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					1
           Learning Objectives
After taking part in this activity, participants should
be better able to:
 – Assess the significant clinical consequences and
   burden of AF
 – Apply new practice guidelines/best practices and
   performance measures for the management of AF
 – Interpret the latest clinical data on rate-control and
   rhythm-control strategies for the management of
   patients with AF
 – Demonstrate an evidence-based approach for
   reducing thromboembolic risk in patients with AF

                                                            2
       Faculty Disclosure
The Network for Continuing Medical Education
requires that CME faculty disclose, during the
planning of an activity, the existence of any
personal financial or other relationships they or
their spouses/partners have with the commercial
supporter of the activity or with the manufacturer of
any commercial product or service discussed in the
activity.

Faculty and planner disclosure information is
included in the handout materials.
Epidemiology and
Burden of Disease




                    4
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

Presentation
● A 65-year-old man presents with episodes of
  palpitations, weakness, and significant
  lightheadedness
● He describes his symptoms, which have been
  occurring as often as 3 times each day for about 1
  week, as severe and debilitating




                                                        5
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

Medical History/Current Medications
The patient has been diagnosed with diabetes,
hypertension, and sleep apnea syndrome, and is taking
the following medications:

   – Lisinopril 10 mg/d
   – Metoprolol 50 mg/d
   – Insulin (0.6 U/kg nightly)




                                                        6
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

 Physical Findings
● BP: 145/90 mm Hg; HR: 85 bpm
● Weight: 180 lb (82 kg); height: 5’10”; BMI: 25.9 m2/kg
● Chest auscultation and heart sounds
   – Normal S1 and S2, no murmurs
   – Irregularly irregular rhythm
● Abdominal examination findings: soft and nontender




                                                           7
                         Epidemiology of AF
   ● Most common sustained cardiac arrhythmia1
   ● Currently affects 5.1 million Americans2
   ● Prevalence expected to increase to 12.1 million by 2050
     (15.9 million if increase in incidence continues)2
   ● Preferentially affects men and the elderly1,2
   ● Lifetime risk of developing AF: ~1 in 4 for adults 40
     years of age3


1. Lloyd-Jones D, et al. [published online ahead of print December 17, 2009].
   Circulation. doi:10.1161/CIRCULATIONAHA.109.192667.
2. Miyasaka Y, et al. Circulation. 2006;114(2):119-125.
3. Lloyd-Jones DM, et al. Circulation. 2004;110(9):1042-1046.                   8
           AF Is the Leading Cause of
         Hospitalizations for Arrhythmia
                                               Hospital Admissions in US
                           AF
                         AFL
           Cardiac arrest
   Conduction disease
                Junctional
        Premature beats
                Sick sinus
              Unspecified
                           VF
                           VT
                                0            200             400   600         800   1000
                                                   Hospital Days (thousands)
N=517,699 (representing 10% of CV admissions).
VF, ventricular fibrillation; VT, ventricular tachycardia.
Adapted from Waktare JE, et al. J Am Coll Cardiol. 1998;81(suppl 5A):3C-15C.                9
                Mortality After Diagnosis of AF
                    100
                                            4-month                         Post-4 months
                     80                     HR, 9.62                        HR, 1.66
      Survival, %




                     60


                     40

                                 MN-white expected
                     20          Observed
                              P<.0001                         P<.0001
                     0
                          0     2       4     6    8   10 0     2       4   6     8     10
                                Years From AF Dx                Years After 4 Mo
                                                                  From AF Dx

Reproduced with permission from Miyasaka Y, et al. J Am Coll Cardiol. 2007;49(9):986-992.    10
          One Fifth of Heart Failure Patients
             Develop AF Within 4 Years
                                                   Unadjusted cumulative incidence of first AF
                                         0.4         after heart failure – Framingham Study
           Cumulative Incidence of AF


                                         0.3


                                         0.2


                                         0.1


                                           0
                                               0          2        4            6      8         10
                                                                        Years
    No. at risk 708                                     323       230           146    92        62

                                          Development of AF was associated with increased mortality:
                                        HR, 1.6 (95% CI, 1.2-2.1) in men; 2.7 (95% CI, 2.0-3.6) in women

Reproduced with permission from Wang TJ, et al. Circulation. 2003;107(23):2920-2925.                       11
                               AF Is a Marker for Worse Outcomes
                                in Heart Failure: CHARM Program
      Time to cardiovascular death or heart failure hospitalization
                               0.50       Low EF:
                                          Hazard ratio 1.29
                                                                                   AF at baseline (Low EF) <0.40
       Distribution Function


                               0.45
                                          (95% CI 1.14 – 1.46)                     No AF at baseline (Low EF)
                               0.40
                                          P<.001
            Cumulative




                               0.35                                                AF at baseline (Preserved)
                               0.30                                                LVEF >0.40
                               0.25                                                No AF at baseline (Preserved)
                               0.20
                               0.15                                  Preserved EF (PEF):
                                                                     Hazard ratio 1.72
                               0.10
                                                                     (95% CI 1.45 – 2.06)
                               0.05                                  P<.001
                                  0
                                      0           1              2    3     3.5
Number at risk
No AF & Low EF                    3906         3207         2755     1963         AF predicted mortality for both
No AF & PEF                       2545         2294         2096     1276         preserved EF and depressed EF
                                                                                   groups, and CV death or heart
AF & Low EF                        670          509          417      289
                                                                                     failure hospitalizations for
AF & PEF                           478          399          353      203
                                                                                         preserved EF group


Reproduced with permission from Olsson LG, et al. J Am Coll Cardiol. 2006;47(10):1997-2004.                    12
  Impact on QoL: AF vs Other CV Illness
                                                  General population1
                                                  Recent MI1
                         100
                                                  AF2
                          90                      HF1
          SF-36 scalea




