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Jose Osorio, MD

www.theafcenter.com
www.theafcenter.com
Atrial Fibrillation

Demographics by Age

U.S. population
x 1000

Population with AF
x 1000
Population with
atrial fibrillation

30,000

500
400

U.S. population
20,000

300
200
10,000

100
0

0
<5

5- 10- 15- 20- 25- 30- 35- 40- 45- 50- 55- 60- 65- 70- 75- 80- 85- 90- >95
9 14 19 24 29 34 39 44 49 54 59 64 69 74 79 84 89 94

Adapted from Feinberg WM. Arch Intern Med. 1995;155:469-473.
Age, yr

www.theafcenter.com
5
4.78

5.16

5.42 5.61

4.34

4
3.80
3
2

2.08

2.26

2.44

2.66

2.94

3.33

1

20
60

20
50

20
45

20
40

20
35

20
30

20
25

20
20

20
15

20
10

20
05

20
00

0

19
95

Adults with AF, MM

6

Year
Go A, et al. JAMA. 2001;285:2370-2375.

www.theafcenter.com
Atrial Fibrillation

Costs to the health care system

A LOT!!
Average hospital stay = 5 days
Mean cost of hospitalization = $18,800
Does not include:

Costs of cardioversions/ablations/surgery
Costs of drugs/side effects/monitoring
Costs of AF-induced strokes
Estimated US cost burden 15.7 billion

www.theafcenter.com
First
Detected

Paroxysmal
(Self-terminating)

Persistent
(Not self-terminating)

Permanent

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

Paroxysmal
◦ few seconds to days, then
stops on its own
◦ Typically younger, healthier
patients



Healthier
“Lone Afib”

Persistent
◦ does not stop by itself but will
stop with a medication or
cardioversion



Permanent
◦ present all the time and
cannot be fixed with
medication or cardioversion

More
Comorbidities
• Identify potential causes and
comorbidities
• Stroke Prevention
• Treating AF symptoms

www.theafcenter.com




Thyroid Disease.
Alcohol Consumption.
Cardiac Surgery.









15% to 33% of CABG patients
38% to 64% of valve surgery.

Valvular Disease.
Heart Failure.
WPW
Hypertension/LVH

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www.theafcenter.com
Atrial Fibrillation
Obstructive Sleep Apnea
20 –

15 –

OSA

Cumulative
10 –
Frequency
of AF (%)
5–

No OSA
0–
0

1

2

3

4

5

6

No OSA

8

9

10

11

12

13

14

15

Years

Number at Risk
OSA

7

844

709

569

478

397

333

273

214

173

134

110

94

70

46

29

8

2,209

1,902

1,616

1,317

1,037

848

641

502

393

296

217

195

130

94

69

28

Cumulative frequency curves for incident atrial fibrillation (AF) for subjects < 65 years of age with and without obstructive sleep apnea (OSA)
during an average 4.7 years of follow-up. p = 0.002
Gami, et al. JACC 2007;49:565-71

www.theafcenter.com
• Identify potential causes and comorbidities

• Stroke Prevention
• Treating AF symptoms

www.theafcenter.com
Atrial Fibrillation and Strokes
• 5-fold higher risk of stroke
• Over 87% of strokes are thromboembolic
• >90% of thrombus originates in the Left Atrial
Appendage (LAA)

• Stroke is the number one cause of long-term disability
and the third leading cause of death in patients with AF

www.theafcenter.com
• 500,000 strokes/year in U.S.
• Up to 20% of ischemic strokes occur in
patients with atrial fibrillation
Percent of Total Strokes
Attributable to Atrial Fibrillation

35
30
25
20

%
15
10
5
0

50-59

60-69
Stroke 22(18), 1991

70-79

80-89
3000838-7

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

>90% of strokes
in AF patients are
secondary to LAA
emboli

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Cardiac failure
Hypertension
Age >75
Diabetes
Stroke – 2 points

Limitation
CHADS2 of 0 or 1 patients
may still have a moderate
risk for stroke
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Atrial Fibrillation

Stroke Prophylaxis

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Atrial Fibrillation

Challenges in Stroke Prevention
• Warfarin
• Not always well-tolerated
• Less than 50% of patients eligible are being
• Time at therapeutic range - low
• Prevent Ischemic Strokes  Cause Hemorrhagic Strokes

www.theafcenter.com
• Warfarin still cornerstone of therapy
• Assuming 51 ischemic strokes/1000 pt-yr
• Warfarin prevented 28 strokes at expense of 11
fatal bleeds
• Aspirin prevented 16 strokes at expense
of 6 fatal bleeds

• Warfarin
• 60-70% risk reduction vs no treatment
• 30-40% risk reduction vs aspirin
Cooper: Arch Int Med 166, 2006
Lip: Thromb Res 118, 2006

