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

Siegal D et Al. Circulation 2012;126:1630-1639

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

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)

Santangeli P et Al. Circ Arrhythm Electrophysiol. 2012;5:302-311

• 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).

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

Healey JS et Al. Circulation. 2012;126:343-348

D 110 D 150 W 17.8% 17.7% 21.6%

•  In case of urgent surgery Major bleeding

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

•  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

Winckle RA et Al. J Cardiovasc Electrophysiol 2012, 23, 264-268

Dabigatran is safe and well tolerated after AF ablation.

45% 28% 27%

* Later expanded to 500 pts with identical results

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

Lakkireddy D et Al. J Am Coll Cardiol 2012;59: 1168–74

•  Independent predictor of bleeding or TE complications – Dabigatran use (OR: 2.76; p =0.01) – Age >75 (OR: 2,34; p=0.046)

Periprocedural Dabi in AF RFCA •  156 similar pts post AA RFCA : D (31) and W (125) •  Bleeding complications from h 48 to week 1

Snipelisky D et Al. J Interv Card Electrophysiol 2012 Aug 7

Bleeding-related complications similar for W and D D associated with more procedural variability in ACT than W

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.

Camm AJ et al. Eur Heart J doi:10.1093/eurheartj/ehs253

•  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

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 ?

Heidbuchel H et Al. Europace (2013) 15, 625–651

•  Discontinue NOACs 24 h before elective procedure in pts with nal kidney function

•  Procedure can be performed at trough NOAC concentration (i.e. 12 or 24 h after last intake)

•  If procedures that carry a ‘risk for major bleeding’, it is recommended to take the last NOAC 48 h before.

When to stop the NOACs ?

•  Discontinue NOACs 24 h before elective procedure in pts with nal kidney function

•  Procedure can be performed at trough NOAC concentration (i.e. 12 or 24 h after last intake)

•  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 ?

•  Discontinue NOACs 24 h before elective procedure in pts with nal kidney function

•  Procedure can be performed at trough NOAC concentration (i.e. 12 or 24 h after last intake)

•  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

Torn M, Rosendaal FR. Oral anticoagulation in surgical procedures: risks and recommendations. Br J Haematol 2003;123:676–82

When to stop the NOACs ?

•  Discontinue NOACs 24 h before elective procedure in patients with a normal kidney function

•  Procedure can be performed at trough NOAC concentration (i.e. 12 or 24 h after last intake)

•  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

Torn M, Rosendaal FR. Oral anticoagulation in surgical procedures: risks and recommendations. Br J Haematol 2003;123:676–82

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

• Single center retrospective analysis of 54 pts (61y; CHADS 2= .9) • Ctd Rivaroxaban; 10% Addal Aspirin or Clopidogrel • Stoke, TIA, Peric eff = 0 • 2/54: femoral hematoma

Uninterrupted Rivaroxaban in AF RFCA

Bleeding rates comparable to W 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

Lakkireddy D et Al. HRS 13 Abst (AB33-01)

R (dose held on the day of procedure) appears to be equally safe and effective when compared to uninterrupted W.

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

Primary endpoint:

Incidence of major bleeding

30 ± 5 d after ablation

procedure

Catheter ablation

procedure IV heparin

(target ACT = 3–400s,

3-325 s preferred)

Study population: Pts with Parox. or

persistent non-valvular AF

First ever

catheter ablation for AF

30±5 d follow-up

Rivaroxaban 20 mg od

VKA (INR 2–3)

VKA (INR 2–3)

Rivaroxaban 20 mg od

≥ 28 d R

N~250

1:1

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