Transcript Section III: Catheter Ablation for the Treatment of AFib

Circumferential Electroanatomical
Ablation around PV Ostia
• 3D-electroanatomic maps (CARTO™ System) showing
pre- and post-ablation electrical activity
• Endpoint is complete electrical isolation of left atrium
Pre-ablation
Post-ablation
Point by point
RF lesions
Delayed
activation
reproduced with permission, Pappone C, et al. Circulation (2001) 104: 2539
CARTOMERGE™ Image Integration
Software Module
Combines 3D-electroanatomic mapping with CT or
MR images by the following steps:
1.
Import pre-acquired MRI or CT
scan images from radiology
scanners and workstations
2.
Process the MRI or CT images
on the CARTO™ XP in order to
select the chambers of interest
3.
Register the selected chamber
in order to “merge” the
processed image with
electroanatomical map from
CARTO™ XP
CARTOMERGE™ Image Integration
Software Module
– Very precise guidance
– Visualization of anatomic variations
– Identification of different cardiac structures and chambers
of interest
AP view
PA view
PV Antrum Isolation Guided by
CARTOMERGE™ Image Integration
Software Module
RUPV
LUPV
RMPV
LA
AC
RLPV
LLPV
Courtesy of Professor Antonio Raviele, Mestre, Italy
Endocardial Section Before and After
RF Ablation - LPV
LUPV
LUPV
LAp
LAp
LLPV
LLPV
Identification of the left mitral appendage ridge
Courtesy of Professor Antonio Raviele, Mestre, Italy
Endocardial Section Before and After
RF Ablation - RPV
RUPV
RUPV
RLPV
RMPV
RLPV
RMPV
Courtesy of Professor Antonio Raviele, Mestre, Italy
Navigation Directly Within the CT/MRI
Image using CARTOMERGE™ Image
Integration Software Module
Superimposed Anatomical CT
Information and CARTO™ System
Electroanatomical Map
3. Technological Aspects
Cardiac Imaging Techniques
Cardiac Imaging Techniques
• Fluoroscopy
• Angiography
• Intracardiac echography
• Cardiac spiral CT
• Cardiac MRI
3. Technological Aspects
Cardiac Imaging Techniques –
fluoroscopy and angiography
Catheter Visualization under
Fluoroscopic Guidance
Right upper PV
RA catheters
Transseptal sheath
Catheter Visualization under
Fluoroscopic Guidance
Ablation
catheter
LAO
LASSO®
RAO
Angiographic Visualization of LUPV
reproduced with permission, Haïssaguerre M, et al. N Engl J Med (1998) 339: 659
3. Technological Aspects
Cardiac Imaging Techniques –
Intracardiac Echocardiography
(ICE)
Intracardiac Echocardiography (ICE)
• Visualization of
– Transseptal puncture
– PV anatomy
– Ostium diameter
– Circular mapping catheter
• Monitoring of ablation
– Energy delivery
– Tissue catheter interface
– Thrombus/char formation
• PV Doppler flow to assess for narrowing
Transseptal Puncture Visualized by ICE
Courtesy of Professor Antonio Raviele, Mestre, Italy
ICE: PV Anatomy
Location of left upper and lower PVs
LA
LLPV
LLPV
LUPV
LUPV
Courtesy of Professor Antonio Raviele, Mestre, Italy
ICE: PV Anatomy
Visualization of PV anatomy: left common ostium
Courtesy of Professor Antonio Raviele, Mestre, Italy
ICE: PV Anatomy
Visualization of PV anatomy: right pulmonary veins
RSPV
RIPV
Courtesy of Professor Antonio Raviele, Mestre, Italy
ICE: PV Anatomy
Visualization of PV anatomy: RSPV, LSPV
and LA Posterior wall
Courtesy of Professor Antonio Raviele, Mestre, Italy
Correlation between ICE and Spiral CT
Carena between left PVs
LASSO®
ICE
Spiral CT
Courtesy of Professor Antonio Raviele, Mestre, Italy
PV Anatomy and Circular Mapping
Catheter Positioning
PV Ostium: Correlation Angiography-ICE
in 19/125 PV (15%)
LASSO®
LASSO®
Marrouche NF, et al. Circulation (2003) 107: 2710
Monitoring of RF Energy Delivery
RF energy titration
Scattered microbubbles
Brisk shower of microbubbles
Courtesy of Professor Antonio Raviele, Mestre, Italy
Visualization of Endothelial and
Subendothelial Injury
Courtesy of Professor Antonio Raviele, Mestre, Italy
Early Detection of Complications
Monitoring of thrombus/char formation
Soft thrombus
on transseptal
sheath
Courtesy of Professor Antonio Raviele, Mestre, Italy
Esophagus Location as imaged
by ICE
Esophageal contrast
Courtesy of Professor Antonio Raviele, Mestre, Italy
3. Technological Aspects
Cardiac Imaging Techniques –
CT and MRI
Cardiac CT Imaging – Epicardial and
Endocardial Views
Cardiac CT and MRI Imaging –
Epicardial Views
3. Technological Aspects
Future Technologies
The EP Lab of the Future
CARTO™ RMT System
• Integrated system incorporating the Niobe™
steering system with the CARTOTM XP Navigation
System
• Magnetic remote control technology
• Operator located away from X-ray exposure, not
requiring lead vests
Niobe® is a trademark of Stereotaxis, Inc
Magnetic Remote Controlled
Ablation
• Niobe-Artis™
– Magnetic remote control navigation
– CARTO™ RMT System (Magnetic
Compatible CARTO™ XP System)
– Operates in the Niobe-Artis
environment in stowed or active
positions
– Ability to use standard NAVISTAR®
Catheters
The third-party trademarks used herein are trademarks of their respective owners
Summary
• Catheter ablation for AFib has undergone significant
methodological and technical revolution since its
initial appearance two decades ago
• Discovery that PVs are a major source of ectopic
triggers was pivotal in determining efficacy of
procedure
• Significant technological advances in catheters and
imaging are further improving the efficiency of
catheter ablation
• 3D reconstructions of actual left atrial PV anatomy
using CT, MRI, or intracardiac echography enables
ever more accurate placement of lesions
4. Success Rates with
Catheter Ablation
Clinical Outcomes with Catheter
Ablation
1. Meta-analyses, worldwide survey,
results from pioneering centres
2. Comparative studies:
• Non-randomized and randomized controlled
trials
Success Rates with
Catheter Ablation
1. Meta-analyses, worldwide
survey, results from pioneering
centres
Meta-analysis of Catheter Ablation
Studies (I)
Patients
Paroxysmal
AF
SHD
Linear
443
75%
26%
33%
55%
Focal
508
81%
35%
54%
71%
2,187
83%
36%
62%
75%
Circumferential
(all)
15,455
68%
37%
64%
74%
Circumferential
(LACA, WACA)
2,449
65%
37%
59%
72%
Circumferential
(PVAI)
11,132
68%
42%
67%
76%
559
51%
49%
75%
87%
23,626
61%
55%
63%
75%
Ablation method
Isolation
Substrate ablation
(CFAE)
TOTAL
6-month cure
6-months OK
Cure (by each author’s criteria) means no further AFib 6 months after the procedure in the absence
of AAD.
