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St Jan Hospital, Bruges EHRA Training Centre for Electrophysiology University Hospital Ghent Mattias Duytschaever, MD,PhD Brussels 5th of Sept 2013 Role.

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Presentation on theme: "St Jan Hospital, Bruges EHRA Training Centre for Electrophysiology University Hospital Ghent Mattias Duytschaever, MD,PhD Brussels 5th of Sept 2013 Role."— Presentation transcript:

1 St Jan Hospital, Bruges EHRA Training Centre for Electrophysiology University Hospital Ghent Mattias Duytschaever, MD,PhD Brussels 5th of Sept 2013 Role of novel oral anticoagulants in ablation of atrial fibrillation Brugada Syndrome Twenty Years of Scientific Progress

2 38y old, paroxysmal AF and PSVT Catheter ablation of AF

3 Robotic PVI Segmental PVICircumferential PVI Single Shot PVI Repeat PVI Cornerstone: A strategy of PV isolation and re-isolation Catheter ablation of AF

4 Worldwide Survey Updated Worldwide Survey Date of procedures Published No of patients Circ Circ Arr Major Complications (%) Stroke/TIA0.94 Tamponade Major Vascular PV stenosis – intervened Permanent phrenic nerve palsy Atrium-esophageal Fistulae-0.04 Death Incidence of peri-operative clinical stroke/TIA is 1% Catheter ablation of AF: Stroke/TIA

5 5 BIBE E 08/2011 air, gas, tissue, fat, blood,… Diffusion weighted Imaging (MRI) ACE (asymptomatic cerebral emboli) SCL (silent cerebral lesions) ACI (acute cerebral ischemia) ASE (acute silent emboli),… Incidence of peri-operative silent cerebral lesions Catheter ablation of AF: Stroke/TIA

6 6 BIBE E 08/2011 Irrigated-RF Cryoballoon 5.6 Silent Cerebral Lesions (% of patients) Gaita et al (1) PVAC Siklody et al (2) Siklody et al, JACC 2011;58: Gaita et al, JCE 2011;22: No overt neurological events 1 to 5 lesions/ patient Incidence of peri-operative silent cerebral lesions Catheter ablation of AF: Stroke/TIA

7  SCL are observed up to 47% after cardiac valve replacement Knipp et al, EJCTS 2004  SCL are observed up to 14% after irrigated-tip RF ablation Gaita et al, Circ 2010  No proven relation between SCL and stroke/congnitive dysfunction Kruis et al, SCVA 2010  Most SCL (up to 94%-100%) are transient Deneke et al, Heart Rhythm 2011 Rillig et al, Circ A&E 2011 Gaita et al, Circ 2010 How concerned should we be? Catheter ablation of AF: Stroke/TIA

8 Tissue: Thrombus at RF lesion Catheter: Char on RF catheter Sheath: Air or thrombus from sheaths Pre existing LA thrombus Iatrogenic embolus Catheter ablation of AF: Stroke/TIA Aetiology of clinical stroke/TIA (1%) Heart Rhythm Jun;4(6):

9 Cryothermal Lesion Khairy et al. Circulation 2003 Irrigated RF Lesion Packer at al (JACC 2013) Multi-centre Cryoballoon 2.2 % stroke Wilber et al (JAMA 2010) Multi-centre Irrigated RF 0,0% stroke Risk factors for peri-operative stroke/TIA Catheter ablation of AF: Stroke/TIA

10 39 strokes in 6454 pts (0.6%) CHADS 2 2 or more: ≈ 5-fold risk Di Biase et al, Circulation. 2010;121: Catheter ablation of AF: Stroke/TIA Risk factors for peri-operative stroke/TIA

11 Patient selection Strict peri and intra operative anti-coagulation Routine screening TEE? Meticulous de airing of sheaths Early heparinization before transseptal puncture Continuous flush with heparinzed saline Irrigated catheters, cryoballoon, … Minimal catheter time in LA Inspection of catheter if low power Delay electrical ardioversion? Avoid extensive substrate ablation (non-compliance)? How to avoid peri-operative stroke/TIA? Strategies

