ATRIAL FIB
         BRILLATION
New Advances in Management
    Roy Sauberma MD FACC
      y        an,
Murgatroyd F, et al.: Lancet 1993;341:1317-22
www.escardio.org/guidelines
www.escardio.org/guidelines
Atrial Fibrillati can severely
                  ion
    affect the live of patients,
      ff t th li es f ti t
 producing variou symptoms that
                  us
reduce the patien Quality of Life
                  nt’s
Zimetbaum, et al.: PACE 1999;22(Part II):782
                     C
Jung, et al.: J Am Coll Cardiol 1999;33(2):104A
www.escardio.org/guidelines
Wolf PA, et al.: Stroke 1991;22:983-8
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
www.escardio.org/guidelines
Warfarin (CCoumadin)
INR testing required (target = 2 3)
                               2-3)
           Daily d
                 dosing
         Generic a
                 available


      Dabigatran (Pradaxa)
                 n
     No INR testi required
                  ing
Twice daily dosing (75 mg, 150 mg)
                 g
       No generic available
                 c
Stro
                                   oke
                                             D 110mg vs.          D 150mg vs.
            D 110mg   D 150mg   warfar
                                     rin
                                              Warfarin             Warfarin


            Annual    Annual    Annuaal      RR                   RR
                                                           P                 P
             rate
               t       rate
                         t       rate
                                   t       95% CI
                                             %                  95% CI
                                                                  %


Stroke or                                    0.91                0.66
systemic
   t   i     1.5
             15%       1.1
                       11%       1.7
                                 1 7%                  0.34
                                                       0 34                <0.001
                                                                           <0 001
Embolism                                   0.74-1.11           0.53-0.82


                                             0.92
                                             0 92                0.64
                                                                 0 64
Stroke       1.4 %     1.0 %     1.6 %                 0.41                <0.001
                                           0.74-1.13           0.51-0.81
Bleeding
                                      g
                D        D                    D 110mg vs.         D 150mg vs.
                                Warfar
                                     rin
              110mg    150mg                   Warfarin            Warfarin

              Annual   Annual   Annuaal       RR                  RR
                                                        p                    p
               rate     rate     rate       95% CI              95% CI
                                                                0.91
                                                                0 91
                                              0.78     <0.00
Total         14.6%    16.4%     18.2%
                                     %                          0.86-      0.002
                                           0.74-0.83     1
                                                                0.97
                                             0.80                0.93
Major         2.7 %    3.1 %     3.4 %                 0.003                0.31
                                           0.69-0.93           0.81-1.07
Life-                                                           0.81
                                             0.68      <0.00
Threatening
          g   1.2 %    1.5 %
                         5       1.8 %                          0.66
                                                                0.66-       0.04
                                                                               4
                                           0.55-0.83
                                                  8      1
major                                                           0.99
Gastro-
                                             1.10                 1.50
intestinal     1.1 %   1.5 %     1.0 %                 0.43                <0.001
                                           0.86 1.41
                                           0.86-1.41           1.19 1.89
                                                               1.19-1.89
Major
M j
FDA NEWS RELEASE
For Immediate Release: Oct. 19, 2010




FDA approves Pradaxa to prevent str
                                  roke in people with atrial fibrillation
The U.S. Food and Drug Administration today approved Pra   adaxa capsules (dabigatran etexilate) for the prevention of
stroke and blood clots in patients with abnormal heart rhyt
                                                          thm (atrial fibrillation).
LAA OCCLUDERS
 A
  Investigational
www.escardio.org/guidelines
www.escardio.org/guidelines
J Am Coll Cardiol 2004:43;1201-8
               o
J Am Coll Cardiol 2004:43;1201-8
               o
AV NODAL ABLATION


• Rapid, uncontrolled ven
    p ,                 ntricular rates during AF
                                             g

• Refractory or intolerant o antiarrhythmic therapy
           y               of        y            y
AV Nodal Ablation
      al
      a
Pacemaker Required
        r
Subjective Benefits of AV Nodal Ablation
   1.0
   10                                                110