OK means improvement (fewer episodes, no episodes with previously ineffective AAD).
SHD indicates structural heart disease.
Fisher JD, et al. PACE (2006) 29: 523
Meta-analysis of Catheter Ablation
Studies (II)
Condition / Type of
AFib
Patients
Paroxysmal
AFib
SHD
1,026
86%
3%
81%
72%
350
29%
100%
74%
79%
Paroxysmal AFib
3,880
100%
23%
64%
73%
Persistent –
Permanent AFib
3,741
0%
82%
66%
74%
No structural HD
Structural HD
6-month cure
6-months OK
Cure (by each author’s criteria) means no further AFib 6 months after the procedure in the absence
of AAD.
OK means improvement (fewer episodes, no episodes with previously ineffective AAD).
SHD indicates structural heart disease.
Fisher JD, et al. PACE (2006) 29: 523
Worldwide Survey on Efficacy and
Safety of Catheter Ablation for AFib
Worldwide Survey on the Methods,
Efficacy, and Safety of Catheter Ablation
for Human Atrial Fibrillation
Cappato, R, Calkins, H, Chen, S-A, et al.
Circulation (2005) 111: 1100
• Types of AFib treated by catheter ablation
– Paroxysmal AFib - 100% of centers
– Persistent AFib - 53% of centers
– Permanent AFib - 20% of centers
Worldwide Survey on Efficacy and
Safety of Catheter Ablation for AFib
• Total success rate: 76%
• Of 8745 patients:
– 27.3% required 1 procedure
– 52.0% asymptomatic without drugs
– 23.9% asymptomatic with an AAD within <1 yr
• Highly variable outcome between centres
Cappato R, et al. Circulation (2005) 111: 1100
Results from Pioneering Centres
• Total success rate: 75-88%
SHD,
%
Tool(s)
AF Free
(Off drugs), Follow-up,
End point
%
d
Study
Year
Ouyang
et al
2004
41
63 ± 9
100
NA
CARTO
PV Isolation
76
178
Haïssaguerre
et al
2004
70
53 ± 8
NA
43
Fluoro
PV Isolation
79
210
Mansour
et al
2004
40
55 ± 10
80
13
CARTO
PV Isolation
75
330
Marrouche
et al
2003
259
54 ± 11
51
21
ICE
PV Isolation
87
347
Oral
et al
2003
40
3
CARTO
EGM
Reduction
88
365
Pappone
et al
2003
589
6
CARTO
EGM
Reduction
79
861
Total
Follow-up Age, y
Parox,
%
1039
54 ± 11 100
65 ± 9
69
81.0
Verma A & Natale A Circulation (2005) 112: 1214
Success Rates with
Catheter Ablation
2. Comparative studies:
Non-randomized, controlled trials
Non-Randomized Trials
Mortality, Morbidity, and Quality of Life
after Circumferential Pulmonary Vein
Ablation for Atrial Fibrillation Fibrillation
Outcomes from a Controlled Nonrandomized Long-term Study
Pappone, C, Rosanio, S, Augello, G, et al.
J Am Coll Cardiol (2003) 42: 185
• 1,171 consecutive patients with symptomatic AFib
enrolled between 1998 and 2001
• 589 ablated patients were compared with 582 who
received antiarrhythmic medications for SR control
Improved Survival with Catheter
Ablation vs Drug Treatment
Ablation Group
Medical Group
Survival probability (%)
100
90
Expected
Observed
80
70
60
One-sample log-rank test
Obs=36, Exp=31, Z=0.597, p=0.55
0
0
180
360
540
720
900
Days of follow-up
One-sample log-rank test
Obs=79, Exp=341, Z=7.07, p<0.001
1080 0
180
360
540
720
900
1080
Days of follow-up
Pappone C, et al. J Am Coll Cardiol (2003) 42: 185
More AFib-Free Patients with Catheter
Ablation vs Drug Treatment
AFib-free
survival probability (%)
100
80
60
40
Ablation Group
Medical Group
20
0
0
100
200
300
Follow-up (days)
No. at risk
Ablation
589
507
479
379
282
217
135
Medical
582
456
354
277
207
141
97
Pappone C, et al. J Am Coll Cardiol (2003) 42: 185
Catheter Ablation has a Beneficial
Effect on Cardiac Function
Catheter Ablation for Atrial Fibrillation in
Congestive Heart Failure
Hsu, L-F, Jaïs, P, Sanders, P, et al.
N Engl J Med (2004) 351: 2373
• Evaluation of left ventricular function and
dimensions, symptom score, exercise capacity, and
quality of life in 58 consecutive patients with
congestive heart failure (CHF) who were undergoing
catheter ablation for AFib versus 58 patients without
CHF who were undergoing ablation
Significantly Improved Cardiac
Function, Symptoms, Exercise Capacity,
and QoL
p<0.001
60
p<0.001
p<0.001 p<0.001
40
20
40
LV fractional
shortening (%)
LV ejection
fraction (%)
80
0
1
3
6
20
10
12
0
1
3
6
12
60
p=0.001
70
p=0.03
p=0.02 p=0.001
60
50
40
0
1
3
Month
6
12
LV end-systolic
diameter (%)
80
LV end-diastolic
diameter (mm)
30
p<0.001
p<0.001 p<0.001
0
0
0
p<0.001
p<0.001 p<0.001 p=0.001 p=0.001
50
40
30
0
0
1
3
6
12
Month
Hsu LF, et al. N Engl J Med (2004) 351: 2373
Success Rates with Catheter
Ablation
2. Comparative studies:
Randomized controlled trials
Recent Randomized Clinical Trials of
Catheter Ablation
RF ablation vs AAD as first-line treatment for
AFib
• Wazni OM et al. JAMA (2005) 293: 2634-2640
Catheter ablation in drug-refractory AFib
• Stabile G et al. Eur Heart J (2006) 27: 216-221
Circumferential PV ablation for chronic AFib
• Oral H et al. N Engl J Med (2006) 354: 934-941
Randomized Clinical Trial of RF Ablation
vs Antiarrhythmic Drugs
Radiofrequency Ablation vs
Antiarrhythmic Drugs as First-line
Treatment of Symptomatic Atrial
Fibrillation
A Randomized Trial
Wazni, OM, Marrouche, NF, Martin, DO, et al.
