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Michael J. Cowley, MD, MSCAI

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1 Michael J. Cowley, MD, MSCAI
Selection and Use of Basic Equipment: Guide Catheters, Wires and Balloons Michael J. Cowley, MD, MSCAI NIC Mid-term Meeting, Hyderabad April 15, 2016

2 Basic Guiding Catheter Functions
Supportive conduit for advancement of guidewires and devices Vehicle for contrast injection Measure blood pressure

3 Important Guiding Catheter Features
Atraumatic tip Proper preformed shape co-axial with vessel Torque control Kink resistance Radiopacity

4 Guide Catheter Construction

5 Guide Catheter Sizing Diameter Length Lumen size required
Access site & prox coronary size 5-7 F femoral; 5-6F radial Length 100 cm standard >100 cm in tortuous aorta or radial access in tall patient <100 cm for distal sites (snake graft, tortuous IMA)

6 Proper Left Guide Catheter Position

7 Guide Catheter Selection
Aortic Configuration Normal Dilated Narrow or Short Coronary Orientation (take off) Normal, Upward (high), Downward SVG Orientation RCA: horizontal or downward LCA: Horizontal or superior

8 Guiding Catheter Support

9 Possible Solutions when the RCA Originates More Anteriorly
Right Judkins Right Judkins or Hockey Stick Left Amplatz or Hockey Stick Left Amplatz or Left Judkins (out of plane)

10 Guide Catheter Options for Difficult Right Coronary Cannulation
Hockey Stick Amplatz EBU or Left Graft LIMA or XBRCA LIMA catheter useful for upward - oriented RCA origin or Shepherd’s Crook Curve

11 Guide Selection for Vein Grafts
Left Bypass; Hockey Stick or Amplatz Left Multipurpose; Right Bypass Right Judkins or Multipurpose Hockey Stick Right Judkins (JR4) will cannulate most grafts

12 Physics of Guide Catheters for Left Coronary Artery in Transfemoral and Transradial PCI
Ikari et al J Invas Cardiol 2005;17:

13 Radial vs Femoral Access

14 Guide Selection and Use Influence Support
h q Angle provides greater Backup Support

15 Backup Force with Various Guide Shapes
JL JL deep BL 3.5 IL 4 IL4 Power

16 Guide Catheter Support
Approach Femoral > L Radial > R Radial Power support angle ( q ) Contralateral aortic wall angle q Deep seating vs power curves XB, EBU, Amplatz, Ikari Coaxial alignment Larger French size

17 Guide Wires

18 Basic Characteristics
Coronary Guide Wires Basic Characteristics Steerable “Deliverable” Atraumatic Tip Adequate Rail Support Smooth Coating Tip Polymer sleeve or Coil-Spring Tip Platinum,Tungsten, steel Central Core Stainless steel Durasteel™ nitinol/Elastinite® Lubricious Coating Silicone PTFE Hydrophilic

19 Guidewire Construction
3 Basic Components Central Core Stainless steel Durasteel™ nitinol/Elastinite® Tip Polymer sleeve or Coil-Spring Tip Platinum Tungsten Stainless Steel Lubricious Coating Silicone PTFE Hydrophilic

20 Tip Coil with Shaping Ribbon Design
Guidewires Tip Coil with Shaping Ribbon Design

21 Guidewires Core-to-Tip Design

22 Smooth Taper Core Grind Design
Guidewires Smooth Taper Core Grind Design

23 Guidewires Core Diameter Smaller Diameter: More Flexibility
Diameter affects flexibility, support and torque Smaller Diameter: More Flexibility Larger Diameter : More Support & Torque Larger Diameter – mor e support for tracking bulky devices; more supportive rail; however, takes away from overall performance

24 Guidewires Core Taper Longer taper: better wire tracking, less prolapse Shorter taper: better support, more prolapse

25 Core Taper Short tapers produce h longitudinal support but also h tendency to prolapse Prolapse

26 Core Taper Long or gradual tapers provide greater tracking and less tendency to prolapse Successful Tracking

27 Affects flexibility, support, steering and tracking
Guidewires Core Material Affects flexibility, support, steering and tracking Stainless Steel Nitinol/Elastinite®

28 Guidewires Core Material Stainless steel
Original core material technology Good support, push force and torque Less flexible than newer core materials

29 Guidewires Core Wire: Coil Spring:
Ground and tapered on the distal end to increase flexibility Coil Spring: Typically soldered to core wire at point where inside diameter of coil spring matches the outside diameter of the core wire

