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Atrial Fibrillation Evidence Based Care 2011 Allan Anderson, MD, FACC, FAHA Division of Cardiology Projection for Prevalence of Atrial Fibrillation: 5.6 Million by 2050 Adults with atrial fibrillation in millions Projected number of adults with atrial fibrillation in the United States between 1995 and 2050 7.0 6.0 5.16 5.0 5.42 5.61 4.78 4.34 4.0 3.80 3.33 3.0 2.26 2.08 2.0 2.44 2.66 2.94 Upper and lower curves represent the upper and lower scenarios based on sensitivity analyses. 1.0 0 1990 1995 2000 2005 2010 2015 2020 2025 2030 Years Go AS et al. JAMA. 2001;285:2370-2375. 2035 2040 2045 2050 Cumulative mortality over 3 years (%) Atrial Fibrillation Is Associated With Increased Mortality 80 With atrial fibrillation Without atrial fibrillation 70 65.1* 60 54.5 47.4* 50 40 30 71.3 38.6 51.0* 47.5 36.1* 34.0 30.2* 62.4 25.4* 20 10 0 65-74 years of age 75-84 years of age * Significantly different from patients with atrial fibrillation (P<.05). Wolf PA et al. Arch Intern Med. 1998;158:229-234. 85-89 years of age Atrial Fibrillation: Major Cause of Stroke in the United States 15% of all strokes attributable to atrial fibrillation 75,000 strokes per year attributable to atrial fibrillation 3- to 5-fold increase in risk of stroke in patients with atrial fibrillation Stroke risk persists even in asymptomatic atrial fibrillation Go AS et al. JAMA. 2001;285:2370-2375; Go AS. Am J Geriatr Cardiol. 2005;14:56-61; Wolf PA et al. Stroke. 1991;22:983-988; Benjamin EJ et al. Circulation. 1998;98:946-952; Page RL et al. Circulation. 2003;107:1141-1145. Increasing Hospitalizations in the United States When Atrial Fibrillation Is Principal Diagnosis Prevalence per 10,000 persons (National Hospital Discharge Survey) 140 120 100 80 60 40 20 0 1985 1987 1989 1991 1993 1995 1997 1999 Year Age (years) 85+ 75 to 84 65 to 74 Wattigney WA et al. Circulation. 2003;108:711-716. 55 to 64 35 to 54 Atrial Fibrillation Adversely Affects Quality of Life (QoL) 120 Lower scores = poorer QoL 100 80 Atrial fibrillation 92 88 85 SF-36 score 78 68 60 54 70 71 76 81 68 Post myocardial infarction Controls 59 40 20 0 General health Physical function Social function Mental health Dorian P et al. J Am Coll Cardiol. 2000;36:1303-1309. Famous Fibrillators Famous Fibrillators Famous Fibrillators Famous Fibrillators Famous Fibrillators Famous Fibrillators Famous Fibrillators Atrial Fibrillation 2011 Patterns of AF Evaluation of Patient Evidence Base Rate Management Rhythm Management Prevention of thromboembolism New stuff Patterns of Atrial Fibrillation First Detected Paroxysmal (Self terminating) Persistent (Non self terminating) Permanent Fuster, V. et al. J Am Coll Cardiol 2011;57:e101-e198 Atrial Fibrillation Evaluation of Patients History and physical examination Presence and nature of associated symptoms Clinical type (1st episode, paroxysmal, persistent, permanent) Onset/date of discovery of 1st episode Frequency, duration, precipitating factors, mode of termination Response to therapies Establish underlying heart disease or other treatable conditions (e.g., hyperthyroidism, alcohol) Atrial Fibrillation Evaluation of Patients ECG Verify rhythm LVH? Pre-excitation (WPW)? Bundle branch block? Prior MI? Measure and follow intervals (R-R, QRS, QT) in conjunction with drug therapy Atrial Fibrillation Evaluation of Patients Transthoracic echocardiogram Valvular disease Chamber sizes/ventricular function Peak RV systolic pressure (pulmonary hypertension) LVH Pericardial disease Atrial clot (usually not helpful, requires TEE) Atrial Fibrillation Evaluation of Patients Other studies 6 minute walk test: evaluate adequacy of rate control Stress test Holter monitor Adequacy of rate control Reproduce exercise-induced AF Presence of ischemia (regarding use of IC drugs) Verify/establish diagnosis Adequacy of rate and/or rhythm control Transesophageal echocardiogram (TEE) LA clot Guide to cardioversion (expedited) The Guidelines Class I: Conditions for which there is evidence and/or general agreement that a given procedure/therapy is beneficial, useful, and effective. Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of performing the procedure/therapy. IIA: Weight of evidence/opinion is in favor of usefulness/efficacy. IIB: Usefulness/efficacy is less well established by evidence/opinion. Class III: Conditions for which there is evidence and/or general agreement that a procedure/therapy is not useful or effective and in some cases may be harmful. Level of Evidence A: Data derived from multiple randomized clinical trials or meta-analyses. B: Data derived from a single randomized trial, or nonrandomized studies. C: Only consensus opinion of experts, case studies, or standard-of-care. Expert Opinion One who knows enough jargon to be both confusing and dangerous. Ambrose Bierce 1842-1913 Consensus General agreement within a group, especially after protracted, lengthy, bitter debate and loss of life. Opinion obtained by straw polling when the opposition is not present. See team building. The current thinking of the team supervisor. Rate or Rhythm Control? Comparison of Trials Rate vs. Rhythm Control Clinical Events Stroke/Embolism Trial Patients (n) AF Duration Patients in SR * NR Death Rate Rhythm Rate Rhythm 35% vs. 63% (at 5 y) 88/2027 93/2033 310/2027 356/2033 AFFIRM 4060 RACE (2002) 522 1 to 399 d 10% vs. 39% (at 2.3 y) 7/256 16/266 18/256 18/266 PIAF (2000) 252 7 to 360 d 10% vs. 56% (at 1 y) 0/125 2/127 2/125 2/127 STAF (2003) 200 6±3 mo 11% vs. 26% (at 2 y) 2/100 5/100 8/100 4/100 HOT CAFÉ (2004) 205 7 to 730 d NR vs. 64% 1/101 3/104 1/101 3/104 (2002) Rate Control Efficacy in Permanent Atrial Fibrillation: a Comparison between Lenient versus Strict Rate Control II RACE II 614 patients with permanent AF (age </= 80) Lenient rate control (HR<110 at rest) OR Strict rate control HR < 80 at rest, AND HR < 110 during moderate exercise Composite outcome: CV death, hospitalization for HF, systemic embolism, bleeding, lifethreatening arrhythmia Follow-up: At least 2 years; maximum – 3 years Van Gelder IC, Groenveld HF, Crijns HJ, et al. N Engl J Med 2010;362:1363-1373. Rate Control Efficacy in Permanent Atrial Fibrillation: a Comparison between Lenient versus Strict Rate Control II RACE II 3 year cumulative incidence of primary outcome P < 0.001 Target HR goal(s) 12.9% - lenient 14.9% - strict 304 (97.7%) – lenient 204 (67%) – strict P < 0.001 Total Visits 75 – lenient 684 - strict P < 0.001 Van Gelder IC, Groenveld HF, Crijns HJ, et al. N Engl J Med 2010;362:1363-1373. Atrial Fibrillation The “Thou Shalt’s” Pharmacologic Rate Control (Class I) Measurement of the heart rate at rest and control of the rate using pharmacological agents (either a beta blocker or non-dihydropyridine calcium channel antagonist, in most cases) are recommended for patients with persistent or permanent AF. (Level of Evidence: B) Atrial Fibrillation The “Thou Shalt’s” Pharmacologic Rate Control (Class I) In the absence of pre-excitation, intravenous administration of beta blockers (esmolol, metoprolol, or propranolol) or nondihydropyridine calcium channel antagonists (verapamil, diltiazem) is recommended to slow the ventricular response to AF in the acute setting, exercising caution in patients with hypotension or HF. (Level of Evidence: B) Atrial Fibrillation The “Thou Shalt’s” Pharmacologic Rate Control (Class I) Intravenous administration of digoxin or amiodarone is recommended to control the heart rate in patients with AF and HF who do not have an accessory pathway. (Level of Evidence: B) Atrial Fibrillation The “Thou Shalt’s” Pharmacologic Rate Control (Class I) In patients who experience symptoms related to AF during activity, the adequacy of heart rate control should be assessed during exercise, adjusting pharmacological treatment as necessary to keep the rate in the physiological range. (Level of Evidence: C) Atrial Fibrillation The “Thou Shalt’s” Pharmacologic Rate Control (Class I) Digoxin is effective following oral administration to control the heart rate at rest in patients with AF and is indicated for patients with HF, LV dysfunction, or for sedentary individuals. (Level of Evidence: C) Atrial Fibrillation The “Thou Shalt Not’s” Pharmacologic Rate Control (Class III) Digitalis should not be used as the sole agent to control the rate of ventricular response in patients with paroxysmal AF. (Level of Evidence: B) Catheter ablation of the AV node should not be attempted without a prior trial of medication to control the ventricular rate in patients with AF. (Level of Evidence: C) Atrial Fibrillation The “Thou Shalt Not’s” Pharmacologic Rate Control (Class III) In patients with decompensated HF and AF, intravenous administration of a non-dihydropyridine calcium channel antagonist may exacerbate hemodynamic compromise and is not recommended. (Level of Evidence: C) Intravenous administration of digitalis glycosides or nondihydropyridine calcium channel antagonists to patients with AF and a pre-excitation syndrome may paradoxically accelerate the ventricular response and is not recommended. (Level of Evidence: C) Therapy to maintain sinus rhythm in patients with recurrent paroxysmal or persistent atrial fibrillation Wann, L. S. et al. J Am Coll Cardiol 2011;57:223-242 Atrial Fibrillation The “Thou Shalt’s” Maintenance of sinus rhythm (Class I) Before initiating