Procédures d’Ablation et NACO Dr Walid AMARA GHI Le Raincy-Montfermeil Relations d’intérêt: Boehringer Ingelheim, BMS, Pfizer, Bayer : Honoraires pour présentations Sorin, Medtronic, St. Jude, Biotronik, Boston Scientific : Subventions de recherche
Classical Approach to Surg/Ablation in AF Pts • Warfarin should be interrupted 5 d before surgery • VKA resumed at the maintenance dose D1 or 2 after surgery ESC Guidelines for AF. Europace (2010) 12, 1360–1420 Knight B. J. Am. Coll. Cardiol. 2012;59;1175-1177 Periprocedural Heparin Bridging in VKA Pts • 34 studies; >12000 Pts • OR for bleeding = 2,26 with low dose LMWH compared to non bridged pts • With similar TE risk Siegal D et Al. Circulation 2012;126:1630-1639
Periprocedural Complications of AF RFCA of under Therapeutic Warfarin Reduces : Evidence from a Meta-Analysis • Review of evidence on the impact of Ctd W compared with Disctd W on periprocedural complications of AF RFCA • 27 402 pts included (6400 undergoing ablation with CW) • Decrease of TE compl. (OR= 0.10; P<0.001) and min bleeding (OR, 0.38; P<0.002) compared with DW. • No increased risk of major bleeding (OR, 0.67; P=0.30), including cardiac tamponade (OR, 0.69; P=0.57). Santangeli P et Al. Circ Arrhythm Electrophysiol. 2012;5:302-311
Concerns for Periablation Management with new OAC 1. Prolonged drug effect in renal insufficiency 2. Limited experience with clinical laboratory testing to confirm lack of residual anticoagulant effect 3. Lack of a reversal agent
Dabigatran vs Warfarin Results From RE-LY Trial • Bleeding from 7 d before-30 d after invasive procedures (PM/ ICD, dental, diagnostic proc, cataract, colonoscopy, joint replacement) • 4591 pts ≥ 1 procedure – 24.7% D 110 mg – 25.4% D 150 mg – 25.9% W • D last dose 49 (35– 85) h • W last dose given 114 (87–144) h • In case of urgent surgery D 110 D 150 W 17.8% 17.7% 21.6% Major bleeding Healey JS et Al. Circulation. 2012;126:343-348
Outcomes After Cardioversion and Ablation in the ROCKET AF Trial • 14,264 pts; FU=2.1 y; 143 pts ECV, 142 PCV, and 79 AFAbl • In both groups similar outcomes – Stroke/systemic embolism (R:1.88% vs. W:1.86%) – Death (R:1.88% vs. W:3.73 %) . Piccini JP et Al. J Am Coll Cardiol 2013;61:1998–2006
Dabigatran Immediately After AF Ablation 45% 28% 27% • 123* pts started on D after AF abl. – PAF in 26 (21%) – Pers in 81 (66%) – LSPers in 16 (13%) • No pre or per procedural TE episodes or bleeding • No postablation strokes, TIA, or systemic TE * Later expanded to 500 pts with identical results Dabigatran is safe and well tolerated after AF ablation. Winckle RA et Al. J Cardiovasc Electrophysiol 2012, 23, 264-268
Periprocedural D Versus W in AF RFCA Pts • Multicenter (8), observational registry of AF ablation • 290 pts (145 D vs 145 pts with ctd periprocedural W; INR 2-3,5 ) • D Hold dose of morning of procedure • D resumed 3h after hemostasis • Independent predictor of bleeding or TE complications – Dabigatran use (OR: 2.76; p =0.01) Lakkireddy D et Al. – Age >75 (OR: 2,34; p=0.046) J Am Coll Cardiol 2012;59: 1168–74
Periprocedural Dabi in AF RFCA • 156 similar pts post AA RFCA : D (31) and W (125) • Bleeding complications from h 48 to week 1 Bleeding-related complications similar for W and D D associated with more procedural variability in ACT than W Snipelisky D et Al. J Interv Card Electrophysiol 2012 Aug 7 D possible alternative to W
2012 focused update of the ESC Guidelines for the management of atrial fibrillation Periprocedural Ablation • No controlled data on risk– benefit profile on uninterrupted NOACs but known risk for bleeding events when switching or bridging of anticoagulants. • Data from a limited case series suggest that appropriate post- ablation management with dabigatran is associated with a low risk of embolic or bleeding complications, although brief interruption of D use is associated with more TE and bleeding complications Camm AJ et al. Eur Heart J doi:10.1093/eurheartj/ehs253
Dabigatran and Rivaroxaban Surgery or Programmed Interventions • Following attitude is proposed – Low hemorrhagic risk » stop 24 h before procedure » resume 24 h later – Moderate/high hemorrhagic risk » Stop at D-5 » resumption as a function of the procedure – Non programmed surgery/procedure » Maximize delay as much as possible AFSSAPS April 2012