30 Guidewires Core Material Nitinol / Elastinite®
Super-elastic alloy designed for kink resistance Excellent flexibility and steering

31 Work-Horse Guide Wire Characteristics
Intermediate Core Diameter Gentle Core Taper Resilient Core with good torque control Soft Tip Coils or Covers Smooth Coating

32 Ideal Workhorse Wire Soft, flexible and atraumatic tip
Excellent torque transfer (1:1) Good tactile feel Excellent steerability and pushability Supportive but tracks well in tortuous vessels Facilitates balloon and stent delivery

33 Coronary Guidewires Workhorse Hydrophilic CTO Extra Support
HTF, BMW, Prowater, Runthrough, ATW Hydrophilic Whisper, Choice PT CTO Fielder XT, Miracle Bros, Confianza Extra Support

34 Coronary Guide Wire Characteristics
Unfavorable Features Steerable “Deliverable” Stiff Tip Increased Rail Support Hydrophilic Coating Atraumatic Spring Tip Adequate Rail Support Smooth Coating Dissections & Perforations Straightening Artifacts Perforation

35 Pseudo-lesion Safian et al

36 Balloon Angioplasty

37 Current Clinical Usage
Balloon Angioplasty Current Clinical Usage Pre-dilation Stent Deployment Post-dilation gioplasty

38 Anatomy of a Balloon Catheter
Over-The-Wire (OTW) Balloon Catheter Monorail (Rx) Balloon Catheter

39 Balloon Catheter Performance
Handling Inflation Trackability Pushability Crossability Entry profile Crossing profile Compliance Compliant Semi-compliant Non-compliant Dilating Force Nonimal Pressure Rated burst pressure

40 Balloon Catheter Characteristics
Trackability Pushability Crossability Entry profile Crossing profile

41 Key Performance Characteristics
Balloon Angioplasty Key Performance Characteristics Compliance Dilatation force Presenter When talking about balloon materials and performance, we need to consider compliance and dilatation force. First, let’s talk about compliance.

42 Balloon Angioplasty Compliance
The rate of the change in balloon diameter over a range of inflation pressures Determined in unconstrained environment Does not address resistance to expansion

43 Balloon Materials & Performance
Compliance Compliant Semi-Compliant Diameter (mm) Presenter This chart illustrates the different types of balloon materials and their relative growth as pressure increases. Non-Compliant Atmospheres (ATM)

44 Balloon Compliance Material Growth Above Nominal Compliant Polyolofin
~20% Semi-compliant Polyethylene or Nylon ~10% Non Compliant PET ~0-5%

45 Balloon Performance Compliance Chart Derived from bench testing
3.0 mm Balloon Derived from bench testing In vitro, 37º in water bath Unreliable in vivo Significant overestimation of actual MLD by IVUS ~20% less than stated chart size

46 Balloon Compliance Charts
3.0 mm Balloon RB RB Diam (mm) RB N N N

47 Materials & Performance
Balloon Angioplasty Materials & Performance Dilatation force The radial force exerted by the balloon on the coronary lesion or metal stent Dilatation force is a function of Inflation pressure Balloon material (compliance) Presenter Dilatation force is the radial force exerted by the balloon on the coronary lesion or metal stent. Dilatation force is a combined measure of: Inflation Pressure: The pressure applied to inflate the balloon. Balloon Material: A more compliant balloon material results in reduced dilatation force at the lesion. More non-compliant balloon material provides greater dilatation force at the lesion.

48 Balloons grow in areas of least resistance
Growth is more significant as pressure increases Balloons grow in areas of least resistance Low and focal growth as pressure increases Designed for dilatation of calcified or resistant lesions

49 Dilatation Force (Straw Test)
Balloon Performance Dilatation Force (Straw Test) Semi-compliant Low-compliant Non-compliant Dilatation Force NC LC SC Presenter This chart illustrates the test you just saw. The lines show the growth of each type of balloon material, and the dots indicate at which ATM that material popped the straw. As you can see, the low compliant balloon required four more ATM of pressure than the non-compliant balloon to apply the same amount of dilatation force to the straw. The semi-compliant balloon required twice as much pressure to equal the dilatation force of the non-compliant balloon. Pressure (ATM)

50 Materials & Performance
Compliant & Semi-compliant Balloons Better flexibility & trackability Better cross and recross performance Limited durability Increased diameter and longitudinal growth variance Limited dilatation force Presenter Because the compliant balloon is softer and more flexible, it has the ability to more easily traverse through the twists and turns of difficult anatomy. The thin compliant material is also able to cross difficult or tight lesions because of these soft, flexible traits. The soft, flexible material however, limits the balloon’s durability and allows for greater variance in diameter and longitudinal growth.

