EP Studies, Ablation, and 3-D Cardiac Mapping. Diagnosis and Treatment of Heart Arrhythmias

Transcription

1 EP Studies, Ablation, and 3-D Cardiac Mapping Diagnosis and Treatment of Heart Arrhythmias April 14, 2018 Territory Manager: Matt Dodge Clinical Account Specialist: Chris Rutherford Regional Technology Specialist: Heidi Helmer 1 Biosense Webster, Inc Business Review

2 Agenda Background & Prevalence of Heart Arrhythmias History & Development of EP Technology The EP Study Carto Technology Diagnosis- 3-D Mapping Treatment- Ablation Therapy

3 What exactly is Cardiac Electrophysiology? Electrophysiology (EP) is the branch of invasive cardiology which deals with the diagnosis and treatment of abnormal heart rhythms (EP studies/ablations/implantable devices) and issues related to autonomic dysfunction resulting in syncope

4 Historical Highlights of How EP Has Developed 1969: Ben Scherlag PhD describes method of recording HIS bundle electrograms, essentially opening the field of clinical EP 1970 s Refinement in concepts of programmed stimulation for arrhythmia study (Mark Josephson et al) 1978 Mirowski describes preliminary ICD data in dogs, human implants soon follow RF ablation techniques developed at University of Oklahoma (Jackman) Present Day: 3-D Mapping/Biventricular Pacing/Transvenous/Pulmonary Vein Isolation..

5 Common Tachyarrhythmias Studied in the EP Lab - Paroxysmal Supraventricular Tachycardia (PSVT) Frequency of 2.3 per 1000 in US Atrial Ventricular Nodal Tachycardia (AVNRT) * 60% of PSVT Atrial Ventricular Reciprocating Tachycardia (AVRT) * 30% of PSVT Atrial Tachycardia (AT) * 10% of PSVT - Atrial Flutter (AFL) - Atrial Fibrillation (AF) Highest Frequency of all Tachyarrhythmias in general population - Ventricular Tachycardia (VT) Approximately 300,000 deaths per year in US Orejarena LA, Vidaillet H Jr, DeStefano F, et al. Paroxysmal supraventricular tachycardia in the general population. J Am Coll Cardiol. 1998;31(1): McNally B, Robb R, Mehta M, Vellano K, Valderrama AL, Yoon PW, et al. Out-of-hospital cardiac arrest surveillance --- Cardiac Arrest Registry to Enhance Survival (CARES), United States, October 1, December 31, MMWR Surveill Summ Jul (8):1-19

6 Afib Has Significant Medical, Economic and Quality of Life Impacts Atrial fibrillation (Afib) is the most common heart rhythm disorder in the U.S. 1 More than 50% of patients don t respond to or cannot tolerate drug therapy 2 Afib increases a person s risk for stroke five-fold 3 Condition can have a significant negative impact on quality of life 4 In the U.S. alone, Afib puts an estimated $16 billion burden on the health care system each year 5 3 million in the U.S. and 20 million worldwide affected by Afib; prevalence projected to increase significantly as population ages Fibrillation-AFib 2. Calkins et al. Circ Arrhythm Electrophysiol 2009;2: Wolf et al. Stroke 1991;22: Deaton et al. Heart Lung 2003;32: Piccini et al. Circ Cardiovasc Qual Outcomes. 2012;5: Chugh et al. Circulation 2014;129: THERMOCOOL Navigation Catheters are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO Systems (excluding NAVISTAR RMT THERMOCOOL Catheter).

7 Prevalence of Atrial Fibrillation 3.1 Million +1 Million by 2020 <10% Mission: provide better access to those eligible patients for ablation therapy Chugh et al. Circulation 2014;129:

8 Drug Resistant Paroxysmal Afib Remains Significantly Undertreated There are over 3.5 million patients diagnosed with atrial fibrillation in the US, making it a significant area of interest for healthcare providers. How many of these patients are effectively treated with ablation therapy? What percentage of the patients eligible actually receive the treatment? The 2017 AHA/ACC/HRS Guidelines for AFib Management provide the highest level of recommendation (Class 1, Level of Evidence: A) for catheter ablation as treatment for drugrefractory, symptomatic paroxysmal AFib. 1. Applies US Census population data and internal calculations to: Chugh SS1 et al. Circulation Feb 25;129(8): Chiang CE1 et al. Circ Arrhythm Electrophysiol Aug 1;5(4): Calkins et al. Circ. Arrhythm Electrophysio 2009;2: January CT, Wann LS, Alpert JS, Calkins H, et al AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation: Executive Summary. J Am Coll Cardiol. 2014;64(21):