                          80

                          70

                          60

                          50

                          40
                                 Physical  Vitality   General    Mental   Emotional   Social
                               functioning             health    health     role    functioning
                                                                 index
                                                       Baseline score
aHighernumbers indicate higher QoL.
SF-36 = Medical Outcomes Study Short Form 36.
1. Ware JE, et al. New England Medical Center Health Survey; 1993.
2. Dorian P, et al. J Am Coll Cardiol. 2000;36(3):1303-1309.                                      13
          AF Is Associated With
     Increased Thromboembolic Risk
          ● Major cause of stroke in elderly1
          ● 5-fold ↑ in risk of stroke1,2
          ● 15% of strokes in US are attributable to AF3
          ● Stroke severity (and mortality) is worse with AF
            than without AF4
          ● Incidence of all-cause stroke in patients
            with AF: 5%1
          ● Stroke risk persists even in asymptomatic AF5

1.   Fuster V, et al. J Am Coll Cardiol. 2001;38(4):1231-1266.
2.   Benjamin EJ, et al. Circulation. 1998;98(10):946-952.
3.   Atrial Fibrillation Investigators. Arch Intern Med. 1994;154(13):1449-1457.
4.   Dulli DA, et al. Neuroepidemiology. 2003;22(2):118-123.
5.   Page RL, et al. Circulation. 2003;107(8):1141-1145.                           14
Pathophysiology




                  15
                     Pathophysiology of AF
                                        ?Inflammation
             • HTN and/or
               vascular
               disease


                                        Compliance
             • Mitral                                            • Left ventricular hypertrophy
               regurgitation
                                  Atrial dilatation/stretch      • Diastolic dysfunction




                                Stretch-activated channels       ?Inflammation
                                Dispersion of refractoriness
                                Pulmonary vein focal/discharges?


                               Increased vulnerability to AF?


Adapted with permission from Gersh BJ, et al. Eur Heart J Suppl. 2005;7(suppl C):C5-C11.          16
What Happens When AF Persists?

                              Electro-
  Structural                physiologic
 Remodeling                 Remodeling
  LA and LAA dilatation    Decrease in Ca++ currents
  Fibrosis                 Shortening of atrial action
                             potential
                            Increased importance of
                             early activating K+
                             channels: IKur, IKto



 Remodeling explains why “AF begets AF”
                                                           17
                             Classification of AF

                                            Recurrent AFa
                                              (≥2 episodes)




         Paroxysmal                                                               Persistent

       • Arrhythmia                                                             • Arrhythmia does
         terminates                                                               not terminate
         spontaneously                                                            spontaneously
       • AF is sustained
                                               Permanent
                                                                                • AF is sustained
         ≤7 days                                                                  >7 days
                                          • Both paroxysmal and
                                            persistent AF can
                                            become permanent

aTermination   with pharmacologic therapy or direct-current cardioversion does not change the designation.
Fuster V, et al. Circulation. 2006;114(7):e257-e354.                                                     18
Clinical Evaluation




                      19
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

ECG Findings




                                                        20
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

Echocardiogram Findings
● Mild LVH and nl LV function
  – LV wall thickness 1.3 cm
  – LA size 4.2




                                                        21
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

What other tests would you perform for
this patient at this time?
A.   6-Minute walk or exercise test
B.   Holter monitoring/event recording
C.   Electrophysiology study
D.   Cardiac catheterization
E.   Cardiac MRI
F.   None



                                                        22
        Clinical Evaluation for AF Patients:
        Etiology, AAD Risk, Embolic Risk
● Treatment of AF is dependent on etiologic (cause, severity,
  reversible/modifiable) as well a patient factors (embolic risk, concomitant
  disorders)
● Some anatomic or functional disorders pose risks from AAD treatment (eg,
  organ toxicity and ventricular proarrhythmia)
● At a minimum, an evaluation requires
      – History         – Echocardiogram
      – Physical        – Blood chemistries
      – ECG             – Stress test (if CAD is suspected)
      – Chest x-ray (and possibly PFTs) if pulmonary disease is suspect
        and/or HF is a consideration
● Current guidelines emphasize the prospectively determined CHADS2
  risk-scoring system for embolic risk

Fuster V, et al. Circulation. 2006;114(7):e257-e354.                            23
        Conditions Frequently Associated
             With Nonvalvular AF1-4
             ●    Hypertension
             ●    Aging
             ●    Male sex
             ●    Obesity/metabolic syndrome/diabetes
             ●    Ischemic heart disease
             ●    Heart failure/diastolic dysfunction
             ●    Obstructive sleep apnea
             ●    Physical inactivity
             ●    Thyroid disease
             ●    Inflammation?
1.   Wattigney WA, et al. Circulation. 2003;108(6):711-716.
2.   Gersh BJ, et al. Eur Heart J Suppl. 2005;7(suppl C):C5-C11.
3.   Fuster V, et al. J Am Coll Cardiol. 2006;48(4):854-906.
4.   Mozaffarian D, et al. Circulation. 2008;118(8):800-807.       24
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

What is the patient’s diagnosis?
A.   Paroxysmal AF
B.   Persistent AF
C.   Permanent AF
D.   Other




                                                        25
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

Would you recommend antithrombotic
therapy for this patient at this time?
 A. Yes
 B. No




                                                        26
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

If so, which risk stratification model
would you use to decide on the strategy?
A. ACCP
B. AFI (Atrial Fibrillation Investigators)
C. CHADS2
D. Framingham study
E. SPAF (Stroke Prevention and Atrial Fibrillation)
   Investigators
F. Other

                                                        27
        CHADS2 Risk Criteria for Stroke
             in Nonvalvular AF
                            Risk Factors        Score

   C      Recent congestive heart failure         1

   H      Hypertension                            1

   A      Age ≥75 y                               1

   D      Diabetes mellitus                       1
      History of stroke or transient ischemic
   S2 attack                                      2

Gage BF, et al. JAMA. 2001;285(22):2864-2870.           28
   Stroke Risk in Patients With Nonvalvular AF Not
 Treated With Anticoagulation Based on the CHADS2
                        Index

Patients
(N=1733)                          (95% CI)                            CHADS2 Score
  120                                                                      0
    463                                                                        1
    523                                                                        2
    337                                                                        3
    220                                                                        4         Warfarin
     65                                                                        5
       5                                                                       6

                0        5     10    15     20     25                  30
                        Adjusted Stroke Rate (% per y)
CHADS2, Congestive heart failure, Hypertension, Age >75, Diabetes mellitus, and prior Stroke or
transient ischemic attack.
Gage BF, et al. JAMA. 2001;285(22):2864-2870.                                                       29
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

