Euro cto club breakfast symposium

Advanced tools and
techniques to address
challenging coronary
interventions
Gerald S. Werner MD PhD
Medizinische Klinik I
Klinikum Darmstadt GmbH
Darmstadt, Germany

Disclosures
Speaker is a paid consultant of Teleflex

The basic rules for CTO approach
• Bilateral access to visualize the wire
position and wire progress
• Maximum back-up by guide catheter for
wire and balloon advancement (options for
anchoring)
• Microcatheter over the wire approach
essential
• Know your wires

What you need to treat a CTO
• Guiding catheters
• Microcatheters
• Guide wires
• Dedicated devices (BridgePoint)
• Balloon catheters
• Guideliner/Guidezilla
• Rotablator (Laser)
• Stents
• IVUS

Common Clinical Challenges
• Guide catheter support and device delivery
• Guidewire support and deliverability
• Navigating complex anatomy
• Exchanging over-the-wire catheters

What is Guide Extension?
Potential Indicators for Guide Extension:
• Lack of guide support or guide catheter back-out
• RCA
• Radial access
• Tortuosity
• Calcium
• Ostial lesions
Rapid-exchange, coaxial
“mother-and-child”
guide catheter support

Guideliner® V3 Catheter Product Features
Proximal Tab
• GL French size – indicates
compatible guide catheter
• GL inner diameter (inches)
• Five sizes – 5F, 5.5F, 6F, 7F, & 8F
Stainless Steel Push Rod
• Strength & kink resistance, optimal push
• 0.056” lumen through 6F guide catheter
Half-Pipe Design
• Aligns device for seamless delivery
• 17 cm length
Coil Reinforced Guide Extension
• Flexibility & kink resistance for deep-
seating in tortuous vessels
• 25 cm rapid exchange section
• Extend up to 10 cm out of 5-7F
guide catheter (10cm for 8F)

Added Back-up Support
Without With Guide
catheter tip
GuideLiner®
V3 Catheter
tip
GuideLiner® V3 Catheter puts the guide into a more
supportive position against both the aortic valve cusp &
the opposite wall of the aorta

Added Back-up Support
Testing completed by Vascular Solutions, Inc. Bench testing data may not be indicative of clinical performance.
Testing has shown that extending a GuideLiner® V3
Catheter just 5mm beyond a 6F guiding catheter
greatly increases back-up support

Coaxial Alignment
GuideLiner® V3 Catheter creates coaxial alignment
for devices to track smoothly into the coronary artery
Without With

Distal Device Delivery
Proximal to Distal Stenting easier achieved with a
Guide Extension

Guide Extension Deployment Techniques
• Avoid advancing the Guideliner without a
leading balloon
• Balloon inflation out of the Guideliner and
advancing it while deflating the balloon makes
it possible to conquer even most tortuous
segments

GuideLiner® V3 Catheter Product Specifications
Model Size
Required Guide
Catheter I .D.
GuideLiner
I.D.
Tip O.D.
RX
Length
Working
Length
5569 5F
5F I.D. ≥0.056”
(1.42 mm)
0.046"
(1.17 mm)
0.053”
(1.35mm)
25 cm 150 cm
5570 5.5F
6F I.D. ≥0.066”
(1.68 mm)
0.051"
(1.30 mm)
0.063”
(1.60mm)
25 cm 150 cm
5571 6F (5-in-6)
6F I.D. ≥ 0.070”
(1.78 mm)
0.056”
(1.42 mm)
0.067”
(1.70mm)
25 cm 150 cm
5572 7F (6-in-7)
7F I.D. ≥ 0.078”
(1.98 mm)
0.062”
(1.57 mm)
0.075”
(1.90mm)
25 cm 150 cm
5573 8F (7-in-8)
8F I.D. ≥ 0.088”
(2.24 mm)
0.071”
(1.80 mm)
0.085”
(2.16mm)
25 cm 150 cm
Factors to consider when choosing guide extension:
• Vessel size
• Lesion location
• Lesion complexity
• Adjunctive tools and therapies

