Improved clinical outcomes Evidence on venous thrombectomy followed by stenting

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

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

Venous outflow obstruction webs, spurs, chords

Venous disease Western Europe Venous Outflow Obstruction Country: Western Europe Population 18 Years Age 1 333.294.710 2016 Projection Acute Incidence 2 Annual Patients % Obstuctive Component Annual Treatable Patients DVT 0,25% 833.237 61% Chronic C6 Active Ulcers 0,1% 333.295 60,00% 199.977 *UK, DE, IT, ES, FR, NL CVD (C2-C6): 104.254.585 23.458.348 3 508.274 CEAP Classification Prevalence 4 Affected Population % Obstuctive Component Treatable Patients C0 No Disease 9,7% 32.396.246 N/A 0 C1 Reticular Veins 59,0% 196.643.879 N/A 0 C2 Varicose Veins 14,3% 47.627.814 22,00% 10.478.119 C3 Edema 13,4% 44.694.821 21,80% 6 9.743.471 C4 Skin Pigmentation 2,9% 9.532.229 21,80% 6 2.078.026 C5 Healed Ulcers 0,6% 2.066.427 21,80% 6 450.481 5 7 1. Wikipedia, 2016: Western Europe [https://en.wikipedia.org/wiki/western_europe] 2. Coon WW, Willis III PW, Keller JB. Venous thromboembolism and other venous disease in the Tecumseh Community Health. Circulation. 1973;48:839-846. 3. 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;19:366-371. 4. 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;48:680-87. 5. 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. 1984 Feb;24(2):97-100. 6. Raju S, Neglén P. High prevalence of nonthrombotic iliac vein lesions in chronic venous disease: A permissive role in pathogenicity. J Vasc Surg. 2006;44:136-44. 7. 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;53:1303-1308.

PTS is high with conservative therapy

Catheter-directed thrombolysis plus anticoagulation versus anticoagulation alone in the treatment of proximal deep vein thrombosis - a meta-analysis Vasa 2015 May;44(3):195-202

Iliofemoral patency after 6 months Persistent obstruction within iliac vein Vasa 2015 May;44(3):195-202

Standard Treatment vs. CDT Enden T, et al: CaVenT Study Follow-Up 24 months: Number needed to treat: 7 Lancet. 2012 Jan 7;379(9810):31-8.

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 112-117 (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

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)

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

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

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

PEARL Comparison Treatment of Lower Extremity DVT PEARL * Venous CaVenT Registry CDT Standard Onset of DVT Symptoms Acute 67% ( 14 days) 66% ( 10 Days ) 100% 21 days Chronic 33% (>14 days) 16% (>10 Days ) NA Acute & Chronic NA 19% NA Primary Lytic TPA Urokinase TPA NA CDT Drip Times (mean) 17 hrs 48 hrs 57.6 hrs (2.4 days) NA Procedure Times CDT (N=29) CDT+PPS/RL (N=172) PPS/RL (N=115) Bleeding Complications 40.9 hrs NA NA NA 22.0 hrs NA NA NA 2.0 hrs NA NA NA 4.5% (major & minor combined) 11% (major); 16% (minor) 22% (major & minor combined) 0% *Garcia,MJ, et al. J Vasc Interv Radiol 2015; 26:777-785 Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 Enden, Haig Y. Lancet 2012:379:31-38

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

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

25 years, female, nonsmoking patient. Back pain during last weeks

6 10 French Veniti Vici

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

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