3000838-10

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Low INR <1.6
Efficacy

4-fold

Therapeutic
INR 2-3
High INR >3.2
0

20

40

60

80

100

%
Bungard: Pharmacotherapy 20:1060, 2001

3000838-14

www.theafcenter.com


Novel Anticoagulants
◦ Pradaxa – Dabigatran
◦ Xarelto – Rivaroxaban
◦ Eliquis – Apixaban

www.theafcenter.com


Contraindications for anticoagulants:
◦
◦
◦
◦
◦

Bleeding
Hemorrhagic Stroke
Frequent Falls
Low Platelet Count
Recent Surgery

Patient’s choice

www.theafcenter.com




What can we offer patients that cannot take oral
anticoagulants?
Or do not want to take OACs

◦ Left Atrial Appendage Closure

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Pericardial Access

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3000838-18

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Device

Day 0

Day 2-14

Preimplant interval

Day 45
postimplant
Device subject takes
warfarin

Ongoing to 5 years
Device subject has ceased
warfarin

Control

Device subject gets implant
Randomize

Control subject takes warfarin

Day 0

Ongoing to 5 years

3000838-60

www.theafcenter.com
• Primary Efficacy Endpoint
• All stroke: ischemic or hemorrhagic
• deficit with symptoms persisting more than 24 hours

•
•

or
• symptoms less than 24 hours confirmed by CT or
MRI
Cardiovascular and unexplained death: includes
sudden death, MI, CVA, cardiac arrhythmia and
heart failure
Systemic embolization

www.theafcenter.com
Baseline Risk Factors
WATCHMAN
N= 463

Control
N= 244

P-value

1

158/463 (34.1)

66/244 (27.0)

0.3662

2

157/463 (33.9)

88/244 (36.1)

3

88/463 (19.0)

51/244 (20.9)

4

37/463 (8.0)

24/244 (9.8)

5

19/463 (4.1)

10/244 (4.1)

6

4/463 (0.9)

5/244 (2.0)

Paroxysmal

200/463 (43.2)

99/244 (40.6)

Persistent

97/463 (21.0)

50/244 (20.5)

Permanent

160/463 (34.6)

93/244 (38.1)

6/463 (1.3)

2/244 (0.8)

57.3 ± 9.7

56.7 ± 10.1

460 (30.0, 82.0)

239 (30.0, 86.0)

CHADS2 Score

AF Pattern

Unknown
LVEF %

0.7623

0.4246

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Randomization allocation (2 device : 1 control)
Device
Cohort
900 pt-yr

Posterior
Probabilities

Control

Events
(no.)

Total
pt-yr

Rate
(95% CI)

Events
(no.)

Total
pt-yr

Rate
(95% CI)

Rel. Risk
(95% CI)

Noninferiority

Superiority

20

582.3

3.4
(2.1, 5.2)

16

318.0

5.0
(2.8, 7.6)

0.68
(0.37, 1.41)

0.998

0.837

Event-free
probability

1.0

ITT Cohort:
Non-inferiority criteria
met

WATCHMAN
0.9

Control
0.8
0

365

730

1,095

52
92

12
22

Days
244
463

147
270

3001664-2

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



Oral Anticoagulation is still considered first
line therapy
Lariat Device
◦ Reserved for patients with Contraindications to oral
anticoagulants



Watchman device
◦ Great results in patients that were eligible to take
warfarin
◦ May become first line therapy
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

What if my patient is back to Sinus Rhythm?



Does he still need anticoagulation?



What about after cardioversion?

www.theafcenter.com
30
Rate
Rhythm

25

Mortality, %

20
p=0.078 unadjusted

15

p=0.068 adjusted
10
5
0
0

1

2

3

Rhythm N:

2033

1932

Time (years)
1807
1316

Rate N:

2027

1925

1825

1328

4

5

780

255

774

236

The AFFIRM Investigators. N Engl J Med. 2002;347:1825-1833.
www.theafcenter.com
Rate

Rhythm

Ischemic stroke

77 (5.5%)*

80 (7.1%)*

INR < 2.0

27 (35%)

17 (21%)

Not taking
warfarin

25 (32%)

44 (55%)

* p=0.79
The AFFIRM Investigators. N Engl J Med. 2002;347:1825-1833.

www.theafcenter.com




AFFIRM has demonstrated that rate control
is an acceptable primary therapy in a
selected high-risk subgroup of AF patients
with minimal symptoms

Discontinuation of OAC in patients with
risk factors for stroke after CV or while on
rhythm control drugs is not appropriate
◦ Asymptomatic recurrences

www.theafcenter.com
• Identify potential causes and comorbidities
• Stroke Prevention

• Treating AF symptoms

www.theafcenter.com
ANTITHROMBOTIC RX
AND

RHYTHM
CONTROL

OR ?

RATE
CONTROL

www.theafcenter.com
ANTITHROMBOTIC RX
AND

RHYTHM
CONTROL
Greater AF
Symptoms

OR ?

