NEW FONTIERS IN SFA STENTING FINAL

New Frontiers in SFA Stenting IN 2008 : 

New Frontiers in SFA Stenting IN 2008 Mr.Mohamed Omar El-Farok M.Sc, FRCS

What is new in 2008 : 

What is new in 2008 Better drugs Better tools Better techniques Better results Mr.Mohamed Omar El-Farok M.Sc, FRCS 2

Which platform to use : 

Which platform to use Aorot iliac = 0.035 system Tibials = 0.014 system SFA = 0.035 & 0.014 systems ? Mr.Mohamed Omar El-Farok M.Sc, FRCS 3

Basic structure of intervention: : 

Basic structure of intervention: Initialization Main interventional cycle termination 4 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Initialization: : 

Initialization: Assess the patient , indication and clinical condition Assess the access site , previous scar , pulse quality Assess images to inflow , ouflow , lesion and access site Have plane A and B Prepare tools and run a mental senario 5 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Main interventional cycle : 

Main interventional cycle It is three steps , Assess , Intervene , Repeat Mainly use telescopic system , 0.014 wire or 0.035 platform Cross over technique is preferred to ipsi-lateral approach 6 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Steps: : 

Steps: 8F Sheath to contralateral CFA at zone 2 Cross the aortic bifurcation with RIM,or SOS-OMNI-HOOK , HOCKY STICK or even PIGTAIL Pass Terumo or normal wire to the other side Put cross over GC 8 F and park on the CFA Assess with angiogram 7 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Steps: : 

Steps: Try to cross the lesion with 0.035 or 0.014 wire platform You can reinforce the wire with Balloon or Catheter or the GC or telescopic system The nearer to the lesion the more success you will get Gentle maneuvers is advisable and study the wire behavior 8 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Steps: : 

Steps: Park the wire to popliteal artery and always be ware of the distal end of your wire The guide wire tip should not pass distal to part II of the popliteal artery to avoid distal injury Balloon dilatation with different techniques Assess with angiogram or duplex and repeat the cycle 9 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Steps: : 

Steps: Always try to be intraluminal and subintimal if every thing failed SFA disease usually starts with adductor canal region and extends in both directions If you want to go inside a stent make the wire in a form of a loop Injection of Hep-Saline may facilitate micro-chanels 10 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Termination When to stop : 

Termination When to stop Success when you have residual stenosis of <30% following plain balloon angioplasty and of <20% following stenting has been achieved The termination criteria may be modified in patients undergoing palliative interventions (improvement of collateral circulation) as opposed to curative interventions (reconstitution of the vascular anatomy). Retraction of tools should be done safely 11 Mr.Mohamed Omar El-Farok M.Sc, FRCS

After care and follow up : 

After care and follow up Continue double antiplatelet therapy Sheath removed from 2-4 hours Mobilization after 4-6 hours Follow-up with clinical and duplex monitoring 12 Mr.Mohamed Omar El-Farok M.Sc, FRCS

SFA : 

SFA The most common cause of claudication Adductor canal area is unique Always treat upstream lesion first Focal stenosis does not necessarly means focal dissease. 13 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Best results in : 

Best results in Male Non diabetic Non smocker Large vessel diameter Short lesion Tasc A 14 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Questions to ask before you start ? : 

Questions to ask before you start ? Access site possible What target size vessel State of collateral Durtion of occlusion Bleeding risk Distal vessel situation Any proximal lesion 15 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Access : 

Access Nearly always contralateral Safer for the patient Much easier than antegrade No post-procedure compression Does not impede flow in the SFA 16 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Wire choices : 

Wire choices Terumo 0.035 260 cm stiff looks for braches , good for subintimal 0.035 PTFE J shaped tip 260 cm wire travels in the main artery 0.035 Amplatz wire for calcific artery 0.018 V 18 wire as stiff as 0.035 17 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Antegrade puncture : 

Antegrade puncture Higher risk of complications Improve wire control Difficult in Obese patients Can casue retroperitoneal haematoma Few tricks 18 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Popliteal approach : 

Popliteal approach The backdoor to SFA Very deep , vein posterolateral Has risk of bleeding and compartement syndrome Use duplex mapping , or angio with road map 19 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Factors affecting success in SFA interventions : 

Factors affecting success in SFA interventions Presenting symptoms claudicants V critical limb ischaemia Lesion length Stenosis versus occlusion State of runoff Diabetes Mellitus 20 Mr.Mohamed Omar El-Farok M.Sc, FRCS

