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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