Intravascular OCT ACR Workflow

1

Artis zee

OPTIS™ Integrated Angio Co-Registration (AC-R) WorkflowErnest Horsley

Cath Lab RadiographerHeart & Stroke Unite Netcare Blaauwberg Hospital

March 2016

2

OPTIS™ Integrated Onboarding Program Erasmus MC Rotterdam Rotterdam March 7th and 8th 2016

3

Optical Coherence TomographyCo-Registration Integration

The OPTIS™ workflow consists of acquiring and selecting a dedicated X-ray image to be used for co-registration, determining the vessel centreline, and performing of the pullback

4

Limitations of Angiography

It’s a Lumenogram of contrast media Flat 2D image of a 3D vessel Limited information about - Type of Plaque

- Generalised Disease- Vessel Wall- Stent Placement- Stent Deployment

5

Architecture Outlines

OPTIS™ Integrated System Architecture Dragonfly™ OPTIS™ Imaging Catheter features OPTIS™ Integrated System Settings Injector Pump Settings X-Ray Equipment Settings

6

OPTIS™ Integrated System Architecture

Tableside Controller

OPTIS™SystemCabinet

Drive-motor & Optical Controller (DOC)

Dragonfly™ OPTIS™Imaging Catheter

7

OPTIS™ Integrated System ArchitectureTableside Controller

Wi-Box™FFR

8

OPTIS™ Integrated System ArchitectureTableside Controller

9

OPTIS™ Integrated System ArchitectureDrive-motor & Optical Controller (DOC)

10

Dragonfly™ OPTIS™Imaging Catheter

Outer Diameter 2.7 Fr (0.90mm) Distal 280mmLow-profile tip

Delivery Rapid Exchange MonorailDual lumen

Working Length 135cmCoating Hydrophilic coating

Min Guiding Cath 6 Fr Guide Catheter 100cmNo Sideholes

Max Guide Wire 0.014”

11

Dragonfly™ OPTIS™Imaging Catheter

PreparationFlush 3.0 ml Undiluted ContrastWipe Heparinised SalineImaging Catheter for OPTIS™ Integrated System

ILUMIEN™ OPTIS™ILUMIEN™ PCI Optimization™ Systems

12

Dragonfly™ OPTIS™ Imaging Catheter

Imaging Catheter

13

Scan Length

Survey High *Resolution

75 mm 54mmLesion Survey

Stent Survey

Triger Manual AutomaticAcquire Angio Yes No*

OPTIS™ Integrated System Setting

14

Pullback type Survey High Resolution*Pullback length 75 mm 54mm**Pullback speed180 frames/sec

36 mm/sec5 fpmm

18 mm/sec10 fpmm

Pullback time 2,1 sec 3,0 secPullback file size 375 MB 540 MB

OPTIS™ Integrated System Setting

* Default ** Stent Evaluation

15

Automatic Pullback Injector Pump Settings

Contrast Strength 300 – 400 mg I/mlContrast Pressure 600 PSI minimum

> 450 PSI Acist > 300 PSI Medrad

Rise Time No Rise 0.0 SecContrast Volume* 14ml @4ml/s = 3.5 sec

12ml @3ml/s for RCA

It takes < 2 seconds to fill the artery to the distal pointIt takes 2,1 second for a pull back at 75mm/sec (Survey Mode 75mm @ 5fpmm)

16

Manual Pullback Injector Pump Settings

Contrast Strength 300 – 400 mg I/mlContrast Pressure 600 PSI minimum

> 450 PSI Acist > 300 PSI Medrad

Rise Time No Rise 0.0 SecContrast Volume* 35ml @3ml/s = 11.6 sec

40ml @4ml/s = 10 sec

3ml/s for Regular Coronary Angiogram4ml/s for CABG & Large vessels12 – 18 ml Contrast use should be achieved

17

X-ray Equipment Settings

Frame rate of 30fps > 15fps Un-subtracted image (DA not DSA) Co-Registration on A-Plane only (Bi-Plane)

Co-Registration software needs to register the OCT imaging catheter position

Start Acquisition Before Pull Back initiated End Acquisition After Pull Back has ceased

