EP1 (W4/W5/W6)

What technology does the ViewMate Multi Ultrasound System utilize?

Zone sonography

How does zone sonography differ from conventional technology?

Zone sonography: Large zone acquisition that is 10x faster, software-based with cost-effective upgrades, data retained, both premium near and far field image quality and portability

Conventional: Line-by-line data acquisition, hardware-based, data discarded, tradeoff between image quality and portability

What are some product features of the ViewMate Multi Ultrasound System?

- Easier viewing, display swivels 180 degrees

- Larger screen with rich and intuitive interface

- New touch panel enables gesture control

-Redesigned control panel, 20% fewer buttons (compared to the ViewMate Ultrasound Console) for easy case annotation

- Transducer storage, now more elevated for easier access

- Boosted processing power, faster performance today

- More compact, collapsible for small footprint and better portability

What does the ViewFlex Catheter Interface Module (CIM) do?

- Isolates the patient from the system

- Removes the need for a sterile sleeve during setup via an integrated cable

What does the ViewFlex CIM do if the catheter temperature exceeds a safe limit?

Auto shutdown

What are the ViewMate Multi Ultrasound System Transducers?

- New L9-3S Linear Transducer, Field of View 43.7: MM

- New SP5-1S Phased Transducer, Field of View: 90 degrees

- New L16-4HS Linear Transducer, Field of View: 25.3 MM

- New P8-2S Phased Transducer, Field of View: 90 degrees

- New CW2S Continuous Wave Transducer

- New P8-2Ts Transesophageal (TEE) Transducer

- P8-3 Transesophageal (TEE) Transducer

- P8-3m Transesophageal (TEE) Transducer

What is the ViewFlex Xtra ICE Catheter's IFU?

Indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow, and other devices within the heart

What are the product features of the ViewFlex Xtra ICE Catheter?

- Four-way tip deflection, catheter rotations adjustments can be made with a single hand

- Auto-locking steering, eliminates need to lock deflection position and catheter will stay where it's steered

- Ergonomic handle design (similar to the Agilis NxT Steerable Introducer), alignment of ridges on both rotational knobs allows for tactile feel to ensure the catheter is returned to non-deflected position

- No sterile cover needed

What do the distal and proximal knobs on the ViewFlex Xtra ICE Catheter do?

- Distal (grey): Rotational control for anterior/posterior deflection

- Proximal (green): Rotational control for left/right deflection

How do we remember the direction of each knob on the ViewFlex Xtra ICE Catheter?

"Anterior Away" and "Right Away"

What enhancements were made for the ViewFlex X Ice Catheter, Sensor Enabled?

- Sensor enabled, incorporates 2 sensors inside the transducer to enable tip displayed in EnSite X EP System

- 11% softer shaft, easier positioning within the heart with an optimized curve shape

- Navigation indicators, simplified ICE navigation with a new P/A knob (blue/red) and color indicators on the L/R knob (yellow/green)

- Extension cable, added 4" (~10 cm longer) extension cable for added maneuverability

- New connector and edge card, incorporates SE plug into new edge card

What attributes were maintained between the ViewFlex Xtra and ViewFlex X SE?

- Same ergonomic handle design, neutral deflection ridge

- Premium image quality

- Consistent catheter handling (unique autolocking handle, 4-way steering, responsive catheter maneuvering/torque response)

- Doesn't require sterile bagging

- Single cable from catheter handle

What is the catheter size of both the ViewFlex Xtra and ViewFlex X SE?

9 Fr

What is the introducer size of both the ViewFlex Xtra and ViewFlex X SE?

10 Fr

What is the insertable length of both the ViewFlex Xtra and ViewFlex X SE?

90cm

What is the tip deflection of both the ViewFlex Xtra and ViewFlex X SE?

Anterior/posterior, left/right, +/- 120 degree flexion

What is the transducer type of both the ViewFlex Xtra and ViewFlex X SE?

64 element phased array

What is the Ensite X EP system integration of both the ViewFlex Xtra and ViewFlex X SE?

ViewFlex Xtra is unable to visualize, ViewFlex X SE is sensor enabled and able to visualize

What is the US ICE catheter share?

78% Biosense Webster, 22% Abbott

When did the ViewMate Ultrasound Console and ViewFlex Xtra launch?

2012

When did the ViewFlex X launch?

2026

What is Abbott's primary competitor and market leader in ICE?

Biosense Webster, AcuNav and SoundStar

When did AcuNav launch?

2000

When did CartoSound and SoundStar launch?

2007

What is the background on Biosense Webster (previously Siemens) and AcuNav catheters?