My personal sizing approach
• I prefer to use the appropriate size as it
provides the maximum working lumen
• In exceptional cases I use a smaller diameter
in case of difficult delivery or extrem bends

Guide Extension Case Example
LAD CTO with extreme tortuosity and
calcification

7Fr EBU3.75SH via Rt radial
PCI

Guideleiner with Tazuna 1.25mm

RCA CTO: Guideliner assisted reverse CART

Ante: 7Fr AL1.0 SH 100cm via Rt femoral
Retro: 7Fr EBU4.0 SH 100cm via Rt radial
PCI

Antegrade approach
Sasuke with Hornet14

Retrograde approach
Tip injection with Caravel

Retrograde approach
Carvel with SION

Caravel with Gaia3rd
Retrograde approach
Tip injection

Ante: Hornet14 with 2.0mm TAZUNA
Retro: Caravel with Gaia3rd
R-CART with 7Fr Guideliner

Externalization and wiring to PL
Sasuke with XT-R

RCA CTO: Guideliner assisted retrograde
procedure with tip-in exchange within the
Guideliner

PCI for RCA
Antegrade; 7Fr AL1.0 SH via Rt TFA
Retrograde; 7Fr EBU3.75 SH via Rt TRA

Antegrade approach
Finecross with XT

Retrograde approach
Caravel with SION

Retrograde approach
Caravel with Ultimate

R-CART
Ante: XT with 3.0x15mm
Retro: Caravel with Gaia3rd

Rendezvous Technique
Trunpike Spiral in the Anteguide

Caravel go into the Guideliner

Novel tool if you desire to use BOTH guide extension and
trapping technique
TrapLiner® Catheter = GuideLiner® V3 Catheter + integrated
trapping balloon
Two key design differences versus GuideLiner® V3 Catheter:
1. 3 mm balloon located on pushrod (hypotube) proximal
to collar
2. Shorter guide extension & half-pipe designed to position
integrated trapping balloon more distal in guide catheter
TrapLiner® Catheter Overview
3 cm
Hypotube
pushrod
Trapping
balloon
13 cm
Guide Extension
Half-pipe
1.
2.
2 cm

Kambis Mashayekhi
Deputy Medical Director
Clinic for Cardiology and Angiology II
Director of CTO and CHIP
University Heartcenter Bad Krozingen
Integrating Microcatheters into Complex Interventions –
How to use torqueable microcatheters to your advantage

Disclosure Statement of Financial Interest
• Consulting Fees/Honoraria
• Ashai Intecc, Teleflex, Cordis, Abbott,
Biotronik, Terumo, AstraZeneca,
Daiichi Sankyo
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation
with the organization(s) listed below.
Affiliation/Financial Relationship Company

I, Kambis Mashayekhi, received speaker honorary from Teleflex for this
presentation.
Disclosure Statement of Financial Interest

Microcatheters
• Maintain wire access beyond lesion
• Enhance guidewire steering and support
• Improve penetration power of guidewire tip
• Change guidewire direction

Microcatheters
Microcatheters are for guidewires what guide extensions are for balloons and stents
Three primary categories based on construction:
• Polymer only straightforward “transit catheters”
• Braided high flexibility, slips through microchannels and tight tortuosity
• Coil and braid high torque combined with flexibility to navigate and maneuver complex
vasculature
Each category serves a purpose, depending on the anatomy and lesion characteristics

Microcatheter Spectrum
“Transit” catheters
Braid only
Simple, cost
effective
Flexibility,
profile, push
Braid and coil
Specialty
catheters
Torque response
with flexibility
Polymer only
Added rotational
assistance
General use,
tortuosity
Directional /
dual lumen
Workhorse in
complex PCI cases
Tortuosity, side
branch access
Complex lesions
Minnie® Catheter Supercross™
Microcatheters
Turnpike®
Turnpike® LP
Catheters
SuperCross™
angled tip
Microcatheter
Twin-Pass®
Catheter
Turnpike® Spiral
Turnpike® Gold
Catheters
External threaded
coil

