«Κατάλυση Πνευμονικών Φλεβών: Στόχος είναι η βελτίωση της πρόγνωσης ή μόνο της ποιότητας ζωής;»

«Κατάλυση Πνευμονικών Φλεβών: Στόχος είναι η βελτίωση της πρόγνωσης ή μόνο της ποιότητας ζωής;» Παναγιώτης Ιωαννίδης Διευθυντής Τμήματος Αρρυθμιών & Επεμβατικής Ηλεκτροφυσιολογίας Βιοκλινικής Αθηνών ΠΑΝΕΛΛΗΝΙΑ ΣΕΜΙΝΑΡΙΑ ΟΜΑΔΩΝ ΕΡΓΑΣΙΑΣ Ιωάννινα, 13-2-2016

The Value of AF Ablation Symptomatic relief Quality of Life Thromboembolism?? Need for OAC Continuation Mortality?

Γιατρέ, μετά το ablation ΔΕΝ θα έχω φόβο για εγκεφαλικό. Έτσι δεν είναι; Μακάρι να μάθω την απάντηση πριν το τέλος της καριέρας μου

Μείωση της θνητότητας και βελτίωση της ποιότητας ζωής ασθενών που υποβλήθηκαν σε κατάλυση ΚΜ σε σύγκριση με φαρμακευτική θεραπεία (μη τυχαιοποιημένος πληθυσμός) Pappone et al, JACC 2003;42:185-97

Can Ablation Reduce the Incidence of Stroke? Thromboembolic Events Late After AF Ablation Study Year Patients (n) Mean CHADS 2 Annual TE off W Annual TE on W Oral et al 1 2006 755 1,5 0% 0,6% Nademanee et al 2 2008 517 1,4 0,6% 2,0% Bunch et al 3 2009 630 1,6 0% 0,8% Themistoclakis et al 4 2010 3355 ~1,0 0,03% 0,23% Weighted Mean ~>1.0 0,08% 0,68% For a patient with CHADS 2 of 1,0: Expected annual TE rates: On ASA 2,8%/year X 0,8 = 2,2%/year On Warfarin 2,8%/year X 0,3 = 0,8%/year 1 Oral et al. Circulation 2006;114:759-765 2 Nademanee et al. JACC 2008;51(8):843-9 3 Bunch et al. J C E. 2009;20:988-93 4 Themistoclakis et al. JACC 2010 ;55:735-43

Can Ablation Reduce the Incidence of Stroke? Thromboembolic Events Late After AF Ablation Study Year Patients (n) Mean CHADS 2 Annual TE off W Annual TE on W Oral et al 1 2006 755 1,5 0% 0,6% Nademanee et al 2 2008 517 1,4 0,6% 2,0% Bunch et al 3 2009 630 1,6 0% 0,8% Themistoclakis et al 4 2010 3355 ~1,0 0,03% 0,23% Weighted Mean ~>1.0 0,08% 0,68% For a patient with CHADS 2 of 1,0: Expected annual TE rates: On ASA 2,8%/year X 0,8 = 2,2%/year On Warfarin 2,8%/year X 0,3 = 0,8%/year 1 Oral et al. Circulation 2006;114:759-765 2 Nademanee et al. JACC 2008;51(8):843-9 3 Bunch et al. J C E. 2009;20:988-93 4 Themistoclakis et al. JACC 2010 ;55:735-43

Defining The Net Clinical Benefit of Warfarin Anticoagulation in Atrial Fibrillation Net Clinical Benefit = ( TE rate off warfarin TE rate on warfarin ) Weight X ( ICH rate on warfarin ICH rate off warfarin ) TE: Thromboembolic Events ICH: Intracranial Hemorrhages Rate: annual event rate % Warfarin effective if annual TE rate >/=1.5 Singer et al Ann Intern Med. 2009;151:297-305

164 patients after AF ablation - 9.1y follow-up - 7 pts with thromboembolism 13 pts with a history of TE prior to ablation (mean CHA2DS2-VASc score 3.2± 1.0) - 10 in SR - One patient had a TE during late FU (without evidence of arrhythmia recurrence) FU: 9.5 years Mean=3.1 Annual TE rate 0.41% Annual death rate 0.58% In a multivariate logistic model including hypertension, structural heart disease, dyslipidemia, CHA2DS2-VASc 2, and amiodarone, the only characteristics that remained significant were CHA2DS2-VASc 2 (OR = 2.67 [1.14; 6.25],P = 0.023) and amiodarone (OR = 4.62 [1.85;11.58], P = 0.001) Tran et al. PACE 2015; 38:499 506