12 CHADS 0 Preserved EF% Man CHADS 1-2 Low EF% Female <65yrs CHADS ≥ yrs ≥75yrs Safety (%) Efficacy (%) Duytschaever et al, Indian Pacing and Electrophysiology Journal, 2012 Chao et al HR 2011 Chen et al JACC 2004 Zado et al, JCE 2008 Patient selection “Efficacy and safety go hand in hand”

13 Strict peri and intra operative anti-coagulation 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation Pre-procedural anticoagulation: The Consensus Statement does not specifically allude to this issue. The authors state however that the anticoagulation guidelines that pertain to cardioversion should be adhered to in patients presenting in AF. 1 Procedural anticoagulation: Heparin should be administered prior to or immediately following transseptal puncture during AF ablation procedures and adjusted to maintain an ACT of 300 to 400 seconds. Post-procedural anticoagulation: the Consensus Statement reemphasizes the role of post-procedural warfarin (for at least 2 months) in all patients regardless of CHADS. Real-life experience: “warfarin for a least 1 month before and after the procedure, with or without pre-operative bridging, in all patients” Calkins et al, Heart Rhythm ;9:

14 Month-1Day-1Day 0Day +1+1monthDay -10Day +10 ASAHH A simplified strategy in CHADS 0 or 1 patients with par/pers AF taking ASA (or no AC) at the time of procedural planning (n=214) Strict peri and intra operative anti-coagulation Duytschaever et al, Journal of Cardiovasc Electrophysiol. 2013;24: Stop ASA 11 days before the procedure 10 days of subcutaneous LMWH Last injection evening before procedure Heparin before transsept ACT>350s No TOE Protamine 24h of heparin 10 days of subcutaneous LMWH Restart ASA at D11 Injection of LMWH Heparin H Ablation Day 0

15 Strict peri and intra operative anti-coagulation Duytschaever et al, Journal of Cardiovasc Electrophysiol. 2013;24: A simplified strategy in CHADS 0 or 1 patients with par/pers AF taking ASA (or no AC) at the time of procedural planning

16 Duytschaever et al, Journal of Cardiovasc Electrophysiol. 2013;24: Stroke/TIA 0% Strict peri and intra operative anti-coagulation 0% (%) Tamponade (%) 1.4% Major vasc access (%) A simplified strategy in CHADS 0 or 1 patients with par/pers AF taking ASA (or no AC) at the time of procedural planning (n=214)

17 Strict peri and intra operative anti-coagulation 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation Pre-procedural anticoagulation: The Consensus Statement does not specifically allude to this issue. The authors state however that the anticoagulation guidelines that pertain to cardioversion should be adhered to in patients presenting in AF. 1 Procedural anticoagulation: Heparin should be administered prior to or immediately following transseptal puncture during AF ablation procedures and adjusted to maintain an ACT of 300 to 400 seconds. Post-procedural anticoagulation: the Consensus Statement reemphasizes the role of post-procedural warfarin (for at least 2 months) in all patients regardless of CHADS. Real-life experience: “warfarin for a least 1 month before and after the procedure, with or without pre-operative bridging, in all patients” Calkins et al, Heart Rhythm ;9:

18 Warfarin with bridgingUninterrupted warfarin (all INR>2) warfarinstop 3 days before LMWHbridging untill evening before TEEbefore procedure Heparinduring procedure LMWHevening of procedure warfarinevening of procedure Protamineend/before sheath pulled out uninterrupted - no TEE during procedure - evening of procedure end/before sheath pulled out In practice: warfarin before & after; bridging or uninterrupted Strict peri and intra operative anti-coagulation

19 Di Biase et al, Circulation. 2010;121: Preference for uninterrupted warfarin (case-controlled analysis) Strict peri and intra operative anti-coagulation Warfarin with bridging (irrigated RF) Uninterrupted warfarin (irrigated RF)

