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Atrial fibrillation
Epidemiology, pathogenesis,
diagnosis and treatment
Dr. dr. Hendro Darmawan, MSc, SpJP
RS BMC, 31 October 2012
DR. Dr. H. Hendro Darmawan, MSc, SpJP, FIHA
 Pekerjaan :
Direktur Utama RS Bogor Medical Center
 Pendidikan :
* Dokter Umum FKUI Jakarta 1980
* Dokter Spesialis Jantung dan Pembuluh Darah FKUI Jakarta 1989
* MSc in Epidemiology, University of Illinois Urbana Champaign, USA 1991
* Doktor Epidemiologi Klinis FKM UI 2007
 Organisasi :
* Anggota IDI
* Anggota PERKI
* Anggota American Heart Association, Council of Epidemiology
* Ketua PERSI Cabang Bogor
 Disorganised electrical and mechanical
activity that originates in the atria with an
irregular ventricular response
 AF is an arrhythmia characterized by
uncoordinated atrial activation, with
consequent deterioration of atrial mechanical
function
 Condition in which the normal contractions of
the atria are replaced by a rapid irregular
twitching
Atrial fibrillation
Normal
sinus
rhythm
Atrial
fibrillation
Atrial fibrillation – ECG
Atrial Fibrillation  Epidemiology, pathogenesis, diagnosis and treatment
Prevalence of AF
 AF is considered highly prevalent1–6
- ATRIA study – prevalence in US population estimated at ~1%:1
 Prevalence estimated for AF:1–10
- US: 3.3 million people
- Europe: > 6 million people
- Asia-Pacific: incidence of AF is not known in many Asia-Pacific
countries; prevalence ranges from 770 to 1,634 per
100,000 population
- Latin America: incidence of AF is not known in many Latin
American countries; in Brazil ~1.5 million people are thought to be
living with AF
1. Go AS et al. JAMA 2001;285:2370–2375; 2. Heeringa J et al. Eur Heart J 2006;27:949–953; 3. Frost L et al. Int J Cardiol 2005;103:78–84;
4. DeWilde S et al. Heart 2006;92:1064–1070; 5. Miyasaka Y et al. Circulation 2006;114:119–125; 6. Zhou Z and Hu D. J Epidemiol 2008;18:209–
216; 7. Fuster V et al. Circulation 2006;114:700–752; 8. Zimerman LI et al. Arq Bras Cardiol 2009;92:1–39; 9. ESC Guidelines Eur Heart J 2010;
31:2369-2429; 10.Naccarelli GV et al. Am J Cardiol 2009;104(11):1534-9
Atrial fibrillation
Epidemiology
 The most prevalent
sustained rhythm disorder
 Accounts for 1/3 of
hospitalisations due to
cardiac rhythm
disturbances
 Estimated prevalence in
USA 2.2 and worldwide
5.5 million
Arrhythmia-related hospitalisations
in the US
Atrial flutter 4%
Paroxysmal
supraventricular
tachycardia 6%
Atrial
fibrillation 34%
Ventricular
fibrillation 2%
Ventricular
tachycardia 10%
Miscellaneous 21%
Conduction
abnormalities 8%
Sick sinus
syndrome 9%
Premature
beats 6%
Bialy D et al. J Am Coll Cardiol 1992;19:41A
Age (years)
Prevalence
%
Prevalence of atrial fibrillation increases
with age
0.5
1.8
4.8
8.8
0
2
4
6
8
10
50-59 60-69 70-79 80-89
Wolf PA et al. Stroke 1991;22:983-8
Framingham Study
Atrial fibrillation increases mortality
50
40
30
20
10
0
0 1 2 3 4 5 6 7
Subjects dead in follow-up
(%)
Years of follow-up
Men AF
Women AF
Men no AF
Women no AF
0
0.4
0.8
1.2
1.6
2.0
Adjusted odds ratio
Men Women
95% Cl 1.2–1.8 1.5–2.2
Odds ratio for death
Benjamin EJ et al. Circulation 1998;98:946–52
A
T
R
I
A
L
F
I
B
Alcohol
Thyroid disease
Rheumatic heart disease
Ischaemic heart disease
Atrial myxoma
Lung (pulmonary embolism)
Phaeochromocytoma
Idiopathic
Blood pressure (hypertension)
Other causes are known
What causes atrial fibrillation?