JAMA (2005) 293: 2634
• Multicentre, prospective, randomized study of 70
patients with monthly symptomatic AFib episodes
for at least 3 months not treated with AADs
• Patients were randomized to receive either PVI
using RF ablation (n=33) or AAD treatment
(n=37), with 1-year follow-up
Pulmonary Vein Isolation Considered as
First-line Treatment of Symptomatic AFib
233
Patients Screened
163 Excluded
132 Did not meet criteria
31 Refused
70 Randomized
33 Assigned to receive
PV isolation
37 Assigned to receive
AADs
1 Lost to follow-up
2 Lost to follow-up
32 included in primary
analysis
35 included in primary
analysis
Wazni OM, et al. JAMA (2005) 293: 2634
Baseline Characteristics
Characteristics
Age, mean (SD), y
Pulmonary Vein
Isolation Group
(n=33)
Antiarrhythmic
Drug Group
(n=37)
53 (8)
54 (8)
4.1 (0.8)
4.2 (0.7)
5 (2.0)
5 (2.5)
32 (97)
35 (95)
1 (3)
2 (5)
Structural heart disease
and hypertension
8 (25)
10 (28)
Left ventricular ejection
fraction, mean (SD),%
53 (5)
54 (6)
Use of β-blocker therapy
19 (57)
23 (62)
Left atrial size, mean (SD), cm
Duration of atrial fibrillation,
mean (SD), months
Atrial fibrillation
Paroxysmal
Persistent
*Data are presented as No. (%) unless otherwise specified
Wazni OM, et al. JAMA (2005) 293: 2634
One-Year Follow-up Results by
Treatment Group
No. (%) of Patients
Characteristics
Symptomatic atrial fibrillation
recurrence
Pulmonary Vein
Isolation Group
(n=32)
Antiarrhythmic
Drug Group
(n=35)
p value
4 (13)
22 (63)
<0.001
3 (9)
19 (54)
<0.001
0
0
NA
2 (6.3)
1 (2.9)
0.60
0
3 (8.6)
0.20
Mild
1 (3)
0
0.50
Moderate
1 (3)
0
0.50
0
0
NA
Hospitalization
Thromboembolic events*
Bleeding
Bradycardia
Pulmonary vein stenosis†
Severe
NA = not applicable.
*Defined as transient ischemic events, stroke, deep vein thrombosis, or pulmonary embolism.
†Mild pulmonary vein stenosis is defined as less than 50%; moderate, 50% to 70%; and severe, more
than 70%.
Wazni OM, et al. JAMA (2005) 293: 2634
Kaplan-Meier Curve of AFib-Free
Survival
AFib.free survival
1.0
0.8
0.6
0.4
PVI Group
Antiarrhythmic Drug
Group
0.2
0
0
100
200
300
Follow-up (days)
No. at risk
PVI Group
32
28
28
28
28
28
28
Antiarrhythmic
Drug Group
35
343
23
19
13
13
13
Wazni OM, et al. JAMA (2005) 293: 2634
AFib Event Recordings
Pulmonary
Vein Isolation
(n=4)
Antiarrhythmic
Drugs
(n=4)
Study
Initiation
Study
Completion
Study
Initiation
Study
Completion
Corrected
difference
in mean change
(95% CI)
13 (6)
1 (2)
12 (7)
6 (4)
-6 (-13 to 1)
0.05
Duration
of episodes,
mean (SD), s
480 (30)
15 (12)
520 (40)
45 (15)
10 (-7 to 27)
0.63
Ventricular rate,
mean (SD),
beats/min
138 (26)
126 (18)
126 (35)
92 (21)
22 (16 to 28)
0.001
0
2
0
16
No. of episodes,
mean (SD)
Time patients
are in
asymptomatic
episodes of AF, %
p
value
AF = atrial fibrillation; CI = confidence interval
Wazni OM, et al. JAMA (2005) 293: 2634
Quality of Life Assessment
Pulmonary Vein
Isolation Group
(n=32)
Antiarrhythmic
Drug Group
(n=35)
Baseline
Follow-up
Baseline
Follow-up
Corrected difference
in mean change
at 6 mo (95% CI)
General health
57 (2)
9 (1)
57 (2)
68 (2)
11 (8 to 14)
<0.001
Physical
functioning
71 (3)
97 (3)
69 (2)
75 (7.5)
20 (13.2 to 24.2)
0.001
Role physical
73 (5)
71 (2)
51 (5)
53 (3)
14.9 (9.9 to 19.9)
0.047
Bodily pain
71 (3)
97 (1)
70 (3)
90 (3)
6 (1.5 to 9.5)
0.004
Mental health
65 (4)
65 (2)
64 (2)
68 (3)
-4 (-3.5 to -7.5)
0.62
Social
functioning
78 (3)
93 (3)
76 (3)
82 (2)
9 (7.5 to 11.5)
0.004
Role emotional
70 (1)
76 (1)
70 (1)
75 (1)
1 (−4.0 to 4.3)
0.90
Vitality
52 (4)
65 (1)
51 (1)
60 (2)
4 (1.7 to 5.7)
0.21
Short-Form 36
Subscale
p
value
CI = confidence interval.
*Quality of life was assessed using the Medical Outcomes Study 36-item Short-Form health survey
(Short-Form 36) and was measured at enrollment and 6-month follow-up visit.
Wazni OM, et al. JAMA (2005) 293: 2634
Randomized Clinical Trial of Catheter
Ablation in Drug-Refractory AFib
Catheter Ablation Treatment in Patients
with Drug-refractory Atrial Fibrillation: a
Prospective, Multi-centre, Randomized,
Controlled Study (Catheter Ablation For
The Cure Of Atrial Fibrillation Study)
Stabile, G, Bertaglia, E, Senatore, G, et al.
J Eur Heart J (2006) 27: 216
• Multicentre, prospective, controlled, randomized trial
to investigate the adjunctive role of ablation to AAD
therapy in preventing AFib relapses in patients with
paroxysmal or persistent AFib in whom AADs had
already failed.
Catheter Ablation vs. AADs Alone in
Drug-refractory AFib
Prospective, multicentre, randomized, controlled trial
Patients with AFib
(n=137)
AADs plus
catheter ablation
(n=68)
AADs alone
(n=69)
12 months
91.3%
at least one arrhythmia
occurrence
44.1%
at least one arrhythmia
occurrence
Stabile G, et al. Eur Heart J (2006) 27: 216
Ablation Combined with AADs is Superior to
AADs alone in Preventing AFib Recurrences
1 year follow up
Ablation Group
Medical Group
AFib-free survival (%)
100
80
60
40
20
0
0
1
2
3
4
5
6
7
8
9
10
11
12
Months
Stabile G, et al. Eur Heart J (2006) 27: 216
Randomized Clinical Trial of Circumferential
PV Ablation for Chronic AFib
Circumferential Pulmonary-Vein Ablation
for Chronic Atrial Fibrillation
Oral, H, Pappone, C, Chugh, A, et al.
