What is behind Rhythmia ™ Continuous Mapping and Automation? State clearly the goals of the session as described above. No focus on competitor but on what Rhythmia can do to be able to use it with customers. GOALS: A- Understand why Rhythmia is accepting beats automatically with more than 99% accuracy due to the different Beat Acceptance Criteria B- Be able to explain and give examples of application of the different criteria What is behind Rhythmia ™ Continuous Mapping and Automation?

Rhythmia™ Mapping system Messaging Clarity for Accurate Mapping Superior resolution & signal quality Thousands vs. hundreds of points Allow full visualization of arrhythmia for accurate targeting RHYTHMIA™ MAPPING SYSTEM CLARITY EFFICIENCY CONFIDENCE Efficiency in Diagnosis and Treatment Ideal blend of speed, automaticity and ease-of-use Continuous mapping – No point-by-point acquisition Eliminate need for time- consuming manual annotations Confidence with vMap™ Clearly assess gaps and lesions Confirm arrhythmia termination in minutes Potentially reveal hidden arrhythmias Slides 1 and 2 to link the session to what they already know from the Sales presentation

Ideal Blend of Speed, Automaticity and Ease-of-Use Continuous Mapping Algorithm evaluates every electrogram against user-defined criteria for inclusion in map Fully automated intelligent annotation Beat Template facilitates continuous mapping of ectopic beats Propagation Reference facilitates rejection of ectopic beats Simultaneous map creation (Anatomy, Activation, Voltage) Enhanced, robust triggering process for accurate beat recognition Slides 1 and 2 to link the session to what they already know from the Sales presentation Case images courtesy of W. Jackman, MD & H. Nakagawa, MD. University of Oklahoma Health Sciences Center. Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

Evidence Validation Who can recall the paper that demonstrated the clinical accuracy of continuous mapping? Slides 3 and 4 to link the session to the evidence we have on the topic: 99,8%. Engage them trying to get them to recall the paper.

Evidence Nakagawa, et al. Rapid, high-resolution electroanatomical mapping: Evaluation of a new system in canine atrial linear lesion model. Circulation: Arrhythmia & Electrophysiology. 2012, 5: 417-424. Slides 3 and 4 to link the session to the evidence we have on the topic: 99,8%. Engage them trying to get them to recall the paper.

RA sinus map with standard beat metrics Why have beat metrics? RA sinus map with standard beat metrics Slides 6 and 7: to explain visually why beat metrics is important Images from Rhythmia simulator

Garbage in = garbage out RA sinus map without beat metrics If you do not know well the current level and knowledge in your group, we propose you the following exercise: Ask the audience the following 3 questions: Why have beat metrics? How do you tell the difference between Sinus rhythm and AT? How do you tell the difference between VT1 and VT2? List their answers in a flipchart so you can link them afterwards to the different beat metrics. Use to exercise to identify level of group and build from there so they will understand the beat metrics session. Try to adapt the rest of the session to the level of the group. Images from Rhythmia simulator

What Beat Metrics is? Automatic selection of beats Beat Acceptance Criteria Cycle length Propagation reference Electrogram stability ECG morphology reference Respiration Mapping catheter movement Tracking quality Automatic selection of beats Correct rhythm Correct position Beat metrics allow the operator to specify criteria for beat acceptance Same judgments made by good mappers but automated CL ∆R S ECG RSP M TR Slides 8 and 9: introduce the concept of beat metrics and the list. Notice we are not covering V window due to complexity and no real a beat metrics.

How do they appear in the screen? Beat Acceptance Criteria Cycle length (CL) Propagation reference (ΔR) Electrogram stability (S) ECG morphology reference ‘’favourite beat’’ (ECG) Respiration (RSP) Mapping catheter movement (M) Tracking quality (TR) Slides 8 and 9: introduce the concept of beat metrics and the list. Notice we are not covering V window due to complexity and no real a beat metrics.

