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Current Mangement of Atrial Fibrillation: An Evidence-Based Approach John D. Hummel, MD Ohio State University Medical Center Ross Heart Hospital Columbus, Ohio Learning Objectives • Understand the guidelines for anticoagulation and where there is latitude for physician decisionmaking. • Be able to discriminate between patients requiring restoration of sinus rhythm vs. rate control alone. • Be able to determine when patients should be evaluated for curative ablation. Projected Number of Adults With AF in the US: 1995 to 2050. Adults with AF, MM 6 5 4.78 5.16 5.42 5.61 4.34 4 3.80 3 2 2.08 2.26 2.44 2.66 2.94 3.33 1 Year Go A, et al. JAMA. 2001;285:2370-2375. 20 60 20 50 20 45 20 40 20 35 20 30 20 25 20 20 20 15 20 10 20 05 20 00 19 95 0 Atrial Fibrillation: Costs to the Health Care System ALOT!! 35% of arrhythmia hospitalizations Average hospital stay = 5 days Mean cost of hospitalization = $18,800 Does not include: Costs of outpatient cardioversions Costs of drugs/side effects/monitoring Costs of AF-induced strokes Estimated US cost burden 15.7 billion Classification of Atrial Fibrillation ACC/AHA/ESC Guidelines First Detected Paroxysmal (Self-terminating) Persistent (Not self-terminating) Permanent DIAGNOSTIC WORKUP • • • • • • • • • • Minimum Evaluation History and physical – Sx with AF, CV dz Electrocardiogram – WPW, BBB, LVH, MI Echocardiogram – LVH, LAE, EF, Valve Dz Labs – TSH, Renal fxn, LFTs Additional Testing ETT – CAD, Exercise induced SVT / AF Holter / Event Monitor – Confirm AF and Sxs TEE – LA clot EPS – SVT triggered AF AHA / ACC / ECS Guidelines 2006 AF: TREATMENT OPTIONS Rate control Pharmacologic • Ca2+ blockers • -blockers • Digitalis • Amiodarone Nonpharmacologic • Ablate and pace Prevent remodeling Maintenance of SR Pharmacologic Class IA Class IC Class III -blocker ACE-I ARB Adapted from Prystowsky, Am J Cardiol. 2000;85:3D-11D. Stroke prevention Nonpharmacologic Pharmacologic • Warfarin • Thrombin inhibitor • Aspirin Catheter ablation Surgery (MAZE) Pacing Nonpharmacologic • Removal / isolation LA appendage Risk Factors for Thromboembolism in AF High-Risk Factors Previous CVA / TIA / Embolism Mitral Stenosis Prosthetic heart valve Moderate-Risk Factors Age > 75 yrs HTN CHF DM EF < 35% Weaker-Risk Factors Female CAD Thyrotoxicosis Age 65 – 74 yrs AHA / ACC / ECS Guidelines 2006 Recommended Therapy High-risk factor or > 2 moderate-risk factors Coumadin INR 2-3 (mechanical valve INR > 2.5) 1 moderate-risk factor ASA or Coumadin No risk factors ASA 81-325mg daily AF THERAPY ANTITHROMBOTIC RX AND RHYTHM CONTROL OR ? RATE CONTROL AFFIRM Trial: Rate vs Rhythm Control Management Strategy Trial • Design – 5-year, randomized, parallel-group study comparing rate control vs. AARx attempt at NSR – Primary endpoint: overall mortality • Patient population – – – – – – 4060 patients with AF and risk factors for stroke Mean Age = 69 yo Hx of hypertension: 70.8% CAD: 38.2% Enlarged LA: 64.7% Depressed EF: 26.0% The AFFIRM Investigators. N Engl J Med. 2002;347:1825-1833. AFFIRM: All-Cause Mortality 30 Rate Rhythm 25 Mortality, % 20 p=0.078 unadjusted 15 p=0.068 adjusted 10 5 0 0 1 2 3 Rhythm N: 2033 1932 Time (years) 1807 1316 Rate N: 2027 1925 1825 The AFFIRM Investigators. N Engl J Med. 2002;347:1825-1833. 