future devices of venous interventions · • from the literature and my study, iliac vein stenting...

Future Devices of Venous

Interventions

Director of Peripheral Vascular Medicine Department of

Shin Kong Wu Ho-Su Memorial Hospital, Taiwan

Interventional Cardiologist Tien-Yu Wu MD

Disclosure

Speaker name:

.................................................................................

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

Increased Awareness

AHA PTS

Guidelines

CIRSE Stent

Guidelines

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

CDC Thrombophilia

pilot sites

AHRQ: VTE #1

prevention opportunity

APHA-CDC leadership

conference

US Senate declares

March DVT awareness

month

NQF/Joint Commissions,

and CMS policies

NIH funding DVT and

venous disease

CDC Thrombosis and Hemostasis Centers Research and Prevention

Network established; CDC & NATT promote awareness

ASH Surveillance

Workshop

Surgeon General Call

to Action

SVS/AVF DVT

Guidelines

AHA DVT Guidelines

ATTRACT Trial

Beckman M, et al. Am J Prev Med. 2010

Vedantham S, et al. Rationale Am Heart J. 2013

Jaff MR, et al. Circulation. 2011

Kahn SR, et al. Circulation. 2014

Meissner H, et al. J Vasc Surg 2012

Mahnken AH, et al. Cardiovasc Intervent Radiol. 2014

Current Venous Intevention

• Acute or chronic deep vein thrombosis

• CDT or PMT

• PTA with stenting

• May-Thurner Syndrome

• Iliac vein stenting placed an important

role to restore and maintain venous out

flow

• PCDT

• Did not prevent the development of PTS

• Significant higher rate of major bleeding

within 10 days (1.7% vs 0.3%; P = .049)

• Reduce early DVT symptoms as well as

PTS severity

In the past decades

• Only Wall stent and arterial Nitinol stent

available

• Wall stent

• Better radial force

• Foreshortening

• Migration

• Arterial Nitinol stent

• Weak radial force

• Not large enough

• No stents design for Vein

May-Thurner Syndrome

Wall stent

Nitinol stent

Wall stent vs Nitinol stent

Wall stent vs Nitinol stent

Artery Nitinol Stent

Anatomy

What is a workman without his tools？

Ideal Venous Stent Design

• Large diameters design

• Easy and accurate deployment

– Easy to deploy

– Radiopaque

– Limited foreshortening

• Long lengths

• Balance between radial force and flexibility

– High radial force

– High compression resistance

– High flexibility

VENOVO Venous Stent

BARD Next Generation Venous stent

VENOVO® Venous Stent

• Self expanding nitinol

• Flexible, fine tubular

mesh prosthesis

• Outward radial force

established vessel patency

• Ends flared 3mm to ensure

adequate wall apposition

VENOVO® Venous Stent

3 radiopaque

tantalum markers

3 nitinol

connectors

6 nitinol

connectors

3 non-radiopaque

nitinol markers

VENOVO®

Venous Stent Delivery System

• Tri-axial system

• 0.035”, over-the-wire

• Safety lock slider

• Dual speed thumbwheel

– Large thumbwheel for slow deployment

– Small thumbwheel for fast deployment

VENOVO® Venous Stent System

Stent Diameters

10 mm 12 mm 14 mm 16 mm 18 mm 20 mm

Ste

nt

Length

s

40 mm

8F 9F 10F

60 mm

80 mm

100 mm

120 mm

140 mm

160 mm

Radial Force and Crush Resistance

Stent Flexibility

BARD N= 20

Optimed Sinus Venous N=3

Cook Zilver Vena N -3

Visibility

Ovine Model, AP View

Compressed stent prior to

deployment

Ovine Model, AP View

During stent deployment

Ovine Model, AP View

Post stent deployment

VERNACULAR Trial

The BARD®

VENOVO®

Venous Stent Study - A Prospective, Non-

Randomized, Multi-Center, Single-Arm Study of the Treatment

of Iliofemoral Occlusive Disease – an Assessment for

Effectiveness and Safety

Design: Prospective, multi-center, non-randomized, single-arm

Core lab & DSMB

Purpose: to assess the safety and effectiveness of the VENOVO®

Venous Stent for the treatment of iliofemoral occlusive disease

including Acute or Chronic Deep Vein Thrombosis (DVT), May-

Thurner Syndrome, or any combination of the above.

Investigative Sites: 35 sites in the US, Europe, and Australia/NZ

Subjects: 170 subjects

Key Inclusion/Exclusion

Inclusion

Unilateral disease of

common femoral,

common/external iliac

Symptomatic venous

outflow obstruction

> 50% by venography

CEAP >3 or VCSS >2

RVD 7 mm - 19 mm

Exclusion

Contralateral disease

and lesions that extend

into IVC or below

lesser trochanter

Uncorrectable bleeding

diathesis or active

coagulopathy

Previous venous stents

Can’t cross occlusion

VERNACULAR Trial • Primary endpoints:

• Primary patency (12 months)

• Freedom from MACE (30 days)

• Evaluated against literature derived performance

goals

• Key secondary endpoints:

• VCSS/ CEAP/ QoL assessment

• Procedure/technical success

• Freedom from TVR/TLR

• Primary patency at 24 and 36 mo.

• Stent fracture

• The result is still pending

IVUS Guide Iliac Vein Stenting (2012-2016, 22+ months mean follow-up)

Procedure successful rate 100 % Tien-Yu Wu et al. paper submitted

Tien-Yu Wu et al. paper submitted

Numbers of Stent Occlusion

Primary Patency

Patency = Duplex study + free from clinical symptom Tien-Yu Wu et al. paper submitted

Risk factor vs stent occlusion

Tien-Yu Wu et al. paper submitted

Tien-Yu Wu et al. paper submitted

Symptom improvement

Average CEAP reduction: 2.66

Conclusion

• From the literature and my study, iliac vein

stenting has be proved to be safe and

effective in treating certain iliac vein

disease.

• The venous system is quite different from

artery. It shouldn’t be treated in the same

way (stent). We need more adequate design

of the devices for venous system.

• We hope the venovo venous stent could

give us a promising result in the near future.

Thank You!

Future Devices of Venous

Interventions

Director of Peripheral Vascular Medicine Department of

Shin Kong Wu Ho-Su Memorial Hospital, Taiwan

Interventional Cardiologist Tien-Yu Wu MD