scholarly journals Patency and Clinical Outcomes of a Dedicated, Self-Expanding, Hybrid Oblique Stent Used in the Treatment of Common Iliac Vein Compression

2016 ◽  
Vol 24 (1) ◽  
pp. 159-166 ◽  
Author(s):  
Anna K. Stuck ◽  
Samuel Kunz ◽  
Iris Baumgartner ◽  
Nils Kucher

Purpose: To investigate the clinical outcomes of a dedicated hybrid oblique nitinol stent that has been specifically designed to treat common iliac vein compression. Methods: The Bern Venous Stent Registry database was interrogated to identify all patients who had at least 6-month follow-up after treatment with the sinus-Obliquus hybrid stent for common iliac vein compression. The search identified 24 patients (mean age 39±18 years; 20 women) who matched the search criteria. Ten patients had postthrombotic syndrome (PTS), another 10 patients had acute iliofemoral thrombosis after catheter-directed therapy, and 4 patients had nonthrombotic iliac vein compression. Primary treatment success was defined as antegrade flow and stenosis <30% on venography and evidence of a spontaneous Doppler signal in the treated segment. Stent patency was assessed using duplex ultrasound. Clinical outcomes were evaluated using a clinical symptom score (Villalta) and the revised venous clinical severity score (rVCSS) at 3, 6, and 12 months in follow-up. Results: Primary treatment success was achieved in all patients. Mean follow-up was 10±3 months. Primary patency estimates by Kaplan-Meier analysis were 92% at 6 months [95% confidence interval (CI) 71% to 98%] and 83% (95% CI 54% to 95%) at 10 months. Three symptomatic patients underwent reintervention for early and late stent thromboses and the third for in-stent restenosis, resulting in secondary patency of 100%. Overall, all patients had clinical improvement at the latest follow-up; 50% reported complete resolution of symptoms. In patients with PTS, the Villalta score decreased by 6±6 points (p=0.02) and the rVCSS score by 3±1 points (p=0.05). Among deep vein thrombosis patients, none developed PTS. Conclusion: In patients with common iliac vein compression, the oblique hybrid nitinol stent appears to provide excellent early patency and clinical outcomes.

VASA ◽  
2020 ◽  
Vol 49 (4) ◽  
pp. 301-308 ◽  
Author(s):  
Tim Sebastian ◽  
Michael Lichtenberg ◽  
Oliver Schlager ◽  
Houman Jalaie ◽  
Rick de Graaf ◽  
...  

Summary: Background: Physical attributes of conventional stents used in the ilio-caval territory are often unfavorable in the presence of external compression close to the bifurcation. A hybrid oblique stent was developed for the treatment of common iliac vein compression without compromising the contralateral iliac vein inflow. Patients and methods: The ongoing international monitored TOPOS study enrolled 60 patients with post-thrombotic syndrome (PTS) treated with the sinus-Obliquus stent (optimed) and provisional distal stent extension. At 3-month follow-up, patency rates were obtained from duplex ultrasound, and clinical outcomes were assessed by the Villalta score, revised venous severity score (rVCSS), pain intensity score and chronic venous disease quality of life questionnaire (CIVIQ-20). Results: Mean age was 46.6 ± 14.9 years (68.3 % women). Mean number of implanted stents was 1.9 ± 0.6; 12 (20 %) patients received the hybrid oblique stent only. Forty-eight (80 %) patients had distal stent extension, and 42 (70 %) had stents below the inguinal ligament. Four (7 %) patients (all with stent extension) developed stent thrombosis. Primary and secondary patency rates at 3 months were 93.1 % (95 %CI 83.3–98.1 %), and 100 % (95 %CI 93.8–100 %), respectively. Improvement in Villalta, rVCSS, CIVIQ-20, and pain intensity score from baseline to 3-month follow-up was 6.9 ± 1.4 points (95 %CI 4.1–9.8; p < 0.0001), 3.4 ± 1.0 points (95 %CI 1.3–5.4 points; p < 0.01), 13.6 ± 2.7 points (95 %CI 8.2–19.0 points; p < 0.0001), and 2.4 ± 0.5 (95 %CI 1.4–3.3; p < 0.0001), respectively. At follow-up, 38 (63 %) patients were free from the PTS and none developed contralateral deep vein thrombosis. Conclusions: In patients with PTS and common iliac vein compression, treatment with the hybrid oblique stent with provisional stent extension resulted in high patency rates and improvement in PTS severity and quality of life at 3-month. Two-year results of TOPOS will assess the durability of this treatment.


2020 ◽  
pp. 026835552094621
Author(s):  
Tjun Y Tang ◽  
Mervin HH Lim ◽  
Karthikeyan Damodharan ◽  
Charyl JQ Yap ◽  
Shaun QW Lee ◽  
...  