1328 4 5 780 255 774 236 AFFIRM: Adverse Events Rate Rhythm Ischemic stroke 77 (5.5%)* 80 (7.1%)* INR < 2.0 27 (35%) 17 (21%) Not taking warfarin 25 (32%) 44 (55%) * p=0.79 The AFFIRM Investigators. N Engl J Med. 2002;347:1825-1833. AF Rate vs. Rhythm Control Trials: Implications • AFFIRM has demonstrated that rate control is an acceptable primary therapy in a selected high-risk subgroup of AF patients • Continuous anticoagulation seems warranted in all patients with risk factors for stroke – Asymptomatic recurrences Atrial fibrillation Rate control – the problem: Increased rates – more symptomatic, greater hemodynamic impact. Persistent increased rates – tachycardia induced cardiomyopathy Rate control – the goal: PAF – control symptomatic tachycardia Chronic afib – mean 24hr HR < 80-90 bpm Atrial fibrillation Rate control – Drug Therapy: Digoxin – controls resting rate, OK in CHF patients . Beta, Ca+2 blockers – controls resting and exercise rates. Best therapy – combination of beta blocker and digoxin. Even in the best of circumstances pacing support is sometimes required APPROACHES TO AF THERAPY Rate control plus anticoagulation preferred • • • • • • No or lesser AF symptoms Longer AF Hx More SHD Toxicity Risk Elderly Greater risk of proarrhythmia Rhythm control preferred • • • • • Greater AF symptoms Symptoms despite rate control Younger age No or lesser SHD Rx option of class IC AAD In anticoagulation candidates, continue anticoagulation indefinitely Atrial Fibrillation Length of time in AF prior to cardioversion • Duration of AF is the best predictor of recurrent AF after cardioversion Patients in sinus rhythm (%) 100 < 3 Months 3 - 12 Months > 12 Months 80 60 40 * 20 0 *P = <0.02 Initial Dittrich HC. Am J Cardiol. 1989;63:193-197. One month post-CV Six months post-CV AF TREATMENT GOALS • AF is rarely life-threatening and is typically recurrent • Treatment goals in symptomatic pts – frequency of recurrences – duration of recurrences – severity of recurrences • Minimize risk of tachycardia induced cardiomyopathy • Safety is primary concern Rhythm Control for AF: Commonly Used Oral Antiarrhythmic Drugs Class IA Class IC Class III Quinidine Propafenone Sotalol Procainamide Propafenone SR Amiodarone Disopyramide Flecainide Dofetilide Procainamide, disopyramide, and amiodarone are not FDA-approved for treatment of AF. Miller and Zipes. In: Braunwald, et al (eds). Heart Disease. 6th ed. 2001. AF Efficacy: Maintaining NSR > 6 Months 70 60 NSR, % 50 40 30 20 10 0 No drug Quin Diso Prop Flec Sot Dof Azim Amio ORGAN TOXICITY • Examples: – Lupus, agranulocytosis, thrombocytopenia, optic neuritis, pulmonary fibrosis, hepatitis, etc. • Negligible: – Dofetilide, flecanide, propafenone, sotalol • Acceptible: – Azimilide, disopyramide • High: – Amiodarone, procainamide, quinidine Drug-Induced Proarrhythmia - Torsades Factors Which Influence Ventricular Proarrhythmia Risk • • • • • • • Hypokalemia, hypomagnesemia Long QT at baseline CHF / Decreased EF / Ventricular hypertrophy Bradycardia Female gender Reduced drug metabolism or clearance Amiodarone has lowest risk Atrial fibrillation Heart disease Antiarrhythmic None Vagal afib HTN CAD CHF/Substantial LVH IC Disopyramide IC (if no sig. LVH) Sotalol Amiodarone Alternatives to Drug therapy “Non-Pharmacologic Therapy” Coumadin – LAA closure (Watchman) Rate Control – AVN RFA + PCMK AARx – Adjunctive AFL RFA AARX – Curative Afib RFA WATCHMAN® LAA Filter System Complete AVN ablation Pacemaker Placement AVN RF ablation Objective Benefits of AV nodal Ablation 70 55 50 mean 54 + 7 60 mean 34 + 5 LVESD (mm) LVEF (%) 45 50 mean 43 + 8 40 p < 0.001 30 40 mean 40 + 5 35 30 p < 0.003 25 20 20 Before After A Left ventricular ejection fraction (%) Rodriguez LM. Am J Cardiol. 