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OCT
Optical Coherence Tomography
Advanced Imaging to guide complex
interventions
• Basics of OCT
• OCT System overview
• OCT Catheter
• OCT Procedure
• OCT Image Interpretation
• Clinical Trials
• Case Based Discussion on Demo OCT Laptop
WHAT IS IN STORE FOR THE DAY…
Proprietary and confidential — do not distribute
OCT BASICS
TIME FOR HIGH RESOLUTION IMAGING
WHAT IS OCT?
Optical Coherence Tomography (OCT) is an optical imaging modality
that uses near-infrared light to create high-resolution images of tissue
microstructure.
Optical  of or relating to light (visual)
Coherence  a measure of the correlation between phases of a wave
or waves
Tomography  method of producing images from a series of single
planes or slices (Greek “TOMOS=Slice”)
5
WHAT IS INTRAVASCULAR OCT?
OCT is an optical imaging modality that uses near-infrared light
(1250-1350nm) for high-resolution imaging of vessel anatomy,
tissue microstructure and stents.
Key Features:
Uses light, not sound
Does not use X-ray
Image acquisition is fast
Images acquired are sharp,
detailed and easy to interpret
6
INTRAVASCULAR OCT
Flexible fiber-optic catheter used for light delivery
Fiber rotates to create image frames
Fiber pulls back to map vessel segment
• The more frames per mm, or high frame density, the higher the
resolution
7
MICHELSON INTERFEROMETER 1881
Albert Michelson (1852-1931)
Nobel Prize Physics 1907
Time Domain OCT (TD-OCT): (older generation)
Non-Commercially available for cardiovascular use
2001 to the present
Moderate image quality
slower imaging speeds (full pullback 30s) and made it
necessary to totally block the blood flow in the vessel
using an occlusion balloon
Frequency Domain OCT (FD-OCT):
Commercially available for cardiovascular use 2010 to
the present
Exceptional image quality
Fast imaging (full pullback 3s) : 10 to 100x increase in
speed
Rapid contrast flush instead of balloon occlusion
TIME VS. FREQUENCY DOMAIN
INTRAVASCULAR OCT
C7-XR system: FD-OCT
100 fps, 20 mm/s pullback
M3 system: TD-OCT
20 fps, 1 mm/s pullback
Gonzalo, N. Optical Coherence Tomography for the Assessment of Coronary
Atherosclerosis and Vessel Response after Stent Implantation. Rotterdam, the
Netherlands: Optima Grafische Communicatie; 2010.
improved image
quality
Light is too fast for direct echo measurement  interferometry
Compares path length between known reference arm and sample arm
Mechanical reference arm motion limits imaging speed
TIME DOMAIN OCT (M2/M2X/M3)
intensity
axial distance
Demod Amp
Broadband
Source
D
Tissue
Mirror
Reflections
(moving)
Time Domain OCT: fixed laser signal, moving mirror
Measurement of interference pattern spectrum + Fourier transform
Signal generated from all depths simultaneously
Faster image acquisition without loss of quality
greater penetration depth
FREQUENCY DOMAIN OCT (C7-XRTM AND
ILUMIENTM)
Swept Laser
D
λ
intensity
intensity
distance
FFT
Amp
Frequency Domain OCT: sweeping laser signal, fixed mirror
OCT IMAGE ACQUISITION
OCT CATHETER MOVEMENT – REAL TIME
PULLBACK GENERATION
One pullback  270 – 540 frames
16
IMAGE DISPLAY
17
“L-Mode”
longitudinal view
“B-Mode”
cross-sectional view
INTRAVASCULAR OCT
Rotate a sensor & Pullback
distal
proximal
Catheter with fiber-optic core used for light delivery
• Fiber rotates to create image frames
• Fiber-optic core pulls back to map vessel segment
• During the pullback, blood clearing is required to get a good image quality.
Sensor
Lens
Optic fiber
OCT catheter
Better image quality by:
(1) Faster rotation
(2) Slower pullback
PRINCIPLE OF CATHETER BASED
INTRAVASCULAR IMAGING
1st line
A-Line
distal
proximal
Sensor
A-LINE ACQUISITION
2nd line 3rd 4th 5th
1st 2nd
3rd
1 2 3 4 5 6 7 ………………………………………………………………………………………………..…n
depth
R-THETA CONVERSION (FRAME)
1 2 3 4 5 6 7 ……………………………………………………………………………………………..…n
1,2,3 4,5,6
One frame  560 axial lines
Computer make lines to
circle
A pulse of light is sent
out that bounces off
the different layers of
tissue and returns
back to be analyzed by
the system.
The catheter can be seen
in the middle of the
image, with the optical
fiber at its core.
Measure echo time delay
of reflected light waves
Ilumien each frames =
504 A lines
Optis and optis integrated
each frame = 560 A limes
IMAGE (FRAME)
DIFFERENCE OF RESOLUTION.
Direction
of
beam
High resolution Low resolution
Unable to
distinguish.
Distinguishable
each component
Axial direction
Lateral direction
2 TYPES OF
RESOLUTION(AXIAL/LATERAL)
Axial: parallel to the beam = along the vessel
Lateral: perpendicular to both the beam and the catheter = cross-section of vessel
※JACC vol.37, No.5, 2001 1478-92(IVUS consensus report)
The ability of an imaging system to resolve detail in the object that is being imaged
IVUS/OCT: smaller beam size & larger
number of A-Lines
TO GET BETTER RESOLUTION (LATERAL
RESOLUTION)
Lateral resolution is
around
With OCT 20 to 40 µm
RESOLUTION
400 pix
600
pix
200
pix
130 pix
RESOLUTION
400 pix
600
pix
200
pix
130 pix
Proprietary and confidential — do not distribute
OCT SYSTEM OVERVIEW
OCT EVOLUTION
29
1999-2001
PTCA balloon + ImageWire
TM
R&D prototypes
Not commercially
available
Inside PTCA balloon
‘Snapshot’ flush imaging
2007
M3 System
CE mark
20 fps / 240 lines
Occlusion + flush
2004
Soft occlusion balloon + ImageWireTM
M2 System
CE mark
15 fps / 200 lines
Occlusion + flush
2009
C7XR™ System
CE mark, FDA cleared
100 fps / 500 lines
NO occlusion
Occlusion-free DragonflyTM
30
2011-12 2013-15 2016
ILUMIEN™ System
ILUMIEN™ OPTIS™
System
OPTIS™ Integrated
System
OPTIS™ Mobile
System
• Commercially
available 2011
• 100 fps / 54 mm
pullback
• Combined FFR and
OCT
• Wireless FFR
• 180 fps/75 and 54 mm
pullback
• Advanced software
tools
• Real time 3D
reconstruction
• Pullback initialization
from DOC
• Integrated in the
Cath lab
• Angio Co-
Registration With
tableside FFR/ OCT
controller
• Integrates with
Multiple Cath labs
• Angio Co-
Registration With
tableside FFR/ OCT
controller
FFR and OCT System
2nd Gen FFR and OCT
System
Cath lab integrated FFR
and OCT system
Latest system with 3D
OCT, FFR, ACR & MSO
2015
Current Generation PCI Optimization Systems
31
2016/17 OCT PRODUCT LAUNCHES
OPTIS™ Mobile System OPTIS™ Mobile Upgrade Kit
(Ilumien™ OPTIS™ Systems only)
OPTIS™ Metallic Stent
Optimization Software-
MSO
(Software Version E.4)
OPTIS™ Mobile
Workstation
(Accessory for OPTIS™
Integrated System)
Mobile System integrated into
Cath lab during procedure to
offer angio co-registration
• Angio Co-registration
• Wireless Tableside Controller
• Mobile cart connect into Cath
Lab during procedure
• Enables the use in multiple
labs
• Will include E.4 after LMR
Enables angio co-registration
function on Ilumien™ OPTIS
System
• Angio Co-registration (ACR)
• Wireless Tableside Controller
• Mobile cart connect into Cath
Lab during procedure
• Enables the use of OCT-ACR
and FFR in multiple labs
• Leverage options to include E.4
New clinically relevant
software enhancements for
pre and post PCI
• Stent roadmap on angio co-
registration
• New default view with
automated measurements
from lumen profile
• Acute Stent detection and
apposition assessment
• Expanded 3D imaging
Standard available for bug fixes only
Offered as another point of
control to operate the
OPTIS Integrated system
• Optional control point for
non-sterile personnel to
perform all input/viewing
functions available on
OPTIS Integrated System
Note: All systems having MSO must be updated to E.4.1 version by Service team.
