European Society of Cardiology
Paris August 29th 2011
Debate:
“Catheter ablation is
indicated in longterm persistent atrial
fibrillation”
Attila Kardos MD
Contra
John Camm
St. George’s University of London
United Kingdom
European Society of Cardiology
Paris August 29th 2011
Debate:
“Catheter ablation is indicated in longterm persistent atrial fibrillation”
Contra
John Camm
Conflicts of Interest: Consultant/Advisor/Speaker
Advisor / Speaker : Ambit, Servier, Novartis, sanofi aventis, Astra Zeneca,
Cardiome, Astellas, Menarini, Xention, Bristol Myers Squibb, Daiichi, Bayer,
Merck, Medtronic, St. Jude, Biotronik, Boehringer Ingleheim, Takeda,
GlaxoSmithKline, Boston Scientific, Pfizer, Actelion, Johnson and Johnson
● Atrial trigger substrate ablation
1
Left atrial or AV node/His bundle
2
“Catheter ablation is indicated for what??
in long-term persistent atrial
● Less AF
● Improved
fibrillation”
CV outcomes
3
What does this mean?
● Long-standing
 6 months, 1 year, 2 years
● Permanent
Types of Atrial Fibrillation
First diagnosed episode of atrial fibrillation
Paroxysmal
(usually ≤ 48 h)
Persistent
(requires CV)
Redesignation
to allow new
attempt at
rhythm
control
Long-standing
Persistent (> 1 year)
Permanent
(accepted)
European Society of Cardiology Guidelines for the Management of Atrial Fibrillation.
Europace 2010;12:1360-420
How Many Data Are There?
Most are not relevant to the debate
Long-term Outcome after PVI
Pts
total (n)
Ablation
strategy
FU (months,
mean ± SD)
Arrhythmia free
survival (%)
Complications (%)
204
PVI / PVI+LL
41.4±6.2 /
39.7±5.5
41
2%
1:1
segmental PVI vs.
circumferential PVI
110
PVI
48±8
56
1%
Bertaglia
2009
Observational
177
PVI / PVI+LL
49.7±13.3
58
n.r.
Bhargava
2009
Observational
1404
PVI / PVI+LL
59±16
73
3%
Tsou
2010*
Observational
123
PVI
71±18
71
n.r.
Wokhlu
2010
Observational
774
PVI / PVI+LL
36±22.8
64
n.r.
Ouyang
2010
Observational
161
PVI
57.6
47
2%
Weerasooriya
2011
Observational
100
PVI / PVI+LL
60
32
6%
Author
Study type
Gaita
2008
Randomized
Fiala
2008
Randomized
1:1
PVI vs. PVI + LL
PVI: pulmonary vein isolation; LL: left lines; n.r.: not reported;
*only pts free from AF one year after ablation were included! Regarding to a total of 239 patients who underwent AF ablation: success rate
after 71±18 months was only 36.4%!
Catheter Ablation Efficacy
•
•
•
N = 774; 45% persistent
38% PVI, 62% WACA 62%
Recurrence rate per months:
3-6 months: 5.8%
6-12 months: 1.3%
12-30 months: 0.9%
No recurrence
Late
First recurrence, %
100
Very late
Mid-term
80
p <0.001
57%
60
37%
40
27%
20
0
0
6
12
39%
Paroxysmal AF
Persistent AF
18
24
30
Any recurrence
Age
Male
Persistent AF
Hypertension
Diabetes
Hyperlipidemia
CHF/EF < 50%
DCM
Valvular
HOCM
Sleep apnea
BMI
Family Hx of AF
LA  45 mm
WACA
0
Months after ablation
Wokhlu A, et al. J Cardiovasc Electrophysiol 2010;21:1071-8
0.05
0.67
<0.001
0.02
<0.001
0.11
0.89
0.11
0.18
0.40
0.50
0.75
0.03
0.003
0.009
0.5
1
1.5
2
2.5
Hazard ratio
3
3.5
4
Long Term Maintenance of SR post RFA
Comparison of Baseline Clinical Characteristics
SR (n:517)
AF (n:118)
p value
Age (yrs)
67±12
67±12
0.9
AF duration (months)
36±57
57±79
0.008
Ejection fraction (%)
51±14
51±12
0.97
LA size (mm)
45±6
48±7
0.0001
Paroxysmal (n: 254)
226
28 (11%)
Persistent (n: 146)
124
22 (15%)
Permanent *(n: 235)
167
68 (29%)
FU: 836±605 days
Type of AF
0.0001
* > 2 years
“Univariate and multivariate analysis of discrete variables clearly demonstrated that
AF duration >2 years and left atrial size >50 mm were negative predictors of
maintaining SR (p < 0.01), whereas…”
Nademanee K, et al. JACC 2008; 51:843-9
Systematic Review
Persistent versus Paroxysmal AF
Meta-analyses of
univariable AF
recurrence rates by
AF type in 31 studies:
•
•
Studies statistically
heterogeneous
Non-paroxysmal AF
predicted AF
recurrence (RR:
1.59; 95% CI: 1.38–
1.82; p < 0.001)
Favours persistent
Balk E, et al. J Cardiovasc Electrophysiol 2010;21:1208-16
Favours paroxysmal
Ablation of Persistent AF
Predictors of Arrhythmia Recurrence after the Index Procedure:
● 395 patients with persistent AF (duration: 16 m)
● 134 patients long standing persistent (> 1 year)
