Left Atrial Appendage Closure and Cardiac Arrhythmia Manish

Left Atrial Appendage Closure and Cardiac Arrhythmia Manish Shah MD Program Director Cardiac Electrophysiology Training Med. Star Washington Hospital Center

Manish Shah, MD Disclosures Consultant: Boston Scientific Biosense Webster Speakers Bureau: Boston Scientific

Typical Management of Patients with Atrial Fibrillation CAN I STOP OAC? + Symptoms AAD + OAC Fail AAD No Afib Catheter Ablation + Afib REDO ABLATION

Atrial Fibrillation Ablation: Continued OAC Treatment Required • Post Afib ablation recurrence rates ~30%1 • CABANA TRIAL (RCT, N=2204) – Serious Stroke 0. 3% (Ablation) vs 0. 6% (Drug), P=0. 19 • Clinical Guidelines do not recommend stopping oral anticoagulation in CHA 2 Ds 2 -VASc score of 2 or greater 1 Palligaard JL et al. Eur Heart J 2018; 39: 442 -449

CHA 2 DS 2 VASc Score Predicts Events Post AF Ablation Intermountain Heart Study – USA cohort 2179 patients undergoing 1 st ablation procedure Jacobs V et al, Heart Rhythm 2015

CHA 2 DS 2 VASc Score Predicts Events After AF Ablation Several studies have shown that CHA 2 DS 2 VASc score still predicts stroke following AF ablation, although risk seems higher in those with documented recurrent AF

Catheter Ablation of Atrial Fibrillation N Engl J Med 2016; 374: 2235 -2245

LAA Electrical Isolation May Reduce AFIB 7 studies (2 RCT, Different Procedural Methods a. MAZE Study: RCT -> PVI vs PVI + Lariat N= 600 Lakireddy 2015: Prospective: Lariat f/b afib ablation Di Blasé 2016 – RCT -> LAAEI vs No LAAEI Panikker 2016 – prosp -> LAAEI Park 2016 – Retrospective Di Blasé 2010 Retrospective Romanov 2016 – RCT -> Surgical AF +/- LAAEI Lee 2014 – Retrospective -> MV surgery +/ Friedman et al. J Am Coll Cardiol EP 2018; 4: 112– 20

Meta- Analysis – Effectiveness of LAA Electrical Isolation in Reducing AT/AF Friedman et al. J Am Coll Cardiol EP 2018; 4: 112– 20

Increased Incidence of LAA Thrombus post LAA Electrical Isolation N = 50 patients undergoing LAA electrical isolation Post procedure OAC encouraged 2 patients suffered CVA/TIA 10/47 (21%) had LAA Thrombus Andreas Rillig, MD*; Roland R. Tilz, MD, FHRS* et al. Circ Arrhythm Electrophysiol. 2016; 9: e 003461

Ridge Edema – Consequence of RF ablation Will ablation energy modality and LAAC Type (disk vs plug) affect outcomes? Courtesy Dr. Karen Phillips

Concomitant Atrial Fibrillation and LAAC Reasons to Consider Advantages • Single Procedure and single transeptal puncture • For bleeder’s combined overlap of OAC (6 -12 weeks) • Patients with elevated CHADSVASC can then stop anticoagulant Reasons for Pause • Increased complications ? • Possibility ablation may affect LAAO results • Possibility LAAO may affect later redo ablations • Is LAAC as effective as DOAC?

Watchman LAAC Immediately After Radio Frequency Ablation edema Edema at LAA ridge more proximal than usual deployment for Watchman however would involve “landing zone” for Amulet Watchman Courtesy of Shep Doshi

Single Centre Series: PVI + LAAC Feasibility and Safety Studies Cohort Size LAAC Device Implant success Pericardial Tamponade Stroke Embolization Boersma 2012 Netherlands 30 Watchman 100% 0 1/30 (3%) Phillips 2015 Australia 98 Watchman 100% 0 0 Calvo 2015 Spain 35 Watchman 29, ACP 6 97% 3/35 (95%) 0 Romanov 2015 Russia 48 Watchman 87% 0 0

Effect of LAA Closure on AF/AT Recurrence • RCT of AF ablation vs AF Ablation + LAAC (N= 94) • Initial AF burden higher in LAAC arm (3 months) • No significant difference between groups for AF/ AT freedom at 24 months (66% vs. 60%) Romanovv A. JICE 2015

Feasibility and Safety: Multi-Center Registry • 139 patients AF abl + Watchman implant procedure 2013 - 2015 • 10 centres – Europe, Russia, Middle East, Australia • High volume AF proceduralists ≥ 50 AF abl / year • Ablation modality included irrigated RF and cryoballoon Karen P. Phillips et al Europace 2017 0, 1 -7

Multicentre Registry Procedural Success • Following ablation 100% Watchman implant success (139 patients) • Satisfactory occlusion 100% / complete occlusion 97% • Post procedure 38% on warfarin, 55% NOAC, 6% dual antiplatelet Karen P. Phillips et al Europace 2017 0, 1 -7

Periprocedural Complications Multicentre Registry Pericardial Stroke Device tamponade embolization 1/139 (0. 7%) 0 0 Coronary Air Embolism 1/139 (0. 7%) Hypotension Vascular access 1/139 (0. 7%) • 7 day device or procedure related SAE rate 0. 7% • 30 day device or procedure related SAE rate 1. 4% 0

Multicentre Registry Combined AF Ablation + Watchman Implant Conclusions • Combined procedure is feasible • Excellent safety in hands of high volume proceduralists • Long term outcomes on stroke / mortality still awaited

Typical Management of Patients with Atrial Fibrillation √ Minimal Complications √ Feasibility + Symptoms AAD + OAC Fail AAD Should I Stop OAC? LAAC + No Afib Catheter Ablation + Afib REDO ABLATION

OPTION Trial To determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following catheter ablation for patients with NVAF. Approximately 1600 subjects at 130 sites world-wide Randomized 1: 1 (Device to OAC) Follow-Up at 3, 12, 24, and 36 months Patient Populations Sequential Prior ablation procedure for NVAF between 3 and 6 months prior to randomization OR Concomitant Planning to have catheter ablation within 10 days of randomization Medication Regimens Device Group Market approved OAC and aspirin (75 -100 mg recommended) for 90 days followed by aspirin through at least 12 -months post-implant (recommended for duration of the trial). Note: This trial will be run using investigational product (WATCHMAN FLX) Control (OAC) Group Market approved OAC used per IFU for atrial fibrillation stroke prevention for the duration of the trial.