Proprietary and confidential — do not distribute
OPTICAL COHERENCE TOMOGRAPHY - SYSTEM OVERVIEW
Proprietary and confidential — do not distribute
DOC (Drive Motor & Optical Controller)
CPU (Central Processing Unit)
ENGINE (Infrared Light Source)
Physician and Operator Monitors
Monitors
DOC ( DRIVE MOTOR AND OPTICAL CONTROLLER )
1 Emergency shutoff – stops rotation, pullback and
scanning
2 Enable scanning; second push will start
pullback in manual trigger mode
3 Toggle between Live and Standby
4 Unload catheter
1
2
3
4
DragonflyTM
Duo /
DragonflyTM
Optis
OCT Catheter
OCT
ILUMIEN / ILUMIEN OPTIS™ / OPTIS™ RANGE – BOTH OCT & FFR
PressureWireTM
AerisTM
PressureWireTM
X
ILUMIEN™ Console
Ilumien Optis Console
Wireless
FFR
COMPARISON TO ILUMIEN ENGINE
ILUMIEN ILUMIEN OPTIS/OPTISi & Mobile
Parameter Nominal
Settings
Long
Pullback High-resolution Pullback
Engine speed 100 frames/sec 180 frames/sec 180 frames/sec
Pullback speed 20 mm/sec 36 mm/sec 18 mm/sec
Frame density 5 frames/mm 5 frames/mm 10 frames/mm
Pullback length 54 mm 75 mm 54 mm
Pullback time 2.7 sec 2.1 sec 3.0 sec
Contrast (Max) 14 ml at 4 ml/sec 10 ml at 4 ml/sec 14 ml at 4 ml/sec
File size 271 frames
270 MB
375 frames
375 MB
540 frames
540 MB
Key Features of Abbott - OCT
More
Information
Same Time
Same Contrast
ILUMIEN OPTIS & MSO SOFTWARE
Reviewing an acquired Image
– Entering note
– Bookmark
– Calibration
Performing the Measurements
– Lumen Profile
– MLA /AS% / DS% Mean Diameter
– Dynamic stent planning
Automated Measurements
Stent Roadmap
Apposition Indicator
3D Bifurcation Mode
 Side-branch detection
 Carina view
Expanded 3D Navigation
 3D flythrough view
 Object segmentation
37
OPTIS™ Stent Optimization Software
broadens the clinical utility for OCT to
guide daily decision making for complex
PCI both pre and post stenting though:
CLINICAL APPLICATIONS OF OCT
38
• Measurement of reference segments
• MLA/MLD measurement and identification
• Tissue differentiation
• Lumen morphology
• Potential culprit lesion
Pre-PCI and
Lesion
Assessment
• Lesion coverage and deployment
mapping
• Underexpansion and apposition
• Lumen optimization
• Identification of sub-optimal stent
results
PCI Guidance
• Restenosis measurements
• Tissue coverage assessment
• Visualization of absorption and remodeling
of bioabsorbable stents
• Lesion progression
Stent Follow-up
Proprietary and confidential — do not distribute
OCT CATHETER
OCT Dragonfly Range Of Catheters
40
Usable length: 135 cm
Outer diameter: 2.7 F (distal)
Wire lumen: 0.014”
Hydrophilic Coating
DRAGONFLY™ DUO IMAGING CATHETER
SPECIFICATIONS
Lens
INTRODUCING LATEST OCT CATHETER
DragonflyTM
OPTISTM
Simplifies the OCT procedure
TIP MARKER
DUAL LUMEN for GUIDEWIRE EXIT
Easier loading ; reduce potential for lens damage
and kinking
Lens Marker
Facilitates Angio Co-Registration
©2018 Abbott. All Rights Reserved. IN CP0007-EN 02/18
Dragonfly
Duo
Dragonfl
y
OPTIS
Dragonfly™ OPTIS™ changes vs. Dragonfly™ Duo Catheters
1. Dual lumen
2. Smoother transition zone
3. Shorter rail
4. Dedicated purge exit
TIP DESIGN DRAGONFLY™ OPTIS CATHETER
DUO VS OPTIS
Lens
DUO
OPTIS
Catheter design changes:
• Rapid exchange tip
– Improves catheter performance
– Reduces risk of damage and kinking
• Support for continuous calibration*
– Reduces steps necessary during calibration
• Shaft guide marker at 90 cm
– Aids in understanding distal tip position during
radial procedures
• Gray hub
– Differentiates Dragonfly OPTIS catheter from
previous Dragonfly catheters
DRAGONFLY™ OPTIS™ IMAGING CATHETER
*Refer to D.2 or E.2 Software
Note: The Dragonfly OPTIS imaging catheter is designed for use with the ILUMIEN OPTIS PCI Optimization and OPTIS
integrated systems equipment. It should not be used with older model OCT systems.
ILUMIEN™, ILUMIEN™ OPTIS™ PCI
Optimization and OPTIS™ integrated
systems software
Dragonfly™ OPTIS™ imaging
catheter
Proprietary and confidential — do not distribute
OCT PROCEDURE
Performing an OCT Procedure
OCT PROCEDURE
CONFIDENTIAL – FOR INTERNAL USE ONLY
 Preparation Console / Catheter / Contrast
 Position Catheter
 Purge
 Puff
 Pullback
 Troubleshooting
The 4 P’s
PERFORMING AN OCT EXAM - REQUIREMENTS
Required Material and Equipment
• ILUMIEN™ or Optis System
• Dragonfly™ or Dragonfly Duo Imaging Catheter
• Sterile DOC Cover
• 3 ml purge syringe
• Contrast media indicated for coronary use, for purging and flush (allow 15 mL
for each run planned)
• 0.014 inch guidewire (with torque device if desired)
• Guide catheter (6 French, 0.068 inch ID or larger, with no side holes)
• Sheath introducer (to match guide catheter)
• Hemostatic Y-Adapter/Connector
• Heparinized, physiologic saline solution, for hydrophilic catheter preparation
• Power injector pump for coronary angiography
(capable of injecting 4.0 ml/sec for a total of 14 ml in 3.5 second)
CONFIDENTIAL – FOR INTERNAL USE ONLY
Large Lumens increase device compatibility and allow more dye flow for better
visualization
FFR is strongly recommended in 6F
OCT dragonfly is compatible with 6F large Lumen ID > 0.068”
GUIDE CATHETER INNER LUMEN
Mach 1
Boston
Runway
BSC
Vista
Brite
Cordis
Sherpa
Active /
Balanced
MDT
Launcher
MDT
Heartrail
Climber
Terumo
5F .058” .058” .058” .059”
6F .070” .070" .067” .070” .070” .071” .071”
7F .081” .078” .081” .081” .081”
8F .091” .088” .090” .090”
Allows for antegrade flow through the holes
and out through the distal tip.
Drawbacks:
• Decrease arterial visualization.