Magnani JW et al. Circulation 2011; 124: 1982-1993
Increased potential
for atrial fibrillation
Increased atrial
pressures
Hypertension
High left
ventricular pressures
Hypertension increases the risk of developing
atrial fibrillation almost two-fold
Slowing of atrial
conduction velocity
Impaired ventricular filling
Left atrial enlargement
Left ventricular hypertrophy
Patients with AF have an approximately
fivefold increased risk of ischaemic stroke
2-yearage-adjusted
incidenceofstroke/1,000
Individuals
with AF*
Individuals
without AF
Risk ratio=4.8
p<0.001
0
10
20
30
40
50
60
Framingham Heart Study (N=5,070)
Wolf PA et al. Stroke 1991;22:983–988
*Patients were untreated with antithrombotic therapy when this study was performed in line with clinical
practice at the time
Wolf PA, et al. Stroke 1991; 22: 983-988
%
AF prevalence
Strokes attributable
to AF
Age Range (years)
0
10
20
30
50–59 60–69 70–79 80–89
Framingham
 Approximately 5-fold increased risk of stroke
 Quantify stroke risk: CHADS2/ CHA2DS2-VASc
 AF strokes have worse outcomes
 Costly health care ~ $16 billion/year
Lone AF (younger persons without evidence of cardiovascular or
precipitating disease)
Transient AF (caused by reversible disorders)
First detected
Paroxysmal
Self-terminating
Persistent
Not self-terminating
Permanent
Recurrent AF
(two or more episodes)
Atrial fibrillation – clinical classification
Fuster V et al. Eur Heart J 2006;27:1979–2030
Classification
 Paroxysmal: terminates in < 7 days
 Persistent: fails to terminate within 7 days
 Permanent: > 1 year
 Lone: Individuals without structural heart
disease, < 60 yrs old
Paroxysmal
Self-Terminating
Persistent
Lasts > 7 Days
Permanent
Cardioversion
Failed or Not
Attempted
Normal Sinus Rhythm
Atrial Fibrillation
Paroxysmal AF is as likely
to cause stroke as
persistent or permanent AF
Atrial fibrillation – consequences
Loss of atrial systolic function (atrial
contribution to ventricular filling is lost)
Irregular rapid ventricular contractions
Abnormal blood flow and stasis in
the atria
Cardiac output reduced
Formation of intra-atrial thrombus
Right
atrium
Left
atrium
Atrial fibrillation – manifestations
 Palpitations
 Rapid heartbeat
 Sudden pounding in the chest
 Dizziness
 Syncope
 Chest discomfort
 Shortness of breath
Symptoms of AF
Strategies for treating atrial fibrillation
 Rhythm control (including cardioversion)
OR
 Rate control
PLUS
 Anticoagulation therapy
 Hemodynamic stabilization
Rhythm and rate control approaches
Rhythm control
 Cardioversion
(electrical or
pharmacological)
 Pharmacological agents
(Class IC and III
antiarrhythmics)
 Surgery
(maze procedure, ablation)
 Device implantation
(pacemaker)
Rate control
 Pharmacological agents
(AV node blockers)
 Surgery with device
implantation (ablation plus
pacemaker insertion)
Pacemaker image courtesy of
St Jude Medical, Inc
Rate Control
 Medications
- Metoprolol / Esmolol: IV or Oral
- Diltiazem: IV or Oral
- Verapamil: Oral Only
- Digoxin: Patients with hypotension
- Amiodarone: Also for rhythm control
Rhythm Control
 Synchronized DC cardioversion
- Emergencies/Hemodynamic instability
- Greater efficacy than medications
 Pharmacologic cardioversion
- If AF < 7days – dofetilide, flecainide, ibutilide,
propaferone or amiodarone
- If AF > 7 day – dofetilide or amiodarone
Electrical cardioversion
Recommendations for successful cardioversion:
 Antiarrhythmic drugs to maintain normal sinus rhythm
 Anticoagulation >3 weeks before and >1 month after chemical or
electrical cardioversion, or permanently if necessary
 Transoesophageal echocardiogram (TEE) to detect any clot in the
left atrial appendage before cardioversion
 Successful cardioversion is more likely if the patient:
- has no other cardiovascular problems
- has normal sized atria
- has been in atrial fibrillation for a relatively short period
- had factors contributing to atrial fibrillation (e.g., hyper- or
hypothyroidism)
Heart rhythm
in atrial fibrillation
Cardioversion
shock
Normal heart
rhythm
ECGMetal
paddle
Vaughan Williams classification of antiarrhythmic agents
Verapamil, diltiazemCalcium channel blockIV
Ibutilide, sotalol*,
dofetilide, amiodarone*
Potassium channel block, increase
repolarisation and refractoriness
III
Propanolol, esmolol,
atenolol, sotalol*
b-adrenergic blockade, slow sinus
rhythm, prolong PR interval
II
Propafenone, flecainide,
amiodarone*
Little effect on repolarisation
(most potent Na+ channel block)
IC
Lidocaine, tocainideShorten repolarisationIB
Quinidine, procainamide,
disopyramide, amiodarone*
Prolong repolarisationIA
Sodium channel blockI
ExamplesActionClass
Antiarrhythmics used for: 1. Conversion of AF
2. Prevention of recurrence of AF
* mixed effects across different classes
Chaudhry GM & Haffajee CI. Crit Care Med 2000;28:N158–64
Patient with diagnosis of atrial fibrillation
Hemodynamically
stable
Control ventricular
rate:
Diltiazem
Cardioversion
Yes No
Spontaneous conversion to sinus rhythm
Assess cause
of atrial
fibrillation
Yes No
Contraindication to cardioversion?
Cont’
•Beta Blockers
•Calcium Channel blockers
•Digoxin
•Amiodarone
Unstable…
•Hypotension
•Confusion
•Angina
•….
Long standing
HTN
Ischemic heart dz
CHF
Hyperthyroidism
PE
Lung ca
Alcohol
Hypothermia
Electrolytes imbalance
Etc. .
UCLA Family Medicine Department IMG Program Carlos Yoo
Consider long-term
anticoagulation
Cardioversion
Yes No
>48hs<48hs
Start Heparin IV
•Immediate
medical or
electrical
cardioversion
•Later elective
cardioversion after
3weeks of warfarin
• Early TEE-guided
cardioversion
Atrial fibrillation persist?
Assess cause of atrial
fibrillation
Yes
No
Cont’
Long standing HTN
Ischemic heart dz
CHF
Hyperthyroidism
PE
Lung ca
Alcohol
Hypothermia
Electrolytes imbalance
Etc. .
Warfarin Aspirin
ESC 2012 guidelines: selection of patients
for OACs
Non-valvular atrial fibrillation Valvular atrial fibrillation
< 65 years and lone AF including women
Stroke risk assessment using CHA2DS2-VASc
0 1 ≥2
Assess bleeding risk (HAS-BLED score);
consider patient values/preferences
New oral anticoagulant;
rivaroxaban, dabigatran
apixaban
Vitamin K antagonistNo antithrombotic therapy
Oral anticoagulant
Yes
Camm AJ et al. Eur Heart J 2012 Slide line preferred; dotted line alternative
 Assess stroke risk exclusively with CHA2DS2-
VASc and no longer use CHADS2
 ESC Guidelines recommend anticoagulation
for stroke prevention with CHA2DS2-VASc
score of 1 or greater
 Preference given to novel, non-monitored
anticoagulants: apixaban, rivaroxaban, and
dabigatran
Congestive heart failure or LVEF < 35% 1
Hypertension 1
Age > 75 years 2
Diabetes mellitus 1
Stroke/TIA/systemic embolism 2
Vascular Disease (MI/PAD/Aortic plaque) 1
Age 65-74 years 1
Sex category (female) 1
Moderate-High risk > 2
Low risk 0-1
Lip GYH, Halperin JL. Am J Med 2010; 123: 484.