RATE
CONTROL

Minimal or no
symptoms
www.theafcenter.com
Atrial Fibrillation
Treatment Options

• Rate Control
• Rhythm Control
• Medications
• Cardioversion
• Ablation

www.theafcenter.com
www.theafcenter.com
74 yo medically refractory AF, Echo – Normal
AA Rx - Verapamil, Rythmol, Betapace, Norpace
I
II
III
V1
RSPV
dist
RSPV
prox

*

LIPV

RA

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Atrial Fibrillation
Afib Triggers

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Atrial Fibrillation
Afib Triggers

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Radiofrequency Ablation

Cryoablation

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www.theafcenter.com
1. Access
targeted vein

2. Inflate and
position

3. Occlude and
ablate

4. Assess PVI

60
60
www.theafcenter.com
Delay

Increased
Delay

Isolation

Images: Courtesy of Dr. Schwagten, ZNA Middelheim, Belgium (above)
and Dr. Vogt, Herz- und Diabeteszentrum NRW, Germany (right)
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Lasso Guided PV Isolation
Before Ablation

During Ablation

A PV

A PV

After Ablation

I
PV-d
CS-p
CS-7/8
CS-5/6
CS-3/4
CS-d
HRA
PV-1/2
PV-2/3
PV-3/4
PV-4/5
PV-5/6
PV-6/7
PV-7/8
PV-8/9
PV-9/10
PV-10/1

100 ms

A
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Pappone C, et,al.J Am Coll Cardiol. 2006 Dec 5;48(11):2340-7.
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Freedom from AF Recurrence

P<0.001

Pappone C, J Am Coll Cardiol 2003

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QOL Following Ablation vs.
Medical Therapy for AF

Pappone C, et.al. JACC 42:185-97, 2003
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LV Function after AF Ablation
Patients with of Without CHF

Hsu LF, et.al., NEJM 351:2372-83, 2004

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CRYO Procedure Experience
Impacts Treatment Success
P < 0.001 by quartile (Wald)
OR = 1.14 for each procedure

Treatment Success

100%

90%

69%

66%

80%
56%
60%
40%

20%
0%

25
centers
n=43
1st and 2nd
procedures

14
centers
n=38
3rd – 5th
procedures

10
centers
n=42
6th – 11th
procedures

4
centers
n=40
12th – 23rd
procedures

69
www.theafcenter.com


Candidates for ablation
◦ Symptomatic atrial fibrillation despite medical
therapy
 Paroxysmal Afib
 easy to determine

 Persistent Afib
 Symptoms related to Afib?

 Structural Heart Disease / LA dimension
 Comorbidities

www.theafcenter.com


AF is rarely life-threatening and is typically
recurrent



Treatment goals in symptomatic pts

◦ frequency, duration and severity of recurrences
◦ Reduce Stroke Risk
◦ Minimize risk of tachycardia induced
cardiomyopathy

www.theafcenter.com
Atrial Fibrillation




Highly Prevalent Condition
Treatment
◦ driven by symptoms



Atrial fibrillation ablation
◦
◦
◦
◦




Effective
Reduces or eliminates symptoms
Reduces risk of stroke
Significantly improves quality of life

www.theafcenter.com
205-939-0073
www.theafcenter.com

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Atrial Fibrillation - From Diagnosis to Treatment - St Vincent's Birmingham

Notas do Editor

  1. Arctic Front demonstrates a simple, straightforward approach to PVI which can be obtained in 4 steps. Step 1: Lead your guide wire/Achieve mapping catheter into the targeted veinStep 2: Inflate the Arctic Front balloon in the left atrium. Once inflated, position the balloon at the PV atrum.Step 3: To assure occlusion, inject dye into the targeted pulmonary vein to make sure the vein is completely occluded. Once assured, ablate the PV for 240 seconds (the dosage used in the STOP AF trial).Step 4: Assess pulmonary vein isolation with the Achieve mapping catheter
  2. The majority of STOP AF investigators were first-time users of Arctic Front.As with any new technology or technique, there is a learning curve. Procedural effectiveness is linked to the number of procedures completed. This link is evident when displayed by quartiles with each quartile increasing its treatment success in the sequence those procedures were performed. Treatment success is inclusive of both acute procedural success and freedom from chronic treatment failure at 12 months.In the graph above, each bar represents approximately 41 cryoablation procedures (range 38-43). In the first bar, Quartile 1, there are 25 centers and 43 procedures. These procedures represent the 1st and 2nd Arctic Front procedures the 25 centers performed. The success rate for just these procedures was 56%.In the second bar, Quartile 2, there are 14 centers and 38 procedures. These procedures represent the 3rd – 5th Arctic Front procedures the 14 centers performed, for a success rate of 66%. Only 14/25 centers enrolled to this point. In the third bar there are 10 centers and 42 procedures. These procedures represent the 6 – 11th Arctic Front procedures those 10 centers performed, for a success rate of 69%.Finally, the last bar represents four centers and 40 procedures. These four centers performed at least 12 and up to 23 Arctic Front procedures. Only four centers enrolled this many ablation patients. The success rate for these specific procedures was 90%.