• Increase use of contrast
Media
• Systemic drug delivery
NB: GUIDE CATHETER WITH SIDE
HOLES SHOULD
NOT BE USED WITH FFR and OCT
SIDE HOLES IN GUIDES
OCT PROCEDURE – REQUIRED MATERIALS
51
DOC – Bedside
control to initiate
pullback, able to run
at fast speed
Dragonfly Duo Imaging Catheter
DOC Cover
Ilumien / Optis Console
Non Sterile Devices Sterile Devices
3ml Syringe
PREPARATION: STARTING UP THE OCT SYSTEM
CONFIDENTIAL – FOR INTERNAL USE ONLY
PREPARATION: ADD A NEW PATIENT
CONFIDENTIAL – FOR INTERNAL USE ONLY
PREPARATION: PATIENT DATA
CONFIDENTIAL – FOR INTERNAL USE ONLY
PREPARATION: STEP BY STEP ON THE SCREEN
CONFIDENTIAL – FOR INTERNAL USE ONLY
PREPARATION DOC COVER
Give the DOC Cover to the physician
Pass the DOC through the DOC cover
Pull the DOC cover
“Telescoping style” fold DOC Cover
Tab labeled “Insert DOC Here”
DOC cover length increased from 60 inches to 96 inches
Sterile blue cover wrapped around DOC cover
Plastic ring around the DOC cover opening
CONFIDENTIAL – FOR INTERNAL USE ONLY
PREPARATION: CATHETER PREPARATION
1. Remove catheter from hoop
2. Wipe shaft to activate hydrophilic
coating
3. Gently purge catheter with 3ml
syringe filled with 100% contrast
PRIOR to connection
4. Inject until 3 drops exit tip
5. Leave syringe attached for repeat
purging in vivo
CONFIDENTIAL – FOR INTERNAL USE ONLY
Don’t touch inner fiber
optics!
Preparation: Connect the catheter to the DOC
CONFIDENTIAL – FOR INTERNAL USE ONLY
PREPARATION: TEST IMAGE
To Test the Image hold the catheter
CONFIDENTIAL – FOR INTERNAL USE ONLY
PREPARATION SUMMARY
1. Add a new patient Data
2. Pass the doc through the DOC cover
3. Activate catheter hydrophilic coating of Catheter
4. Gently purge catheter with 3ml syringe filled with 100% contrast
5. Connect the catheter to the DOC
6. Test The image
7. Auto-calibrate
8. Prepare and Connects Automatic injector pump to the manifold
CONFIDENTIAL – FOR INTERNAL USE ONLY
PROCEDURE-READY
Automatic injector pump
connects to manifold
3 cc contrast syringe
remains connected
DOC
6-7 F guide catheter
(no side holes)
0.014" standard guidewire
Dragonfly catheter
loaded with guidewire
Y should not be tighten too much
CONFIDENTIAL – FOR INTERNAL USE ONLY
BACKLOADING THE DRAGONFLY DUO ONTO THE
GUIDEWIRE
Entry portal is blue. Exit portal for guidewire is distal to proximal
marker.
Tortuous Anantomy or Long stent : Disconnect the DOC and the
catheter / Or use 2 guide wires
Proximal
marker
Lens located at end of
torque wire
CONFIDENTIAL – FOR INTERNAL USE ONLY
When manipulating the catheter the system must be in Standby
mode
INSERTION AND POSITIONING DRAGONFLY OPTIS
CONFIDENTIAL – FOR INTERNAL USE ONLY
Lens
Guidewire is prevented from
going down image core and wall
improves kink resistance
Pinhole to reduce
blood ingress
Simplifies the OCT procedure
POSITIONING DRAGONFLY DUO/ OPTIS
• Distance from the Distal marker to
Lens Marker = 26mm
• Distance from Lens Marker to the
proximal Marker= 50mm
Frame the specific region of
interest in the High-resolution
Mode
• Distance from lens to Lens marker
is = 2 mm
Proximal and Lens markers are on the
torque wire and then the markers
move during the pullback
Markers 26 mm
apart
Pullback length: 54mm Or 75mm
Lens
2 mm Distal Marker
Lens
Marker
Proximal
Marker
Markers 50
mm
apart
POI 54MM
POI 75MM
Insertion and positioning of the Dragonfly catheter should be done in
the “Stand by” Mode
CONFIDENTIAL – FOR INTERNAL USE ONLY
PULLBACK PREP: PURGING
Blood Purged
If blood creeps into catheter lumen, purge with attached
contrast syringe.
CONFIDENTIAL – FOR INTERNAL USE ONLY
To purge the catheter the system must be in Standby mode
PULLBACK PREP: PUFF
Marginal, Blood Swirls Optimal
Clearance
During live scan, use a puff of contrast to evaluate clarity.
CONFIDENTIAL – FOR INTERNAL USE ONLY
Blood Clearance
CONFIDENTIAL – FOR INTERNAL USE ONLY
RBC mixed into flush
fluid
Flush contrast diluted
with saline, less
viscous, does not flush
all RBC
Data on file at LLI
Blood Speckle
• Turbulent flow between
flush and blood
• Flush not filling lumen,
perhaps going into other
arteries
OR
• End of flush bolus
Blood swirls
CONFIDENTIAL – FOR INTERNAL USE ONLY
PULLBACK: AUTOMATIC TRIGGER
When the Trigger Type is set to Automatic
• Press Live View,
• Press the “Enable Pullback” button to allow the system to detect initiation of
the imaging flush.
• Inject Flush Now.” The imaging pullback will start automatically when clear
image frames are detected.
Note that the Enabled state lasts for 15 seconds.
CONFIDENTIAL – FOR INTERNAL USE ONLY
PULLBACK: MANUAL TRIGGER
When the Trigger Type is set to Manual
• Press Live View,
=> The Enable Pullback button changes to Start
Pullback
• Inject Flush Media
• Press start Pullback or F5 or Button on the
DOC when blood is cleared from the vessel
lumen
Note that the Enabled state lasts for 15 seconds.
When the Trigger Type is set to Pressure,
the DOC motor does not speed up until a signal is
received from the pressure transducer.
CONFIDENTIAL – FOR INTERNAL USE ONLY
FOR A NEW & PROPER ACQUISITION
FOLLOW THE 5 P’S
PREPARATION of the system & catheter
POSITION the catheter relative to target lesion/stent
PURGE blood from catheter lumen, if present
PUFF of contrast to evaluate clearance
PULLBACK! Image acquisition
CONFIDENTIAL – FOR INTERNAL USE ONLY
Proprietary and confidential — do not distribute
OCT IMAGE
INTERPRETATION
Proprietary and confidential — do not distribute
TIPS FOR IMAGE INTERPRETATION
BACTE-RIA
B- Backscatter
A- Attenuation
C- Composition
T- Texture
E- Edge
RIA
July 14, 2024
Enter presentation title via "insert>header and footer>footer" | 74
OCT IMAGE INTERPRETATION TERMINOLOGY
Backscatter
• The reflection of light waves off the tissue and back to the Dragonfly catheter
– High backscatter means a brighter pixel
• Also described as a “signal rich” region
– Low backscatter means a darker pixel
• Also described as a “signal poor” region
Attenuation
• The reduction in intensity of the light waves as they pass through tissue due to
absorption or scattering
– High attenuation means the light cannot penetrate very deep
– Low attenuation means the light can pass through to allow visualization of
deeper tissue
OCT IMAGE INTERPRETATION TERMINOLOGY
Composition
• Homogeneous
– Uniform in structure ( Uniform or similar pixels)
• Heterogeneous
– Structure consists of dissimilar elements ( Non-uniform or dissimilar pixels)
Texture
• Coarse
• Fine
76
OCT IMAGE INTERPRETATION TERMINOLOGY
Edge/Border
• The creation of a border is due to the interface between different
tissue types
• One of the parameters used to differentiate plaque types
Calcium Lipid
IMAGE ORIENTATION
Normal coronary artery
Uniform silhouette
3 layers visible in vessel wall
Data on file at LLI
Imaging
catheter
Guidewir
e shadow
Adventitia
Media
Intima
78
FIBROUS PLAQUE
79
 Homogeneous
 High backscatter
 signal rich
 brighter pixel
 Finely textured
 Low attenuation
 deeper tissue can be
visualized
Proprietary and confidential — do not distribute
Fibrous Rich Plaque, Homogeneous
EEM
80 Not to be distributed or reproduced
CALCIFIED PLAQUE
Sharp edges
Heterogeneous
Low backscatter