                                                     100
   .90

                                                         90
   .80

                                                         80
   .70
    70




                                                  PGWB
MHIQ




                                                         70

   .60
                                                         60

   .50                              p < 0.01                                                   p < 0.01
                                                         50

   .40
    40                                                   40


       0                                                 30
           Pre                        Post                      Pre                     Post
  McMaster Health Index Questionnaire physical            Psychological General Well-Being Index scores
  dimension scores before and after procedure.            before and after procedure. High score =
  High score = better functional capacity.                greater perception of health and well-being.
                            Kay GN, et al.: Am J Cardiol 1988;62:741-4
Objective Benefits of AV Nodal Ablation
                                    f
           70                                                            55
                                                   mean
                                                   54 + 7                50
           60                                                                 mean
                                                                         45   40 + 5




                                                                   mm)
                  mean
      %)




                                                            LVESD (m
           50                                                                                          mean
LVEF (%




                  43 + 8                                                 40
                                                                                                       34 + 5
                                                                         35
           40

                                               p < 0 001
                                                   0.001                 30                            p < 0 003
                                                                                                           0.003
           30
                                                                         25

           20                                                            20
                           Before          After                                  Before       After

                                LVEF (%)                                               LVESD (mm)



                           Rodriguez LM, et al.: Am J Cardiol 1993;72:1137-41
                                                  m
Amio
p<0.01




J Am Coll Cardiol 2003 Jul 2;42(1):30-2
                l
5-8% of AF pa
                 atients remain

             highly symp
               g y ymptomatic,
                             ,
require at least one ca
                      ardioversion per year,
  despite antiarrhythm drug therapy !!
                     mic



    Seidl K, et al.: J Am Coll Cardiol 1999;33(2):146A
www.escardio.org/guidelines
2011 ACCF/AHA/HRS Focused Update on the Management of
Patients With Atrial Fibrillation (Updating the 2006 Guideline)
                                n

A Report of the Americ College of Cardiology
                     can
Foundation/American H Heart Association Task
Force on Practice Guidelines




         Wann LS et al.: J Am C Cardiol 2011;57:223-42
                              Coll
Ablation Therapy f Patients with
                                  bl i     h    y for     i       ih
                                   Paroxysmal Attrial Fibrillation
           Class I
           Catheter ablation performed in e
                                          experienced centers* is useful in
           maintaining sinus rhythm i sele t d patients with significantly
              i t i i     i     h th in lected ti t       ith i ifi     tl
           symptomatic, paroxysmal AF wh have failed treatment with an
                                          ho
           antiarrhythmic drug and have no
                     y          g         ormal or mildly dilated left atria,
                                                        y
           normal or mildly reduced LV funnction, and no severe
           pulmonary disease.
           (Level of Evidence: A)

*Refers to pulmonary vein isolation with catheter ablation. An experienced center is defin as one performing more than 50 AF catheter ablation cases per year. Evidence-based
                                                                                         ned
technical guidelines including operator training and experience necessary to maximize ra ates of successful catheter ablation are not available; each center should maintain a
database detailing procedures; success and complications engage strategies for continu
                                              complications,                             uous quality improvement, and participate in registries and other efforts pooling data in
                                                                                                      improvement
order to develop optimal care algorithms .



                                                 Wann LS et al.: J Am C Cardiol 2011;57:223-42
                                                                      Coll
Ablation Therapy f Patients with
                                  bl i     h    y for     i       ih
                                   Paroxysmal Attrial Fibrillation
           Class I
           Catheter ablation performed in e
                                          experienced centers* is useful in
           maintaining sinus rhythm i sele t d patients with significantly
              i t i i     i     h th in lected ti t       ith i ifi     tl
           symptomatic, paroxysmal AF wh have failed treatment with an
                                          ho
           antiarrhythmic drug and have no
                     y          g         ormal or mildly dilated left atria,
                                                        y
           normal or mildly reduced LV funnction, and no severe
           pulmonary disease.
           (Level of Evidence: A)

*Refers to pulmonary vein isolation with catheter ablation. An experienced center is defin as one performing more than 50 AF catheter ablation cases per year. Evidence-based
                                                                                         ned
technical guidelines including operator training and experience necessary to maximize ra ates of successful catheter ablation are not available; each center should maintain a
database detailing procedures; success and complications engage strategies for continu
                                              complications,                             uous quality improvement, and participate in registries and other efforts pooling data in
                                                                                                      improvement
order to develop optimal care algorithms .