18

Procedure Outlines

Key Benefits of AC-R Good AC-R Practice

Co-Registration Workflow

19

Key Benefits of Angio Co-Registration

Facilitates OCT-guided PCI therapy Collects key clinical vessel information with 1 angio Reduces learning curve to assess location of OCT Increases confidence in position of OCT features Improves workflow efficiency into PCI Reduction in contrast & radiation wrt OCT wo AC-R

20

Artery Selection

Lesion Length Suitable Landing zone beyond stenosis

Reasonable Calibre Not Excessively Torturous

Eccentricity Collaterals Reference Vessel Diameter – MLA >4.0 mm2

OCT > IVUS stenosis severity in vessels <3.0 mm

21

Good Angio Co-Registration PracticeGood Angio Acquisition is key for successful AC-RAcquisition The cine recording must encompass the

entire OCT pullback, Start to End

Field of View X-ray equipment must be Stationery From the Guiding Catheter tip to the

radiopaque section of the Guidewire

Views Avoid vessel Foreshortening Overlapping branches *(Spider view) Radiopaque structures (clips, devices)

22

Good Angio Co-Registration PracticeGood Angio Acquisition is key for successful AC-RSoftware Designed for Coronary Angio (Dist-Prox)

Guide Cath• Good engagement in vessel ostium• Stable • No Sideholes

Workflow • One person co-ordinates workflow• Talk the Procedure

23

Good Angio Co-Registration PracticeIf you can see the imaging catheter radiopaque marker band on the angio, so can the software

Proximal Guide Catheter Radiopaque MarkerGood engagement

Distal Guidewire Radiopaque Marker

OCT Lens

Software reads image from Distal (Inferior) to Proximal (Superior)

Avoid vessel foreshortening & overlapping branches

24

Co-Registration Workflow

In the Patient Summary menu (or after adding a new patient),click + New OCT Recording at the bottom of the screen

25

Dragonfly™ OPTIS™ Imaging Catheter

Remove Imaging Catheter from the sterile packaging & place it onto the sterile field, along with the DOC cover and 3 ml syringe

Gently remove the Imaging Catheter from its hoop

Wipe the shaft with gauze moistened with heparinized saline to activate the hydrophilic coating

Gently purge the catheter through the side port with supplied 3 ml syringe filled with 100% contrast until 3 to 5 drops exit tip. Leave syringe attached for repeat purging in vivo prior to each imaging pullback

26

Drive-motor & Optical Controller

Insert the DOC into the sterile bag

Remove the cap from the catheter

Align hub tabs with notches, push the hub into the DOC until it cannot go any further, and twist slightly clockwise until it locks

Observe that the LED lights flash as the DOC connects, and that the system performs an automatic calibration

Establish that the OPTIS™ system has recognized the appropriate imaging catheter on the monitor

27

Load the imaging catheter onto the guidewire.

Confirm the recording settingsPullback TypeTrigger TypeAcquire Angio etc. – in the upper left hand corner of the screen

And Pump Injector settings check

Ensure that the imaging catheter is not rotating, if necessaryClick on Standby View or press the Live View button on the DOC

Dragonfly™ OPTIS™ Imaging Catheter

28

Under fluoroscopic guidance, advance the catheter to the target area, so that the Lens Marker and Proximal Marker will frame the area of interest

Ensure Acquire Angio is selected if co-registration is desired and then press the Live View button on the DOC or click on Live View on the screen to start live-scan imaging

Confirm that the imaging core is still purged of bloodPlace system in Standby View to purge againAfterwards, return to Live View to confirm

Dragonfly™ OPTIS™ Imaging Catheter

29

Dragonfly™ OPTIS™ Imaging Catheter

Confirm that the imaging core is still purged of bloodPlace system in Standby View to purge againAfterwards, return to Live View to confirm

Blood in Lumen Clear Lumen

30

Click Auto Calibrate on the screen or the Enable button on the DOC to auto calibrate the catheter

Inject a small puff of contrast through the guide catheter to determine adequate blood clearance of the distal vessel

This will help determine guide catheter alignment and position prior to image acquisition

Dragonfly™ OPTIS™ Imaging Catheter

31

Automatic OCT PullbackOnce ready to coordinate the cine, flush, and OCT pullback, click Enable Pullback

Step on the cine pedal and begin the flush protocol to start the pullbackThe flush protocol is the same as all OCT recordings

Step off the cine pedal after the OCT pullback has completed.

