Haemodynamic study of left nonthrombotic iliac vein lesions: a preliminary report.

Nonthrombotic iliac vein lesions (NIVLs) are significant causes of chronic venous insufficiency (CVI) in the left lower limb and symptom recurrence following left lower limb varicose vein treatment. The goal of this study was to explore the haemodynamic and morphological characteristics of iliac veins in patients with NIVLs. Pressure at the caudal end of the stenotic left common iliac vein (LCIV) segment, local blood flow velocity, and time-averaged wall shear stress in the stenotic segment exhibited positive correlations with the clinical CVI classification (R = 0.92, p < 0.001; R = 0.94, p < 0.001; R = 0.87, p < 0.001), while the relative retention time showed a negative correlation (R = -0.94, p < 0.001). The pressure difference (∆P) between the two ends of the stenotic segment and the velocity difference (∆V) between the stenotic segment and the caudal end were positively correlated with the clinical classification (R = 0.92, p < 0.001; R = 0.9, p < 0.001). The cross-sectional area stenosis rate and length of the stenotic LCIV segment were positively correlated with the clinical classification (R = 0.93, p < 0.001; R = 0.63, p < 0.001). The results suggest that haemodynamic assessment of the iliac vein could effectively portray blood flow disturbances in stenotic segments of the LCIV, potentially reflecting the degree of iliac vein stenosis. Haemodynamic indicators are correlated with the severity of clinical CVI symptoms.

Venous Compressive Disorders.

Venous compressive disorders are a heterogenous group of vascular syndromes characterized by extrinsic venous compression that can lead to complications of venous hypertension or venous thrombosis. Endovascular damage secondary to deep venous thrombosis (DVT) can result in post-thrombotic syndrome (PTS), a potentially debilitating condition that can be associated with significant morbidity in the pediatric population. Here we discuss 4 venous compressive disorders: iliac vein compression (May-Thurner syndrome [MTS]); subclavian vein compression at the venous thoracic inlet (Paget-Schroetter syndrome); left renal vein compression (nutcracker syndrome); and popliteal vein compression (popliteal entrapment syndrome) with a focus on clinical evaluation and diagnostic methods. Where endovascular therapy is appropriate, specific procedural considerations including procedure indications, equipment, procedural steps, technical challenges, complications, clinical follow-up and expected outcomes are discussed.

Consensus Statement on the Management of Nonthrombotic Iliac Vein Lesions From the VIVA Foundation, the American Venous Forum, and the American Vein and Lymphatic Society.

A nonthrombotic iliac vein lesion is defined as the extrinsic compression of the iliac vein. Symptoms of lower extremity chronic venous insufficiency or pelvic venous disease can develop secondary to nonthrombotic iliac vein lesion. Anatomic compression has been observed in both symptomatic and asymptomatic patients. Causative factors that lead to symptomatic manifestations remain unclear. To provide guidance for providers treating patients with nonthrombotic iliac vein lesion, the VIVA Foundation convened a multidisciplinary group of leaders in venous disease management with representatives from the American Venous Forum and the American Vein and Lymphatic Society. Consensus statements regarding nonthrombotic iliac vein lesions were drafted by the participants to address patient selection, imaging for diagnosis, technical considerations for stent placement, postprocedure management, and future research/educational needs.

The Safety and Efficacy of ZelanteDVT™ Catheter Rheolytic Thrombectomy in the Treatment of Patients with Iliac Vein Stent Thrombosis.

BACKGROUND: To examine the safety and efficacy of ZelanteDVT™ catheter rheolytic thrombectomy in the treatment of patients with iliac vein stent thrombosis. METHODS: A retrospective analysis method was conducted by means of collecting the data of 32 patients who had completed the treatment of iliac vein stent thrombosis with ZelanteDVT catheter rheolytic thrombectomy from March 2019 to March 2023. Data on clinical characteristics, technical success, clinical success, complications, and early follow-up were analyzed. RESULTS: The technical success rates were 100%, intraoperatively, in which 22 cases were improved to thrombus clearance Grade II (50-90%), 10 were Grade III (>90%). There were 21 cases treated with subsequent catheter-directed thrombolysis, and the average urokinase administration of (120.90 ± 29.63)∗10ˆ4 units. The clinical success rates were 100% and the swelling of the affected limbs were significantly improved, a significant difference in the pre/postoperative between-thigh circumference difference [(5.16 ± 1.08) vs. (1.75 ± 0.84), P < 0.000]. The pre/postoperative Venous Clinical Severity Score was [(12.94 ± 1.70) vs. (7.44 ± 1.31), P < 0.000]. No serious complications occurred during the perioperative period. The postoperative and 12-month stent patency rate was 100.00% (32/32) and 71.88% (23/32), respectively. CONCLUSIONS: The ZelanteDVT catheter rheolytic thrombectomy seems to have a promising application prospect for the treatment of patients with iliac vein stent thrombosis.