N Engl J Med (2006) 354: 9
• Randomized, controlled study investigating efficacy
of circumferential pulmonary vein ablation in
maintaining sinus rhythm in patients with chronic
AFib
Randomized Controlled Trial of Amiodarone +
Cardioversion + Catheter Ablation
Long-term SR maintained in most patients with chronic
AFib after PV ablation
Patients with chronic AFib
(n=146)
Amiodarone &
cardioversion
plus PV ablation
(n=77)
Amiodarone &
cardioversion
(n=69)
12 months
3%
AFib-free without AADs
74%
AFib-free without AADs
Oral H, et al. N Engl J Med (2006) 354: 9
Patient Characteristics
Control
(n=69)
Circumferential
pulmonary-vein
ablation (n=77)
58 ± 8
55 ± 9*
62
67
7
10
4±4
5±4
Left atrial diameter (mm)
45 ± 5
45 ± 6
Left ventricular ejection fraction (%)
56 ± 7
55 ± 7
Structural heart disease (no. of patients)
6
6
- nonischemic cardiomyopathy
1
2
- coronary artery disease
4
3
- valvular heart disease
0
1
- congenital heart disease
1
0
No. of previously ineffective anti-arrhythmic drugs
2.1 ± 1.2
2.0 ± 1.2
No. of prior cardioversions
1.7 ± 1.0
2.2 ± 1.7
Characteristic
Age (yr)
Sex (no. of patients)
- Male
- Female
Duration of atrial fibrillation (yr)
Plus-minus value are means ± SD; *p=0.03.
Oral H, et al. N Engl J Med (2006) 354:9
Sinus Rhythm Maintained in Majority of
Patients Undergoing PV Ablation for
Chronic AFib
100
Circumferential
pulmonary-vein ablation
Control
Sinus rhythm (%)
80
60
40
20
0
1
2
3
4
5
6
7
8
9
10
11
12
Months
Oral H, et al. N Engl J Med (2006) 354: 9
Summary of Published RCTs
to date
Type
of AFib
Ablation
group
Wazni
et al. 2005
Symptomatic
Stabile
et al. 2006
Oral
et al. 2006
Author
Afib-free at 1 year
Comparator
n
Ablation Comparator
PV
isolation
AADs
70
87%
37%
Drugrefractory
Ablation
+ AADs
AADs
137
56%
9%
Chronic
Ablation +
amiodarone
Amiodarone
147
78%
4%
RCTs Presented as Abstract
Type
of AFib
Ablation
group
Pappone
et al. 2006
Paroxysmal
Jais
et al. 2006
Paroxysmal
Author
Afib-free at 1 year
Comparator
n
Ablation Comparator
Circumferential
PV ablation
AADs
198
84%
24%
Ostial PV
isolation
AADs
112
75%
7%
4. Success Rates with
Catheter Ablation
Early Recurrence After Ablation
Early Recurrence after Ablation
• AFib episodes that occur early (ERAF) after ablation
and do not persist beyond the initial weeks after the
procedure are common and have been reported in
35-46% of patients with paroxysmal and persistent
AFib
Early Recurrences Post-Ablation
• 35% within the first 15 days
Cumulative percent of patients
with recurrent AFib (%)
70
60
50
40
30
20
10
0
0
10
20
30
40
50
60
Time to 1st episode of AFib (days)
Oral H, et al. J Am Coll Cardiol (2002) 40: 100
Catheter Ablation is Successful
in the Long Term
No ERAF
ERAF
Freedom from Recurrent AFib
1.0
0.8
0.6
0.4
0.2
0
0
2
4
6
8
10
12
Months after PV isolation
Oral H, et al. J Am Coll Cardiol (2002) 40: 100
Clinical Significance of Early Recurrences of Atrial
Fibrillation or Atrial Flutter after Pulmonary Vein
Antrum and Superior Vena Cava Isolations
Sakis Themistoclakis, Robert A. Schweikert,
Walid I. Saliba, Jennifer E. Cummings, Aldo
Bonso, Antonio Rossillo, Oussama Wazni,
William A. Belden, Michelle Williams-Andrews,
Dhanumjaya Lakkireddy, Antonio Raviele,
Andrea Natale
Division of Cardiology, Umberto I Hospital, MestreVenice, Italy
Cleveland Clinic Foundation, Cleveland, OH
American College of Cardiology 55th Annual Scientific Session, Atlanta, March 11-14, 2006
Predictors of Early Recurrence of
AF/AFL
Patient population: 1272/1495 pts
ERAF
NO ERAF
Unadjusted OR
P
N = 497
N = 775
(95% CI)
Age (y), mean (SD)
56.6 (10.8)
55.5 (11.1)
1.009 (0.998-1.019)
0.080
Gender, male, n (%)
394 (79.27)
589 (78.32)
0.933 (0.706-1.232)
0.626
Paroxysmal, n (%)
233 (46.88)
463 (59.74)
Reference
Persistent, n (%)
86 (17.30)
117 (15.09)
1.493 (1.075 – 2.075)
0.017
Permanent, n (%)
178 (35.81)
195 (25.16)
1.842 (1.419 – 2.391)
< 0.001
Duration (y), mean (SD)
7.45 (6.47)
6.28 (5.31)
1.034 (1.011-1.058)
0.004
LA size, mean (SD)
4.42 (0.93)
4.42 (2.61)
1.001 (0.941- 1.065)
0.957
LVEF, mean (SD)
53.48 (8.43)
53.82 (8.58)
0.995 (0.981-1.009)
0.518
AF type
American College of Cardiology 55th Annual Scientific Session, Atlanta, March 11-14, 2006
Long-term Outcome in Patients
with and without ERAF/AFL
Population: 1495 pts with follow up of 22±9.8 months
100
Arrhythmia free off AAD
Late recurrences
p<0.00001
87
80
(%)
60
52
48
40
20
0
13
ERAF/AFL
No ERAF/AFL
American College of Cardiology 55th Annual Scientific Session, Atlanta, March 11-14, 2006
Predictors of Late Recurrences in
Patients with ERAF
Patient population: 497 pts
AF Rec
No AF Rec
Unadjusted OR
P
N = 228
N = 269
(95% CI)
Age (y), mean (SD)
56.18 (10.7)
57.05 (10.88)
0.992 (0.976 – 1.009)
0.379
Gender, male, n (%)
179 (78.51)
216 (80.30)
0.896 (0.579 – 1.386)
0.623
Paroxysmal, n (%)
89 (39.03)
144 (53.53)
Reference
Persistent, n (%)
44 (19.30)
42 (15.61)
1.661 (0.997 – 2.769)
0.052
Permanent, n (%)
95 (41.67)
83 (30.86)
1.841 (1.233 – 2.748)
0.003
AF duration (y), mean (SD)
7.75 (6.38)
7.20 (6.54)
1.013 (0.980 – 1.046)
0.428
LA size, mean (SD)
4.58 (0.78)
4.29 (1.02)
1.458 (1.117 – 1.902)
0.005
53 (8.61)
53.89 (8.28)
0.987 (0.965 – 1.924)
0.266
AF type
LVEF, mean (SD)
American College of Cardiology 55th Annual Scientific Session, Atlanta, March 11-14, 2006
Clinical Implications of Early
Recurrence after Ablation
• Early recurrences of AFib are more frequent in
patients with:
– Persistent and permanent AFib
– Longer history of AFib
• ERAF do not necessarily predict the failure of the
procedure
• ERAF may be a transient phenomenon and often
patients with ERAF have no further AFib during longterm follow up
• Temporary AAD therapy may be more appropriate
than an early repeat ablation procedure
Mechanisms of AFib Recurrences
after Ablation
Presumed mechanism of ERAF
• Transient stimulatory effect of RF (inflammatory
response, abnormal acetylcholine release after
damage of vagal nerve fibres )
• Delayed therapeutic effect of RF (growth of RF
lesion)
Oral H, et al. J Am Coll Cardiol (2002) 40: 100
Pappone C, et al. Circulation (2004) 109: 327
Delayed Cure Despite Early Recurrence
After PV Isolation for AFib
Delayed cure: early recurrence(s) of AFib
with subsequent absence of AF beyond 3 months
Acute cure
(n=24)
Delayed cure
(n=10)
Failure
(n=16)
Time frame
Pre
3 mo
Pre
3 mo
Pre
3 mo
Left atrial
size (mm)
38 ± 2
37 ± 2
45 ± 4
42 ± 3*
46 ± 3
46 ± 3
105 ± 11
106 ± 15
137 ± 22
120 ±
26*
122 ± 17
128 ± 23
38 ± 10
33 ± 15
74 ± 26
56 ± 20*
68 ± 20
66 ± 25
P-wave
duration (ms)
P-wave
dispersion (ms)
*p<0.05 compared with preprocedure value.