801 patients pairs propensity matched 15 demographic and clinical characteristics and baseline medication use Reynolds et al. Circ Cardiovasc Qual Outcomes 2012;5:171-181

114 pts underwent AF ablation Follow-up: 7-day Holter before, right after ablation, and at 3, 6, and 12 months Higher incidence of asymptomatic episodes after catheter ablation Symptom based follow-up would overestimate the success rate Hindricks et al. Circulation 2005;112:307-313

86 pts (PM recipients) underwent ablation for symptomatic AF 32% n=21 19 few and short (<60sec) Only 2(3%) of asymptomatic pts had long duration episodes Verma et al. J Cardiovasc Electrophysiol 2007;18:601-606

Healey et al. NEJM 2012;366:120-9

2179 patients who underwent a first ablation procedure for AF Both the CHADS2 and CHA2DS2-VASc scores were excellent in stratifying patients for 5-year outcomes after AF ablation Jacobs et al. Heart Rhythm 2015;12:681-686

Trials comparing Rate Control vs Rhythm control in AF Wyse et al. NEJM 2002;347:1825-33 Stelnberg et al. Circulation 2004;109:1973-80 Van Gelder et al. NEJM 2002;347:1834-40 Hohnloser et al. Lancet 2000;356:1789-94 Carlsson et al. JACC 2003;41:1690-6 Roy et al. NEJM 2008;358:2667 77

AFFIRM Trial: Rhythm vs Rate Control Cumulative mortality from any cause in the rhythm-control group and the rate-control group AAD Efficacy Rhythm Control: 62% Rate Control: 35% Cross-over: Rhythm Rate: 37,5% Rate Rhythm: 14,9% Oral Anticoagulation: Rate: 85% Rhythm: 70% Wyse et al. NEJM 2002;347:1825-33

AFFIRM: Independent predictors of survival (On treatment analysis) The risks of AADs counterbalance the benefits of sinus rhythm Corley et al. Circulation 2004;109:1509-13

Can Ablation Prevent the Excess Mortality of Atrial Fibrillation? Cause Cause AF or AF Death Death

Can Ablation Prevent the Excess Mortality of Atrial Fibrillation? Cause Cause Cause or or AF AF Death AF Death Death

Can Ablation Prevent the Excess Mortality of Atrial Fibrillation? Cause Cause Cause or or AF AF Death AF Death Death

Can Ablation Prevent the Excess Mortality of Atrial Fibrillation? Cause Cause Cause or or AF AF Death AF Death Death

Can Ablation Prevent the Excess Mortality of Atrial Fibrillation? Cause Cause Cause or or AF AF Death AF Death Death

ATHENA Trial (post hoc analysis): Dronedarone reduces the risk of stroke Dronedarone reduced the risk of stroke from 1.8% per year to 1.2% per year The effect was similar whether or not patients receiving oral anticoagulant therapy, Significantly greater effect in patients with higher CHADS2 scores. Connolly et al. Circulation 2009;120:1174-1180

it's the sinus rhythm, stupid!

Can Ablation Affect Mortality? A Meta-analysis of 8 Randomized Trials Author/study Publication year Randomized patients Age (y) Deaths Follow-up (mo) Type of AF Quality score Ablation arm AAD arm Ablation arm AAD arm A4 14 2008 112 50 ± 11 52 ± 11 0 2 12 Paroxysmal 2 APAF 12 2006 198 55 ± 10 57 ± 10 0 0 12 Paroxysmal 2 Oral et al 11 2006 146 55 ± 9 58 ± 8 1 0 12 Chronic 3 Forleo et al 15 2009 70 63 ± 9 65 ± 7 0 0 12 Paroxysmal and persistent Stabile et al 13 2006 137 62 ± 9 62 ± 11 1 2 12 Paroxysmal and persistent Wazni et al 10 2005 70 53 ± 8 54 ± 8 0 0 12 Paroxysmal and persistent Krittayaphong 2003 30 55 ± 11 49 ± 15 0 0 12 Paroxysmal and et al 16 persistent 3 3 3 1 ThermoCool 2008 167 56 ± 9 56 ± 13 1 0 9 Paroxysmal 2 AF [17] and [18] Dagres et al. Am Heart J. 2009;158:15-20

