1. Atrial Fibrillation:Continuum of CareHarpreet S. Grewal, MD, FACC, FHRSDirector, Cardiac ElectrophysiologyNovember 14, 2014 2. AFs Increasing Impact on Healthcare Highly symptomatic and affects quality of life Accounts for 15% of all stroke in U.S. Increasing prevalence due to aging population1 Friberg L et al. Stroke in paroxysmal atrial fibrillation: report from the Stockholm Cohort of Atrial Fibrillation. Eur Heart J 2010 31 (8):967-975.2 Fuster V, et al ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of theAmerican College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of CardiologyCommittee for Practice Guidelines Eur Heart 2006 J 27 (16):1979-2030.3Miyakasa et al. Circulation. 2006;114:119-125 3. Cost of AF on the Healthcare System Direct medical costs are 73% higher in AF patients National cost is between $6-26 billion* Includes costs for claims with a primary AF diagnosis and claims for antiarrhythmic drugs Includes costs for claims with a primary cardiovascular diagnosis (excluding AF) and claims for non-antiarrhythmic cardiovascular drugs AF, atrial fibrillation, CV, cardiovascular, OP, outpatientEstimation of Total Incremental Health Care Costs in Patients with Atrial Fibrillation in the United States. Kim et al. Circ Cardiovasc Qual Outcomes 2011;4:313-320 4. AF Affects Atrial Mechanical Function 5. Various Mechanisms Contribute to AF 6. Impact of Aging and Obesity on AF Prevalence BMI is a determinant of left atrial size Left atrial enlargement is a precursor to AFObesity and the Risk of New-Onset Atrial Fibrillation. Wang et al. JAMA 2004;294:2471-2477 7. Subtypes of AF AF Episode:AF documented by ECG monitoring and has a duration of at least 30s Paroxysmal:recurrent AF (2 episodes) that terminates spontaneously within 7 days Persistent:AF sustains >7 days, or lasts less than 7 days but necessitatespharmacologic or electrical cardioversion Longstanding persistent (permanent):AF that persists despite pharmacologic or electrical cardioversionCalkins et al. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of AF. Hearty Rhythm, Vol 9, No 4, April 2012 8. 2011 ACCF/AHA/HRS AF Treatment Guidelines 9. Anticoagulation TherapyAnticoagulation therapy for patients undergoing catheterablation for AF should be done in accordance with 2012HRS/EHRA/ECAS Expert Consensus Statement onCatheter and Surgical Ablation of AFThe safety of discontinuing anticoagulation therapy followingcatheter ablation of atrial fibrillation has not beenestablished; anticoagulation therapy in such patientsshould be administered in accordance with the 2012HRS/EHRA/ECAS Expert Consensus Statement onCatheter and Surgical Ablation of AFCalkins et al. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of AF. Hearty Rhythm, Vol 9, No 4, April 2012 10. Anticoagulation Therapy 11. Rhythm Control is Superior to Rate Control and MayImprove Long-Term CareRate control: minimize symptoms and reduce heart rateRhythm control: restore and/or maintain sinus rhythmA large retrospective, population-based study with long-termfollow-up investigated rate vs. rhythm control strategiesFindings suggest the mortality was similar between the two groups untilyear 4 but decreased steadily in the rhythm control group after year 5.Rhythm control therapy is superior in the long-termIonescu-Ittu et al. Comparative Effectiveness of Rhythm Control vs Rate Control Drug Treatment Effect on Mortality in Patients With Atrial Fibrillation. Arch Internal Medicine Vol 172. No. 13 July 2012 12. Rhythm Vs. Rate Control Have Similar Long-Term Effects toMortality Reduction 13. Long-Term Research: The Cabana Clinical Trial Study compares RF ablation vs. antiarrhythmic