Affirm Points. Affirm Issues. Moe Wavelet Experiment. Why are we having this discussion? Progress in Atrial Fibrillation Ablation?

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1 Progress in Atrial Fibrillation Ablation? Why are we having this discussion? Laurent Lewkowiez, MD Director Cardiac Electrophysiology St. Joseph s Cardiac and Vascular Institute Clinical Assistant Professor of Medicine UCDHSC Affirm Issues Affirm Points 37.5% Rhythm group crossed over to rate control 15% Rate group crossed over to rhythm control Patients were treated with best therapy 2/3 started on Sotalol or Amiodarone. 2/3 on Amiodarone at some point during study. Rhythm Control efficacy 82%, 73%,63 % at 1,3,5 Yrs. 80% of patients in rate control met rate controlled goals. Demonstrates suboptimal efficacy of pharmacologic rhythm control Patients and physicians unhappy with current therapeutic options as demonstrated by high crossover Is this applicable to younger population? Were symptomatic patients withheld? Would nonpharmacologic maintenance of sinus rhythm yield same result? Presence of Sinus rhythm and Mortality Moe Wavelet Experiment Risk of death.53 for for patients who maintained sinus rhythm in affirm study. GK Moe, Am Heart J, 7,1959 1

2 Long Term outcome of Cox maze Procedure 178 patients Concomitant Procedure 59(29%) 52% PAF 48% Chronic atrial fibrillation 93% Freedom from atrial fibrillation and aflutter without medications 100% with medications 2.2% Mortality Original Percutaneous Approach to Atrial fibrillation Linear Ablation Swartz Hassaguerre Nadamanee Kay Linear ablation mimicking Maze procedure Long fluoroscopy time minutes Thrombotic Complications Incessant reentrant left atrial tachyardia s due to Gaps in lines. Cox Et al Annals of Surgery 224, september 1996 Catheter Base Linear Ablation Linear catheter ablation tempered enthusiasm 6% Tamponade 5.4% Pacemaker implantation 5.4% CVA 3.4% Pulmonary Vein stenosis 3.3% Pulmonary Embolus 3.3% Pulmonary Hemorrage 2 patients developed Radiation burns Haissaguerre, Catheter ablation of Arrhythmias, 2 nd edition,113 Focal Initiators of atrial fibrillation Triggers and pulmonary vein electrograms 2

3 Landmark evidence regarding initiation of atrial fibrillation 45 patients with paroxysmal atrial fibrillation treated with RF 64% had one focus 20% demonstrated two foci 15.5% demonstrated 3 or 4 foci 80% initial success 62% free of atrial fibrillation at mos Limitations of approach of focal pulmonary vein ablation Triggers difficult to identify Atrial fibrillation masks trigger requiring frequent cardioversion Some patients demonstrated new foci after ablation 56% and 13 % of patients required two or three ablations attempts respectively Limited efficacy 40% asymptomatic PV stenosis Chen et al circ 199;100 Pulmonary vein stenosis (Cleveland clinic) experience Magnetic resonance angiography to identify pulmonary vein stenosis Incidence varied widely with approach. Highest with distal PV ablation(15.5% severe) Lowest with ICE guidance of LA PV junction and microbubbles to predict overheating (1.4% severe) Needed to avoid placing lesions in pulmonary veins due to stenosis. Saad et al, circ,2003;108 Arrhythmia Free Survival % Focal versus Ostial Vein isolation (74) (27) (56) (45) (39) (31) P<0.001 (17) (15) Months (26) (14) (13) (13) Ostial PV Isolation (26) PV Focal ablation (12) Need for real time catheter position and location with respect to pulmonary veins Left Atrial anatomy complex Assessment by fluoro alone difficult Needed means to ablate pulmonary vein foci without damaging veins Gerstenfeld, JCE. 14(4)2003 3