51 Materials & Performance
Compliant & Semi-Compliant Balloons Used for Pre-dilatation Gain lesion access/ prepare vessel for stent Determine lesion length/diameter Determine lesion morphology Trade-offs Potential growth outside lesion Unwanted vessel expansion Presenter Compliant and semi-compliant balloons are used primarily for pre-dilatation of a vessel prior to stent implantation. More compliant balloons are typically made of a softer and more flexible material. In these balloons, pressure migrates to the area of the balloon with the least resistance which can be outside the lesion area or metal stent. This can cause a “dog-boning” effect which could result in damage of healthy tissue outside the intended treatment area, as shown in the illustration.

52 Materials & Performance
Non-Compliant Balloons Durability “Focused” radial force to lesion / stent Less diameter / longitudinal growth variance Reduced flexibility, trackability Limited cross and re-cross performance Limited sizing flexibility Presenter The non-compliant balloon is typically stiffer and thicker for added durability, making it more difficult to traverse this balloon through tortuous anatomy. The non-compliant balloon will likely be more difficult to cross or recross a lesion due to its thickness and profile characteristics. Yet, this type of balloon material provides more “focused” dilating force because it has less diameter and longitudinal growth variance.

53 Materials & Performance
Non-Compliant Balloons Used for Post-dilatation Maximum dilatation force Focal stent expansion Lowest longitudinal growth Presenter Less compliant balloons are typically stiffer, thicker and less susceptible to growth outside of a lesion. In this case, the less compliant balloon holds its shape despite added ATM pressure. This results in the balloon’s ability to exert more force against a hard lesion or metal stent, potentially increasing dilatation success. The size growth and pressure characteristics of a less compliant balloon are similar to a basketball. As a basketball is inflated, it will form its shape at a relatively low pressure. However, the basketball can still be deformed if you push into it. As you continue to inflate the basketball to higher and higher pressures, the shape and size of the ball does not change but it becomes increasingly more difficult to deform its shape by squeezing it.

54 Device Delivery Problems
Inability to Pass Balloon/stent around bend Better Guide support Stiffer guide wire Buddy wire Guideliner More flexible stent Shorter stent

55 Pre-PCI Planning Access site and guide catheter selection ?
Guidewire characteristics desired ? Strategies to be used balloon, modified balloon, direct stent ? BMS, DES ? Alternative equipment / techniques (Plan B)

56 Balloon Angioplasty Alone
Treatment of focal in-stent restenosis (especially BMS or multiple layers ) Anastomosis lesions soon after surgery Bifurcations (treatment of daughter limb ) Small vessels ( <2mm )

57 Balloon Angioplasty Role with Stenting Pre-dilatation Post-dilatation
Gain lesion access / prepare vessel for stenting Determine lesion length / diameter Determine lesion morphology Post-dilatation Ensure full stent expansion / apposition of stent Optimize Minimum Lumen Diameter (MLD) Presenter Balloon usage in PTCA procedures has changed with the development and widespread adoption of stent technology. Currently, there are three main uses for a balloon during PTCA procedures: Plain Old Balloon Angioplasty, or POBA: A procedure where the balloon is used alone to dilate the vessel. Because this procedure has been associated with higher restenosis rates, the percentage of pure POBA procedures has decreased significantly in the last five to 10 years and is now estimated to be less than 10% of all PTCA procedures. Pre-Dilatation: The use of the balloon before the implantation of a stent, to gain access to the lesion, to prepare the vessel for the stent, or to determine the attributes of the lesion to aid in stent selection. Post-Dilatation: The use of a balloon inside an already deployed stent. Post-dilatation is used by physicians to ensure that the stent is fully expanded or apposed in the vessel, ensure MLD, and help avoid complications such as SAT (Source: Cheneau, et al. Circulation 2003;108;43-47), that have been associated with unapposed stents. With the introduction of drug-eluting stents, proper stent apposition also ensures that the drug is in contact with the artery wall.

58 Summary Proper choice of equipment facilitates best results with PCI:
Shortens procedure times Improves succss rates Reduces complications and adverse events

59

60 Selection and Use of Basic Equipment : Guiding Catheters, Wires and Balloons
Michael J. Cowley, MD, MSCAI Professor of Medicine Virginia Commonwealth University Feb 19, 2016


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