20 Di Biase et al, The COMPARE trial, LB session, HRS, Denver 2013 Strict peri and intra operative anti-coagulation The COMPARE trial Multi-centre prospective open-label, single-blind RCT n= 1584 pts with AF at risk for TE, undergoing AF ablation 1:1 RCT, uninterrupted warfarin (W) vs bridging with LMW heparin (B) TE: 0.25% (W) vs. 3.7%, (B) (p<0.001) Major bleeding: 0.38% (W) vs. 0.76%, (B) (N.S) Preference for uninterrupted warfarin (randomised-controlled trial)

21 Month-1Day-1Day 0Day +1+1monthDay -10Day +10 WARFH Practical application for uninterrupted Warfarin Strict peri and intra operative anti-coagulation Warfarin (INR >2.0) Last dose evening before the proecdure Heparin before transsept ACT>350s No TOE Protamine No heparin Restart warfarin evening of the procedure Dosage of warfarin of paticular interest Heparin H Ablation Day 0 All issues with VitK antagonists INR control is essential

22 22 BIBE E 08/2011 XIX IXa VIIIa Va II FibrinFibrinogen AT III Adapted from Weitz & Bates, J Thromb Haemost 2005 TF/VIIa Xa IIa thrombin Apixaban Edoxaban Rivaroxaban Ximelagatran Dabigatran ORAL “Direct thrombin” Inhibitors “Direct fXa” Inhibitors What about NOACs? Strict peri and intra operative anti-coagulation

23 23 BIBE E 08/2011 DabigatranApixaban Mechanismdirect thrombin inhibitor Bio-availiblity (%)6% Time to peak C (h) Rivaroxaban direct fXa inhibitor 60-80%50% 3h Half-life (h)12-17h5-13h9-14h Renal clearance (%)80% renal33% renal25% renal Prodrugyesno Common Dosage150 & 110mg bid20 mg od5 mg bid Food effectnoyesno What about NOACs? Strict peri and intra operative anti-coagulation Antidote

24 24 BIBE E 08/2011 Katsnelson, Circulation 2012 Dabi 110mgDabi 150mg Can we extropolate? And if so, what is the ideal “uninterrupted”scheme? Strict peri and intra operative anti-coagulation

25 What is the efficacy (TE events) and safety (incidence of bleeds) of peri- operative use of NOACs in the setting of catheter ablation of Afib?

26 Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Published strategies (dabigatran compared to warfarin) Wazni et al Lakireddy et al Nin et al *“Goal of these strategies: to minimise time spent with subtherapeutic anticoagulation without compromising bleeding risk” Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Last dose 0h [12h in between dosages] Maddox et al S/E of Strategies of ‟ uninterrupted” NOACs Last dose 12h [24h in between dosages] Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Morady et al Wazni et al Last dose 24h [36h in between dosages] Dosage of dabigatran of paticular interest Skipped dosage of dabigatran

27 Single centre, retrospective observational, non-randomised case controlled n= 191 pts undergoing AF ablation with peri procedural dabigatran 53% parox AF, CHADS 1.0±0.9 Control: n=572 uninterrupted warfarin (INR 2-3) Pre: >30days of D 150mg BD, last dose: 24h before Peri: UFH to target ACT of s (after TS) TEE in all (was negative in all, although last dose 24h), no protamine Post: 1st dose of Dabi 4 hours after vascular hemostasis (>3months) (no bridging) TE events: 0% (D) vs. 0% (W), NS Major bleeds: 2.1% (1% tamponade)(D) vs 2.1% (1% tamponade)(W), NS All pts with tamponade had uneventful recovery Kim and Morady et al, Heart Rhythm 2013;10: S/E of Strategies of ‟ uninterrupted” NOACs Last dose 24h before the procedure (Michigan experience)

28 S/E of Strategies of ‟ uninterrupted” NOACs Last dose 24h before the procedure (Michigan experience) Kim and Morady et al, Heart Rhythm 2013;10:

29 S/E of Strategies of ‟ uninterrupted” NOACs Last dose 24h before the procedure (Michigan experience) Kim and Morady et al, Heart Rhythm 2013;10:

30 Wazni et al, Circ EP 2013;6: Single centre, retrospective observational, non-randomised case controlled n= 344 pts undergoing AF ablation with peri procedural dabigatran ≈60% paroxysm AF, CHADS 0 40%, CHADS 1 40% CHADS 2 or more 20% Control: n=344 matched uninterrupted warfarin (INR 2-3) Pre: >30days of D 150mg BD, last dose: 24h to 12hbefore Peri: UFH to target ACT of s (before TS) (with protamine) TEE only if presenting in AF and low compliance to AC Post: 1st dose of D immediately after hemostasis (i.e. at the end of the procedure in the EP lab) TE events: 0,3% (D) vs. 0,3% (W), NS Major bleeds: 1.2% (D) (0.9% tamponade) vs 1.5% (W) (0.9% tamponade), NS All tamponades had uneventful recovery after protamine/ pericardiocentesis S/E of Strategies of ‟ uninterrupted” NOACs Last dose 24h before the procedure (Cleveland experience)

31 Wazni et al, Circ EP 2013;6: S/E of Strategies of ‟ uninterrupted” NOACs Last dose 24h before the procedure (Cleveland experience)

32 When held for approximately 24 hours before the procedure (with a restart early after vascular hemostasis), dabigatran appears to be as safe and effective as uninterrupted warfarin for periprocedural anticoagulation in patients undergoing catheter ablation for AF S/E of Strategies of ‟ uninterrupted” NOACs Last dose 24h before the procedure

33 Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Published strategies (dabigatran compared to warfarin) Wazni et al Lakireddy et al Nin et al *“Goal of these strategies: to minimise time spent with subtherapeutic anticoagulation without compromising bleeding risk” Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Last dose 0h [12h in between dosages] Maddox et al S/E of Strategies of ‟ uninterrupted” NOACs Last dose 12h [24h in between dosages] Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Morady et al Wazni et al Last dose 24h [36h in between dosages] Dosage of dabigatran of paticular interest Skipped dosage of dabigatran

34 Multi-centre (n=8) “prospective” observational, non-randomised case controlled n= 145 pts undergoing AF ablation with peri procedural dabigatran 57% par AF, CHADS 0 or 1 = 78% Control: 145 matched uninterrupted warfarin Pre: >30days of well-dosed D, last dose: 12h before Peri: UFH (starting before TSP) to ACT s (protamine N.R.) Post: D within 3 hours after hemostasis… TE events: 2.1% (3 strokes)(D) vs. 0%, (W) (NS) Major bleeds: 6% (9 tamponades)(D) vs 1% (2 tamponades)(W) (p=0.019) Lakkireddy et al, JACC 2012;59: Last dose 12h before the procedure (8-centre study) S/E of Strategies of ‟ uninterrupted” NOACs

35 Lakkireddy et al, JACC 2012;59: In patients undergoing AF ablation, warfarin is safer and more effective than periprocedural dabigatran Last dose 12h before the procedure (8-centre study) S/E of Strategies of ‟ uninterrupted” NOACs

36 Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Published strategies (dabigatran compared to warfarin) Wazni et al Lakireddy et al Nin et al *“Goal of these strategies: to minimise time spent with subtherapeutic anticoagulation without compromising bleeding risk” Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Last dose 0h [12h in between dosages] Maddox et al S/E of Strategies of ‟ uninterrupted” NOACs Last dose 12h [24h in between dosages] Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Morady et al Wazni et al Last dose 24h [36h in between dosages] Dosage of dabigatran of paticular interest Skipped dosage of dabigatran

