DISCLOSURE. Atrial Fibrillation Management An Evidence-based Approach OBJECTIVES BACKGROUND AFFIRM 9/16/2015

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Death (%) Mortality (%) 9/16/2015 DISCLOSURE Atrial Fibrillation Management An Evidence-based Approach Jonathon Adams, MD, FHRS Relevant Financial Relationship(s) None Off Label Usage None OBJECTIVES

1 Death (%) Mortality (%) 9/16/2015 DISCLOSURE Atrial Fibrillation Management An Evidence-based Approach Jonathon Adams, MD, FHRS Relevant Financial Relationship(s) None Off Label Usage None OBJECTIVES What are the goals of AF therapy? Who needs anticoagulation & what drug to use? When is rate control appropriate & what is the target? Who needs antiarrhythmic drugs? What is ablation & who are the best candidates? What else can be done? BACKGROUND Estimated million with AF in U.S. Affects 9% people age > 65 Affects 2% people age < ,000 hospitalizations / year Cost $6 billion / year 5-Fold increased risk for stroke Increased risk of death January CT, et al. JACC, 2014;64(21): ATRIAL FIBRILLATION MORTALITY Framingham Study Years Old Men AF Women AF Men w/o AF Women w/o AF Years Old AFFIRM 30 Rhythm Control 25 Rate Control Follow-up (yr) Follow-up (yr) Benjamin, et al. Circ 98:946, P= Years AFFIRM Investigators. NEJM 347:1825,

CRITICISMS OF AFFIRM AFFIRM SUBSTUDY Rhythm control achieved in 63% at 5 yrs Option to D/C warfarin in Rhythm Control arm Crossover 38% Rhythm control Rate Control 15% Rate control Rhythm Control

2 CRITICISMS OF AFFIRM AFFIRM SUBSTUDY Rhythm control achieved in 63% at 5 yrs Option to D/C warfarin in Rhythm Control arm Crossover 38% Rhythm control Rate Control 15% Rate control Rhythm Control AFFIRM Investigators. Circ 109:1509, 2004 GOALS OF MANAGEMENT ANTICOAGULATION Stroke risk reduction Prevent tachycardia-mediated cardiomyopathy Relieve symptoms Hypertrophic Cardiomyopathy Eur Heart J 2012;33: WHAT ABOUT ASPIRIN? AVERROES Study Outcome Stroke or systemic embolism Hospitalization for cardiovascular cause Major bleeding Apixaban (N=2808) 51 (1.6% per yr) 367 (12.6% per yr) 44 (1.4% per yr) Aspirin (N=2791) 113 (3.7% per yr) 455 (15.9% per yr) 39 (1.2% per yr) Hazard Ratio (95% CI) 0.45 ( ) 0.79 ( ) 1.13 ( ) <0.001 < CHA 2 DS 2 VASc = 1 Event rates per 100 PYs at 1 year follow-up No Rx Aspirin Warfarin No risk factors Ischemic Stroke Death ICH Risk factor Ischemic Stroke Death ICH Connolly, et al. NEJM 364;9, 2011 Lip, et al. JACC 65(14):1385,

3 RHYTHM CONTROLLED Still Need Anticoagulation? May still have breakthrough asymptomatic AF Patients may have stroke despite no AF Case Period (1-30 days) NON-PHARMACOLOGIC STROKE PREVENTION AF No AF Control Period ( days) AF 15 3 No AF Turakhia, et al. Circ Arrhythm Electrophysiol, Jul 2015 GOALS OF MANAGEMENT Stroke risk reduction Prevent tachycardia-mediated cardiomyopathy Relieve symptoms RATE CONTROL What is adequate rate control? AFFIRM 80 bpm at rest 110 bpm with 6-min walk RACE II Lenient rate control <110 bpm at rest Patients must remain asymptomatic & LVEF preserved AFFIRM Investigators. NEJM 347:1825, 2002 Van Gelder, et al. NEJM 362;15:1363, 2010 GOALS OF MANAGEMENT Stroke risk reduction Prevent tachycardia-mediated cardiomyopathy Relieve symptoms RHYTHM CONTROL Antiarrhythmic drugs Class IC Class III Catheter ablation 3

ANTIARRHYTHMIC DRUGS ANTIARRYTHMIC DRUGS Structurally Normal Heart Flecainide Propafenone Dronedarone Sotalol Dofetilide LVH (LV wall > 15 mm) CAD Dronedarone Dronedarone Sotalol Dofetilide CHF

4 ANTIARRHYTHMIC DRUGS ANTIARRYTHMIC DRUGS Structurally Normal Heart Flecainide Propafenone Dronedarone Sotalol Dofetilide LVH (LV wall > 15 mm) CAD Dronedarone Dronedarone Sotalol Dofetilide CHF Dofetilide Sotalol* Beware of drug interactions Propafenone & Flecainide Can organize AF to atrial flutter with 1:1 AV conduction Must be used with AV nodal antagonists Dofetilide & Sotalol Dofetilide MUST be initiated as inpatient Practice patterns variable for sotalol initiation Dronedarone Contraindicated in NYHA III-IV CHF or decompensated CHF in previous 4 weeks Amiodarone January, et al. Circ 129, CATHETER ABLATION CONCEPT ABLATION METHODS RADIOFREQUENCY CRYOBALLOON CATHETER ABLATION GOALS OF ABLATION LSPV RSPV Relieve symptoms or alleviate complicating factors of AF Ablation has NOT been shown to reduce mortality CABANA trial ongoing Ablation does NOT obviate need for anticoagulation Continue to use CHA 2 DS 2 Vasc score LIPV E RIPV 4

