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Atrial Fibrillation Ablation Pilot Registry

1-year follow-up results

Elena Arbelo1, Josep Brugada 1, Gerhard Hindricks2, Aldo Maggioni3, Luigi Tavazzi4, Panos Vardas5, Frédéric Anselme6, Giuseppe Inama7, Pierre Jais8, Zbigniew Kalarus9, Josef Kautzner10, Thorsten Lewalter11, Georges Mairesse12, Julian Perez-Villacastin13, Sam Riahi14, Milos Taborsky15, George Theodorakis16, Serge Trines17, on the behalf of the Atrial Fibrillation Ablation Pilot Study Investigators*

1Department of Cardiology, Thorax Institute. Hospital Clínic de Barcelona. University of Barcelona. Barcelona, Spain 2Heart Center. University of Leipzig. Leipzig, Germany 3Associazione Nazionale Medici Cardiologi Ospedalieri Research Center. Florence, Italy 4GVM Care and Research, E.S. Health Science

Foundation, Maria Cecilia Hospital, Cotignola, Italy

5Department of Cardiology, Heraklion University Hospital, Crete, Greece 6 Service De Cardiologie, Hopital Charles Nicolle, Rouen Cedex, France 7 Ospedale Maggiore Di Crema, Crema, Italy 8 Hôpital Cardiologique du Haut-Lévêque, Bordeaux-Pessac, France 9 Department of Cardiology,

Silesian Academy of Medicine, Zabrze, Poland 10 Department of Cardiology, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic 11Department of Cardiology, Isar Heart Centre, Muenchen, Germany 12 Cliniques du Sud Luxembourg - Vivalia, Arlon, Belgium

13 Hospital Clinico Universitario San Carlos, Madrid, Spain 14 Aalborg Hospital, Aalborg, Denmark 15 Internal Cardology Dept., Faculty Hospital

Olomouc, Olomouc, Czech Republic 16 Henry Dunant Hospital/Errikos Dynan Hospital, Athens, Greece 17 Department of Cardiology, Leiden University Medical Centre, Leiden, The Netherlands

EURObservational Research Programme

I have nothing to disclose

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.

EURObservational Research Programme

Atrial Fibrillation Ablation Pilot Registry

Methods

Study design Prospective, multicentre, observational survey of consecutive patients (20 patients/centre) undergoing a first AFib ablation procedure, followed-up for 1 year.

 4 Western European countries: Belgium, France, Germany and the Netherlands.  2 Eastern European countries: Czech Republic and Poland.  3 Southern European countries: Greece, Italy and Spain.  1 Northern European country: Denmark. Site selection hospitals with ≥50 AFib ablation procedures/year The EURObservational Research Department of the ESC operationally coordinated the project, managed the database and performed the statistical analyses.

Atrial Fibrillation Ablation Pilot Registry

Methods

Definitions

One-year success: survival free from any documented atrial arrhythmia, with or without antiarrhythmic drugs, as assessed from the end of the 3- month blanking period to 12 months following the ablation procedure*. Arrhythmia recurrence: an electrocardiographically documented episode

• f AFib or atrial flutter lasting at least 30 seconds, after a 3-month blanking

period*. A blanking period of 3 months was employed after ablation. Early recurrences of within the first 3 months were not classified as failure of the procedure.

*Cavo-tricuspid isthmus-dependent flutter was excluded from this definition.

12-month follow-up window (± 4 weeks)

1410 patients included 1300 patients at 12-month follow-up 1390 patients at discharge 1391 patients with ablation Procedure performed 1 death during the in-hospital phase 90 lost to Follow- up (6.5%) 19 patients without ablation

50 100 150 200 250 300 350

Centres In-Hospital Phase Centres in 12-month Follow-up Phase Patients In-Hospital Phase Patients in 12-month Follow-up Phase

Atrial Fibrillation Ablation Pilot Registry

Baseline characteristics

TOTAL (n=1391) Age (years), median (IQR) > 65 years, % 60 (52 – 66) 31.3 Females, % 27.9 Cardiovascular risk factors Diabetes mellitus, % Hypertension, % Active smokers, % Hypercholesterolemia, % 8.3 50.1 12.1 32.5 Lone atrial fibrillation, % 38.3

No significant differences in:

• Age.
• Gender
• Cardiovascular risk factors
• BMI
• Comorbidities.
• Prior cardioembolic events
• CHADS2 / CHADS2-Vasc Score
• Underlying cardiomyopathy
• Implanted devices.
• Baseline BP.
• Baseline creatinine
• Baseline hemoglobine.

