What are the Novel Devices and Technologies in 2014 to Treat Peripheral Artery Disease Mehdi H Shishehbor, DO, MPH, PhD Director, Endovascular Services Staff, Interventional cardiology and Vascular Medicine Cleveland Clinic Current limitations Associated with SFA Treatment • Patency – Long lesions • Re-stenosis • Stent Fracture – Re-stenosis – Thrombosis – Pseudoaneurysm • Cost Scheinert D, et al JACC 2005; 45 (2):312-315 Binary restenosis @ 12 months (%) Lesion/stent Length and Patency PTA PLUS PROVISIONAL STENT PRIMARY STENT Shillinger,M 2009 ABSOLUTE ASTRON RESILIENT FAST ABSOLUTE FAST ASTRON RESILIENT Length of the lesion (cm) Binary restenosis @ 12 months (%) Comparison of SFA Trials PTA ALONE PTA PLUS PROVISIONAL STENT PRIMARY STENT ZILVER Balloon suboptimal DES Shillinger & Baumgartner 2010 ABSOLUTE ASTRON RESILENT RESILIENT FAST ZILVER Balloon optimal PTA plus stent ASTRON FAST RESILIENT ZILVER PTX Length of the lesion (cm) ABSOLUTE Binary restenosis @ 12 months (%) Comparison of SFA Trials PTA ALONE PTA PLUS PROVISIONAL STENT PRIMARY STENT ZILVER PTX Balloon suboptimal DES VIABAHN Shillinger & Baumgartner 2010 ABSOLUTE ASTRON RESILENT RESILIENT FAST ZILVER Balloon optimal PTA plus stent FAST ABSOLUTE MCQUADE 25 CM ASTRON KEDORA 25 CM RESILIENT ZILVER PTX FISCHER Length of the lesion (cm) Standard Nitinol Stents (SNS) Smart (Cordis) Wire Interwoven Stents Covered/Stent Grafts SUPERA (Abbott Vascular) Viabahn (Gore) Protégé Everflex (eV3) LifeStent (Bard) Luminexx (Bard) Absolute (Abbott) Xpert (Abbott) Zilver / PTX (Cook) Complete SE (Medtronic) Misago (Terumo) FlexStent (Flexible Stent Tech) Fluency (Bard) Paradigm Shift! • Angioplasty alone • Drug coated balloon • Spot stenting • TACK-IT technology Current limitations Associated with BKA Treatment • Patency – Long lesions • Limited Stent options – DES • Data on DEB now ?? • Angioplasty Currently No DEB are available for Below Knee Disease!! Manual Rotation/Spining Mechanical Rotation/Spining Differential Dissection Viance TM TruePath Wildcat TM TM TM Crosser TM Frontrunner Speaker Name Kittycat TM Ocelot TM Percent Success Ann Vasc Surg 2014 Aug;28(6):1439-48 83 year old female • Hypertension • HL • DM • CR ~ 1.2 • Presents with rest pain and large ulcer EVENTS • Seen by vascular surgery 03/2012 • Offered Fem-BK bypass and TMA • Refused TMA • Late March Undergo Fem-BK bypass using vein • Early April with severe rest pain • Graft occluded –long TPA and Angioplasty EVENTS • A few hours later with no pulse in the foot • Repeat angiogram shows graft is occluded • Again angioplasty and Lovenox • Offered BKA but she refused • Discharged • Mid April came to see me crying in rest pain Post Procedure 0.18 Post Procedure Weeks Post-intervention THANK YOU!! [...]... Unique nitinol “constraining structure” • Shields vessel wall from torsional shear stress caused by balloon “unfolding” • Uniformly distributes longitudinal & circumferential forces • Modifies plaque via:  “Pillows”: Vessel dilatation without cutting or scoring  “Grooves”: Stress relief, plaque modification What Does this Mean Clinically? Bail-Out Stenting Rates • Fewer dissections 20% • More aggressive... 12MO 30D 3MO 6MO 12MO dUS, QVA Clinical BTK: dUS, QVA • • • • • Study Endpoints: Late Lumen Loss – Angiography (QVA Core Lab) Patency Rate – Duplex Ultrasound (dUS Core Lab) TLR Rate Amputation Free Survival Rutherford Grade change Why CTOs are a Problem? • Time Commitment & skill set • Failure rate • More complications • Cost • More radiation and contrast • Poor Patency Lancet 2005 Dec 3;366(9501):1925-34... 30% of CTOs Can Not be Crossed in the Antegrade Approach Lancet 2005 Dec 3;366(9501):1925-34 J Endovasc Ther 2008;15:594–604 Manual Rotation/Spining Mechanical Rotation/Spining Differential Dissection Viance TM TruePath Wildcat TM TM TM Crosser TM Frontrunner Speaker Name Kittycat 2 TM Ocelot TM Percent Success Ann Vasc Surg 2014 Aug;28(6):1439-48 83 year old female • Hypertension • HL • DM • CR ~