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

Disclosure

Speaker name:

Michael Lichtenberg

I have the following potential conflicts of interest to report:

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)

I do not have any potential conflict of interest

X

X

Venous disease Western Europe

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.

*UK, DE, IT, ES, FR, NL

Country: Western Europe Population ≥ 18 Years Age 1 2016 Projection

Incidence 2 Annual Patients Annual Treatable Patients

DVT 0,25% 833.237 61% 3 508.274

CEAP Classification Prevalence 4 Affected Population 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% 5 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

C6 Active Ulcers 0,1% 333.295 60,00% 7 199.977

CVD (C2-C6): 104.254.585 23.458.348

% Obstuctive Component

Venous Outflow Obstruction

333.294.710

Acute

% Obstuctive Component

Chronic

Venous outflow obstruction

webs, spurs, chords

Konservative Therapie

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: 1105–1112

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

Iliofemorale

Offenheitsrate nach

6 Monaten

Persistierende

venöse Obstruktion

Im FU

Vasa 2015 May;44(3):195-202

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

23 y female

patient

65 y male

patient 80 y female

patient

Indication for proximal venous thrombectomy

CDT with

high risk

CDT with

high risk

AngioJet® EKOS® Peripheral

Infusion System Trellis™ System

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

Early Clot Removal Many Choices

6 – 10

French

Aspirex® (Rotational thrombectomy) Indigo System ® (Penumbra)

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

6 – 10

French Veniti Vici

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

PEARL Comparison Treatment of Lower Extremity DVT

PEARL* Venous Registry†

CaVenT‡

CDT Standard

# of Patients 329 287 90 99

# of Sites 32 63 20

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%

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 *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

PEARL* Venous Registry†

CaVenT‡

CDT Standard Overall % Thrombus

Removal 96% 83% 89% NA

By Lytic Groups: % thrombus removal

CDT (N=28)

93% NA NA

CDT+PPS/RL (N=167)

97% NA NA

PPS/RL (N=113)

95% NA NA

Acute: % Thrombus Removal

97% 86% 89%

Chronic: % Thrombus Removal

95% 68% NA

Primary Patency NA 6 Mon=65%; 12 Mon=60%

6 Mon = 65.9% 6 Mon = 47.4%

Freedom from Rethrombosis

6 Mon= 87%; 12 Mon=83%

NA NA NA

*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

PEARL Comparison Treatment of Lower Extremity DVT

• 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)

Two center retrospective data analysis for DVT thrombectomy with the Aspirex® catheter

43 Aspirex thrombectomy procedures for

iliofemoral DVT

Technical success analysis

Safety analysis

Dr. Thomas Heller Dr. Michael Lichtenberg

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

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.

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),

Leg pain and leg swelling were significantly improved in patients who received

PCDT vs no-PCDT: (leg pain, 10 days: -1.62 vs -1.29; P = .019; 30 days: -2.17

vs -1.83; P = .026) (leg swelling, 10 days: -0.26 vs +0.27; P = .024; 30 days: -

0.74 vs -0.28; P = .051).

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

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

THANK YOU FOR YOUR ATTENTION

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