Weight (points)
Risk Profile Class / Level
CHA2DS2-VASc = 0
No antithrombotic therapy
I B
CHA2DS2-VASc = 1
VKA (INR 2-3)
Or
Dabigatran / Rivaroxaban / Apixaban
IIa A (Favored)
CHA2DS2-VASc ≥ 2
VKA (INR 2-3)
Or
Dabigatran / Rivaroxaban / Apixaban
I A (Favored)
CHA2DS2-VASc score and stroke risk in
patients with AF
Item Points
Previous stroke
TIA or systemic
embolism
2
Age ≥75 years 2
Congestive heart
failure*
1
Hypertension 1
Diabetes mellitus 1
Age 65–74 years 1
Female gender 1
Vascular disease 1
CHA2DS2-
VASc
1-year
stroke rate
9 23.64%
8 22.38%
7 21.50%
6 19.74%
5 15.26%
4 9.27%
3 5.92%
2 3.71%
1 2.01%
0 0.78%
*Or moderate-to-severe left ventricular systolic dysfunction (left ventricular ejection fraction ≤40%)
Olesen JB et al. BMJ 2011;342:d124; Camm AJ et al. Eur Heart J 2010;31:2369–2429
Add points
together
Hypertension (> 160 mm Hg systolic) 1
Abnormal renal or hepatic function 1-2
Stroke 1
Bleeding history or anemia 1
Labile INR (TTR < 60%) 1
Elderly (age > 75 years) 1
Drugs (antiplatelet, NSAID) or alcohol 1-2
High risk (> 4%/year) > 4
Moderate risk (2-4%/year) 2-3
Low risk (< 2%.year) 0-1
Pisters R, et al. Chest 2010; 138: 1093.
Lip GYH, et al. J Am Coll Cardiol 2010; 57: 173.
Weight (points)
Risk Score for Predicting Bleeding in
Anticoagulated Patients with Atrial Fibrillation
Hankey GJ and Eikelboom JW. Circulation. 2011; 123: 1436-1450
Patients with bleeding on NOAC therapy
Mild bleeding
Moderate-Severe
bleeding
Life-threatening
bleeding
• Delay next dose or
discontinue treatment
as appropriate
• Mechanical compression
• Surgical intervention
• Fluid replacement and
hemodynamic support
• Blood product transfusion
• Oral charcoal
• Hemodialysis
• ? Prothrombin Complex
Concentrate?
(Circulation 2011; 2011: 124: 1573-9)
• Consideration of rFVIIa
or PCC
• Charcoal filtration
• ? Prothrombin Complex
Concentrate
(Circulation 2011; 2011: 124:
1573-9)
► CHA2DS2-VASc has replaced CHADS2 as the
predominant assessment tool to predict stroke
risk (ESC 2012 AF Guidelines Update).
► HAS-BLED has gained dominance as the most
predictive bleeding index. It is best used as a
cautionary “yellow flag” rather than as a reason
to withhold anticoagulation (ESC 2012).
Warfarin better Control better
AFASAK
SPAF
BAATAF
CAFA
SPINAF
EAFT
100% 50% 0 -50% -100%
Aggregate
RRR of stroke:
62%
RRR All-cause mortality:
26%
RRR, relative risk reduction.
Hart RG, et al. Ann Intern Med. 1999;131:492-501.
VKAs are associated with major bleeding,
particularly among the elderly
• Consecutive admitted patients with AF who started warfarin were identified
from January 2001 to June 2003 and followed for 1 year
• Patients had to be ≥65 years of age, have established care at the study
institution, and have their warfarin managed on site
Days on warfarin
Cumulativeincidencewith
majorhaemorrhage
0.10
0.08
0.06
0.04
0.02
0.00
0 100 200 300 400
Age 80 years
Age <80 years
Hylek EM et al. Circulation 2007;115:2689–2696
VKAs have a narrow therapeutic window
• INR below 2 is associated with
an increased risk of ischaemia
• INR above 3 is associated
with an increased risk of
haemorrhagic stroke
1. Amouyel P et al. Eur J Intern Med 2009;20:63–69; 2. Pouyanne P et al. BMJ 2000;320:1036
VKA-related haemorrhage is the leading cause of iatrogenic hospitalization,
accounting for 13% of hospitalizations due to drug-related adverse events2
Ischaemic stroke1 Haemorrhagic stroke1
0 1 2 3 4 5 6
0
2
4
6
8
10
12
Strokerateper
100patient-years
0 1 2 3 4 5 6
0
2
4
6
8
12
16
Strokerateper
100patient-years
Observed
Predicted
95% CI
Observed
Predicted
95% CI
10
14
1) Delayed onset/offset
2) Unpredictable dose response
3) Narrow therapeutic index
4) Drug-drug, drug-food interactions
5) Problematic monitoring
6) High bleeding rate
7) Slow reversibility
VKAs have many drug–drug interactions
Increased INR response Decreased INR response
Coumadine Package Insert US revised January 2010
Despite continued use of warfarin, NOACs are
considered by many professional medical
organizations to be the “best option” for
anticoagulation of SPAF patients:
► ESC 2012 AF Update Guidelines
► ACCP 2012 Guidelines
► Canadian AF Guidelines
“ ”
Targets for anticoagulants
VKA VKA
Inactive Factor
Active Factor
Transformation
Catalysis
X IX
IXa
Thrombin
X
a
Fibrinogen Fibrin
Prothrombin
VIITF VIIa
Clot formation
Initiation
Propagation VKA
Direct Factor Xa inhibition
Rivaroxaban
Apixaban
Edoxaban
Betrixaban
Direct Factor IIa inhibition
Dabigatran
II
IIa
Piccini JP et al. Curr Opin Cardiol 2010;25:312–320; Spyropoulos AC et al. Expert Opin Investig Drugs 2007;16:431–440
Features Warfarin New Agents
Onset Slow Rapid
Dosing Variable Fixed
Food effect Yes No
Drug interactions Many Few
Monitoring Yes No
Half-life Long Short
Antidote Yes No
45
Stroke & SEE
Ischemic &
Unsp. Stroke
Hemorraghic
Stroke
Miller CS, et al. Am J Cardiol 2012;110(3):453-460.