Quantitative 2-Dimensionsal Digital Subtraction Venography for Venous Interventions: Validation in Phantom and In Vivo Porcine Models.

PURPOSE: To determine the feasibility of using a 2-dimensional quantitative digital subtraction venography (qDSV) technique that employs a temporally modulated contrast medium injection to quantify blood velocity in phantom, normal, and stenotic porcine iliac vein models. MATERIALS AND METHODS: Blood velocity was calculated using qDSV following temporally modulated pulsed injections of iodinated contrast medium and compared with Doppler ultrasound (US) measurements (phantom, in-line sensor; in vivo, diagnostic linear probe). Phantom evaluation was performed in a compliant polyethylene tube phantom with simulated venous flow. In vivo evaluation of qDSV was performed in normal (n = 7) and stenotic (n = 3) iliac vein models. Stenoses were created using endovenous radiofrequency ablation, and blood velocities were determined at baseline, after stenosis, after venoplasty, and after stent placement. RESULTS: In the phantom model, qDSV-calculated blood velocities (12-50 cm/s) had very strong correlations with US-measured velocities (13-51 cm/s) across a range of baseline blood velocities and injection protocols (slope, 1.01-1.13; R2 = 0.96-0.99). qDSV velocities were similar to US velocities regardless of injection method: (a) custom injector, (b) commercial injector, or (c) hand injection. In the normal in vivo model, qDSV-calculated velocities (5-18 cm/s) had strong correlation (slope, 1.22; R2 = 0.90) with US-measured velocities (3-20 cm/s). In the stenosis model, blood velocities at baseline, after stenosis, after venoplasty, and after stent placement were similar on qDSV and US at all time points. CONCLUSIONS: Venous blood velocity was accurately quantified in a venous phantom and in vivo porcine models using qDSV. Intraprocedural changes in porcine iliac vein blood velocity were quantified with qDSV after creation of a stenosis and subsequently treating it with venoplasty and stent placement.

Interventional treatment for post-thrombotic chronic venous obstruction: Progress and challenges.

Chronic venous obstruction, including nonthrombotic iliac vein lesions and post-thrombotic syndrome, presents a significant burden on patients' quality of life and health care systems. Venous recanalization and stenting have emerged as promising minimally invasive approaches, yet challenges in patient selection, procedural techniques, and long-term outcomes persist. This review synthesizes current knowledge on the interventional treatment of post-thrombotic syndrome, focusing on the evolution of endovascular techniques and stenting. Patient selection criteria, procedural details, and the characteristics of dedicated venous stents are discussed. Particular emphasis is given to the role of inflow and other anatomical considerations, along with postoperative management protocols for an optimal long-term outcome.

Application of 4D flow MRI for exploring factors affecting haemodynamics of iliac veins in asymptomatic population.

BACKGROUND: Haemodynamics plays an important role in the development of vascular disease. There is currently a lack of studies evaluating the characteristics and affecting factors of the iliac vein haemodynamics in clinical practice. OBJECTIVE: The goal of this study was to use 4D flow MRI to explore the haemodynamic characteristics of iliac veins and its affecting factors in an asymptomatic population. METHODS: Thirty consecutive volunteers without venous-related symptoms or signs underwent four-dimensional postprocessing of their MRI images. Relevant parameters, the demographic data, common iliac vein-inferior vena cava angle, iliac vein area, tortuosity, iliac vein mean flow, mean velocity was computed and analysed. T tests and Spearman's tests were used for analysing. A P value of 0.05 or less was considered significant. RESULTS: Height and iliac vein area were positively correlated with flow, while degree of stenosis, and common iliac-inferior vena cava angle were negatively correlated with that. Degree of stenosis was positively correlated with velocity, but the common iliac-inferior vena cava angle and iliac vein tortuosity were negatively correlated with that. The mean flow and velocity of iliac veins in females were lower than males. The mean flow and velocity of the left iliac veins were lower than those of the right. CONCLUSION: The height, gender, tortuosity, degree of stenosis, common iliac vein-inferior vena cava angle of the iliac vein are important factors that affect flow and velocity of the iliac veins. There were differences in haemodynamic parameters of the bilateral iliac veins.