                                                 Wann LS et al.: J Am C Cardiol 2011;57:223-42
                                                                      Coll
AF Tr
                      riggers




Haissaguerre, et al.: J Cardiova Electrophysiol 1996;7:1132-44
                               asc
AF Tr
                 riggers




Haissaguerre, et. al.: N E
                         Engl J Med 1998;339:659-66
Nathan, et. al.: Circulation 1966;34;412-22
                     u
AF Tr
                 riggers




Haissaguerre, et. al.: N E
                         Engl J Med 1998;339:659-66
Li ewire™ TC
                        Live i
                       Ablatio Catheters
                             on
Diagnostic Catheters
                                              Guiding Introducers




                                            Specialty Spiral Catheters
    Introducers        Steerab Diagnostic
                             ble
                            Catheters
                            C
Wide Area Circum
               mferential Ablation




        Oral et al.: Circulat
                            tion 2003;108;2355-60
Procedural Success
     P    d al S
Elimination of Pulmo
                   onary Vein Potentials
            During A
                   Ablation
Cryoballoo Ablation
C b ll on Abl ti
Cryoballoo Ablation
C b ll on Abl ti
STOP AF TRIAL
             F
Sustained Treatment of Paroxysmal Atrial
            Fibrillati Trial
                     ion
STOP AF TRIAL
              F
• Palpitations decreased from 86% to 25%
                         d
• Fatigue decreased from 76% to 13%
                          m
• Rapid heartbeat decre  eased from 66% to 16%
• Diffi lt b thi decreased from 54% to 9%
  Difficulty breathing            df         t
• Dizziness decreased fr  rom 48% to 9%
• Fainting decreased fro 4% to 1%
                         om
• Overall quality of life significantly improved
Hansen Robotic System
         b      y
Hansen Robotic System
         b      y
AF ABL
                      LATION

   Benefits
       f                                         Risks

                                          Bleeding
Restoration of sinus rhythm               Stroke
                                          Pneumothorax
Relief of AF-related symptoms
          AF related                      Pulmonary vein stenosis
                                          P l            i t     i
Elimination of antiarrhythmic Rx          Diaphragmatic paralysis
                                ulation
Less need for long-term anticoagu         Myocardial infarction
                                          Esophageal fistula
                                          Other atrial arrhythmias
AF remains a m
             major public h l h issue
                      l health
      Increasin population at risk
              ng
      Significan morbidity & costs
        g      nt        y

Anticoagulants reduce stroke risk
             s
      Warfarin
      Dabigatra
              an

Drug therapy available for symptom relief
             a
      Rate cont agents
              trol
      Antiarrhy
              ythmic drugs
              y         g

Catheter-based ablative therapies have emerged
             d
      AV nodal ablation to control AF rate
             l
      Pulmonary vein isolation to prevent AF recurrence
Berkeley Heights
       y
    Mill
       lburn
    Bay
      yonne

