the evidence for venous interventions · occlusion 30-70% 56-73% 66-87% 4-6y neglén p, hollis kc,...

The evidence for venous interventions is evolving-

many patients do actually benefit

Nils Kucher

University Hospital Bern

Switzerland

Disclosure

Speaker name:

Nils Kucher

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

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Venous Intervention

Acute DVT treatment

Catheter-directed thrombolysis

+/- Stenting

Chronic venous obstruction

Endovascular reconstruction

Stenting

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

Venous Anatomy – Iliac Veins

Iliofemoral Deep Vein Thrombosis

Catheter-Directed Thrombolysis (CDT)

RCT Year N Venous patency @ 6 months

CDT Control

Venous reflux @ 6 months

CDT Control

PTS @ 6-24 months

CDT Control

Recurrent VTE @ 6 months

CDT Control

Elsharawy1 2002 35 72% 12% 11% 41% - - - -

TORPEDO2 2010 183 - - - - 3.4% 27.2% 2.3% 14.8%

CaVent 3 2012 209 66% 47% - - 41% 56% - -

1 Elsharawy M, et al. Eur J Vasc Endovasc Surg 2002;24:209-214 2 Sharifi M, et al. Catheter Cardiovasc Interv 2010;76:316-325 3 Enden T, et al. Lancet 2012;379:31-38

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%

The Bern Acute DVT Experience 2010-2013 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


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 %

Stenting site

IVC 6 %

Common iliac vein 83 %

External iliac vein 71 %

Common femoral vein 30 %

Femoral vein 7%

The Bern Acute DVT Experience 2010-2013 Adjunctive therapy


The Bern Acute DVT Experience 2010-2013 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 %

Venous Intervention

Acute DVT treatment

Catheter-directed thrombolysis

+/- Stenting

Chronic venous obstruction

Endovascular reconstruction

Stenting

Etiology

Cumulative Patency rate Duration

of f/u Primary

Assist –

Primary Secondary

All 67-83% 89% 93% 6-8y

Non-thrombotic

stenosis 79% 100% 100% 6y

Postthrombotic -

non-occlusive 38-57% 63-80% 74-86% 4-6y

Postthrombotic -

occlusion 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;46:979-90.

Raju et al. Best management options for chronic iliac vein stenosis and occlusion J Vasc Surg 2013;57:1163-1169

Patency Rates 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

Clinical Benefit of Chronic Venous Intervention

1. Neglén P. Thrasher TL, Raju S. Venous outflow obstruction: An underestimated contributor to chronic venous disease. J Vasc Surg 38:879-885, 2003.

2. 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;42:1138-44.

3. 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;46:979-90.

4. 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. 2007 Jan;245(1):130-9

5. 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, 53:1303-8

6. 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.

2012 Feb;26(2):185-9.

Sinus Obliquus May Thurner Hybrid Stent (Optimed)

Oblique (35°) design

for protection of

contralateral

iliac vein inflow

with 4 markers

for correct

positioning

High-

flexibility part:

Open-cell

design

High-radial-

force part:

Closed-cell

design

Vici Stent (Veniti)

• Laser-cut nitinol stent with closed-cell design

with flexible interconnections

• High radial force, moderate flexibility

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

the evidence for venous interventions · occlusion 30-70% 56-73% 66-87% 4-6y neglén p, hollis kc,...

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