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PTA OVERVIEW AND HARDWARE DEEPAK NANDAN. INTRODUCTION Endovascular revascularization of infrarenal aortic and iliac disease- high rate of technical success.

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Presentation on theme: "PTA OVERVIEW AND HARDWARE DEEPAK NANDAN. INTRODUCTION Endovascular revascularization of infrarenal aortic and iliac disease- high rate of technical success."— Presentation transcript:

1 PTA OVERVIEW AND HARDWARE DEEPAK NANDAN

2 INTRODUCTION Endovascular revascularization of infrarenal aortic and iliac disease- high rate of technical success and with lower morbidity and mortality than open bypass surgery Preferred modality for treatment of patients with Trans-Atlantic Inter- Society Consensus Document (TASC) II type A and B lesions Surgical revascularization preferred for patients with TASC type C and D lesions In contemporary practice, surgery is reserved for failure of endovascular approach

3 Modified TASC Morphological Classification (TransAtlantic Inter-Society Consensus)

4 TASC -Femoral-Popliteal Lesions

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6 AortoIliac and Common Femoral Intervention

7 5 YEAR PATENCY RATES OF AORTOILIAC INTERVENTIONS

8 Vessel diameter VesselSize in mm Infrarenal Aorta14-20 Common Iliac8-12 External Iliac7-10 Common femoral6-7

9 Recommendation for vascular access of aortoiliac intervention Location of lesionVascular access Aortic bifurcationBilateral retrograde CFA Ostial common iliacIpsilateral retrograde CFA, brachial artery Common and EIA stenosisIpsilateral retrograde, contralateral CFA Common and EIA occlusionIpsilateral+/- contralateral CFA, brachial artery Common femoralContralateral retrograde CFA Common, EIA,SFA, poplitealContralateral retrograde CFA

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11 This angiogram in the anteroposterior (AP) view shows common, internal, and external iliac arteries. If the external iliac arteries are not well visualized in the AP view, then contralateral views should be used. For example, left external iliac artery is best imaged in the right anterior oblique30. The CFA is imaged by placing a 5F multipurpose catheter in the contralateral side after crossing the contralateral CFA with an angled glide wire. The ostium of the superficial femoral artery (SFA) and the profunda femoris artery are best imaged in the ipsilateral 30 angulation. The middistal SFA and the popliteal are best visualized in the AP view. The tibioperoneal vessels are seen well in an ipsilateral 10 angulation, whereas the pedal arch vessels are imaged in the contralateral10 angulations.

12 Vascular Access Relatively disease-free, without signi Ca Over a bony structure, if possible Angle of entry- 30⁰-45⁰ Obtained with an 18-gauge needle that will accommodate most “ or smaller Wires A smaller 21-gauge needle with a inch wire - “micropuncture kit” (Cook, Bloomington, IN) Used for difficult femoral, brachial, radial, or antegrade femoral approaches

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14 Retrograde Common Femoral Artery Access Common access site used for peripheral diagnostic angiography and intervention Prevent injury to the less diseased extremity Contralateral femoral retrograde access iliac occlusions are best treated from a contralateral approach SFA,PFA- lesions OF CFA/involve SFA/PFA ostium - allows treatment B/L disease with a single arterial puncture

15 Femoropopliteal Artery Intervention Contralateral femoral retrograde access : Manual of carotid and peripheral vascular Intervention, Thosaphol Limpijankit MD, Beyond Enterprise Thailand 2008;290 AdvantageDisadvantage Less subsequent complications including hemorrhage from puncture site Working from a distance with exchange- length wires and balloons Ability to image CFA and its bifurcationLack of support while traverse of critically narrowed or occluded sites Ability to treat iliac and infrainguinal disease in the same setting

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18 Antegrade Common Femoral Artery Access Required for infrainguinal proced Approx 3cm CFA lies betw ligament & FA bifurcation Inorder to access CFA, skin entry- prox to ing ligm Access too close to F bifurc –inadeq working room to selectively cath SFA Ipsilateral popliteal retrograde access Useful in SFA occlusion with failure to cross from contralateral or antegrade Ostial SFA/CFA lesions may also be approached via PA in acute angled terminal ao bifurc CI- aneurysms of PA, pathology of popliteal fossa- Baker’s cyst

19 Brachial Artery Access Pref access for visc arterial [CA, SMA] interventions PC approach at BA can lead to a ↑compli rate – UL arts – smaller, prone to spasm – A small hematoma- Could lead to brachial plexopathy Itv req >6F sheaths/smaller pt→open approach preferred Left BA access pref over Rt- can avoid carotid origin A micropuncture tech should be used for all PC BA intervention Left brachial approach has approximately 100 mm greater reach than the right brachial approach

20 Estimated distances from FA access

21 GUIDEWIRES

22 Guidewires are used to introduce, position, and exchange catheters In a standard guide wire, a stainless steel coil surrounds a tapered inner core A central safety wire filament is incorporated to prevent separation in case of fracture 5 charecterstics- size, length, stiffness, coating, and tip configuration Typically they are 100 to 120 cm in length but can also be 260 to 300 cm ( good rule of thumb to follow is that the guidewire should be twice the length of the longest catheter being used ) Tip of the wires can be straight, angled, or J-shaped Varying degrees of shaft stiffness- extra support,to provide a strong rail to advance catheters in tortuous anatomy vs extremely slick hydrophilic with low friction

23 Wire selection Diameter vary from 0.014“ to 0.038“ Most commonly used size is 0.018“/0.035“ ( upper extremity) and 0.014“/ 0.018“ ( lower extremity) Length between 130 and 300cm Tip configurations are; straight, angled Tip and J shape Varying degrees of shaft stiffness ( e.g. extra support, super stiff wires) allow advancement of stiff devices Hydr-angle tip– Glidewire Can be used for crossing tight lesions and can be advanced independent of a guidewire 038:18g needle, 018:21g needle

