EPPT: Virtual Session #1

1. What are two navigation modes offered in Ensite X EP System?

2. What mapping systems can accommodate both modes?

1. VoXel Mode (magnetic field) and NavX mode (impedance field)

   1. VoXel Mode → procedural stability in various cases, ranging from AF to VT

2. Only Abbott Ensite X

Two elements of a navigation mode and how each is generated in NavX versus VoXel

1. Coordinate system

   1. NavX: 6 locating electrodes

   2. VoXel: PRS-P and PRS-A sensors

2. Electroanatomical 3D space

   1. NavX: Human body with various baseline impedances = impedance field

   2. VoXel: Field frame - generates magnetic field

What is the human bioelectrical impedance? Why is our impedance system considered dynamic?

Impedance ranges from 150 to 900 ohms. Dynamic because our body is composed of different tissues (i.e. nervous, connective, cardiac, etc) and fluids (air, blood, etc) with different resistances to electrical current. Changes in fluid volume, systole/diastole, creation of scar tissue, etc. all lead to fluctuating system impedances

What kind of data points are collected by catheter electrodes in…

1. NavX Mode? And how are structures visualized?

2. VoXel Mode?

1. Impedance data points (GREEN) - we can visualize structures due to local changes in thoracic impedance. See electrodes in impedance field

   1. *Orange points are SE points (magnetic data from magnetic sensor)

2. Magnetic data points (BLUE)

What is the purpose of NavX (SE) Field Scaling?

NavX Field Scaling: To linearize the impedance data by scaling our model based on the location of electrodes, and thereby improve the accuracy of the anatomic model. We use this since the body does not stay in a static condition, so visualization in NavX Mode may be compromised.

NavX SE Field Scaling: To provide additional model and catheter correction using secondary magnetic data, as long as the catheter is an SE catheter, we are working in a magnetic field, and we’ve collected SE points (ORANGE). Compensates for non-linearity of the impedance field

How do we generate an impedance field, and when does it become active?

Place 6 locating electrodes on patient, 3 sets at 180 degrees from each other.

*Current from Ensite X Amplifier → locating electrodes → current travels through body → system reference patch as primary receiver (ground), electrode as secondary receiver (picks up on local impedance changes in response to current)

We generate current and set baseline impedance when we VALIDATE the system - bioimpedance scaling, accounting for patient weight and patch placement

What sensors create the impedance field and coordinate system? What is the origin?

The 6 locating electrodes create xyz coordinate system. Origin is the intersection of these mapping patches, ideally at the heart

Where do we place the different-colored locating electrodes?

1. Red

2. Black

3. Orange

4. Green

5. Brown

6. Blue

1. Red = left

2. Black = front

3. Orange = right

4. Green = neck

5. Brown = back

6. Blue = left leg

Why do we experience visualization distortion with NavX Mode?

Because the body has a dynamic impedance field, so the system’s understanding of catheter placement will shift as impedance changes

Describe four key factors that impact an impedance-based system. Others?

1. Baseline versus arrhythmic state - think cardioversion, altering arrhythmic state - changes BP and blood volumes

2. Guidewires - metal introduction, devices in the body

3. Bodily fluids

4. Respiration

   *Others: patient movement, patch movement, EMI, ablation

Describe when model/mapping data can be collected and when catheters can be visualized in NavX Mode:

1. Standard catheters

2. Sensor Enabled tools

1. Data collection - always, visualization - always

2. Data collection - always, visualization - always

Two KEY features associated with NavX Mode

Flexible workflows with 3rd party catheters

Minimal fluoroscopy usage required

Describe the construction of the proximal and distal ends of an SE catheter and what types of data they collect and/or need to be visualized

1. Proximal RIGID end = shaft with magnetic sensor, collects VoXels (impedance fiducials, points that link magnetic and impedance data). Visualized based on magnetic data.

2. Distal FLEXIBLE end = paddle or loop, visualized based on impedance and magnetic data, so requires VoXel points to be visualized and to collect data

Low confidence versus high confidence states for SE tools

Low confidence = only SE shaft (and proximal electrodes) are visualized and can collect 3D data and VoXels due to low-density VoXel clouds. The remaining electrodes are grayed out.

*Note: Standard catheters cannot collect data in VoXel Mode.

High confidence = all electrodes are visualized and can collect 3D data due to high-density VoXel clouds (HD gridX is the exception, and standard catheters won’t collect 3D data)

What sensor should be the first one to connect and the last one to disconnect?