Turnpike® Catheters
Uniquely constructed microcatheters with dual-layer coil +
braided shaft provides an ideal combination of flexibility &
torque when delivered over 0.014" guidewires
Standard: Long, flexible tapered
tip
Spiral: Distal external coil for
assistance in rotational
advancement
Gold: Metal threaded tip for
leading edge rotational
advancement
LP: Lower profile & increased
flexibility
Each tip configuration contains unique design elements to
address varying clinical challenges

Shaft Construction
Multi-layer shaft provides combination of flexibility and
torque response
PTFE liner:
Facilitates smooth
guidewire movement
Braid:
For tensile strength
Polymer outer layer + hydrophilic coating
lubricious outer surface
Dual-layer, bidirectional coil:
Adds kink-resistance & torque
(single coil in distal 21 cm of LP shaft)

Standard
Unique dual-coil + braid shaft design provides ideal
combination of flexibility and torque response
• Long, flexible tapered tip for tracking
• Tungsten loaded distal tip for visibility under fluoroscopy
• Catheter advanced with clockwise or counter-clockwise
rotations

Spiral
External coil on distal shaft provides additional
rotational advancement
• 2cm nylon coil provides “front-wheel drive” in complex lesions
• Advance with clockwise rotation, remove with counter-clockwise
Outer nylon coil on distal 2 cm
Contraindicated for use in vessels with an effective diameter smaller than 1 mm.

Turnpike® Spiral - active support
Image courtesy of Kambis
Mashayekhi, MD

Gold
Threaded, gold-plated tip combined with outer nylon
coil on distal shaft provides added rotational support in
advancing through resistant lesions over a guidewire
• Threaded distal tip provides leading edge rotational advancement
• 2cm nylon coil provides “front-wheel drive” in complex lesions
• Advance with clockwise rotation, remove with counter-clockwise
Contraindicated for use in vessels with an effective diameter smaller than 1 mm.

Low Profile (LP)
Low-profile distal taper provides greater tip &
distal shaft flexibility for advancement
through extreme tortuosity
• 15% lower crossing profile than standard Turnpike® Catheter1
• Distal shaft 79.4% more flexible than standard Turnpike® Catheter1
• Comparable torque response to Asahi Corsair® Catheter1
• Catheter advanced with clockwise or counter-clockwise rotations
Distal shaft tapers to a single coil 21 cm from tip
1. Data on file at Teleflex. Comparative data may not be indicative of
clinical performance.

Ipsilateral LCX-Occlusion (Typ IC-D)
Case 1
6F-approach “Soft” antegrade attempt
Images courtesy of Kambis Mashayekhi, MD

Case 1

Case 1
Image courtesy of Teleflex, Inc.

Case 1
Turnpike® LP Final Result

Case 2
8F support Typ IC-D connection

Image courtesy of Kambis
Mashayekhi, MD

“Tip-In” technique Final Result
Case 2

How to use torqueable microcatheters
Image courtesy of Kambis Mashayekhi, MD

Turnpike® Catheter Techniques
1. Turnpike® Standard and LP Catheters provide torque response, and can be
rotated, in both a clockwise and counter-clockwise fashion
2. Turnpike® Spiral and Gold Catheters are rotated clockwise to advance and
counter-clockwise for removal
3. Alternating direction of rotation (on Turnpike® Standard and LP Catheters)
when against significant resistance is good practice
– Releases torque build-up in catheter shaft
4. For all Turnpike® Catheters: Do not rotate catheter more than two consecutive
360° rotations in either direction if the distal tip is not also rotating and
advancing
5. Replace device when it starts to “wear out”
– Noticeable decrease in guidewire movement within catheter