Impact of native iliac vein aspect ratio on initial clinical presentation and outcomes following stenting for symptomatic chronic iliofemoral venous obstruction.

OBJECTIVE: Venous stenting has become the first line of treatment for patients with symptomatic chronic iliofemoral venous obstruction (CIVO) in whom conservative therapy has failed. Intravascular ultrasound (IVUS) interrogation with the use of normal minimal luminal diameters or areas has become the standard to confirm the diagnosis and determine the adequacy of stenting. However, the aspect ratio (ratio between the maximal and minimal luminal diameters) has also been put forth as a possible metric for determining stent adequacy. This study explores the utility of the native iliac vein and stent aspect ratios in determining the initial presentation and outcomes after stenting. METHODS: A retrospective analysis of contemporaneously entered data from patients who underwent stenting for quality of life (QoL)-impairing clinical manifestations of CIVO for whom conservative therapy had failed formed the study cohort. The limbs were grouped into three at the time of intervention using the IVUS-determined native vein aspect ratio: group I, those with a ratio of ≤1.4; group II, those with a ratio of 1.41 to 1.99; and group III, those with a ratio of ≥2. The characteristics appraised initially and after stenting included the venous clinical severity score, grade of swelling (GOS), visual analog scale (VAS) for pain score, and the CIVIQ-20 QoL score. Analysis of variance and paired and unpaired t tests were used for comparison of clinical and QoL variables, and Kaplan-Meier analysis was used to evaluate stent patency, with the log-rank test used to discriminate between different curves. RESULTS: There were a total of 236 limbs (236 patients). The median age for the entire cohort was 62 years (range, 16-92 years). There were 161 women in the study, and left laterality was more common (137 limbs). Post-thrombotic obstruction was noted in 201 limbs (86%). The median body mass index was 36 kg/m2. There were 54 (23%), 64 (27%), and 118 (50%) limbs in groups I, II, and III, respectively. The median follow-up was 65 months. For the entire cohort, after stenting, the venous clinical severity score improved from 6 to 4 (P < .0001) at 3 months and remained at 4 at 6 months (P < .0001), 12 months (P < .0001), and 24 months (P < .0001). The GOS for the entire cohort improved from 3 to 1 (P < .0001) at 3 months and remained at 1 at 6 months (P < .0001), 12 months (P < .0001), and 24 months (P < .0001). The VAS for pain score for the entire cohort improved from 7 to 0 (P < .0001) at 3 months, increased to 2 (P < .0001) at 6 months, and remained at 2 (P < .0001) at 12 months. At 24 months, the VAS for pain score worsened to 3 (P < .0001). For the entire cohort, the CIVIQ-20 score improved from 62 to 40 (P < .0001). There was no difference in the GOS, VAS for pain score, or CIVIQ-20 score between the groups at baseline or at 6, 12, and 24 months after intervention. At 60 months, the primary stent patency was 89% for group I, 80% for group II, and 75% for group III (P = .85). The primary assisted stent patency was 100% for group I, 98% for group II, and 98% for group III (P = .5). Secondary patency was 100% for groups II and III (P > .5). Reintervention was pursued for QoL-impairing clinical manifestations in 53 limbs (22%) without a significant difference between the three groups (P = .13). CONCLUSIONS: The native vein aspect ratio does not appear to determine the initial clinical presentation or QoL or impact the clinical or QoL outcomes after stenting for CIVO. Following stenting, no patient had an aspect ratio >2, with 97% of patients having an aspect ratio ≤1.4 and the remaining 3% having an aspect ratio of 1.41 to 1.99. IVUS-determined minimal cross-sectional luminal area and not the aspect ratios should be used for confirmation of the diagnosis of CIVO and to assess the adequacy of stenting.