The system reference electrode as part of the NavX system

True or False: The order of catheter insertion is critical when working in VoXel mode

True

Two KEY advantages of VoXel mode

Linear data, unaffected by impedance conditions → better model accuracy

Long-term model and map stability with an unchanging metal baseline

Why are SE ablation catheters considered to always be in high confidence?

Because the electrodes are located so closely to the magnetic sensor

Describe when model/mapping 3D data can be collected and catheters can be visualized in VoXel mode:

1. SE tools (diagnostic, mapping - Advisor FL/VL/Grid)

2. Standard tools (i.e. Farawave, Inquiry, JSN Quad)

3. SE Ablation tools and HD GridX

1. Data collection AND visualization: in high confidence, enough VoXels collected.

2. Data collection: never. Visualization: in high confidence, enough VoXels collected.

3. Data collection AND visualization: always

What is the purpose of adding the secondary impedance system to VoXel mode?

To transform the coordinates to the magnetic coordinate system, to allow visualization and data collection from more electrodes than those closely located to the magnetic sensor

PRS-P patches:

1. Placement

2. Two purposes

1. On the patient’s back, 8 cm apart around the heart

2. Positional reference for magnetic coordinate system, AND used to detect and compensate for patient movement

True or False: Theoretically, as long as the PRS-P patches do not move relative to each other, our VoXel model remains unaffected.

True

What happens if we are unable to return the PRS-P patch to its original location?

Our model loses accuracy due to change in metal baseline. In extreme cases where we cannot return to valid position, we lose our model, maps, and AutoMarks and have to start over.

PRS-A sensor:

1. Purpose

2. What setting in Ensite directly correlates to this sensor?

1. To detect metal distortion

2. “Check Metal Field” and “Set Metal Baseline”

What does the “Check Metal Field” setting do? What are the recommended setups for the lab to meet lab characterization?

It compares the current PRS-A measured position with known values collected during lab characterization.

Have the I-I at its highest position in AP, table at 3 ft, and PRS-A in magnetic detection box

What does “Set Metal Baseline” do? What are the recommended setups for the lab at this point?

Sets a baseline for metal distortion in reference to PRS-A for the remainder of the case.

Have the table at the desired height and I-I at its desired height in AP

What 4 factors primarily affect a magnetic primary system?

1. Fluoroscopy machines and the position of the I-I

2. Anesthesia cart metal components

3. Lab setup tables or monitor boom

4. Height of patient table

What are the signs of and allowable ranges for metal distortion?

1. Signs: data collection stops, distortion meter turns red, PRS-A and PRS-P indicators turn red

2. For NavX, range I to III. For VoXel, range I to II

The coordinate plane for BSW’s magnetic primary mapping system in Carto is based on what location?

The patient bed rather than the patients themselves

3 keywords linked to Ensite X: Mapping without compromise

POWERFUL

RELIABLE

EFFICIENT

*Adopt many different workflows with two different navigation modes

Name the 21 patches and sensors placed on a patient’s body and what they do

1. 6x locating electrodes - generate low-intensity current, create impedance field in NavX mode

2. 1x RL ECG electrode - specialized 12-lead patch that works with system reference patch to cancel out powerline noise picked up by this reference

3. 1x system reference electrode - grounding pad/electrical reference for NavX system impedance and EKG measurements

4. 4x patient reference sensors - used for VoXel mode to create coordinate system and monitor metal distortion

5. 9× 12-lead electrodes - for precordial leads and limb leads, get “high-level” electrical signal data

4 steps of skin preparation prior to patient patching

1. Shave excess hair where electrodes and patches will be used

2. Prep skin by abrading it with gauze pad or similar material

3. Clean the surface with soap/water

4. Ensure skin is completely dry before patching

Where are the following patches/electrodes placed:

1. System reference electrode

2. RL ECG electrode

3. 6 locating electrodes

4. PRS-P patches

5. PRS-A patch

6. Defib patches

1. On patient’s abdomen, avoid skin folds or bellybutton

2. Placed on right (or left) leg

3. Right/left under armpit, back of neck, inner LL, front and back

   1. Be mindful of BP cuffs

   2. Watch out for groin areas

4. Place around the heart or close to

5. 30 deg from midline, angled 45 deg or less from patient table, over the patient’s heart

6. Back patch below the clavicle and to the left of the spine; front patch also below clavicle, more centered

   1. *In PVC/VT cases, place like for a heart cath procedure to pass through ventricles

T or F: for pediatric cases, you can cut the locating electrodes and system reference patch to fit their bodies.