If you were stratifying this patient’s risk
based on CHADS2, what score would he
receive?
A.   0
B.   1
C.   2
D.   ≥3




                                                        30
             Clinical Evaluation for Selecting
                 Antithrombotic Therapy
●     Consider the following before selecting an anticoagulation strategy:
      – Bleeding or thrombotic risk, history of/tendency for injuries
      – Concomitant requirement for warfarin or antiplatelet therapy
      – Drug compliance history and willingness for dietary compliance
      – Concomitant therapies (including prescription drugs,
        OTCs, herbals)
      – Patient activities that risk injury or are contraindications
        to warfarin
● Perform a clinical evaluation is prior to initiating anticoagulation strategy
● Testing the genetic pattern of warfarin metabolism may be helpful in
  facilitating the initiation phase of warfarin therapy


Fuster V, et al. Circulation. 2006;114(7):e257-e354.                          31
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

What antithrombotic strategy would
you suggest?
 A.   Aspirin 80 mg/d
 B.   Aspirin 325 mg/d
 C.   Warfarin INR 2-3.5
 D.   Warfarin INR 1.5-2.5
 E.   Clopidogrel 75 mg/d + aspirin 80 mg/d
 F.   Dabigatran 110 mg/bid


                                                        32
Treatment




            33
             Treatment Goals and Strategies
           Rate control          Maintenance of SR                     Stroke prevention




Pharmacologic             Pharmacologic Nonpharmacologic
•   Ca2+ blockers                                                     Pharmacologic
•   -blockers                                                        • Warfarin
•   Digitalis                                                         • Aspirin
•   Amiodarone                                                        • Thrombin Inhibitor
•   Dronedaronea            Class IAb       Catheter ablation         Nonpharmacologic
                            Class IC        Pacing
                                                                      • Removal/isolation
                            Class III       Surgery
Nonpharmacologic                                                        LA appendage
• Ablate and pace           -blocker       Implantable devices

                                               a Onlyin patients with nonpermanent AF; b the
                                 CCB
      Prevent Remodeling       ACE-I, ARB      antiarrhythmic drug classes are based on the
                                               Vaughan Williams classification.
                                Statins
                                Fish oil
                                                                                           34
                 ACC/AHA/ESC 2006 Atrial Fibrillation Guidelines


  Rhythm Control Therapies to Maintain Sinus Rhythm
                                             Maintenance of SR


         No (or minimal)            Hypertension                    CAD                      HF
          heart disease

           Flecainide              Substantial LVH               Dofetilide             Amiodarone
          Propafenone
                                                                  Sotalol                Dofetilide
             Sotalol
                                   No           Yes

  Amiodarone        Catheter                                              Catheter        Catheter
   Dofetilide       ablation                            Amiodarone
                                                                          ablation        ablation

                                                           Note: In 2009, the FDA approved
                   Flecainide              Amiodarone
                  Propafenone                              dronedarone to reduce the risk of CV
                     Sotalol                               hospitalization in patients with paroxysmal or
                                             Catheter
                                             ablation
                                                           persistent AF or AFL, with a recent episode of
                                                           AF/AFL and associated CV risk factors, who
          Amiodarone        Catheter                       are in sinus rhythm or who will be
           Dofetilide       ablation
                                                           cardioverted. Consensus regarding its place in
                                                           the treatment paradigm is not yet available.

                                                                                                      35
Reproduced with permission from Fuster V, et al. Circulation. 2006;114(7):e257-e354.
   Individualized Patient Management
 AF chronicity                                       Pharmacologic
  Paroxysmal
  Persistent                     Maintain sinus
  Chronic                                           Catheter ablation
                                    rhythm

 AF symptoms                                           Surgical maze
  Aggravation of HF                               +/- valve/CAD surgery


 Anticoagulation
  Risk/benefit
                                                     Pharmacologic
 Therapy tolerance
  Risk/benefit                    Rate control

                                                      AVJ ablation
 ICD or pacer


Courtesy of KA Ellenbogen, MD.                                            36
                      Rate Control
● End point
   – Resting and ambulatory ventricular rates similar
     to those expected in sinus rhythm
   – Best assessed with Holter monitoring
   – Determining pulse on exam and heart rate on
     ECG are not sufficient

● Methods
   – Digitalis: in sedentary patients or CHF
   – β-blockers and/or CCBs (verapamil, diltiazem): needed in
     most active individuals
   – AVN ablation plus pacemaker: in resistant patients

● Special considerations
   – Brady-tachy syndrome (pindolol, or pacer plus drugs)
   – Preexcitation (focus on the BT as well as the AVN)
                                                                37
                           Cardioversion
Direct Current                                    Conversion With Class IC Rx
  – Biphasic is best                               Conversion Rates From AF to
    (can do internal CV if needed)                Sinus Rhythm at 3 and 8 Hours
Intravenous AAD
                                               100%
  – Ibutilide is best of the available drugs                     3 hours
    (2 mg/30 min; have MgSO4 available)                          8 hours
  – Amiodarone (≥1 g over 24 h)                80%                                   72%
  – Procainamide, quinidine                                                          (44/61)
  – Emerging drugs (eg, vernakalant)
                                               60%                         51%
Oral AAD                                                         39%       (31/61)
  – Oral IC is best (70%-80% by 6-8 h;         40%               (24/62)
    mean, <4 h)
  – Dofetilide (30%-50% by 48 h)                        18%
                                                       (11/62)
    (500 μg bid)                               20%
  – Amiodarone (30 mg/kg), IA are
    other alternatives
                                                0%
  – Emerging drugs                                       Placebo           Propafenone
                                                                             600 mg
                                               Adapted from Capucci A, et al.
                                               Am J Cardiol. 1994;74(5):503-505.
                                                                                               38
                              “Pill in the Pocket”
Candidates
• Recognized acute and recent onset
• No AAD risk markers
• Adequate tolerance (no pulmonary edema, syncope, etc)

               Step 1                                Step 2                 Step 3
• Rate control (~100 bpm)              • Propafenone 600 mg        • Observe for effect
  to prevent 1:1 flutter                 (single dose)               and tolerance
• Short-acting CCB or                  • Flecainide 300 mg           (first episode)
  β-blocker                              (single dose)