Favors
NOACs
Favors
Warfarin
13%
55%
Major
ICH
GI
Bleeding
iller CS, et al. Am J Cardiol 2012;110(3):453-460.
51%
Favors Favors
• Oral direct thrombin inhibitor
• Twice daily dosing
• Renal clearance
Dabigatran
• Direct factor Xa inhibitor
• Once daily (maintenance), twice daily (loading)
• Renal clearance
Rivaroxaban
• Direct factor Xa inhibitor
• Twice daily dosing
• Hepatic clearance
Apixaban
• Direct factor Xa inhibitor
• Once daily dosing
• Hepatic clearance
Edoxaban
Circulation 2010;121:1523
ESC 2012 guidelines: recommendations for
new OACS
• Dabigatran 150 mg bid
• Dabigatran 110 mg bid in:
• ≥ 80 years
• Concomitant use of
interacting drugs
• HAS-BLED ≥ 3
• CrCl 30-49 mL/min
• Peri-cardioversion
• No recommendation in
severe renal impairment
CrCl < 30 mL/min
• Apixaban
• No recommendation in
severe renal impairment
CrCl <30 mL/min
• No recommendation for
cardioversion *
• Approved by FDA on
Dec. 28, 2012 and by
EMA on Nov 20, 2012..
All NOACs are recommended for SPAF in patients at risk of
stroke (CHA2DS2-VASc≥2) in preference over a VKA
• Rivaroxaban 20 mg od
• Rivaroxaban 15 mg od
with:
• HAS-BLED ≥3
• CrCl 30-49 mL/min
• No recommendation in
severe renal impairment
CrCl < 30 mL/min
• No recommendation for
cardioversion*
Camm AJ et al. Eur Heart J 2012; od=once daily; bid=twice daily*based on lack of published data
Properties of an ideal oral anticoagulant
Once
daily
No
significant
food
interactions
Predictable
response
No routine
coagulation
monitoring
Fixed
dosing
Wide
therapeutic
window
IDEAL      
Warfarin 
Rivaroxaban      
Dabigatran     
Apixaban     
ESC 2012 guidelines: ASA/DAPT
• Antiplatelet therapy for SPAF should be limited to patients who
refuse/cannot take VKAs/NOACs
– Consider in patients who refuse OAC and at low bleeding risk
• DAPT (ASA/clopidogrel) or
• less effectively ASA
• No evidence for the decrease in total or CV mortality with ASA (or
antiplatelet drugs) in SPAF
• Antiplatelet therapy (including ASA monotherapy) carries a similar
risk of major bleeding and ICH as OAC, particularly in the elderly
Camm AJ et al. Eur Heart J 2012; DAPT=dual antiplatet therapy; ICH=intracranial haemorrhage
ROCKET AF
Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition
Compared with Vitamin K Antagonism for Prevention of
Stroke and Embolism Trial in Atrial Fibrillation
ROCKET AF - Rivaroxaban vs
warfarin – Study design
Rivaroxaban
N=7131
Warfarin
N=7133
Primary endpoint: stroke or non-CNS systemic embolism
INR target: 2.5
(2.0–3.0 inclusive)
20 mg od
(15 mg od for CrCl 30–49
ml/min)
Atrial fibrillation
Randomized
double blind
Monthly monitoring
Adherence to standard-of-care guidelines
*Enrolment of patients without prior stroke, TIA or systemic embolism and only two factors capped at 10%
Risk factors
Stroke, TIA or
systemic embolism
OR
• CHF
• Hypertension
• Age  75
• Diabetes
At least 2
or 3
required*
Patel MR et al. N Engl J Med 2011;365:883–891
N= 14,264
Number of subjects at risk
Rivaroxaban 6,958 6,211 5,786 5,468 4,406 3,407 2,472 1,496
Warfarin 7,004 6,327 5,911 5,542 4,461 3,478 2,539 1,538
ROCKET AF
Rivaroxaban vs warfarin – Results: Efficacy- PPP
PPP=Per-protocol population – as treated = all ITT patients without major predefined protocol violations
Days since randomization
Warfarin
Rivaroxaban
HR 0.79 (0.66, 0.96)
p<0.001 (non-inferiority)
0 120 240 480 600 720
0
1
2
3
4
5
6
840360
Cumulativeeventrate(%)
Stroke or systemic embolism
Patel MR et al. N Engl J Med 2011;365:883–891
ROCKET AF
Rivaroxaban vs warfarin – Conclusions
• Based on the prespecified primary efficacy outcome:
– A once-daily fixed-dose regimen of rivaroxaban was non-inferior to warfarin for
prevention of stroke or non-CNS systemic embolism
– Rivaroxaban was superior to warfarin while patients were taking study drug
– A sensitivity analysis in the ITT population that followed all patients in the trial until
completion showed a benefit for rivaroxaban, but did not reach superiority
• Safety:
– Similar overall incidence of bleeding and adverse events
– Increase in gastrointestinal bleeds but fewer intracranial haemorrhages and less
fatal bleeding with rivaroxaban
• Implication:
– Rivaroxaban, administered once daily, has demonstrated non-inferiority to
warfarin in the prevention of stroke or systemic embolism, with similar overall
bleeding and fewer intracranial haemorrhages and fatal bleeds
Patel MR et al. N Engl J Med 2011;365:883–891
KEY POINTS
► VKA is a very effective for SPAF but related to some
limitations that can lead to underuse by both patient
and physician.
