionnaire]) for those with a BMI <30 kg/m2 (group I) and a BMI ≥30 kg/m2 (group II). Paired and unpaired t tests were used for comparisons of the clinical variables and a Kaplan-Meier analysis was used to evaluate stent patency. RESULTS: Of the 464 limbs in the study cohort, 122 were in group I and 342 in group II. The median BMI was 26.3 kg/m2 (interquartile range, 19.6-29.9 kg/m2) in group I and 38.9 kg/m2 (interquartile range, 30.0-66.9 kg/m2) in group II. The IVUS luminal area-determined degree of compression was higher in group I than in group II across the common iliac, external iliac, and common femoral segments (P < .01). The supine foot venous and femoral venous pressures were higher in group II than in group I (P < .001). The ejection fraction was higher (57.4% vs 45.6%; P = .0008) and residual volume fraction was lower (27.5% vs 40.5%; P = .0008) in group II than in group I. Although the baseline VCSS and GOS were lower in group I than in group II (P < .05), no differences were found in the VAS for pain scores or ulcer prevalence. The median follow-up was 22 months. At 24 months after stenting, improvement was found in the VCSS, GOS, and VAS for pain score in both groups. The CIVIQ-20 QOL score had improved from 58.1 to 18.8 in group I (P = .0002) and from 60 to 37.5 in group II (P < .0001). At 5 years, primary patency was 70% in group I and 73% in group II (P = .6) and primary assisted patency was 100% in both groups (P = .99) without a significant difference in the reintervention rate (P = .5). CONCLUSIONS: Obese patients with CIVO-impairing QOL have a lesser degree of iliofemoral venous stenosis, more severe venous hypertension, and better calf pump function than their nonobese counterparts. After stenting, no differences were found in the clinical, stent patency, or QOL-related outcomes between the two groups.

An overview of in-stent restenosis in iliofemoral venous stents.

BACKGROUND: Although endovenous stents have been associated with overall low morbidity, they can require reinterventions to correct stent malfunction due to in-stent restenosis (ISR). ISR has often occurred iliofemoral venous stents but has not been well described. It has been reported to develop in >70% of patients who have undergone iliofemoral venous stenting. We sought to provide an overview of ISR in iliofemoral venous stents, including the pathologic, diagnostic, and management considerations and the identification of several areas of potential research in the future. METHODS: A search of reported English-language studies was performed in PubMed and the Cochrane Library. "In-stent restenosis," "vein," "venous," "iliac," and "iliofemoral" were used as keywords. The pertinent reports included in the present review had addressed the pathology, diagnosis, and current management options for ISR. RESULTS: ISR refers to the narrowing of the luminal caliber of the stent owing to the development of stenosis inside the stent itself. ISR should be differentiated from stent compression. Two main types of ISR have been described: soft and hard lesions. These lesions respond differently to angioplasty. Stent inflow and shear stress are important factors in the development of ISR. The treatment options available at present include balloon angioplasty (hyperdilation or isodilation), laser ablation, atherectomy, and Z-stent placement. CONCLUSIONS: Reintervention for ISR should be determined by the presence of residual or recurrent symptoms and not simply by a numeric value obtained from an imaging study. Overall stent occlusion due to ISR is rare, and no role exists for prophylactic angioplasty to treat asymptomatic ISR. The current treatment options for ISR are mostly durable and effective. However, more research is needed on methods to prevent the development of ISR. The role of antiplatelet and anticoagulant agents in the prevention of ISR requires further investigation, with particular attention to unique subset of patients (after thrombosis vs nonthrombotic iliac vein lesions). For high-risk, post-thrombotic patients, anticoagulation can be considered to prevent ISR. The role of triple therapy (anticoagulation and dual antiplatelet therapy) in the prevention of ISR remains unclear.

Phlegmasia Cerulea Dolens: a sudden unexpected death with hypothesis of medical malpractice.

ABSTRACT: Phlegmasia Cerulea Dolens (PCD) is a severe and rare form of venous thrombosis of the lower extremities, caused by a subtotal or complete occlusion of venous outflow by a thrombus. PCD should be considered a real medical emergency; complications include necrosis and gangrene of the affected limb, amputation, massive pulmonary embolism and, in extreme cases, the death of the patient. Case Report. A 63-years-old man was admitted to the Emergency room with localized pain on the right calf, hyperthermia, cold sweating and vomiting episodes. Five days prior he developed flu-like symptoms, joint pain and cold sensation unresponsive to treatment. Ultrasound examination showed a deep venous thrombosis of the lower right limb with partial occlusion of common iliac and femoral veins. The patient was treated with low molecular weight heparin given twice daily. He began to develop severe hypotension and metabolic acidosis, with tachycardia and atrial fibrillation. Despite the treatment, there was no improvement and he developed severe sinus node dysfunction. He failed to respond to all resuscitative efforts and died. Family members complained Authority, assuming it was a medical error. The clinical-forensic investigation is essential to determine the causes and manner of death and to assess medical responsibility and liability.

