ESC in Saudi Arabia
The Atrial Fibrillation Ablation Registry
Professor Josep Brugada Chairman Executive Committee Atrial Fibrillation Ablation registry
EURObservational Research Programme
Primary endpoint To describe the clinical epidemiology of patients undergoing an AFib ablation procedure, and the diagnostic / therapeutic processes applied in these patients across Europe.
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
1410 patients included
19 patients without ablation 1391 patients with ablation Procedure performed 1 death during the in-hospital phase
1390 patients at discharge 90 lost to Followup (6.5%)
1300 patients at 12-month follow-up
Atrial Fibrillation Ablation Pilot Registry
Baseline characteristics TOTAL (n=1391)
Age (years), median (IQR) > 65 years, % Females, % Cardiovascular risk factors Diabetes mellitus, % Hypertension, % Active smokers, % Hypercholesterolemia, % Lone atrial fibrillation, %
60 (52 – 66) 31.3 27.9 8.3 50.1 12.1 32.5 38.3 ESC in Saudi Arabia – Speaker Prof. Josep Brugada
Atrial Fibrillation Ablation Pilot Registry
Baseline characteristics TOTAL (n=1391)
Type of AFib Paroxysmal, % Persistent , % Permanent, % Not defined, % Long-lasting persistent/permanent,%* Indications for ablation Symptoms, % Quality of life, % Desire for drug-free lifestyle, % Desire for sinus rhythm, %
66.8 27.6 4.5 1.2 7.3 89.9 73.6 35.3 39.9
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
Atrial Fibrillation Ablation Pilot Registry
Procedure
TOTAL (n=1391) Energy source Non-irrigated radiofrequency, % Radiofrequency with closed irrigation, % Radiofrequency with open irrigation, % Cryoablation, % Duty-cycled radiofrequency energy, % Laser balloon (endoscopic ablation system),% Achievement of entrance and exit block: LSPV, %* LIPV, %* RSPV, %* RIPV, %*
4.0 2.2 78.1 13.5 4.4 0.8 96.8 96.4 96.4 95.9
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
Atrial Fibrillation Ablation Pilot Registry
Follow-up status
Type of ECG monitoring Electrocardiogram, % Holter monitoring, % Transtelephonic monitoring, % Implanted monitoring systems, % ECG + holter, % ECG + transtelephonic monitoring, % ECG + implanted monitoring systems, % 3 or more, % None, %
Other cardiovascular tests 75.9 52.2 8.2 4.4 43.0 2.6 1.5 5.8 18.3
Transthoracic echocardiogram, % Transesophageal echocardiogram, % Chest X-ray, % Coronary angiography, % Cardiac CT, % Cardiac MRI, % EP study, % Myocardial scintigraphy, % Other tests, %
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
29.2 9.2 5.2 1.4 3.0 2.7 2.5 0.5 5.8
Atrial Fibrillation Ablation Pilot Registry
Follow-up status
Readmissions, % Secondary to AF / atrial flutter / tachycardia, % Secondary to other cardiovascular events, % Secondary to non-cardiovascular events, %
30.0 20.9 4.5 4.5
Repeat ablation procedure, % Percutaneous AF ablation, %* Surgical ablation, %* Other, % (AVN ablation, AT ablation, etc.)*
18.3 85.0 4.3 10.7
% of repeat ablation procedures. ** % of hospital readmissions due to other cardiovascular events *
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
Atrial Fibrillation Ablation Pilot Registry
Follow-up status
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
Atrial Fibrillation Ablation Pilot Registry
Follow-up status
Sinus rhythm Other rhythms Heart rate (bpm) mean ± SD median (IQR)
68.7 ± 11.5 67 (60 – 67)
P <0.0001
91.7 ± 26.2 90 (70 – 100)
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
TOTAL 71.4 ± 15.8 69 (61 – 79)
Atrial Fibrillation Ablation Pilot Registry
Follow-up status
12-month 12-monthFU: FU:64.7% 64.7%under underanticoagulation anticoagulation
%
CHADS2, % Anticoagulation Anticoagulationatat12-m 12-mFU FUaccording according totocardioembolic cardioembolicrisk risk
CHADS2-Vasc, % 0 53.1 1 69.0 >1 81.6
ESC in Saudi Arabia â&#x20AC;&#x201C; Speaker Prof. Josep Brugada
0 48.0 1 63.3 >1 76.2
Atrial Fibrillation Ablation Pilot Registry
Follow-up status
12-month 12-monthFU: FU:32.1% 32.1%under underAADs AADs
%
ESC in Saudi Arabia â&#x20AC;&#x201C; Speaker Prof. Josep Brugada
3 â&#x20AC;&#x201C; 12 MONTH FU
BLANKING
1300 patients at 12 months follow-up 19 Unknown status at follow up 192 patients with recurrence during blanking period (15.1%)
69 patients with at least one recurrence between 3 and 12 months after the procedure (37%)
123 patients with NO recurrence between 3 and 12 months after the procedure (63%)
333 patients with at least one recurrence at 12-month followup after the blanking period (26.1%)
12-MONTH RESULTS
22deaths deathsduring duringblanking blanking period period
22deaths deathsbetween between33 and and 12 12months months after the procedure after the procedure (1(1with withatatleast leastone one recurrence) recurrence)