► Novel Oral Anticoagulants offer favourable risk–
benefit profile compare to VKA, with significant
reductions in stroke, intracranial haemorrhage, and
mortality, and with similar major bleeding as for
warfarin.
• Rivaroxaban, administered once daily, has demonstrated
non-inferiority to warfarin, both in primary and secondary
prevention of stroke or systemic embolism with similar
overall bleeding and fewer intracranial haemorrhages and
fatal bleeds

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Atrial Fibrillation Epidemiology, pathogenesis, diagnosis and treatment

  • 1. Atrial fibrillation Epidemiology, pathogenesis, diagnosis and treatment Dr. dr. Hendro Darmawan, MSc, SpJP RS BMC, 31 October 2012
  • 2. DR. Dr. H. Hendro Darmawan, MSc, SpJP, FIHA  Pekerjaan : Direktur Utama RS Bogor Medical Center  Pendidikan : * Dokter Umum FKUI Jakarta 1980 * Dokter Spesialis Jantung dan Pembuluh Darah FKUI Jakarta 1989 * MSc in Epidemiology, University of Illinois Urbana Champaign, USA 1991 * Doktor Epidemiologi Klinis FKM UI 2007  Organisasi : * Anggota IDI * Anggota PERKI * Anggota American Heart Association, Council of Epidemiology * Ketua PERSI Cabang Bogor
  • 3.  Disorganised electrical and mechanical activity that originates in the atria with an irregular ventricular response  AF is an arrhythmia characterized by uncoordinated atrial activation, with consequent deterioration of atrial mechanical function  Condition in which the normal contractions of the atria are replaced by a rapid irregular twitching Atrial fibrillation
  • 7. Prevalence of AF  AF is considered highly prevalent1–6 - ATRIA study – prevalence in US population estimated at ~1%:1  Prevalence estimated for AF:1–10 - US: 3.3 million people - Europe: > 6 million people - Asia-Pacific: incidence of AF is not known in many Asia-Pacific countries; prevalence ranges from 770 to 1,634 per 100,000 population - Latin America: incidence of AF is not known in many Latin American countries; in Brazil ~1.5 million people are thought to be living with AF 1. Go AS et al. JAMA 2001;285:2370–2375; 2. Heeringa J et al. Eur Heart J 2006;27:949–953; 3. Frost L et al. Int J Cardiol 2005;103:78–84; 4. DeWilde S et al. Heart 2006;92:1064–1070; 5. Miyasaka Y et al. Circulation 2006;114:119–125; 6. Zhou Z and Hu D. J Epidemiol 2008;18:209– 216; 7. Fuster V et al. Circulation 2006;114:700–752; 8. Zimerman LI et al. Arq Bras Cardiol 2009;92:1–39; 9. ESC Guidelines Eur Heart J 2010; 31:2369-2429; 10.Naccarelli GV et al. Am J Cardiol 2009;104(11):1534-9
  • 8. Atrial fibrillation Epidemiology  The most prevalent sustained rhythm disorder  Accounts for 1/3 of hospitalisations due to cardiac rhythm disturbances  Estimated prevalence in USA 2.2 and worldwide 5.5 million Arrhythmia-related hospitalisations in the US Atrial flutter 4% Paroxysmal supraventricular tachycardia 6% Atrial fibrillation 34% Ventricular fibrillation 2% Ventricular tachycardia 10% Miscellaneous 21% Conduction abnormalities 8% Sick sinus syndrome 9% Premature beats 6% Bialy D et al. J Am Coll Cardiol 1992;19:41A
  • 9. Age (years) Prevalence % Prevalence of atrial fibrillation increases with age 0.5 1.8 4.8 8.8 0 2 4 6 8 10 50-59 60-69 70-79 80-89 Wolf PA et al. Stroke 1991;22:983-8 Framingham Study
  • 10. Atrial fibrillation increases mortality 50 40 30 20 10 0 0 1 2 3 4 5 6 7 Subjects dead in follow-up (%) Years of follow-up Men AF Women AF Men no AF Women no AF 0 0.4 0.8 1.2 1.6 2.0 Adjusted odds ratio Men Women 95% Cl 1.2–1.8 1.5–2.2 Odds ratio for death Benjamin EJ et al. Circulation 1998;98:946–52
  • 11. A T R I A L F I B Alcohol Thyroid disease Rheumatic heart disease Ischaemic heart disease Atrial myxoma Lung (pulmonary embolism) Phaeochromocytoma Idiopathic Blood pressure (hypertension) Other causes are known What causes atrial fibrillation?