SFA devices : 

SFA devices Mostly non FDA approved: Hellical stents. Stainless steel stents. Nitinol stents. Covered stents. Laser devices Rotablators. 8/20/2010 21 Mr.Mohamed Omar El-Farok M.Sc, FRCS

Changing Practice patterns : 

Changing Practice patterns

Case Presentation : 

Case Presentation The man with 6 stents

Clinical Data : 

Clinical Data 64 years, Male CAD Risk factors: Heavy Smoking for 23 years hyerlipidemic Symptoms: progressive angina of 2 months duration Absolute walking capacity 40m Clinical exam: ABI right = 0.5 left = 0.4 ECG: 2 mm ST depression in the anterolateral leads Echo: Mid and apical septal hypokinesia, normal EF

Coronary Angiography : 

Coronary Angiography

Peripheral Angiography : 

Peripheral Angiography Total left SFA occlusion Focal right SFA tight stenosis

Clinical problems ..?!! : 

Clinical problems ..?!! How to approach such a patient with multiple vascular bed affection? PCI vs CABG? Bilateral fem-pop bypass vs PTA? Which comes first?

Problems … : 

Problems … Staged procedure vs single setting? Multiple vascular access site ?!! Dye nephropathy?

Intended strategy : 

Intended strategy Preparation of the patient with optimal hydration. GP IIB/IIIA inhibitor right femoral approach PCI to LAD Contralateral PTA to left SFA Right SFA …… ?!!!!

Coronary intervention : 

Original POBA to Diagonal Coronary intervention After Predilation After 2 PESs

Coronary intervention ... result : 

Coronary intervention ... result

Peripheral …?! Left SFA total occlusion : 

Peripheral …?! Left SFA total occlusion POBA SP Predilation 7.0 x 150 6.0 x 120

Peripheral Left SFA total occlusion : 

Peripheral Left SFA total occlusion

Slide 34: 

Peripheral …?! Right SFA lesion Approach Double curve catheter Yashwant, AJR:154, January 1990 Directional Accordion Catheter Miles et al., AJR:151, July 1988 Suture Reshaping of Simmons catheter Cobra Catheter Abd. Loop Cope, J Invas. Cardiol;10 (7):443,1998

Peripheral …?! Right SFA total occlusion : 

Peripheral …?! Right SFA total occlusion Same puncture site Retrograde sheath inverted to antegrade ipsilateral position Antegrade PTA to right SFA

Peripheral …?! Right SFA total occlusion : 

Peripheral …?! Right SFA total occlusion

Final results : 

Final results Total procedure time = 80 min Total flourscopy time 19 min Dye = 280 ml non-ionic

5 months later … : 

5 months later … Recurrence of symptoms in left leg: Absolute walking capacity 60m ABI = 0.5

Left SFA total re-occlusion : 

Left SFA total re-occlusion After SmartControl 6 x 100

Slide 46: 

Let us give you a hand

Slide 47: 

The well-established S.M.A.R.T.eR Stent + A unique, innovative delivery system

Slide 48: 

The highest manufacuring standards The best stent design Great clinical outcomes Micromarker technology A low profile, 6F delivery system A unique inner catheter coil for low deployment forces and flexibility An advanced deployment system for total control of stent release The Cordis brand for quality. The S.M.A.R.T. Control Nitinol Stent System has EVERYTHING

S.M.A.R.T.Control Stent Characteristics : 

S.M.A.R.T.Control Stent Characteristics Nitinol Lasercut,electropolished Multisegmented Design Micromesh Geometry Micromarkers Minimal Foreshortening Clinical Results

Why NITINOL for stents? : 

Why NITINOL for stents? Self expanding Super elasticity Through body heat Shape recoverable Biocompatible MR-compatible Radiopaque High resistance to crush Constant, gentle outward pressure

Multisegmented Design : 

Multisegmented Design 18 circumferential ‘V’s Connected every 3rd V Bridges alternating up and down Every V is 2 mm long Every V acts as a separate stent 2 mm

Multisegmented DesignConnecting bridges are essential ! : 

Multisegmented DesignConnecting bridges are essential ! Other design 6 connecting bridges every 2 mm S.M.A.R.T.Control

Micromesh Geometry : 