Product Indications
Minnie® Support Catheter
The Minnie support catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the
arterial and/or coronary vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional
devices. The Minnie support catheters also may be used to subselectively infuse/deliver therapeutic agents.
The Minnie support catheters are contraindicated for use in synthetic vascular grafts due to the potential for graft perforation.
Turnpike® Catheters
The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be
used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.
The Turnpike Spiral and Turnpike Gold catheters are contraindicated for use in vessels with an effective diameter smaller than 1mm.
SuperCrossTM Microcatheters
The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary
and/or peripheral vasculature. It may be used
to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and
therapeutic agents.
The SuperCross microcatheter is contraindicated for high pressure injections and for use in the cerebral vasculature.
Twin-Pass® Dual-Access Catheters
The Twin-Pass Torque catheter is intended to access discrete regions of the coronary and/or peripheral vasculature. It may be used to
facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary
and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, and for use
during two guidewire procedures. The Twin-Pass is also used to sub selectively infuse/deliver diagnostic or therapeutic agents.
The Twin-Pass catheter is contraindicated for high pressure injections and for use in the cerebral vasculature.

The statements herein reflect the personal experience and opinion of the speaker.
This information is provided for clinical education purposes and is not intended to
be a substitute for sound clinical judgment or decision making, or professional
experience relative to diagnostic and treatment options of a specific patient's
medical condition.
Please see the Instructions for Use for a complete listing of the indications,
contraindications, warnings and precautions.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a
physician.
Results from case studies are not predictive of results in other cases. Results in
other cases may vary.
Teleflex, the Teleflex logo, Minnie, SuperCross, Turnpike and Twin-Pass are
trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in
the U.S. and/or other countries. Other names may be trademarks of their
respective owners.
Information in this material is not a substitute for the product Instructions for Use.
Not all products and/or services may be available in all countries. Please contact
your local representative. Revised: 02/2019.
© 2019 Teleflex Incorporated. All rights reserved. MC-004584

Trapping basics and the
optimal use of guide
extensions with
integrated trapping
balloon
Elliot Smith MD FRCP
Consultant Cardiologist
Applying Advanced Techniques to
Simplify your Complex Procedures
Anthony'Mathur
Dan'Jones
Francesca'Pugliese
Roshan'Weerackody
Cardiogenic Shoc
Symposium
Patients'with'Recurrent'Chest'Pain'
after'Bypass'Surgery'(CABG):'

Why Trap?
• In CTO PCI wire position is precious
– Maintain wire position (mm precision)
• Use of multiple OTW and RX technologies require exchanges
• Exchange of devices with ‘long / doc’ wires or hydraulic
exchanges risk loss of wire position, damage to the vessel,
and may lead to procedural failure

Case Illustration
• Short Lesion
• Previous fail x 2
• Post CABG
• No Retro options (LIMA to
D1, septals to RCA)

Undilatable lesion
proximal to
occlusion
– multiple
balloons tried
Anchor
Balloon
Lesion undilatable
Knuckle proximal to distal cap

Progression of knuckle
6F system
Lesion yields
Long wire exchange
Bring in MC (Cross Boss)
Knuckle propagates
>>>>> Loss of distal
visualisation

Standard Balloon Trapping Technique
Enables OTW catheter exchange over a short
(~190cm) guidewire without losing wire positioning
1. Rapid-exchange (RX) PTCA or dedicated trapping
balloon advanced to distal end of guide
2. OTW catheter tip pulled proximal to balloon
3. Balloon inflated to “trap” guidewire against
inner wall of guide catheter

DEDICATED TRAP BALLOONS
More space in Guide
Can trap mc’s in 6/7F
Learn compatibilities
WILL NOT EXIT GUIDE

With Guide
catheter tip
GuideLiner® V3
Catheter tip
GuideLiner® V3 Catheter puts the guide into a more supportive position
against both the aortic valve cusp & the opposite wall of the aorta
Why combine Trap and Guide Extesnion?

