Con: The Answer is You Don’t Know

Slides:

Advertisements

Similar presentations

Infrapopliteal Sirolimus-Eluting Versus Bare Metal Stents for Critical Limb Ischemia: Long-Term Angiographic and Clinical Outcome in >100 Patients Dimitris.

Advertisements

Drug Coated Balloons From Bench to Bedside Service de Radiodiagnostic et Radiologie Interventionnelle Université de Lausanne Salah D. Qanadli, MD, PhD,

Zilver PTX Trial Bhagat K. Reddy, MD, FACC

Superficial Femoral Artery Stents - Bare, Covered, or Drug-Coated – “The Data and The HYPE” Dennis F. Bandyk, MD Division of Vascular & Endovascular Surgery.

FAST (Femoral Artery Stenting Trial) Final Results Hans Krankenberg (on behalf of the FAST Investigators) Hamburg University Cardiovascular Center Prof.

Biondi-Zoccai: Peripheral interventions – metcardio.org Basic principles of peripheral interventions Giuseppe Biondi Zoccai University.

MassMedic Presentation Innovation Accelerated SM.

Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions – Balloon Angioplasty versus primary Stenting: A prospective, multi-centre, randomised.

UpdateDEB Lesions Learned from the Trials and Daily Clinical Practice Ralf Langhoff, MD Center for Vascular Medicine Berlin-Wilmersdorf St. Gertrauden.

University of Modena and Reggio Emilia Vascular Surgery – Director: prof. Coppi Silingardi R. Veronesi J. Gennai S.

Peripheral Interventions: Unmet needs!

Superficial Femoral Artery – Where Does the Data Stand? Director, Endovascular Services Mehdi H. Shishehbor, DO, MPH, PhD Cleveland Clinic.

November 9, 2015 February 20, 2017 Using real world evidence – industry perspective Pma indication expansion Melissa hasenbank, phd Sr. Clinical Research.

Renal Sympathetic Denervation View From the EU

Lawrence A. Garcia, MD DISCLOSURES Consulting Fees

Global Experience with Peripheral DCBs/Stent Studies: C.R. Bard

Novel Trial Design Focus - Left Main and “All Comers” DES Studies: All-Comers Studies. Interventional View Jeffrey J. Popma, MD Director, Innovations in.

Conflict of Interest Statement

CLI and Device Intervention Across the Pacific – An FDA View

What should be the optimal Design for TAVI Procedure.

CRT 2012 Venous Disease.

William A. Gray, MD DISCLOSURES Consulting Fees

Can Drug-Coated Balloons Work in Synergy with Stent Grafts?

Management of Aortic and Aortoiliac Stenoses and Occlusions

Managing Carotid Disease after CREST – CEA: Still the Gold Standard

INFRATIBIAL INTERVENTIONS Current Results with DES

Office of Medical Devices II,

New Stent Designs Applicable for Renal Intervention

Lutonix® Paclitaxel-Coated Balloon to Treat Obstructive Lesions in the Superficial Femoral and Popliteal Arteries Preliminary Six-Month Results from.

OUS Data: What does the CE Mark Really Mean?

Impact of Radial Access on Bleeding

David H. Deaton, MD Chief, Endovascular Surgery

Clinical Usefulness of Post-Stenting FFR

Novel Devices Focus – The Path Forward for DEB and New DES and Bioabsorbable Stents Academic View Bruno Scheller, MD Klinische und Experimentelle Interventionelle.

Stent Graft for the Treatment of ISR:

(DES)+BVS +DCB for long diffuse LAD disease

Renal Denervation Next Steps

DES in the SFA: Will it ever work? Lewis B. Schwartz, M.D., F.A.C.S.

Treatment of iliac vein obstruction

Aorta Infrarenal Stenosis: BE, SE or Covered Stents? CRT 2012

University of Pennsylvania

CRT Washington, D.C. February 23, 2010 Tim A. Fischell, M.D. FACC

Japan-USA Synergies: Academic View

Restenosis in Peripheral Arteries

First-in-Man, First In The USA: What’s The Difference?

Current Results of Drug Coated Balloons for Infrapopliteal Disease

The TREAT Study: Can Devices Lower Bleeding Rates?

Are We Moving Away from Surgery for the Common Femoral Lesion?

CRT 2010 Washington DC, January 21, 2010

SYNTAX at 2 Years: This Interventionalist’s Perspective

Debate: The Femoral Artery - Common Femoral & Popliteal Artery Stenosis: “No Stent Zones” Are Best Managed Surgically Rabih A. Chaer MD Assistant Professor.

CRT 2010 Washington DC, January 21, 2010

Subintimal Tracking and Reentry for CTO STAR Method

Instent Restenosis and Occlusion: Time for Surgical Revision?

