Improved clinical outcomes Evidence on venous mechanical thrombectomy followed by stenting

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1 Improved clinical outcomes Evidence on venous mechanical thrombectomy followed by stenting Michael K. W. Lichtenberg, MD, FESC Vascular Centre Arnsberg, Germany German Venous Centre Arnsberg, Germany

2 Disclosure Speaker name: Michael Lichtenberg I have the following potential conflicts of interest to report: X Consulting (CR Bard, Veniti, Volcano, Biotronik, Terumo, Boston, Straub Medical,Veryan, TVA medical, Spectranetics, Cook, Optimed) Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) X I do not have any potential conflict of interest

3 Venous disease Western Europe Venous Outflow Obstruction Country: Western Europe Population 18 Years Age Projection Acute Incidence 2 Annual Patients % Obstuctive Component Annual Treatable Patients DVT 0,25% % Chronic C6 Active Ulcers 0,1% ,00% *UK, DE, IT, ES, FR, NL CVD (C2-C6): CEAP Classification Prevalence 4 Affected Population % Obstuctive Component Treatable Patients C0 No Disease 9,7% N/A 0 C1 Reticular Veins 59,0% N/A 0 C2 Varicose Veins 14,3% ,00% C3 Edema 13,4% ,80% C4 Skin Pigmentation 2,9% ,80% C5 Healed Ulcers 0,6% ,80% Wikipedia, 2016: Western Europe [ 2. Coon WW, Willis III PW, Keller JB. Venous thromboembolism and other venous disease in the Tecumseh Community Health. Circulation. 1973;48: Oguzkurt L, Ozkan U, Ulusan S, Koc Z, Tercan F. Compression of the left common iliac vein in asymptomatic subjects and patients with left iliofemoral deep vein thrombosis. J Vasc Interv Radiol. 2008;19: Maurins U, Hoffmann BH, Lösch C, Jöckel K-H, Rabe E, Pannier F. Distribution and prevalence of reflux in the superficial and deep venous system in the general population - results from the Bonn Vein Study, Germany. J Vasc Surg. 2008;48: Ananikian PP, Nanian AM, Galstian SM, Pogoisan BS. Clinical aspects, diagnosis and treatment of varicose veins of the lower limbs associated with extravasal compression of the external iliac vein. Kardiologiia Feb;24(2): Raju S, Neglén P. High prevalence of nonthrombotic iliac vein lesions in chronic venous disease: A permissive role in pathogenicity. J Vasc Surg. 2006;44: Marston W, Fish D, Unger J, Keagy B. Incidence of and risk factors for iliocaval venous obstruction in patients with active or healed venous leg ulcers. J Vasc Surg. 2011;53:

4 Venous outflow obstruction webs, spurs, chords

5 Konservative Therapie

6 KAHN et al. Determinants of health-related quality of life during the 2 years following deep vein thrombosis. Journal of Thrombosis and Haemostasis 2009, 6:

7 Catheter-directed thrombolysis plus anticoagulation versus anticoagulation alone in the treatment of proximal deep vein thrombosis - a meta-analysis Vasa 2015 May;44(3):

8 Iliofemorale Offenheitsrate nach 6 Monaten Persistierende venöse Obstruktion Im FU Vasa 2015 May;44(3):

9 Indication for proximal venous thrombectomy 23 y female patient 65 y male patient 80 y female patient CDT with high risk CDT with high risk Young and active patient Descending ileofemoral thrombosis May-Thurner Syndrome Phlegmasia, descending IVC thrombosis Bowel cancer Stenosis of right iliac vein With thrombus Lymphocele compression

10 EKOS Peripheral Infusion System Early Clot Removal Many Choices Trellis System AngioJet Aspirex (Rotational thrombectomy) Indigo System (Penumbra) 6 10 French M. Lichtenberg (Hrsg.), C. Tiefenbacher, M. Katoh, P. Minko, E. Minar, C. Wissgott, A. Storck, B. Hailer: Thrombektomie: medikamentös, mechnisch, operativ. Uni-med Verlag, 2013

11 21 y, female, descending DVT in May Thurner syndrome. Transpopliteal access, 10 F Aspirex 8 F: blood volume aspiration up to 75 ml/min 10 F: blood volume aspiration up to 130 ml/min

12

13 6 10 French Veniti Vici

14 Standard Treatment vs. CDT Enden T, et al: CaVenT Study Follow-Up 24 months: Number needed to treat: 7 Lancet Jan 7;379(9810):31-8.