Can Ablation Affect Mortality? A Meta-analysis of 8 Randomized Trials Dagres et al. Am Heart J. 2009;158:15-20

Real World Data 4,212 AF ablation pts compared to 16,848 age/gender matched controls with AF (no ablation) and 16,848 age/gender matched controls without AF Bunch et al. J Cardiovasc Electrophysiol 2011;22:839-845

Real World Data 4,212 AF ablation pts compared to 16,848 age/gender matched controls with AF (no ablation) and 16,848 age/gender matched controls without AF Bunch et al. J Cardiovasc Electrophysiol 2011;22:839-845

Real World Data 4,212 AF ablation pts compared to 16,848 age/gender matched controls with AF (no ablation) and 16,848 age/gender matched controls without AF Bunch et al. Heart Rhythm2013;10:1272 1277

Real World Data 4,212 AF ablation pts compared to 16,848 age/gender matched controls with AF (no ablation) and 16,848 age/gender matched controls without AF Bunch et al. Heart Rhythm2013;10:1272 1277

Real World Data 4,212 AF ablation pts compared to 16,848 age/gender matched controls with AF (no ablation) and 16,848 age/gender matched controls without AF Bunch et al. Heart Rhythm2013;10:1272 1277

Real World Data 4,212 AF ablation pts compared to 16,848 age/gender matched controls with AF (no ablation) and 16,848 age/gender matched controls without AF Bunch et al. Heart Rhythm2013;10:1272 1277

AF - CHF Trial 1376 pts (123 sites, 10 countries) with LVEF 35% and recent AF Rhythm Control: antiarrhythmic drugs (amiodarone 82%), cardioversions intended to maintain sinus rhythm Rate Control: b-blockers, digoxin to control ventricular rate ACE inhibition, ß-blockers, and warfarin (> 90%) Mean follow-up: 37 months Roy et al. NEJM 2008;358:2667 77

AF - CHF Trial 1376 pts (123 sites, 10 countries) with LVEF 35% and recent AF Rhythm Control: antiarrhythmic drugs (amiodarone 82%), cardioversions intended to maintain sinus rhythm Rate Control: b-blockers, digoxin to control ventricular rate ACE inhibition, ß-blockers, and warfarin (> 90%) Mean follow-up: 37 months Roy et al. NEJM 2008;358:2667 77

AF - CHF Trial Roy et al. NEJM 2008;358:2667 77

AF-CHF trial: The presence of SR is not associated with better outcomes in patients with AF and CHF (On treatment analysis) Is AF only a marker of more advanced disease? Talajic et al. JACC 2010;55:1796 802

Dilated Cardiomyopathy, EF: 25-30%

Περιμετρική κατάλυση ΠΦ και δημιουργία γραμμών στον αριστερό κόλπο Απομόνωση ΠΦ και γραμμές στο οπίσθιο τοίχωμα Γραμμή αριστερού ισθμού Απομόνωση του αριστερού ωτίου Γραμμές στο ανώτερο και κατώτερο μεσοκολπικό Γραμμή παράλληλα στον κατώτερο ΜΔ

8 years in SR Before Ablation 3 m After Ablation

CASTLE-AF Trial Catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation 420 patients for a minimum of 3 years Follow-up Randomization: Catheter ablation vs conventional treatment Inclusion Criteria: Symptomatic paroxysmal or persistent AF / Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs LVEF 35% / NYHA II ICD for primary or secondary prevention with atrial sensing capabilities or CRT-D device, both with Home Monitoring technology already implanted Patient is willing and able to comply with the protocol and has written informed consent Age >= 18 years Primary endpoint: composite of all-cause mortality or worsening of heart failure Secondary endpoints: all-cause mortality, cardiovascular mortality, cerebrovascular accidents, worsening of heart failure requiring unplanned hospitalization, all-cause hospitalization, quality of life, number of therapies (shock and antitachycardia pacing) delivered by the ICD, time to first ICD therapy, number of device-detected VT-VF, AF burden, left ventricular function, percentage of RV pacing. Study Start Date: January 2008 Estimated Study Completion Date: August 2016 Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure) Sponsor: Biotronik SE & Co. KG Marrouche et al. PACE 2009;32:987-94 http://clinicaltrials.gov/ct2/show/nct00643188?term=castle+af&rank=1