O’Donnell D, et al. Am J Cardiol (2003) 91: 83
Asymptomatic Recurrences after
Ablation
• A number of reports have suggested that current
monitoring/evaluation methods after catheter
ablation may overestimate success due to the
presence of undetected asymptomatic recurrences
• Trans-telephonic ECG monitoring has been shown to
be effective in detecting AFib relapses:
– Trans-telephonic ECG success rate: 72%
– Standard ECG and 24-hour Holter recording success rate:
86%
Neumann T, et al. Europace (2006) 8: 495
Senatore G, et al. J Am Coll Cardiol (2005) 45: 873
Hindricks G, et al. Circulation (2005) 112: 307
5. Complication Rates
Meta-analyses, worldwide
survey, results from pioneering
centres
Meta-analysis of Complications
from Catheter Ablation Studies
Proc Time*
Repeat
proc
PV stenosis
CVA
TIA
Other
Linear
289
43%
0.3%
0.6%
0%
7.5%
Focal
302
34%
0.6%
0%
0.2%
5.5%
Isolation
278
21%
4.5%
1.1%
0.2%
1.7%
Circumferential
(all)
201
24%
1.2%
0.8%
0.4%
5.8%
Circumferential
(LACA, WACA)
174
9%
0.4%
0.3%
0.6%
8.9%
Circumferential
(PVAI)
209
26%
1.7%
1.1%
0.4%
16.8%
Substrate ablation
(CFAE)
194
22%
0%
0.2%
0%
1.2%
TOTAL
212
25%
1.5%
0.7%
0.5%
5.2%
Ablation method
*Procedure time (min)
Fisher JD, et al. PACE (2006) 29: 523
Meta-analysis of 7 Series
Major complications with pulmonary vein ablation
in 1049 patients (7 series)
n=29
3.0
Occurrence (%)
2.5
2.0
1.5
n=13
1.0
0.5
0
n=8
n=5
Air emboli
n=4
n=3
n=3
n=1
Tamponade
Bradycardia
CVA
TIA
Phrenic nerve
PV stenosis
PV dissect
Packer DL, et al. J Cardiovasc Electrophysiol (2003) 14: S296
Worldwide Survey of Complications
Reported in Catheter Ablation Studies
Major complications
Complication type
Patients (n)
Patients (%)
4
0.05
107
1.22
Sepsis, abscesses, or endocarditis
1
0.01
Pneumothorax
2
0.02
Hemothorax
14
0.16
Permanent diaphragmatic paralysis
10
0.11
Femoral pseudoaneurysm
47
0.53
Arterovenous fistulae
37
0.42
Valve damage
1
0.01
Aortic dissection
3
0.03
For all types of procedures (n=8745 patients)
Periprocedural death
Tamponade
Cappato R, et al. Circulation (2005) 111: 1100
Worldwide Survey of Complications
Reported in Catheter Ablation Studies
Patients (n)
Patients (%)
For procedures involving left atrial ablation (n=7154 patients)
Stroke
20
0.28
Transient ischaemic attack
47
0.66
- Acute
23
0.32
- Chronic
94
1.31
2
0.03
15
0.21
3
0.04
41
057
51
0.71
524
5.9
PV stenosis (No. with >50% stenosis)
PV stenosis (No. with closure)
- Acute
- Chronic
PV stenosis (Patients with symptoms)
- Acute
- Chronic
PV stenosis (Patients undergoing intervention)
- Percutaneous
- Surgical
Total
Cappato R, et al. Circulation (2005) 111: 1100
Complications Reported by Leading
Centres
Major complications with pulmonary vein ablation
in 1039 patients (6 series)
Events
(n)
Rate
(%)
Range in studies
(%)
Transient ischaemic attack
4
0.4
0-3
Permanent stroke
1
0.1
0-1
Severe PV stenosis
(>70%, symptomatic)
3
0.3
0-3
13
1.3
0-5
Tamponade / perforation
5
0.5
0-3
Severe vascular access
complication
3
0.3
0-4
Complication
Moderate PV stenosis
(40-70%, asymptomatic)
Verma A & Natale A Circulation (2005) 112: 1214
Cardiac Tamponade
Cardiac Tamponade
• 15/632 (2.4%) perforations requiring
pericardiocentesis
– Left atrium – 60%
– Right atrium - 6.7%
– Right ventricle - 33.3%
• 2 patients required surgical closure
• CONCLUSION: The incidence of perforation during
ablation of the left atrium is low. Most perforations
occur in the left atrium; however, few require
surgical closure. Although less than with
uncomplicated procedures, the majority of patients
with complete ablations achieve long-term
elimination of AFib.
Bunch TJ, et al. J Cardiovasc Electrophysiol (2005) 16: 1172
Cardiac Tamponade
• 348 consecutive AFib catheter ablations over 1 year
(PVI plus linear lesion at mitral isthmus in 73% and
tricuspid isthmus in 76%)
– Tamponade occurred in 10 of the patients (2.9%) during the
creation of linear ablation lesions
• 398 consecutive AFib catheter ablations in the
following year with RF power for linear lesions
limited to < 42W
– Tamponade occurred in 4 patients (1%) during the creation
of linear ablation lesions
Hsu LF, et al. PACE (2005) 28: S106
Thromboembolic Complications
Thromboembolic Complications
Cardiovascular Complication Associated
with Pulmonary Vein Ablation
Kok, LC, Mangrum, JM, Haines, DE, et al.