– signal poor
Low attenuation
– deeper tissue can be visualized
81 Data on file at LLI
Proprietary and confidential — do not distribute
Calcium
Fibrous
82 Not to be distributed or reproduced
Calcium and Fibrous Plaque
LIPID PLAQUE
High attenuation
• low tissue penetration
Diffuse shadowy edges
High backscatter on surface
Low backscatter deeper
83
Data on file at LLI
Proprietary and confidential — do not distribute
SYSTEMATIC APPROACH FOR OCT IMAGE
INTERPRETATION
/ MAJOR PLAQUE CHARACTERISTICS
(Signal Rich /poor) (Backscatter high or low )
Bright / Dark
Edge
Sharp v s diffuse
Attenuation (Absorption)
low vs high
Homogeneous / Heterogeneous
Yes or no
Proprietary and confidential — do not distribute
SYSTEMATIC APPROACH FOR OCT IMAGE
INTERPRETATION
Lesion
Signal /Backscatter Brighter Signal Backscatter Darker
Attenuation (Absorption)
High (signal poor)
Low
Sharp edge
Calcium
Diffuse edge
Heterogeneous Homogeneous
Lipid
Attenuation (Absorption)
Low
Homogeneous
Fibrous
Gonzalo N. 2010 ”Optical Coherence Tomographty for the Assessment of Coronary Atherosclerosis
and Vessel Response after Stent implantation”. (Thesis)
PLAQUE TYPES - RECOGNITION
Fibrous Bright pixels Finely textured Deep penetration Homogeneous
Lipid Dark pixels Diffuse edge Low penetration Homogeneous
Calcium Dark pixels Sharp edge Deep penetration Heterogeneous
Fibrous Lipid Calcium
86
Gonzalo N. 2010 ”Optical Coherence Tomographty for the Assessment of Coronary
Atherosclerosis and Vessel Response after Stent implantation”. (Thesis)
Proprietary and confidential — do not distribute
PCI FOLLOW UP
Bioabsorbable vascular
scaffold
Strut appearance
is translucent
Metal stents
Struts are opaque
Bright reflection on
the surface of the
stent strut
Struts cast a shadow into the
vessel wall
Data on file at LLI
Images: European Heart Journal (2011):32;294–304
Proprietary and confidential — do not distribute
PCI FOLLOW UP
Proprietary and confidential — do not distribute
PCI FOLLOW UP
Proprietary and confidential — do not distribute
PCI FOLLOW UP VESSEL WALL DAMAGE
Tissue prolapse
Convex shaped protrusion of tissue
between adjacent stent struts
towards the lumen without
disruption of the continuity of
the luminal vessel surface
Data on file at LLI
Image: Image: Gonzalo N. Optical Coherence Tomography for the
Assessment of Coronary Atherosclerosis and Vessel Response
After Stent Implantation (Thesis) 2010
Proprietary and confidential — do not distribute
STENT STRUT APPOSITION
Strut malapposition
Undersized Stent
Proprietary and confidential — do not distribute
PCI FOLLOW UP STENT STRUT
COVERAGE
2 months 7 months
Data on file at LLI
Images: Dr. Suzuki, Toyohashi Heart Center
Data on file at LLI
Proprietary and confidential — do not distribute
PCI FOLLOW UP NEOINTIMAL
HYPERPLASIA
In-stent restenosis
Thick layer between stent
struts and lumen
Data on file at LLI
Stent struts
Proprietary and confidential — do not distribute
In-Stent Restenosis
94 Not to be distributed or reproduced
Proprietary and confidential — do not distribute
PCI FOLLOW UP THROMBOSIS
Data on file at LLI
Thrombus
Stent struts
Data on file at LLI
Proprietary and confidential — do not distribute
PCI FOLLOW UP THROMBUS – RED
(ACUTE)
Thrombus – red
Absorbs near-infrared light
High backscatter on surface
due to signal attenuation
Appears as a bright mass
Shadow (cannot see behind it)
Data on file at LLI
Red thrombus
Data on file at LLI
Proprietary and confidential — do not distribute
White thrombus
PCI FOLLOW UP THROMBUS – WHITE
(CHRONIC)
Thrombus – white
High backscatter
Low attenuation
Can see behind it
Data on file at LLI
Proprietary and confidential — do not distribute
PCI FOLLOW UP VESSEL WALL DAMAGE
Edge dissection
A disruption of the vessel
luminal surface in the edge
region
Easy to interpret using
cross-sectional and
longitudinal views
Data on file at LLI
Image: Columbia Presbyterian Hospital
Proprietary and confidential — do not distribute
PCI FOLLOW UP VESSEL WALL DAMAGE
Intimal tear
 Clear visualization of even small
irregularities
Data on file at LLI
Proprietary and confidential — do not distribute
WHAT’s NEW in OCT
Automated Measurements
Stent Roadmap
Apposition Indicator
3D Bifurcation Mode
 Side-branch detection
 Carina view
Expanded 3D Navigation
 3D flythrough view
 Object segmentation
OPTIS™ Stent Optimization Software broadens the clinical utility for OCT
to guide daily decision making for complex PCI both pre and post stenting
though:
WHAT’S NEW?
NEW DEFAULT WITH LUMEN PROFILE
 Automated
measurements
 Close out X
added for both
Lumen Profile
and L-mode
 TSC also easy
to toggle
 Menu/Settings
to change this
default
STENT ROADMAP WITH OPTIONAL BOOKMARKS
 Displays lumen profile
markers: distal, proximal
landing and MLA on the
co-registration angiogram
image
 Optional bookmarks
 Icon to toggle this view on
and off
 2.8 mm tolerance ( ±1.4mm
on each end)
Note: OCT Frame Indicator
changes
 Thinner for less angio-
obstruction
 Length reduced from 3mm
to 2mm (±1.0mm on each
end)
STENT DISPLAY FOR APPOSITION INDICATOR
 Displays sent apposition information in four locations
 Apposition indicator bar
 L-mode
 Stent roadmap
 Cross-sectional view (dots)
APPOSITION THRESHOLDS: OPTIONAL ADJUSTMENT
 Measurement is taken from
the leading edge of the stent
or what is closest to the
lenses of the OCT catheter
 Software identifies struts that
are >25% malapposed across
a 1mm length
 Default Settings:
 >300 microns red
 >200 microns yellow
 <200 microns silver
 Could also take the red down
to 200 if user would rather see
only two colors
 Note: this functionality is not
available for BVS
3D BIFURCATION MODE
 Side branches are displayed as pink dots on the lumen
profile and dotted lines trailing into the L-mode
 3D Bifurcation mode will open with the view that matches
the closes side branch view of where the OCT frame
marker is currently positioned
 Bifurcation mode is hidden if no side branches are
detected that are approximately 1.5mm diameter or
greater
 The software default zoom level for bifurcation mode is
optimized for the OCT system not the demo laptop. You
may want to zoom out when you first open the bifurcation
mode.
 If you don't have a TSC, you can hold down the
right mouse button and use the zoom bar at the
far left of the 3D screen to adjust the zoom
3D NAVIGATION WITH NEW 3D OPTIONS MENU
3D OBJECT DISPLAY VIEW OPTIONS:
Lumen Mode
Tissue + Lumen
Mode
Stent Only Mode
 Additional Options:
 Individually turn
up to two
guidewire (s)
on/off
 Turn side-branch
(es) on or off
 Note:
 Guidewire
rendering may
vary due to
shadow, artifact
or out of the cut-
plane
Flythrough
*any of the above modes can
be viewed in the flythrough
view
AptiVue™ Software for OPTIS™ (version E.5.1)
Features:
Automated Stent Expansion Calculations
 Under expansion Indicator for BMS/DES
 2 Methods – Dual and Tapered
Resting Index, Resting Full Cycle Ratio (RFR)1
– Identifies ischemia-causing lesions like FFR
without hyperemia
– Allows pullbacks to assess serial lesions and
diffuse disease
Personally Identifiable Information (PII)
Security
 Full Encryption of patient data
 User authentication (login)