Atrial Fibrillation Ablation Pilot Registry

Baseline characteristics

TOTAL (n=1391) Type of AFib Paroxysmal, % Persistent , % Permanent, % Not defined, % Long-lasting persistent/permanent,%* 66.8 27.6 4.5 1.2 7.3 Indications for ablation Symptoms, % Quality of life, % Desire for drug-free lifestyle, % Desire for sinus rhythm, % 89.9 73.6 35.3 39.9

No significant differences in:

• Associated symptoms
• Pecipitating factors
• Prior cardioversions
• Indications for ablation

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),% 4.0 2.2 78.1 13.5 4.4 0.8 Achievement of entrance and exit block: LSPV, %* LIPV, %* RSPV, %* RIPV, %* 96.8 96.4 96.4 95.9

No significant differences in:

• Left and right atrial linear

ablation

• Fractionated electrogram

ablation

• Autonomic ganglionated

plexi ablation

Atrial Fibrillation Ablation Pilot Registry

Follow-up status

Type of ECG monitoring Periodical visit with ECG, % 76.6 Holter monitoring, % 52.9 Transtelephonic monitoring, % 8.4 Implanted monitoring systems, % 4.5 ECG + holter, % 43.6 ECG + transtelephonic monitoring, % 2.6 ECG + implanted monitoring systems, % 1.6 3 or more, % 5.6 None, % 18.3

12-month follow-up Clinical visit 58.4% Telephone contact 41.6%

Other cardiovascular tests

Transthoracic echocardiogram, % 30.0 Transesophageal echocardiogram, % 9.4 Chest X-ray, % 5.4 Coronary angiography, % 1.4 Cardiac CT, % 3.1 Cardiac MRI, % 2.8 EP study, % 2.6 Myocardial scintigraphy, % 0.6 Other tests, % 6.0

Atrial Fibrillation Ablation Pilot Registry

Follow-up status

Readmissions, % 30.0 Secondary to AF / atrial flutter / tachycardia, % 21.1 Secondary to other cardiovascular events, % 4.4 Secondary to non-cardiovascular events, % 4.6 Repeat ablation procedure, % 18.4 Percutaneous AF ablation, %* 85.0 Surgical ablation, %* 4.3 Other, % (AVN ablation, AT ablation, etc.)* 10.7

Acute coronary syndrome, %** Heart failure, %** Coronary intervention, %** Other, %** 5.1 23.7 23.7 69.5

* % of repeat ablation procedures. ** % of hospital readmissions due to other cardiovascular events

Atrial Fibrillation Ablation Pilot Registry

Follow-up status

72,3 41,8 37,6 24,4 13,7 10,4 3,8 1,1 13,1 34,3 12,6 12,8 6,2 3,2 4,8 0,6 3,7 54,9 10 20 30 40 50 60 70 80 90 100 Baseline 12-month FU

Atrial Fibrillation Ablation Pilot Registry

Follow-up status

88,1 7,6 1,2 1,4 1,7

Baseline rhythm at 12-month FU

Sinus rhyhtm Atrial fibrillation Common atrial flutter Atypical atrial flutter Pacemaker rhythm

Sinus rhythm Other rhythms P TOTAL Heart rate (bpm) mean ± SD median (IQR) 68.7 ± 11.5 67 (60 – 67) 91.7 ± 26.2 90 (70 – 100) <0.0001 71.4 ± 15.8 69 (61 – 79)