  • 12. Magnani JW et al. Circulation 2011; 124: 1982-1993
  • 13. Increased potential for atrial fibrillation Increased atrial pressures Hypertension High left ventricular pressures Hypertension increases the risk of developing atrial fibrillation almost two-fold Slowing of atrial conduction velocity Impaired ventricular filling Left atrial enlargement Left ventricular hypertrophy
  • 14. Patients with AF have an approximately fivefold increased risk of ischaemic stroke 2-yearage-adjusted incidenceofstroke/1,000 Individuals with AF* Individuals without AF Risk ratio=4.8 p<0.001 0 10 20 30 40 50 60 Framingham Heart Study (N=5,070) Wolf PA et al. Stroke 1991;22:983–988 *Patients were untreated with antithrombotic therapy when this study was performed in line with clinical practice at the time
  • 15. Wolf PA, et al. Stroke 1991; 22: 983-988 % AF prevalence Strokes attributable to AF Age Range (years) 0 10 20 30 50–59 60–69 70–79 80–89 Framingham  Approximately 5-fold increased risk of stroke  Quantify stroke risk: CHADS2/ CHA2DS2-VASc  AF strokes have worse outcomes  Costly health care ~ $16 billion/year
  • 16. Lone AF (younger persons without evidence of cardiovascular or precipitating disease) Transient AF (caused by reversible disorders) First detected Paroxysmal Self-terminating Persistent Not self-terminating Permanent Recurrent AF (two or more episodes) Atrial fibrillation – clinical classification Fuster V et al. Eur Heart J 2006;27:1979–2030
  • 17. Classification  Paroxysmal: terminates in < 7 days  Persistent: fails to terminate within 7 days  Permanent: > 1 year  Lone: Individuals without structural heart disease, < 60 yrs old
  • 18. Paroxysmal Self-Terminating Persistent Lasts > 7 Days Permanent Cardioversion Failed or Not Attempted Normal Sinus Rhythm Atrial Fibrillation Paroxysmal AF is as likely to cause stroke as persistent or permanent AF
  • 19. Atrial fibrillation – consequences Loss of atrial systolic function (atrial contribution to ventricular filling is lost) Irregular rapid ventricular contractions Abnormal blood flow and stasis in the atria Cardiac output reduced Formation of intra-atrial thrombus Right atrium Left atrium
  • 20. Atrial fibrillation – manifestations  Palpitations  Rapid heartbeat  Sudden pounding in the chest  Dizziness  Syncope  Chest discomfort  Shortness of breath Symptoms of AF
  • 21. Strategies for treating atrial fibrillation  Rhythm control (including cardioversion) OR  Rate control PLUS  Anticoagulation therapy  Hemodynamic stabilization
  • 22. Rhythm and rate control approaches Rhythm control  Cardioversion (electrical or pharmacological)  Pharmacological agents (Class IC and III antiarrhythmics)  Surgery (maze procedure, ablation)  Device implantation (pacemaker) Rate control  Pharmacological agents (AV node blockers)  Surgery with device implantation (ablation plus pacemaker insertion) Pacemaker image courtesy of St Jude Medical, Inc
  • 23. Rate Control  Medications - Metoprolol / Esmolol: IV or Oral - Diltiazem: IV or Oral - Verapamil: Oral Only - Digoxin: Patients with hypotension - Amiodarone: Also for rhythm control
  • 24. Rhythm Control  Synchronized DC cardioversion - Emergencies/Hemodynamic instability - Greater efficacy than medications  Pharmacologic cardioversion - If AF < 7days – dofetilide, flecainide, ibutilide, propaferone or amiodarone - If AF > 7 day – dofetilide or amiodarone
  • 25. Electrical cardioversion Recommendations for successful cardioversion:  Antiarrhythmic drugs to maintain normal sinus rhythm  Anticoagulation >3 weeks before and >1 month after chemical or electrical cardioversion, or permanently if necessary  Transoesophageal echocardiogram (TEE) to detect any clot in the left atrial appendage before cardioversion  Successful cardioversion is more likely if the patient: - has no other cardiovascular problems - has normal sized atria - has been in atrial fibrillation for a relatively short period - had factors contributing to atrial fibrillation (e.g., hyper- or hypothyroidism) Heart rhythm in atrial fibrillation Cardioversion shock Normal heart rhythm ECGMetal paddle
  • 26. Vaughan Williams classification of antiarrhythmic agents Verapamil, diltiazemCalcium channel blockIV Ibutilide, sotalol*, dofetilide, amiodarone* Potassium channel block, increase repolarisation and refractoriness III Propanolol, esmolol, atenolol, sotalol* b-adrenergic blockade, slow sinus rhythm, prolong PR interval II Propafenone, flecainide, amiodarone* Little effect on repolarisation (most potent Na+ channel block) IC Lidocaine, tocainideShorten repolarisationIB Quinidine, procainamide, disopyramide, amiodarone* Prolong repolarisationIA Sodium channel blockI ExamplesActionClass Antiarrhythmics used for: 1. Conversion of AF 2. Prevention of recurrence of AF * mixed effects across different classes Chaudhry GM & Haffajee CI. Crit Care Med 2000;28:N158–64
  • 27. Patient with diagnosis of atrial fibrillation Hemodynamically stable Control ventricular rate: Diltiazem Cardioversion Yes No Spontaneous conversion to sinus rhythm Assess cause of atrial fibrillation Yes No Contraindication to cardioversion? Cont’ •Beta Blockers •Calcium Channel blockers •Digoxin •Amiodarone Unstable… •Hypotension •Confusion •Angina •…. Long standing HTN Ischemic heart dz CHF Hyperthyroidism PE Lung ca Alcohol Hypothermia Electrolytes imbalance Etc. .