4 Circular Lasso mapping Typical lasso position at vein ostium RSPV RIPV LSPV LIPV RAO LAO Isolation of Pulmonary Vein Foci by Disconnection (----) of the Atrialization of Pulmonary Veins Selected - Based on Electrogram Recordings or Nonselected Pulmonary Vein * * * * Pre Post Tip electrode Electroanatomic Mapping Location sensor (S) C1 D1 S D3 Ring electrode D2 C2 Puller wire magnetic fields Left Atrium C3 C1, C2, C3 represent coils which generate magnetic fields D1, D2, D3 represent the distances from the sensor to the coils Gepstein, L. et al. Circ.95:6, 1612 Electroanatomic Mapping ICE (AcuNav) Guided Transseptal Puncture Ren et al J of Echo,

5 = Intracardiac echo to define pulmonary vein anatomy Intravascular ultrasound Identifies intraprocedural Thrombus Ren et al J of Echo, 2002 Long term efficacy segmental PV Isolation (University of Michigan) 187 consecutive patients two year follow up 70% freedom atrial fibrillation in PAF patients 25% Freedom atrial fibrillation in chronic atrial fibrillation Vagotonic atrial fibrillation predicted failure 2% major complication rate Oral et al, abstract Jacc 828, 3/03/04 Pappone follow up results post atrial fibrillation ablation 251 consecutive pts PAF 85% afib free Chronic afib 68% afib free 11% required drugs 10.5 month f/u 0.8% tamponade No difference between those with complete lines and those without regarding success. Increased Area of Left Atrium ablated correlated with freedom from Afib Pappone et al Circ 2001, Validation of Pappone at (University of Michigan) Validation of Pappone Oral et al, Circ 203;108 Oral et al, Circ 203;108 5

6 Pappone vagal effect The vagal hypothesis Voltage map Pre and Post RF P <.002 Elicited vagal response with RF Attenuated Vagal response Abolished vagal Response pt 100 pt Freedom from Afib at 12 mos No vagal reflex vagal denervation Complex fractionated atrial electrograms( CFAE) a surrogate for slow and complex conduction? Areas of fractionation were stable in patients Septum, PV, Roof La common locations 95% termination after RF of CFAE (28%required Ibutilide) Reproducible results we are all worms, but I do believe that I am a glow worm Sir Winston Churchill Nademanee JACC (43), 2004 Worldwide state of catheter atrial fibrillation ablation First World Wide Survey Published Results 8745 patients from 777 centers, Repeat Ablation in 20 to 40% of patients. Success rate ranges from 15 to 86% Success off antiarrhythmic drugs 15-56% Success rate of ablation generally approaches 70% in the best hands Cappato et al, Cir

7 WWS I Atrial Fibrillation ablation Complication Rates. 6% overall major complication Tamponade 1.2% CVA and TIA 1% PV stenosis.5-1% Groin complication 1% Esophageal fistula.1% Death.1% Defining Outcomes It depends on how you define alone William Jefferson Clinton at Grand Jury Testimony. Consensus Statement Definitions of Success Freedom of Afib/atrial flutter/ atrial tachycardia OFF DRUG RX is the Primary Endpoint Atrial tachycardia and flutter should be considered treatment failures Episodes lasting longer than 30 seconds are considered recurrence Second Worldwide Afib ablation Survey Data Presented at Boston AFib symposium 2009 Included data Success rate 70% versus 52% 10% drug use versus 24% 75% paf, 65% persistent, 63% permanent Single procedural success should be reported in all trials. Calkins, HRS 2007 Second Worldwide Afib ablation Survey Data Centers with greater than 300 procedures per year had success rate greater than 75% off drugs at one year. Although more than one procedure may have been utilized. Complications at High Volume Center 1000 consecutive PVI Death.2% Major complications ( defined as life threatening) 3.9% Tamponade 1.3% Vascular Complication 1.1% Atrial esophageal fistula 0.2% Risk factors for complications, Age over 75 and CHF Degres et al, JCE