1993;72:1137-1141. Before After B Left ventricular end systolic diameter (mm) Complete AVN Ablation Advantages: 100% efficacy 85% symptomatic improvement Improved EF (LV remodeling) Eliminates need for rate control drugs Disadvantages: Pacemaker dependant Good Candidates: Tachy / Brady Syndrome PCMK in Place – CHF with BiV device Medication refractory / intolerant Elderly 60 F with PAF treated with Rythmol Presented with recurrent tachycardia Atrial Flutter Circuit Atrial Flutter Circuit Atrial Flutter Ablation Atrial Flutter RFA Atrial Flutter Ablation Approximately 15% of AF patients treated with an AA will develop AFL Advantages: 95% efficacy ≈ 80% arrhythmia control if AARx continued As primary Tx RFA more effective than AARx Disadvantages: Invasive Good Candidates: Typical AFL (IVC / TV isthmus) Primary AFL or AARx related AFL Focal Origin of Atrial Fibrillation Hassaiguerre M, NEJM, 1998 • 94% of AF triggers from Pulmonary Veins • “90 – 95% of all AF is initiated by PV ectopy” RA LA SVC 17 31 FO Pulmonary Veins 6 IVC CS 11 74 yo medically refractory AF, Echo – Normal AA Rx - Verapamil, Rythmol, Betapace, Norpace I II III V1 RSPV dist RSPV prox LIPV RA * Lasso Catheter Circular Mapping & Ablation Catheter in Right Superior Pulmonary Vein Atrial Fibrillation Ablation Atrial Shell and Cardiac MRI 45 yo F with medically refractory Highly Symptomatic PAF 45 yo F with Medically Refractory PAF CT Scan / Carto Images – PA View 45 yo with PAF Conversion of AF to NSR, LSPV with AF Abl Lasso LSPV CS Current State of Curative Catheter-Based RFA Procedural Success & Complications • Total Patients > 800 (70% PAF) • Expected success @ 1yr – ≈ 70% after first procedure – ≈ 80% after second procedure • Complications ≈ 2 to 3% – – – – – Tamponade – 0.6% Pulmonary vein stenosis – 0.6% TIA / CVA – 0.5% Esophageal-LA fistula - 0 Groin Bleeding / Hematoma (Last 200 pts complications < 1%) Atrial Fibrillation: Ablation vs Drug Rx. Ablation 80% success PV stenosis AE fistula TIA/CVA Drug Rx. 50% success Proarrhythmia End Organ Toxicity No Free Lunch Torsades AE fistula PV stenosis Current State of Curative Catheter-Based RFA Who is a good candidate? Symptomatic / Frequent AF Limited Heart Dz EF > 35% LA < 5.5cm No MS / Rheumatic Dz Younger Patients No LA thrombus or Hx of CVA Medically Refractory / Intolerant (Ablation now second line therapy) Industry Estimates: AF Demographics • Approximately 26,000 AF ablation procedures (surgery + EP) were performed in 2004. • • AF Patients Treated (1%) 26,000 Currently, only about 1% of AF population being addressed with curative therapies. AF Patients 2,400,000 Estimates for EP Afib RFA: 2005 = 19,000 2006 = 21,000 AF Patients AF Patients Treated Physicians estimate apporx. 30% of Afib pts are RFA candidates. Atrial Fibrillation Ablation Evolution of the Moving Target Esophageal Fistulas Left Atrial Flutters Tamponade TIA/CVA Early Rumors (20 hr cases) Mid 90’s Left Sided Focal IVUS / Transeptal Right Sided Linear WACA + Linear Lasso PV Isolation Hybrid Approaches 3D Mapping CT integration 2006 Fractionated Egms PV Stenosis Phrenic Nerve Injury The Trouble With a Moving Target Back to the Right Side Need for Stereotaxis, Cryoablation, HIFU? Atrial Fibrillation New Technology Coming Your Patients Way at Ohio State University Stereotaxis – Magnetic Catheter Navigation Energy Sources High Intensity Focused Ultrasound (HIFU) Cryoablation Balloon Watchman – Left Atrial Appendage Closure A-Fib vs. EP Labs