24 Guidewire- Lesion Interaction Floppy portion moving in a linear fashion Floppy portion piles up prox to lesion—no chance to cross- backup,redirect,if straight tip→steerable Floppy tip bent with min R—Cautiously adv wire- once crossed, wire should straighten- advancing a “buckledup” wire- force→embolization Floppy tip “buckledup” —backup,redirect,adv - dissect,embolz,wire damag

25 Guide wire Functions PTA Guidewires are designed to: Track through the vessel – Access a lesion – Cross a lesion – Provide device delivery support PTA Guide wires

26 Core Material Affects flexibility, support, steering and tracking Stainless Steel Nitinol (more flexible) High Tensile Strength Stainless Steel

27 Core Diameter Larger core diameter: increased support for device delivery and vessel straightening good torque Smaller core diameter: for enhanced tracking and flexibility

28 Core-to-Tip Shaping ribbon Force transmission Tactile feedback Tip stiffness/Tip-load Better steering Better shapability Flexibility, softness Ability to prolapse Frontline/Workhorse,floppy Tip style Long tapers Increased steerability Increased flexibility Short tapers Increased support Increased Torque

29 Coils & covers Outer coils Tip coils only Polymer cover Polymer sleeveTip coils

30 Coils & covers Coils provide tactile feedback, radiopacity and maintain constant overall diameters Polymer covers/sleeves provide optimal lubricity to overcome resistance and access to the lesion Allows smooth tracking through tortuous anatomy Better device tracking over the guidewire Not to be confused with coating (hydrophilic or hydrophobic)

31 Covers and Coatings – Summary Lu br ici ty Delivery &Device Interaction Tactile Feedback (related to coils) No Coating Hydrophobic Coating Hydrophilic Coating Polymer Cover with hydrophilic Coating

32 PTA GUIDE WIRES Glidewire (TERUMO) Peripheral Guidewires (0.032"-0.038") Standard Glidewire Shapeable Tip Glidewire Long Taper Glidewire Stiff Shaft Glidewire Stiff Shaft Long Taper Glidewire 1 cm Taper Glidewire J-Tip Glidewire Bolia Curve Glidewire Glidewire Advantage ™ Small Vessel Guidewires (0.018"-0.025") Glidewire Standard and Shapeable T ip Glidewire GT Super-Selective Glidewire Gold Terumo Glide Technology ™ hydrophilic coating smooth, rapid movement through tortuous vessels crossability over difficult lesions Core-to-tip design provides 1:1 torque ratio elastic nitinol core for optimal performance Resists kink &Retains shape Tungsten in polyurethane jacket- radiopacity Carries the risks of vessel dissection and perforation should not be used to traverse needles because of the potential of shearing

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34 Terumo invents the Hybrid Technology for Guide Wires and creates the Radifocus® Glidewire AdvantageT: crossing the lesion and delivering the interventional device using only one wire for a reduced risk of complications, a greater efficiency and a shorter procedure time

35 ABBOT Hi-Torque Steelcore Peripheral Guide Wire (190/300 cm) Hi-Torque Spartacore Peri Wire Excellent.014" Support SS shaft Superb Steerability and a Soft Shapeable Tip Core-to-tip design 130/190/300 cm lengths MICROGLIDE Coating PTFE up to distal 7 cm (130 cm) Available in 5 and 10 cm

36 Hi-Torque Supra Core 35 One-to-one torque exceptionalsteerability MICROGLIDE coating Radiopaque tip 035" shaft Soft Shapeable tip Hi-Torque Versacore Guide Wire Torqueable wire for deliverability through tortuous or challenging lesions Soft shapeable tip designed to for lesion acces

37 BOSTON SCIENTIFIC

38 Amplatz Super Stiff Guide Wire For stiffness, strength and stability during catheter placement and exchange Diameters: 0.035", 0.038" Lengths: 145cm,180cm, 260cm Tips Styles: Straight, J, Short Core Material: Stainless steel Coating: PTFE Magic Torque Guide Wire Magic Markers spaced at 1cm increments designed for enhanced visualization and excellent torque control Diameters: 0.035" Lengths:180cm, 260cm Tips Styles: Straight (shapeable) Core Material: Stainless steel Coating: Glidex Hydrophilic Coating (tip)

39 Meier Guide Wire Stiff shaft excellent supp flexible tip is ( AAA endovascular graft procedures) Diameters: 0.035" Lengths: 185cm, 260cm, 300cm Tips Styles: J, C Core Material: Stainless steel Coating: PTFE Platinum Plus Guide Wire Designed for negotiation of tortuous anatomy and contralateral approaches Diameters: 0.014", 0.018", 0.025" Lengths (cm): 60, 145, 180, 260, 300 Tips Styles: Straight – Long or short taper Core Material: Stainless steel Coating: Glidex Hydrophilic

40 Thru way Guide Wire Designed for excellent performance in acutely angled vessels, such as renals and other peripheral interventions Diameters: 0.014", 0.018" Lengths (cm): 130, 190, 300 Tips Styles: Straight, J Core Material: Stainless steel Coating: Silicone

41 CORDIS EMERALD™ Guidewires Fi xed-Core, PT F E Coated, Exchange Wires

42 COOK Amplatz Stiff Wire Guides Stiff shaft Gradual transition to a very flexible distal tip – TFE Coated Stainless Steel-035,038: 145,180,260-straight – TFE Coated Stainless Steel with Heparin Coating-035: 145,180,260-straight 8 cm-flexi tip Amplatz Extra-Stiff Wire Guides ↑ inner diameter -extra- stiff + tip flexibile – TFE Coated Stainless Steel-025,035,038: 80,145,180,260- straight & curved: – 300-straight – TFE Coated Stainless Steel with Heparin Coating-035: 80,145,180,260- straight & curved