32

Automatic OCT PullbackOnce ready to coordinate the cine, flush, and OCT pullback, click Enable Pullback

Step on the cine pedal and begin the flush protocol to start the pullbackThe flush protocol is the same as all OCT recordings

Step off the cine pedal after the OCT pullback has completed.

33

Manual OCT PullbackOnce ready to coordinate the cine, flush, and OCT pullback, click Enable Pullback

Step on the cine pedal and Begin the flush protocol Start the pullback

Pullback stopsEnd the flush protocolStep off the cine pedal

34

OCT-Angio Co-RegistrationClick on the Co-Register button in the lower right-hand corner of the screen to start the co-registration workflow

Choose the frame of angiography that will display the entire vessel best

Note if Imaging Catheter is disconnected the buttons at the bottom of the screen swap

35

OCT-Angio Co-RegistrationAfter choosing the best frame, plot at least 2 control points within the target vessel where the OCT pullback was performed

The first control point should be placed near or on the radiopaque portion of the guidewire, within the target vessel, by clicking once to place it

At least one more control point needs to be placed within the target vessel, closer to the distal tip of the guide catheter

The user may choose to place several more control points to ensure that the software tracks along the pullback, but these additional points also need to be selected from distal to proximal

36

OCT-Angio Co-RegistrationTips for good control point placement

Control points must be placed from distal to proximal on the guidewire

Ensure the control points are within the target vessel

The first and last control points must encompass the OCT pullback between them

Do not place a control point in the contrast cloud/reflux into the aorta

Do not double back – Restart

Verify that the path displayed on the OCT pullback aligns with the target vessel. Click on Confirm

37

OCT-Angio Co-RegistrationReview the software tracking the Lens Marker in the left image and the entire pullback traced in the right image and if accurate, click on Accept

Verify the accuracy of the co-registered pullback by moving the Current Frame Indicator to a location that displays a visible anatomical landmark and see if this correlates with the location of the lens on the angiography

The lens is represented by a small white rectangle if the software is certain of the pullback tracking – red if not.

38

OCT-Angio Co-RegistrationPrior to starting any measurements or opening the Lumen Profile, the software will prompt a calibration verification step when using Dragonfly™ Imaging Catheter or Dragonfly™ Duo Catheter

39

OCT-Angio Co-RegistrationWhen complete, click End Review to return to the Patient Summary screen

40

Unload DOCDisconnecting Imaging Catheter from DOC

Always press the Eject button before removing the Imaging Catheter, failure to do so can damage the DOC

Unloading Imaging Catheter

Ensure that the imaging catheter is not rotating, if necessary press the Live View button on the DOC

Press Eject button on the DOCThe probe retracting is audible and the Pullback motion LEDs blink

When LEDs stop blinking disconnect the imaging catheter by turning it anti-clockwise

41

Despite the overall attractiveness of OCT, some drawbacks include

• Need for extra contrast• Limited ability to image very large vessels given limited depth of penetration (imaging

>4.5 mm diameter vessels is difficult)• Difficulty to image true aorto-ostial disease (IVUS is preferred in this scenario)• Blood pool artefact (this occurs when the lumen is not devoid of blood because of

inadequate contrast injection – the erythrocytes cause a severe scatter of light)• Stitch artefact (usually only subtle and not a major issue; this artifact relates mostly to

catheter movement within the vessel and appears as an abrupt step in the vessel wall)• If the catheter does not sit coaxially within the vessel then an oblique cut may be made

through the lumen and vessel wall• Given the imaging catheter remains in the artery, there may be a tendency to straighten

the vessel, cause vessel concertina and perhaps even distort stents of questionable longitudinal Strength

• In the early phases of operator inexperience, there can be difficulty identifying calcium and differentiating it from lipid rich plaque

42

Acknowledgements

Slides And Resources

Jurgen Ligthart, Erasmus MC RotterdamFelipe Hernandes, MadridMuhammad Naveed Saeed, Riyadh

THANK YOU

43