9 U.S. Ablation Procedure Volume 400, , , , , , , , , , , , , , , , ,190 CAGR AF 16.6% VT 5.8% AFL 3.9% 100,000 SVT 2.7% 50,000 ALL 9.8% Catheter ablations are projected to continue increasing over the next five years THERMOCOOL Navigation Catheters are approved for drug refractory recurrent symptomatic atrial fibrillation, when used with CARTO Systems (excluding NAVISTAR RMT THERMOCOOL Catheter) Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission. As these estimates are from a third party source, Biosense Webster, Inc. does not make and hereby disclaims any and all representations or warranties relating to the sufficiency and/or accuracy of the information provided by Millennium Research Group and shall not in any way be liable for the same.

10 So What is an EP Study and Catheter Ablation? An Electrophysiology (EP) Study is a diagnostic test to measure the electrical conduction properties of the heart and diagnose arrhythmias or other conduction abnormalities. A Catheter Ablation is the treatment of these arrhythmias by applying energy such as radiofrequency (RF), at an intensity level strong enough to convert the targeted area into non-conductive scar tissue.

11 Look Familiar?

12 The EP Study Setup Patient arrives in the EP or Cath lab, is transferred onto a fluoroscopy exam table and prepped 12 lead Defibrillator NIBP Cuff or placement of radial art line Oxygen and O2 monitor Site skin prep which will vary some depending on access sites Sterile drape Conscious sedation or Anesthesia Other per Lab or physician (anatomical positioners, Capnography, extra IV, etc.)

13 The EP Study Access Venous access is obtained and percutaneous access sheaths are placed A modified Seldinger approach with a 7cm needle is used to insert a guidewire into the access site Common access sites are RFV, LFV, RIJ vein, or a combination thereof Multiple sheaths may be placed at a single access site Sheaths are inserted over the wire Sheaths vary in size from 6fr to 9fr Most sheaths are 11cm but specialized sheaths can be up to 77cm plus in length Arterial access may also be placed via RFA/LFA

14 Access Locations Internal Jugular (IJ) Subclavian Vein Subclavian Vein Brachial Vein Right Femoral Artery (RFA) Right Femoral Vein (RFV) Left Femoral Artery (LFA) Left Femoral Vein (LFV)

15 Catheter Placement Under fluoroscopy, two or more specialized diagnostic catheters are inserted via the previously placed sheaths and guided through the venous system into the heart and positioned at specific areas of the conduction system. Platinum rings on the catheters, called Electrodes, are used to pace and record electrical signals from the respective cardiac tissue they are in contact with. The most common placements are: HRA (high right atrium) near Sinus Node for Atrial pacing and recording HIS Bundle used to assess the AV Node CS (Coronary Sinus) - for recording of simultaneous RA/LA/RV/LV signals RVA (Right Ventricular Apex) for ventricular pacing and recording The recorded signals are sent to a monitoring system via a high tech amplifier and displayed on a monitor screen for the Electrophysiologist to view and assess.

16 4 to 10 French Fixed curves Steerable 4 20 electrodes per catheter Different curves designed to fit specific anatomical locations EP Catheters Biosense Webster, Inc.

17 Standard Catheter Placement For an EP Study and Associated Signals

18 Conduction System Quick Review SA Node Internodal Tracts and Bachman s Bundle His Bundle AV Node Bundle Branches Purkinje Fibers

19 Normal Conduction Normal cardiac conduction pathway 19 Biosense Webster, Inc Business Review

20 Normal Sinus Rhythm Starts at the SA Node Normal intrinsic rate BPM Propagates across both RA and LA simultaneously 20 Biosense Webster, Inc Business Review

21 Normal Sinus Rhythm Spreads rapidly Across the atrial tissue causing both atria to contract P-Wave Forces blood into the ventricles 21 Biosense Webster, Inc Business Review

22 Normal Sinus Rhythm Controlled propagation AV Node : Gate Keeper AV delay allows the ventricles to fill with blood from the atria 22 Biosense Webster, Inc Business Review

23 Normal Sinus Rhythm Rapid conduction Right Bundle Branch Left Bundle Branch 23 Biosense Webster, Inc Business Review

24 Normal Sinus Rhythm Ventricles depolarize QRS Ventricular contraction occurs forcing blood from both the RV and the LV. 24 Biosense Webster, Inc Business Review

25 Normal Sinus Rhythm Ventricular repolarization T-Wave Resting phase Most vulnerable time 25 Biosense Webster, Inc Business Review