Subsequent events
• Treat at home (convenient and inexpensive)
• Improves QoL, reduces ER visits/hospitalization, costs

Acute load on chronic therapy
• 2 extra “pill in the pocket” dosing regimens have been used to treat breakthrough
  episodes (max. daily dose vs substitute bolus dose)a

Alboni P, et al. N Engl J Med. 2004;351(23):2384-2391.
aReiffel   JA. Pacing Clin Electrophysiol. 2009;32(8):1073-1084.                          39
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

Which of the following management
goals may not be necessary in every
patient with AF?
A. Control of the ventricular rate
B. Reduction of thromboembolism risk (particularly
   stroke)
C. Restoration and maintenance of sinus rhythm




                                                        40
           AAD Treatment Goals
● Remember to keep goals realistic!
● AF is rarely life-threatening and is usually recurrent
● Thus, goals should be to:
   – Reduce the frequency of recurrences
   – Reduce the duration of recurrences
   – Reduce the severity of recurrences
   – Minimize intolerance and risk of therapy



                                                           41
        Antiarrhythmic Drugs for AF
● Class I:
   – Class IC: propafenone (also very weak β-blocker), flecainide
       (no β-blockade effects)
          • Sustained-release propafenone (Rythmol SR) and
            flecainide are bid;
          • Propafenone appears to be less proarrhythmic
   – Class IA: disopyramide, quinidine, procainamide
          • No longer included in the ACC/AHA/ESC algorithm
          • Disopyramide may be useful in vagally induced AF

● Class III:
   –   Sotalol (class III plus β-blocker)
   –   Dofetilide (pure class III)
   –   Amiodarone (class III plus class I, II, IV)
   –   Dronedarone (similar to amiodarone with different pharmacokinetics
       and markedly reduced organ toxic potential)
                                                                        42
    Ventricular Proarrhythmia With AAD
● Torsade de pointes:
   – A consequence of class III and
     IA AAD
   – Incidence varies within drug class,
     and with LVH
   – Can be as low as 0.1%-0.4%

● Monomorphic VT:
   – A consequence of class I AAD
     (esp. IC) in SHD (ischemic,
     impaired cell connections)
   – Thus, class I AAD are contraindicated
     as first-line therapy in SHD patients

● Ventricular fibrillation:
   – May degenerate from TdP or VT
   – May be idiopathic

                                             43
                  Mortality Associated With Flecainide and
                 Encainide for Supraventricular Arrhythmias
                14            Estimated 1-Year Mortality (Point Estimate, 95% CI)
                12

                10
 Mortality, %




                 8

                 6

                 4

                 2

                 0
                          CAST               CAST       Comparison        Comparison       Flecainide   Flecainide
                        Enc + Flec          Placebo        SVA             Expected*          SVA       Expecteda
 Total N =                 720                725          165                 -              238           -
1 Year N =                 272                286          144                 -               93           -

 Exponential Model
    aBased           on age, race, and sex-specific mortality rates in the United States in 1980.
   Adapted from Pritchett EL, Wilkinson WE. Am J Cardiol. 1991;67(11):976-980.                                 44
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

What treatment to manage the AF
would you suggest at this time?
A.   Catheter ablation
B.   Flecainide
C.   Dronedarone
D.   Amiodarone
E.   AV node ablation and PPM




                                                        45
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

If dronedarone is chosen, where
should treatment be initiated?
 A. Inpatient administration is mandatory
 B. Outpatient administration is feasible




                                                        46
          Site of AAD Initiation
● Inpatient is mandated for dofetilide
● The recommendations are mixed for sotalol (PI says
  inpatient, ACC/AHA/ESC guidelines allow outpatient
  initiation in patients without TdP risk markers who
  are in NSR)
● The only class IA agent approved for AF is quinidine,
  with initiation as an inpatient
● Outpatient is allowed for class IC and dronedarone, and
  is customary for amiodarone (which is not FDA approved
  for AF), assuming normal SN and normal conduction


                                                          47
  Judging Antiarrhythmic Efficacy
● In patients with symptomatic AF:
  – Reduction or abolishment of symptoms

● In symptomatic and asymptomatic AF patients:
  – Normalization of pulse on self-examination twice a day
  – Assessment with autotriggered loop recorder
    (devices that can be patient triggered and can
    automatically record for programmed criteria,
    including AF)
  – Assessment with pacemaker interrogation

                                                             48
Dronedarone vs Amiodarone: Structural and
        Functional Characteristics
        = Shared
                                     Blocks Multiple K Channels                        = Dronedarone

                                              Overall Effects
                                   Slows heart rate
  Na+   Channel                                                                   Anti-ischemic &
                                   Slows ventricular rate in AF                   Antifibrillatory
      Blockade                     Prolongs APD and QT/QTc
                                   Similar EP and antifibrillatory effects in
                                    ventricles and atria
                                   Reduces effect of EDA in M-cells and PF
                                                                                   Improves LVEF
 Sympatholytic                     Reduces intrinsic and drug-induced
                                    heterogeneity of myocardial refractoriness
                                                                                       in CHF
   Blockade
                                   Negligible proarrhythmia and no anti-
                                    torsadogenic potential                           Reduces
                                   No negative inotropy                           Likelihood of
                                   Elimination half-life 1-2 days                  Pulmonary
  Ca++ Channel                                                                       Fibrosis
   Blockade
                                    Reduces Likelihood of Thyroid                A Much Shorter
                                         Hormone Effects                            Half-lifea
 a1   to 2 days for dronedarone vs 30 to 50 days for amiodarone.
                                                                                                49
 Zimetbaum PJ. N Engl J Med. 2009;360(18):1811-1813..
                              The ERATO Rate-Reduction Trial
ERATO: Primary Study End Point                                        ERATO: Secondary Study End Point
Dronedarone Significantly Decreased                                   Dronedarone Significantly Decreased
Ventricular Rate (24-hour Holter)                                     Maximal Exercise Ventricular Rate

(Mean ± SEM)                               Placebo                    (Mean ± SEM)                                 Placebo
                                           Dronedarone 400 mg bid                                                  Dronedarone 400 mg bid




                                                                      Ventricular Rate (bpm) During
                        95                                                                            170
                                                          90.2                                        165                             159.6
Ventricular Rate, bpm




