Balloons and Wires Adam B. Greenbaum, MD Associate Director, Cardiac Cath Lab Henry Ford Heart and Vascular Institute No relationships to disclose in relation to this talk Some of the uses of the products discussed in this talk may be “off-label” “Still the Staples of PCI”

Equipment Selection PCI devices are commodity items in most situations Similar performance in >90% of cases Differences in engineering Device “anatomy” - design, construction, specifications Differences in applications Device “physiology” - performance, specialty situations General Principles

Dilation Catheters Balloon material Compliance Burst pressure Rewrap (i.E. Cutting balloon) Tip transition “Entry profile” Balloon transition “Crossing profile” Distal balloon / tip length / flexibility Force transmission (push) OTW vs Rx Product Engineering “Crossing efficiency” “Dilating efficiency”

Compliance mm At m Compliant Semi Least compliant

Compliance mm At m Don’t confuse burst pressure with compliance (“high- pressure” vs “noncompliant”)

Linear vs Hinged Compliance mm At m

Hinged Compliance Compliant Semi Least mm At m Don’t confuse “hinged” compliance with “semi” compliant

Hinged Compliance mm At m Most are now also in the “least compliant” category”

Compliance “What it means to you!” Compliant balloon Noncompliant balloon Ca ++

Compliance mm At m Stent Delivery Balloons

“Pre and post dilation” Balloon size “2.5mm for all” vs :1 balloon:artery ratio? Balloon length Shorter than intended stent length Balloon material Whatever it takes to cross and dilate Duration of inflation 90 seconds; ? Ischemic preconditioning “Definitive result” Balloon size 1-1.1:1 balloon:artery ratio Balloon length  2mm on each; longer when lesion on bend Balloon material Compliant first; noncompliant if lesion fails to yield Duration of inflation Optimal 5-7 minutes;  3 minutes Balloon Dilation General Concepts POBA EraStent Era

Graph compliance Check rated burst Tests to perform (outside the body) “tip bend” “finger drag” Tests to perform (inside the body) When will not cross, try same size and length balloon of another company with similar compliance using same guide and wire How to Evaluate a New Balloon mm Atm

Guidewires Product Engineering Core composition Material Tensile steel vs elastic Diameter Taper Cover Coils vs polymer Coating Hydrophobic vs hydrophilic Flexibility Support Safety Wire Deliverability Device Deliverability

General Construction 3 cm radiopaque tip coils “Flexibility Zone” Stainless steel intermediate coils “Working Zone” Stainless steel core “Sprayed” or “dripped” coating Flat shaping ribbon 0.014”

Core Material Hi-Torque Floppy II ® Elastinite™ distal core Hi-Torque Balance Middleweight™ Stainless steel core

Core Taper

Conventional Tapered Core RESPONSEASE™ Parabolic Core Segmental tapered core Transitionless parabolic core grind

Tip Transition “Unibody” construction vs distal weld joint

Coil Transition Jointless Spring Coil integrated two different metal by welding in advance of coiling process. Regular structure of coil screwed and brazed two different metal after coiling process.

Torque Response The wire is rotated through a tortuous tube and the rotation response is measured at the distal tip Ideally, the torque response would be 1:1 R25 R30 R25 Inner Dia.φ0.4mm L=300mm PE Tube GW Test Method

Torque Response Courtesy – Abbott Vascular

Transition and Deliverability Courtesy – Abbott Vascular

Support The wire is fixed/secured at various distances from the tip, the wire is then bent to test the force needed for bending Lower support decreases friction/vessel wall injury and increases wire deliverability May adversely effect device deliverability/trackability GW Test Method

Core transition and Support Iron Man Grand Slam All Star BHW Courtesy – Abbott Vascular

Specialty Wires Polymer tip wires Tapered tip wires Stainless steel vs polymer Cordis Wedge tip Sequential tip stiffness wires Side branch access wires Cordis Regatta SB Steerable wires Cordis; Stereotaxis Marker wires Wiggle wire Tortuousity Total occlusions Side branch access/rescue

Polymer Tip Wires Polymer sleeve REGATTA™ HS guidewire Conventional guidewire BSCI Choice PT and PT Extra support BSCI PT2 (nitinol core) Excellent torque response for nitinol Cordis Shinobi and Shinobi Plus Cordis Regatta HS GDT Whisper and Whisper MS GDT Pilot 50, 150 and 200 tip strengths

Tapered Tip Wires Stainless steel intermediate coils Unique tapered tip coils, 0.014” to 0.010” in the distal 3 cm 0.010” tip Cross-It™ XT Family Range of tip stiffnesses 3 cm radiopaque tip coils REGATTA™ HS Guidewire ASAHI CONFIANZA™ PRO 9.009” Hydrophobic Coating 19.9 cm Hydrophilic Coating 1 mm Hydrophobic Coating ASAHI CONFIANZA™ 9.009” Hydrophobic Coating

Tip Load Tip load value (tip stiffness) gives a numeric value to the tip The buckling load is defined as tip load The distance from the lower end of the pipe to the upper side of the electronic balance is 10mm Keep in mind, tip load only measures how much force it takes to “buckle” the tip of the wire Test Method GW Electronic Balance 10 mm

Red line indicates length of tapers/grinds Yellow is platinum coils Black is stainless steel coils Unit of measurement, mm Tip Load Courtesy – Abbott Vascular

Side Branch Access Wires Conventional wires REGATTA™ SB Guidewire Conventional Wire REGATTA™ SB Guidewire Shaping Ribbon

Marker Wires Radiopaque markers 20mm Distal guide wire tip 5mm 15mm Radiopaque spring tip

Based on HI-TORQUE FLOPPY II EXTRA SUPPORT Wire Specialty Wires Wiggle™ Wire

Wiggle™ Wire Theory Henry Ford Experience Near 100% stent recrossing success

Tip Shaping Lesion Specific Bending “Secondary” bend “Entry” angle 45º vs 90º “Primary” bend “Reach”

Tip Shaping Lesion Specific Bending “Reach”

How to Evaluate and New Wire Questions to ask Steel core or nitinol core “Tip to core” or shaping ribbon Broad transition vs short transition Polymer tip or stainless steel coils Tests to perform (outside the body) “tip tap” “finger nail drag” “Hang” test Tests to perform (inside the body) Wire with your fingers Slow 360° turn x few (torque response) Enter a few branches Make sure guide and device are well known to you “Hang Test”