Current Algorithm Improvements
 2nd Guide wire detection
 Stent rendering in 3D
1. Svanerud et al. VALI.DATE RFR. EuroIntervention 2018.
Proprietary and confidential — do not distribute
SUMMARY: OCT FOR PCI OPTIMIZATION
Pre- and post-stent assessment
Stent size selection and landing
zone planning
Position, expansion, apposition
Intimal tear, dissection, false lumen
Tissue prolapse
Calcification
PCI follow-up
Strut coverage
Neo-intimal growth
Restenosis/thrombosis
Data on file at LLI
OPTIMIZE YOUR PCI WITH OCT
OCT has clear advantages for stent optimization – PCI OPTIMIZATION
It’s all about the lumen
Fast, easy to use, easy to read
10 times Superior Image Resolution than IVUS
112
OCT IN CATH LAB
Pre - PCI OCT Pull Back
• Check Clearance and then only do Pull Back – PUFF
• Calibration
• If ACR –CO Register
• Morphology – Calcified, Lipid & Fibrotic lesions zones, healthy 3
layered zones (180D)
• Landing Zone – Distal & Proximal Luminal & EEL Dimensions
(Mean Diameter), Length of the lesion
• Dissection
• Thrombus presence
113
OCT IN CATH LAB
Post - PCI OCT Pull Back
• Calibration
• Lumen Profile, Rendered Stent, If ACR – Co Register
• Lumen Profile - Place the Distal & Proximal Markers in the edge of
the stent
• Check for Edge dissections
• Check for MLA – Ilumien 3 Crieteria
• Apposition
114

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New OCT Slides for revascularisation and decision making

  • 1. Proprietary and confidential — do not distribute OCT Optical Coherence Tomography Advanced Imaging to guide complex interventions
  • 2. • Basics of OCT • OCT System overview • OCT Catheter • OCT Procedure • OCT Image Interpretation • Clinical Trials • Case Based Discussion on Demo OCT Laptop WHAT IS IN STORE FOR THE DAY…
  • 3. Proprietary and confidential — do not distribute OCT BASICS
  • 4. TIME FOR HIGH RESOLUTION IMAGING
  • 5. WHAT IS OCT? Optical Coherence Tomography (OCT) is an optical imaging modality that uses near-infrared light to create high-resolution images of tissue microstructure. Optical  of or relating to light (visual) Coherence  a measure of the correlation between phases of a wave or waves Tomography  method of producing images from a series of single planes or slices (Greek “TOMOS=Slice”) 5
  • 6. WHAT IS INTRAVASCULAR OCT? OCT is an optical imaging modality that uses near-infrared light (1250-1350nm) for high-resolution imaging of vessel anatomy, tissue microstructure and stents. Key Features: Uses light, not sound Does not use X-ray Image acquisition is fast Images acquired are sharp, detailed and easy to interpret 6
  • 7. INTRAVASCULAR OCT Flexible fiber-optic catheter used for light delivery Fiber rotates to create image frames Fiber pulls back to map vessel segment • The more frames per mm, or high frame density, the higher the resolution 7
  • 8. MICHELSON INTERFEROMETER 1881 Albert Michelson (1852-1931) Nobel Prize Physics 1907
  • 9. Time Domain OCT (TD-OCT): (older generation) Non-Commercially available for cardiovascular use 2001 to the present Moderate image quality slower imaging speeds (full pullback 30s) and made it necessary to totally block the blood flow in the vessel using an occlusion balloon Frequency Domain OCT (FD-OCT): Commercially available for cardiovascular use 2010 to the present Exceptional image quality Fast imaging (full pullback 3s) : 10 to 100x increase in speed Rapid contrast flush instead of balloon occlusion TIME VS. FREQUENCY DOMAIN INTRAVASCULAR OCT C7-XR system: FD-OCT 100 fps, 20 mm/s pullback M3 system: TD-OCT 20 fps, 1 mm/s pullback Gonzalo, N. Optical Coherence Tomography for the Assessment of Coronary Atherosclerosis and Vessel Response after Stent Implantation. Rotterdam, the Netherlands: Optima Grafische Communicatie; 2010. improved image quality
  • 10. Light is too fast for direct echo measurement  interferometry Compares path length between known reference arm and sample arm Mechanical reference arm motion limits imaging speed TIME DOMAIN OCT (M2/M2X/M3) intensity axial distance Demod Amp Broadband Source D Tissue Mirror Reflections (moving)
  • 11. Time Domain OCT: fixed laser signal, moving mirror
  • 12. Measurement of interference pattern spectrum + Fourier transform Signal generated from all depths simultaneously Faster image acquisition without loss of quality greater penetration depth FREQUENCY DOMAIN OCT (C7-XRTM AND ILUMIENTM) Swept Laser D λ intensity intensity distance FFT Amp
  • 13. Frequency Domain OCT: sweeping laser signal, fixed mirror
  • 15. OCT CATHETER MOVEMENT – REAL TIME
  • 16. PULLBACK GENERATION One pullback  270 – 540 frames 16
  • 18. INTRAVASCULAR OCT Rotate a sensor & Pullback distal proximal Catheter with fiber-optic core used for light delivery • Fiber rotates to create image frames • Fiber-optic core pulls back to map vessel segment • During the pullback, blood clearing is required to get a good image quality. Sensor Lens Optic fiber OCT catheter Better image quality by: (1) Faster rotation (2) Slower pullback
  • 19. PRINCIPLE OF CATHETER BASED INTRAVASCULAR IMAGING 1st line A-Line distal proximal Sensor
  • 20. A-LINE ACQUISITION 2nd line 3rd 4th 5th 1st 2nd 3rd 1 2 3 4 5 6 7 ………………………………………………………………………………………………..…n depth
  • 21. R-THETA CONVERSION (FRAME) 1 2 3 4 5 6 7 ……………………………………………………………………………………………..…n 1,2,3 4,5,6 One frame  560 axial lines Computer make lines to circle
  • 22. A pulse of light is sent out that bounces off the different layers of tissue and returns back to be analyzed by the system. The catheter can be seen in the middle of the image, with the optical fiber at its core. Measure echo time delay of reflected light waves Ilumien each frames = 504 A lines Optis and optis integrated each frame = 560 A limes IMAGE (FRAME)
  • 23. DIFFERENCE OF RESOLUTION. Direction of beam High resolution Low resolution Unable to distinguish. Distinguishable each component
  • 24. Axial direction Lateral direction 2 TYPES OF RESOLUTION(AXIAL/LATERAL) Axial: parallel to the beam = along the vessel Lateral: perpendicular to both the beam and the catheter = cross-section of vessel ※JACC vol.37, No.5, 2001 1478-92(IVUS consensus report) The ability of an imaging system to resolve detail in the object that is being imaged
  • 25. IVUS/OCT: smaller beam size & larger number of A-Lines TO GET BETTER RESOLUTION (LATERAL RESOLUTION) Lateral resolution is around With OCT 20 to 40 µm
  • 28. Proprietary and confidential — do not distribute OCT SYSTEM OVERVIEW
  • 29. OCT EVOLUTION 29 1999-2001 PTCA balloon + ImageWire TM R&D prototypes Not commercially available Inside PTCA balloon ‘Snapshot’ flush imaging 2007 M3 System CE mark 20 fps / 240 lines Occlusion + flush 2004 Soft occlusion balloon + ImageWireTM M2 System CE mark 15 fps / 200 lines Occlusion + flush 2009 C7XR™ System CE mark, FDA cleared 100 fps / 500 lines NO occlusion Occlusion-free DragonflyTM
  • 30. 30 2011-12 2013-15 2016 ILUMIEN™ System ILUMIEN™ OPTIS™ System OPTIS™ Integrated System OPTIS™ Mobile System • Commercially available 2011 • 100 fps / 54 mm pullback • Combined FFR and OCT • Wireless FFR • 180 fps/75 and 54 mm pullback • Advanced software tools • Real time 3D reconstruction • Pullback initialization from DOC • Integrated in the Cath lab • Angio Co- Registration With tableside FFR/ OCT controller • Integrates with Multiple Cath labs • Angio Co- Registration With tableside FFR/ OCT controller FFR and OCT System 2nd Gen FFR and OCT System Cath lab integrated FFR and OCT system Latest system with 3D OCT, FFR, ACR & MSO 2015 Current Generation PCI Optimization Systems
  • 31. 31 2016/17 OCT PRODUCT LAUNCHES OPTIS™ Mobile System OPTIS™ Mobile Upgrade Kit (Ilumien™ OPTIS™ Systems only) OPTIS™ Metallic Stent Optimization Software- MSO (Software Version E.4) OPTIS™ Mobile Workstation (Accessory for OPTIS™ Integrated System) Mobile System integrated into Cath lab during procedure to offer angio co-registration • Angio Co-registration • Wireless Tableside Controller • Mobile cart connect into Cath Lab during procedure • Enables the use in multiple labs • Will include E.4 after LMR Enables angio co-registration function on Ilumien™ OPTIS System • Angio Co-registration (ACR) • Wireless Tableside Controller • Mobile cart connect into Cath Lab during procedure • Enables the use of OCT-ACR and FFR in multiple labs • Leverage options to include E.4 New clinically relevant software enhancements for pre and post PCI • Stent roadmap on angio co- registration • New default view with automated measurements from lumen profile • Acute Stent detection and apposition assessment • Expanded 3D imaging Standard available for bug fixes only Offered as another point of control to operate the OPTIS Integrated system • Optional control point for non-sterile personnel to perform all input/viewing functions available on OPTIS Integrated System Note: All systems having MSO must be updated to E.4.1 version by Service team.
