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

Abstract

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.

Keywords

Deep vein stenting venovo venous stent vascular patency post-thrombotic syndrome non-thrombotic iliac vein lesion May–Thurner syndrome

Get full access to this article

View all access options for this article.

References

Neglén

Thrasher

Raju

Venous outflow obstruction: an underestimated contributor to chronic venous disease. J Vasc Surg 2003; 38: 879–885.

Kahn

Partsch

Vedantham

, et al. on behalf of the Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of post-thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardization. J Thromb Haemost 2009; 7: 879–883.

Liddell

Evans

NS.

May-Thurner syndrome vascular medicine (London, England). Vasc Med 2018; 23: 493–496.

Raju

Neglen

High prevalence of nonthrombotic iliac vein lesions in chronic venous disease: a permissive role in pathogenicity. J Vasc Surg 2006; 44: 136–143.

Neglen

Darcey

Olivier

, et al. Bilateral stenting at the iliocaval confluence. J Vasc Surg 2010; 51: 1457–1466.

Neglen

Berry

Raju

Endovascular surgery in the treatment of chronic primary and post-thrombotic iliac vein obstruction. Eur J Vasc Endovasc Surg 2000; 20: 560–571.

Wen-da

Yue-Xin

Stenting for chronic obstructive venous disease: a current comprehensive meta-analysis and systematic review. Phlebology 2016; 31: 376–389.

Razavi

Jaff

Miller

LE.

Safety and effectiveness of stent placement for iliofemoral venous outflow obstruction: systematic review and meta-analysis. Circ Cardiovasc Interv 2015; 8: e002772.

Lichtenberg

MKW

de Graaf

Stahlhoff

, et al. Venovo venous stent in the treatment of non-thrombotic or post-thrombotic iliac vein lesions – short-term results from the Arnsberg venous registry. VASA 2019; 48: 175–180.

10.

Jalaie

Arnoldussen

Barbati

, et al. What predicts outcome after recanalization of chronic venous obstruction: hemodynamic factors, stent geometry, patient selection, anticoagulation or other factors? Phlebology 2014; 29: 97–103.

11.

Gagne

Kucher

, et al. Long-term clinical outcomes and technical factors with the wallstent for treatment of chronic iliofemoral venous obstruction. J Vasc Surg Venous Lymphat Disord 2019; 7: 45–55.

12.

Mandel

Ostrozhynskyy

Hingorani

, et al. Underexpansion of wallstents((R)) in the treatment of nonthrombotic iliac vein lesions. Ann Vasc Surg 2018; 52: 163–167.

13.

van Vuuren

Doganci

Wittens

Patency rates and clinical outcomes in a cohort of 200 patients treated with a dedicated venous stent. J Vasc Surg Venous Lymphat Disord 2018; 6: 321–329.

14.

Lichtenberg

de Graaf

Stahlhoff

, et al. Patency rates, safety and clinical results of the sinus-Obliquus venous stent in the treatment of chronic ilio-femoral venous outflow obstruction – data from the arnsberg venous registry. VASA Zeitschrift Gefasskrank 2019; 48: 270–275.

15.

O'Sullivan

GJ.

Iliofemoral venous stenting extending into the femoral region: initial clinical experience with the purpose-designed zilver vena stent. J Cardiovasc Surg 2013; 54: 255–261.

16.

Razavi

Marston

Black

, et al. The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction. J Vasc Surg Venous Lymph Disord 2018; 6: 192–200.

17.

BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease. Available from: https://ClinicalTrials.gov/show/NCT02655887 (2016, accessed 11 March 2020).

18.

Lee

QWS

Gigson

Chan

, et al. A comparison between Caucasian and Asian superficial venous anatomy and reflux patterns – implications for potential precision endovenous ablation therapy. Phlebology 2020; 35: 39–45.

19.

Tang

Goh

Damodharan

, et al. RE: “long-term follow-up of stenting across the ilio-caval confluence in patients with iliac venous lesions”: the value of using IVUS and a dedicated oblique venous stent for deep vein work involving the ilio-caval bifurcation. J Thromb Thrombol 2019; 47: 328–330.

20.

Rutherford

Padberg

Jr Comerota

, et al. Venous severity scoring: an adjunct to venous outcome assessment. J Vasc Surg 2000; 31: 1307–1312.

21.

Vasquez

Munschauer

CE.

Venous clinical severity score and quality-of-life assessment tools: application to vein practice. Phlebology 2008; 23: 259–275.

22.

Dabir

Feisst

Thomas

, et al. Physical properties of venous stents: an experimental comparison. Cardiovasc Interv Radiol 2018; 41: 942–950.

23.

Stuck

Kunz

Baumgartner

, et al. Patency and clinical outcomes of a dedicated, self-expanding, hybrid oblique stent used in the treatment of common iliac vein compression. J Endovasc Ther 2017; 24: 159–166.

24.

Lee

Park

K-M

, et al. Contralateral deep vein thrombosis after iliac vein stent placement in patients with May-Thurner syndrome. J Vasc Interv Radiol 2018; 29: 774–780.

25.

Jiang

, et al. Technical details and clinical outcomes of transpopliteal venous stent placement for postthrombotic chronic total occlusion of the iliofemoral vein. J Vasc Interv Radiol 2014; 25: 925–932.

26.

Rosales

Sandbaek

Jorgensen

JJ.

Stenting for chronic post-thrombotic vena cava and iliofemoral venous occlusions: mid-term patency and clinical outcome. Eur J Vasc Endovasc Surg 2010; 40: 234–240.

27.

Neglén

Raju

In-stent recurrent stenosis in stents placed in the lower extremity venous outflow tract. J Vasc Surg 2004; 39: 181–187.

28.

Black

Gwozdz

Karunanithy

, et al. Two year outcome after chronic iliac vein occlusion recanalisation using the vici venous stent((R)). Eur J Vasc Endovasc Surg 2018; 56: 710–718.

29.

Neglen

Tackett

Jr Raju

Venous stenting across the inguinal ligament. J Vasc Surg 2008; 48: 1255–1261.

30.

van Vuuren

de Wolf

Wittens

CH.

Relevance of flexibility versus radial force in rigid versus more flexible venous stents?

Phlebology 2019; 34: 459–465.

31.

Razavi

Black

Gagne

, et al.; VIRTUS Investigators. Pivotal study of endovenous stent placement for symptomatic iliofemoral venous obstruction. Circ Cardiovasc Interv 2019; 12: e008268.

32.

Yap HY, Loa J, Tosenovsky PJ, et al. Use of anticoagulation therapy post deep venous stenting for post-thrombotic disease and non-thrombotic iliac vein lesions - Any consensus? Phlebology, 2020; 35: 545–547.

33.

Mekaj

Duci

, et al. New oral anticoagulants: their advantages and disadvantages compared with vitamin K antagonists in the prevention and treatment of patients with thromboembolic events. Ther Clin Risk Manag 2015; 11: 967–977.

34.

Milinis

Thapar

Shalhoub

, et al. Antithrombotic therapy following venous stenting: international delphi consensus. Eur J Vasc Endovasc Surg 2018; 55: 537–544.

35.

Tosenovsky

One-year results of iliocaval stenting. Ann Vasc Surg 2019; 59: 208–216.

36.

Langwieser

Bernlochner

Wustrow

, et al. Combination of factor Xa inhibition and antiplatelet therapy after stenting in patients with iliofemoral post-thrombotic venous obstruction. Phlebology 2016; 31: 430–437.