Benefits of US EFS: A Clinical Perspective

Percutaneous Reconstruction of the Aortoiliac Bifurcation

Precise and Durable Outcomes With the GORE® TIGRIS® Vascular Stent

Are we using fewer Covered Stents for SFA Occlusive Disease?

Giuseppe Biondi Zoccai

Significant (greater than $10K)

How and why this study may change my practice ?

Role of simple and complex hybrid revascularization procedures for symptomatic lower extremity occlusive disease Hasan H. Dosluoglu, MD, Purandath Lall,

A novel endovascular treatment for long-standing high-flow arteriovenous fistula Jonathan D. Hodgkinson, MRCS, Nicholas Cheshire, MD, Colin Bicknell,

Clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices

Endovascular management of multiple arteriovenous fistulae following failed laser- assisted pacemaker lead extraction David J. O'Connor, MD, Jay Gross,

Courtney J. Warner, MD, MS, Alexander J. Horvath, BA, Richard J

Endovascular aortoiliac grafts in combination with standard infrainguinal arterial bypasses in the management of limb-threatening ischemia: Preliminary.

Division of Endovascular Interventions

Endovascular repair of a penetrating thoracic aortic ulcer by way of the carotid artery Michael J Heidenreich, MD, David G Neschis, MD, Michael J Costanza,

Long-Term Outcomes of an Endovascular-First Approach for Diabetic Patients With Predominantly Tibial Disease Caitlin W. Hicks, MD, MS, Joseph K. Canner,

Presentation transcript:

Con: The Answer is You Don’t Know Iliac and Femoral Stent Trials are a Waste of Time and Taxpayer Money Con: The Answer is You Don’t Know David H. Deaton, MD Chief, Endovascular Surgery Georgetown University Hospital

David H. Deaton, MD DISCLOSURES Consulting Fees Honoraria Aptus Endosystems, Inc., ROX Medical Honoraria m2s, Inc. Grants/Contracted Research Boston Scientific Corporation, Terumo Medical Corporation I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation. I intend to reference the published data from FDA sanctioned trials of devices that have not been approved yet. I will describe these devices and how they are physically different from current devices.

Pre Test Are bile ducts different than blood vessels? A) no, they’re both tubes B) no, they both accept a guidewire and a balloon C) no, they both carry liquids D) A,B, and C are correct E) Yes

They’re all the same: Boats

Are different vascular beds really all that different? YES Carotid – high flow, focal disease, sensitive end organ Iliac – Intracavitary, often calcified, short Femoral – Extracavitary, enveloped by muscle / fascia, long Tibial – Extracavitary, small vessels, diffuse disease

Do we need to test devices in different environments? Journal of Vascular Surgery, Volume 48, Issue 2, Pages 435-440, August 2008

The SFA Environment See 000-10-715 p.7 90° flexion 0° flexion

The SFA Environment See 000-10-715 p.7

Can small changes make big differences in outcome? YOU BETCHA! The deHavilland Comet 1 WindowShape

Stent Patterns SENTINOL ABSOLUTE PRO ABSOLUTE XCEED LIFESTENT FLEXSTAR XL PROTEGE EVERFLEX E·LUMINEXX SMART CONTROL

Clinical Rates of Stent Fracture in the SFA Duda SH, et al. Circ. 2002; 106:1505-1509. Schillinger M, et al. New Engl. J. Med. 2006; 354:1879-1888. Schlager O, et al. J. Endovasc. Ther. 2005; 12:676-684. Krankenberg H, et al. Circ. 2007; 116:285-292. Katzen BT. Transcatheter Cardiovascular Therapeutics, Washington, 2007. Scheinert D. Leipzig Interventional Course, Leipzig, 2008. Ferreira M, et al. Eur. J. Vasc. Endovasc. Surg. 2007; 34:702-708. Schroë H, et al. CIRSE, 2006; Duda S. Leipzig Interventional Course. Leipzig, Germany, 2009.

S.M.A.R.T. Stent Fracture in SIROCCO Lansky AJ. Angiographic analysis of strut fractures in the SIROCCO trial and relationship to adverse clinical events. Transcatheter Cardiovascular Therapeutics, Washington, D.C., 2004.

Instent Restenosis

Modern Stent Manufacturing The Devil is in the details….. Modern Stent Manufacturing Raw Tubing Laser Cut Stent Descaled Stent Finished Stent START Laser Cutting Descaling Electropolishing

Caveats Trials for indication should be limited to applications that are clinically and physiologically different Trials should be limited to applications that are likely to see significant clinical usage

Considerations Clinical need Do trials inhibit clinical practice… Unmet clinical need, or…. Yet another stent without demonstrated additional benefit Do trials inhibit clinical practice… No, but unregulated use with bad long-term outcomes will threaten all endovascular Who’s being regulated ? Industry not Physicians

despair.com

Thank you