CABANA TRIAL Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial 3000 patients will be randomized in a 1:1 ratio to treatment with the strategy of catheter ablation vs. that of state-of-the-art drug therapy for either rate or rhythm control. 3 yrs of enrollment Inclusion Criteria: documented AF episodes 1 hour in duration; with 2 episodes over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week 65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure, Prior stroke or TIA, LA size 5.0 cm (or volume index 40 cc/m2), or EF 35. Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify Study Start Date: August 2009 Estimated Study Completion Date: September 2015 http://clinicaltrials.gov/ct2/show/nct00911508?term=cabana&rank=1

CABANA TRIAL Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial Primary Endpoint and Objective Mortality Secondary Endpoints and Objectives A composite endpoint consisting of total cardiovascular mortality, disabling stroke, cardiac arrest, or heart failure hospitalization Cardiovascular death Disabling stroke Arrhythmic death and cardiac arrest Heart failure death and hospitalization Life threatening complications from therapy Time to clinical AF recurrence AF burden Medical costs and medical resource utilization Quality of Life Study Start Date: August 2009 Estimated Study Completion Date: September 2015 http://clinicaltrials.gov/ct2/show/nct00911508?term=cabana&rank=1

Συμπεράσματα Οι ασθενείς μετά από κατάλυση κολπικής μαρμαρυγής παρουσιάζουν μικρότερη της αναμενόμενης επίπτωσης ΑΕΕ Σε συγκρίσεις μη τυχαιοποιημένων αλλά ισοσταθμισμένων πληθυσμών η κατάλυση αποδεικνύεται καλύτερη από την συντηρητική θεραπεία σε βαρύνοντες κλινικούς στόχους (θνητότητα, θρομβοεμβολικά επεισόδια) Εάν αυτό είναι αποτέλεσμα πραγματικά θετικής επιδράσεως ή οφείλεται στα πλαίσια στρεβλώσεων είναι άγνωστο. Γι' αυτό και μέχρι να υπάρξουν σαφή δεδομένα, συστήνεται η χορήγηση αντιπηκτικής αγωγής ανάλογα με το CHA 2 DS 2 -VAScσκορ και ανεξαρτήτως της επιτυχίας της επέμβασης. Είναι δύσκολο να υπάρξει τυχαιοποιημένη μελέτη με ξεκάθαρα αποτελέσματα γιατί είναι αναμενόμενο ένα μεγάλο ποσοστό μεταπήδησης συμπτωματικών ασθενών από την ομάδα της φαρμακευτικής αγωγής στην ομάδα του Ablation. Είναι σαφές ότι υπάρχει ανάγκη δεδομένων από τυχαιοποιημένη μελέτη που θα εκτιμήσει την αναγκαιότητα αντιπηκτικής αγωγής μετά από κατάλυση κολπικής μαρμαρυγής.

Τουλάχιστον θα μπορέσω να κόψω τα αντιπηκτικά; Πρέπει να πω την κασέτα για τα CHA2DS2-VASc

Τουλάχιστον θα μπορέσω να κόψω τα αντιπηκτικά; Τουλάχιστον ας του δώσω μια ελπίδα

Τουλάχιστον θα μπορέσω να κόψω τα αντιπηκτικά; άλλωστε το προσδόκιμο της καριέρας μου θα είναι μεγάλο

Τουλάχιστον θα μπορέσω να κόψω τα αντιπηκτικά; εκτός αν μειώσουν κι άλλο τα ΚΕΝ

Ευχαριστώ για την προσοχή σας!