5 SUCCESS IN AF ABLATION SUCCESS IN AF ABLATION Type of AF N Paroxysmal 9,590 2 nd International Ablation Registry Success w/o AADs Rate Median (IQR) 74.9% ( ) Success w/ AADs Rate Median (IQR) 9.1% ( ) Overall Success Rate Median (IQR) 83.2% ( ) Pulmonary Vein Isolation vs Antiarrhythmic Drug Therapy As First-Line Treatment of Paroxysmal Atrial Fibrillation Outcome Recurrence of any atrial arrhythmia > 30 secs PVI* (N=66) 36 (54.5%) Drug (N=61) 44 (72.1%) Hazard Ratio (95% CI) 0.56 ( ) 0.02 Persistent 4, % ( ) 10.0% ( ) 75.0% ( ) Symptomatic AF, atrial flutter, or AT 31 (47%) 36 (59%) 0.56 ( ) 0.03 Permanent 1, % ( ) 7.9% ( ) 72.3% ( ) Symptomatic AF 27 (40.9%) 35 (57.4%) 0.52 ( ) 0.02 *Adverse events 9% in PVI group Cappato, et al. Circ A&E 3:32, Morillo, et al. JAMA 311(7):692, RF vs CRYOBALLOON Primary Endpoint: Freedom from AF & Absence of Persistent Complications Outcome RF Cryo (Non-Infer) Intention to Treat 6 months 63.1% 64.1% months (redo allowed) Single Procedure 70.7% 73.6% < % 60.4% - Per-Protocol 6 months 64.3% 65.3% months 73.0% 74.5% <0.001 RF vs CRYOBALLOON Type of Complication RF (N=159) Cryo (N=156) Vascular 5 (3.1%) 8 (5.1%) Pericardial effusion 3 (1.9%) 2 (1.3%) Pulmonary vein stenosis 0 0 N/A Phrenic nerve palsy 0 9 (5.8%) TIA / Stroke 0 0 N/A Total 8 (5.0%) 19 (12.2%) *Redo rate 19% in both groups Luik, et al. Circ Aug 17, Luik, et al. Circ Aug 17, COMPLICATIONS OF CRYOBALLOON Single Center Study 500 Consecutive Procedures Type of Complication N Rate (%) Death 0 0 Tamponade Retroperitoneal hematoma Femoral pseudoaneurysm Symptomatic persisting phrenic nerve palsy Atrio-esophageal fistula 0 0 Stroke / TIA Severe pulmonary vein stenosis 0 0 Total Mugnai, et al. Heart Rhythm 12:1476, COMPLICATIONS OF RF ABLATON 2 nd International Ablation Registry Type of Complication N Rate (%) Death Tamponade Pneumo / hemothorax Sepsis, abscess, endocarditis Permanent phrenic nerve injury Femoral pseudoaneurysm / AV fistula 152 / / 0.54 Valve damage / requiring surgery 11 / Atrio-esophageal fistula Stroke / TIA 37 / / 0.71 Pulmonary vein stenosis Total Cappato, et al. Circ A&E 3:32,

Probability of AF (%) Freedom from AF w/o AADs or PVI Total Freedom from AF 9/16/2015 IMPACT OF OBESITY Framingham Data 4% increase in AF risk per 1 kg/m 2 increase in BMI Obesity associated with

6 Probability of AF (%) Freedom from AF w/o AADs or PVI Total Freedom from AF 9/16/2015 IMPACT OF OBESITY Framingham Data 4% increase in AF risk per 1 kg/m 2 increase in BMI Obesity associated with increased left atrial dimensions LIFESTYLE MODIFICATION LEGACY Trial Weight loss associated with stepwise improvement in BP, lipids, glycemic control, hscrp 0.20 Men Women Follow-up (yrs) Obese Overweight Normal BMI Follow-up (yrs) P< Follow-up (days) WL >10% WL 3-9% WL <3% Follow-up (days) Wang, et al. JAMA 292:20, Parthak, et al. JACC 65(20):2159, LIFESTYLE MODIFICATION LEGACY Trial SLEEP APNEA ORBIT-AF Registry of 10,132 AF patients Follow-up 2 years 1,841 had OSA (18.2%) Parthak, et al. JACC 65(20):2159, Holmqvist, et al. Am Heart J 169:647, ORBIT-AF ORBIT-AF Reduce progression of AF with CPAP therapy Holmqvist, et al. Am Heart J 169:647, Holmqvist, et al. Am Heart J 169:647,

7 FUTURE Await results of CABANA Does rhythm control with ablation improve survival? New ablation tools Multipoint ablation (lasso) Laser balloon Next generation cryoballoon Rotor mapping Hybrid ablation Left atrial appendage occlusion / exclusion Reversal agents for NOACs New antiarrhythmic drugs SUMMARY AF is common & associated with increased mortality Current data do not support improved survival with available rhythm control tools CHA 2 DS 2 VASc for nonvalvular AF Benefit of aspirin is negligible Ablation now an option as 1 st line therapy for paroxysmal AF Don t underestimate the value of lifestyle modification 7

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