Basics Timing reference (R) Defines reference time for each beat in the system Propagation reference (ΔR) Second time reference used by propagation reference beat metric to validate morphology Only shown for maps with ΔR beat metric enabled Slides 10 and 11: we explain basic concepts they need to understand the different beat metrics. Focus only in 3: reference, propagation reference and mapping window. Nothing on triggering or V blanking or P blanking just to focus on the concepts needed for the session. Propagation reference in the image is: time between CS 3-4 and CS 7-8 which could help to define other rhythms

Basics Mapping window (window of interest): The portion of the cardiac cycle that is analysed by the mapping system (before and/or after R) Electrograms in the mapping window are represented as mapping points on the map.   For activation maps, the mapping points are coloured according to their position in the mapping window (ms) For voltage maps, the mapping points are coloured according to the size of the recorded electrogram ( mV) Electrograms outside the mapping window are not considered as mapping points Slides 10 and 11: we explain basic concepts they need to understand the different beat metrics. Focus only in 3: reference, propagation reference and mapping window. Nothing on triggering or V blanking or P blanking just to focus on the concepts needed for the session.

Cycle Length CL Overtake

Cycle Length CL Used to recognize changes in rhythm and rate, limits accepted beats to the target rhythm/arrhythmia Accepts beat if cycle length is within the specified acceptance range Threshold is ± X ms from target cycle length Helps reject PACs / PVCs and other ectopic beats Refers to the stability or regularity of the electrical reference (time ‘’0’’). Atrial maps typically use an atrial EGM from a CS electrode pair for the electrical reference. Ventricular maps typically use a QRS complex (max. R wave or min. S wave) of a surface ECG for the electrical reference Hurts when Acceptable range is large, which is common in sinus CL changes or drifts without morphology change Does nothing when pacing (if pacing signal is used for reference)

CL Cycle Length example General example settings: Sinus CL= 50m mSec Tachy CL = 15 mSec Paced CL = 5 mSec Example for Aflutter: CL is usually very regular therefore we would suspect the arrhythmia may have changed (or stopped) if it the cycle length changes by more than 10-20ms. Therefore most operators would set this as the limit. Small image refers to the way you can set up CL (CL could be controlled by Beat Metric Acceptance and also Metric graph). The green bar is the range in where CL (white line) would be accepted. If CL exceeded the green bar, the beat would not be included.

∆R Propagation Reference Offside in football: it is really important to understand the position of one player related to the others when passing the ball.

Propagation Reference Limits beats to target rhythm Accepts beat if time difference between timing and propagation reference events are within the specified acceptance range Threshold is ± X ms from target time difference Helps Identify changes in activation pattern reject PACs / PVCs and other ectopic beats, especially as pacing capture verification Typically used for atrial maps Propagation reference: The time it takes for conduction between electrodes is highly specific to the activation pattern and cycle length of the arrhythmia, this is usually set to 5ms for stable tachycardias. If the cycle length were to change the conduction velocity naturally will change and therefore the propagation reference not be met, conversely if the arrhythmia changed so will be the time between the propagation reference in most circumstances. Hurts when No good second reference EGM is available Reference catheter waveforms change Does nothing when Timing and propagation reference signals are too close together Disabled by default during ventricular mapping

∆R Propagation Reference Δ R Time R Event Δ R Event General example settings: +/- 5ms from the selected offset R Event Δ R Event

Can you see the difference? Propagation Reference ∆R Can you see the difference? How long does it take for you to decide if the beat is correct or incorrect?

Can you see the difference? Propagation Reference ∆R Can you see the difference? The ΔR target offset from the setup is 18.9ms with an approved variance of +/- 5ms. Here, the top corner beat has a ΔR timing of 20ms, within the limits. However, the bottom corner beat has a ΔR timing of 11ms, outside the limit. 18.9ms (target) – 11ms (measured by me) = 7.9ms (measured by me) 7.4ms measured by Rhythmia) 7.4ms is 2.4ms out of the target offset of 5ms. Therefore, the beat is rejected.

