Long-term Efficacy and
Safety of Catheter
Ablation for AF: What is
the Evidence?
AHA QCOR Washington DC
D. George Wyse MD PhD
May 20, 2010
Disclosures*
DSMB, SC or Grant Reviewer
(Research)
• Boerhinger Ingelheim (PHRI); RE-LY; RE-LYABLE
• Medtronic (Mayo) – TRENDS; PACIFIC
• Sanofi Aventis/Bristol Myers Squibb (PHRI)
- ACTIVE-A; ACTIVE –W; ACTIVE-I
• Bristol Myers Squibb/Pfizer (DCRI) – ARISTOTLE
• Sanofi Aventis – BOREALIS, DETECT-AF
• Biotronik (Axio) - IMPACT
• Boston Scientific/Guident (PHRI) - SIMPLE
• NHLBI (DCRI; U Penn) – TACT; COAG
• European Commission – FP-7 Grant Applications
• Sanofi Aventis (PHRI) – POSEIDON
PHRI – Population Health Research Institute – McMaster University
DCRI – Duke Clinical Research Institute; Mayo – Mayo Clinic
Axio – Axio Research Corporation
* All < $10,000
U. Penn – University of Pennsylvania
Advisory
Board
• Merck
• Bayer
Speaker
• Sanofi Aventis
• BMS
Outline
• Key Patient Characteristics of RCT of LA/PV RFA
and AAD
• Quantitative “Gradient” between Groups of SR
vs. AF in AAD vs. RFA RCT
• Goals for Therapy of AF
•
•
•
•
Reduce Mortality
Prevent Stroke/SE
Preserve/Improve Ventricular Function and Prevent CHF
Relief of Symptoms
• RFA of AV Junction and Pacemaker
Age and Duration of Follow-up in RTC
of LA/PV Catheter Ablation for RFA
Study
N
Mean/median Age
Mean FU
Haissaguerre (2000)
90
51
0.7
Natale (2000)
15
59
0.8
Oral (2003)
40
51
0.5
RAAFT Pilot (2005)
70
53
1.0
APAF (2006)
198
56
1.0
CACAF (2006)
137
62
1.0
A4 (2008)
112
51
1.0
CABANA Pilot (2009)
60
64
1.0
AAD RCT: AFFIRM, AF-CHF & ATHENA
N = ~ 10,000
Mean Age = 70y
Mean FU = 4.5y
Table unpublished, courtesy of Win Shen – Mayo University
Quantitative “Gradient”
Gradient = 70%
SR vs. AF; AAD vs. RFA
PABA-CHF – not “prevalence”
Gradient = 40%
AFFIRM
New Engl J Med 2002;347:1825
New Engl J Med 2008;358:2667
New Engl J Med 2008;359:1778
Gradient = 40%
AF-CHF
Goals of Therapy for AF
Reduce Mortality
Death After RFA for AF
Short-term
1.8
1.6
1.4
Based on 45, 115
procedures in 35, 569
patients between
1995-2006 = 0.98 per
1,000
Percent
1.2
1
0.8
0.6
0.4
JACC 2009;53:1798
0.2
0
PV
n
Se
is
os
A
TI
ke
ro nj
St e l I
ss N
Ve ic
n
re
Ph X
o
em X
H mo
eu
Pn s
i
ps de
Se na
po
m
Ta
th
ea
D
Circulation 2005;111:1100
Death After RFA for AF
Long-term
• 65 ± 9 years
• PAF = 69%
• No CV Dis = 34%
• LVEF = 54 ± 12%
Death in RCT vs. AAD
• RR = -0.003 (95% CI
-0.01- 0.02; p = 0.74)
Am Heart J 2009;158:15
+ Annual Mortality in AFFIRM ~ 3.5%
J Am Coll Cardiol 2003;42:185
Prevent Stroke/SE
Stroke/TIA from RFA for AF
Short-term
“Yin-Yang” of Anticoagulation
1.8
1.6
Percent
1.4
1.2
1
0.8
0.6
0.4
0.2
0
PV
is
os
en
St
A
TI
ke
j
ro
St l I n
e
ss N
Ve ic
n
re
Ph X
o
em X
H mo
eu
Pn
is e
ps ad
Se n
po
m
Ta
th
ea
D
Circulation 2005;111:1100
Stroke/SE after RFA
Short-term
Stroke in RCT vs. AAD
• RR = 0.004 (95% CI
-0.01-0.02; p = 0.54)
Am Heart J 2009;158:15
Circulation 2006;114:759
Impact of Absence of AF on Stroke
Stroke In AF Patients
Cardioembolic
~60 - 65%*
Other
~35 - 40%*
•LAA
•LA
•LV
•Valves
Atheroembolic
Arterial Thrombosis
Hemorrhage
Other
* Neurology 1993;43:32 & Arch Intern Med 2005:165:1185
Perception of AF after RFA
Episodes of AF
Circulation 2005;112:307
% Episodes with
No Symptoms
AF Patterns Before/After AF
Ablation with 24/7 Monitoring
• “Permanent
Cure” after
3 mo blanking
= 3/14
J Cardiovasc Electrophysiol 2007;18:818
Preserve/Improve Ventricular Function & Prevent CHF
RFA and LV Function
A meta analysis of RCT
A = RR for reduced LVEF vs. normal LVEF
B = Absolute % LVEF after vs. before RFA
Relief of Symptoms
Symptoms
Ablation vs. AAD
• Symptomatic AF
• Failed at least 1 AAD
• No amiodarone in 6 months
• LA diameter <5cm
• Mean age = 56y
• Mean follow-up = 13 months
J Am Med Assoc 2010;303:333
Symptoms of AF
CCS- SAF Class N = 484
30
Percent
25
20
15
Percent
10
5
0
0
1
2
3
4
Symptom Class
Circ Arrhythmia EP 2009:2;218
CABANA Trial
Design
Qualifying
AF
R
RF Ablation
PV isolation ± Center
Preferred Enhancements
Drug Therapy
Rate or Rhythm Control
Ablate [and Pace]
Effects of AV Junction Ablation
& Pace
A Meta Analysis
Circulation 2000;101:1138
PACIFIC Trial Pilot
Qualifying AF
(Failed 1 Drug Therapy)
Age ≥65y
R
AV Junction Ablation
+ Device
Drug Therapy
Rate or Rhythm Control
R
RV Apex Pacing
Biventricular Pacing