- 2000: AcuNav entered market with Siemens (sold 50,000 catheters by 2006)

- 2006: Formed partnership with Biosense Webster (J&J)

- 2007: Biosense Webster took over complete distrbution of AcuNav catheters (still manufactured by Siemens Medical)

Are AcuNav catheters only used for EP?

No, 70% EP and 30% interventional

What are the key points to remember about AcuNav catheters?

- 8F and 10F intracardiac ultrasound catheter options

- 64 element phased array

- 4 directional steering

- Handle is not sterile

- 90 cm insertable length

What are the key points to remember about SoundStar catheters?

- 8F and 10F catheter options

- No autolock

- 90 cm

What is CartoSound?

- Legacy software

- 2D ultrasound image superimposed

- 3D image created by manually drawing contours on the mapping system

- Can be used in all four chambers of the heart

What is CartoSound FAM?

- Newest software

- AI assisted contour drawing of LA

- 3D model for LA only

What are the key points to remember about Siemens/Biosense Webster, Philips, and Boston Scientific's competitive ICE catheters?

- AcuNav (Siemens/Biosense Webster): 8 Fr size option, not sterile handle

- SoundStar (Siemens/Biosense Webster); Integrated with mapping softwares CartoSound and CartoSound FAM, 8 Fr size options, more flexible

- VeriSight (Phillips): Most cardiac ultrasound market share, same model as 4D ICE

- Ultra ICE (Boston Scientific): Low cost, radial ICE

Which ultrasound consoles utilize zone sonography and which ones do not?

Yes: Abbott ViewMate Multi Ultrasound System, Abbott ViewMate Ultrasound Console

No: GE Vivid IQ, Siemens AcuSon SC2000, Phillips EPIQ

Which ultrasound consoles utilize simultaneous dual imaging and which ones do not?

Yes: Abbott ViewMate Multi Ultrasound System, Abbott ViewMate Ultrasound Console

No: GE Vivid IQ, Siemens AcuSon SC2000, Phillips EPIQ

What are the key advantages of Abbott ultrasound consoles over GE, Siemens, and Phillips?

Zone sonography and simultaneous dual imaging

What is the monitor size of the ViewMate Multi Ultrasound System?

23.8"

What is the monitor size of the ViewMate Ultrasound Console?

19"

What is the touch screen size of the ViewMate Multi Ultrasound System?

15.6" (color)

What is the touch screen size of the ViewMate Ultrasound Console?

There is no touch screen

What does the Abbott icon/9-dot box at the top left of the image sector represent in ICE?

Inferior anatomy, assuming a femoral vein approach; corresponds to the handle of the catheter (i.e., patient's feet)

What view might we see as the ViewFlex Xtra is advanced up the IVC?

Liver View (IVC at top, vessels on left, hepatic vein on right)

What are the key points on Home View during ICE?

- Once the Liver View appears on the screen, slowly advance the catheter into the RA to get into Home View

- The RA, TV, and RV will be visible

- This is the starting point from which all other intracardiac anatomy can be found

- The catheter's raised notches are aligned, directed towards the ceiling, and the catheter is in the neutral position

Why would we rotate the catheter counter-clockwise from Home View for?

Crista terminalis (this is the only anatomical target where the catheter would be rotated counter-clockwise from Home View)

How do we get to the cavotricuspid isthmus (CTI) view during ICE?

From Home View, withdraw the catheter into the IVC until the eustachian ridge comes into view

How do we get to the right ventricular outflow tract (RVOT) view during ICE?

From Home View, rotate the catheter slightly clockwise (i.e., to the patient's left)

How do we get to the fossa ovalis (TS) view during ICE?

From the RVOT view, use some posterior tilt and possibly right steering to optimize viewing the fossa

How do we get to the left atrial appendage (LAA) view during ICE?

From Home View, clock the catheter until you see the RVOT, then keep clocking the catheter until the LAA appears (along with the mitral valve and coronary sinus, in the same imaging plane)

How do we get to the left pulmonary vein (LPV) view during ICE?

From the LAA view, continue rotating the catheter clockwise and you will see the descending aorta, LIPV, and LSPV ("Pantlegs")

How do we get to the posterior wall/esophagus during ICE?

From the LPV view, continue rotating the catheter clockwise and you will see the posterior wall of the LA and the esophagus

How do we get to the RIPV during ICE?

From the posterior wall and esophagus, continue rotating the catheter clockwise to see the RIPV ("Micky Mouse" Ear 1)

How do we get to the RSPV during ICE?

From the RIPV, rotate the catheter slightly clockwise to view the RSPV ("Micky Mouse" Ear 2)

Both RPV's are often seen in the same imaging plane (RPV view), so how can we identify the RIPV versus the RSPV?

RIPV will be more to the left (inferior side and Abbott icon) whereas RSPV will be more to the right (superior side)

How do we get to the right ventricle view during ICE?