J Cardiovasc Electrophysiol (2002) 13: 764
• 56 patients undergoing RF ablation for a focal source of
AFib
• Cerebrovascular event occurred in 3/56 (5%)
• 2 with prior history of TIA
Thromboembolic Complications
• LA thrombus formation identified using ICE
• Observed in 24/232 (10.3%)
• Patients with LA thrombus:
– Increased LA diameter (4.8 vs 4.5 cm)
– Spontaneous echo contrast (67% vs 3%)
– History of persistent AFib (29% vs 6%)
• No patient (0%) with LA thrombus suffered a clinical
thromboembolic complication
Ren J-F, et al. J Am Coll Cardiol (2004) 43: 1861
Thromboembolic Complications
Embolic events and char formation during
pulmonary vein isolation in patients with
atrial fibrillation: impact of different
anticoagulation regimens and importance
of intracardiac echo imaging
Wazni, OM, Rossillo, A, Marrouche, NF, et al.
J Cardiovasc Electrophysiol (2005) 16: 576
• 785 patients undergoing catheter-based PVI for treatment
of drug refractory, symptomatic AFib
Thromboembolic Complications
Distribution of embolic events according
to the anticoagulation protocol
10
Stroke/TIA
8
Patients (%)
p=0.01
6
p=0.4
p=0.34
4
2
0
ACT 250-300
(194 pts)
ACT 300-350+
INTEGRILIN
ACT 350-400
(411 pts)
(180 pts)
Wazni OM, et al. J Cardiovasc Electrophysiol (2005) 16: 576
Thromboembolic Complications
Bleeding complications
Hematoma
Pericardial effusion
Tamponade
ACT = 250-300
1
1
1
ACT = 300-350 + Epti
2
1
1
ACT = 350-400
2
0
0
ACT = activated clotting time; Epti = eptifibatide.
Wazni OM, et al. J Cardiovasc Electrophysiol (2005) 16: 576
Thromboembolic Complications
Distribution of embolic events according
to the energy delivery strategy
8
Stroke/TIA
Patients (%)
6
p=0.2
p=0.029
4
2
0
Ultrasound
(33 pts)
Temperature control
(482 pts)
ICE + Bubbles
(270 pts)
Wazni OM, et al. J Cardiovasc Electrophysiol (2005) 16: 576
Thromboembolic Complications
• More aggressive anticoagulation with heparin
reduced peri-procedural embolic events
• The use of platelet inhibition does not have
incremental beneficial effect
• None of the anticoagulation protocols abolished char
formation
Wazni OM, et al. J Cardiovasc Electrophysiol (2005) 16: 576
Thromboembolic Complications
• A high flow perfusion rate through sheaths (80 ml/h)
and a higher concentration of heparin for the transseptal sheath (1000 units/cc) before deployment
reduce the risk of thrombus formation and
thromboembolic complications
Cauchemez B, et al. J Cardiovasc Electrophysiol (2004) 15: 276
Maleki K, et al. J Cardiovasc Electrophysiol (2005) 16: 561
Pulmonary Vein Stenosis
Pulmonary Vein Stenosis
Pulmonary Vein Stenosis after Catheter
Ablation of Atrial Fibrillation
Robbins, IM, Colvin, EV, Doyle, TP, et al.
Circulation (1998) 98: 1769
• First report in 1998
Pulmonary Vein Stenosis
• Balloon inflation in ostium of left superior PV. Note severe
stenosis at junction of PV with LA, as demonstrated by waist
on 12-mm-diameter balloon.
Robbins IM, et al. Circulation (1998) 98: 1769
Reported Frequency of PV Stenosis
Linear ablation
• Reported rates of between 2-7%
Focal or segmental AF ablation
• Gerstenfeld and coworkers reported an 8.3%
occurrence of clinically relevant PV stenosis in an
early series of 40 patients undergoing focal AFib
ablation
• Haïssaguerre et al reported a 5% occurrence rate
but have recently suggested a decrease to 1%
overall with additional experience in ablation
• Pappone et al. reported a 1% PV stenosis rate with
ablation limited to atrial tissue outside the PV orifice
Packer D, et al. Circulation (2005) 111: 546
Reported Frequency of PV Stenosis
• The prevalence of PV stenosis has decreased through
a range of factors, including
(1) abandonment of in-vein ablation at the site of the AFib
focus
(2) limiting ablation at or outside the orifice of the vessel
(3) the use of ICE to guide catheter placement and monitor
energy delivery
(4) a reduction in target ablation temperature and the
amounts of energy deliveries
(5) increased operator experience
Packer D, et al. Circulation (2005) 111: 546
Frequency of Severe Pulmonary Vein
Stenosis
Pulmonary Vein Stenosis after
Radiofrequency Ablation of Atrial
Fibrillation
Functional Characterization, Evolution, and Influence of the
Ablation Strategy
Saad, EB, Rossillo, A, Saad, CP, et al.
Circulation (2003) 108: 3102
• PV isolation performed in 608 patients
• Electroanatomic approach used in 71 and circular mapping in
537 (distal isolation, 25; ostial isolation based on PV
angiography, 102; guided by intracardiac echocardiography,
140; with energy delivery based on visualization of
microbubbles, 270
• Severe (70%) narrowing detected in 21 patients (3.4%)
Frequency of Severe Pulmonary
Vein Stenosis
Distribution of severe PV stenosis according to ablation
strategy used to isolate PVs
p=0.835
25
p=0.02
CARTO™
Circular mapping
20
20
15.5
(%)
15
p=0.029
10
5
2.9
1.4
0
Carto
(n=71)
Distal isolation Proximal Angio
(n=25)
(n=102)
ICE
(n=140)
0
ICE with Bubbles
(n=270)
Saad EB, et al. Circulation (2003) 108: 3102
Frequency of Severe Pulmonary Vein
Stenosis
• Real-time imaging is valuable in preventing severe
PV stenosis
• Continuous visualization associated with energy
titration based on the generation of microbubbles
contributes to successful proximal isolation of PVs
• The incidence of severe PV stenosis seems to be
declining with better imaging techniques to ensure
ostial isolation and to guide power titration
Saad EB, et al. Circulation (2003) 108: 3102
Pulmonary Vein Stenosis Presentation
Clinical presentation and CT findings in patients
with severe PV stenosis
n (%)
Patients
21
Clinical presentation
- cough
8 (38.1)
- dyspnea
11 (52.4)
- pleuritic chest pain
6 (28.6)
- hemoptysis
5 (23.8)
- asymptomatic
8 (38.1)
Spiral CT, >70% PV stenosis, No. occluded
- LSPV
14 (6)
- LIPV
15 (7)
- RSPV
4 (1)
- RIPV
3 (1)
LS = left superior; LI = left inferior; RS = right superior; RI = right inferior.