Atrial Fibrillation

  • 1.
    ATRIAL FIB BRILLATION New Advances in Management Roy Sauberma MD FACC y an,
  • 5.
    Murgatroyd F, etal.: Lancet 1993;341:1317-22
  • 6.
  • 15.
  • 16.
    Atrial Fibrillati canseverely ion affect the live of patients, ff t th li es f ti t producing variou symptoms that us reduce the patien Quality of Life nt’s
  • 17.
    Zimetbaum, et al.:PACE 1999;22(Part II):782 C
  • 18.
    Jung, et al.:J Am Coll Cardiol 1999;33(2):104A
  • 20.
  • 23.
    Wolf PA, etal.: Stroke 1991;22:983-8
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
    Warfarin (CCoumadin) INR testingrequired (target = 2 3) 2-3) Daily d dosing Generic a available Dabigatran (Pradaxa) n No INR testi required ing Twice daily dosing (75 mg, 150 mg) g No generic available c
  • 31.
    Stro oke D 110mg vs. D 150mg vs. D 110mg D 150mg warfar rin Warfarin Warfarin Annual Annual Annuaal RR RR P P rate t rate t rate t 95% CI % 95% CI % Stroke or 0.91 0.66 systemic t i 1.5 15% 1.1 11% 1.7 1 7% 0.34 0 34 <0.001 <0 001 Embolism 0.74-1.11 0.53-0.82 0.92 0 92 0.64 0 64 Stroke 1.4 % 1.0 % 1.6 % 0.41 <0.001 0.74-1.13 0.51-0.81
  • 32.
    Bleeding g D D D 110mg vs. D 150mg vs. Warfar rin 110mg 150mg Warfarin Warfarin Annual Annual Annuaal RR RR p p rate rate rate 95% CI 95% CI 0.91 0 91 0.78 <0.00 Total 14.6% 16.4% 18.2% % 0.86- 0.002 0.74-0.83 1 0.97 0.80 0.93 Major 2.7 % 3.1 % 3.4 % 0.003 0.31 0.69-0.93 0.81-1.07 Life- 0.81 0.68 <0.00 Threatening g 1.2 % 1.5 % 5 1.8 % 0.66 0.66- 0.04 4 0.55-0.83 8 1 major 0.99 Gastro- 1.10 1.50 intestinal 1.1 % 1.5 % 1.0 % 0.43 <0.001 0.86 1.41 0.86-1.41 1.19 1.89 1.19-1.89 Major M j
  • 33.
    FDA NEWS RELEASE ForImmediate Release: Oct. 19, 2010 FDA approves Pradaxa to prevent str roke in people with atrial fibrillation The U.S. Food and Drug Administration today approved Pra adaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhyt thm (atrial fibrillation).
  • 34.
    LAA OCCLUDERS A Investigational
  • 36.
  • 38.
  • 39.
    J Am CollCardiol 2004:43;1201-8 o
  • 40.
    J Am CollCardiol 2004:43;1201-8 o
  • 41.
    AV NODAL ABLATION •Rapid, uncontrolled ven p , ntricular rates during AF g • Refractory or intolerant o antiarrhythmic therapy y of y y
  • 46.
  • 47.
  • 48.
    Subjective Benefits ofAV Nodal Ablation 1.0 10 110 100 .90 90 .80 80 .70 70 PGWB MHIQ 70 .60 60 .50 p < 0.01 p < 0.01 50 .40 40 40 0 30 Pre Post Pre Post McMaster Health Index Questionnaire physical Psychological General Well-Being Index scores dimension scores before and after procedure. before and after procedure. High score = High score = better functional capacity. greater perception of health and well-being. Kay GN, et al.: Am J Cardiol 1988;62:741-4
  • 49.
    Objective Benefits ofAV Nodal Ablation f 70 55 mean 54 + 7 50 60 mean 45 40 + 5 mm) mean %) LVESD (m 50 mean LVEF (% 43 + 8 40 34 + 5 35 40 p < 0 001 0.001 30 p < 0 003 0.003 30 25 20 20 Before After Before After LVEF (%) LVESD (mm) Rodriguez LM, et al.: Am J Cardiol 1993;72:1137-41 m
  • 52.
  • 53.
    p<0.01 J Am CollCardiol 2003 Jul 2;42(1):30-2 l
  • 54.
    5-8% of AFpa atients remain highly symp g y ymptomatic, , require at least one ca ardioversion per year, despite antiarrhythm drug therapy !! mic Seidl K, et al.: J Am Coll Cardiol 1999;33(2):146A
  • 55.
  • 56.
    2011 ACCF/AHA/HRS FocusedUpdate on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline) n A Report of the Americ College of Cardiology can Foundation/American H Heart Association Task Force on Practice Guidelines Wann LS et al.: J Am C Cardiol 2011;57:223-42 Coll
  • 57.