  • 32. Proprietary and confidential — do not distribute OPTICAL COHERENCE TOMOGRAPHY - SYSTEM OVERVIEW
  • 33. Proprietary and confidential — do not distribute DOC (Drive Motor & Optical Controller) CPU (Central Processing Unit) ENGINE (Infrared Light Source) Physician and Operator Monitors Monitors
  • 34. DOC ( DRIVE MOTOR AND OPTICAL CONTROLLER ) 1 Emergency shutoff – stops rotation, pullback and scanning 2 Enable scanning; second push will start pullback in manual trigger mode 3 Toggle between Live and Standby 4 Unload catheter 1 2 3 4
  • 35. DragonflyTM Duo / DragonflyTM Optis OCT Catheter OCT ILUMIEN / ILUMIEN OPTIS™ / OPTIS™ RANGE – BOTH OCT & FFR PressureWireTM AerisTM PressureWireTM X ILUMIEN™ Console Ilumien Optis Console Wireless FFR
  • 36. COMPARISON TO ILUMIEN ENGINE ILUMIEN ILUMIEN OPTIS/OPTISi & Mobile Parameter Nominal Settings Long Pullback High-resolution Pullback Engine speed 100 frames/sec 180 frames/sec 180 frames/sec Pullback speed 20 mm/sec 36 mm/sec 18 mm/sec Frame density 5 frames/mm 5 frames/mm 10 frames/mm Pullback length 54 mm 75 mm 54 mm Pullback time 2.7 sec 2.1 sec 3.0 sec Contrast (Max) 14 ml at 4 ml/sec 10 ml at 4 ml/sec 14 ml at 4 ml/sec File size 271 frames 270 MB 375 frames 375 MB 540 frames 540 MB Key Features of Abbott - OCT More Information Same Time Same Contrast
  • 37. ILUMIEN OPTIS & MSO SOFTWARE Reviewing an acquired Image – Entering note – Bookmark – Calibration Performing the Measurements – Lumen Profile – MLA /AS% / DS% Mean Diameter – Dynamic stent planning Automated Measurements Stent Roadmap Apposition Indicator 3D Bifurcation Mode  Side-branch detection  Carina view Expanded 3D Navigation  3D flythrough view  Object segmentation 37 OPTIS™ Stent Optimization Software broadens the clinical utility for OCT to guide daily decision making for complex PCI both pre and post stenting though:
  • 38. CLINICAL APPLICATIONS OF OCT 38 • Measurement of reference segments • MLA/MLD measurement and identification • Tissue differentiation • Lumen morphology • Potential culprit lesion Pre-PCI and Lesion Assessment • Lesion coverage and deployment mapping • Underexpansion and apposition • Lumen optimization • Identification of sub-optimal stent results PCI Guidance • Restenosis measurements • Tissue coverage assessment • Visualization of absorption and remodeling of bioabsorbable stents • Lesion progression Stent Follow-up
  • 39. Proprietary and confidential — do not distribute OCT CATHETER OCT Dragonfly Range Of Catheters
  • 40. 40
  • 41. Usable length: 135 cm Outer diameter: 2.7 F (distal) Wire lumen: 0.014” Hydrophilic Coating DRAGONFLY™ DUO IMAGING CATHETER SPECIFICATIONS Lens
  • 42. INTRODUCING LATEST OCT CATHETER DragonflyTM OPTISTM Simplifies the OCT procedure TIP MARKER DUAL LUMEN for GUIDEWIRE EXIT Easier loading ; reduce potential for lens damage and kinking Lens Marker Facilitates Angio Co-Registration ©2018 Abbott. All Rights Reserved. IN CP0007-EN 02/18
  • 43. Dragonfly Duo Dragonfl y OPTIS Dragonfly™ OPTIS™ changes vs. Dragonfly™ Duo Catheters 1. Dual lumen 2. Smoother transition zone 3. Shorter rail 4. Dedicated purge exit TIP DESIGN DRAGONFLY™ OPTIS CATHETER
  • 45. Catheter design changes: • Rapid exchange tip – Improves catheter performance – Reduces risk of damage and kinking • Support for continuous calibration* – Reduces steps necessary during calibration • Shaft guide marker at 90 cm – Aids in understanding distal tip position during radial procedures • Gray hub – Differentiates Dragonfly OPTIS catheter from previous Dragonfly catheters DRAGONFLY™ OPTIS™ IMAGING CATHETER *Refer to D.2 or E.2 Software Note: The Dragonfly OPTIS imaging catheter is designed for use with the ILUMIEN OPTIS PCI Optimization and OPTIS integrated systems equipment. It should not be used with older model OCT systems. ILUMIEN™, ILUMIEN™ OPTIS™ PCI Optimization and OPTIS™ integrated systems software Dragonfly™ OPTIS™ imaging catheter
  • 46. Proprietary and confidential — do not distribute OCT PROCEDURE Performing an OCT Procedure
  • 47. OCT PROCEDURE CONFIDENTIAL – FOR INTERNAL USE ONLY  Preparation Console / Catheter / Contrast  Position Catheter  Purge  Puff  Pullback  Troubleshooting The 4 P’s
  • 48. PERFORMING AN OCT EXAM - REQUIREMENTS Required Material and Equipment • ILUMIEN™ or Optis System • Dragonfly™ or Dragonfly Duo Imaging Catheter • Sterile DOC Cover • 3 ml purge syringe • Contrast media indicated for coronary use, for purging and flush (allow 15 mL for each run planned) • 0.014 inch guidewire (with torque device if desired) • Guide catheter (6 French, 0.068 inch ID or larger, with no side holes) • Sheath introducer (to match guide catheter) • Hemostatic Y-Adapter/Connector • Heparinized, physiologic saline solution, for hydrophilic catheter preparation • Power injector pump for coronary angiography (capable of injecting 4.0 ml/sec for a total of 14 ml in 3.5 second) CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 49. Large Lumens increase device compatibility and allow more dye flow for better visualization FFR is strongly recommended in 6F OCT dragonfly is compatible with 6F large Lumen ID > 0.068” GUIDE CATHETER INNER LUMEN Mach 1 Boston Runway BSC Vista Brite Cordis Sherpa Active / Balanced MDT Launcher MDT Heartrail Climber Terumo 5F .058” .058” .058” .059” 6F .070” .070" .067” .070” .070” .071” .071” 7F .081” .078” .081” .081” .081” 8F .091” .088” .090” .090”
  • 50. Allows for antegrade flow through the holes and out through the distal tip. Drawbacks: • Decrease arterial visualization. • Increase use of contrast Media • Systemic drug delivery NB: GUIDE CATHETER WITH SIDE HOLES SHOULD NOT BE USED WITH FFR and OCT SIDE HOLES IN GUIDES
  • 51. OCT PROCEDURE – REQUIRED MATERIALS 51 DOC – Bedside control to initiate pullback, able to run at fast speed Dragonfly Duo Imaging Catheter DOC Cover Ilumien / Optis Console Non Sterile Devices Sterile Devices 3ml Syringe
  • 52. PREPARATION: STARTING UP THE OCT SYSTEM CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 53. PREPARATION: ADD A NEW PATIENT CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 54. PREPARATION: PATIENT DATA CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 55. PREPARATION: STEP BY STEP ON THE SCREEN CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 56. PREPARATION DOC COVER Give the DOC Cover to the physician Pass the DOC through the DOC cover Pull the DOC cover “Telescoping style” fold DOC Cover Tab labeled “Insert DOC Here” DOC cover length increased from 60 inches to 96 inches Sterile blue cover wrapped around DOC cover Plastic ring around the DOC cover opening CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 57. PREPARATION: CATHETER PREPARATION 1. Remove catheter from hoop 2. Wipe shaft to activate hydrophilic coating 3. Gently purge catheter with 3ml syringe filled with 100% contrast PRIOR to connection 4. Inject until 3 drops exit tip 5. Leave syringe attached for repeat purging in vivo CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 58. Don’t touch inner fiber optics! Preparation: Connect the catheter to the DOC CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 59. PREPARATION: TEST IMAGE To Test the Image hold the catheter CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 60. PREPARATION SUMMARY 1. Add a new patient Data 2. Pass the doc through the DOC cover 3. Activate catheter hydrophilic coating of Catheter 4. Gently purge catheter with 3ml syringe filled with 100% contrast 5. Connect the catheter to the DOC 6. Test The image 7. Auto-calibrate 8. Prepare and Connects Automatic injector pump to the manifold CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 61. PROCEDURE-READY Automatic injector pump connects to manifold 3 cc contrast syringe remains connected DOC 6-7 F guide catheter (no side holes) 0.014" standard guidewire Dragonfly catheter loaded with guidewire Y should not be tighten too much CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 62. BACKLOADING THE DRAGONFLY DUO ONTO THE GUIDEWIRE Entry portal is blue. Exit portal for guidewire is distal to proximal marker. Tortuous Anantomy or Long stent : Disconnect the DOC and the catheter / Or use 2 guide wires Proximal marker Lens located at end of torque wire CONFIDENTIAL – FOR INTERNAL USE ONLY When manipulating the catheter the system must be in Standby mode