Saad EB, et al. Ann Intern Med (2003) 138: 634
Avoiding PV Stenosis in Patients
Undergoing Ablation
• Performing PVI on the atrial side, far away from PV
ostium (more than 1.5 mm) as in the circumferential
or antral approach, has dramatically reduced the
incidence of severe PV stenosis (from less than 1%
to 0%)
Management of PV Stenosis
Clinical Presentation, Investigation, and
Management of Pulmonary Vein Stenosis
Complicating Ablation for Atrial Fibrillation
Packer, DL, Keelan, P, Munger, TM, et al.
Circulation (2005) 111: 546
• Percutaneous intervention produces rapid and
dramatic symptom relief in patients with highly
symptomatic PV stenosis after radiofrequency
ablation for AFib
Evolution of PV Narrowing
• No patients with normal spiral CT at 3 months had
stenosis at 6-12m CTS
• Progression from mild or moderate to severe
stenosis was observed in 3/74 patients (4%)
• One of which occurred within 3 months of ablation. 2
patients had progression between 3-6 month followup
Saad EB, et al. Circulation (2003) 108: 3102
Treatment of Pulmonary Vein Stenosis
Transcatheter Angioplasty for Acquired
Pulmonary Vein Stenosis after
Radiofrequency Ablation
Quershi, AM, Prieto, L, Latson, LA, et al.
Circulation (2003) 108: 1336
• Retrospective review of data from 19 patients with
pulmonary vein stenosis who underwent
catheterization and angiography
Qureshi AM, et al. Circulation (2003) 108: 1336
Treatment of Pulmonary Vein Stenosis
• Balloon stent angioplasty
Qureshi AM, et al. Circulation (2003) 108: 1336
Pre-existing PV Stenosis in Patients
Undergoing Ablation
• Details of congenital PV stenosis in 178 patients
before ablation
• Five PVs in 5 patients (2.8%) showed at least 50%
stenosis before ablation. Two types of pre-existing
PV stenosis:
– Type I - external compression of PV by the descending
aorta, observed in LIPV
– Type II - focal narrowing of PV, observed in RSPV
• Detection of this condition by 3D CT or MRA before
catheter ablation can provide information for
planning of ablation strategy and prevent
misdiagnosis of ablation-related PV stenosis
Wongcharoen W, et al. J Cardiovasc Electrophysiol (2003) 17: 423
Atrio-esophageal Fistula
Atrio-esophageal Fistula – First
Reported Case
• First reported case
• RF catheter ablation in a 72-year-old man
• PV isolation using an 8-mm-tip electrode (60 W or
55 °C) guided by a 25-mm circular catheter
• Patient presented with seizures on day 22 of follow-
up followed by hematemesis due to left atrialesophageal fistula
Scanavacca MI, et al. J Cardiovasc Electrophysiol (2004) 15: 960
CT Analysis of the LA and
Esophagus
• Implications for catheter ablation
• Topographic anatomy of the esophagus and the
posterior LA visualised using helical CT scan of the
chest with 3D reconstruction
– The esophagus and posterior LA wall are in close contact
over a large area that may often lie within the
– There is marked variation in the anatomic relationship of
the esophagus and the posterior LA
– Both the esophageal and atrial walls are quite thin.
However, a layer of adipose tissue may serve to insulate the
esophagus from thermal injury, explaining why atrioesophageal fistulas are rare
Lemola K, et al. Circulation (2004) 110: 3655
CT Analysis of the LA and
Esophagus
• Fat layer (FL) visible in image on left
Lemola K, et al. Circulation (2004) 110: 3655
CT Analysis of the LA and
Esophagus
• Relationship of esophagus to posterior LA wall on 3D CT images.
• A. Positioned very close to ostia of left-sided; oblique course from left
to right as it travels caudally B; closer to right-sided PVs than leftsided PVs C.
• D. Sagittal section. Esophagus wraps around posterior left atrium
along its entire length (D)
Lemola K, et al. Circulation (2004) 110: 3655
Atrio-esophageal Fistula:
Additional Cases
• 2 cases reported in 4360 patients treated in
two centres - incidence of 0.05%
• Patients developed symptoms compatible with
endocarditis 3 to 5 days after ablation
• Both suffered multiple gaseous and/or septic embolic
events causing cerebral and myocardial damage
• One patient survived after emergency cardiac and
esophageal surgery
Pappone C, et al. Circulation (2004) 109: 2724
Characteristics of 9 Reported
Cases
Description of an additional 9 cases
Characteristics of patients
Male sex
Mean time to presentation (d)
Deaths (n/n)
Presenting symptoms
Sepsis
Neurologic symptoms
MI or ischaemia
Overt GI bleeding
Diagnosis by CT
Diagnosis confirmed by autopsy
Diagnosis only by autopsy
n=4
12.3
9/9
9/9
8/9
2/9
3/9
3/4
9/9
6/9
Cummings JE, et al. Ann Intern Med (2006) 144: 572
Characteristics of 9 Reported
Cases
Relationship between atrio-esophageal fistula and
volume of centre
Case-patient
Annual reported
volume of AFib
ablation cases (#/y)
1
2
3
4
5
6
7
8
9
<100
>300
100-150
<100
>300
200-250
>300
<100
100-150
Cummings JE, et al. Ann Intern Med (2006) 144: 572
Real-time Monitoring of Luminal
Esophageal Temperature
• 3 patients undergoing catheter ablation during real-
time monitoring of luminal esophageal temperature
• Enhances recognition of esophageal heating and
adds useful information beyond that provided by
fluoroscopic assessment of esophageal position
Perzanowski C, et al. J Cardiovasc Electrophysiol (2006) 17: 166
Phrenic Nerve Injury
Frequency of Phrenic Nerve Injury
• 18 cases out of 3755 procedures (0.48%)
– 16 right PNI during ablation of right superior PV (12) or SVC
disconnection (3)
– 2 left PNI during ablation of LA appendage
Sacher F, et al. J Am Coll Cardiol (2006) 47: 2498
Symptoms and Diagnosis of
Phrenic Nerve Injury
• Immediate features:
9 patients diagnosed acutely with:
– Dyspnea
– Cough
– Hiccup
– and/or sudden diaphragmatic elevation
• Diagnosis after ablation: dyspnea in 7; radiography
in 2
• Four asymptomatic
• Complete or partial recovery in the majority
Sacher F, et al. J Am Coll Cardiol (2006) 47: 2498
Post Atrial Ablation Left Atrial
Tachycardia / Flutter
Post Atrial Ablation Left Atrial
Tachycardia / Flutter
• 10% of cases observed during procedure
• Time to appearance: mean 2-3 months post ablation
– Range 1.2-24% of cases
– Mean 10% (251/2718)
Raviele A, et al. J Cardiovasc Electrophysiol (2006) 16: 298
Post Atrial Ablation Left Atrial
Tachycardia/Flutter
Author
Patients
LAT/FL
Time to LAT/FL
(months)
Kanagataran 2001
71
14 (20%)
NR
Villacastin 2003
30