43 Amplatz Ultra-Stiff Wire Guides The increased inner diameter of the wire guide coil allows utilization of an ultra-stiff mandril while maintaining tip flexibility – TFE Coated Stainless Steel-035,038: 80,145,180- straight – TFE Coated Stainless Steel with Heparin Coating- 035: 145,180-straight 8cm-flexi tip

44 Roadrunner Extra-Support Wire Complex diagnostic/interventions - where extra support needed for cath exchange /manipulation of devices Heavy-duty nitinol alloy mandril provides support while imparting 1:1 torque response to distal platinum spring coil tip Angled tip facilitates directional control Lubricious TFE coating -low coefficient of friction 014, ,270,300

45 Cope Mandril Wire Guides I Stainless Steel Platinum coil ↑visualization and an angled floppy tip for precise directional control ,60,100,125 Standard taper-7cm coil Cope Mandril Wire Guides II Nitinol kink resistant 1:1 torque control Platinum coil -↑visualization angled floppy tip for precise directional control ,100,125 Standard taper-7cm coil, short taper-7cm coil

46 Rosen Curved Wire Guides The heavy-duty mandril, 2 cm flexible tip and tightened “J” configuration Ideal for Renal int- less traumatic TFE Coated Stainless Steel-035: 80,145,180,220,260 TFE Coated Stainless Steel with Heparin Coating-035: 145,180,260

47 The Graduate Measuring Wire Guides Used to determine accurate sizing of vessel Gold radiopaque markers delineate 25 cm length Six distal markers are spaced 1 cm apart. Four proximal markers are spaced at 5 cm increments ,180

48 Reuter Tip Deflecting Wire Guide Used with Reuter Tip Deflecting Handle for curving or deflecting catheter tips during selective and superselective angiography Facilitates catheter tip movement by controlling the deflection of the wire guide tip within catheter lumen Distal tip of wire guide must never extend beyond tip

49 BIOTRONIK Cruiser Guide Wire 0.014“ L: 190 cm Tip Shape: Straight and J Cruiser-18 Hi-support Guide Wire 0.018” Stiff: 195 cm and 300 cm Medium: 195 cm and 300 cm

50 Catheter An “ideal catheter” should be able to sustain high-pressure injections, to track well, be nonthrombogenic, have good memory, and should torque well

51 Catheter ( diagnostic/ guiding) Length depends on location for using Sizes are 5 to 8 French a) abdominal aorta = 60 to 80 cm length b) BTK,carotid or subclavian areas 100 to 125cm length Polyethylene- ↓coef friction, pliable Polyurethane- softer, even ↑pliable→ tracks wires better Nylon- stiffer, can tolerate ↑flow rate- amenable to angio Teflon- stiffest- used mainly for dilators & sheaths wire braid in the wall to impart torquibility and strength

52 Guiding Catheter vs Sheath Operator dept Sheaths are designed with a simple diaphragm or a hemostatic valve, guiding catheters always require hemostatic valves be attached During intervention, the guide catheter or sheath should be placed near the lesion to provide for better visualizationand improved support Flush /Non-Sel Selective CATHETERS

53 Vascular sheaths allow for easy exchange and introduction of catheters and guidewires. They have a hemostatic valve that prevents blood reflux and air embolism. Furthermore, they protect the vessel entry point from intimal injury and should be used whenever multiple guidewire exchanges are anticipated. Sizing of sheaths is based on their internal diameter: a 7 Fr sheath will accept up to a 7 Fr catheter. Sheaths come in multiple lengths. In addition, the side port of the sheath can be used to inject contrast or measure arterial pressure. All sheaths are packaged with dilators. Dilators serve as an obturator for entry of the sheath and also help to progressively enlarge the track once guidewire entry has been established Guiding catheters and sheaths can be used to facilitate passage of a smaller endovascular device through a tortuous curve. They are particularly useful in the renal and carotid system or contralateral iliac system

54 BALKIN Sheath (cook) Contralateral access to the iliac artery Flexibility without kinking or compression Radiopaque band- identifies precise location of sheath’s distal tip for positioning accuracy The Check-Flo valve prevents blood reflux and air aspiration during catheter manipulations 5.5 Fr-8 Fr- 40cm -.038” compatible

55 Super Arrow-Flex® Sheath /Dilator Set with 90° curved tip (ARROW International) 6-7Fr 45cm length Assures successful access to the renal arteries. “Y” Connector + Tuohy Hemostasis Valve a+ 3-Way Stopcock 90° Curved Tip Both sheath and dilator have a curved tip for easy access to the renal artery Sheath replaces guide catheter -eliminates the need for using a guiding catheter - reducing size of puncture Radiopaque tip marker-locate and control sheath advancement into RA

56 TERUMO GUIDING SHEATH( Pinnacle Destination) Pinnacle Destination Guiding Sheaths (5-8 Fr) 5-8 F 45,65,90 Hydrophilic coating All dilators are 0.038" wire compatible

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64 TERUMO Glidecath (4 Fr)-65,100, Glidecath (4 Fr) Glidecath XP (5 Fr)-65, Glidecath XP (5 Fr) Glidecath (5 Fr)-65, Glidecath (5 Fr)

65 TERUMO GLIDE CATH Hydrophilic Coated Catheters Hydrophilic coated distal tip (15 cm) for smooth passage through tortuous vasculature Double-braided stainless steel mesh middle layer ↑ shaft rigidity and torque transmission Nylon-rich polyurethane inner layer for smooth flow of therapeutic agents and 0.035"/0.038" embolization coils Large lumen (0.038" wire compatible) and small profile (4 Fr) is ideal for: Use as a guiding catheter for microcatheters Diagnostic procedures that require high flow rates Excellent trackability and navigation –most tortuous anatomies