From Home View, keep the TV in view and use anterior tilt; advance the catheter across the TV and into the RV, releasing the anterior flexion once you are in the RV

How do we get to the left ventricle long axis view during ICE?

From the RV view, slowly rotate clockwise to visualize the long axis view of the left ventricle

What do we use the left ventricle (LV) long axis view for during iCE?

Pericardial effusion can be visualized along the posterior wall of the LV from this view

How do we get to the LV short axis view during ICE (and what are we hoping to visualize)?

From the LV long axis view, rotate the catheter slightly clockwise to visualize the anterior papillary muscle

In what cases would we want to visualize the papillary muscle using ICE?

VT procedures

How do we get to the mitral valve (MV) short axis view during ICE?

From the LV short axis view, withdraw the catheter slightly to visualize the mitral valve in short axis

How do we get to the aortic valve (AV) short axis view during ICE?

From the MV short axis view, rotate the catheter clockwise to visualize the aortic valve (AV) short axis, LAA, LA, LSPV, and ridge

In the AV valve short axis view during ICE, where is each cusp positioned?

- The cusp that is closest to the LAA is the LCC

- The cusp that is closest to the catheter is the RCC

- The cusp that remains is the NCC

How do we get to the RVOT pulmonary artery view during ICE?

From the AV short axis view, slightly withdraw the catheter to visualize the AV short axis, pulmonic valve (PV), and pulmonary artery (PA)

What is the first troubleshooting step if ICE has problems with image quality?

Unplug and re-plug the catheter into the CIM, then re-select the appropriate transducer

What are the best practices for connecting ICE?

- Seat/push the catheter into the CIM, press down on both sides making sure it's secure

- Ensure the connector cartridge (gold end of catheter) does not get wet

What are the three settings on the system itself to improve ICE images?

Gain, TGC, depth

What is gain during ICE?

- Overall image brightness

- Do not over gain the image

- Clockwise/right = bright, Counter-clockwise/left = dark (on knob)

What is TGC during ICE?

- Adjusts the brightness in a specific region of the image

- Top (near catheter) = near field, bottom (far from catheter) = far field

- TGC sliders can be in a straight line down the middle

- Right = bright, left = dark (on slider)

What is depth during ICE?

- Controls the viewable area in the imaging sector and affects the frame rate

- Should be at the minimum required to visualize structures

- Lower/more shallow imaging depth = higher frame rate, deeper imaging depth = lower frame rate

- Higher frame rate = better resolution

- Toggle up to increase (bigger/more superficial), toggle down to decrease (smaller/deeper)

What is color flow doppler and how do we remember it?

- Direction of blood flow is portrayed by the color of the flow pattern

- BART

- Blue = flow Away from the transducer

- Red = flow Towards the transducer

- Deep color = lower velocity/laminar flow

- Light color = higher velocity/non-laminar flow

How do we turn on/off or adjust color flow doppler on the system itself during ICE?

- "C" (color) knob

- Push down on knob to turn on/off

- Clockwise/right = increase, counter-clockwise/left = decrease

What are the Advisor VL and FL Mapping Catheter, Sensor Enabled indicated for?

Sensor enabled steerable mapping catheters used to record signals and perform cardiac pacing during diagnostic EP studies

Where cab the Advisor VL and FL Mapping Catheter, Sensor Enabled be used?

These catheters can only be used to map the ATRIAL regions of the heart

What are the key product features of the Advisor FL?

- Fixed loop mapping catheter

- 10 electrodes

- 2 sizes options: 15mm and 20 mm loop (both uni- and bi-directional, D and DF)

- 7.5 Fr

- 1 magnetic sensor integrated between 2 shaft electrodes (#11 and #12)

What are the key product features of the Advisor VL?

- Variable loop mapping catheter

- Loop actuator for adjusting loop diameter size (15mm - 25mm)

- 10 and 20 electrode options

- Uni- and bi-directional

- 7.5 Fr

- 2 magnetic sensor integrated between 2 shaft electrodes (#11 and #12)

What is the Advisor HD Grid Mapping Catheter, Sensor Enabled indicated for?

Multiple electrode EP mapping of cardiac structures in the heart (i.e., recording or stimulation only)

Where can the Advisor HD Grid Mapping Catheter, Sensor Enabled be used?

This catheter is intended to obtain EGMs in the ATRIAL and VENTRICULAR regions of the heart

What are the key product features of the HD Grid SE?

- 16 electrodes, 1mm length

- Patented coupler joining frames

- 3-3-3 ring spacing

- Irrigation port

- 2 electrodes on distal shaft, 2 magnetic sensors located between shaft electrodes

- "FLEXABILITY" shaft platform handle (8 Fr)

- Universal actuator design (allows for deflection independent of handle position)

- Tension "locking" allows for variable control (the amount of friction increases as the knob is rotated clockwise until it reaches the fully "+" position)

- Bi-directional deflection (only available in D/F curve)

- Irrigation connection

What are key points to remember about the orientation of the HD Grid SE when the tension knob on the handle is FACING UP?

