8/16/2016. Disclosures. Is Uninterrupted OAC Standard of Care for AF Ablation? CHRS 2016, San Francisco. Risk of Stroke Peri-Ablation

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1 Disclosures Is Uninterrupted OAC Standard of Care for AF Ablation? CHRS 2016, San Francisco Atul Verma, MD FRCPC FHRS Director, Heart Rhythm Program Southlake Regional Health Centre Newmarket, Ontario, Canada Chair, Heart Rhythm Working Group, Cardiovascular Care Network Associate Professor, University of Toronto Adjunct Professor, McGill University Moderate Support (research) Biosense Webster Bayer Inc Boehringer Ingelheim Medtronic Inc Advisory Board, Speakers fees Bayer Inc Biosense Webster Boehringer Ingelheim Medtronic Inc St Jude Medical Inc Risk of Stroke Peri-Ablation Peri-ablation thromboembolism is a risk Caused by combination of: Peri-procedural AF Ablation procedure causing atrial tissue disruption Ablation procedure causing atrial dysfunction Instrumentation of atrium causing thrombus Peri-ablation stroke risk is 0.5-2% (Cappato et al, Worldwide survey of AF ablation, 2010) Options for Reducing Stroke Risk Oral anticoagulation for minimum of 1 month pre-ablation Intraoperative anticoagulation with IV heparin to keep ACT > sec Post-operative oral anticoagulation for minimum of 3 months Pre-procedural transesophageal echocardiography to rule out LAA clot 1

2 Peri-procedural Anticoagulation Strategies Key Considerations Bridging strategy with VKA Continuous oral anticoagulation with VKA Minimally interrupted NOAC with no bridging Uninterrupted NOAC with no bridging Prevent thromboembolic events Minimize bleeding risk of procedure Procedure involves multiple venous access points Hematomas are most common complication (1-5%) Retroperitoneal, rectus bleeding can occur (1%) Pseudoaneurysm also a risk (1%) Be able to reverse life threatening bleeding Cardiac perforation causing tamponade occurs in 0.5-1% Urgent pericardial drainage required Urgent reversal of anticoagulation 7 Rationale for Uninterrupted OAC Concept really originated in days of VKA for OAC Cessation of OAC pre-ablation with VKA required: Stopping medication days in advance Bridging patients with LMWH for higher risk patients (persistent AF, CHADS score) Stopping LMWH pre-ablation Re-starting LMWH post-ablation along with VKA Bridging with LMWH until VKA therapeutic Bridging Strategy Was the most common technique Recommended by 2007/12 HRS Consensus Guideline on Oral VKA for one month pre-ablation VKA held 4 days in advance of ablation LMWH full dose is initiated 2 days pre-ablation No LMWH on morning of procedure Post-procedure, LMWH reinitiated in the evening Typically, half dose used to bridge out until INR therapeutic VKA restarted same day post-ablation in double dose x 2 days 2

3 Bridging Strategy Continuous VKA Group 1 = full dose bridge out Group 2 = half dose bridge out Wazni et al, Circulation 2007 Hussein et al, Heart Rhythm 2009 Continuous VKA Continuous VKA Group 1 = full dose bridge out Group 2 = half dose bridge out Group 3 = continuous VKA Wazni et al, Circulation 2007 Santagneli et al, Card Res Pract 2011 (report of 6454 patients) 3

4 13 14 COMPARE Trial DiBiase et al, Circulation 2014 COMPARE Trial Warfarin discontinuation = 1 mg/kg BID enox bridge in and 0.5 mg/kg BID bridge out COMPARE Trial COMPARE Trial RRR of continuous VKA vs interrupted warfarin group 4

5 Novel OACs Meta-Analysis NOACs for Dabigatran, Rivaroxaban, Apixaban, and Edoxaban are now approved for stroke prevention in AF Several potential advantages for peri-ablation management: No monitoring required No bridging required Offset and onset of action within 2-6 hours 23 = dabigatran 6 = rivaroxaban Most were minimally interrupted Vallakati et al, Cardiol Ther 2016 June Meta- Analysis NOACs for Composite endpoint of stroke, TIA, SE, and silent cerebral embolism Meta- Analysis NOACs for Composite endpoint of stroke, TIA, SE 5

6 21 22 Meta- Analysis NOACs for VENTURE AF Cappato et al, EHJ 2015 Randomized trial examining continuous OAC with rivaroxaban vs continuous OAC with warfarin Composite endpoint of bleeding events VENTURE AF VENTURE AF 6

7 26 RECIRCUIT Trial - Dabigatran Dabigatran 150 mg BID Patients with paroxysmal or persistent NVAF scheduled for catheter ablation, eligible for dabigatran 150 mg BID (n=652) R Warfarin (INR ) Primary endpoint: major bleeding Randomization between continuous apixaban and continuous VKA Target enrolment = 630 patients total Endpoint = Death, Stroke, Major Bleeding MRI sub-study to assess for silent cerebral emboli peri-ablation. Randomization (4 to 8 weeks before ablation) Day 0 (ablation) Day 30 follow-up Day 60 follow-up 7