The evidence for venous interventions is evolving- many patients do actually benefit. Nils Kucher University Hospital Bern Switzerland

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2 The evidence for venous interventions is evolving- many patients do actually benefit Nils Kucher University Hospital Bern Switzerland

3 Disclosure Speaker name: Nils Kucher X X I have the following potential conflicts of interest to report: Consulting/Honoraria: BTG, Optimed, Cook, Volcano Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

4 Venous Intervention Acute DVT treatment Catheter-directed thrombolysis +/- Stenting Chronic venous obstruction Endovascular reconstruction Stenting

5 Venous Intervention Acute DVT treatment Catheter-directed thrombolysis +/- Stenting Chronic venous obstruction Endovascular reconstruction Stenting

6 Conservative Management of Iliofemoral DVT In less than 50%, venous patency is achieved Up to 30% suffer recurrent DVT More than 60% have an underlying venous stenosis as a reason for pour patency and a trigger for recurrent DVT More than 50% suffer the post-thrombotic syndrome (PTS) 15% develop venous ulcers Akesson H, J Vasc Surg 1990

7 Venous Anatomy Iliac Veins

8 Iliofemoral Deep Vein Thrombosis Catheter-Directed Thrombolysis (CDT) RCT Year N Venous 6 months Venous 6 months 6-24 months Recurrent 6 months CDT Control CDT Control CDT Control CDT Control Elsharawy % 12% 11% 41% TORPEDO % 27.2% 2.3% 14.8% CaVent % 47% % 56% - - Thrombolysis duration 2.4 ± 1.1 days Thrombolysis dose: up to 20 mg t-pa per day (Major bleeding 9%), Stenting rate in CaVent: 17% 1 Elsharawy M, et al. Eur J Vasc Endovasc Surg 2002;24: Sharifi M, et al. Catheter Cardiovasc Interv 2010;76: Enden T, et al. Lancet 2012;379:31-38

9 The Bern Acute DVT Experience Fixed-dose regimen: rt-pa 20mg/15h Demographics N = 87 Age, mean ± SD 42 ± 21 y Women 60 % Body mass index, mean (range) 26 ± 5 Engelberger R, Kucher N, et al. Thromb Haemost 2014

10 The Bern Acute DVT Experience Adjunctive therapy Ilio-femoral DVT (n=87) Prolonged thrombolysis Mean 19 ± 6 hours, tpa dose 22 ± 10 mg 7% Stenting 1 Stent (mean 1.9 ± 1.3 stents) 80 % IVC 6 % Common iliac vein 83 % Stenting site External iliac vein 71 % Common femoral vein 30 % Femoral vein 7% Engelberger R, Kucher N, et al. Thromb Haemost 2014 Engelberger R, Kucher N, et al. Thromb Haemost 2014

11 The Bern Acute DVT Experience Clinical Outcomes Ilio-femoral DVT (n=87) Follow up duration Mean (range) 273 d (1-819) Major bleeding 12 months 1% Primary patency 12 months 87% Secondary patency 12 months 96% Post-thrombotic syndrome 12 months 6 % Engelberger R, Kucher N, et al. Thromb Haemost 2014

12 Venous Intervention Acute DVT treatment Catheter-directed thrombolysis +/- Stenting Chronic venous obstruction Endovascular reconstruction Stenting

13 Patency Rates Chronic Venous Intervention Etiology Primary Cumulative Patency rate Assist Primary Secondary Duration of f/u All 67-83% 89% 93% 6-8y Non-thrombotic stenosis Postthrombotic - non-occlusive Postthrombotic - occlusion 79% 100% 100% 6y 38-57% 63-80% 74-86% 4-6y 30-70% 56-73% 66-87% 4-6y Neglén P, Hollis KC, Olivier J, and Raju S. Stenting of the venous outflow in chronic venous disease: long-term stent-related outcome, clinical, and hemodynamic result. J Vasc Surg 2007;46: Raju et al. Best management options for chronic iliac vein stenosis and occlusion J Vasc Surg 2013;57:

14 Clinical Benefit of Chronic Venous Intervention Venous outflow obstruction plays an important role in clinical expression of CVD, particularly pain 1,3-4 Ulcerated limbs have a high rate of obstruction (37-52%) 5-6 Stenting results in impressive clinical relief of pain, swelling, VCSS, VDS and QoL, even when associated reflux is left untreated 1-3 Treatment results in healing of ulcers, despite untreated reflux, in 55-58% of the patients 1,3,6 1. Neglén P. Thrasher TL, Raju S. Venous outflow obstruction: An underestimated contributor to chronic venous disease. J Vasc Surg 38: , Hartung, Otero A, Boufi M et al. Mid-term result of endovascular treatment for symptomatic chronic nonmalignant iliocaval venous occlusive disease. J Vasc Surg 2005;42: Neglén P, Hollis KC, Olivier J, and Raju S. Stenting of the venous outflow in chronic venous disease: long-term stent-related outcome, clinical, and hemodynamic result. J Vasc Surg 2007;46: Delis KT, Bjarnason H, Wennberg PW, Rooke TW, Gloviczki P. Successful iliac vein and inferior vena cava stenting ameliorates venous claudication and improves venous outflow, calf muscle pump function, and clinical status in post-thrombotic syndrome. Ann Surg Jan;245(1): Marston et al. Incidence of and risk factors for iliocaval venous obstruction in patients with active or healed venous leg ulcers J Vasc Surg 2011, 53: Alhalbouni S, Hingorani A, Shiferson A, Gopal K, Jung D, Novak D, Marks N, Ascher E., Iliac-femoral venous stenting for lower extremity venous stasis symptoms.,ann Vasc Surg Feb;26(2):185-9.

15 Sinus Obliquus May Thurner Hybrid Stent (Optimed) Highflexibility part: Open-cell design High-radialforce part: Closed-cell design Oblique (35 ) design for protection of contralateral iliac vein inflow with 4 markers for correct positioning

16 Vici Stent (Veniti) Laser-cut nitinol stent with closed-cell design with flexible interconnections High radial force, moderate flexibility

17 Take Home Messages Iliofemoral DVT has poor outcomes with conventional therapy CDT plus routine stenting of underlying stenosis is associated with patency rates >90% and low rates of PTS and should be considered for most patients with acute iliofemoral DVT Data from larger RCTs are not far away for the most conservative physicians Stenting of iliofemoral stenosis in patients with established PTS is becoming routine clinical practice in many centers

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