66 SOS Omni selective catheter Soft, atraumatic, Super-radiopaque tip Reforming in desc thoracic aorta – below great vessels rather than transverse arch –safety Pulled from the desc ao into abd ao with a floppy guidewire “leading,” sometimes with a rotating motion Soft, flexible atraumatic tip can be placed deeper into the artery (>1 cm), ↓chance of “catheter kickout.” Shaped tip allows the guidewire to flick into the origin of the RA

67 Omni Flush Angiographic Catheter Flush aortography B/L“run off” studies of LL Cross ao bifurcation with ease for C/L diagnostics in interventional procedures Super-Radiopaque tip Reforms and maintains shape—even under injection pressure—with less catheter whipping-less vessel wall injury Less contrast reflux than other flush catheters-lower total contrast dose

68 4F IMPRESS Simmons 1 Catheter 65cm..038 Side Ports:N/A Catheter Shape:SIMMONS 1 French Size:4 5F IMPRESS Simmons 2 Catheter 65cm..038 Side Ports:N/A Catheter Shape:SIMMONS 2 French Size: 5

69 Microcatheters (TERUMO) Progreat ™ (2.4 Fr, 2.7 Fr)- 110/130- OD 2.9Fr/2.7 Progreat ™ (2.4 Fr, 2.7 Fr) Progreat ™ Ω (2.8 Fr)- 110/130- OD 3Fr/2.8 Progreat ™ Ω (2.8 Fr)

70 Slip-Cath Beacon Tip Catheters (C00K) Hydrophilic Coating Enhanced radiopaque Beacon tip Sixteen stainless steel wire braid imparts 1:1 torque control to catheter tip & ↑pushability Nylon material resists softening during prolonged catheter manipulation

71 Slip-Cath Beacon Tip Catheters

72 CXI Support Catheters(C00K) For use in small vessel/superselective anatomy for diagn & interv procedures, incl peripheral use Low profile from tip to hub ensures smooth transition through small vessels Shaft's polymer material offers desired flexibility Braided SS entire length -pushability Hydrophilic coating Embedded radiopaque markers -size the vessel segment length

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74 Veripath Peripheral Guiding Catheter(ABBOT) Three-Layer Construction 50 cm length 5 catheter shapes 6,7,8 F 014/018

75 CORDIS

76 Kumpe catheter

77 Accesses and Selective Guiding Catheters for Some Basic Interventions Carotid Artery 1.First choice access—either FA 2.Alternative access—left BA 3.Selective catheter— Right carotid: H1,Simmons,Vitek Left carotid : angled glidecath,H1,Simmons Subclavian Artery 1.First choice—either FA 2.Alternative access—ipsilateral BA 3.Selective catheter– angled Glidecath,H1,Simmons,H3 Celiac or SMA 1.First choice—either FA 2.Alternative access—left BA 3.Selective catheter—RIM,Chuang

78 Renal Artery 1.First choice—contralateral FA 2.Alternative access—left BA 3.Selective catheter—C2,RDC,Sos-omni Infrarenal Aorta 1.First choice —either FA 2.Alternative access—left BA 3.Selective catheter—omni-flush,RIM,C2 Superior Femoral Artery 1.First choice—contralateral FA 2.Alternative—ipsi retro FA for run-off; ipsi antegrade for interv 3.Selective catheter—Berenstein,Kumpe,Vertebral Tibial Arteries 1.First choice—contralateral FA 2.Alternative—ipsi retro FA for run-off; ipsi antegrade for interv 3.Selective catheter—Kumpe,Vertebral

79 Vessel size The vessel in each territory have their own different size, important to know to choose a proper balloon or stent

80 Balloons

81 In selecting a balloon, the following criteria should be considered : a) Guidewire ( 0.014“, 0.018“, 0.035“) b) Over the wire (OTW) or monorail system c) Shaft length Balloon shaft lengths are commonly 75 cm or 120 cm, can be coaxial or monorail and designed to be inserted over in., in., or in. wires 0.014“ balloon system is usually for carotid, vertebral, renal, infrapopliteal arteries 0.018“ balloon system also in SFA, infrapopliteal- operator dept 0.035“ balloon system for subclavian, innominate, aortoiliac, superficial femoral artery

82 Circumfer force/tension (T) exerted on wall of an inflatd balln ~P within balln & R (T=P×R)(LAPLACE) Larger ballns -require ↓P than smaller ballns to generate substantial dilating forces Larger vessels (Ao) require ↓P to dilate & rupture 1. Diameter matching vessel beyond lesion 2.Balloon length should be > lesion 3.Balloon centered on lesion & inflated slowly 4.Inflation maintained for 20s- deflated- reinflated 3 inflations of 20s Patient’s complaint of low back pain during balloon inflation may be a warning sign of adventitial stretch, which may occur before aortic rupture

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84 ATB ADVANCE PTA Dilatation Catheter Advance 14LP Advance 18LP Advance 35LP (C00K) Designed for iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral Also intended for postdilatation of balloon-expandable peripheral vascular stents 40,80,120 Low profile Hydrophilic

85 Advance 14LP (C00K) Low Profile Provides the trackability and pushability to reach even the most remote infrapopliteal lesions Hydrophilic coating on balloon and distal shaft, along with a smooth tip transition Maintains super-low profile after inflation 4 Fr sheath compatibility for all sizes 20 to 200 mm in 2, 2.5, 3, 4 mm D 170

86 FoxCross.035 PTA (ABBOT) D-(3-14 mm), L-( mm), and cath L (50, 80 &135 cm)-OTW Good trackability, rapid inflation/deflation Crossability -useful in calcified lesions 5-7 F Guide wire compatibility: 035 Nylon Polymer JETCOAT coating