Micromesh Geometry Benefits: - no plaque prolapse high radial strength consistent radial strength

Micromesh GeometrySmallest cellsize compared to competition : 

0.200” 0.170” 0.13” 0.087” Micromesh GeometrySmallest cellsize compared to competition S.M.A.R.T.Control Other design

Micromesh + Multisegmented DesignOptimal & unique wall apposition : 

S.M.A.R.T. Control Braided Design Micromesh + Multisegmented DesignOptimal & unique wall apposition

MicroMarker TechnologyNitinol laser-cut : 

MicroMarker TechnologyNitinol laser-cut + Tantalum Laser Cut Markers Radiopaque tantalum micromarkers Mechanically fixed in laser cut end-tabs Six markers on each stent end

MicroMarker TechnologyNitinol laser-cut : 

SEM Photograph Conical fit Secured on the outside MicroMarker TechnologyNitinol laser-cut

Safety in Stent placement : 

Pre-Deployment Stent release Fully Deployed Safety in Stent placement The markers are the stent itself !

Flared Ends : 

Flared Ends 1 mm Flare Anchors the stent Immediate wall apposition to aid in accurate placement 1 mm

Immediate Wall apposition Secure placement : 

Immediate Wall apposition Secure placement S.M.A.R.T. 14 x 60mm Competition 14 x 60mm

Multisegmented DesignControlled & predictable release : 

Competitive design No wallappositioning Immediate wall contact after 3-4 segments (less than 8 mm !) Multisegmented DesignControlled & predictable release

Multisegmented DesignControlled & predictable release : 

Wallstent 6x24 mm S.M.A.R.T. 6x30 mm Insignificant foreshortening Security in stent placement Multisegmented DesignControlled & predictable release

Clinical Experience: Ilio-femoral indication : 

Clinical Experience: Ilio-femoral indication CRISP Study Abstract at CIRSE Full paper submitted SIROCCO Study Sirolimus-coated / uncoated S.M.A.R.T.stents Publication in Circulation 2002/09 Individual center reports High patency (> 80%) for S.M.A.R.T in SFA. Biamino et al. 80% assisted patentcy 1y Bosiers et al. 85,2% primary patency 1y Mewissen 88% primary patency 1y S.M.A.R.T.eR Registry Multicenter experience in 383 patients.

S.M.A.R.T. Stent Summarythe 3 M’s : 

MicroMarker TechnologyFor excellent visibility The Markers are the Stent itself !! 6 markers on each end Laser-cut, no welds Micromesh and Multisegmented Design For continuous wall appositioning No plaque prolapse Diameterconformability No compromise in bends Most closed-cell design S.M.A.R.T. Stent Summarythe 3 M’s

Delivery systemCordis solution part I : 

Delivery systemCordis solution part I Retraction of outer catheter Stent pushes to outer catheter NO compression of inner member Accuracy of placement Easy and predictable release

Delivery systemCordis solution part II : 

Delivery systemCordis solution part II A high-tech ‘Twist-and-Shift’ deployment system: a TUNING WHEEL for micro-control of stent release A PULL BACK LEVER for rapid deployment

S.M.A.R.T. Control : 

S.M.A.R.T. Control The S.M.A.R.T. Stent Proven design with great clinical outcome “Micromarker” technology Micro-markers will aid in visualizing the ends of the stent during deployment. “Coil” Inner Shaft Design A less compressible shaft will reduce SDS movement during deployment. Controlled Deployment The addition of a deployment mechanism to improve control during positioning and deployment.

Technical summary : 

Technical summary 6F delivery system for 6-10mm diameter Stent diameters 6, 7, 8, 9, 10 mm Stent lengths 20, 30, 40, 60, 80, 100 mm SDS length 80, 120 cm SDS Profile 6F from hub to tip Guidewire compatibilty .035” CSI / GC 6F / 8F 7F delivery system for 12-14mm diameter Stent diameters 12, 14mm Stent lengths 30, 40, 60, 80mm SDS length 80, 120 cm SDS Profile 7F from hub to tip Guidewire compatibilty .035” CSI / GC 7F / 9F

Technical summary 2 : 

Technical summary 2 7F delivery system for 6-8mm diameter Stent diameters 6, 7, 8mm Stent lengths 120 mm SDS length 80, 120 cm SDS Profile 7F from hub to tip GW compatibilty .035” CSI / GC 7F Pullback device without handle

Thank you : 

Thank you