Atrial Fibrillation Ablation Pilot Registry 1-year follow-up results - PowerPoint PPT Presentation

EURObservational Research Programme Atrial Fibrillation Ablation Pilot Registry 1-year follow-up results Elena Arbelo 1 , Josep Brugada 1 , Gerhard Hindricks 2 , Aldo Maggioni 3 , Luigi Tavazzi 4 , Panos Vardas 5 , Frédéric Anselme 6 , Giuseppe Inama 7 , Pierre Jais 8 , Zbigniew Kalarus 9 , Josef Kautzner 10 , Thorsten Lewalter 11 , Georges Mairesse 12 , Julian Perez-Villacastin 13 , Sam Riahi 14 , Milos Taborsky 15 , George Theodorakis 16 , Serge Trines 17 , on the behalf of the Atrial Fibrillation Ablation Pilot Study Investigators* 1 Department of Cardiology, Thorax Institute. Hospital Clínic de Barcelona. University of Barcelona. Barcelona, Spain 2 Heart Center. University of Leipzig. Leipzig, Germany 3 Associazione Nazionale Medici Cardiologi Ospedalieri Research Center. Florence, Italy 4 GVM Care and Research, E.S. Health Science Foundation, Maria Cecilia Hospital, Cotignola, Italy 5 Department 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 11 Department 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 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 12-month follow-up window (± 4 weeks) 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 of 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.

350 Centres In-Hospital Phase 1410 patients included Centres in 12-month Follow-up Phase Patients In-Hospital Phase 300 19 patients Patients in 12-month Follow-up Phase without ablation 250 1391 patients with ablation Procedure performed 200 1 death during the 150 in-hospital phase 100 1390 patients at discharge 50 90 lost to Follow- up (6.5%) 0 1300 patients at 12-month follow-up

Atrial Fibrillation Ablation Pilot Registry Baseline characteristics No significant differences in : TOTAL • Age. (n=1391) • Gender Age (years), • Cardiovascular risk factors median (IQR) 60 (52 – 66) • BMI > 65 years, % 31.3 • Comorbidities. Females, % 27.9 • Prior cardioembolic events Cardiovascular risk factors • CHADS 2 / CHADS 2 -Vasc Score Diabetes mellitus, % 8.3 • Underlying cardiomyopathy Hypertension, % 50.1 • Implanted devices. Active smokers, % 12.1 • Baseline BP. Hypercholesterolemia, % 32.5 • Baseline creatinine Lone atrial fibrillation, % 38.3 • Baseline hemoglobine.

Atrial Fibrillation Ablation Pilot Registry Baseline characteristics TOTAL (n=1391) Type of AFib Paroxysmal, % 66.8 No significant differences in : Persistent , % 27.6 • Associated symptoms Permanent, % 4.5 • Pecipitating factors Not defined, % 1.2 • Prior cardioversions Long-lasting persistent/permanent,% * 7.3 • Indications for ablation Indications for ablation Symptoms, % 89.9 Quality of life, % 73.6 Desire for drug-free lifestyle, % 35.3 Desire for sinus rhythm, % 39.9

Atrial Fibrillation Ablation Pilot Registry Procedure TOTAL (n=1391) Energy source Non-irrigated radiofrequency, % 4.0 No significant differences in : • Left and right atrial linear Radiofrequency with closed irrigation, % 2.2 Radiofrequency with open irrigation, % 78.1 ablation • Fractionated electrogram Cryoablation, % 13.5 ablation Duty-cycled radiofrequency energy, % 4.4 • Autonomic ganglionated Laser balloon (endoscopic ablation system),% 0.8 plexi ablation Achievement of entrance and exit block: LSPV, % * 96.8 LIPV, % * 96.4 RSPV, % * 96.4 RIPV, % * 95.9