When to stop the NOACs ? • Procedure can be performed at trough NOAC concentration (i.e. 12 or 24 h after last intake) • Discontinue NOACs 24 h before elective procedure in pts with n al kidney function • If procedures that carry a ‘risk for major bleeding’, it is recommended to take the last NOAC 48 h before. Heidbuchel H et Al. Europace (2013) 15, 625–651
When to stop the NOACs ? • Procedure can be performed at trough NOAC concentration (i.e. 12 or 24 h after last intake) • Discontinue NOACs 24 h before elective procedure in pts with n al kidney function • If procedures that carry a ‘risk for major bleeding’, it is recommended to take the last NOAC 48 h before. Heidbuchel H et Al. Europace (2013) 15, 625–651
When to stop the NOACs ? • Procedure can be performed at trough NOAC concentration (i.e. 12 or 24 h after last intake) • Discontinue NOACs 24 h Torn M, Rosendaal FR. Oral before elective procedure in anticoagulation in surgical pts with n al kidney function procedures: risks and recommendations. Br J Haematol 2003;123:676–82 • If procedures that carry a ‘risk for major bleeding’, it is recommended to take the last NOAC 48 h before. Heidbuchel H et Al. Europace (2013) 15, 625–651
When to stop the NOACs ? • Procedure can be performed at trough NOAC concentration (i.e. 12 or 24 h after last intake) • Discontinue NOACs 24 h before elective procedure in Torn M, Rosendaal FR. Oral anticoagulation in surgical patients with a normal kidney procedures: risks and function recommendations. Br J Haematol 2003;123:676–82 • If procedures that carry a ‘risk for major bleeding’, it is recommended to take the last NOAC 48 h before. Heidbuchel H et Al. Europace (2013) 15, 625–651
When to stop the NOACs ? Heidbuchel H et Al. Europace (2013) 15, 625–651
Truly uninterrupted Dabi vs W in AF RFCA • 212 pts in D and 251 in W group (both well matched) • Patients instructed to take their morning D before Abl • PVI in PAF, + substrate modification in Pers AF • ACT for > 400 s (441 pts) or > 350 s (22 pts) Maddox W et Al. doi: 10.1111/jce.12143
Uninterrupted Rivaroxaban in AF RFCA • Single center retrospective analysis of 54 pts (61y; CHADS 2= .9) • Ctd Rivaroxaban; 10% Addal Aspirin or Clopidogrel • Stoke, TIA, Peric eff = 0 Bleeding rates comparable to W • 2/54: femoral hematoma Bockstall K et Al. HRS 13 Abst (PO06-85) • Multicenter, prospective study of R held day before to 6 h after hemostasis in 314 pts with AF ablation (157 in each group) • Age = 62 ±9 y; 62% females and 62% PAF; • Major bleeding in 3 R (1.9%) and 4 W (2.5%) pts (p =1.0). • Minor bleeding in 12 R (7.6%) and 14 W (8.9%) (p =0.682). • 1 TIA in each group (p =1.0). No periprocedural stroke/death R (dose held on the day of procedure) appears to be equally safe and effective when compared to uninterrupted W. Lakkireddy D et Al. HRS 13 Abst (AB33-01)
NOACs in a Real-World Cohort of Pts Undergoing AFCA • Prospective study of 259 AFCA pts; NOACs for ≥ 3 m post-CA • 54 pts (21%) on NOACs before CA – Last D dose evening before the procedure. – Last R dose day before the procedure (morning) • Post ablation 38% D 110 mg, 56% 150 mg, and 6% R 20 mg. • 4 PP TE & major bleeding (1.5%), all wo NOACs prior to abl Eitel C et Al. doi:10.1093/europace/eut128
Ultrasound Guided Venous Puncture • Most peri ablation complication (pericardial effusion, groin hematomas, AV fistulas, and pseudoaneurysms) are related to technical factors, more than anticoagulation • 100 RFA & UGPV pts (67±12 y VKA=82, D=18) vs non ACoag 50 pts (19 EPS, 31 RFA) • Mean INR = 2,49 ± 0,54. • UGVP successful in all pts • One minor groin hematoma/ in Acoag (0.66%) Errahmouni A et Al; Submitted; let’s wait ! Read it, Do it and you’ll like it !
Conclusion Venture AF: Study Design • Randomized, open-label, active-controlled study • Objective: To explore the clinical utility of rivaroxaban 20 mg once daily in pts with non-valvular AF who undergo catheter ablation compared to uninterrupted VKA Study population: Rivaroxaban Catheter Rivaroxaban Primary Pts with Parox. or ablation 20 mg od 20 mg od endpoint: persistent non- procedure N~250 Incidence of valvular AF IV heparin ≥ 28 d 30±5 d major bleeding (target R 30 ± 5 d First ever ACT = 3–400s, follow-up after ablation catheter ablation 3-325 s 1:1 procedure for AF preferred) VKA VKA (INR (INR 2–3) 2–3) www.clinicaltrials.gov/NCT01729871
Conclusion • Données encourageantes concernant l’utilisation des NACO dans la FA et notamment en cas d’ablation • Manque de données quant à la gestion du traitement en péri- procédure
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