87 10 55 63 1 2 24 54 1 1 28

10 20 30 40 50 60 70 80 90 100 Vitamin K antagonist Dabigatran LMWH Antiplatets

At discharge Before 12-month visit After 12-month visit

Atrial Fibrillation Ablation Pilot Registry

Follow-up status

CHADS2-Vasc, % 1 >1 48.0 63.3 76.2

Anticoagulation at 12-m FU according to cardioembolic risk

CHADS2, % 1 >1 53.1 69.0 81.6

12-month FU: 64.7% under anticoagulation

%

23 4 10 22 9 16 3 7 16 9 12 2 5 14 8

5 10 15 20 25 Amiodarone Dronadorone Propafenone Flecainide Other antiarrhythmic

At discharge

Atrial Fibrillation Ablation Pilot Registry

Follow-up status

12-month FU: 32.1% under AADs

%

192 patients with recurrence during blanking period (15.1%) 1087 patients with NO recurrence during blanking period (84.9%) 19 Unknown status at follow up 69 patients with at least one recurrence between 3 and 12 months after the procedure (37%) 2 deaths between 3 and 12 months after the procedure (1 with at least one recurrence) One-year SUCCESS in 944 patients (73.7%) 123 patients with NO recurrence between 3 and 12 months after the procedure (63%) 2 deaths during blanking period 1300 patients at 12 months follow-up 4 deaths at 12-month follow-up (1 included in recurrences) 333 patients with at least one recurrence at 12-month follow-up after the blanking period (26.1%) 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%) One-year FAILURE in 337 patients (26.3%)

BLANKING 3 – 12 MONTH FU

944 patients with NO recurrence at 12-month follow-up (73.7%)

12-MONTH RESULTS

Without AADs: 56.6% With AADs: 43.4%*

Atrial Fibrillation Ablation Pilot Registry

Follow-up status

Patients with

• ne-year success

(n =944) Patients with recurrence (n =337) p TOTAL (n=1281) Body Mass Index (kg/m²) median (IQR) 27 (24 – 30) 28 (25 – 31) 0.039 27 (25 – 30) Type of AFib Paroxysmal, % Persistent , % Permanent, % Not defined, % 68.5 27.2 3.3 1 62.0 28.2 8.3 1.5 0.012 67.0 27.4 4.5 1.1 Lone atrial fibrillation, % 40.6 34.2 0.039 38.9 LA diametre (mm) median (IQR) 42 (38 – 46) 44 (41 – 48) 0.001 42 (39 – 47) Recurrence during blanking, % 13.0 21.1 <0.001 15.1

Atrial Fibrillation Ablation Pilot Registry

Follow-up status

OR 95% CI p-value LA diameter during hospital stay (8 mm interval) 0.82 0.66 – 1.02 0.0686 Type of AF (Permanent AF vs Paroxysmal AF) 0.52 0.28 – 0.95 0.1000 Recurrence during blanking period 2.94 2.11 – 4.10 <0.0001

EURObservational Research Programme

OR 95% CI p-value LA diameter during hospital stay (8 mm interval) 0.81 0.67 – 0.99 0.0428 Type of AF (Permanent AF vs Paroxysmal AF) 0.50 0.28 – 0.89 0.0279 Multivariate analysis

Atrial Fibrillation Ablation Pilot Registry

Follow-up status

Overall adverse events In-hospital 12-month FU Cardiovascular, % Bradycardia requiring pacemaker implantation 3.3 0.2 2.02 1.02 Peripheral/vascular, % AV fistula, % Pseudoaneurysm, % Hematoma/bleeding requiring evacuation or transfusion, % Peripheral thromboembolic event, % 1.3 0.43 0.43 0.36 0.07 0.71 0.47 0.24

• PV stenosis (≥75%) 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, %

Cardiovascular, % Non-cardiovascular, % Unknown, % 0.07 0.31 0.16 0.08 0.08

OVERALL, % 7.7 2.6

Atrial Fibrillation Ablation Pilot Registry

Follow-up status

Mortality after catether ablation of AFib In-hospital phase, (%) Cardiovascular, % 1 (0.07) 1( 0.07) 12-month follow-up, (%) Cardiovascular, % Non-cardiovascular, % Unknown, % 4 (0.31) 2 (0.16) 1 (0.08) 1 (0.08)

Infective endocarditis 1 hemorrhagic stroke, 1 ischemic VF Pancreatitis (metastatic) Out-of-hospital SD 38-days after AFA

EURObservational Research Programme

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

• f patients suffering from atrial fibrillation.

