Procdures dAblation et NACO Dr Walid AMARA GHI Le - - PowerPoint PPT Presentation

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

• f 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

• r 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

• f 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