                                 90.6                                                                       162.4




                                                                            Maximal Exercise
                        90                                                                            160
                                                                                                      155
                                 86.5                                                                       152.6
                        85                           11.7 bpma                                        150                         24.5 bpma
                                                     (P<.0001)                                        145                         (P<.0001)

                        80                                                                            140
                                                                                                      135
                        75                                                                            130
                                                          76.2                                                                        129.7
                                                                                                      125
                        70                                                                            120
                                  Baseline              D14                                                    Baseline             D14
                                              Time                                                                         Time
                             aTreatment   effect estimate by ANCOVA                                   aTreatment   effect estimate by ANCOVA

Adapted with permission from Davy JM, et al. Am Heart J. 2008;156(3):527:e1-527.e9.                                                            50
                         EURIDIS and ADONIS Primary End Point:
                         Patients With First Recurrence of AF/AFL

                       0.8           EURIDIS                                                   0.8              ADONIS




                                                                       Cumulative Incidence
Cumulative Incidence




                       0.7                                                                     0.7
                       0.6                                                                     0.6
                       0.5                                                                     0.5
                       0.4                                                                     0.4
                       0.3                                                                     0.3
                       0.2                                                                     0.2
                       0.1     Log-rank test results: P=.01                                    0.1       Log-rank test results: P=.002
                    0.0                                                                         0.0
                   Time                                                                        Time
                  (days) 0      60    120   180    240    300    360                          (days) 0     60    120 180 240 300 360

                                                       Placebo                     Dronedarone 400 mg bid

                         Results: a significant and consistent reduction in first recurrence of AF/AFL

          AF, atrial fibrillation; AFL, atrial flutter.

          Adapted with permission from Singh BN, et al. N Engl J Med. 2007;357(10):987-999.                                              51
       EURIDIS and ADONIS: Dronedarone Reduced
        Ventricular Rate at First AF/AFL Recurrence
                                                    Placebo   Dronedarone
 Mean Ventricular Rate (with TTM)




                                    120           P<.001            117.5
                                          116.6                             P<.001
                                    115

                                    110
                                                  104.6
                                    105                                     102.3
                                    100

                                     95   n=102   n=188             n=117   n=199

                                     90
                                            ADONIS                    EURIDIS
 TTM, transtelephonic monitoring.
Singh BN, et al. N Engl J Med. 2007;357(10):987-999.                                 52
ANDROMEDA Primary End Point: Time to
Death or Hospitalization for Worsening HF

                                                Placebo   Dronedarone 400 mg bid
                                                 n=317            n=310

 No. of patients with end point                     40                  53

 RR                                                          1.38

 95% CI                                                   (0.92-2.09)

 Log-rank’s test result (P value)                            .12

      All-cause mortality: placebo, n=12; dronedarone, n=25; HR, 2.13; P=.03




Køber L, et al. N Engl J Med. 2008;358(25):2678-2687.                          53
  Athena: Primary Outcome Results
         Cumulative Incidences for the Composite of First
     Hospitalization Due to CV Events or Death From Any Cause

                                     100
           Cumulative Incidence, %



                                     75



                                     50                                          Placebo

                                               P<.001
                                     25                                    Dronedarone



                                      0
                                           0            6   12        18    24         30
                                                                 Months


Reproduced with permission from Hohnloser SH, et al. N Engl J Med. 2009;360(7):668-678.     54
                                           ATHENA Post Hoc Analysis:
                                              Reduction in Stroke
                          5
                                  HR=0.66 (95%Cl, 0.46-0.96)
                                           P=.027                                            • Dronedarone reduced the
                                                                    Placebo
Cumulative Incidence, %




                          4                                                                    risk of stroke from 1.8%
                                                                    (n=70, annual rate=1.8%)
                                                                                               per year to 1.2% per year
                                                                                               (HR, 0.66; P=.027)
                          3
                                                                    Dronedarone                • The effect of dronedarone
                                                                    (n=46, annual rate=1.2%)     was similar whether or not
                          2                                                                      patients were receiving
                                                                                                 oral anticoagulant therapy
                          1                                                                    • Dronedarone had a
                                                                                                 greater effect in patients
                          0                                                                      with higher CHADS2
                              0       6    12     18    24     30                                scores
                                            Months


Reproduced with permission from Connolly SJ, et al; for the ATHENA Investigators
Circulation. 2009;120(13):1174-1180.                                                                                    55
 Emerging Antiarrhythmic Drugs for AF
 ● Agents under study for sinus rhythm maintenance
    – “Atrial-selective” (“atrial-specific”) agents
          • Vernakalant (Kynapid®) is pending FDA approval (in
            October 2010, the FDA suspended enrollment of the
            ACT 5 trial due to patient safety concerns)
          • Others
 ● Agents under study for pharmacologic cardioversion
    – “Atrial-selective” (“atrial-specific”) agents
    – Others
 ● Agents currently marketed for a non-AF indication
    – Ranolazine (Ranexa®)
 ● Agents with unconventional anti-arrhythmic mechanisms
    – Stretch receptor antagonists, sodium-calcium exchanger
       blockers, late sodium channel inhibitors, gap junction modifiers
                                                                      56
Savelieva I, Camm J. Europace. 2008;10(6):647-665.
Preventing Thromboembolism




                             57
                ACC/AHA/ESC 2006 Atrial Fibrillation Guidelines


             Preventing Thromboembolism
   I     IIa IIb III
  A                         Antithrombotic therapy to prevent thromboembolism is recommended
                            for all patients with AF, except those with lone AF or contraindications

                            The antithrombotic agent should be chosen based upon the absolute
                            risks of stroke and bleeding and the relative risk and benefit for a
  A                         given patient




  A                         For patients at high risk of stroke,a chronic oral anticoagulant therapy
                            with a vitamin K antagonist (INR 2.0 to 3.0) is recommended, unless
                            contraindicated


  A
                            Anticoagulation with a vitamin K antagonist is recommended for
                            patients with >1 moderate risk factorb

aFactors  include prior stroke, TIA, or systemic embolism, rheumatic mitral stenosis, mechanical heart valve.
bAge   ≥75 years, hypertension, diabetes mellitus, HF, or impaired LV systolic EF.
Fuster V, et al. Circulation. 2006;114(7):e257-e354.                                                    58
               ACC/AHA/ESC 2006 Atrial Fibrillation Guidelines