Objectives Deep venous stenting with intravascular ultrasound (IVUS) guidance is gaining favour as the treatment modality of choice for symptomatic ilio-femoral venous occlusive disease. The aim was to determine the short-term patency and symptomatic relief gained using the Bard Venovo™ and Optimed Sinus Obliquus™ stents in the endovascular treatment of non-thrombotic iliac vein lesions (NIVL) and post-thrombotic venous obstruction (PTO) from two Asian tertiary vascular centres. Methods Sixty patients (males = 21/60 (35.0%); median age 67 years (interquartile range 54–77)) who underwent IVUS interrogation and ilio-femoral stenting (June 2018–May 2019) in two Asian centres were prospectively followed. Clinical improvement was determined by the revised Venous Clinical Severity Score (rVCSS), pain using the Visual Analogue Scale (VAS) and ulcer healing rate. Patency rates were evaluated using Duplex ultrasound and computer tomography venogram. Results Seventy-one legs were interrogated and stented; 11/60 (18.3%) patients had a bilateral procedure. Indications for surgery were PTO ( n = 11/71 (15.5%)) and NIVL ( n = 60/71 (84.5%)). Twenty-seven of 71 (38.0%) patients had CEAP 6 disease. The median follow-up was 283 (interquartile range 211–370) days. Technical and procedural success was both 100%. Twenty-one of 71 (29.6%) legs had a combination of Venovo™ and Sinus Obliquus™ stents inserted for concurrent ilio-caval and iliac lesions. There were no major post-operative complications. Six-month primary, assisted primary and secondary patency rates were 94.1, 97.1 and 100%, respectively. There were no stent fractures. Mean rVCSS and VAS improved from 12.26 (±3.31) to 4.33 (±2.78) and 6.97 (±1.38) to 2.03 (±1.65), respectively, at three months (p < 0.01). Complete ulcer healing was seen in 27/27 (100%) patients at three months. Conclusion Use of Venovo™ and Sinus Obliquus™ stents for symptomatic ilio-femoral venous disease showed excellent six-month primary patency rate with no stent fractures. There were significant clinical improvement and low-device-related complications. Longer follow-up is awaited to see how these dedicated venous stents perform.


VASA ◽  
2019 ◽  
Vol 48 (5) ◽  
pp. 381-388 ◽  
Author(s):  
Katalin Mako ◽  
Attila Puskas

Summary. Iliac vein compression syndrome (May-Thurner syndrome – MTS) is an anatomically variable clinical condition in which the left common iliac vein is compressed between the right common iliac artery and the underlying spine. This anatomic variant results in an increased incidence of left iliac or iliofemoral vein thrombosis. It predominantly affects young women in the second or third decades of life with preponderance during pregnancy or oral contraceptive use. Although MTS is rare, its true prevalence is underestimated but it can be a life-threatening condition due to development of pulmonary embolism (PE). In this case based review the authors present three cases of MTS. All patients had been previously confirmed with PE, but despite they were admitted to hospital, diagnosed and correctly treated for PE and investigated for thrombophilia, the iliac vein compression syndrome was not suspected or investigated. With this presentation the authors would like to emphasize that MTS is mostly underdiagnosed, and it needs to be ruled out in left iliofemoral vein thrombosis in young individuals.


2020 ◽  
pp. 026835552097727
Author(s):  
GuangMing Tan ◽  
Bryan PY Yan

Background Phlegmasia Cerulae Dolen (PCD) is potentially a lethal disease but there is currently no established treatment algorithm for it. The aim of this study was to assess the safety and effectiveness of single stage endovascular pharmacomechanical thrombectomy with venoplasty and stenting in the treatment of PCD. Method This was a retrospective single centre observational study of consecutive patients who underwent endovascular intervention for the treatment of PCD between June 2016 and March 2020. Clinical and procedural details were recorded. Procedural and clinical success rate, procedural complications, and 30 days mortality were reported. Result 11 patients were treated during the study period. 2 (18.2%) had active malignancy. 63.6% were uncomplicated PCD on presentation. Common iliac vein compression or stenosis were demonstrated in all patients. Venous stents were implanted in all cases and procedures were successful in all cases. All patients had symptoms improvement at 72 hours post procedure. Other than 2 major bleeding complications, there was no other adverse event. The 30 days mortality was 18.2%. Active malignancy and the presence of anaemia were significantly associated with major complications. Conclusion Single stage endovascular thrombectomy and stenting was effective and safe in the treatment of patients with PCD. Common Iliac vein compression was a common underlying cause of PCD.


2016 ◽  
Vol 32 (1) ◽  
pp. 43-48 ◽  
Author(s):  
Pamela S Kim ◽  
Muath Bishawi ◽  
David Draughn ◽  
Marab Boter ◽  
Charles Gould ◽  
...  