2 (6.6%)
2
Oral 2003
80
1 (1.2%)
NR
Ernst 2003
88
6 (7.0%)
NR
Gerstenfeld 2004
341
10 (3.4%)
5.7+2.8**
Mesas 2004
276
13 (4.7%)
2.6+1.6**
Pappone 2004
560
39 (7.0%)*
2.4/2.9
Jaïs 2004
100
12 (12%)
NR
Oral 2004
100
21 (21%)
NR
Ouyang 2005
100
21 (21%)
0.21
Cummings 2005
737
23 (3.1%)
NR
Chugh 2005
349
85 (24%)
>3-4
Hocini 2005
20
4 (20%)
>13
*28 (10%) in patients undergoing CPVA; 11 (3.9%) in patients undergoing CPVA + linear lesions
** Time to LAT/FL ablation
Raviele A, et al. J Cardiovasc Electrophysiol (2006) 16: 298
Mechanisms of Post Atrial Ablation
LAT/FL
Principal mechanisms
• Macro-reentry in 76%
• More rarely, ectopic focus
• Underlying cause thought to be due to interruptions
in the lesion lines
• Often requires a second ablation procedure to
eliminate the arrhythmia
Raviele A, et al. J Cardiovasc Electrophysiol (2006) 16: 298
Mechanisms of Post Atrial Ablation
LAT/FL
Role of linear lesions in reducing LAT/FL
• Some authors have proposed to perform empirical
linear lesions in addition to PVI at the level of the
mitral isthmus, poster wall and roof of left atrium to
prevent the occurrence of this pro-arrhythmic
complication
Italian Guidelines on Management of Atrial Fibrillation GIAC (2006) 9: 1
Mechanisms of Post Atrial Ablation
LAT / FL
Role of linear lesions in reducing LAT/FL
Pappone et al 2004
• CPVA only
10%
• CPVA plus linear lines
3.9%
Pappone C, et al. Circulation (2004) 110: 3036
Mechanisms of Post Atrial Ablation
LAT / FL
Role of linear lesions in reducing LAT/FL
• However, the real value of such lesions is still the object
of debate and according to other authors such lesions
may be pro-arrhythmic rather than anti-arrhythmic,
especially if conduction block is not confirmed at the
end of the procedure
• Additional linear lesions
14-21%
Jaïs P, et al. Circulation (2004) 110: 2996
6. Cost effectiveness
Catheter Ablation May Be More Costeffective than Pharmacological Therapy
After 5 years, the cost of RF ablation was below that of medical
management and further diverged thereafter
118 patients with symptomatic,
drug-refractory AFib
1.52 ± 0.71 ablation procedures
32 weeks
Pharmacological treatment
Catheter ablation
€1590/year
€4715 followed by
€445/year
Weerasooriya R, et al. PACE (2003) 26: 292
Differences in Hospital Visits and Costs
with and without Catheter Ablation
Although the initial cost of ablation is high, after ablation,
utilization of healthcare resources is significantly reduced
No ablation
Catheter ablation
Clinical visits per year
7.4 (2.5)
1.1 (0.6)
Emergency room visits per year
1.7 (0.9)
0.03 (0.17)
Hospitalization days per year
1.6 (0.8)
0 (0)
$1920 (889)
$87 (68)
Healthcare costs per year
Goldberg A, et al. J Interv Card Electrophysiol (2003) 8: 59
Catheter Ablation Cost-Effective in
Patients at High Risk of Stroke
Model to compare the cost-effectiveness of left
atrial catheter ablation (LACA), amiodarone, and
rate control therapy in the management of AFib
The use of LACA may be cost-effective in patients
with AFib at moderate risk for stroke
This model did not find it to be cost-effective in
low-risk patients.
Conclusions
Cost-effective in patients at moderate or
high risk of stroke
Chan DP, et al. J Am Coll Cardiol (2006) 47: 2513
7. Indications
Suitability Criteria for Catheter Ablation
• General referral criteria for catheter ablation
– patients with paroxysmal or persistent AFib
– refractory to pharmaceutical intervention
– left atrium size less than 5.0 cm
– absence of severe structural heart disease
– younger patients
• General criteria of unsuitability for catheter
ablation
– upper limit of left atrial size between 5.5 and 6.0 cm
– lower limit of LVEF between 30% and 35%
– prior heart surgery
– older patients with permanent AFib
Guidelines for Catheter Ablation
Class I
Paroxysmal/persistent AFib
non-elderly patients
refractory to pharmacological therapy
severe symptoms that significantly affect QoL
Class IIa
Chronic AFib
non-elderly patients
refractory to pharmacological therapy
severe symptoms that significantly affect QoL
Paroxysmal/persistent/chronic AFib
arrhythmia causing significant deterioration of cardiac function
refractory to pharmacological therapy
Italian Guidelines on Management of Atrial Fibrillation GIAC (2006) 9: 1
Guidelines for Catheter Ablation
Class IIb
Paroxysmal/persistent AFib
elderly patients
refractory to pharmacological therapy
severe symptoms that significantly affect QoL
Other patients that are:
informed about risk/benefits of procedure
choose procedure for personal reasons
Italian Guidelines on Management of Atrial Fibrillation GIAC (2006) 9: 1
Current ACC/AHA/ESC Guidelines
Recurrent
Paroxysmal AF
Minimal or
no symptoms
Disabling symptoms
in AF
Anticoagulation and rate
control as needed
Anticoagulation and rate
control as needed
No drug for prevention
of AF
AAD therapy
AF ablation if AAD
treatment fails
ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation
J Am Coll Cardiol (2006) 48: 854
Current ACC/AHA/ESC Guidelines
Maintenance of Sinus Rhythm
No (or minimal)
heart disease
Hypertension
Flecainide
Propafenone
Sotalol
Amiodarone
Doeftilide
Substantial LVH
Catheter
ablation
No
Yes
Flecainide
Propafenone
Sotalol
Amiodarone
Amiodarone
Dofetilide
Catheter
ablation
Coronary artery
disease
Heart
failure
Dofetilide
Sotalol
Amiodarone
Doeftilide
Amiodarone
Catheter
ablation
Catheter
ablation
Catheter
ablation
ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation
J Am Coll Cardiol (2006) 48: 854
Recent Commentary
Why Ablation for AFib might be Considered FirstLine Therapy for Some Patients
“Current therapies, especially AAM, not only
are ineffective but also pose a threat to patient
QoL and even longevity.
In the hands of experienced operators, AF ablation is
an effective, safe, and established treatment for AF
that offers an excellent chance for a lasting cure …
unlike other therapies, ablation tackles AF at its
electrophysiological origin.”
Verma A & Natale A Circulation (2005) 112: 1214
Summary of catheter ablation
• High success rate
• Improves survival, cardiac function and freedom from
recurrence
• New data from RCTs confirm benefits
• Safe, with a risk comparable to other low-risk, routine
interventions
• Cost effective compared to standard pharmacological
therapy, at least in patients at moderate
thromboembolic risk