CME Lecture for the medical staff at St Vincent's Hospital.
Atrial fibrillation is a common rhythm disorder. There are many treatment options available today.
5. 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
7.
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
8. • Identify potential causes and
comorbidities
• Stroke Prevention
• Treating AF symptoms
www.theafcenter.com
11. 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
12. • Identify potential causes and comorbidities
• Stroke Prevention
• Treating AF symptoms
www.theafcenter.com
13. 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
14. • 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
www.theafcenter.com
15.
>90% of strokes
in AF patients are
secondary to LAA
emboli
www.theafcenter.com
24. 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
25. • 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
www.theafcenter.com
29.
What can we offer patients that cannot take oral
anticoagulants?
Or do not want to take OACs
◦ Left Atrial Appendage Closure
www.theafcenter.com
39. 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
40. • 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
42. 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
www.theafcenter.com
43.
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
www.theafcenter.com
44.
What if my patient is back to Sinus Rhythm?
Does he still need anticoagulation?
What about after cardioversion?
www.theafcenter.com
47.
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
48. • Identify potential causes and comorbidities
• Stroke Prevention
• Treating AF symptoms
www.theafcenter.com
53. 74 yo medically refractory AF, Echo – Normal
AA Rx - Verapamil, Rythmol, Betapace, Norpace
I
II
III
V1
RSPV
dist
RSPV
prox
*
LIPV
RA
www.theafcenter.com
62. 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
www.theafcenter.com
63.
64. Pappone C, et,al.J Am Coll Cardiol. 2006 Dec 5;48(11):2340-7.
www.theafcenter.com
65. Freedom from AF Recurrence
P<0.001
Pappone C, J Am Coll Cardiol 2003
www.theafcenter.com
66. QOL Following Ablation vs.
Medical Therapy for AF
Pappone C, et.al. JACC 42:185-97, 2003
www.theafcenter.com
67. LV Function after AF Ablation
Patients with of Without CHF
Hsu LF, et.al., NEJM 351:2372-83, 2004
www.theafcenter.com
70.
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
71.
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
72. 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
Notas del editor
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
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%.