Background Several studies have shown comparable early efficacy of mechanochemical ablation to endothermal techniques. The goal of this report was to show if early efficacy is maintained at 24 months. Methods This was a two-year analysis on the efficacy of mechanochemical ablation in patients with symptomatic C2 or more advanced chronic venous disease. Patients with reflux in the great saphenous vein involving the sapheno-femoral junction and no previous venous interventions were included. Demographic information, clinical, and procedural data were collected. The occlusion rate of treated veins was assessed with duplex ultrasound. Patient clinical improvement was assessed by Clinical-Etiology-Anatomy-Pathophysiology (CEAP) class and venous clinical severity score. Results Of the initial 126 patients, there were 65 patients with 24 month follow-up. Of these 65 patients, 70% were female, with a mean age of 70 ± 14 years and an average body mass index (BMI) of BMI of 30.5 ± 6. The mean great saphenous vein diameter in the upper thigh was 7.6 mm and the mean treatment length was 39 cm. Adjunctive treatment of the varicosities was performed in 14% of patients during the procedure. Closure rates were 100% at one week, 98% at three months, 95% at 12 months, and 92% at 24 months. There was one patient with complete and four with partial recanalization ranging from 7 to 12 cm (mean length 9 cm). There was significant improvement in CEAP and venous clinical severity score (P < .001) for all time intervals. Conclusion Early high occlusion rate with mechanochemical ablation is associated with significant clinical improvement which is maintained at 24 months, making it a very good option for the treatment of great saphenous vein incompetence.


2019 ◽  
Vol 35 (4) ◽  
pp. 255-261
Author(s):  
Naomi DE Thierens ◽  
Suzanne Holewijn ◽  
Wynand HPM Vissers ◽  
Debbie AB Werson ◽  
Jean Paul PM de Vries ◽  
...  

Objective The aim of the study is to report long-term results after mechano-chemical ablation for the treatment of great saphenous vein incompetence. Methods Mechano-chemical ablation was performed using the ClariVein device with polidocanol as the sclerosant. Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification, Venous-Clinical-Severity-Score (VCSS), anatomical-success, RAND-SF36 and the Aberdeen-Varicose-Vein-Questionnaire (AVVQ) were obtained by clinical examination, questionnaires and duplex ultrasonography through five years’ follow-up (Clinicaltrials.gov, NCT01459263). Results Ninety-four patients (113 great saphenous veins) were included in the study. Five-year follow-up data were available for 75 limbs (66.4%). Freedom from anatomical failure was 78.7% (N = 45) with 64.6% (N = 42) having an improvement in the VCSS ≥1. A total of five reinterventions were performed through five years with a median time to reintervention of 38 months. The VCSS at five years was 2 (IQR 1; 4) and was still significantly improved compared to baseline (p < 0.001). A deterioration of the VCSS was observed in 21.5%. Conclusion Through five-year follow-up, there are a significant number of anatomical and clinical failures in this series, mainly driven by partial recanalizations.


2017 ◽  
Vol 33 (8) ◽  
pp. 547-557 ◽  
Author(s):  
Krishna Prasad Bellam Premnath ◽  
Binu Joy ◽  
Vijayakumar Akondi Raghavendra ◽  
Ajith Toms ◽  
Teena Sleeba

Various treatment methods are available for the treatment of varicose veins, and there has been a recent surge in the usage of cyanoacrylate glue for treating varicose veins. Purpose To investigate the technical possibility, efficiency and safety of cyanoacrylate adhesive embolization and sclerotherapy using commonly available n-butyl cyanoacrylate glue for the treatment of primary varicose veins due to great saphenous vein reflux with or without incompetent perforators. Materials and Methods One hundred forty-five limbs of 124 patients with varicose veins due to great saphenous vein reflux were subjected to cyanoacrylate adhesive embolization and sclerotherapy – adhesive embolization of great saphenous vein in the thigh and perforators using cyanoacrylate followed by sclerotherapy of any residual varicose veins in the leg. Procedural success, venous closure rates and clinical improvement were assessed. Follow-up for 1, 3, 6, 9 and 12 months was obtained. Results Technical success rate was 100%. Saphenous vein closure rate was 96.5% at one year. There was no femoral venous extension of cyanoacrylate in any of the patients. Posterior tibial vein extension of cyanoacrylate was seen in three patients (2.6%) without untoward clinical effect.Significant improvement was found in venous clinical severity score (VCSS) from a baseline mean of 7.98 ± 4.42 to 4.74 ± 3, 1.36 ± 1.65 and 0.79 ± 1.19 at 1, 6 and 12 months’ follow-up. Ulcer healing rate was 100%. Conclusion Cyanoacrylate adhesive embolization and sclerotherapy for the treatment of primary varicose veins is efficacious and can be performed as an outpatient procedure, but has a guarded safety profile due to its propensity to cause deep venous occlusion if not handled carefully.


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