87 ABBOT Fox sv PTA Catheter OTW designed for challenging small vessel procedures Range of BTK and SFA sizes (2-6 mm) 90,150 Sheath Compatibility:4F for all sizes Guide wire compatibility:.014"/.018 Fox Plus PTA Catheter Low Profile Compatible with a 5 Fr sheath up to 7mm balloons Shaft Technology-dual lumen-Rapid infl and deflation JET coated - Reduces friction and facilitates access and crossing of target lesions

88 Sterling Balloon Dilatation Catheters (BOSTON SCIENTIFIC) Breakthrough 4F Profile Both Over-the-Wire and rapid exchange 40,80,135 Specifically designed for use in carotid, renal and lower extremity arteries

89 Sterling SL Balloon Dilatation Cath long lengths-BTK - specifically designed - infrapopliteal procedures 014, 018 OTW and Monorail 90,150 Sterling ES Balloon Dilatation Cath 0.014" balloon cath Ultra-low profile balloon Both OTW and rapid exchange platforms.017" tip entry profile 140

90 BIOTRONIK Passeo-18 Passeo-35 Balloon Catheter 0.018” /.035” OTW Hydrophobic patchwork coated balloon ensures a smooth crossing through tortuous vessels and across high grade stenosis whilst minimising the risk of slippage during inflation experienced using hydrophilic coated balloons

91 Stents a)Balloon-expandable b)Self-expandable c)Stent graft

92 Balloon-expandable stents Require positive pressure for expansion Typically rigid with high radial force Size of the balloon-expandable stent equals to the size of the reference vessel diameter Ideal for immobile sites of the body subclavian, renal, mesenteric, iliac arteries and at ostial locations

93 PALMAZ Bal-Exp Stent (unmounted) CORDIS Closed cell SS Stent D (Expanded) 4-8mm Stent L (Unexpanded) 10,15,20,29,39mm Sheath Introducer 6F, 7F

94 Dynamic Renal (BIOTRONIK) Balloon-Expandable Cobalt Chromium Stent 0.014” / Rx Dynamic Balloon-Expandable Stainless Steel Stent 0.035” / OTW

95 SELF EXPANDABLE Stents Deployed in vessels that are flexible or twist during movement of neck, shoulder or leg Carotid, Axillary, SFA, Popliteal artery Nitinol - metal - provides best flexibility and memory Stent is simply compressed over a stent delivery catheter and covered with a sheath Stent deployment is achieved by pulling back the sheath Stent diameter should be 1-2mm larger than the reference vessel diameter- adequate stent apposition with the vessel wall

96 Self-expandable Stents Some degree of foreshortening- to be taken into account when choosing More difficult to place with absolute precision Generally comes in longer length than BES Their ability to continually expand after delivery allows them to accommodate adjacent vessels of different size

97 Self-expanding stents are deployed by retracting a restraining sheath and usually consist of Elgiloy (a cobalt, chromium, nickel alloy) or Nitinol (a shape memory alloy composed of nickel and titanium), the latter of which will contract and assume a heat-treated shape above a transition temperature that depends upon the composition of the alloy. Self-expanding stents will expand to a final diameter that is determined by stent geometry, hoop strength, and vessel size

98 BX- vs SX stents for iliac intervention BX stentSX stent Advantages High radial forceElasticity, flexibility Minimal foreshorteningConformability Good visibilityMRI compatibility Absolute precisionContinually expand – vessel size Disadvantages Risk of edge dissectionNeed post-dil Stent crushingSuboptimal radial strength Incomplete stent appositionForeshortening Artifacts on MRINon precise Suitable lesions Heavily calcified lesionsNon-ostial lesion ImmobileEIA; CFA -mobile OstialLong lesions

99 Decision between SE or BE stents in Iliac Lesions Balloon expandable – Aortoiliac bifurcation – Common iliac – Calcified lesions – Chronic occlusions (?) Self expanding – Vessels flexible/twist during movement – Tortuous vessels – Distal external iliac artery – Contralateral approach – Long diffuse lesions – Aortoiliac bifurcation (long lesions)

100 Stent Grafts Combination of a metal stent covered with fabric Used to exclude aneurysm, treat perforations when prolonged balloon inflation failled Wallgraft and Viabahn are the two options currently available for treatment of perforations of aneurysm in larg vessels

101 Equipment Ipsilateral retrograde approach Contralateral approachBrachial artery approach 6-8F Sheath, length 11cm or 23cm6-8F cross- over Sheath6-7F 90cm sheath 6-7F Guiding catheter 0.035“ wire, length cm 0.035“ wire, length cm 0.035“ wire compatible Balloon catheter, diam. 6-9mm, Shaft length 75-90cm Balloon catheter, diam. 6-9mm, Shaft length 75-90cm Balloon catheter, diam. 6-9mm, Shaft length 130cm BX stent, diam. 8-9mm, shaft length cm BX stent, diam. 8-9mm, shaft length 130cm SX stent, diam.8-14mm, shaft length cm SX stent, diam.8-14mm, shaft length 130cm

102 Retrograde iliac stent placement

103 Cross-over stent placement

104 Subintimal angioplasty Hydrophilic wire not passing Carefully adv into subintimal plane- if not spontaneously, gentle inflation of balloon at edge of the plaque Wire traversed the lesion subintimaliy Hydrophilic catheter or other re-entry device passed OTW to guide it back into lumen Standard angioplasty of subintimal plane performed, with stent placement

