Use of the VENOVO™ and Sinus Obliquus™ venous stents in the treatment of non-thrombotic or post-thrombotic iliac vein lesions - Short-term results from a multi-centre Asian cohort

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 (TM) and Optimed Sinus Obliquus (TM) 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 (TM) and Sinus Obliquus (TM) 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 (TM) and Sinus Obliquus (TM) 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.

Automated summary

The study aimed to evaluate the short-term patency and symptomatic relief gained using Bard Venovo and Optimed Sinus Obliquus stents in the endovascular treatment of NIVL and PTO from two Asian tertiary vascular centers. The results showed excellent primary patency rate without stent fractures, significant clinical improvement, and low device-related complications. Longer follow-up is needed to assess the long-term performance of dedicated venous stents.