37 Last dose 0h before the procedure (“true non-interrupted”) Maddox et al, JCE 2013;24: Single centre, retrospective observational, non-randomised case controlled n= 212 pts undergoing AF ablation with peri procedural dabigatran ≈60% parox AF, CHADS 0.9±0.9 Control group: n=251 uninterrupted warfarin (INR 2-3) Pre: >30days of D 150mg BD, last dose: morning of the procedure (0h) Peri: UFH to target ACT of > s (before or after TS) TEE in all before procedure, protamine to reverse Post: 1st dose of Dabi evening of the procedure (for >3months) (no bridging) TE events 0.4% (TIA) (D) vs. 0% (W) (NS) Bleeding: 0.9% (D) vs 2.3% (W) (NS) All bleedings could be managed conservatively (none receiving reversal agents) S/E of Strategies of ‟ uninterrupted” NOACs

38 Maddox et al, JCE 2013;24: “True uninterrupted dabigatran appears to be as safe and effective as uninterrupted warfarin for periprocedural anticoagulation in patients undergoing ablation of AF” Last dose 0h before the procedure (“true non-interrupted”) S/E of Strategies of ‟ uninterrupted” NOACs

39 In patients undergoing AF ablation with peri-procedural dabigatran, compared to uninterrupted warfarin, the TE event rate is… 0% (vs 0%, NS) (Kim et al) 0% (vs 0%, NS) (Kim et al) 0.3% (vs 0.3%, NS) (Wazni et al) 0.3% (vs 0.3%, NS) (Wazni et al) 2.1% (vs 0%, NS) (Lakkiredy et al) 2.1% (vs 0%, NS) (Lakkiredy et al) 0% (vs 2%, NS) (Nin et al) 0% (vs 2%, NS) (Nin et al) 0.4% ( vs 0%, NS) (Maddox et al) 0.4% ( vs 0%, NS) (Maddox et al) Efficacy S/E of Strategies of ‟ uninterrupted” NOACs dabigatran as effective as warfarin

40 Boveda et al, Heart 2013;July A meta-analysis of 15 studies on 1823 patients on dabigatran S/E of Strategies of ‟ uninterrupted” NOACs dabigatran as effective as warfarin

41 In patients undergoing AF ablation with peri-procedural dabigatran, compared to uninterrupted warfarin, the major bleed event rate is… 2.1% (vs 2.1%, NS) (Kim et al) 2.1% (vs 2.1%, NS) (Kim et al) 1.2% (vs 1.2%, NS) (Wazni et al) 1.2% (vs 1.2%, NS) (Wazni et al) 6% (vs 1%, p<.005) (Lakkiredy et al) 6% (vs 1%, p<.005) (Lakkiredy et al) - (-) (Nin et al) - (-) (Nin et al) 0.9% ( vs 2.3%, NS) (Maddox et al) 0.9% ( vs 2.3%, NS) (Maddox et al) Safety S/E of Strategies of ‟ uninterrupted” NOACs dabigatran as safe as warfarin

42 Boveda et al, Heart 2013;July S/E of Strategies of ‟ uninterrupted” NOACs A meta-analysis of 15 studies on 1823 patients on dabigatran dabigatran as safe as warfarin

43 In patients undergoing AF ablation with peri-procedural rivaroxaban, (not compared to warfarin) the TE event rate is… 0% (-)(San Diego)n=54 0% (-)(San Diego)n=54 1% (-)(San Francisco)n=120 1% (-)(San Francisco)n=120 0% ( vs 0%, NS)(Lakkireddy et al) n=157 vs 157 0% ( vs 0%, NS)(Lakkireddy et al) n=157 vs 157 0% (-)(Munich)n=170 0% (-)(Munich)n=170 0% (-)(Reddy et al)n=54 0% (-)(Reddy et al)n=54 Rivaroxaban seems effective (as uninterrupted warfarin) Preliminary and incomplete efficacy data on rivaroxaban Last dose 0h Last dose 72h Last dose 12h Last dose 24h Last dose 36h S/E of Strategies of ‟ uninterrupted” NOACs