Back-up Slides

Annual Stroke and Death Risk in AF Patients Drug Trial ROCKET AF 1 ARISTOTLE 2 ENGAGE AF 3 RE-LY 4 Rivaroxaban 20 mg vs. warfarin Apixaban 5 mg vs. warfarin Edoxaban 60 mg vs. warfarin Edoxaban 30 mg vs. warfarin Dabigatran 150 mg vs. warfarin Patients (n) 14264 18201 21105 18113 CHADS 2 (result) 2 (3.5) 1 (2.1) 2 (2.8) 0 (2.1) TTR (mean) 55% 62% 65% 64% Efficacy ITT ITT ITT ITT Stroke or systemic embolism in Warfarin (%/year) Stroke or systemic embolism in NOAC (%/year) HR; (95%CI) 0.88; 0.75-1.03; p for noninferiority<0.001, p for superiority p=0.12 All cause mortality 2.42%; 1.60% 1.80% 1.71% Dabigatran 110 mg vs. warfarin 2.12% 1.27% 1.57% 2.04% 1.11% 1.54 % 1.87% vs. 2.21%; 0.85; 0.70-1.02; p=0.073 0.79; 0.66-0.95; p=0.01 3.52% vs. 3.94% 0.89; 0.80-0.998; p=0.047 0.87; 0.73-1.04; p=0.08 3.99% vs. 4.35% 0.92; 0.83-1.01; p=0.08 1.13; 0.96-1.34; p=0.10 3.80% vs. 4.35%; 0.87; 0.79-0.96; p=0.006 0.65; 0.52-0.81; p<0.001 3.64% vs. 4.13%; 0.88; 0.77-1.00; p=0.051 0.90; 0.74-1.10; p=0.30 3.75% vs. 4.13%; 0.91; 0.80-1.03; p=0.13 1 Patel et al. NEJM 2011;365:883-891 2 Granger et al. NEJM 2011;365:981-92 3 Giugliano and Ruff et al. NEJM 2013;369:2093-2104 4 Connolly et al. NEJM 2009;361:1139-1151

Annual Stroke and Death Risk in AF Patients Drug Trial ROCKET AF 1 ARISTOTLE 2 ENGAGE AF 3 RE-LY 4 Rivaroxaban 20 mg vs. warfarin Apixaban 5 mg vs. warfarin Edoxaban 60 mg vs. warfarin Edoxaban 30 mg vs. warfarin Dabigatran 150 mg vs. warfarin Patients (n) 14264 18201 21105 18113 CHADS 2 (result) 2 (3.5) 1 (2.1) 2 (2.8) 0 (2.1) TTR (mean) 55% 62% 65% 64% Efficacy ITT ITT ITT ITT Stroke or systemic embolism in Warfarin (%/year) Stroke or systemic embolism in NOAC (%/year) HR; (95%CI) 0.88; 0.75-1.03; p for noninferiority<0.001, p for superiority p=0.12 All cause mortality 2.42%; 1.60% 1.80% 1.71% Dabigatran 110 mg vs. warfarin 2.12% 1.27% 1.57% 2.04% 1.11% 1.54 % 1.87% vs. 2.21%; 0.85; 0.70-1.02; p=0.073 0.79; 0.66-0.95; p=0.01 3.52% vs. 3.94% 0.89; 0.80-0.998; p=0.047 0.87; 0.73-1.04; p=0.08 3.99% vs. 4.35% 0.92; 0.83-1.01; p=0.08 1.13; 0.96-1.34; p=0.10 3.80% vs. 4.35%; 0.87; 0.79-0.96; p=0.006 0.65; 0.52-0.81; p<0.001 3.64% vs. 4.13%; 0.88; 0.77-1.00; p=0.051 0.90; 0.74-1.10; p=0.30 3.75% vs. 4.13%; 0.91; 0.80-1.03; p=0.13 1 Patel et al. NEJM 2011;365:883-891 2 Granger et al. NEJM 2011;365:981-92 3 Giugliano and Ruff et al. NEJM 2013;369:2093-2104 4 Connolly et al. NEJM 2009;361:1139-1151

