4/14/2016 Disclosures Medtronic Spectranetics 2016 Tenaxis - - PowerPoint PPT Presentation

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2016 UCSF Vascular Symposium

James J Zimmerman, M.D.

Palo Alto Medical Foundation Director Vascular and Endovascular Interventions at Sequoia Hospital, Redwood City, California

Societal, Clinical, and Radiographic Definition of Venous Stenosis: A Moving T arget?

Disclosures

• Medtronic
• Spectranetics
• Tenaxis Medical – SAB
• Volcano Corporation
• W.L. Gore

Venous Insufficiency Prevalence

An estimated 25 million people in the U.S. have varicose veins

• 4.5 million new diagnoses are made annually
• 2 to 6 million have more advanced forms of venous insufficiency

(swelling or skin changes)

• Nearly 500,000 have painful venous ulcers
• Venous disease has a negative impact on QOL
• Leads to diability and early retirement

Only 1.7 million actually seek treatment $1-2 billion/year treating ulcers in the U.S.

• 2 Key Questions

When is ilio-caval compression hemodynamically significant?

• When is it responsible

for symptoms?

What is the best non-invasive method of studying patients for this problem?

2. 1.

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Societal and QOL Impact of Ilio-Caval Stenting

Neglen, P., K.C. Hollis, J. Olivier, and S. Raju, Stenting of the venous outflow in chronic venous disease: long-term stent-related outcome, clinical, and hemodynamic result. J Vasc Surg, 2007. 46(5): p. 979-990

Leg pain Work related leg pain Sleep disturbance due to leg pain Effect on social activities Effect on morale

The results are durable

Improvement in all categories of CIVIQ

How do we find ICVO in this guy? Options for Evaluation

• Lower extremity for obstruction and insufficiency
• Iliac vein duplex for obstruction and trabeculation

Duplex ultrasound CT venography MR venography Ascending venography IVUS

CT Venography

• Thin cut 3D CT venography
• 1mm cuts
• Examined in multiple planes
• Max % of narrowing of iliac or IVC

recorded

• CT 3-D reconstructions

Marsten et al, JVS 2011;53:1308-8

> 90% correlation with IVUS IF contrast bolus is well timed

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Incidence of Ilio-Caval Obstruction on CT/MRI

Study Design

• 78 limbs in 64 patients
• CEAP class 5 or 6 CVI
• All tested with CT or

MR venography for ilio-caval obstruction Ilio-caval stenosis % of total cases 100% 8.8% 80-99% 14.0% 50-79% 14.0% 30-49% 5.3% 10-29% 17.5% 0-10% 42.1% Correlating Duplex Exams >80% 23% false negative >50% 37% false negative

Marsten et al, JVS 2011;53:1308-8

Need for Pre-Procedure Imaging?

Berland NYU Veith 2014

• + in 31 patients
• in 17 patients

MRV/CTV in 48 patients

• 11 were false negatives
• IVUS demonstrated >50% stenosis

Of those negative: 11/17 (65%) patients who had a negative MRV/CTV were positive by IVUS

Ilio-Caval Venography

May reveal obstruction if in correct plane Degree of collateral development is useful Low sensitivity

Marsten et al, JVS 2011;53:1308-8

Venography vs IVUS

• Venography significantly understimates the

degree of stenosis by 30%

• Inaccurately detects obstruction in >70% of

patients

• Superior in showing intraluminal details.
• Trabiculations and webs
• IVUS sensitivity in detecting obstruction > 90%

Raju D, NaglenP . High prevalence of nonthrombolic iliac vein lesions in chronic venous disease: a permissive role in pathogenicity. J Vasc Surg 2000;44:136-63. Neglen P , Raju D. Intravascular ultrasound scan evaluation of the obstructed vein. J Vasc Surg 2000;35:694-700.

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Factors Influencing Arterial vs Venous Pressure

ARTERIAL

• High pressure
• High resistance
• Vessels get smaller

VENOUS

• Low pressure
• Low resistance
• Collaterals get larger
• Geometry of vessel may matter

My Algorithm – Who Gets a Study

• Unilateral swollen leg
• +/- history DVT
• No toe or forefoot swelling
• Lower extremity duplex
• +/- insufficiency
• Positive iliac duplex for trabeculation or old DVT
• C4-C6 disease unresponsive to conventional therapy
• Bilateral leg swelling with history DVT

81% had >50% area reduction ~90% had symptomatic improvement

Berland NYU Veith 2014

My Algorithm – What Do They Get

Qualifying patients receive ascending venogram plus IVUS

Venous compression R Iliac Artery L Iliac Vein Wallstent 18mm x 90mm Normal lumen Post stent lumen

Pre Post

% Compression Treatment 70% Wallstent 50%-70% ? <50% No Intervention

When is a Vein Obstructed Enough?

“When a venous stenosis should be considered ”critical” is not known. In lieu of adequate hemodynamic tests, it appears that IVUS determination of morphologic significant stenosis is presently the best available method for the diagnosis of clinically significant iliac vein obstruction.”

Neglen and Raju. “Intravascular ultrasound scan evaluation of the obstructed vein”. JVS April 2002.

50% 70% 80%

? ?

No Consensus

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Can Iliac Stenting Help?

BEFORE: AFTER:

You Decide!

Thank You!

Jim Zimmerman, M.D.

Societal, Clinical and Radiographic Definition of Venous Stenosis: A Moving T arget?

James J. Zimmerman, MD Palo Alto Medical Foundation Director Vascular and Endovascular Interventions at Sequoia Hospital, Redwood City, CA