Atrial Fibrillation Ablation Pilot Registry Follow-up status Clinical visit 58.4% 12-month follow-up Telephone contact 41.6% Other cardiovascular tests Type of ECG monitoring Transthoracic echocardiogram, % 30.0 Periodical visit with ECG, % 76.6 Transesophageal echocardiogram, % 9.4 Holter monitoring, % 52.9 Chest X-ray, % 5.4 Transtelephonic monitoring, % 8.4 Coronary angiography, % 1.4 Implanted monitoring systems, % 4.5 ECG + holter, % 43.6 Cardiac CT, % 3.1 ECG + transtelephonic monitoring, % 2.6 Cardiac MRI, % 2.8 ECG + implanted monitoring systems, % 1.6 EP study, % 2.6 3 or more, % 5.6 Myocardial scintigraphy, % 0.6 None, % 18.3 Other tests, % 6.0

Atrial Fibrillation Ablation Pilot Registry Follow-up status Readmissions, % 30.0 Acute coronary syndrome, % ** 5.1 Secondary to AF / atrial flutter / tachycardia, % 21.1 Heart failure, % ** 23.7 Secondary to other cardiovascular events, % 4.4 Coronary intervention, % ** 23.7 Secondary to non-cardiovascular events, % 4.6 Other, % ** 69.5 Repeat ablation procedure, % 18.4 Percutaneous AF ablation, % * 85.0 Surgical ablation, % * 4.3 Other, % (AVN ablation, AT ablation, etc.) * 10.7 * % of repeat ablation procedures. ** % of hospital readmissions due to other cardiovascular events

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

Atrial Fibrillation Ablation Pilot Registry Follow-up status Baseline rhythm at 12-month FU 1,2 1,4 7,6 1,7 Sinus rhyhtm Atrial fibrillation Common atrial flutter Atypical atrial flutter Pacemaker rhythm 88,1 Sinus rhythm Other rhythms P TOTAL Heart rate (bpm) <0.0001 mean ± SD 68.7 ± 11.5 91.7 ± 26.2 71.4 ± 15.8 median (IQR) 67 (60 – 67) 90 (70 – 100) 69 (61 – 79)

Atrial Fibrillation Ablation Pilot Registry Follow-up status 12-month FU: 64.7% under anticoagulation 100 87 90 At discharge 80 Before 12-month visit After 12-month visit 70 63 60 55 54 % 50 40 28 30 24 20 10 10 2 1 1 1 0 0 Vitamin K Dabigatran LMWH Antiplatets antagonist CHADS 2 , % CHADS 2 -Vasc, % 0 53.1 0 48.0 Anticoagulation at 12-m FU according to cardioembolic risk 1 69.0 1 63.3 >1 81.6 >1 76.2

Atrial Fibrillation Ablation Pilot Registry Follow-up status 12-month FU: 32.1% under AADs 25 23 22 At discharge 20 16 16 15 14 12 % 10 10 9 9 8 7 5 4 5 3 2 0 Amiodarone Dronadorone Propafenone Flecainide Other antiarrhythmic

1300 patients at 12 months follow-up BLANKING 19 Unknown status at follow up 192 patients with recurrence during 2 deaths during blanking 1087 patients with NO recurrence blanking period (15.1%) period during blanking period (84.9%) 69 patients with at 123 patients with 264 patients with 821 patients 2 deaths between 3 least one NO recurrence at least one with NO and 12 months 3 – 12 MONTH FU recurrence between between 3 and 12 recurrence recurrence after the procedure 3 and 12 months months after the between 3 and 12 at 12-month (1 with at least one after the procedure procedure months after the follow-up recurrence) (37%) (63%) procedure (24.3%) (75.7%) 333 patients with at least one 4 deaths at 12-month 944 patients with NO recurrence at 12-month follow-up follow-up recurrence at 12-month after the blanking period (26.1%) (1 included in recurrences) follow-up (73.7%) Without AADs: 56.6% 12-MONTH One-year FAILURE in One-year SUCCESS in 337 patients (26.3%) 944 patients (73.7%) RESULTS With AADs: 43.4% *