anti-arrhythmic drug therapy, treatment of precipitating or reversible causes of AF is recommended. (Level of Evidence: C) Atrial Fibrillation The “Thou Shalt Not’s” Maintenance of sinus rhythm (Class III) Antiarrhythmic therapy with a particular drug is not recommended for maintenance of sinus rhythm in patients with AF who have well-defined risk factors for proarrhythmia with that agent. (Level of Evidence: A) Pharmacological therapy is not recommended for maintenance of sinus rhythm in patients with advanced sinus node disease or AV node dysfunction unless they have a functioning electronic cardiac pacemaker. (Level of Evidence: C) Prevention of Thromboembolism Effects on all stroke (ischemic and hemorrhagic) of therapies for patients with atrial fibrillation Stroke Risk Prediction in AF CHADS2 Criteria CRITERIA SCORE Prior stroke or TIA 2 Age > 75 years 1 Hypertension 1 Diabetes Mellitus 1 Heart Failure 1 Walraven WC et al. JAMA 2001;285:2864–70 (426). Stroke Risk Prediction in AF CHADS2 Criteria Patients Adjusted stroke rate/yr with 95% CI CHADS2 Score 1733 120 1.9 (1.2 -3.0) 463 2.8 (2.0-3.8) 523 4.0 (3.1-5.1) 337 5.9 (4.6-7.3) 220 8.5 (6.3-11.1) 65 12.5 (8.5-17.5) 5 18.2 (10.5 – 27.4) Walraven WC et al. JAMA 2001;285:2864–70 (426). 0 1 2 3 4 5 6 Atrial Fibrillation The “Thou Shalt’s” Prevention of thromboembolism (Class I) Antithrombotic therapy to prevent thromboembolism is recommended for all patients with AF, except those with lone AF or contraindications. (Level of Evidence: A) The selection of the antithrombotic agent should be based upon the absolute risks of stroke and bleeding and the relative risk and benefit for a given patient. (Level of Evidence: A) Atrial Fibrillation The “Thou Shalt’s” Prevention of thromboembolism (Class I) For patients without mechanical heart valves at high risk of stroke, chronic oral anticoagulant therapy with a vitamin K antagonist is recommended in a dose adjusted to achieve the target intensity INR of 2.0 to 3.0, unless contraindicated. Factors associated with highest risk for stroke in patients with AF are prior thromboembolism (stroke, TIA, or systemic embolism) and rheumatic mitral stenosis. (Level of Evidence: A) Anticoagulation with a vitamin K antagonist is recommended for patients with more than 1 moderate risk factor. Such factors include age 75 y or greater, hypertension, HF, impaired LV systolic function (ejection fraction 35% or less or fractional shortening less than 25%), and diabetes mellitus. (Level of Evidence: A) Atrial Fibrillation The “Thou Shalt’s” Prevention of thromboembolism (Class I) INR should be determined at least weekly during initiation of therapy and monthly when anticoagulation is stable. (Level of Evidence: A) Aspirin, 81–325 mg daily, is recommended as an alternative to vitamin K antagonists in low-risk patients or in those with contraindications to oral anticoagulation. (Level of Evidence: A) For patients with AF who have mechanical heart valves, the target intensity of anticoagulation should be based on the type of prosthesis, maintaining an INR of at least 2.5. (Level of Evidence: B) Antithrombotic therapy is recommended for patients with atrial flutter as for those with AF. (Level of Evidence: C) Atrial Fibrillation The “Thou Shalt Not’s” Prevention of thromboembolism (Class III) Long-term anticoagulation with a vitamin K antagonist is not recommended for primary prevention of stroke in patients below the age of 60 y without heart disease (lone AF) or any risk factors for thromboembolism. (Level of Evidence: C) Dabigatran (Pradaxa) Direct thrombin inhibitor Dose: CrCl > 30: 150 mg twice daily CrCl < 30: 75 mg twice daily See prescribing information on transitions between warfarin or parenteral anticoagulants Dabigatran (Pradaxa) 1.5 % risk of life threatening bleeding vs. 1.8% for warfarin (RE-LY) Avoid with Rifampin (P-gp inducer) Pregnancy Class C Major side effects: bleeding; gastrointestinal Dabigatran versus Warfarin in Patients with Atrial Fibrillation RE-LY Non-inferiority trial 18,113 patients randomized 110 or 150 mg dabigatran – blinded Adjusted dose warfarin – unblinded 2.0 year median follow-up Primary outcome: stroke or systemic embolization Connolly SJ, et al. N Engl J Med 2009; 361:1139-1151. RE-LY Cumulative Hazard Rates for the Primary Outcome of Stroke or Systemic Embolism According to Treatment Group. Connolly SJ et al. N Engl J Med 2009;361:1139-1151. A Few Words About AF Ablation Increasingly effective procedure, depending on type of AF Paroxysmal > Persistent > Permanent Failure of drug therapy or importance of maintaining SR for hemodynamic purposes Not without risk – requires experience Thank You! Questions??