  • 28. UCLA Family Medicine Department IMG Program Carlos Yoo Consider long-term anticoagulation Cardioversion Yes No >48hs<48hs Start Heparin IV •Immediate medical or electrical cardioversion •Later elective cardioversion after 3weeks of warfarin • Early TEE-guided cardioversion Atrial fibrillation persist? Assess cause of atrial fibrillation Yes No Cont’ Long standing HTN Ischemic heart dz CHF Hyperthyroidism PE Lung ca Alcohol Hypothermia Electrolytes imbalance Etc. . Warfarin Aspirin
  • 29. ESC 2012 guidelines: selection of patients for OACs Non-valvular atrial fibrillation Valvular atrial fibrillation < 65 years and lone AF including women Stroke risk assessment using CHA2DS2-VASc 0 1 ≥2 Assess bleeding risk (HAS-BLED score); consider patient values/preferences New oral anticoagulant; rivaroxaban, dabigatran apixaban Vitamin K antagonistNo antithrombotic therapy Oral anticoagulant Yes Camm AJ et al. Eur Heart J 2012 Slide line preferred; dotted line alternative
  • 30.  Assess stroke risk exclusively with CHA2DS2- VASc and no longer use CHADS2  ESC Guidelines recommend anticoagulation for stroke prevention with CHA2DS2-VASc score of 1 or greater  Preference given to novel, non-monitored anticoagulants: apixaban, rivaroxaban, and dabigatran
  • 31. Congestive heart failure or LVEF < 35% 1 Hypertension 1 Age > 75 years 2 Diabetes mellitus 1 Stroke/TIA/systemic embolism 2 Vascular Disease (MI/PAD/Aortic plaque) 1 Age 65-74 years 1 Sex category (female) 1 Moderate-High risk > 2 Low risk 0-1 Lip GYH, Halperin JL. Am J Med 2010; 123: 484. Weight (points)
  • 32. Risk Profile Class / Level CHA2DS2-VASc = 0 No antithrombotic therapy I B CHA2DS2-VASc = 1 VKA (INR 2-3) Or Dabigatran / Rivaroxaban / Apixaban IIa A (Favored) CHA2DS2-VASc ≥ 2 VKA (INR 2-3) Or Dabigatran / Rivaroxaban / Apixaban I A (Favored)
  • 33. CHA2DS2-VASc score and stroke risk in patients with AF Item Points Previous stroke TIA or systemic embolism 2 Age ≥75 years 2 Congestive heart failure* 1 Hypertension 1 Diabetes mellitus 1 Age 65–74 years 1 Female gender 1 Vascular disease 1 CHA2DS2- VASc 1-year stroke rate 9 23.64% 8 22.38% 7 21.50% 6 19.74% 5 15.26% 4 9.27% 3 5.92% 2 3.71% 1 2.01% 0 0.78% *Or moderate-to-severe left ventricular systolic dysfunction (left ventricular ejection fraction ≤40%) Olesen JB et al. BMJ 2011;342:d124; Camm AJ et al. Eur Heart J 2010;31:2369–2429 Add points together
  • 34. Hypertension (> 160 mm Hg systolic) 1 Abnormal renal or hepatic function 1-2 Stroke 1 Bleeding history or anemia 1 Labile INR (TTR < 60%) 1 Elderly (age > 75 years) 1 Drugs (antiplatelet, NSAID) or alcohol 1-2 High risk (> 4%/year) > 4 Moderate risk (2-4%/year) 2-3 Low risk (< 2%.year) 0-1 Pisters R, et al. Chest 2010; 138: 1093. Lip GYH, et al. J Am Coll Cardiol 2010; 57: 173. Weight (points) Risk Score for Predicting Bleeding in Anticoagulated Patients with Atrial Fibrillation
  • 35. Hankey GJ and Eikelboom JW. Circulation. 2011; 123: 1436-1450 Patients with bleeding on NOAC therapy Mild bleeding Moderate-Severe bleeding Life-threatening bleeding • Delay next dose or discontinue treatment as appropriate • Mechanical compression • Surgical intervention • Fluid replacement and hemodynamic support • Blood product transfusion • Oral charcoal • Hemodialysis • ? Prothrombin Complex Concentrate? (Circulation 2011; 2011: 124: 1573-9) • Consideration of rFVIIa or PCC • Charcoal filtration • ? Prothrombin Complex Concentrate (Circulation 2011; 2011: 124: 1573-9)
  • 36. ► CHA2DS2-VASc has replaced CHADS2 as the predominant assessment tool to predict stroke risk (ESC 2012 AF Guidelines Update). ► HAS-BLED has gained dominance as the most predictive bleeding index. It is best used as a cautionary “yellow flag” rather than as a reason to withhold anticoagulation (ESC 2012).
  • 37. Warfarin better Control better AFASAK SPAF BAATAF CAFA SPINAF EAFT 100% 50% 0 -50% -100% Aggregate RRR of stroke: 62% RRR All-cause mortality: 26% RRR, relative risk reduction. Hart RG, et al. Ann Intern Med. 1999;131:492-501.
  • 38. VKAs are associated with major bleeding, particularly among the elderly • Consecutive admitted patients with AF who started warfarin were identified from January 2001 to June 2003 and followed for 1 year • Patients had to be ≥65 years of age, have established care at the study institution, and have their warfarin managed on site Days on warfarin Cumulativeincidencewith majorhaemorrhage 0.10 0.08 0.06 0.04 0.02 0.00 0 100 200 300 400 Age 80 years Age <80 years Hylek EM et al. Circulation 2007;115:2689–2696
  • 39. VKAs have a narrow therapeutic window • INR below 2 is associated with an increased risk of ischaemia • INR above 3 is associated with an increased risk of haemorrhagic stroke 1. Amouyel P et al. Eur J Intern Med 2009;20:63–69; 2. Pouyanne P et al. BMJ 2000;320:1036 VKA-related haemorrhage is the leading cause of iatrogenic hospitalization, accounting for 13% of hospitalizations due to drug-related adverse events2 Ischaemic stroke1 Haemorrhagic stroke1 0 1 2 3 4 5 6 0 2 4 6 8 10 12 Strokerateper 100patient-years 0 1 2 3 4 5 6 0 2 4 6 8 12 16 Strokerateper 100patient-years Observed Predicted 95% CI Observed Predicted 95% CI 10 14
  • 40. 1) Delayed onset/offset 2) Unpredictable dose response 3) Narrow therapeutic index 4) Drug-drug, drug-food interactions 5) Problematic monitoring 6) High bleeding rate 7) Slow reversibility
  • 41. VKAs have many drug–drug interactions Increased INR response Decreased INR response Coumadine Package Insert US revised January 2010
  • 42. Despite continued use of warfarin, NOACs are considered by many professional medical organizations to be the “best option” for anticoagulation of SPAF patients: ► ESC 2012 AF Update Guidelines ► ACCP 2012 Guidelines ► Canadian AF Guidelines “ ”