Addressing the Impact of Deep Venous Stenting on the Management of Venous Ulcer.

BACKGROUND: Venous ulcers are a late and severe form of chronic venous insufficiency and account for 70% of all etiologies that cause leg ulcers in the lower limb, and they account for 20% of the 2.5 million cases complaining of chronic venous disease. Our study aims to investigate the effect of venous stenting of the deep veins on the healing of the venous ulcer. METHODS: This is a single-center, retrospective study conducted on prospectively recorded medical records of 78 patients with chronic deep venous diseases-C6 (either nonocclusive iliac venous lesion or post-thrombotic syndrome). Our lesion involved May-Thurner lesions, occlusions, insufficiencies, or stenoses owing to an affection of the venous outflow segment. All our patients underwent endovascular management, and those who did not respond successfully were transitioned to compression therapy. We then compared the outcomes of both groups in terms of ulcer healing and quality of life. RESULTS: A total of 78 patients (78 limbs), with a mean age of 39.6 ± 8.06 (range: 22-60) years, were treated. Fifty-four patients (67.9%) were males, and 24 (32.1%) were female. The etiology was primary nonocclusive iliac venous lesion in 12 limbs (16.2%) and secondary post-thrombotic obstructions in 66 (83.7%). Follow-up of the ulcer with compliance to compression therapy and standard care of the ulcer, sustained ulcer healing (reduction in ulcer area) was achieved in 60% of limbs, and most of the nonocclusive healing occurred within the first 3 months (P < 0.01). CONCLUSIONS: Our results show that deep venous stenting is associated with high wound healing rates. This rate reaches a statistically significant difference in 3 months, but this difference doesn't reach statistical significance at 6 months, with less recurrence and improved quality of life with a high cumulative patency rate, and compression therapy is the mainstay of the conservative management of venous ulceration.

Single-session mechanical thrombectomy for iliofemoral deep vein thrombosis using a dual mechanism of action device combining basket and rotational thrombectomy.

OBJECTIVE: Interventional treatments for acute iliofemoral deep vein thrombosis (DVT) remain controversial after publication of the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) study. Interventions have been shown to reduce post-thrombotic syndrome severity and improve quality of life in DVT patients, but have been accompanied by risk of major bleeding from thrombolytics. We describe thrombus removal using a novel combined basket-rotational thrombectomy device that minimizes the need for thrombolytics or repeat procedures. METHODS: The aim of this prospective, nonrandomized, multicenter, first-in-human study of 19 patients with acute iliofemoral DVT was to evaluate the safety and performance of the Pounce venous thrombectomy system ≤12 months after treatment. The primary performance end point was defined as procedural success through achievement of Society of Interventional Radiology (SIR) grade II lysis in treated vessels with freedom from procedural adverse events. Secondary end points included venous disease severity assessments using the Villalta scale and the Venous Clinical Severity Score, patient quality-of-life measurement using the Venous Insufficiency Epidemiological and Economic Study-Quality of Life questionnaire, and calf circumference measurements taken at baseline, 24 hours, and 1 month. RESULTS: The primary end point of complete or near-complete thrombus removal (Society of Interventional Radiology grade II or III) was achieved in all patients. All study device-related safety end points were met, with no major bleeding or device-related adverse events. Of the 19 patients treated, 16 (84.2%) did not receive thrombolytics during the procedure. Post-thrombotic syndrome (Villalta scale >4) was identified in 17 of 19 patients (89.5%) at baseline, 4 of 13 patients (30.8%) available for follow-up at 6 months, and 2 of 11 patients (18.2%) at 12 months. The median Venous Clinical Severity Score decreased (P < .001) from 8.5 (interquartile range [IQR], 7-10) at baseline to 4 (IQR, 2-4) at 1 month after the procedure and was similar at 6 months (2; IQR, 2-5) and 12 months (2; IQR, 1.5-3) after the procedure. The median Venous Insufficiency Epidemiological and Economic Study-Quality of Life questionnaire score improved (P < .001) by 39 from baseline (57; IQR, 53.5-74) to 1 month (96; IQR, 86-101) after the procedure, and remained high at 6 months (99; IQR, 75-103) and 12 months (98; IQR, 94.5-100). The median calf circumference decreased (P = .089) from 39 cm (IQR, 35-47.8 cm) at baseline to 36 cm (IQR, 32.5-40.5 cm) at 24 hours after the procedure and was 34.5 cm (IQR, 33.2-38.5 cm) at 1 month. CONCLUSIONS: The Pounce device is safe and effective for removal the of thrombus in patients with acute iliofemoral DVT. Initial results demonstrate improvements in venous disease severity and patient quality of life.