drug therapy for AF Includes Cost comparison QOL comparison Results expected in 2015 10 research centerswww.cabanatrial.org 14. AF is a Progressive DiseasePappone et al. Atrial Fibrillation progression and management: A 5 year prospective follow-up study. Heart Rhythm, Vol 5, No11 November 2008 15. AF is a Progressive Disease AF is more likely to progress once it becomes persistent Patients with comorbidities such as age, heart failure anddiabetes are more likely than those with lone AF toprogress As AF progresses, the heart becomes more fibrotic AF is more difficult to treat, the more it progresses AF progression is associated with increased risk formorbidity and mortalityPappone et al. Atrial Fibrillation progression and management: A 5 year prospective follow-up study. Heart Rhythm, Vol 5, No11 November 2008 16. Progression of AF Less Likely with RhythmControl Strategy Record AF was a worldwide prospective survey of AF management(N=2,137) Progression of AF occurred in 15% of patients after the 1st year Rhythm control patients were less likely to show progression thanrate control 11% rhythm control group showed AF progression 26% rate control group showed AF progression Of the patients with AF progression: 61% had developed permanent AF 39% had developed persistent AFDeVos et al. Progression of atrial fibrillation in the registry on cardiac rhythm disorders assessing the control of atrial fibrillation cohort: Clinical correlates and the effect ofrhythm-control therapy. Am Heart J 2012, 163:887-93 17. Effect of Catheter Ablation on Progression of PAFRF ablation reduces the rate of progression of paroxysmal AF to persistent AF. Age,duration and diabetes are independent risk factors for progression to persistent AF afterRF ablation.Jongnaransin et al Effect of Catheter Ablation on Progression of Paroxysmal Atrial Fibrillation J Cardiovasc Electrophysiol, Vol. 23, pp. 9-14, January 2012 18. High Adverse Events with ADT 19. Efficacy of ADT vs. Catheter Ablation 20. RF Ablation Studies for AF Report Higher Efficacy Ratesthan Studies of AAD TherapyMeta-analysis comparing RF catheter ablation andantiarrhythmic drug therapy (ADT) Patients free of AF recurrence: 77% of RF catheter ablation (n=3,562) 52% of Antiarrhythmic drug therapy (n=3,180) Complication rates: 5% RF Catheter ablation 30% Antiarrhythmic drug therapyCalkins et al. Treatment of Atrial Fibrillation With Antiarrhythmic Drugs or Radiofrequency Ablation: Two Systematic Literature Reviews and Meta-Analyses Circ ArrhythmElectrophysiol 2009;2;349-361 21. RF Ablation Lowers the Risk of Death, Stroke andDementiaBunch et al. Patients Treated With Catheter Ablation for Atrial Fibrillation Have Long-Term Rates of Death, Stroke and Dementia Similar to Patients Without AtrialFibrillation. J Cardiovasc Electrophysiol, Vol. 22, pp. 839-845, August 2011 22. RF Catheter Ablation Reduces the Risk of Stroke/TIAThe study found a significant difference in the risk of stroke/TIA between the twogroups. 3.4% RF ablation group 5.5% non-ablation group (antiarrhythmic drug therapy)Reynolds et al. Health Outcomes with Catheter Ablation or Antiarrythmic Drug Therapy in Atrial Fibrillation, Results of a Propensity-Matched Analysis. Circ Cardiovasc Outcomes. February 28,2012 23. AF Significantly Reduces Quality of LifeDorian et al. The Impairment of Health-Related Quality of Life in Patients With Intermittent Atrial Fibrillation: Implications for the Assessment of Investigational Therapy JACC Vol. 36,No. 4, 2000 24. RF Ablation Improves Patient Quality of LifeReynolds et al. Improvements in Symptoms and Quality of Life in Patient With Paroxysmal Atrial Fibrillation Treated with Radiofrequency Catheter Ablation Versus Antiarrhythmic Drugs.Circ Cardiovasc Qual Outcomes. 