44 S/E of Strategies of ‟ uninterrupted” Riva In patients undergoing AF ablation with peri-procedural rivaroxaban, (not compared to warfarin), the major bleed rate is… N.R. (-)(San Diego)n=54 N.R. (-)(San Diego)n=54 N.R. (-)(San Francisco)n=120 N.R. (-)(San Francisco)n= % ( vs 2.5%, NS)(Lakkireddy et al) n=157 vs % ( vs 2.5%, NS)(Lakkireddy et al) n=157 vs 157 0% (-)(Munich)n=170 0% (-)(Munich)n=170 2% (-)(Reddy et al)n=54 2% (-)(Reddy et al)n=54 Rivaroxaban seems safe (as uninterrupted warfarin) Preliminary and incomplete safety data on rivaroxaban Last dose 0h Last dose 72h Last dose 12h Last dose 24h Last dose 36h

45 Role of novel oral anticoagulants in ablation of atrial fibrillation In patients undergoing AF ablation, the overall peri-operative incidence of stroke/TIA is 0.5 to 1% (≈CHADS score) Among a variety of preventive measures, strict peri and intra operative anticoagulation is essential In AF patients with no indication for routine anticoagulation, a short and simplified AC strategy with LMWH seems safe and effective Uninterrupted warfarin should be preferred over warfarin with bridging (COMPARE trial) When held for approximately 24 to 0 hours before the procedure (with a restart early after vascular hemostasis), dabigatran appears to be as safe and effective as uninterrupted warfarin These results appear to apply for FXa inhibitors as well

46 However …before updating the guidelines (or changing your routine), one shoud realize the limitations of the aforementioned studies All studies are underpowered (low event rate) All case controlled (not randomised) Applicable to specific patients What if warfarin before? What is ASA or no AC before? Role of novel oral anticoagulants in ablation of atrial fibrillation

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48 How to avoid peri-operative stroke/TIA? …. Stefansdottir et al, Stroke 2013;44:

49 Brain volume (% of total intracranial volume) 71.0 No AF Stefansdottir et al, Stroke 2013;44: Parx AFPers/perm AF How to avoid peri-operative stroke/TIA? AF has already a negative effect on the brain (independent of cerebral infarcts)

50 Brain volume (% of total intracranial volume) 71.0 No AF Stefansdottir et al, Stroke 2013;44: Parx AFPers/perm AF How to avoid peri-operative stroke/TIA? AF has already a negative effect on the brain (independent of cerebral infarcts)

51 No data so far on the effect of different dosages Check your own possible confounding factors: protamine, UFH before TS? Operator? TEE before leading to non-ablation? TEE during? Ablation strategy? Energy? antFXa activity if it could be measured? AF at presentation? Cardioversion? Time to and dose to therapueitc ACT is longer inn D vs W? single groin vs double groin centres? French size? What if antidote is availbale fXa inhibitors Considerations Are we there yet?

52 Any true RCTs in large sample size(in conrast to case controll, …in contarts to meta analyis cumlating all pts): is this feasible Larger Sample size: thousands of subjects need to be recruited to assess the frequency of rare complications like stroke/TIA and bleeding Control arm: uninterrupted warfarin? Dedicated apixaban trial is undergoing How to buidl up evidence? Wanted? Realistic? Are we there yet?

53 Heidbuchel et al, EHJ 2013;34: With the limited data available, if a strategy of bridging and restarting of anrticoagulation is chosen and appropriately excecuted, NOACS seem to allow such On the othe rhand a too aggressively shortened peri- procedural cessation of NOACs and/or no bridging may be less safe when compared to unintterrupted warfarin both concerning bleeding and carioembolic complications Change the respective guidlienes…. Are we there yet?

54 Single-centre retrospective observational, non-controlled n= 123 pts consistently started with D after AF ablation 54% prior ECV, CHADS 1.2+/-1.0… Control: no control arm Pre: 45% warfarin (with bridge to LMWH), 27.6% dabi, 21.1% ASA, 5.7% no, (if DABI than last dose 36h to 60h before) Peri: UFH to target ACT 225, at the end enoxa 0.5mg/kg Post: ° 2nd injection of enoxa 0.5mg/kg 12h later (bridging) ° 1st dabigatran at 22h postablation (start or restart) TE: 0% (uncontrolled)- Bleeding: 0% (uncontrolled) Winkle et al, JCE 2012;23: Californian single-centre experience on dabigatran Remaining Q: What if on Warfarin before?