False - you can cut locating electrodes, but not the system reference patch

Ensite X Amplifier Front Panel: Describe what the following Ensite X Amplifier Status Indicator lights tell us (AND, if applicable, what we should do):

1. Steady Orange

2. Flashing Orange

3. Steady Orange/Green

4. Flashing Green

5. Steady Green

6. Off

1. System performing self-testing

2. Something has failed - restart or call technical service

3. Restart or call technical service

4. Check fiber-optic cable between Ensite X Amplifier and DWS; verify Ensite X DWS is powered on

5. System is ready

6. System is turned off

Tell me what connections each of these ports #1-8 support on the front panel of the Ensite X Amplifier.

1. SurfaceLink Port where the SurfaceLink houses the locating electrodes, 12-lead, RL, and ECG electrodes → enable current to be sent to locating electrodes, and ECG and EGM data to be sent to Ensite X and recording system

2. PRS ports (interchangeable) for magnetic field

3. SE ports for SE ablation catheters

4. Bank 1, green supports </= 10 electrodes, blue supports 11-22 electrodes or 20-pin CIM. Channels 1-56

5. Bank 2B for 80-pin CIM, only use channels 57-120. Can’t use if Bank 2A is in use

6. Bank 2A, green supports </= 10 electrodes, blue supports 11-22 electrodes or 20-pin CIM. Channels 57-120. Can't use if Bank 2B is in use

7. Stimulator connection ports to connect a pacing stimulator

8. Ampere Connect connection. Connects to back of Ampere Generator. Passes along catheter location and EGM data. Channels 53-56 in Bank 1

Tell me what connections each of these ports #1-9 support on the back panel of the Ensite X Amplifier.

1. Power cable

2. Grounding cable

3. LC Fiber optic connection for Amplifier to back of Ampere RF Generator as Dual Fiber Optic connection - RF metrics (temp, power, impedance, current, energy) and AutoMarks

4. LC Fiber optic connection to DWS - all data

5. Ethernet connection to back of TactiSys - communicates contact force

6. Field frame connection

7. EGM output channels 1-56 (or 52 for third party since 53-56 have different pin out), direct connect to Claris or 56 pin-out to 3rd party recording system

8. EGM output channels 57-120, direct connect to Claris or 64 pin-out to 3rd party recording system

9. ECG output channels to recording system, direct connect to Claris our 12-lead ECG output module box to 3rd party recording system

Corresponding recording system channel numbers for the following port numbers

Port 1 (green)

Port 2 (green)

Port 3 (green)

Port 4 (blue)

Ampere Connect

Port 5 (green)

Port 6 (green)

Port 7 (blue)

Port 8 (blue)

1: 1-10

2: 11-20

3: 21-30

4: 31-52

AC: 53-56

5: 57-66

6: 67-76

7: 77-98

8: 99-120

Describe ECG Signal Path with Claris

See picture

Describe ECG signal path with 3rd party recording system

See picture

If I don’t have what sensors connected to the Ensite X Amplifier, I can still operate in NavX mode but cannot collect SE points for NavX SE field scaling?

The PRS sensors - connect to the front of the Ensite X Amplifier

If SE diagnostic catheters (i.e. HD Grid) don’t get plugged into the SE magnetic ports, how is their SE information connected to Ensite X?

The direct connect cables have a built-in SE connection

What is the magnetic (SE) port for?

For Sensor Enabled Ablation catheters - Tacticath SE, TactiFlex SE, and FlexAbility SE

It communicates magnetic and sensor information to Ensite X, enabling us to collect VoXels from the shaft magnetic sensor

Describe my two options for external stimulator connection ports

One set for ablation catheter, one set for diagnostic catheter

How should I position the field frame cable to connect to…

1) Ensite X back panel

2) Field frame

1) 3 o’clock notch

2) 6 o’clock notch

If I want to connect an Ampere Remote Controller, what cable should I use, where should things connect, and what info does the small fiber optic cable transmit?

Use a double fiber optic cable from the back of Ampere (upper two ports) and connect it to the back of the remote controller

Small fiber optic connection enables the standby button to be turned on/off

Describe what piece of equipment has the following connection ports, and describe what connects/what information is transmitted

This is the back of Ampere RF Generator

Left: connects to the back of CoolPoint to transmit irrigation information for the catheter

Right: connects to Claris or a 3rd party recording system to provide RF metrics to this system

What happens to impedance if I add another grounding pad?

Current flows more easily through the tissue to reach the grounding pads, so lower baseline impedance recorded at tissue surface

Two scenarios that would automatically require the use of two grounding pads

Ablating above 50 W

Using an 8 mm ablation catheter

The TactiSys RF cable (teal to yellow connection, back of TactiSys to the front of the Ampere) enables what 3 things?

Enables power, delivery of RF from ablation catheter

Transmits information about catheter location and EGMs