2010;3:615-623.) 25. RF Ablation Improves Patient Quality of LifeReynolds et al. Improvements in Symptoms and Quality of Life in Patient With Paroxysmal Atrial Fibrillation Treated with Radiofrequency Catheter Ablation Versus AntiarrhythmicDrugs. Circ Cardiovasc Qual Outcomes. 2010;3:615-623.) 26. RF Catheter Ablation is Safe & Effective in Octogenarians Up to 10% of people over 80 have AF Up to 25% of strokes in this group are due to AF This study compared safety and efficacy of RF ablation in two groups; greater andless than 80 years Success rates and complications were similar between the two groupsSantangeli et al. Catheter Ablation of Atrial Fibrillation in Octogenarians: Safety and Outcomes. J Cardiovasc Electrophysiol, Vol. 23, pp. 687-693, July 2012 27. Advances in Techniques/Technology Have ImprovedSuccess Rates CARTO 3 EP Navigation System allows forvisualization of the cardiac anatomy andelectrical signals in 3-D Irrigated RF ablation catheters can beprecisely navigated with accuracy +/- 1mm 3-D visualization of anatomy and cathetersreduces the need for fluoroscopy**Always verify catheter tip location using fluoroscopy or IC signals and consult the Carto System User Guide regarding recommendations for fluoroscopy use. 28. Integration with Leading Technologies Optimizes Procedures Pre-acquired images from CT or MRIscans can be anatomically registeredto CARTO System maps Integration with ACUNAV cathetersprovides real-time intracardiacultrasound imaging, registered withthe CARTO 3 System maps Fluoroscopy views are registeredand stored on the CARTO 3System, providing one integratedview for streamlined navigation 29. Anatomical Registration To CT And MRI Scans ProvideAdditional Confidence in Navigation Pre-acquired images from CT or MRIscans can be anatomically registeredto CARTO maps Pre-acquired images showingcardiac structures minimize mappingtime during procedure 30. Registration to Real-time Ultrasound Contributes to ProcedureSafety and Efficiency Combines real-time 3-Dintracardiac ultrasound (ICE) intointegrated CARTO maps Minimize time of the left side ofthe heart by generating a 3-Dreconstruction of the left atriumfrom the right atrium Enhances visualization oftransseptal puncture, thrombusformation and RF catheter tip totissue contactCARTOSOUND Image Integration Software ModuleThe CARTOSOUND Image Integration Software Module can reconstruct 3D anatomical structures from a series of ultrasound images captured using theCARTO System SOUNDSTAR Catheter. A series of 90 planar ultrasound slices (left panel) are used to reconstruct a detailed, real-time CARTOSOUNDModule 3D Model (right panel). 31. RF Catheter Ablation with Irrigation Constant irrigation flow lowerstip-to-tissue temperatures andreduces the risk of charring orclotting Creates consistent lesion sizesregardless of tip orientation Bidirectional steering and shaftvisualization improvingorientation, maneuverability andmay reduce the need forfluoroscopyThermoCool SF Catheter with Irrigated Porous Tip*Always verify catheter tip location using fluoroscopy or IC signals and consult the Carto System User Guide regarding recommendations for fluoroscopy use. 32. Thermocool SF Catheter with Surround FlowTechnology Optimizes CoolingTHIN & STRONG WALL Promotes highly efficient internal and external coolingPOROUS TIP Enables maximum cooling efficiency regardless ofcatheter orientationHOLLOW TIP Ensures fluid reaches all areas of the tip at evenpressureDIVERTERS & CENTRALIZED SENSOR Promote uniform flow within the tipAtsushi Ikeda; Hiroshi Nakagawa; Tushar Sharma; Jan V Pitha; Ralph Lazzara; Warren M Jackman Univ of Oklahoma Health Sciences Cntr,Oklahoma City, OK. Comparison of 12 and 56 Hole Open Irrigation Electrodes in Electrode Cooling, Radiofrequency Lesion Depth, and Thrombus;Circulation. 