The role and principles of stenting in acute iliofemoral venous thrombosis.

Catheter-directed interventions for acute iliofemoral deep venous thrombosis (DVT) have been increasingly used over the past 15 years to target severe symptomatology and prevention of post-thrombotic syndrome incidence or reduce its severity if it were to develop. Aside from successful thrombus removal, adjunctive stents are frequently required to treat an uncovered lesion or significant residual thrombus to ensure quality of life improvement besides retarding DVT recurrence and post-thrombotic syndrome. As the evidence is mounting, the need and role for stenting, as well as the principles of an optimal technique, in the acute DVT setting are now better understood. Accumulating experience appears to favor stenting in the acute setting. The diameter of the stent, the length, the extent of overlapping, and the landing zones are crucial determinants of a successful durable outcome. This article endeavors to guide the interventionalist on stenting when encountering a patient with acute symptomatic iliofemoral DVT with concerns of quality of life impairment.

Initial experience with the ambulatory management of acute iliofemoral deep vein thrombosis with May-Thurner syndrome with percutaneous mechanical thrombectomy, angioplasty and stenting.

OBJECTIVE: Patients undergoing intervention for acute iliofemoral deep vein thrombosis (IFDVT) with May-Thurner syndrome (MTS) typically require inpatient (IP) hospitalization for initial treatment with anticoagulation and management with pharmacomechanical thrombectomy. Direct oral anticoagulants and percutaneous mechanical thrombectomy (PMT) devices offer the opportunity for outpatient (OP) management. We describe our approach with these patients. METHODS: Patients receiving intervention for acute IFDVT from January 2020 through October 2022 were retrospectively reviewed. Patients undergoing unilateral thrombectomy, venous angioplasty, and stenting for IFDVT with MTS comprised the study population and were divided into two groups: (1) patients admitted to the hospital and treated as IPs and (2) patients who underwent therapy as OPs. The two groups were compared regarding demographics, risk factors, procedural success, complications, and follow-up. RESULTS: A total of 92 patients were treated for IFDVT with thrombectomy, angioplasty, and stenting of whom 58 comprised the IP group and 34 the OP group. All 92 patients underwent PMT using the Inari ClotTriever (Inari Medical), intravascular ultrasound, angioplasty, and stenting with 100% technical success. Three patients in the IP group required adjuvant thrombolysis. There was no difference in primary patency of the treated IFDVT segment at 12 months between the two groups (IP, 73.5%; OP, 86.7%; P = .21, log-rank test). CONCLUSIONS: Patients with acute IFDVT and MTS deemed appropriate for thrombectomy and iliac revascularization can be managed with initiation of ambulatory direct oral anticoagulant therapy and subsequent return for ambulatory PMT, angioplasty, and stenting. This approach avoids the expense of IP care and allows for effective use of resources at a time when staffing and supply chain shortages have led to inefficiencies in the provision of IP care for nonemergent conditions.

Final 3-Year Study Outcomes from the Evaluation of the Zilver Vena Venous Stent for the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction (The VIVO Clinical Study).