The Pilot experience has provided invaluable information for the refinement

• f the data-set for its implementation in a long-term Atrial Fibrillation Ablation

pan-European Registry. Further analyses by geographical areas may contribute by identifying local

• r more generalized needs in relation to this procedure.

Atrial Fibrillation Ablation Pilot Registry

Conclusions

Than ank you

Atrial Fibrillation Ablation Pilot Registry EURObservational Research Programme

APPENDIX Executive Committee (appointed by the ESC Heart Rhythm Association): Josep Brugada (Chairperson), Elena Arbelo, Gerhard Hindriks, Aldo P. Maggioni (non-voting member), John Morgan, Luigi Tavazzi, Panos Vardas Oversight Committee Angeles Alonso, Roberto Ferrari, Michel Komajda, Luigi Tavazzi (Chairman), David Wood, Panos Vardas, Presidents of the ESC Associations Steering Committee Josep Brugada (Chairman), Georges Mairesse (Belgium), Milos Taborsky (Czech Republic), Josef Kautzner (Czech Republic), Thorsten Lewalter (Germany), Sam Riahi (Denmark), Pierre Jais (France), Frédéric Anselme (France), George Theodorakis (Greece), Giuseppe Inama (Italy), Serge Trines (The Netherlands), Zbigniew Kalarus (Poland), Julian Perez Villacastin (Spain). EURObservational Research Program Department Aldo P. Maggioni, Malika Manini, Gérard Gracia, Cécile Laroche, Viviane Missiamenou, Charles Taylor, Marème Konte, Emanuela Fiorucci, Elin Folkesson Lefrancq, Myriam Glémot, Patti-Ann McNeill, Timothée Bois.

Atrial Fibrillation Ablation Pilot Registry EURObservational Research Programme

Participating centres BELGIUM Leuven: H. Heidbüchel, D. Nuyens, Liege: J. Boland, V. Dinraths, J-M. Herzet, E. Hoffer, D. Malmendier, M. Massoz, S. Pourbaix, Yvoir: E. Ballant, D. Blommaert, O. Deceuninck, F. Dormal, O. Xhaet, Aalst: T. De Potter, P. Geelen, Brugge: K. Derycker, M. Duytschaever, R. Tavernier, Y. Vandekerckhove, D. Vankats; CZECH REPUBLIC Ceske Budejovice: A. Bulava, J. Hanis, D. Sitek, Prague 4: M. Blahova, R. Cihak, L. Hanyasova, H. Jansova, P. Peichl, M. Tanzerova,

• D. Wichterle, Hradec Kralove: J. Duda, L. Haman, P. Parizek, Prague: L. Coling, P. Neuzil, J. Petru, L. Sediva, J. Skoda, Trinec: J. Chovancik, M. Fiala,
• R. Neuwirth;