2010; 122: A13198 33. The Lasso Catheter Efficiently Maps Signals fromthe Pulmonary Veins Adjustable tip providesexcellent tissue contactand maneuverability Catheter may be used formapping and validation ofblockThe LASSO Circular Mapping CatheterThe LASSO Circular Mapping Catheter provides high resolution mapping for catheter ablation procedures and is available in various fixed sizes and as a LASSO 2515 NAVVariable Catheter with an adjustable loop diameter from 15 mm to 25 mm. 34. The Ablation ProcedureA minimally invasive technique in whichradiofrequency (RF) energy is used toneutralize small areas of the heart tissuethat generate and conduct abnormalelectrical activity, the source of thearrhythmiaMap Creation VideoAblation Video 35. RF Ablation Involves Lesion Creation to PreventAbnormal Activation RF ablation uses high frequency alternatingcurrent to eliminate or alter thearrhythmogenic substrate An ablation catheter is used to apply RF tothe endocardium to produce continuouslesions (scars) that prevent the abnormalelectrical activation contributing to AF The most common lesion sets includecircling of the pulmonary veins (PVs) calledcircumferential PV isolationSource: Adapted from Calkins H, Brugada J, Packer DL et al. (2007) HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation:recommendations for personnel, policy, procedures and follow-up. A report of the HRS Task Force on Catheter and Surgical Ablation of Atrial Fibrillation developed in partnership withthe EHRA and the ECAS; in collaboration with ACC, AHA, and the STS. Endorsed and approved by the governing bodies of the ACC, AHA, ECAS, EHRA, STS, and the HRS.Europace 9(6):335-379. 36. Case Study Patient characteristics: Age, gender, duration of AF, left atrial size,comorbidities, pharmacological history Ablation procedure utilized: linear, focal, isolation, circumferential,CFAE, combined, etc. Patient Outcomes: AF free, time to AF recurrence, other atrialarrhythmias, quality of life, post-procedure AAD therapy, rhythm controland stroke risk control Complications: adverse events (PV stenosis, stroke, fistula, otherarrhythmias, tamponade, second ablation) 37. Conclusion AF is a progressive disease. The longer the duration of thedisease, the more difficult it is to restore/maintain sinus rhythm RF catheter ablation for paroxysmal AF has been demonstratedto be safe and effective for patients that are refractory orintolerant to antiarrhythmic drugs RF ablation has been demonstrated to have a less AFrecurrences and improves quality of life as compared toantiarrhythmic drugs Referring patients for early intervention, will reduce patientmanagement complexity 38. VIDEO FOR THE ABLATION PROCEDURECREATING THE MAP Return 39. VIDEO FOR THE ABLATION PROCEDUREAF ABLATION Return 40. Introduction to Subtle ClosedChest AblationApril 2014The Numeris & EPiSense Guided marketed systems areindicated for endoscopic coagulation of cardiac tissue. 41. Introduction to SubtleClosed Chest AblationThe Numeris & EPiSense Guided marketed systems areindicated for endoscopic coagulation of cardiac tissue. 42. Epicardial Endoscopic Ablation SystemThe Numeris & EPiSense Guided marketed systems areindicated for endoscopic coagulation of cardiac tissue. 43. Epicardial Endoscopic Ablation SystemThe Numeris & EPiSense Guided marketed systems areindicated for endoscopic coagulation of cardiac tissue. 