Electrogram Stability

Electrogram Stability Rejects unstable beats Accepts beat if all mapping catheter EGMs match previous beat to a specific level Threshold is degree of match (0.0 = perfect match, 1.0 = no match at all) Helps reject Excess catheter movement: Ectopy caused by mechanical contact that has not been detected as a change in cycle length or change in propagation. Electrogram stability: Orion catheter contact with the wall of the heart may cause local mechanical activation but not stop the arrhythmia – this is very useful for this situation where the CL and propagation reference may not be affected because global activation has not changed. The current beat is compared to the previous beat if mechanical activation has not occurred the two beats will be similar. (as compared to the last beat) refers to the stability or reproducibility of consistent EGMs at the same catheter location. Hurts when A:V ratio is not 1:1 and ventricular far field is significant Alternating morphologies Does nothing when bad morphology is stable

Electrogram Stability

ECG Morphology Reference

ECG Morphology Reference Limits beats to target ventricular morphology Accepts beat if QRS matches target ECG morphology of favorite beat to a specific level Threshold is degree of match (0.0 = perfect match, 1.0 = no match at all) Helps: Reject PVCs and other ectopic beats Select only PVCs such as in RVOT Map a specific VT morphology Hurts when QRS morphology is variable, such as due to catheter contact induced bundle block Does nothing for atrial mapping (should be disabled)

ECG Morphology Reference VT match for this map Morphology not matched Similar to template matching in Lab system???

Respiration RSP

RSP Respiration Rejects catheter position variation due to respiration Accepts beats during a consistent respiratory phase (respiratory gated) Helps when tracked catheter position changes with respiration, which is more common with impedance tracking Consistency with point annotation enhances accuracy Ask: how much do you think your heart moves when you breath deeply? Hurts when Respiration is not periodic (patient is breathing irregularly or talking) Does nothing when catheter motion due to respiration is small

Respiration RSP Right map: RSP metric off, Left map: RSP metric on.

Mapping Catheter Movement Tourtle and rabbit (hare)

Mapping Catheter Movement Rejects beats with excess (fast) catheter movement Accepts beat if mapping catheter motion within mapping window is less than a specified amount Threshold is X mm of motion (nominal setting 1mm) Helps Remove “motion blur” noise when catheter moves fast Physicians slow down (turtle, not hare) Mapping catheter movement: (may be harder to understand) encourage discussion about a catheter not moving will give clearer information eg. Like taking a photo of a person sitting still as opposed to moving fast ‘catheter blur’ Electrical data typically recorded from bipoles: two electrodes recording the myocardial activity around the electrode, if the cathteter is moving this data is skewed Hurts when Cardiac motion is large (e.g. near LV apex) Should almost always be enabled

Mapping Catheter Movement If you want to finish your map and have a good quality map, Be the turtle and not the hare! The turtle wins the race!!! Slow and steady wins the race, slow and steady creates a faster, better map.

Tracking Quality TR

TR Tracking Quality Rejects beats when catheter tracking is poor Accepts beat if mapping catheter position uncertainty is less than a specified amount Helps indicate when tracking needs attention Magnetic tracking is poor due to field distortion or patient position relative to sensor Impedance tracking is poor due to incomplete field map or noise Tracking quality: briefly discuss that all mapping systems rely on a stable reference and this beat metric assists to highlight when the reference may need to be reviewed. Explain magnetic tracking: stable magnetic field – if that changes mapping stops Explain impedance – records values for given location in multiple planes, like recognising where you have been before. Hurts when Tracking accuracy is good but quality metric is poor, which occurs with magnetic tracking is some cases. (E.g. using impedance tracked catheter for mapping but magnetic field affected) Should almost always be enabled

Beat Metrics Auto Set-up When a map is automatically configured, beat metrics are set up based on Chamber Rhythm Cardiac events in last 10 seconds of data Auto setup helps but results must be reviewed Especially propagation reference

Exercise in pairs: 10’ Each pair choses one of the following 2 arrhythmias: Atrial Flutter Monomorphic Ventricular Tachycardia (ischaemic) Brainstorm during 5’ in pairs: “How does each criteria help to map this arrhythmia? Share results for each of the 2 arrhythmias (5’) Resources (some ECG´s and Set up to work on each of the 2 examples) Optional exercise depending on timing (10 minutes) Propose exercise to think about 2 concrete taquicardias: Atrial Flutter Monomorphic VT In pairs they have to brainstorm on: How does each criteria help to map this tachycardia? They need to answer YES or NO to each of the criteria and explain WHY. They will have the following materials to work with: ECGs from both tachycardias and a Beat Metrics set-up image to mark YES/NO in the each criteria.

Resources for the exercice Give one printed copy of one of the following 2 slides to each pair Resource for the exercise: you will get printed copies of this for each pair.