26 Baseline Measurements and Programmed Stimulation Baseline conduction times for any patient is the first task in an EP Study and is performed in SR Defines the patient s normal resting state and conduction system characteristics Activation pattern is recorded and conduction times are measured Can identify possible areas of abnormal conduction and concern when compared to established norms In the EP lab, both beats per minute (BPM) and cycle length (CL) can used to measure heart rate and conduction times. However CL, which is measured in milliseconds (ms), is the favored method Small measurements ( ms) are common and these don t translate well into bpm Conversion can be done using formulas if necessary 60000/HR=CL in MS or 60000/CL=HR in BPM Thus a HR of 60 bpm = CL of 1000 ms and vice versa

27 Induction of Dysrhythmia After baseline measurements are obtained, the physician will attempt to induce a dysrhythmia. The chamber (atria or ventricles) are paced with varying pacing maneuvers. These maneuvers mimic physiologic states where tachycardia can start due to depolarization and repolarization states. Pharmacological intervention may be used at this time. Once a tachycardia is induced, the physician will diagnose the rhythm to determine appropriate ablation strategy.

28 Pacing w/extra Stim Induction of SVT Biosense Webster, Inc.

29 Sustained AVNRT

30 SVT can be cured with catheter ablation by applying radiofrequency (RF) energy at the site of SVT origin or critically contributing tissue, creating a permanent scar Catheter Ablation

31 Functional Principle of RF Application Radio Frequency current is passed through the patient circuit. The tissue around the probe tip is heated by the electric current. Power Release The rise in tissue temperature causes a lesion and permanently interrupts transmission of myocardial signals. The tip does not get hot directly. The temperature rise takes place directly in the tissue and is measured by the tip.

32 RF Circuit Circuit consists of RF generator, catheter and indifferent electrode Patient is integral part of the circuit V = I/R

33 In the Beginning There was Fluoro Significant X-ray exposures to patient, Staff, and physician 2D Imaging in a 3D world Moderate accuracy with low confidence in ablation catheter placement reproducibility Orientation issues demanding frequent imaging from multiple angles

34 The Modern Age...3D Mapping Xray usage minimized and thus radiation exposure greatly reduced Very high catheter placement reproducibility/accuracy Visual displays of electrical propagation in the heart Ability to graphically display target areas in the heart

35 Biosense Webster, Inc. Here to Partner with You

36 A Long Legacy of Innovation 1995 CARTO System The innovation and ground-breaking realtime 3D electroanatomical mapping system goes global 1996 NAVISTAR Catheter Approved in Europe for ablation, this milestone signaled an important advance: the first combination diagnostic and ablation catheter 1997 THERMOCOOL Catheter The world s first irrigated-tip catheter is launched in Europe 1997 LASSO Catheter The approval of the world s first circular mapping catheter enables clinicians capture recording from the pulmonary veins 2005 CARTOMERGE Module First module combining precision CARTO XP System maps with pre-acquired 3D CT or MRI images 2006 CARTOSOUND Module The CARTOSOUND Module integrates real-time 3D imaging with intracardiac echo 2009 CARTO System The CARTO System revolutionizes 3D mapping technology by increasing the accuracy, speed and efficiency of the procedure 2009 CARTO CFAE Module Efficiently identify complex fractionated atrial electrograms (CFAE) Find key areas of interest and automatically detects CFAE signals on a 3D map

37 A Long Legacy of Innovation 2010 CARTO Express The CartoXPress Module for the Carto XP System provides fast mapping and enhanced visualization of the Lasso NAV Catheler toop to help you see the target chamber and your primary catheters clearly and accurately 2010 CARTO FAM Module FAM allows you to quickly build a map with Carto system accuracy by using a sensor-based catheter, such as the NaviStar Catheter or Fixed Lasso NAV Catheter 2011 THERMOCOOL SF Catheter Featuring advanced irrigation technology, this catheter maximizes cooling of the catheter tip and optimizes fluid delivery with half the flow rate of earlier Biosense Webster, Inc. generation of catheter without porous tip technology 2011 CARTO 3 System MEM Version The approval of the world s first circular mapping catheter enables clinicians capture recording from the pulmonary veins 2011 CARTO AccuRESP Module The new AccuRESP Module reduces effects of respiration motion for a new level of mapping 2012 CARTOUNVU Module Enabling clinicians to seamlessly merge a static fluoro image with real-time cardiac maps into a single, accurate 3D view 2013 CARTO VISITAG Module The first technology to incorporate parameters of lesion formation that can be indexed by the user according to their ablation strategy 2013 PASO Module The first technology to integrate pace mapping with three-dimensional mapping the PASO Module streamlines VT pace mapping and facilities fast identification of the VT target site 2014 THERMOCOOLSMARTTOUCH Catheter A therapeutic catheter to enable the direct and real time measurement of contract force during catheter ablation procedures