44. What is Benefit of Epicardial Ablation?Long Linear Lesions; DirectionalityEpicardial vs Endocardial AblationBased On IFUsnContact Settings:30 watts for 90 seconds4.5ml/min perfusion flow: 7mmdepthThermoCool Settings:25 watts for 60 seconds30ml/min perfusion flowNo Temperature Control: 3mmdepth 45. What is Benefit of Epicardial Ablation?Long Linear Lesions; DirectionalityEpicardial vs Endocardial AblationBased On IFUsnContact Settings:30 watts for 90 seconds4.5ml/min perfusion flow: 7mm depthThermoCool Settings:25 watts for 60 seconds30ml/min perfusion flowNo Temperature Control: 3mm depth 46. SUBTLE Closed Chest AccessSUBTLE AccessSUBTLE access enables a transdiaphragmatic approach that provides the ability to access theposterior region of a beating heart. The closed chest approach offers surgeons direct visualization tothe posterior of a beating heart through endoscopes, enabling the ability to create bi-atrial, linearlesions without chest incisions or ports. 47. SUBTLE Closed Chest AccessSUBTLE AccessSUBTLE access enables a transdiaphragmatic approach that provides the ability to accessthe posterior region of a beating heart. The closed chest approach offers surgeons directvisualization to the posterior of a beating heart through endoscopes, enabling the abilityto create bi-atrial, linear lesions without chest incisions or ports. 48. SUBTLE Closed Chest AccessAddressed Technical Limitations Better ablation device design / abilityto create complete lesions Direct visibility (endoscopic) Better access (SUBTLE) Posterior isolation48Midline Incision SUBTLE Access 49. SUBTLE Closed Chest AccessAddressed Technical Limitations Better ablation devicedesign / ability to createcomplete lesions Direct visibility (endoscopic) Better access (SUBTLE) Posterior isolation49Midline Incision SUBTLE Access 50. Electrosilencing Posterior Left AtriumDirect Visibility AF Foci Located Along PVTissue Posterior LA DerivesEmbryologically from PVs PVI Does Not AddressReentrant Circuits Need to Ablate Posterior LAto Prevent WaveletsSUBTLE Access EnablesVisualization & Ablation ofPosterior LA 51. Electrosilencing Posterior Left AtriumDirect Visibility AF Foci Located Along PVTissue Posterior LA DerivesEmbryologically from PVs PVI Does Not AddressReentrant Circuits Need to Ablate Posterior LAto Prevent WaveletsSUBTLE Access EnablesVisualization & Ablation ofPosterior LA 52. Multidisciplinary Animation 53. Multidisciplinary Animation 54. Paracardioscopic AccessTransdiaphragmatic Approach to Posterior Atria 55. Paracardioscopic AccessTransdiaphragmatic Approach to Posterior Atria 56. Accessing Posterior Left AtriumCreating Lesions with Direct Visualization 57. Accessing Posterior Left AtriumCreating Lesions with Direct Visualization 58. Access Anterior LPV & Ligament ofMarshall 59. Access Anterior LPV & Ligament ofMarshall 60. Access Anterior RPV & Right Atrium 61. Access Anterior RPV & Right Atrium 62. Percutaneous Endocardial AblationPercutaneous AccessBreakthrough Locations @ PericardialReflections 63. Percutaneous Endocardial AblationPercutaneous AccessBreakthrough Locations @ PericardialReflections 64. Endocardial Ablation LocationsMapping Identifies Breakthrough @ Reflections 65. Endocardial Ablation LocationsMapping Identifies Breakthrough @ Reflections 66. Epicardial Ablation Video 67. Epicardial Ablation Video 68. Multidisciplinary StrategyLeveraging Best Techniques 69. Multidisciplinary StrategyLeveraging Best Techniques 70. Published/Presented OutcomesStudyv% Persistent /Longstanding AFMonitoring Level Procedure Efficacy RedosSerious AdverseEvent Rate5Gilligan D, et alEJICRM Oct 2013. In PressN=4281%Med72h Holter95% @ 1 yr181% @ 1 yr2 6% 4.7%Civello K, et alEJICRM Sept 2013:1-7. Epub.N=10473%Med72h Holter88% @ 1 yr172% @ 1 yr3 2.8%0% < 7d(5.8% > 7d)Gersak B, et alEJTCVS 2014;147-1411-6.N=73100%HighReveals or 7d Holters80% @ 1 yr176% @ 1 yr4 4% 11.0%Thosani AJ, et alAAER 2013;2(1):658.N=4386%Med2wk Monitors89% @ 6 mo1 NR 0%Robinson MC, et alAEP Lab Digest 2012;13(6):34-36.N=42100%MedEKG & Holter Monitors89% @ Avg 13 mo169% @ Avg 13 mo3 4.8% 7%Gersak B, et alAJCE. 