BOTH guide extension and trapping technique
TrapLiner® Catheter = GuideLiner® V3 Catheter + integrated
trapping balloon
Key design differences versus GuideLiner® V3 Catheter:
1. 3 mm balloon located on pushrod (hypotube) proximal to collar
2. Shorter guide extension & half-pipe designed to position
integrated trapping balloon more distal in guide catheter
TrapLiner® Catheter Overview
3 cm
Hypotube
pushrod
Trapping
balloon
13 cm
Guide Extension
Half-
pipe
2 cm

Integrated Trapping Balloon
One balloon size for all models:
• 3 mm x 11 mm (semi-compliant)
• 12atm Nominal / 14atm RBP
• Sufficient trapping force in
guides up to 8Fr (e.g., 6-in-8)
• Located 18cm proximal to distal tip
Gold marker – identifies
proximal end of balloon
3 mm
11
mm
Gold Marker

Benefits of TrapLiner® Catheter
1. Can increase effective inner diameter (I.D.) in guide catheter
compared to traditional trapping techniques
2. Avoids difficulties of trapping with standard guide extension
catheters
Standard Trap / Rx Catches at
transition
Reduced space in Extension
segment

3. Increases effective inner diameter (I.D.) in guide catheter compared to
traditional trapping techniques
6F TrapLiner® Catheter
Trapping = Yes
Guide Extension = Yes
Push Rod O.D. = 0.020”
Effective I.D.1 = 0.050”
PTCA Balloon Example
Trapping = Yes
Guide Extension = No
Avg. O.D.2 ≈ 0.034”
Effective I.D.1 ≈ 0.036”
Trapper® Catheter
Trapping = Yes
Guide Extension = No
Device O.D.3 ≈ 0.026”
Effective I.D.1 ≈ 0.044”
1Based on a 6Fr (0.070”) guide catheter I.D.
2This O.D. represents the average measured on commonly used PTCA balloons in the diameter range of 2.25 to 2.75 mm. Maximum O.D.’s on PTCA balloon catheters at a specific diameter will show variance across
different manufacturers, versions, and lots.
3Device O.D. based on manufacturer labeling.
TrapLiner is a registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. Other names may be trademarks of their respective owners.

6Fr. TrapLiner® Device Compatibility*
• Turnpike® Microcatheters (0.038”)
• Twin-Pass® Dual Access Catheters (0.046”)
• Stingray™ LP Coronary CTO Re-Entry System
(0.042”)
• CrossBoss™ Coronary CTO Crossing Catheter
(0.045”)
TrapLiner, Turnpike and Twin-Pass are registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
Other names may be trademarks of their respective owners.
*Device compatibility based on marketed proximal shaft outer diameter measurements deployed within a 6Fr (0.070”) guide catheter and
not simulated use testing.

• Standard guide extension catheters force operators to trap
proximal to collar
• TrapLiner® Catheter has shorter 13 cm extension to enable
trapping 18 cm from distal tip
• Designed to reduce the incidence of running out of proximal
guidewire
18 cm
Interference length
42 cm
Interference length
4. Avoids difficulties of trapping with standard
guide extension catheters
*Catheters not shown to scale

What’s Similar to GuideLiner® V3 Catheter?
• Guide extension material and functionality
• 150 cm working length
• Guide extension I.D. and O.D. for each
respective size
• Proximal and distal marker band locations
• White positioning marks at 95 cm & 105 cm

What’s different from GuideLiner® V3
Catheter?
GuideLiner® V3Catheter
– 5F, 5.5F, 6F, 7F, & 8F
– 25 cm guide extension
– Stainless steel ribbon wire
pushrod
– Silicone coating
– No balloon
– 17 cm half-pipe
– 6Fr. Effective I.D. = 0.056”1
– 7Fr. Effective I.D. = 0.065” 2
– 8Fr. Effective I.D. = 0.075” 3
TrapLiner® Catheter
• 6F, 7F, & 8F only
• 13 cm guide extension
• Stainless steel hypotube
pushrod
• Hydrophilic coating
• Integrated balloon
• 3 cm half-pipe
• 6Fr. Effective I.D. = 0.050” 1
1. Based on a 6Fr (0.070”) guide catheter I.D
2. Based on a 7Fr (0.078”) guide catheter I.D.
3. Based on 8Fr (0.088”) guide catheter I.D.