  • 43. Targets for anticoagulants VKA VKA Inactive Factor Active Factor Transformation Catalysis X IX IXa Thrombin X a Fibrinogen Fibrin Prothrombin VIITF VIIa Clot formation Initiation Propagation VKA Direct Factor Xa inhibition Rivaroxaban Apixaban Edoxaban Betrixaban Direct Factor IIa inhibition Dabigatran II IIa Piccini JP et al. Curr Opin Cardiol 2010;25:312–320; Spyropoulos AC et al. Expert Opin Investig Drugs 2007;16:431–440
  • 44. Features Warfarin New Agents Onset Slow Rapid Dosing Variable Fixed Food effect Yes No Drug interactions Many Few Monitoring Yes No Half-life Long Short Antidote Yes No
  • 45. 45 Stroke & SEE Ischemic & Unsp. Stroke Hemorraghic Stroke Miller CS, et al. Am J Cardiol 2012;110(3):453-460. Favors NOACs Favors Warfarin 13% 55%
  • 46. Major ICH GI Bleeding iller CS, et al. Am J Cardiol 2012;110(3):453-460. 51% Favors Favors
  • 47. • Oral direct thrombin inhibitor • Twice daily dosing • Renal clearance Dabigatran • Direct factor Xa inhibitor • Once daily (maintenance), twice daily (loading) • Renal clearance Rivaroxaban • Direct factor Xa inhibitor • Twice daily dosing • Hepatic clearance Apixaban • Direct factor Xa inhibitor • Once daily dosing • Hepatic clearance Edoxaban Circulation 2010;121:1523
  • 48. ESC 2012 guidelines: recommendations for new OACS • Dabigatran 150 mg bid • Dabigatran 110 mg bid in: • ≥ 80 years • Concomitant use of interacting drugs • HAS-BLED ≥ 3 • CrCl 30-49 mL/min • Peri-cardioversion • No recommendation in severe renal impairment CrCl < 30 mL/min • Apixaban • No recommendation in severe renal impairment CrCl <30 mL/min • No recommendation for cardioversion * • Approved by FDA on Dec. 28, 2012 and by EMA on Nov 20, 2012.. All NOACs are recommended for SPAF in patients at risk of stroke (CHA2DS2-VASc≥2) in preference over a VKA • Rivaroxaban 20 mg od • Rivaroxaban 15 mg od with: • HAS-BLED ≥3 • CrCl 30-49 mL/min • No recommendation in severe renal impairment CrCl < 30 mL/min • No recommendation for cardioversion* Camm AJ et al. Eur Heart J 2012; od=once daily; bid=twice daily*based on lack of published data
  • 49. Properties of an ideal oral anticoagulant Once daily No significant food interactions Predictable response No routine coagulation monitoring Fixed dosing Wide therapeutic window IDEAL       Warfarin  Rivaroxaban       Dabigatran      Apixaban     
  • 50. ESC 2012 guidelines: ASA/DAPT • Antiplatelet therapy for SPAF should be limited to patients who refuse/cannot take VKAs/NOACs – Consider in patients who refuse OAC and at low bleeding risk • DAPT (ASA/clopidogrel) or • less effectively ASA • No evidence for the decrease in total or CV mortality with ASA (or antiplatelet drugs) in SPAF • Antiplatelet therapy (including ASA monotherapy) carries a similar risk of major bleeding and ICH as OAC, particularly in the elderly Camm AJ et al. Eur Heart J 2012; DAPT=dual antiplatet therapy; ICH=intracranial haemorrhage
  • 51. ROCKET AF Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation
  • 52. ROCKET AF - Rivaroxaban vs warfarin – Study design Rivaroxaban N=7131 Warfarin N=7133 Primary endpoint: stroke or non-CNS systemic embolism INR target: 2.5 (2.0–3.0 inclusive) 20 mg od (15 mg od for CrCl 30–49 ml/min) Atrial fibrillation Randomized double blind Monthly monitoring Adherence to standard-of-care guidelines *Enrolment of patients without prior stroke, TIA or systemic embolism and only two factors capped at 10% Risk factors Stroke, TIA or systemic embolism OR • CHF • Hypertension • Age  75 • Diabetes At least 2 or 3 required* Patel MR et al. N Engl J Med 2011;365:883–891 N= 14,264
  • 53. Number of subjects at risk Rivaroxaban 6,958 6,211 5,786 5,468 4,406 3,407 2,472 1,496 Warfarin 7,004 6,327 5,911 5,542 4,461 3,478 2,539 1,538 ROCKET AF Rivaroxaban vs warfarin – Results: Efficacy- PPP PPP=Per-protocol population – as treated = all ITT patients without major predefined protocol violations Days since randomization Warfarin Rivaroxaban HR 0.79 (0.66, 0.96) p<0.001 (non-inferiority) 0 120 240 480 600 720 0 1 2 3 4 5 6 840360 Cumulativeeventrate(%) Stroke or systemic embolism Patel MR et al. N Engl J Med 2011;365:883–891
  • 54. ROCKET AF Rivaroxaban vs warfarin – Conclusions • Based on the prespecified primary efficacy outcome: – A once-daily fixed-dose regimen of rivaroxaban was non-inferior to warfarin for prevention of stroke or non-CNS systemic embolism – Rivaroxaban was superior to warfarin while patients were taking study drug – A sensitivity analysis in the ITT population that followed all patients in the trial until completion showed a benefit for rivaroxaban, but did not reach superiority • Safety: – Similar overall incidence of bleeding and adverse events – Increase in gastrointestinal bleeds but fewer intracranial haemorrhages and less fatal bleeding with rivaroxaban • Implication: – Rivaroxaban, administered once daily, has demonstrated non-inferiority to warfarin in the prevention of stroke or systemic embolism, with similar overall bleeding and fewer intracranial haemorrhages and fatal bleeds Patel MR et al. N Engl J Med 2011;365:883–891
  • 55. KEY POINTS ► VKA is a very effective for SPAF but related to some limitations that can lead to underuse by both patient and physician. ► Novel Oral Anticoagulants offer favourable risk– benefit profile compare to VKA, with significant reductions in stroke, intracranial haemorrhage, and mortality, and with similar major bleeding as for warfarin. • Rivaroxaban, administered once daily, has demonstrated non-inferiority to warfarin, both in primary and secondary prevention of stroke or systemic embolism with similar overall bleeding and fewer intracranial haemorrhages and fatal bleeds