Clinical Outcomes of Iliac Vein Stenting: A Single-Center Retrospective Study with Extended Follow-up.

Randomized Double-Blinded Study Comparing Clinical Versus Endovascular Treatment of Iliac Vein Obstruction.

The purpose was to evaluate the clinical outcomes of a dedicated venous stent with the tripartite composite segments for the treatment of iliofemoral venous obstruction (IVO) in a mixed cohort of nonthrombotic iliac vein lesion (NIVL) and post-thrombotic syndrome (PTS) over a period of 12 months. The Grency Trial is a prospective, multicenter, single-arm, open-label, pivotal study, which was conducted at 18 large tertiary hospitals in China from August 2019 to October 2020. A total of 133 hospitalized patients were screened and 110 patients with clinical, etiology, anatomical, and pathophysiology clinical class (CEAP) clinical grade C>3 and iliac vein stenosis >50% or occlusion, including 72 patients with NIVL and 38 patients with PTS, were implanted with Grency venous stents. Primary endpoint was stent patency at 12 months follow-up, and secondary outcomes were technical success; improvement in venous clinical severity score (VCSS) at 3, 6, and 12 month follow-up; and rates of clinical adverse events. Among 110 patients who were implanted with Grency venous stents, 107 patients completed the 12 month follow-up. All 129 stents were successfully implanted in 110 limbs. Twelve-month primary patency rate was 94.39% [95% confidence interval [CI]=88.19%-97.91%] overall, and 100% [94.94%-100%] and 83.33% [67.19%-93.63%] in the NIVL and PTS subgroups, respectively. Venous clinical severity score after iliac vein stenting improved significantly up to 12 months follow-up. There were 3 early major adverse events (1 intracerebral hemorrhage and 2 stent thrombosis events related to anticoagulation therapy), and 7 late major adverse events (1 cardiovascular death, 1 intracranial hemorrhage with uncontrolled hypertension, and 5 in-stent restenosis cases without stent fractures or migration). The Grency venous stent system appeared excellent preliminary safe and effective for IVO treatment. Further large-scale studies with longer-term follow-up are needed to evaluate long-term patency and durability of stent.Clinical impactThe design of venous stents for iliofemoral venous obstruction (IVO) must address engineering challenges distinct from those encountered in arterial stenting. The Grency venous stent, a nitinol self-expanding stent specifically tailored for IVO, features a composite structure designed to meet the stent requirements of various iliac vein segments. The Grency Trial is a prospective, multicenter, single-arm, open-label pivotal study aimed at evaluating the efficacy and safety of the Grency stent system. Following a 12-month follow-up period, the Grency venous stent system has demonstrated both safety and efficacy in treating iliofemoral venous outflow obstruction.

Iliofemoral venous obstruction is recognized with increasing frequency as the underlying cause of lower extremity symptoms including edema, pain, skin changes, and, in advanced cases, ulceration. This study sought to evaluate the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction. The ABRE Study (A Multi-Center, Non-Randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction) is a single-arm, multicenter, prospective study that included 200 subjects from 24 global sites. The primary end points were 12-month primary patency and major adverse events within 30 days. Secondary end points included lesion and procedure success, primary-assisted and secondary patency, major adverse events, stent migration, stent fracture, and quality of life changes. End point-related adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. Venous obstruction cause was classified as acute deep vein thrombosis (16.5%, 33/200), post-thrombotic syndrome (47.5%, 95/200), or nonthrombotic iliac vein lesion (36.0%, 72/200). The common iliac and external iliac veins were stented in 96.0% (192/200), 80.5% (161/200) of subjects, respectively. Stent implant into the common femoral vein was required in 44.0% (88/200). Primary patency at 12 months was 88.0% (162/184). Four (2.0%) major adverse events occurred within 30 days. Twelve-month primary-assisted and secondary patency were 91.8% (169/184) and 92.9% (171/184), respectively. No stent fractures or migrations were reported. Mean target limb Villalta score decreased from 11.2±5.6 at baseline to 4.1±4.8 at 12 months, and the mean target limb revised Venous Clinical Severity Score decreased from 8.8±4.7 at baseline to 4.3±3.6 at 12 months. Clinically meaningful improvements in quality of life and venous functional assessment scores from baseline were demonstrated through 12 months in all measures. Symptomatic iliofemoral venous obstruction can be successfully treated with an Abre venous stent. Study outcomes demonstrated a high patency rate with a good safety profile. Patients demonstrated a significant reduction in clinical symptoms and improvement in quality of life that was maintained through 12-month follow-up. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03038438.