PURPOSE: To report 3-year outcomes from a prospective, multicenter, nonrandomized, single-arm study designed to assess the safety and effectiveness of the Zilver Vena Venous Stent for the treatment of symptomatic iliofemoral venous outflow obstruction. MATERIALS AND METHODS: The VIVO study included patients with symptomatic obstruction of 1 iliofemoral venous segment (ie, 1 limb), characterized by a Clinical, Etiological, Anatomic, Pathophysiology (CEAP) clinical classification of ≥3 or a Venous Clinical Severity Score (VCSS) for pain of ≥2. Patients were retrospectively grouped based on baseline clinical presentation as postthrombotic syndrome (PTS), nonthrombotic iliac vein (NIVL) obstruction, or acute deep vein thrombosis (aDVT). Clinical improvement was assessed by change in VCSS, Venous Disability Score, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) scores, and CEAP C classification. Stent performance was evaluated by rates of patency by ultrasound (US), freedom from clinically driven reintervention, and freedom from stent fracture. RESULTS: The 3-year results for the 243 patients in the VIVO cohort included a 90.3% rate of patency by US and a 92.6% rate of freedom from clinically driven reintervention. The 3-year rates of patency by US for the NIVL, aDVT, and PTS groups were 100%, 84.0%, and 86.1%, respectively. Sustained clinical improvement through 3 years was demonstrated by changes in VCSS, Venous Disability Score, CIVIQ-20, and CEAP C classification. No stent fractures were observed. CONCLUSIONS: The VIVO study demonstrated sustained high rates of patency and freedom from clinically driven reintervention and improvements in venous clinical symptoms through 3 years. Each patient group (NIVL, aDVT, and PTS) showed clinical improvement and sustained patency through 3 years; some variation existed among groups (eg, only the NIVL group had a 100% patency rate).

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.

Comparison of anticoagulation vs mechanical thrombectomy for the treatment of iliofemoral deep vein thrombosis.

OBJECTIVE: To compare the comparative effects of treatment with contemporary mechanical thrombectomy (MT) or anticoagulation (AC) on Villalta scores and post-thrombotic syndrome (PTS) incidence through 12 months in iliofemoral deep vein thrombosis (DVT). METHODS: Patients with DVT in the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) randomized trial and the ClotTriever Outcomes (CLOUT) registry were included in this analysis. Both studies evaluated the effects of thrombus removal on the incidence of PTS. Patients with bilateral DVT, isolated femoral-popliteal DVT, symptom duration of >4 weeks, or incomplete case data for matching covariates were excluded. Propensity scores were used to match patients 1:1 who received AC (from ATTRACT) with those treated with mechanical thrombectomy (from CLOUT) using nearest neighbor matching on nine baseline covariates, including age, body mass index, leg treated, provoked DVT, prior venous thromboembolism, race, sex, Villalta score, and symptom duration. Clinical outcomes, including Villalta score and PTS, were assessed. Logistic regression was used to estimate the likelihood of developing PTS at 12 months. RESULTS: A total of 164 pairs were matched, with no significant differences in baseline characteristics after matching. There were fewer patients with any PTS at 6 months (19% vs 46%; P < .001) and 12 months (17% vs 38%; P < .001) in the MT treatment group. Modeling revealed that, after adjusting for baseline Villalta scores, patients treated with AC had significantly higher odds of developing any PTS (odds ratio, 3.1; 95% confidence interval, 1.5-6.2; P = .002) or moderate to severe PTS (odds ratio, 3.1; 95% confidence interval, 1.1-8.4; P = .027) at 12 months compared with those treated with MT. Mean Villalta scores were lower through 12 months among those receiving MT vs AC (3.3 vs 6.3 at 30 days, 2.5 vs 5.5 at 6 months, and 2.6 vs 4.9 at 12 months; P < .001 for all). CONCLUSIONS: MT treatment of iliofemoral DVT was associated with significantly lower Villalta scores and a lower incidence of PTS through 12 months compared with treatment using AC. Results from currently enrolling clinical trials will further clarify the role of these therapies in the prevention of PTS after an acute DVT event.

Diagnosis of chronic iliac venous obstruction.

Stenting has become the first line of treatment for symptomatic chronic iliofemoral venous obstruction in patients with quality-of-life-impairing clinical manifestations who have failed conservative therapy. Patient selection for such intervention is, however, dependent on clear identification of relevant clinical manifestations and subsequent testing to confirm the diagnosis. In this regard, the physician engaged in management of such patients needs to be well-aware of symptoms and signs of chronic iliofemoral venous obstruction, and instruments used to grade chronic venous insufficiency and determine quality of life, in addition to diagnostic tests available and their individual roles. This review serves to provide an overview of the diagnosis of chronic iliofemoral venous obstruction and patient selection for stenting.

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.

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.