4 deaths at 12-month follow-up (1 included in recurrences)
1087 patients with NO recurrence during blanking period (84.9%)
264 patients with at least one recurrence between 3 and 12 months after the procedure (24.3%)
821 patients with NO recurrence at 12-month follow-up (75.7%)
944 patients with NO recurrence at 12-month follow-up (73.7%) Without AADs: 56.6%
One-year FAILURE in 337 patients (26.3%)
One-year SUCCESS in 944 patients (73.7%)
ESC in Saudi Arabia â&#x20AC;&#x201C; Speaker Prof. Josep Brugada
With AADs: 43.4%*
Atrial Fibrillation Ablation Pilot Registry
Follow-up status
Body Mass Index (kg/m²) median (IQR) Type of AFib Paroxysmal, % Persistent , % Permanent, % Not defined, % Lone atrial fibrillation, % LA diametre (mm) median (IQR) Recurrence during blanking, %
Patients with one-year success (n =944)
Patients with recurrence (n =337)
p
TOTAL (n=1281)
27 (24 – 30)
28 (25 – 31)
0.039 0.012
27 (25 – 30)
68.5 27.2 3.3 1 40.6
62.0 28.2 8.3 1.5 34.2
0.039
67.0 27.4 4.5 1.1 38.9
42 (38 – 46) 13.0
44 (41 – 48) 21.1
0.001 <0.001
42 (39 – 47) 15.1
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
Atrial Fibrillation Ablation Pilot Registry
Follow-up status Multivariate analysis
All the variables having p<0.1 in the univariate models
VARIABLE Type of AF (Persistent/Permanent vs Paroxysmal) Lone AF LA diameter (>=45 mm vs <45 mm) LV ejection fraction (10-mm interval) Left atrial linear lesion: Roof line Left atrial linear lesion: Mitral isthmus line Other Left atrial linear lesion Ablation of fractionated electrograms Ablation of ganglionated plexi Recurrence during blanking period
OR 0.87 1.10 0.77 1.08 1.15 1.20 0.72 2.77 0.74 3.01
95% CI 0.63 – 1.20 0.82 – 1.46 0.55 – 1.09 0.90 – 1.29 0.71 – 1.87 0.67 – 2.15 0.39 – 1.32 0.47 – 16.44 0.35 – 1.56 2.17 – 4.16
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
P-VALUE 0.4070 0.5245 0.1394 0.4370 0.5776 0.5491 0.2902 0.2634 0.4229 <0.0001
Atrial Fibrillation Ablation Pilot Registry
Follow-up status
Overall adverse events In-hospital 12-month FU Cardiovascular, % 3.3 2.02 Bradycardia requiring pacemaker implantation 0.2 1.02 Peripheral/vascular, % 1.3 0.71 AV fistula, % 0.43 0.47 Pseudoaneurysm, % 0.43 0.24 Hematoma/bleeding requiring evacuation or transfusion, % 0.36 Peripheral thromboembolic event, % 0.07 PV stenosis (â&#x2030;Ľ75%) requiring intervention, % 0.08 Cerebrovascular event, % 0.58 0.54 Phrenic nerve injury, % 0.14 0.16 Pulmonary, % 0.56 Esophageal ulceration, % 0.07 General, % 0.43 Other, % 30 (2.2%) Death, % 0.31 Cardiovascular, % 0.07 0.16 Non-cardiovascular, % 0.08 Unknown, % 0.08
OVERALL, %
7.7
ESC in Saudi Arabia â&#x20AC;&#x201C; Speaker Prof. Josep Brugada
2.6
Atrial Fibrillation Ablation Pilot Registry
Follow-up status
Mortality after catether ablation of AFib In-hospital phase, (%) 1 (0.07) Cardiovascular, % 1( 0.07) 12-month follow-up, (%) 4 (0.31) Cardiovascular, % 2 (0.16) Non-cardiovascular, % 1 (0.08) Unknown, % 1 (0.08)
Infective endocarditis 1 hemorrhagic stroke, 1 ischemic VF Pancreatitis (metastatic) Out-of-hospital SD 38-days after AFA
ESC in Saudi Arabia â&#x20AC;&#x201C; Speaker Prof. Josep Brugada
Atrial Fibrillation Ablation Registry
Conclusions
The Atrial Fibrillation Ablation Pilot Study the first, systematic, prospective international study specifically designed for collecting information reflecting the current clinical practice in the ablation of AFib. There is clearly a gap between recommendations and the actual clinical practice that should be considered when designing management strategies of patients suffering from atrial fibrillation. The Pilot experience has provided invaluable information for the refinement of the data-set for its implementation in a long-term Atrial Fibrillation Ablation panEuropean Registry. Further analyses by geographical areas may contribute by identifying local or more generalized needs in relation to this procedure.
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
Atrial Fibrillation Ablation Long-Term
• Launch on 29th February 2012 • Target : 3000 patients • Enrolment period : until December 2012 and from January to May for the next years • All 54 ESC member countries were invited in 2011
ESC in Saudi Arabia – Speaker Prof. Josep Brugada
Atrial Fibrillation Ablation Long-Term
Total
Enrolment status up to 28 January 2013
Registered Centres
GEO. ZONE TOTAL
Active Centres
Enrolled Patients
Completed CRFs
EASTERN
36
21
360
294
MIDDLE EAST & NORTH AFRICAN
12
3
8
8
NORTHERN
7
2
58
15
SOUTHERN
49
15
138
117
WESTERN
22
9
87
76
Grand Total
126
50
651
510
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