105 Subintimal angioplasty

106 Femoropopliteal Artery Intervention Four potential routes of access to the SFA and popliteal: Contralateral femoral retrograde access Ipsilateral femoral antegrade access Ipsilateral popliteal retrograde access Brachial retrograde access Balloon Balloon size and length is matched to the size ( ~5-6mm) and lesion length( ~ mm) of SFA Improved angiographic results may be accomplished with prolonged inflation times ( 3-5 minutes) Dissections are commonly seen after balloon dilation ( due to heavy calcification)

107 Femoropopliteal Artery Intervention Stent implantion ( always SX-Stents): Sizing the SX- stent ~ 1mm greater than the RVD of SFA Postdilation with mm diameter balloon Popliteal artery -> avoid stent = high risk of stent compression or fracture SX-Stent problems: Stent fracture -especially in stent overlap “ In-Stent-Restenoses“-in long stented segments, multiple stents DEB

108 Five-year patency (%) of femoral popliteal revascularization

109 Outcome Kasapis C, et al Eur Heart J. 2009;30:44- 55

110 Infrapopliteal Intervention 4 anterior tibial artery 5 tibio-peroneal trunk 6 posterior tibial artery 6a peroneal artery 6b perforating branch of the peroneal artery 6c communicating branch of the peroneal artery 7 dorsalis pedis 8 medial plantar artery 9 lateral artery 10 plantar arch

111 Infrapopliteal Interv Knee-to-foot patency of one of the three branches is usually sufficient to prevent critical lower-limb ischemia Claudication is rarely the result of isolated disease of the infrapopliteal arteries Re-stenosis after intervention in these vessels is typically the highest among the lower limb sites Obstructive disease in these arteries is often occlusive, diffuse and complicated by heavy calcific deposits

112 Vascular Access Cross- over technique ( retrograde access) Ipsilateral antegrade access ( recommended) Retrograde pedal access Brachial access Radial access wire selection only atraumatic 0.014“ / 0.018“ guide wires should be used 0.014“ prefered due to vessel diamet( floppy, medium,stiff) Balloon Angioplasty Low profile balloon with high pushability and trackability Vessel conformability Flexibility in small collateral branches 0.014”/ 0.018" wire compatibility Diameter 1.5mm-4.0mm Long ( mm)& tapered tip to reduce procedure times and dissection

113 Infrapopliteal- Stent implantation Requirements - BTK BE-Stents “PTA balloon like” flexibility Ultra-low profile and extreme flexible delivery system with 0.014” guidewire compatibility mm stent delivery system diameter Long stents ( up to ~ 80mm) 4F introducer sheath compatibility braided sheath design - pushability and flexibility to enable easy negotiation in tortuous anatomies without kinking

114 Infrapopliteal Intervention-Equipment Contralateral approachAntegrade Approach 5F-6F cross-over-sheath, 55cm or 70cm4F-6F short sheath 0.035“ 300cm wire0.035“ 190cm wire 5F-6F Guiding catheter, if no long sheath is used 0.014“-0.018“ wire ( 0.014“ prefered) Balloon catheter, mm diameter, length 20mm- 210mm, shaft length 150cm Balloon catheter, mm diameter, length 20mm- 210mm, shaft length 120cm 0.014“ balloon expandable stent, 150cm shaft length0.014“ balloon expandable stent, 120cm shaft length 0.014“-0.018“ self-expandable stent, long shaft0.014“-0.018“ self-expandable stent, short shaft Guide wire support catheter ( facilitate wire Crossing) Guide wire support catheter ( facilitate wire Crossing)

115 Limb salvage rate is high, but restenoses rate also high Restenoses rates ~ 3 months- depends on severity of disease

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117 Efficacy of Coronary DES in Infrapopliteal Arteries

118 Renal artery stenosis Usually occurs in the proximal 2 cm ~75% of lesions are caused by atherosclerosis Lesions can be single or multiple, unilateral or bilateral (~25%) Diameter: mm for men mm for women Length 3-7 cm –

119 Tool Chest for RAS Treatment Diagnostic Wires – 0.035” for initial catheter placement – Avoid hydrophillic wires Diagnostic catheters – 4-6 Fr Intervention Wires – 0.014” – 0.035” for catheter placement Guiding Sheath Guide Catheter Balloons – Low profile – Undersized for pre-dilation Stents – Balloon expandable (BES)

120 Renal Stents: FDA Status Cordis Palmaz Balloon Expandable Stents – FDA approved for use following sub-optimal PTRA of a de novo or restenotic lesion ( 4mm and < 8mm Medtronic Bridge Extra Support Balloon Expandable Stent System – FDA approved for use following sub-optimal PTRA of a de novo ( 5mm and < 7mm Palmaz® is a trademark of Cordis Corp. Bridge™ is a trademark of Medtronic AVE Inc.

121 Renal artery stenting 1. Catheter or sheath placement 2. Guide wire (0.014“) insertion. Rosen wire has soft curled end- ideal- prevents perforating small renal branch vessels 3.Stent placement -> as soon as the tip reach the lesion GC is pulled back into the Aorta 4.Stent deployment, proximal struts should protrude 1-2mm into the aorta 5. Flaring the ostium of the stent ( optional), opens the way for re-intervention and covers the plaque in the aorta

122 no touch technique, the guide catheter seeks out the ostium with the help of 2 wires

123 Advances in Treatment of Aortoiliac Occlusions

124 Inability to cross an occlusion with a guidewire or to reenter the true lumen beyond the occlusion remains the most common cause for technical failure 1.Front Runner device 2.Crosser catheter 3.Reentry devices

125 The Frontrunner® (Cordis) or Quickcross® catheters are designed to maintain the wire in the center of the lumen and penetrate the plaque and/or thrombus in a controlled fashion Subintimal dissection plane buckling a glide wire the subintimal plane is entered Following with an angled glide catheter-re-enter the lumen distal to the obstruction This step is the limiting factor Adjuncts - Outback® or Pioneer® catheter which allow an angled needle to puncture back into the true lumen

126 FRONTRUNNER ® XP CTO Catheter (cordis) Enables controlled crossing of CTOs using blunt microdissection to create a channel through the occlusion to facilitate wire placement. Low profile. Features a crossing profile of.039" with actuating jaws that open to 2.3 mm. Hydrophilic coating along the entire catheter length to facilitate crossing Catheter steerability.- shapeable distal tip + effective torque control enhance maneuverability and catheter steerability No guidewire lumen.Variable support from advancing and retracting the 4.5F Micro Guide Catheter.