Iliac Vein Stenosis: Is the Data Strong Enough for Stenting in the Young Pelvic Venous Disorders (PeVD) Population?

Iliac vein stenosis is a clinical condition resulting from external compression of the iliocaval venous unit with the consequent remodeling of the vascular wall, hemodynamic alterations, and predisposition to venous thrombosis. As such, the most common indications for percutaneous endovascular iliac vein stenting supported by the literature, include the management of thrombotic and non-thrombotic iliac venous lesions associated with advanced chronic venous disease (CVD). However, its clinical presentation is variable, and it may also include features associated with PeVD such as chronic pelvic pain, perineal heaviness, urinary urgency, postcoital pain, and vulvar or superficial non-saphenous veins varicosities. In this setting, the management revolves around the relieving venous obstruction and restoring normal blood flow through the compressed vein with percutaneous endovascular iliac vein stenting, that can be augmented with ovarian vein embolization (OVE) or direct embolization of the superficial varices. Given the heterogeneity of PeVD presentation and the lack of high-level quality data in outcomes for iliac vein stenosis stenting, this review will discuss the current evidence available for this intervention and clinical issues to consider when evaluating these patients.

Timing of Endovascular Interventions for Iliac Vein Compression Syndrome With Thrombus.

The aim of this study is to explore the timing and method of endovascular intervention for iliac vein compression syndrome (IVCS) with thrombus. Data from 111 patients with IVCS, complicated acute deep vein thrombosis (DVT), or post-thrombotic syndrome (PTS) who underwent endovascular interventions were analyzed retrospectively. Patients were divided into Group A (DVT group), including 56 patients with IVCS and iliofemoral DVT, with or without femoropopliteal DVT, with sudden lower limb swelling, and Group B (PTS group) included 55 patients with IVCS and PTS, including 18 with lower extremity wet ulcers and 32 with lower limb infections. Interventional therapies were used to treat the thrombus and eliminate stenosis and occlusion of the iliac vein. In both groups, clinical symptoms in the lower limbs after surgery were reduced significantly, and PTS incidence was low during long-term follow-up. The cumulative patency rate was 75.2% in the DVT group and 88.6% in the PTS group. Comprehensive interventional therapies are safe and effective in patients with IVCS and thrombi. Long-term efficacy in the PTS group tended to be better than that in the DVT group.

Contemporary treatment of May-Thurner Syndrome.

Compression of the left common iliac vein by the overlying right common iliac artery is a benign anatomic abnormality in most individuals. However, in patients with significant vein compression, outflow obstruction and chronic intraluminal venous damage may lead to May-Thurner Syndrome. This syndrome commonly manifests as unilateral left leg swelling or acute iliofemoral deep venous thrombosis. In addition to clinical findings, diagnosis is made with ultrasound, computed tomography venography, or magnetic resonance venography. The extent of compression of the iliac vein is best determined by venography with intravascular ultrasound. Symptoms and hemodynamic significance of the compression guides the ideal treatment approach. Iliocaval stenting has become the standard treatment for this condition and has promising patency rates and clinical outcomes. This review paper provided an overview of pathophysiology, and utility and limitations of the existing diagnostic modalities and treatment options in the management of May-Thurner Syndrome.

Clinical Outcomes of Stenting Extending Below the Inguinal Ligament for Treatment of Chronic Iliofemoral Venous Obstruction.