How does each criteria help to map Typical Atrial Flutter? √ click the criteria you would use: Why? Resource for the exercise: you will get printed copies of this for each pair. http://lifeinthefastlane.com/ecg-library/atrial-flutter/

How does each criteria help to map Monomorphic VT? √ click the criteria you would use: Why? Resource for the exercise: you will get printed copies of this for each pair. http://lifeinthefastlane.com/ecg-library/ventricular-tachycardia/

How does continous mapping differentiate from manual annotation in a real case? Here you open the following 3 videos in sinus rhythm to show them the differences visually: First 01VIDEOMannualAnnotation.mp4 Shows how to create a map with mannual annotation with Rhythmia, mention that with nother systems you do not have a 64 electrode Orion cath Second 02VIDEOAutomaticAnnotation.mp4 Shows how to create a map with automaric annotation with Rhythmia Third 03VIDEOComparingMapsDoneWithManualAnnotationRightAutommaticAnnotationLeft_2mmprojection.mp4 Compare both previous maps side by side and show differences: number of points acquired, quality of the map.... Talking Points about Comparison with competitors: The goal of this session is not to compare to new systems in the market but to be able to understand better what rhythmia does and be able to explain to customers. Mick will be sharing a slide deck where he compares with both Confidence and Precision Current 1st generation Systems: (CARTO and Velocity) All current 1st generation mapping systems incorporate basic concepts to create their maps: timing reference and mapping window NONE OF THE CURRENT 1st generation SYSTEMS IN THE MARKET CAN DO CONTINOUS MAPPING for both anatomy and electrical points FAM: Fast Anatomy Mapping (only automatic acquisition of anatomy, not for electrical points) Current first generation systems need to acquire points manually and review them manually by an opperator to decide wether they are accepted or not New systems in the market: CONFIDENCE and PRECISION: still not in the market place as full launch, not much information yet, no evidence or published data to understand the real value of their claimed automation. They are both still in a pre-launch phase We are preparing a deck to share with you comparing them to rhythmia with some talking points. Mick already introduced it in the Plenary session. We will set up a call to present it to you in the short term

What are the benefits of continuous mapping? CURRENT CHALLENGES Time-consuming Maps are crude Reliant on other CT/MRI Labor intensive and operator dependent No confident indication of therapy success More art than science Efficiency Labor reduction & comfort Repeatability What are the benefits of continuous mapping? High resolution/density voltage, activation and fractionation maps allows more clarity into arrhythmia mechanism Avoids time consuming manual annotation Eliminates need for point-by-point mapping Ensures small channels and gaps have not been missed Improves mapping speed, no freezing of EGMs FOCUS ON THE EFFICIENCY MESSAGE Repeatability: Maps are accurate and consistent no matter who’s running the system Comfort: System is collecting only the points you want it to collect Ease of use : Simple process to map chambers. Automated data collection. Accuracy: Continuous mapping and auto annotation is correctly creating the maps – 99.8% right first time based on detailed analysis of maps by Jackman/Nakagawa Complexity reduction: Efficient mapping for all rhythm types More science, less art: Less time creating maps, more time spent on effective therapy Predictability: Reduced map variability from consistent criteria application Optimized treatment planning: Reduced variability in mapping times reduces costly and unplanned overtime Potential labor reduction: System simplicity could lead to reduced staff needs Accuracy, Predictability More Science, less art

Summary In most cases, these beat metrics are sufficient to make continuous maps with minimal manual beat rejection Beat Metrics contributes strongly to Rhythmia ™ Mapping system efficiency compared to first generation mapping systems Metrics will continue to evolve

Exercise: “The answer journey” Question for the audience: How does Rhythmia™ Mapping system works so it is accepting beats with a 99,8% accuracy and very limited need of mannual annotation? Work in pairs on how to answer the question (10‘) Share their best answers (10‘) First pair gives their answer to the question Next pair needs to correct it and/or complete it Next pair needs to correct it and/or complete it further, ... ... Each time is more difficult since they have to find new arguments .... Every pair has to participate The answer is not only Beat Acceptance criteria but also: Distance to shell, amplitude of EGMs, Timing of surrounding electrodes. However, the exercise is to focus on the beat acceptance criteria and understanding it better, so focus the answers always on the aspects covered during the session.