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128 CROSSER Catheter (Flow Cardia Inc, Sunnyvale, Calif) High-frequency mechanical vibrations (20, 000 cycles/ second to a depth of 20 µm) propagated through a nitinol core wire to a stainless steel tip A generator, transducer, foot switch, and disposable catheter Generator applies AC current to the piezoelectric crystals in the transducer Vibrational mechanical impact and cavitational effects - penetration 1.1 mm in diameter, monorail, and hydrophilic Can be mounted on a standard 0.014” guidewire Compatible with a 6F guiding catheter Vessel size- a minimum diameter of 2.5 mm is recommended

129 cordis Low profile, 6F sheath compatible Highly visible "L" and "T" markers. Orient the re-entry cannula toward the true lumen easily, eliminating the need for additional visualization equipment Effective torque control On average 8 minutes to gain re-entry (↓ procedure time) Lubricious, hydrophilic coating along the entire catheter length to facilitate subintimal passage Easy to use Cordis

130 OUTBACK CATHETER (J&J, Cordis, New Brunswick, NJ, USA)

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133 Pioneer reentry catheter ( Medtronic) Distal 25-gauge nitinol reentry needle 64-element phased-array IVUS transducer 120 cm long accomm ”guidewires (1 to track the device and 1 for the reentry needle) Compatible with a 7F sheath The device is brought into the subintimal tract over a wire, and under intravascular ultrasound imaging, color flow is identified in the true lumen The catheter is rotated to position the true lumen at the “12 o’clock” position, after which the needle is advanced and the true lumen is wired

134 Advances in Balloon Angioplasty-Based Approaches 1.Drug-coated balloons 2.Cryoplasty 3.Cutting balloons

135 Paclitaxel is the most commonly used agent for drug-coatedballoons (DCBs) high local drug conc and # neointimal proliferation -brief exposure had lower late loss and angiographic restenosis at 6-month follow-up (17% vs 44% in the Thunder study; 19% vs 47%in FemPac) Drug-coated balloons

136 Occlusion,containement &Perfusion therapy low pressure balloon infusion maximizes drug penetration locally within the vessel B-L/10-50mm,DM-1-4mm 134cm-Rapid ex 40,80,90,140 cm -OTW

137 Cryoplasty (PolarCath, Boston Scientific) Combines angioplasty with simultaneous delivery of cold thermal energy to the arterial wall liquid nitrous oxide - balloon inflation/ cooling - 10°C MOA-plaque modification, reduction of elastic recoil, and induction of apoptosis in the smooth muscle cells -↓ dissection and need for stenting Insufficient data to support its routine use

138 Advances in Stent Technology Drug-eluting stents Nitinol self-expanding stents Bioabsorbable stents Nitinol stent grafts and covered stents

139 (cook) The Zilver PTX Drug-Eluting Stent is a self-expanding stent made of nitinol and coated with the drug paclitaxel It is a flexible, slotted tube that is designed to provide support while maintaining flexibility in the vessel upon deployment The stent is preloaded in a 6.0 French delivery catheter inch wire recommended for use in above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 9 mm Zilver PTX ( Cook) showed good results in TASC A/ B lesions(RESILIENT STUDY)

140 COOK Zilver 518 Vascular Self-Expanding nitinol Stent- iliac arteries Recomm 5.0 Fr sheath/7.0 Fr gui ding cath Accepts.018 inch wire Zilver 518 RX Vascular Self-Expanding Nitinol Stent – Rapid Exchange-iliac Recommended 5.0 Fr sheath/7.0 Fr gui ding catheter Accepts.018 inch diameter wire guide.

141 Zilver 635 Vascular Self-Expanding Nitinol Stent Recommended 6.0 Fr sheath/8.0 Fr guiding catheter size Accepts.035 inch diameter wire guide

142 Absolute Pro LL Peripheral Self- Expanding Stent ( ABBOT) 035 designed to treat longer SFA lesions 120,150 Absolute Pro LL

143 Xpert Self-Expanding Stent( ABBOT ) 4F compatible -speci designed for small vessels Peri vessels from D 2-7 mm 018 Nitinol low strut profile Conformability

144 Self-Ex: S.M.A.R.T. CONTROL Iliac (cordis) MicroMesh Geometry, Segmented Design Nitinol 12 Tantalum MicroMarkers define stent ends for easy visualization and placement Stent D 6-10, 12, 14mm (should be 1-2mm >vessel D) 80,120 cm Maximum Guidewire.035" Sheath Compatibility 6F (6-10mm), 7F (12-14mm) Guide Compatibility 8F (6-10mm), 9F (12-14mm ) 4-year follow-up patency rates 79% TLR free after 4 years 59% Binary Restenosis free after 4 years (lowest published)

145 Self-Ex: PRECISE Carotid Stent System (cordis) MicroMesh Geometry, Segmented Design Nitinol Stent D 5-10mm 135cm, Over-the-Wire Maximum Guidewire.018" Sheath Compatibility 5.5F (5-8mm diameters), 6F (9-10mm diameters) Guide Compatibility 7F (5-8mm diameters), 8F (9- 10mm diameters)

146 Self-Ex: PRECISE PRO RX Carotid Stent (cordis) MicroMesh Geometry, Segmented Design Nitinol Stent Diameters 5-10mm 135cm, Rapid Exchange Maximum Guidewire.014" Sheath Compatibility 5F (5-8mm diameters), 6F (9-10mm diameters) Guide Compatibility 7F (5-8mm diameters), 8F (9- 10mm diameters

147 Astron-biotronik Self-Expanding Nitinol Stent 0.035” / OTW

148 Astron Pulsar-Biotronik Self-Expanding Nitinol Stent OTW For treatment of diseases of femoral and infrapopliteal arteries.