BACKGROUND: Patients with chronic iliofemoral venous obstructive lesions that often require stenting extending below the inguinal ligament. However, the issue of stents crossing the inguinal ligament is currently controversial. Some guidelines suggest that it should be avoided, and some guidelines suggest that in order to ensure adequate flow, the inguinal ligament can be crossed if necessary. The aim of this study was to evaluate the technical aspects and examine patency rates of stent placement across the inguinal ligament for managing iliofemoral venous obstruction. METHODS: A retrospective analysis of 127 patients with chronic iliofemoral venous obstruction were treated with interventional surgery in a single institution from January 2012 to January 2018 was conducted. All patients underwent balloon dilatation and placement of at least 2 stents extending below inguinal ligament. Inflow condition, technical success, operation duration, stent patency rates, anticoagulant selection and duration, and complications were recorded after the interventions. RESULTS: The technical success rate was 100%. No major perioperative complications occurred. The mean number of stents was 2.14 ± 0.37. Follow up periods ranged from 12 to 60 months (28.79 ± 10.90 months). Overall cumulative primary, assisted primary, and secondary stent patency rates were 81.9%, 90.5%, and 92.9% at 12 months and 70.4%, 80.9%, and 86.0% at 24 months, and 64.2%, 72.3%, and 74.3% at 36months, respectively. Cumulative patency rates at 12 months, 24 months and 36 months were significantly greater in the patients with "good" inflow as compared to "fair" inflow. The symptoms of all patients improved. None of the stents were compressed, fractured or migrated. CONCLUSIONS: Stenting across the inguinal ligament for treatment of the patients with chronic iliofemoral venous obstruction was a feasible and safe treatment with good patency and clinical results in short and midterm follow up, and stents with good inflow have better patency.

Comparison of Pharmacomechanical Catheter-Directed Thrombolysis versus Catheter-Directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Vein Thrombosis: Measures of Long-Term Clinical Outcome and Quality of Life.

BACKGROUND: We studied the occurrence of post-thrombotic syndrome (PTS) in patients with either Pharmacomechanical Catheter-Directed Thrombolysis (hereafter "pharmacomechanical thrombolysis"; PT) or Catheter-Directed Thrombolysis (CDT) for the treatment of acute iliofemoral deep vein thrombosis (DVT). METHODS: This retrospective study of data archived between September 2013 and September 2015 was surveyed. Two separate patient populations were identified and analyzed: patients were separated into PT group or CDT group. For up to 5 years post-treatment, the incidence, severity of PTS, and chronic venous insufficiency questionnaire (CIVIQ) score difference were compared. RESULTS: The study identified 131 patients divided into PT group (65) and CDT group (66). Within the 5-year follow-up period, there was no significant difference in the incidence of PTS (45.0% PT vs. 57.6% CDT; odds ratio (OR) = 0.602; 95% confidence interval (CI), 0.291-1.242; P = 0.201), but there was reduced severe PTS in the PT group (Villalta scale ≥15 or ulcer:11.7% PT vs. 27.1% CDT; OR 0.355; 95%CI 0.134-0.941, P = 0.039; and Venous Clinical Severity Score (VCSS) ≥8: 13.3%PT vs. 28.8% CDT; OR 0.380; 95% CI 0.149-0.967, P = 0.045). There was also a larger improvement of venous disease-specific quality of life (QOL) in the PT group at 5 years [(62.89 ± 14.19) vs (56.39 ±15.62), P = 0.036] compared to the CDT group. CONCLUSION: In patients with acute iliofemoral DVT treated with PT, PT significantly reduced PTS severity scores, and resulted in greater improvement in venous disease-specific QOL. However, the incidence of was not significantly different from that measured in the CDT.

Effect of Pre-Procedure Clopidogrel With Iliac Vein Stenting in Non-Thrombotic Vein Lesions.

OBJECTIVES: Iliac vein stenting is a relatively new procedure in the treatment of chronic venous insufficiency. Research has shown that it is a safe and effective form of treatment, however, one of the well-known risks is in-stent thrombosis. We hypothesize that a single 75 mg dose of Clopidogrel the night prior to the procedures along with a 3-month regimen post-op would decrease the 30-day thrombosis rate. METHODS: A retrospective study was performed on 3,518 patients from September 2012 to August 2018 who received an iliofemoral stent. Patients were broken down into 2 main groups: those given Clopidogrel post-stent and those given Clopidogrel both pre- and post-stent. In our practice, we prescribe a 3-month course of Clopidogrel after iliac vein stenting. Patients were also checked for any anticoagulant medications pre- and/or post-stent. The 30-day thrombosis rates were recorded for each patient. RESULTS: 1,205 patients received Clopidogrel pre-procedurally and post-procedurally, 1,941 patients received Clopidogrel only post-procedurally. 372 patients were excluded from the study because they were on other anti-coagulant medications. Mean follow-up for this cohort was 17 months. 112 total patients developed some degree of 30 day in-stent thrombosis (3.6%). 74 patients developed a complete thrombosis of the stent and 38 developed a partial (≤60% occlusion) thrombosis. Of the 1,205 patients who were on clopidogrel pre-stenting, 28 had a complete thrombosis and 10 had a partial in-stent thrombosis. Of the 1,941 patients on Clopidogrel only post-stenting, 46 had a complete thrombosis and 28 had a partial in-stent thrombosis. Using the Chi-squared test, there were no statistically significant differences between the group of patients receiving Clopidogrel pre- and post-stent vs. just post-stent with respect to 30-day any degree of thrombosis rates (complete and partial thrombosis) (p = .33). Using the Chi-squared test, there were no statistically significant differences between the group of patients receiving Clopidogrel pre- and post-stent vs. just post-stent with respect to 30-day complete thrombosis rates (p = .93). CONCLUSIONS: There appears to be no statistical difference in 30-day thrombosis rates between those receiving Clopidogrel the night prior vs. those who do not receive Clopidogrel the night prior. Therefore, we conclude that it is not necessary to give this single dose the night prior to iliac vein stenting procedures.