TrapLiner® Catheter Techniques
• Careful handling during prep and deployment
– “Choke up” on catheter during advancement in hemostasis
valve
– Avoid coiling at or distal to trapping balloon
– 13 cm guide extension: Do not extend collar out of guide
– Use proximal marker band (4 mm distal to collar)
• Be prepared for longer balloon inflation time vs. standard
PTCA balloon due to smaller hypotube – USE Saline vs 50/50
• Test guidewire movement prior to exchange
• Remember back-bleeding step after balloon deflation

Trapliner and Antegrade CTO
• Antegrade
– Maintain antegrade wire position / base of operations
– Protect dissection plane against heamatoma
– Facilitate multiple exchanges in difficult cases
• Balloon uncrossable
• Multiple balloons
• Multiple micro catheters / switches (MC fatigue / stalls)

Options for the uncrossable lesion = multiple exchanges
• Enhance guide support
• Lower profile microcatheter
• Penetrative microcatheter
• Low profile balloon (s)
• Laser
• ‘Bury’ microcatheter and advance rotor wire
• CTO specific
– External cap modification
– Sub intimal passage (around the lesion)
– Retrograde puncture
– Retrograde wire trap for support

• TrapLiner® Catheter eliminates need to repeatedly deliver off-the-
shelf trapping balloon for OTW catheter exchanges
• Potential to help reduce procedure time and radiation exposure

Iteration and Quantum leaps in
the CTO space
Wire/balloon/stent
INTIMAL PLAQUE
SUB INTIMAL /
SUB ADVENTITIAL
TRACKING

Trapliner to preventing haematoma in ADR

Re-entry
– CB / SR 70%
(SR 56%: CB 15%)
– Wire based / LAST 25%
– STAR 4%
Antegrade Dissection Re-entry ADR (24%)

Haematoma
47%
Calcification
21%
Other
19%
Proximal cap
penetration
13%
ADRfailuremodes

Control the space?
• Use of CrossBoss for SMALL blunt
dissection
• Preparation - to reduce time
between microcatheter exchanges
(e.g. CrossBoss to Stingray)
• Guide Extension / Trapliner

Long calcific CTO
If you cant
go
through…
…GO
ROUND

Formation of Fielder XT knuckle

Tracking round calcium 2 views

Knuckle for tortuosity, NOT beyond bifurcation

Trapliner and Retrograde
• Antegrade
– Maintain antegrade wire position / base of operations
– Protect dissection plane against heamatoma
– Receive wire in GX assisted Reverse CART
• Retrograde
– Enhance support
– Facilitate exchange of Micro catheter

Guide Extension facilitated Reverse CART
Anterior Origin RCA
Ambiguous Cap
Bifurcation at landing zone

Reverse CART – Antegrade control, mm count
Antegrade knuckle
Bifurcation

GX reverse CART
Antegrade balloon SI space
Retro MC is TRUE LUMEN
Bifurcation

Use then trap out
Dual lumen
microcatheter
• Easy to trap out DL
Micro catheter
• Care with length
dual lumen 135-
145cm
• May need Doc for
the OTW
• Ensure DOC is wire
specific

Case
completion
• Guide support
• Antegrade
control of space
• GX R-CART

Time
20 devices per case.
90 secs to find.
30 mins added to each
case!

Retrograde
Enhance support
Facilitate Microcatheter Exchange

Conclusions
• Trapliner combines GX and dedicated trap
• Facilitates rapid micro catheter / device exchange without loss
of wire position as per trap Time. Rad Contrast
• Augments support as per GX
• Control of SI space
– Minimizes time to exchange
– Block arterial inflow to plane
• Retro guide support / Xchange Mc’s

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