15 Long-Term Results using Catheter-directed Thrombolysis in 103 Lower Limbs with Acute Iliofemoral Venous Thrombosis N. Bækgaard, R. Broholm, S. Just, M. Jørgensen, L.P. Jensen European Journal of Vascular and Endovascular Surgery, Volume 39, Issue 1, Pages (January 2010) All patients with patent veins and normal valve function showed no sign of dermal pigmentation, ulceration or venous claudication at follow-up 1 major bleeding complication

16 PEARL Comparison Treatment of Lower Extremity DVT PEARL * Venous CaVenT Registry CDT Standard # of Patients # of Sites Prior DVT 40% 31% 10% 9% Primary Treatment AngioJet Thrombectomy With or Without PMT CDT CDT LMWH Stent Placement 35% 33% 17% NA Primary access Popliteal Popliteal Popliteal NA Male 57% 48% 64% 62% Age (mean) 52.2 yrs 47.5 yrs 53.3 yrs 50.0 yrs Treatment Location Iliofemoral femoral pop Iliofemoral femoral pop CFV or iliofemoral Limbs Involved Left=62%; Right=38% *Garcia,MJ, et al. J Vasc Interv Radiol 2015; 26: Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 Enden, Haig Y. Lancet 2012:379:31-38 Left=61%; Right=39% Left=60%; Right=40% Left=62%; Right=38% CDT, catheter-directed thrombolysis; CFV, common femoral vein; LMWH, low molecular weight heparin; PMT, pharmacomechanical thrombolysis

17 PEARL Comparison Treatment of Lower Extremity DVT Overall % Thrombus Removal By Lytic Groups: % thrombus removal CDT (N=28) CDT+PPS/ RL (N=167) PPS/RL (N=113) Acute: % Thrombus Removal Chronic: % Thrombus Removal Primary Patency Freedom from Rethrombosis PEARL* Venous CaVenT Registry CDT Standard 96% 83% 89% NA 93% NA NA 97% NA NA 95% NA NA 97% 86% 89% 95% 68% NA NA 6 Mon= 87%; 12 Mon=83% 6 Mon=65%; 12 Mon=60% 6 Mon = 65.9% 6 Mon = 47.4% NA NA NA *Garcia,MJ, et al. J Vasc Interv Radiol 2015; 26: Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 Enden, Haig Y. Lancet 2012:379:31-38

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19 2. Indications for early thrombus removal 2.1. We suggest a strategy of early thrombus removal in selected patients meeting the following criteria: (a) a first episode of acute iliofemoral deep venous thrombosis (b) symptoms <14 days in duration (c) a low risk of bleeding (d) ambulatory with good functional capacity and an acceptable life expectancy (Grade 2C)

20 Two center retrospective data analysis for DVT thrombectomy with the Aspirex catheter Dr. Thomas Heller Dr. Michael Lichtenberg 43 Aspirex thrombectomy procedures for iliofemoral DVT Technical success analysis Safety analysis

21 Ileofemoral DVT therapy with Aspirex catheter May-Thurner syndrom: 43.1 years, 66 % female Cancer patients with more phlegmasia symptoms Duration of symptoms: 1 day 3 months Hemodynamic technical success in cath lab with Aspirex and stent implantation: 97 % (42/43 patients) No prolonged lytic therapy Stent rate 100 % in Arnsberg patients / 95 % Rostock IVUS 100 % Stent rate 1,25 / patient Complications: No bleeding, PE

22

23 The difference in PTS severity was almost entirely seen in the iliofemoral DVT patients with moderate/severe PTS seen in 18.4% of PCDT patients versus 28.2% in the no-pcdt group Overall, the 2-year data supported the use of standard therapy/anticoagulation alone in most DVT patients PCDT was not shown to prevent postthrombotic syndrome (PTS) and was associated with increased bleeding. Leg pain and leg swelling were significantly improved in patients who received PCDT vs no-pcdt: (leg pain, 10 days: vs -1.29; P =.019; 30 days: vs -1.83; P =.026) (leg swelling, 10 days: vs +0.27; P =.024; 30 days: vs -0.28; P =.051). However, PCDT was shown to reduce early DVT symptoms as well as PTS severity The PCDT arm saw a statistically significant higher rate of major bleeding within 10 days (1.7% vs 0.3%; P =.049),

24 Conclusion DVT thrombectomy Is effective in venous thrombus removal Even in more organized thrombus Restores vein patency in upper and lower limb Has low risk and less side effects with PMT No ICU stay End it in the Angiolab PMT will be the standard treatment Treat the underlying reason with a dedicated iliac vein stent

25 THANK YOU FOR YOUR ATTENTION

26 Improved clinical outcomes Evidence on venous mechanical thrombectomy followed by stenting Michael K. W. Lichtenberg, MD, FESC Vascular Centre Arnsberg, Germany German Venous Centre Arnsberg, Germany

Improved clinical outcomes Evidence on venous thrombectomy followed by stenting

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