DENMARK Copenhagen: A. Karlsdottir, S. Pehrson, Aarhus N: C. Gerdes, H. K. Jensen, P. Lukac, J. C. Nielsen, Hellerup: J. Hansen, A. Johannessen, Varde: P. S. Hansen, A. K. Pedersen, Aalborg: F. P. Heath, S. Hjortshoj, A. M. Thogersen; FRANCE Saint-Etienne: A. Da Costa, I. Martel, C. Romeyer-Bouchard, N. Sadki, A. Schmid, Pessac: M. Haissaguerre, M. Hocini, S. Knecht, F. Sacher, Neuilly sur Seine: M. Ait Said, B. Cauchemez, F. Ledoux, O. Thomas, Nantes: J-P. Cebron, N. Decarsin, D. Gras, S. Hervouet, Villeurbanne: C. Durand, A. Durand-Dubief, H. Poty, Tours: D. Babuty, B. Pierre, Toulouse: J-P. Albenque, S. Boveda, N. Combes, R. Mas, Amiens: J-S. Hermida, M. Kubala, Rouen: B. Godin, A. Savouré, Y. Soublin, Grenoble: P. Defaye, P. Jacon, Lille: F. Brigadeau, S. Corbut, F. Flament-Balzola, S. Kacet, D. Klug, D. Lacroix, Saint Denis: X. Copie, L. Gilles, Z. Hocine, O. Paziaud, O. Piot, Rennes: C. Crocq, G. Kaballu, V. Le Moal, P. Lotton, P. Mabo, D. Pavin, Vandoeuvre-les-Nancy: M. Andronache, C. De Chillou, I. Magnin-Poull, Marseille: J-C. Deharo, C. Durand, F. Franceschi, E. Peyrouse, S. Prevot, Paris: M. Etchegoin, F. Extramiana, A. Leenhardt, A. Messali; GERMANY Leipzig: T. Heine, A. Schneider, N. Winter, Coburg: J. Brachmann, G. Ritscher, B. Schertel-Gruenler, H. Simon, A-M. Sinha, O. Turschner,

• A. Wystrach, Bonn Venusberg: M. Stemberg, Hamburg: K-H. Kuck, A. Metzner, R. Tilz, E. Wissner, Hamburg: K. Heitmann, S. Willems, Berlin: D.

Andresen, S. Mueller, Bremen: M. Volkmer, Frankfurt: B. Schmidt; GREECE Athens: A. Kostopoulou, E. Livanis, V. Voudris, Athens: M. Efremidis, K. Letsas, S. Tsikrikas, Athens: E. Christoforatou, P. Ioannidis, A. Katsivas, S. Kourouklis, Athens: G. Andrikopoulos, I. Rassias, S. Tzeis, Thessaloniki: G. Dakos, S. Paraskevaidis, G. Stavropoulos, E. Theofilogiannakos, V. P. Vassilikos; ITALY Pisa (PI): M. G. Bongiorni, G. Zucchelli, Mestre (VE): A. Raviele, S. Themistoclakis, Ferrara (FE): C. Pratola, Castellanza (VA): M. Tritto, Milano (MI): P. Della Bella, P. Mazzone, Milan (MI): M. Moltrasio, C. Tondo, Roma (RM): L. Calo, L. De Luca, F. Guarracini, E. Lioy, Cotignola (RA): L. Dozza,

• E. Frigoli, L. Giannelli, C. Pappone, M. Saviano, G. Schiavina, G. G. Vicedomini, Varese (VA): R. De Ponti, L. A. Doni, R. Marazzi, J. A. Salerno-

Uriarte, C. Tamborini, Torino (TO): M. Anselmino, F. Ferraris, F. Gaita, Mirano (VE): E. Bertaglia, G. Brandolino, F. Zoppo; THE NETHERLANDS Rotterdam: N. De Groot, P. Janse, L. Jordaens, Maastricht: L. Pison, Groningen: C. Roos, I. Van Gelder, Eindhoven: R. Manusama, A. Meijer, P. Van der Voort, Leiden: S. Trines; POLANDSzczecin: J. Kazmierczak, Z. Kornacewicz-Jach, M. Wielusinski, Warszawa: J. Baran, P. Kulakowski, Wroclaw: M. Dzidowski, A. Fuglewicz,

• K. Nowak, Zabrze: P. Pruszkowska-Skrzep, A. Wozniak, Katowice: S. Nowak, M. Trusz-Gluza;

SPAIN Madrid: J. Almendral, F. Atienza, E. Castellanos, C. De Diego, M. Ortiz, Madrid: J. Moreno Planas, N. Perez Castellano, Madrid: J. Benezet, J. Farre Muncharaz, J.M. Rubio Campal, Madrid: A. Hernandez Madrid, R. Matia, Sevilla: E. Arana, A. Pedrote, Madrid: R. Cozar, R. Peinado, I. Valverde, Barcelona: E. Arbelo, A. Berruezo, N. Calvo, E. Guiu, S. Husseini, L. Mont Girbau.