8 Complications of Atrial Fibrillation Johns Hopkins data 517 A fib ablation patients 32 major complications(5%), (9%) first 100 cases 7CVA 8 tamponade 1 PV occlusion 11 vascular injury requiring surgery or transfusion Further Advances in Technology Need to improve lesion formation Need to improve catheter localization Need to improve understanding of anatomy Spragg et al, JCE 19, 2008 Open Cooled Catheter Thermacool catheter study Presented at HRS patients unblinded randomized 70% freedom from any atrial fibrillation 63 % freedom of atrial arrhythmia No serious complications( CVA, death, AV block, PV stenosis One half adverse events of AAD,s Excluded patient with > 30 day duration of afib requiring cardioversion( persistent, permanent) Loyola, Univ Oklahoma, University of Pennsylvania, Cleveland clinic, Mass Gen hosp,brigham and Womens Image Integration Image integration Improves outcomes Retospective muliticenter italian study 573 patient Soca vs Carto vs Merge Result 55.4% vs 59.3 % vs 77.4 % Success off drug 35.5% vs 29.2% vs 43.5% Atypical flutter 6.5% vs 15.9% vs 3.9% Complication 2.1% vs 3.7% vs 2.2% Bertaglia et al, Euopace 2009,11 8

9 Improved Electroanatomic mapping Further Image Integration studies Tang et al, 2008 Chinese med,2009 Reduced flouro time no difference in outcome Kistler et al, 2008 Eur Heart Journal No difference in outcome No difference in flouro time. Recurrence in 58% versus 51% at one year Mainly paroxysmal patients Techniques Stepwise approach Linear ablation 1990s Focal atrial fibrillation ablation 1995 Segmental Ostial isolation 2000 Pv antral Ablation 2002 to present Wide area circumferential ablation 2001 Complex fractionated electrogram ablation 2004 Wilbur et al,, PVAI, CFAE, Roof and Mitral lines 90% one procedure Paroxysmal one year no drug 68% one procedure Persistent one year no drugs Hassaguerre stepwise approach Chronic afib ablation 91% success ( requires repeat procedure in 30%) Stepwise Approach 2006 to present PV isolation + CFAE + Linear ablation Jais, JCE 2006 The Future Robotic Catheter Manipulation Theoretical Advantages I think we all agree the past is over George W Bush 2000 Catheter stability allowing for more complete lesions Improved catheter mobility with less experienced Operator Performed from remote location, reducing radiation dose to Operator. 9

10 Robot Catheter Manipulation 71 patients studied Early complications 6 intraoperative, with 4 severe vascular complications 5 severe PV stenosis All major complications during first 27 procedures Requires 14 french introducer 83% success at one year in similar study. Magnetic Catheter manipulation. Less radiation Expand physicians with technical skill to perform AF ablation Reduced perforations Significant cost Wasni et al, JCE, 2009 LL1 Similar efficacy to standard approach(49% after one, 59% after one or two procedures. Fast Reduced experience Increased Phrenic nerve paralysis (4-8%) 99/124 used 28mmballoon 8 patients Pericardial effusion, 1 hemothorax Cryoballoon High Frequency Ultrasound (HIFU) Study suspended due to unexpected serious adverse events Van belle et al, europace 2008 HDMA Mapping and Ablation Catheter 26 Patients Atrial Fibrillation Progress Continues 100% PV,s isolated 3 month success 85% Paf 41% persistent Advances are predominantly in safety and attempts to bring the procedure to more patients by simplifying the technical requirements of the procedure so that it will be available and effective in the community Meisner et al, JCE,

11 Slide 57 LL1 141 patients, 420 days follow up 59% freedom of afib 24 repeat procedures 4 phrenic nerve palsey, all recovered. Stop Af 243 patients, multicenter randomized three to two for meds or cryoablation. Laurent Lewkowiez, 8/27/2009

12 Results of Atrial fibrillation Ablation with Exit block as Endpoint One year freedom from atrial fibrillation recurrence without drugs 75% One year freedom from atrial fibrillation with addition of previously ineffective drugs 85% Incidence of atypical flutter 6% Incidence of repeat procedure 12 % 11