55 Winkle et al, JCE 2012;23: What if warfarin before? Californian single-centre experience on dabigatran Remaining Q: What if on Warfarin before?

56 <48 hours CHADS- No OAC Cardioversion Acute Anticoagulation (Pericardioversion) Practical flowchart CHADS+ Long-term OAC >48 hours or unknown CHADS-CHADS+ Heparin/LMWHHeparin till INR 4 weeks of OACLong-term OAC INR- or TOE-guided Cardioversion INR- or TOE-guided CHADS + = CHADS 2 score ≥1 CHA 2 DS 2 VASc score ≥ 2 From 5.6% stroke (Bjerkelund et al 1969) to 0.5%

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59 Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Lakireddy et al Winkle et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 ASA or Bridged W or DABIGATRAN HDABIGATRAN Kim et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Duytschaev er et al (Michigan+ Heparin) Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH H Published 2012 strategies (dabigatran) (in every respected journal) ″Uninterrupted NOAC″ H

60 Pre: dabiagtran last dose vening before Peri: Heparin Post: ° Heparine untill next day 16h ° 1st dabigatran next day 20h Bruges Dabiagtran in bruges ″Uninterrupted NOAC″

61 Calkins et al; Circ Arrhythmia Electrophysiol. 2009;2: Safety of Catheter Ablation for AF A Comparison of Non Comparative Trials

62 Dagres et al, JCE 2009 Major complications were defined as the ones that were life threatening, caused permanent harm, and required intervention or prolonged hospitalization. Thirty-nine (3.9%) major periprocedural complications were observed. Role of Operator Experience and Patient Profile Risk factors for Stroke/TIA in AF Ablation

63 Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Lakireddy et al Winkle et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 ASA or Bridged W or DABIGATRAN HDABIGATRAN Kim et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH “Controlled” and non-cntrolled dabiagtarn only data in every respected journal “Uninterrupted” NOAC peri-AF ablation Nin et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRAN H

64 Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Lakireddy et al Winkle et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 ASA or Bridged W or DABIGATRAN HDABIGATRAN Kim et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Published 2012 strategies (dabigatran) (in every respected journal) Nin et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRAN H Pushy Ultrasfe Safe “Uninterrupted” NOAC peri-AF ablation

65 Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Lakireddy et al Winkle et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 ASA or Bridged W or DABIGATRAN HDABIGATRAN Kim et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRANH Published 2012 strategies (dabigatran) (in every respected journal) Nin et al Month-1Day-1Day 0Day +1+1monthDay -10Day +10 DABIGATRAN H Pushy Ultrasfe Safe “Uninterrupted” NOAC peri-AF ablation

66 Haines et al, JICE 2013;june Multi centre, retrospective observational, non-randomised case controlled n= 202 pts undergoing AF ablation with peri procedural dabigatran ≈55% paroxysm AF, CHADS 0 40%, CHADS 1 40% CHADS 2 or more 20% Control: n=202 uninterrupted warfarin (INR 2-3) Pre: a mess Peri: UFH to target ACT of s (before TS) (with protamine) TEE only if presenting in AF and low compliance to AC Post: 1st dose of D 12+/-10h after procedure TE events: 2/202% (D) vs. 0% (W) (NS) Major bleeds: 5/202% (D) vs 3/202% (W) (NS) When held for approximately 24 to 12 hours before the procedure and …. after vascular hemostasis, dabigatran appears to be as safe and effective as uninterrupted warfarin for periprocedural anticoagulation in patients undergoing RFA of AF. S/E of Strategies of ‟ uninterrupted” NOACs A Mess study/ Multicentre/ No Clear protocol

67 What if bleed? No reversal agnets needed I guess because slast dose 24h Look at case reportAC monitoring could become usefull “Uninterrupted” NOAC peri-AF ablation


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