Comparing Safety and Efficacy of Rivaroxaban with Warfarin for Patients after Successful Stent Placement for Chronic Iliofemoral Occlusion: A Retrospective Single Institution Study.

OBJECTIVE: The aim was to compare the safety and effectiveness of rivaroxaban and warfarin as anticoagulants for treating patients with post-thrombotic syndrome (PTS) with chronic iliofemoral venous occlusion undergoing iliofemoral venous stenting. METHODS: This single institution retrospective study analysed patients with PTS with chronic iliofemoral venous occlusion who were prescribed rivaroxaban or warfarin for one year after successfully undergoing iliofemoral venous stenting. The primary safety and efficacy endpoints were bleeding complication rate and primary patency rate at one year. Secondary outcomes included Villalta score, symptom recurrence rate, ulcer healing rate, and clinically driven target lesion revascularisation (CD-TLR) rate during follow up. RESULTS: From January 2016 to December 2017, 154 legs from 154 patients were included in this study (69 in rivaroxaban group and 85 in warfarin group). The groups were well matched for patient demographics, clinical characteristics, and procedural details. There was no significant difference between the rivaroxaban group and warfarin group in bleeding complication rate (10% vs. 16%, p = .23, hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.25 - 1.37) at one year, as well as major bleeding complication rate (0% vs. 2%, p = .20, HR 0.16, 95% CI 0.01 - 2.61) and minor bleeding complication rate (10% vs. 14%, p = .40, HR 0.67, 95% CI 0.27 - 1.66). The primary patency rate was higher in the rivaroxaban group at one year (84% vs. 71%, p = .049, HR 0.50, 95% CI 0.26 - 0.96) and at two years (79% vs. 63%, p = .037, HR 0.52, 95% CI 0.29 - 0.93). At a mean follow up of 24 months (range 1 - 42 months), the rivaroxaban group had a significantly lower post-operative Villalta score (4.87 ± 3.51 vs. 6.88 ± 5.85, p = .010, t = 2.64, 95% CI 0.50 - 3.52), lower rate of symptom recurrence (4% vs. 32%, p < .001), lower CD-TLR rates (3% vs. 13%, p = .039), and higher ulcer healing rate (90% vs. 59%, p = .004) than the warfarin group. CONCLUSION: For PTS patients with chronic iliofemoral venous occlusion undergoing iliofemoral venous stenting, rivaroxaban probably exhibited similar safety but superior efficacy to warfarin. However, further prospective control studies with large sample size are necessary to confirm the results.

Doppler ultrasound and contrast-enhanced ultrasound in detection of stent stenosis after iliac vein stenting.

BACKGROUND: To compare the diagnostic accuracy of Doppler ultrasound (DUS) with contrast-enhanced ultrasound (CEUS) for detection of iliac vein stent stenosis using multidetector computed tomography venography (MDCTV) as the reference method. METHODS: Patients with iliac vein obstructive disease treated with nitinol stents (Smart Control, Cordis, USA) between January 2016 and December 2017 were consecutively included in this study. DUS, CEUS, and MDCTV were carried out in all patients within one week of each other at 1 year post stenting to investigate the presence of stent compression and in-stent restenosis (ISR). RESULTS: The study included 139 patients (87 females; mean age 58 ± 15 years). For detecting stent compression, the kappa coefficient between the ultrasound modality of gray-scale imaging and MDCTV was 0.901, indicating very good agreement between these two modalities. ISR was detected in 50, 61, and 65 patients by DUS, CEUS, and MDCTV, respectively. DUS and CEUS (kappa = 0.449) and DUS and MDCTV (kappa = 0.516) had moderate agreement for ISR diagnosis, while for which CEUS and MDCTV (kappa 0.884) had very good agreement. The sensitivity and specificity of DUS and CEUS for diagnosing ISR were 63.1% and 90.8%, 87.8% and 97.3%, respectively. CONCLUSIONS: CEUS is probably superior to DUS in terms of diagnostic accuracy for the follow-up of patients with iliac vein stent stenosis.