149 Self-expanding stent to the peripheral vasculature via a sheathed delivery system Flexibte mesh tube made from Nitinol Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery and proximal popliteal artery with reference vessel diameters ranging from mm

150 Covered Stents GORE

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152 Jostent Peripheral Stent Graft (Abbot) High grade surgical stainless steel 316L PTFE Graft material Recommended minimum sheath size- introducer size that is two sizes larger than the sheath size Wall thickness after expansion Standard version: 0.40 mm Large version:.45 mm Minimal crimped outer diameter Standard version: 2.3 mm = 7F Large version: 2..7 mm = 8F Minimal deployment pressure 4 bar

153 Biocompatibility, the ability of a material to induce a “normal” response within a host Biodegradation, a biological agent like an enzyme or a microbe is the dominant component in the degradation process. Biodegradable implants are usually useful forshort- term or temporary applications Bioresorption and bioabsorption imply that the degradation products areremoved by cellular activity, such as phagocytosis, in abiological environment Bioerodible polymer is a water-insoluble polymer that has been converted under physiological conditions into water- solublematerials Polylactide and trimethylene carbonate

154 KYOTO-MED GP-JAPAN Biodegradable polymer PLLA (poly-L-lactic acid) Characteristics of being dissolved into water and carbon dioxide and absorbed into vessel tissue within a few years after implantation Metal allergies or pats who are still growing Will not interfere with other procedures such as restenting/Sx More useful for containing drugs compared to metal stent- intended as a platform for drug eluting stents.

155 Advances in Plaque Removal or Debulking Excimer laser Excisional and rotational atherectomy

156 Excimer laser The 308-nm excimer laser -fiberoptic catheters to deliver intense bursts of ultraviolet energy in short pulse durations The adv of uv light – short penetration depth of 50µ m break molecular bonds directly by a photochemicalprocess ability to ablate thrombus and to inhibit platelet aggregation. Removes a tissue layer of 10 µm with each pulse of energy. Ablated only on contact without a rise in temp to surrounding tissue Ability to treat long occlusions and complex disease

157 SPECTRANETICS Turbo Elite® laser catheters utilize ultraviolet light to vaporize arterial blockages into particles, most of which are smaller than a red blood cell. Treat Above-the-Knee Total Occlusions Long Diffuse Disease Treat Below-the-Knee Total Occlusions Long Diffuse Disease Treat Lesions Comprising Multiple Morphologies Atheroma Fibrosis Calcium Plaque

158 Combining a laser guide catheter with an excimer laser atherectomy catheter angled ramp allows for circumferential guidance and positioning of the laser catheter within the vessel

159 SilverHawk Plaque Excision System (Fox Hollow Technologies) cutter blade (long arrow) luminal plaques (small arrow ) Plaques are excised (double arrows) High-speed cutting blade excises a ribbon of plaque that is collected into the catheter nose cone. 7 different sizes monorail catheters meant for rapid exchange and operate over a inch diameter wire system

160 ROTATIONAL ATHERECTOMY DEVICES Pathway Medical PV system (Pathway Medical Technologies,Redmond, Wash) expandable, rotating scraping blades (“flutes”) ports between the flutes that allow flushing and aspiration of plaque material/thrombus

161 The Orbital Atherectomy System (Cardiovascular Systems,St Paul, Minn) high-speed rotational atherectomy system eccentric, diamond-coated abrasive crown When rotated at high speeds, the abrasive crown moves in an orbital path within the artery, potentially creating a lumen larger than the diameter of the crown

162 Pathway Jet Stream Device

163 BRIDGING THE GAP: ROLE OF HYBRID PROCEDURES Multilevel peripheral arterial occlusive disease Older patients with several comorbidities Common examples of hybrid procedures include common femoral artery endarterectomy combined with angioplasty of the iliac or SFA Comparable outcomes to open surgical procedures, but with decreased length of stay, morbidity, and mortality

164 Hybrid procedure for CFA/SFA dis

165 THANKYOU

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167 Antegrade puncture of the patent popliteal artery and successful crossing of the native SFA

168 Vascular Access “ SAFARI” Technique (Subintimal Arterial Flossing with Antegrade–Retrograde Intervention) Useful for completing subintimal recanalization when there is failure to re- enter distal true lumen from antegrade approach or limited target artery available for re-entry Technique improves technical success with subintimal recanalization Limb salvage rates comparable to those with antegrade subintimal recanalization

169 Below the Knee Tools Stiff, steerable guidewire Infrapopliteal PTA Balloon Catheter OTW 0.014” Infrapopliteal Co-Cr Stent System OTW 0.014” Infrapopliteal 0.014” Guidewire Infrapopliteal self-expanding Stent System OTW Crossability Crossing occlusions Avoiding abrasion, damage and risk of dissection Crossing occlusions Avoiding abrasion, damage and risk of dissection Bail-out situations Bail-out situations Dedicated long stent systems Low-profile OTW balloon with suitable sizes in balloon length and diameter. LONG BALLOONS Low-profile OTW balloon with suitable sizes in balloon length and diameter. LONG BALLOONS Drug eluting Balloon Restenosis prevention Paclitaxel-eluting PTA balloon catheter


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