  Preventing Thromboembolism (cont)
   I    IIa IIb III
  A                       INR should be determined at least weekly during initiation of therapy
                          and monthly when stable


  A                       Aspirin, 81-325 mg daily, is recommended in low-risk patients or in
                          those with contraindications to oral anticoagulation



  B
                          For patients with mechanical heart valves, the target intensity of
                          anticoagulation should be based on the type of prosthesis,
                          maintaining an INR of at least 2.5



  C                       Antithrombotic therapy is recommended for patients with atrial flutter
                          as for AF


                    C
                          Long-term anticoagulation is not recommended for primary stroke
                          prevention in patients <60 years without heart disease (lone AF)

Fuster V, et al. Circulation. 2006;114(7):e257-e354.                                            59
                ACC/AHA/ESC 2006 Atrial Fibrillation Guidelines


                     Risk Stratification for AF:
                      Antithrombotic Therapy
Risk Category                                                        Recommendation
Low Risk                                                             Aspirin, 81-325 mg a day
No moderate-risk factors
CHADS2 = 0
Moderate Risk                                                        Aspirin, 81-325 mg a day
One moderate-risk factor                                             or warfarin (INR 2.0-3.0)
CHADS2 = 1
High Risk
Any high-risk factor or ≥2 moderate-risk factors                     Warfarin (INR 2.0-3.0a)
CHADS2 = ≥2
aINR   2.5-3.5 for prosthetic valves. What to do about “weaker” risk factors?

Fuster V, et al. Circulation. 2006;114(7):e257-e354.                                             60
                 Currently Available
                Antithrombotic Agents

    Warfarin
    Low–molecular-weight heparin
    Unfractionated heparin
    Aspirin
    Aspirin + clopidogrela
    Dabigatran

a Not   currently FDA approved.
                                        61
                   Limitations of Warfarin
 Limitations                                       Consequences

 Slow onset of action                              Overlap with parenteral anticoagulant

 Genetic variation in metabolism                   Variable dose requirements

 Multiple food and drug interactions               Frequent coagulation monitoring

 Narrow therapeutic window                         Frequent coagulation monitoring




Hirsh J. N Engl J Med. 1991;324(26):1865-1875.
Bates SM, Weitz JI. Br J Haematol. 2006;134(1):3-19.

Courtesy of PR Kowey, MD.                                                                  62
                       The ACTIVE Studies
ACTIVE-W1
     – Compared warfarin (INR, 2-3) vs clopidogrel 75 mg/d + ASA
         (75-100 mg/d) in high-risk AF patients
     –   6706 patients randomized
     –   1.28 years of follow-up
     –   Primary end point: stroke, systemic embolus, MI, vascular death
     –   Study stopped early due to superiority of warfarin

ACTIVE-A2
     – Compared clopidogrel 75 mg/d + ASA (75-100 mg/d) vs ASA alone in
         high-risk AF patients who could not or would not take warfarin
     –   7554 patients randomized
     –   Same primary end point
     –   3.6 years of follow-up
     –   Stroke occurred in 296 (2.4%/y) patients on clopidogrel + ASA and in
         408 patients (3.3%/y) on ASA alone (RR, 0.72; P<.001). However, major
         bleeding occurred in 251 (2.0%/y) patients on clopidogrel + ASA and in
         162 (1.3%/y) patients on ASA alone (RR, 1.57; P<.001)
1. ACTIVE Investigators. Lancet. 2006;367(9526):1903-1912.                        63
2. ACTIVE Investigators. N Engl J Med. 2009;360(20):2066-2078.
            AHA/ASA 2010 Guidelines for the Prevention of Stroke
                      in Patients With Stroke or TIA


   Recommendations for Atrial Fibrillation
   I    IIa IIb III


  A                         Aspirin alone is recommended for patients
                            unable to take oral anticoagulants


                    B The combination of clopidogrel plus aspirin
                            carries a risk of bleeding similar to that of
                            warfarin and therefore is not recommended for
                            patients with a hemorrhagic contraindication to
                            warfarin (new recommendation)


Furie KL, et al. Stroke. [published online October 21, 2010]. doi:
10.1161/STR.0b013e3181f7d043.                                             64
                      RE-LY: Study Design
                       Nonvalvular atrial fibrillation at moderate
                      to high risk of stroke or systemic embolism
                            (at least 1 additional risk factor)



                                                 R

                  Warfarin
                                        Dabigatran Etexilate   Dabigatran Etexilate
              1 mg, 3 mg, 5 mg
                                            110 mg bid             150 mg bid
                (INR, 2.0-3.0)
                                              n=6000                 n=6000
                   n=6000


      Primary objective: noninferiority to warfarin
      Minimum 1-year follow-up, maximum of 3 years and mean of
       2 years of follow-up
      Primary end point: stroke or systemic embolism
Connolly SJ, et al. N Engl J Med. 2009;361(12):1139-1151.                             65
              RE-LY: Primary Outcome




Reproduced with permission from Connolly SJ, et al; the RE-LY Steering Committee and
Investigators. N Engl J Med. 2009;361(12):1139-1151.                                   66
                  RE-LY: Bleeding Events
              Dabigatran     Dabigatran          Dabigatran 110 mg vs Dabigatran 150 mg
                                        Warfarin
               110 mg         150 mg                   Warfarin          vs Warfarin

                Annual         Annual       Annual         RR                      RR
                                                                     P Value                P Value
                 Rate           Rate         Rate        95% CI                  95% CI

                                                           0.80                    0.93
Major            2.7%            3.1%        3.4%                      .003                   .31
                                                        0.69-0.93               0.81-1.07

Life-
                                                           0.68                    0.81
threatening      1.2%            1.5%        1.8%                     <.001                   .04
                                                        0.55-0.83               0.66-0.99
(major)
Gastro-
                                                           1.10                    1.50
intestinal       1.1%            1.5%        1.0%                       .43                 <.001
                                                        0.86-1.41               1.19-1.89
(major)
                                                           0.79
                                                                                   0.91
Minor            13.2%          14.8%        16.4%      0.74-0.84     <.001                  .005
                                                                                0.85-0.97