  • 63. INSERTION AND POSITIONING DRAGONFLY OPTIS CONFIDENTIAL – FOR INTERNAL USE ONLY Lens Guidewire is prevented from going down image core and wall improves kink resistance Pinhole to reduce blood ingress Simplifies the OCT procedure
  • 64. POSITIONING DRAGONFLY DUO/ OPTIS • Distance from the Distal marker to Lens Marker = 26mm • Distance from Lens Marker to the proximal Marker= 50mm Frame the specific region of interest in the High-resolution Mode • Distance from lens to Lens marker is = 2 mm Proximal and Lens markers are on the torque wire and then the markers move during the pullback Markers 26 mm apart Pullback length: 54mm Or 75mm Lens 2 mm Distal Marker Lens Marker Proximal Marker Markers 50 mm apart POI 54MM POI 75MM Insertion and positioning of the Dragonfly catheter should be done in the “Stand by” Mode CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 65. PULLBACK PREP: PURGING Blood Purged If blood creeps into catheter lumen, purge with attached contrast syringe. CONFIDENTIAL – FOR INTERNAL USE ONLY To purge the catheter the system must be in Standby mode
  • 66. PULLBACK PREP: PUFF Marginal, Blood Swirls Optimal Clearance During live scan, use a puff of contrast to evaluate clarity. CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 67. Blood Clearance CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 68. RBC mixed into flush fluid Flush contrast diluted with saline, less viscous, does not flush all RBC Data on file at LLI Blood Speckle
  • 69. • Turbulent flow between flush and blood • Flush not filling lumen, perhaps going into other arteries OR • End of flush bolus Blood swirls CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 70. PULLBACK: AUTOMATIC TRIGGER When the Trigger Type is set to Automatic • Press Live View, • Press the “Enable Pullback” button to allow the system to detect initiation of the imaging flush. • Inject Flush Now.” The imaging pullback will start automatically when clear image frames are detected. Note that the Enabled state lasts for 15 seconds. CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 71. PULLBACK: MANUAL TRIGGER When the Trigger Type is set to Manual • Press Live View, => The Enable Pullback button changes to Start Pullback • Inject Flush Media • Press start Pullback or F5 or Button on the DOC when blood is cleared from the vessel lumen Note that the Enabled state lasts for 15 seconds. When the Trigger Type is set to Pressure, the DOC motor does not speed up until a signal is received from the pressure transducer. CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 72. FOR A NEW & PROPER ACQUISITION FOLLOW THE 5 P’S PREPARATION of the system & catheter POSITION the catheter relative to target lesion/stent PURGE blood from catheter lumen, if present PUFF of contrast to evaluate clearance PULLBACK! Image acquisition CONFIDENTIAL – FOR INTERNAL USE ONLY
  • 73. Proprietary and confidential — do not distribute OCT IMAGE INTERPRETATION
  • 74. Proprietary and confidential — do not distribute TIPS FOR IMAGE INTERPRETATION BACTE-RIA B- Backscatter A- Attenuation C- Composition T- Texture E- Edge RIA July 14, 2024 Enter presentation title via "insert>header and footer>footer" | 74
  • 75. OCT IMAGE INTERPRETATION TERMINOLOGY Backscatter • The reflection of light waves off the tissue and back to the Dragonfly catheter – High backscatter means a brighter pixel • Also described as a “signal rich” region – Low backscatter means a darker pixel • Also described as a “signal poor” region Attenuation • The reduction in intensity of the light waves as they pass through tissue due to absorption or scattering – High attenuation means the light cannot penetrate very deep – Low attenuation means the light can pass through to allow visualization of deeper tissue
  • 76. OCT IMAGE INTERPRETATION TERMINOLOGY Composition • Homogeneous – Uniform in structure ( Uniform or similar pixels) • Heterogeneous – Structure consists of dissimilar elements ( Non-uniform or dissimilar pixels) Texture • Coarse • Fine 76
  • 77. OCT IMAGE INTERPRETATION TERMINOLOGY Edge/Border • The creation of a border is due to the interface between different tissue types • One of the parameters used to differentiate plaque types Calcium Lipid
  • 78. IMAGE ORIENTATION Normal coronary artery Uniform silhouette 3 layers visible in vessel wall Data on file at LLI Imaging catheter Guidewir e shadow Adventitia Media Intima 78
  • 79. FIBROUS PLAQUE 79  Homogeneous  High backscatter  signal rich  brighter pixel  Finely textured  Low attenuation  deeper tissue can be visualized
  • 80. Proprietary and confidential — do not distribute Fibrous Rich Plaque, Homogeneous EEM 80 Not to be distributed or reproduced
  • 81. CALCIFIED PLAQUE Sharp edges Heterogeneous Low backscatter – signal poor Low attenuation – deeper tissue can be visualized 81 Data on file at LLI
  • 82. Proprietary and confidential — do not distribute Calcium Fibrous 82 Not to be distributed or reproduced Calcium and Fibrous Plaque
  • 83. LIPID PLAQUE High attenuation • low tissue penetration Diffuse shadowy edges High backscatter on surface Low backscatter deeper 83 Data on file at LLI
  • 84. Proprietary and confidential — do not distribute SYSTEMATIC APPROACH FOR OCT IMAGE INTERPRETATION / MAJOR PLAQUE CHARACTERISTICS (Signal Rich /poor) (Backscatter high or low ) Bright / Dark Edge Sharp v s diffuse Attenuation (Absorption) low vs high Homogeneous / Heterogeneous Yes or no
  • 85. Proprietary and confidential — do not distribute SYSTEMATIC APPROACH FOR OCT IMAGE INTERPRETATION Lesion Signal /Backscatter Brighter Signal Backscatter Darker Attenuation (Absorption) High (signal poor) Low Sharp edge Calcium Diffuse edge Heterogeneous Homogeneous Lipid Attenuation (Absorption) Low Homogeneous Fibrous Gonzalo N. 2010 ”Optical Coherence Tomographty for the Assessment of Coronary Atherosclerosis and Vessel Response after Stent implantation”. (Thesis)
  • 86. PLAQUE TYPES - RECOGNITION Fibrous Bright pixels Finely textured Deep penetration Homogeneous Lipid Dark pixels Diffuse edge Low penetration Homogeneous Calcium Dark pixels Sharp edge Deep penetration Heterogeneous Fibrous Lipid Calcium 86 Gonzalo N. 2010 ”Optical Coherence Tomographty for the Assessment of Coronary Atherosclerosis and Vessel Response after Stent implantation”. (Thesis)