● De novo catheter ablation using stepwise
approach
● Follow up 27±7 months
● 108 (27%) patients free of arrhythmia
recurrence with a single procedure
● 312 (79%) patients were free of
arrhythmia after 2.3 ± 0.6 procedures
Baseline variable
P
Hazard
ratio
95% confidence
intervals
Female gender
Duration of persistent AF
>6 months
No. of long-lasting
persistent AF
Congestive heart failure
.001
0.092
0.022–0.386
.001
1.644
1.210–2.235
.049
1.548
1.003–2.389
.001
10.903
2.602–45.694
AF termination
>.001
0.280
0.185–0.425
Baseline AFCL *
>.001
0.983
0.977–0.989
Rostock T, et al. Heart Rhythm 2011 [Epub ahead of press]
* most powerful predictor
Incidence of AF During Very Long-term Follow-up
After Left Atrial Ablation
N = 205; mean age 61  9 years
Long-standing (> 1 year) persistent AF
Median 36 (22-60) months
HTN 77%, SHD 17%
LVEF 60%, LAD 49  6 mm
1
0.9
0.8
0.7
0.6
Mean follow-up
0.5
0.4
0.3
0.2
0.1
0
0
1
Time since
 CPVI alone in 124 (60.5%), CFAEs in 45,



Freedom from AF
Freedom from AF





2
3
1st
ablation, years
4
SVC in 15
Mean follow-up 19  11 months
Overall in SR in 86 (43.2%) after CPVI alone
SR in 67.8% after 1.7  0.8 procedures
1
0.9
0.8
Mean follow-up
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
0
Tilz RR, et al. J Cardiovasc Electrophysiol 2010;21:1085-93
1
2
3
Time since last ablation, years
4
(Long-standing) Persistent AF
Ablation v Medical Treatment
●
●
●
●
Prospective randomised trial; 366 patients assessed for eligibility
RFA (rhythm control): 22 v Medical treatment (rate control): 19
AF duration: RFA : 64 months; Rate control: 62 months
RFA : restoration of sinus rhythm in the long term: 50%
Endpoint (6m FU)
Medical
RFA
18
19
+2.8
+4.5
17
20
+1.4
+6.5
18
20
-2.8
-5.7
Exercise tolerance
15
17
6 minute walk (m)
+21
+20
LVEF (% change)
CMR
LVEF (% change)
RNVG
Quality of Life
MLHFQ
P value
0.1
0.032
0.65
0.96
“RFA improved radionuclide LVEF but did not improve other outcomes and was
associated with a significant rate of serious complications”
MacDonald M, et al. Heart 2011; 97: 740-7
ACCF/AHA/HRS Focused Update
Recommendations for Catheter Ablation
2011 Focused Update
Recommendation
Comments
Class I
1.Catheter ablation performed in experienced
centers* is useful in maintaining sinus rhythm in
selected patients with significantly symptomatic,
paroxysmal AF who have failed treatment with
an antiarrhythmic drug and have normal or
mildly dilated left atria, normal or mildly reduced
LV function, and no severe pulmonary disease.
(Level of Evidence: A)
Circulation 2011;123:e269-367
Modified
recommendation
(class changed from
IIa to I, wording
revised, and LOE
changed from C to
A)
ACCF/AHA/HRS Focused Update
Recommendations for Catheter Ablation
2011 Focused Update
Recommendation
Class IIa
1.Catheter ablation is reasonable to treat
symptomatic persistent AF.
(Level of Evidence: A)
Comments
New
recommendation
Class IIb
1.Catheter ablation may be reasonable to treat
symptomatic paroxysmal AF in patients with
significant left atrial dilatation or with
significant LV dysfunction.
(Level of Evidence: A)
Circulation 2011;123:e269-367
New
recommendation
ESC Guidelines for Ablation of AF
Europace 2010;12:1360-420
Indications for Catheter AF
Variable
More optimal patient
Less optimal patient
Highly symptomatic
Minimally symptomatic
1
0
Paroxysmal
Long-standing persistent
<70 years
70 years
LA size
<5.0 cm
EF
Normal
5.0 cm
Reduced
CHF
No
Yes
Other cardiac disease
No
Yes
Pulmonary disease
No
Yes
Sleep apnea
No
Yes
Obesity
No
Yes
Prior stroke / TIA
No
Yes
Symptoms
Class I and III drugs failed
AF type
Age
*Calkins H, et al. Heart Rhythm 2007;4:816-61
AF Ablation for Long-standing
Persistent AF – Evidence Base
The evidence base is inadequate:
•
•
•
•
•
The trials are few and small
Primary endpoints generally limited to documented symptomatic or
asymptomatic AF (sometimes not documented)
Very small trials have explored CV structural and functional outcomes
Follow-up is short
Trials are conducted only in experienced centres (not “real world”)
“Catheter ablation is indicated in long-term
persistent atrial fibrillation” ????