Annual Stroke and Death Risk in AF Patients Drug Trial ROCKET AF 1 ARISTOTLE 2 ENGAGE AF 3 RE-LY 4 Rivaroxaban 20 mg vs. warfarin Apixaban 5 mg vs. warfarin Edoxaban 60 mg vs. warfarin Edoxaban 30 mg vs. warfarin Dabigatran 150 mg vs. warfarin Patients (n) 14264 18201 21105 18113 CHADS 2 (result) 2 (3.5) 1 (2.1) 2 (2.8) 0 (2.1) TTR (mean) 55% 62% 65% 64% Efficacy ITT ITT ITT ITT Stroke or systemic embolism in Warfarin (%/year) Stroke or systemic embolism in NOAC (%/year) HR; (95%CI) 0.88; 0.75-1.03; p for noninferiority<0.001, p for superiority p=0.12 All cause mortality 2.42%; 1.60% 1.80% 1.71% Dabigatran 110 mg vs. warfarin 2.12% 1.27% 1.57% 2.04% 1.11% 1.54 % 1.87% vs. 2.21%; 0.85; 0.70-1.02; p=0.073 0.79; 0.66-0.95; p=0.01 3.52% vs. 3.94% 0.89; 0.80-0.998; p=0.047 0.87; 0.73-1.04; p=0.08 3.99% vs. 4.35% 0.92; 0.83-1.01; p=0.08 1.13; 0.96-1.34; p=0.10 3.80% vs. 4.35%; 0.87; 0.79-0.96; p=0.006 0.65; 0.52-0.81; p<0.001 3.64% vs. 4.13%; 0.88; 0.77-1.00; p=0.051 0.90; 0.74-1.10; p=0.30 3.75% vs. 4.13%; 0.91; 0.80-1.03; p=0.13 1 Patel et al. NEJM 2011;365:883-891 2 Granger et al. NEJM 2011;365:981-92 3 Giugliano and Ruff et al. NEJM 2013;369:2093-2104 4 Connolly et al. NEJM 2009;361:1139-1151

N=50 pts RCT of persistent AF and EF<50% Optimal medical therapy for 1 month then randomized to continued rate control or ablation Ablation (n=26) Control (n=24) LVEF 31.8±7.7% 33.7±12.1% Co-diagnosis of AF & HF 15 pts 13 pts LVEF Plasma BNP 1.7±0.7 procedures per patient 4.7% Major complication rate (1 stroke and 1 tamponade) Hunter et al. Circ AE 2014;7:31-38

Univariate and Multivariate Logistic Regression Analysis for Strokes Univariate Multivariate Variable OR p Value Variable OR p Value Persistent vs. 1.34 0.40 Persistent vs. 1.02 0.98 paroxysmal AF paroxysmal AF Warfarin use 0.64 0.22 Warfarin use 0.58 0.14 Female vs. male 3.49 <0.001 Female vs. male Diabetes mellitus 0.58 0.38 Diabetes mellitus 3.11 0.003 0.43 0.21 Hypertension 1.44 0.32 Hypertension 1.35 0.51 Congestive heart failure 0.51 0.36 Congestive heart failure 0.36 0.19 Age >75 yrs 1.26 0.59 Age >75 yrs 1.18 0.58 LA remodeling stage 2.04 <0.001 LA remodeling stage Stage II (Q2) vs. I (Q1) 9.8 0.018 Stage III (Q3) vs. I 7.55 0.03 Stage IV (Q4) vs. I 23.4 <0.001 2.91 0.027 Daccarett et al JACC 2011;57:831-8

No OAC 66% 39% No Previous Stroke/TIA (Low Risk) Previous Stroke/TIA (High Risk) Low-risk-group n = 351 High-risk-group n = 80 CHA2DS2-VASc-Score 1.6 ± 1.2 4.2 ± 1.4 Thromboembolic events (stroke / TIA) 1(0.3%) 3(4.3 %) MI 0 1(1.4 %) Death 2 (0.6 %) 0 Major Bleeding 1(0.3%) 1(1.4%) modified from Nuhrich et al. Clin Res Cardiol 2015;104:463-470

Danish national patient registry Risk factors for stroke not associated with equal risk Olesen et al. BMJ 2011;342:d124

108 pts with prior stroke underwent AF ablation CHA2DS2-VASc score=4.1±1.4 AF free: 71 (66%) 55 (77%) off OAC TE in 2.2±1.3 (median 1.8)years of follow-up 0 AF recurrence 37 (34%)m 32 (86.5 %) on OAC TE 1 (A patient with a mechanical valve had a stroke despite OAC) Bleeding: 8.3 % on OAC / 0 % off OAC Winkle et al J Interv Card Electrophysiol 2013;38:147 153