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 CDC Thrombophilia pilot sites APHA-CDC leadership conference NQF/Joint Commissions, and CMS policies NIH funding DVT and venous disease Surgeon General Call to Action SVS/AVF DVT Guidelines AHA PTS Guidelines 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 AHRQ: VTE #1 prevention opportunity US Senate declares March DVT awareness month ASH Surveillance Workshop ATTRACT Trial AHA DVT Guidelines CIRSE Stent Guidelines CDC Thrombosis and Hemostasis Centers Research and Prevention Network established; CDC & NATT promote awareness 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 6 nitinol connectors 3 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
Stent Lengths VENOVO Venous Stent System 40 mm 60 mm 80 mm 100 mm 120 mm 140 mm 160 mm Stent Diameters 10 mm 12 mm 14 mm 16 mm 18 mm 20 mm 8F 9F 10F
Radial Force and Crush Resistance
BARD N= 20 Optimed Sinus Venous N=3 Cook Zilver Vena N -3 Stent Flexibility
Visibility Ovine Model, AP View Post stent deployment Ovine Model, AP View Compressed stent prior to deployment Ovine Model, AP View During 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
Numbers of Stent Occlusion Tien-Yu Wu et al. paper submitted
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
Symptom improvement Average CEAP reduction: 2.66 Tien-Yu Wu et al. paper submitted
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