38 A Long Legacy of Innovation

39 Biosense Webster, Inc. Clinical Support Team Physician Support Procedure Efficiency Product Expertise Technical Support and Troubleshooting Training and Education for EP Lab staff

40 The CARTO 3 System: Actionable Insights The CARTO 3 System Many Arrhythmias, One Solution

41 Strategic roadmap Three Areas of Focus THERMOCOOL SMARTTOUCH SF Catheter Reproducible ablation parameters Temperature feedback integration Lesion estimation

42 CONFIDENSE Mapping Module Overview Multi-Electrode-Mapping (MEM) allows acquisition of a large quantity of points, supporting rapid creation of a more detailed map. Unmet Need: Manual validation of the data in a electro-anatomical high-density map is time consuming. Solution: CONFIDENSE provides rapid acquisition and annotation of points to create high-density maps Sophisticated automation designed to introduce a new degree of insight and increased efficiency

43 CONFIDENSE Mapping Module Integrated Insights CONFIDENSE Mapping Module is a suite of four integrated software programs that support creation and validation of high density maps. Continuous Acquisition Tissue Proximity Indicator (TPI) Wavefront Annotation Map Consistency Automatically acquires points that meet physicians preselected criteria Clearly identifies points that are in close proximity to cardiac tissue A novel algorithm provides automatic and consistent annotation Identifies and evaluates points whose timing is judged to be inconsistent in comparison with neighboring points

44 CARTOREPLAY TM Module Overview Unmet Need: Until now, the only option physicians had to review electrogram data for the entire study was on a recording system. Recording systems do not provide indication of catheter location at the time the electrogram is recorded. Solution: CARTOREPLAY Module provides physicians the means to review retrospective* data and procedural events that were recorded by the CARTO 3 System throughout the entire study. Dual monitors allow the display of CARTO 3 System across two screens for a truly streamlined workflow. * For 18 hours from study start Designed to introduce a new degree of insight and increased efficiency

45 Locate Where to Ablate: Ripple Mapping Ripple Mapping designed to increase efficiency in interpreting arrhythmia mechanisms by: Displaying simultaneous dynamic visualization of entire chambers voltage data over time Showing arrhythmia circuit propagation over chamber independent of window of interest

46 CARTO SMARTTOUCH Technology How Does It Work? We ve combined our catheter technology with a graphic user interface displayed on the CARTO 3 System monitor. Poor tissue contact May result in incomplete lesion formation First therapy FDA approved in the U.S. to enable direct and real-time measurement of contact force during catheter ablation. Too much contact force May result in tissue injury Heart Wall

47 CARTO SMARTTOUCH Technology Delivers a new measure of success In the multicenter SMART-AF clinical study*, the THERMOCOOL SMARTTOUCH Catheter: Success Rate After One Year 90% 88% Demonstrated an overall success rate of 74%* 80% 70% 63% 74% When physicians stayed within a targeted contact force range > 85% of the time, success rates increased up to 88% 60% 50% Tradional catheter with no CF technology THERMOCOOL SMARTTOUCH Catheter THERMOCOOL SMARTTOUCH Catheter CF Rane >= 85% *Success defined as freedom from any symptomatic atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 12 months postprocedure when operator remained in the preset contact force range. Further sub-analysis showed that when the contact force was within investigator-selected range 85% of time, success rate increased by 21% to 88% ( 85%: n=32; <85%: n =73).

48 SMARTABLATE System Integrated Generator, Pump and Remote Control: Single-touch settings for control of all parameters Real-time data and summary screen for procedural information Connection overview displays status of all circuits to the system Flow rate adjusts automatically when RF power is modified Easy-to-load tubing simplifies setup

49 A Strategic Roadmap Provides Acute Focus STRATEGIC APPROACH Biosense Webster, Inc. SOLUTION Locate Where To Ablate Advanced Mapping & Persistent AF Solution Deliver Better Lesion Contact Force Sensing & Lesion Assessment Simplify the Procedure Multi-Ablation & Single Shot Device

50 Clinical & Technical Support Clinical Account Specialists Provide clinical support on the use of the Biosense Webster,Inc. portfolio of products. Streamline workflows to help reduce procedure time Technical Services Work with hospital to ensure equipment is installed properly and runs smoothly

51 CARTO 3 System: EP Lab - Seamless Integration CARTO 3 System SMARTABLATE System Ultrasound CardioLab Fluoroscopy Odyssey HARDWARE SOFTWARE MODULES Therapeutic Diagnostic Ultrasound Sustainability DISPOSABLE CATHETERS

52 THANK YOU!!