    Ablation Therapy fPatients with bl i h y for i ih Paroxysmal Attrial Fibrillation Class I Catheter ablation performed in e experienced centers* is useful in maintaining sinus rhythm i sele t d patients with significantly i t i i i h th in lected ti t ith i ifi tl symptomatic, paroxysmal AF wh have failed treatment with an ho antiarrhythmic drug and have no y g ormal or mildly dilated left atria, y normal or mildly reduced LV funnction, and no severe pulmonary disease. (Level of Evidence: A) *Refers to pulmonary vein isolation with catheter ablation. An experienced center is defin as one performing more than 50 AF catheter ablation cases per year. Evidence-based ned technical guidelines including operator training and experience necessary to maximize ra ates of successful catheter ablation are not available; each center should maintain a database detailing procedures; success and complications engage strategies for continu complications, uous quality improvement, and participate in registries and other efforts pooling data in improvement order to develop optimal care algorithms . Wann LS et al.: J Am C Cardiol 2011;57:223-42 Coll
  • 58.
    Ablation Therapy fPatients with bl i h y for i ih Paroxysmal Attrial Fibrillation Class I Catheter ablation performed in e experienced centers* is useful in maintaining sinus rhythm i sele t d patients with significantly i t i i i h th in lected ti t ith i ifi tl symptomatic, paroxysmal AF wh have failed treatment with an ho antiarrhythmic drug and have no y g ormal or mildly dilated left atria, y normal or mildly reduced LV funnction, and no severe pulmonary disease. (Level of Evidence: A) *Refers to pulmonary vein isolation with catheter ablation. An experienced center is defin as one performing more than 50 AF catheter ablation cases per year. Evidence-based ned technical guidelines including operator training and experience necessary to maximize ra ates of successful catheter ablation are not available; each center should maintain a database detailing procedures; success and complications engage strategies for continu complications, uous quality improvement, and participate in registries and other efforts pooling data in improvement order to develop optimal care algorithms . Wann LS et al.: J Am C Cardiol 2011;57:223-42 Coll
  • 59.
    AF Tr riggers Haissaguerre, et al.: J Cardiova Electrophysiol 1996;7:1132-44 asc
  • 60.
    AF Tr riggers Haissaguerre, et. al.: N E Engl J Med 1998;339:659-66
  • 63.
    Nathan, et. al.:Circulation 1966;34;412-22 u
  • 64.
    AF Tr riggers Haissaguerre, et. al.: N E Engl J Med 1998;339:659-66
  • 66.
    Li ewire™ TC Live i Ablatio Catheters on Diagnostic Catheters Guiding Introducers Specialty Spiral Catheters Introducers Steerab Diagnostic ble Catheters C
  • 70.
    Wide Area Circum mferential Ablation Oral et al.: Circulat tion 2003;108;2355-60
  • 71.
    Procedural Success P d al S Elimination of Pulmo onary Vein Potentials During A Ablation
  • 74.
  • 76.
  • 81.
    STOP AF TRIAL F Sustained Treatment of Paroxysmal Atrial Fibrillati Trial ion
  • 83.
    STOP AF TRIAL F • Palpitations decreased from 86% to 25% d • Fatigue decreased from 76% to 13% m • Rapid heartbeat decre eased from 66% to 16% • Diffi lt b thi decreased from 54% to 9% Difficulty breathing df t • Dizziness decreased fr rom 48% to 9% • Fainting decreased fro 4% to 1% om • Overall quality of life significantly improved
  • 84.
  • 85.
  • 89.
    AF ABL LATION Benefits f Risks Bleeding Restoration of sinus rhythm Stroke Pneumothorax Relief of AF-related symptoms AF related Pulmonary vein stenosis P l i t i Elimination of antiarrhythmic Rx Diaphragmatic paralysis ulation Less need for long-term anticoagu Myocardial infarction Esophageal fistula Other atrial arrhythmias
  • 90.
    AF remains am major public h l h issue l health Increasin population at risk ng Significan morbidity & costs g nt y Anticoagulants reduce stroke risk s Warfarin Dabigatra an Drug therapy available for symptom relief a Rate cont agents trol Antiarrhy ythmic drugs y g Catheter-based ablative therapies have emerged d AV nodal ablation to control AF rate l Pulmonary vein isolation to prevent AF recurrence
  • 91.
    Berkeley Heights y Mill lburn Bay yonne