Major or                                                   0.78                    0.91
                  14.6          16.4%        18.2%                    <.001                  .002
minor                                                   0.74-0.83               0.86-0.97

 Connolly SJ, et al; the RE-LY Steering Committee and Investigators. N Engl J Med.
 2009;361(12):1139-1151.                                                                            67
          Emerging Anticoagulants for
            Stroke Prevention in AF
   Direct factor Xa inhibitors
          –   Apixaban (AVERROES, ARISTOTLE)
          –   Betrixaban (EXPLORE Xa)
          –   Edoxaban (ENGAGE AF–TIMI 48)
          –   Rivaroxaban (ROCKET AF)
   Vitamin K antagonists
       – Tecarfarin




Usman MH, et al. Curr Treat Cardiovasc Med. 2008;10(5):388-397.   68
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

Scheduled Follow-up Visit at 4 Weeks
● The patient continues to take dronedarone as
  prescribed
● His ECG shows sinus rhythm without other
  abnormalities
● He reports no side effects from the medication;
  however, he continues to experience episodes of AF
  2 to 3 times per week that last several hours at a
  time, and complains of severe palpitations and
  fatigue during the AF episodes

                                                        69
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

What treatment would you now
suggest?

A.   Catheter ablation
B.   Flecainide
C.   Dofetilide
D.   Amiodarone
E.   AV node ablation and PPM



                                                        70
Surgical and Catheter Ablation




                                 71
  HRS/EHRA/ECAS 2007 Expert Consensus Statement on Catheter
           and Surgical Ablation of Atrial Fibrillation



        Indications for Surgical Ablation
● Symptomatic AF patients undergoing other cardiac surgery
● Selected asymptomatic AF patients undergoing cardiac surgery
  in whom the ablation can be performed with minimal risk
● Symptomatic AF patients who prefer a surgical approach, have
  failed 1 or more attempts at catheter ablation, or are not
  candidates for catheter ablation

       Best results are obtained in patients with paroxysmal AF
                who are young and otherwise healthy


Calkins H, et al; Heart Rhythm Society Task Force on catheter and surgical
ablation of atrial fibrillation. Heart Rhythm. 2007;4(6):816-861.            72
           Patient Selection for Ablation
 Variable
 Symptoms                       Highly symptomatic    Minimally symptomatic
 Class I and III drugs failed           1                       0
 AF type                            Paroxysmal        Long-standing persistent
 Age                            Younger (<70 years)      Older (70 years)
 LA size                         Smaller (<5.0 cm)       Larger (5.0 cm)
 Ejection fraction                    Normal                 Reduced
 Congestive heart failure               No                      Yes
 Other cardiac disease                  No                      Yes
 Pulmonary disease                      No                      Yes
 Sleep apnea                            No                      Yes
 Obesity                                No                      Yes
 Prior stroke/TIA                       No                      Yes


Courtesy of Hugh Calkins, MD.                                                    73
                     Initiation of AF From
                    Pulmonary Vein Focus




Reprinted with permission from Haissaguerre M, et al. N Engl J Med. 1998;339(10):659-666.   74
               AF Is a Complex Arrhythmia
                                                                           SVC




                                                                        RSPV
                   LSPV




                    LIPV
                                                                    RIPV


                         Vein and
                    ligament of Marshall                                   IVC
Reprinted with permission from Calkins H, et al. Heart Rhythm. 2007;4(6):816-861.   75
Surgical and Minimally Invasive
       Surgical Ablation




                                  76
                       Cox-Maze Procedure




                            In a trial of 190 patients, 1987-1997:
                      92% had freedom from AF and were off AAD agents

Reprinted with permission from Sundt TM 3rd, et al. Cardiol Clin. 1997;15(4):739-748.   77
               ACC/AHA/ESC 2006 Atrial Fibrillation Guidelines


  Recommendations for Catheter Ablation
   I    IIa IIb III
                          Heart rate control:
        B                 When pharmacologic therapy is insufficient or associated
                          with side effects

              C           When rate cannot be controlled pharmacologically or
                          tachycardia-mediated cardiomyopathy is present

                    C     Should not be attempted without prior trial of medication

                          Rhythm control:
        C                 Reasonable alternative to pharmacologic therapy to
                          prevent recurrent AF in symptomatic patients with little or
                          no LA enlargement

Fuster V, et al. Circulation. 2006;114(7):e257-e354.                                  78
  HRS/EHRA/ECAS 2007 Expert Consensus Statement on Catheter
           and Surgical Ablation of Atrial Fibrillation



           Indications for Catheter Ablation
   ● Symptomatic AF refractory or intolerant to at least 1 Class
     1 or 3 antiarrhythmic medication
   ● In rare clinical situations, it may be appropriate
     as first-line therapy
   ● Selected symptomatic patients with heart failure and/or
     reduced ejection fraction
   ● Presence of a left atrial thrombus is contraindication to
     catheter ablation of AF


Calkins H, et al; Heart Rhythm Society Task Force on catheter and surgical ablation of
atrial fibrillation. Heart Rhythm. 2007;4(6):816-861.                                    79
                                                   Efficacy of Catheter Ablation in
                                                          Patients With AF
         Meta-analyzed Proportion of Patients, %   90
                                                                                               42 (3,562)
                                                   75                34 (3,481)   52 (4,786)

                                                        31 (2,800)
                                                   60


                                                   45


                                                   30     57%          71%          72%          77%

                                                   15


                                                    0
                                                          Single-     Multiple-     Single-     Multiple-
                                                        procedure    procedure    procedure    procedure
                                                         success      success      success      success
                                                          off AAD     off AAD     on/off med   on/off med


Adapted with permission from Calkins H, et al. Circ Arrhythmia Electrophysiol. 2009;2(4):349-361.           80
Catheter Ablation of the AV Junction
                    Advantages
                      – Simple
                      – Highly effective
                      – Safe
                      – Allows a reduction in
                        medication
                      – Reduces symptoms
                    But:
                      – Does not prevent AF
                      – Does not restore a normal
                        heart rhythm
                      – Requires placement of a
                        pacemaker
                      – Does not lower the risk
                        of stroke