  • 87. Proprietary and confidential — do not distribute PCI FOLLOW UP Bioabsorbable vascular scaffold Strut appearance is translucent Metal stents Struts are opaque Bright reflection on the surface of the stent strut Struts cast a shadow into the vessel wall Data on file at LLI Images: European Heart Journal (2011):32;294–304
  • 88. Proprietary and confidential — do not distribute PCI FOLLOW UP
  • 89. Proprietary and confidential — do not distribute PCI FOLLOW UP
  • 90. Proprietary and confidential — do not distribute PCI FOLLOW UP VESSEL WALL DAMAGE Tissue prolapse Convex shaped protrusion of tissue between adjacent stent struts towards the lumen without disruption of the continuity of the luminal vessel surface Data on file at LLI Image: Image: Gonzalo N. Optical Coherence Tomography for the Assessment of Coronary Atherosclerosis and Vessel Response After Stent Implantation (Thesis) 2010
  • 91. Proprietary and confidential — do not distribute STENT STRUT APPOSITION Strut malapposition Undersized Stent
  • 92. Proprietary and confidential — do not distribute PCI FOLLOW UP STENT STRUT COVERAGE 2 months 7 months Data on file at LLI Images: Dr. Suzuki, Toyohashi Heart Center Data on file at LLI
  • 93. Proprietary and confidential — do not distribute PCI FOLLOW UP NEOINTIMAL HYPERPLASIA In-stent restenosis Thick layer between stent struts and lumen Data on file at LLI Stent struts
  • 94. Proprietary and confidential — do not distribute In-Stent Restenosis 94 Not to be distributed or reproduced
  • 95. Proprietary and confidential — do not distribute PCI FOLLOW UP THROMBOSIS Data on file at LLI Thrombus Stent struts Data on file at LLI
  • 96. Proprietary and confidential — do not distribute PCI FOLLOW UP THROMBUS – RED (ACUTE) Thrombus – red Absorbs near-infrared light High backscatter on surface due to signal attenuation Appears as a bright mass Shadow (cannot see behind it) Data on file at LLI Red thrombus Data on file at LLI
  • 97. Proprietary and confidential — do not distribute White thrombus PCI FOLLOW UP THROMBUS – WHITE (CHRONIC) Thrombus – white High backscatter Low attenuation Can see behind it Data on file at LLI
  • 98. Proprietary and confidential — do not distribute PCI FOLLOW UP VESSEL WALL DAMAGE Edge dissection A disruption of the vessel luminal surface in the edge region Easy to interpret using cross-sectional and longitudinal views Data on file at LLI Image: Columbia Presbyterian Hospital
  • 99. Proprietary and confidential — do not distribute PCI FOLLOW UP VESSEL WALL DAMAGE Intimal tear  Clear visualization of even small irregularities Data on file at LLI
  • 100. Proprietary and confidential — do not distribute WHAT’s NEW in OCT
  • 101. Automated Measurements Stent Roadmap Apposition Indicator 3D Bifurcation Mode  Side-branch detection  Carina view Expanded 3D Navigation  3D flythrough view  Object segmentation OPTIS™ Stent Optimization Software broadens the clinical utility for OCT to guide daily decision making for complex PCI both pre and post stenting though: WHAT’S NEW?
  • 102. NEW DEFAULT WITH LUMEN PROFILE  Automated measurements  Close out X added for both Lumen Profile and L-mode  TSC also easy to toggle  Menu/Settings to change this default
  • 103. STENT ROADMAP WITH OPTIONAL BOOKMARKS  Displays lumen profile markers: distal, proximal landing and MLA on the co-registration angiogram image  Optional bookmarks  Icon to toggle this view on and off  2.8 mm tolerance ( ±1.4mm on each end) Note: OCT Frame Indicator changes  Thinner for less angio- obstruction  Length reduced from 3mm to 2mm (±1.0mm on each end)
  • 104. STENT DISPLAY FOR APPOSITION INDICATOR  Displays sent apposition information in four locations  Apposition indicator bar  L-mode  Stent roadmap  Cross-sectional view (dots)
  • 105. APPOSITION THRESHOLDS: OPTIONAL ADJUSTMENT  Measurement is taken from the leading edge of the stent or what is closest to the lenses of the OCT catheter  Software identifies struts that are >25% malapposed across a 1mm length  Default Settings:  >300 microns red  >200 microns yellow  <200 microns silver  Could also take the red down to 200 if user would rather see only two colors  Note: this functionality is not available for BVS
  • 106. 3D BIFURCATION MODE  Side branches are displayed as pink dots on the lumen profile and dotted lines trailing into the L-mode  3D Bifurcation mode will open with the view that matches the closes side branch view of where the OCT frame marker is currently positioned  Bifurcation mode is hidden if no side branches are detected that are approximately 1.5mm diameter or greater  The software default zoom level for bifurcation mode is optimized for the OCT system not the demo laptop. You may want to zoom out when you first open the bifurcation mode.  If you don't have a TSC, you can hold down the right mouse button and use the zoom bar at the far left of the 3D screen to adjust the zoom
  • 107. 3D NAVIGATION WITH NEW 3D OPTIONS MENU
  • 108. 3D OBJECT DISPLAY VIEW OPTIONS: Lumen Mode Tissue + Lumen Mode Stent Only Mode  Additional Options:  Individually turn up to two guidewire (s) on/off  Turn side-branch (es) on or off  Note:  Guidewire rendering may vary due to shadow, artifact or out of the cut- plane Flythrough *any of the above modes can be viewed in the flythrough view
  • 109. AptiVue™ Software for OPTIS™ (version E.5.1) Features: Automated Stent Expansion Calculations  Under expansion Indicator for BMS/DES  2 Methods – Dual and Tapered Resting Index, Resting Full Cycle Ratio (RFR)1 – Identifies ischemia-causing lesions like FFR without hyperemia – Allows pullbacks to assess serial lesions and diffuse disease Personally Identifiable Information (PII) Security  Full Encryption of patient data  User authentication (login) Current Algorithm Improvements  2nd Guide wire detection  Stent rendering in 3D 1. Svanerud et al. VALI.DATE RFR. EuroIntervention 2018.
  • 110. Proprietary and confidential — do not distribute SUMMARY: OCT FOR PCI OPTIMIZATION Pre- and post-stent assessment Stent size selection and landing zone planning Position, expansion, apposition Intimal tear, dissection, false lumen Tissue prolapse Calcification PCI follow-up Strut coverage Neo-intimal growth Restenosis/thrombosis Data on file at LLI
  • 111. OPTIMIZE YOUR PCI WITH OCT OCT has clear advantages for stent optimization – PCI OPTIMIZATION It’s all about the lumen Fast, easy to use, easy to read 10 times Superior Image Resolution than IVUS
  • 112. 112
  • 113. OCT IN CATH LAB Pre - PCI OCT Pull Back • Check Clearance and then only do Pull Back – PUFF • Calibration • If ACR –CO Register • Morphology – Calcified, Lipid & Fibrotic lesions zones, healthy 3 layered zones (180D) • Landing Zone – Distal & Proximal Luminal & EEL Dimensions (Mean Diameter), Length of the lesion • Dissection • Thrombus presence 113
  • 114. OCT IN CATH LAB Post - PCI OCT Pull Back • Calibration • Lumen Profile, Rendered Stent, If ACR – Co Register • Lumen Profile - Place the Distal & Proximal Markers in the edge of the stent • Check for Edge dissections • Check for MLA – Ilumien 3 Crieteria • Apposition 114