2012;23:1059-66.N=5094%HighAll Reveals88% @ 1 yr175% @ 1 yr3 2% 10.0%Gehi AK, et alAHeart Rhythm 2013;10:2228.N=10183%(Avg CHADS = 2.1)MedReveal & Holter79.7% @ 1 yr170.5% @ 1 yr1(Survival Analysis)6% 6%Olson J, et alBBoston AF 2012N=11583.5%Med72h Holter84% @ Avg 11.4 mo177% @ Avg 11.4 mo264% @ Avg 11.4 mo34% 6.1%Golden K, et alBHRS 2012N=6188%Med72h Holter79% @ Avg 11 mo166% @ Avg 11 mo3 8% 3.3%Kiser AC, et alAInnovations 2011;6:243247.N=6592%Med/HighReveal or 24h Holter88% @ 1 yr183% @ 1 yr3 NR 7.7%1Efficacy = Sinus Rhythm; 2Sinus Rhythm & No AAD Tx; 3Sinus Rhythm & Off AADs; 4Sinus Rhythm & No Interventions; 5Safety = 30-Day Adverse EventsAPublished Article; BPublished/Presented Abstract; CAccepted Abstract; DSubmitted Article; EAccepted Article 71. Reveal Monitoring OutcomesPublished AF BurdenLow Rate of Atrial Fibrillation Recurrence Verified byImplantable Loop Recorder Monitoring Following a Convergent Epicardial and EndocardialAblation of Atrial FibrillationBORUT GERSAK, M.D., Ph.D., ANDREJ PERNAT, M.D., Ph.D., BORIS ROBIC, M.D., and MATJAZ SINKOVEC, M.D.,Ph.D.,Reveal Monitoring AF Burden at 6, 12 and 24 monthsAF Burden Threshold 6 month 12 month 24 month0.2% 72%(31/43) 56% (18/32) 53% (8/15)0.5% 74%(32/43) 66% (21/32) 60% (9/15)1.0% 77% (33/43) 75% (24/32) 73% (11/15)2.1% 79% (34/43) 73% (24/32) 80% (12/15)3.0% 81% (35/43) 81% (26/32) 87% (13/15)4.2% 81% (35/43) 84% (27/32) 87% (13/15)7 min/day. Threshold based on published Reveal XT outcomes in drug refractory paroxysmal AF prospective randomized study.14 min/day. Threshold based on published catheter ablation outcomes comparing continuous monitoring at 10 min/day to 24-hour, 48-hour, and7-day Holters.30 min/day. Threshold based on cutting HRS recommendations of cumulative AF time in half; the duration of each individual episode wasnot available.43 min/day.1 hour/day. Threshold based on HRS recommendations of cumulative AF time since the duration of each individual episode was not available to compare against the 30seconds limit. 72. Reveal Monitoring OutcomesPublished AF BurdenLow Rate of Atrial Fibrillation Recurrence Verified byImplantable Loop Recorder Monitoring Following a Convergent Epicardial and EndocardialAblation of Atrial FibrillationBORUT GERSAK, M.D., Ph.D., ANDREJ PERNAT, M.D., Ph.D., BORIS ROBIC, M.D., and MATJAZ SINKOVEC, M.D.,Ph.D.,Reveal Monitoring AF Burden at 6, 12, and 24 monthsAF Burden Threshold 6 month 12 month 24 month0.2% 72%(31/43) 56% (18/32) 53% (8/15)0.5% 74%(32/43) 66% (21/32) 60% (9/15)1.0% 77% (33/43) 75% (24/32) 73% (11/15)2.1% 79% (34/43) 73% (24/32) 80% (12/15)3.0% 81% (35/43) 81% (26/32) 87% (13/15)4.2% 81% (35/43) 84% (27/32) 87% (13/15)7 min/day. Threshold based on published Reveal XT outcomes in drug refractory paroxysmal AF prospective randomized study.14 min/day. Threshold based on published catheter ablation outcomes comparing continuous monitoring at 10 min/day to 24-hour, 48-hour, and7-day Holters.30 min/day. Threshold based on cutting HRS recommendations of cumulative AF time in half; the duration of each individual episode wasnot available.43 min/day.1 hour/day. Threshold based on HRS recommendations of cumulative AF time since the duration of each individual episode was not available to compare against the 30seconds limit.