                                                    81
    Catheter Ablation of AF: Meta-analysis
       of 4 Randomized Clinical Trials
Source                                                                  Risk Ratio         % Weight
                                                                         (95% CI)
Pappone et al, 2006                                                  3.86 (2.65-5.63)        37.5

Stabile et al, 2006                                                 6.43 (2.91-14.21)        18.1

Wazni et al, 2005                                                    4.22 (2.14-8.32)        22.0

Krittayaphong et al, 2003                                            2.00 (1.02-3.91)        22.4

Overall (95% CI)                                                     3.73 (2.47-5.63)

                      0.04      0.20       1.00       5.00      25.00
                      ADT More Effective       CPVA More Effective
                                       Risk Ratio

Reproduced with permission from Noheria A, et al. Arch Intern Med. 2008;168(16):581-586.            82
          NaviStar® ThermoCool®
        Diagnostic/Ablation Catheter
●   Steerable, multi-electrode, deflectable
●   3.5-mm tip and 3 ring electrodes
●   6 saline ports in the tip for irrigation and cooling (open irrigation)
●   A location sensor and a temperature sensor incorporated into the tip
●   Approved by the FDA on February 6, 2009, for treatment of AF




                                                                         83
                                        ThermoCool® Catheter vs AAD:
    Freedom From AF Recurrence             Time to Chronic Failures
                                 1.0

                                 0.8
                                                                                   64% Ablation
                                 0.6                                                   (n=103)

                                 0.4                                    P<.001

                                 0.2                                               16% AAD
                                                                                       (n=56)
                                 0.0
                                        0    30   60   90   120 150 180 210       240 270 300        330   360
                                                       Days Into Effectiveness Follow-up
Number of subjects at risk:
 Ablation                              103   69   69   66    63   62    61   54   52       37   15    3     2
   AAD                                 56    39   29   19    16   13    11   10    7       2    0     0     0
Effectiveness cohort, N=159. Circles in the graph represent 14 censored catheter ablation subjects.
Wilber D. Presented at: American Heart Association 2008 Scientific Sessions;
November 11, 2008; New Orleans, LA.                                                                              84
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

Catheter Ablation and Follow-up Visit at
3 Months
● The patient undergoes successful catheter ablation
● On follow-up 3 months post-catheter ablation, he is in
  AF and reports that AF recurred about 3 weeks
  following the ablation procedure and has been
  present constantly since that time
● He complains of continued palpitations and fatigue
● An ECG confirms the presence of AF


                                                        85
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

What treatment would you now
suggest?

A.   Repeat catheter ablation
B.   MiniMaze procedure
C.   DCC
D.   Pharmacologic cardioversion
E.   Amiodarone
F.   AV node ablation and PPM


                                                        86
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

DCC and Follow-up Visit at 6 Months
Post-Catheter Ablation

● The DCC was successful in restoring sinus rhythm
● At a 6-month follow-up visit after the catheter ablation,
  the patient reports 1 episode of AF each month lasting
  approximately 20 minutes




                                                          87
Case:
65-Year-Old Man With Recent Episodes of Palpitations,
Weakness, and Lightheadedness

At this point, what treatment would you
suggest?
A.   Repeat catheter ablation
B.   MiniMaze procedure
C.   DCC
D.   Pharmacologic cardioversion
E.   Dronedarone
F.   AV node ablation and PPM
G.   Clinical follow-up

                                                        88
      Possible “Upstream” Treatments and
        Mechanisms for AF Prevention
   ACEIs/ARBs Statins Glucocorticoids Physical activity Omega-3 fatty acids




       Inflammation Oxidative stress RAAS activity Endothelial function




                         Autonomic nervous system activity
        Plaque stability Atrial remodeling Stabilize left atrial endocardium




                                  Atrial fibrillation


Courtesy of CJ Pepine, MD.                                                       89
 2010 ESC Guidelines
for the Management of
   Atrial Fibrillation




                         90
2010 Guidelines for the Management of AF
                The Task Force for the Management of AF of the
                    European Society of Cardiology (ESC)a

New recommendations
● Addition of “long-standing persistent AF” as a
  patient category
● Introduction of the EHRA symptom score for arrhythmias
● Establishment of better risk profiles to assess who will benefit
  most from new anticoagulants to prevent stroke
     – CHA2DS2-VASc score (refinement of CHADS2 score)
     – HAS-BLED (new score for assessing bleeding risk)

a   Developed together with the European Heart Rhythm Association (EHRA) and endorsed by the
    European Association for Cardio-Thoracic Surgery (EACTS).
    Camm AJ, et al. Eur Heart J. 2010;31:2369-2429.                                            91
2010 Guidelines for the Management of AF (cont)
                 The Task Force for the Management of AF of the
                     European Society of Cardiology (ESC)a

      Changes from the previous ACC/AHA/ESC
      2006recommendations
      ● New guidance in the area of rate control
      ● Advice on how to use the antiarrhythmic drug dronedarone
      ● Formal indications for the use of ablation therapy
      ● Recommendations on “upstream” therapies to prevent the
        deterioration of AF
      ● Advice on certain “special situations”

 a   Developed together with the European Heart Rhythm Association (EHRA) and endorsed by the
     European Association for Cardio-Thoracic Surgery (EACTS).
     Camm AJ, et al. Eur Heart J. 2010;31:2369-2429.                                            92
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
Question-and-Answer
      Session




                      111
          AF Performance Improvement
                Outcomes Study
● NCME has partnered with Harvard Clinical Research Institute (HCRI) to
  evaluate the impact of this educational activity
● The goal of the study is to:
    – help each participating hospital gain perspective on how their
      institution manages AF
    – directly assess improvements in patient outcomes
● Data will be collected via a secure online Web site
● Baseline data will be collected representing a period prior to the grand
  rounds lecture, and then one year as a follow up
● Study closely aligns with QI programs your hospital is already involved
  in (eg, reporting to Joint Commission and CMS)
● $500 honorarium will be provided to each participation institution
● To sign up for the study complete the enrollment form provided to
  your CME coordinator or send an e-mail message to
  AFIBstudy@ncme.com                                                         112
    Thank you
for participating!




                     113

				
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