SHA24/026003

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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