- Spline A is located at the BOTTOM of the HD Grid SE

- Rotate clockwise: Spine A comes TOWARD the operator

- Rotate counter-clockwise: Spine A moves AWAY from the operator

What do we connect the HD Grid SE to for irrigation?

An irrigation system, such as a drug infusion pump or pressure bag

What should the irrigation pump be set at for the HD Grid SE?

Minimum of 2 mL/min or 120 mL/hour

What should the activated clotting time (ACT) be maintained at for the HD Grid SE?

Maintain an ACT of greater than 300 seconds at all times during use of the catheter

What was added to the HD Grid X SE?

2 magnetic sensors on outer splines for enhanced functionality with EnSite X EP system

What are the 6 DOF (degrees of freedom) enabled catheters?

- Advisor HDG

- Advisor HDG X

- Advisor SL

- TactiFlex

What do the 6 DOF enabled catheters include in their design?

2 internal magnetic sensors, combined to create a 6 DOF sensor

What does the 6 DOF sensor provide the Ensite X EP system?

Roll orientation data, which enables the "Deflection Indicator" feature

On bidirectional catheters, what do red and blue correspond to?

- Red = smaller curve

- Blue = bigger curve

On bidirectional catheters, what does the bigger curve have?

- Tactile bump

- "Big Blue Bump"

On unidirectional catheters, what color corresponds to their deflection?

- Red, push the thumb knob forward to deflect

- "PR Interval = Push for Red"

Which mapping catheter does not have 6 DOF and will not show deflection indicators on EnSite X?

Advisor FL

What is the Biosense Webster equivalent to the Advisor family of products?

- Octaray

- Pentaray

- Optrell

How does Optrell compare to HD Grid?

Optrell:

- 2.4mm center-to-center interelectrode spacing, along and across splines

- 48 electrodes distributed over six 2F splines

- Indifferent electrode (TRUE ref electrode) on the shaft

- Bidirectional deflection

- Determines activation direction and wave speed via timing (LAT) with spatial averaging to overcome imprecise timing and EGM complexity

HD Grid:

- 4mm center-to-center, 3mm edge-to-edge design

- 16 electrodes distributed over four 2.5 F splines

- No indifferent electrode for unipolar reference

- Bidirectional deflection

- LAT isn't sufficient for activation direction; OT identifies activation direction and wave speed with less error

What does the HD Wave Solution do?

- 1st attempt to combat "bipolar blindness"

- For each saved map point, data accounts for directionality using orthogonal bipoles (down and across the spline in pairs) and the 12 best duplicates are collected

- For the entire map point set, the best duplicated algorithm compares voltage and amplitude for all co-located map points

What does Omnipolar Technology (OT) do?

Calculates an omnipole signal and makes very LOCAL determinations from a CLIQUE (3 adjacent electrodes, forming 3 unipoles and 2 orthogonal bipoles)

How does OT compare to the HD Wave Solution?

OT has a greater point density, which equals a higher resolution

HD Wave Solution:

- # of points saved to the points list: 24

- # of points saved on the map: 12

- Point spacing: 4mm

OT:

- # of points saved to the points list: 36

- # of points saved on the map: 36

- Point spacing: 2mm

What are the characteristics of an omnipole?

- Local

- Catheter-orientation independence

- Direction

- Speed

Essentially combines the characteristics of unipolar signals, bipolar signals, and the principles of traveling waves

What is the sterile portion of a ViewFlex catheter?

"Tip-to-tail"

Which catheter will be used for integrated Ice?

ViewFlex X SE (only works in VoXel mode, but it is now visible on the system like Carto's solution has been)

What is "contouring"?

Allows us to create a 3D model via ICE, similar to a segmented CT

What is the difference between Carto's SoundStar AI software and Abbott's AI software for integrated ICE?

SoundStar compares the CT to a database of past CT images and chooses the most similar components from other images to determine the anatomy whereas Abbott's AI software will directly identify key structures

Which company has the most cardiac ultrasound market share for all modalities, and who has the biggest for ICE?

Phillips, then Carto (and Abbott)

What are your "Pantlegs" and "Mickey Mouse" during ICE?

- "Pantlegs" = LPVs

- "Mickey Mouse" = RPVs

- Inferior PVs will be visible before the superior PVs when clocking from Home View (for both the left and right sides)

For the Advisor FL, can the size of the catheter be adjusted mid-case?

No, the size set at the beginning of the case cannot change during the case