Predictive Factors of Stent Patency in Iliofemoral Venous Diseases in a Multicentre Cohort Study

Clinical outcomes of venous self-expanding stent placement for iliofemoral venous outflow obstruction

Current literature regarding iliofemoral intervention and stenting is mostly based on Western populations. We present our experience of iliofemoral stenting for chronic venous disease within a South-East Asian population. This is a single-centre retrospective review of a prospectively collected registry. Seventy-one patients with 105 limbs underwent iliac vein IVUS and stenting between 2016 and 2019. All patients underwent pre-procedure ultrasound venous scan and MRI venogram. Pre- and post-operative CEAP classification, Villalta score and Venous Clinical Severity Score (VCSS), technical results, stent patency rates and complication rates are documented. Seventy-six per cent of the cases are non-thrombotic iliac vein lesion, and 68% of patients have C4 to C6 disease. Ten percentage of patients had acute thrombosis on presentation. There was 100% technical success. A 6- and 7-point reduction in the mean VCSS and Villalta score, respectively, were noted post-stenting (baseline of 10 points and P<0.001 in both categories). Post-stenting ulcer healing rate was 91% at 6 and 12months. One-year ulcer recurrence and cellulites recurrence were at 8% and 7%, respectively. One unplanned 30-day readmission (not related to procedure) and no 30-day mortality were noted. Bleeding complication from anticoagulation was 3%. There was 10% in-stent non-flow limiting stenosis on surveillance. One-year primary patency was 91%, and secondary patency was 100%. Within our series, iliofemoral stenting has 100% technical success, with statistically significant reduction in VCSS and Villalta score, good wound healing rates, low ulcer and cellulites recurrence and good primary and secondary patency rates at 1year.

10:30 AM Abstract No. 1 ■ ABSTRACT OF THE YEAR A prospective, multicenter evaluation of the Venovo self-expanding vascular stent used to treat obstructive lesions of the iliac and femoral veins: 12-month results from the VERNACULAR trial

The aim of the study was to investigate venous patency and clinical outcomes for endovascular treatment of iliofemoral venous obstruction in patients with post-thrombotic syndrome (PTS) and non-thrombotic iliac vein lesion (NIVL) with dedicated self-expanding nitinol stents. Data were collected from the prospective Swiss Venous Stent Registry, enrolling consecutive patients with a standardized follow-up procedure since January 2008. Patency was evaluated by duplex sonography and clinical outcome by various scores including the Villalta score at baseline, three, six, and 12 months, and then annually after endovascular therapy. Overall, 93 patients (64 PTS, 29 NIVL) were analysed. Mean follow-up time was 20 ± 16 (range 3-70) months. A total of 11 (12 %) patients had a stent occlusion, all of which occurred in the PTS group, and 13 (14 %) patients had a symptomatic stent stenosis. Primary patency was 79 % (95 % CI 68-87 %) at 12 months and 72 % (95 % CI 59-82 %) at 24 months. In PTS patients, primary patency at 12 months was 75 % (95 % CI 61-84 %) vs. 89 % (95 % CI 63-97 %) in NIVL patients (p = 0.10). Secondary patency at 24 months was 94 % (95 % CI 84-98 %) in PTS and 100 % in NIVL, p = 0.19). Overall, 62 (67 %) patients were free from PTS at the latest follow-up with a Villalta score < 5 points. Predictive factors for the loss of primary patency were stents placed below the inguinal ligament (OR 2.59, 95 % CI, 0.99-6.84, p = 0.05). In symptomatic patients with chronic iliofemoral vein obstruction, endovascular therapy with self-expanding nitinol stents was associated with favourable patency rates and clinical improvement in the majority of patients.

Long-term efficacy following venous stenting for symptomatic iliofemoral venous obstruction: 5 year clinical and stent outcomes in a Southeast Asian population.

Stent patency in patients with advanced chronic venous disease and nonthrombotic iliac vein lesions

Iliac Vein Stenting Following Catheter Directed Thrombolysis for Acute Iliofemoral Thrombosis: Outcomes and Predictors of Failure

Medium-term outcomes after inferior vena cava reconstruction for acute and chronic deep vein thrombosis and retroperitoneal fibrosis

Stent Patency in Patients With Advanced Chronic Venous Disease and Nonthrombotic Iliac Vein Lesions

Contemporary outcomes of elective iliocaval and infrainguinal venous intervention for post-thrombotic chronic venous occlusive disease

Efficacy and Safety of Prophylactic Anticoagulation Versus Therapeutic Anticoagulation After Iliac Vein Stenting in Patients with a Nonthrombotic Iliac Vein Lesion.