Disclosure The Role of LAA Closure in Atrial Fibrillation - PowerPoint PPT Presentation

9/8/2012 Disclosure The Role of LAA Closure in Atrial Fibrillation SentreHeart, Inc • Consultant • Equity holder AF MECHANISM FOR STROKE Irregular Heartbeat Pumping of Blood Disrupted Blood Stagnates in LAA Incubator for Thrombus Location of Thrombus in Patients with AF A cardiac disease that kills # THROMBI # IN % IN SETTING REFERENCE IN LA/LAA LAA LAA TEE 67 66 99% Stoddard, JACC 1995 by producing emboli TEE 35 34 97% Manning, Circulation 1994 The most severe Autopsy 47 35 74% Aberg, Acta. Med. Scan. 1969 TEE 4 2 50% Tsai, JFMA 1990 consequence of AF is TEE 13 12 92% Klein, Int J Card Imaging 1993 TEE & Operation 11 8 73% Manning, Circulation potentially life threatening SPAF III & TEE 20 19 95% Klein, Circulation 1994 TEE 19 19 100% Leung, JACC 1994 Clot dislodges from LAA TEE 6 6 100% Hart, Stroke 1994 embolic events TOTAL 222 201 91% Next Stop: BRAIN 1

9/8/2012 PROTECT AF STUDY Endocardial vs Pericardial Provided Proof of Principle Ease of Use No LA foreign body 3.5% Conclusions: STROKE RATES 3.5% (95% CI) Device is non-inferior 3.0% to warfarin in stroke 2.6% 2.4% 2.5% May provide an 1.9% alternative to warfarin 2.0% 1.6% 1.5% ISCHEMIC HEMORRHAGIC 1.0% ALL 0.5% 0.2% Closure Efficacy 0.0% DEVICE CONTROL Complications Endocardial Devices Pericardial Devices The Watchman Device Surgical (Direct visualization) Devices PROTECT AF STUDY Cardioblate COMPLICATION RATES • Pericardial Effusion 10.00% • Air Embolism 8.00% • Cardiac Tamponade 6.00% Atriclip (FDA approved) • Migration 4.00% • Bleeding •Thrombus 2.00% 0.00% TigerPaw System DEVICE CONTROL 2

9/8/2012 Pericardial Devices Catheter - Based Surgery Performed in OR Performed in cath lab Epitek AEGIS Medical • • Open Chest Percutaneous & Image Guided • • Cardiopulmonary Bypass Immediate, Complete, Permanent • • Technique Variability Closure Training Required on New Techniques • Performed with another open Friedman PA, et al. J Cardio procedure Electrophysiol, Aug 2009 Vol. 20, 908-15 LAA ligation with the LARIAT Suture Delivery Device LARIAT Suture Delivery Device Patients with AF and high risk for embolic events that have limited to no options due to contraindications or intolarnace to OAC. 3

9/8/2012 Capture / Closure Complete <1mm 82 (96%) Objectives of PLACE II Acute Closure 85 <2mm 2 ( 3%) Non-randomized, single center, observational study <3mm 1 ( 1%) Complete <1mm 81 (95%) Objective: Assessing Safety and Efficacy of LAA Closure 1d Closure 85 <2mm 3 ( 4%) <3mm 1 ( 1%) Patients with AF, CHADS2 >1 & Ineligible to Coumadin >30d Closure Complete <1mm 81 (95%) 85 <2mm 3 ( 4%) <3mm 1 ( 1%) Dec 2009 through Dec 2010 >90d Closure Complete <1mm 60 (97%) 81* <2mm 2 ( 3%) <3mm 0 ( 0%) * Four pts had 60d follow up and refused to have 90 d follow up Complete < 1 mm 64 (98%) > 1 year 65 < 2 mm 1 (2%) JACC In Press JACC In Press Adverse Events Percutaneous LAA Ligation 1) Access related complications (2 pericardial access • Feasible related, 1 transseptal related) - 3 (3.5%) • Effective LAA closure 2) No device complications 3) Chest pain due to pig tail catheter - 20 (24%) • Acceptably low access complications and peri- 3) Pericarditis - 2 (2.4%) procedural adverse events 4) Late pericardial - 1 (1.2%) • Future outcome studies needed 5) Thrombus – 1 (1.2%) 6) Strokes – 2 non-embolic strokes (1 hemorraghic and one lacunar). Both > 6 mos after the procedure 7) Deaths – 2 that were > 6 mos after the procedure 4

9/8/2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Rationale for LAA exclusion during AF Surgical Ablation of Atrial Fibrillation Ablation patient ’ s risk factors for stroke and not on the 1. Decisions regarding the use of warfarin more than • Will it allow patients to stop Coumadin? two months following ablation should be based on the • Will it improve ablation outcomes? presence or type of AF 1. Discontinuation of warfarin therapy post ablation is generally not recommended in patients who have a CHADS score > 2 Ablation for Atrial Fibrillation in LAA Exclusion at the time of AF Combination With Left Atrial Appendage Ablation Closure: First Results of a Feasibility Study Strategy of performing AF ablation for the treatment of AF and exclusion of the LAA for stroke prevention - 30 patients were treated with PVI and Watchman device - 30% rate of documented recurrence of AF at 1 year. - A repeated pulmonary vein isolation was performed successfully in 4 patients, without interference of the LAA closure device. - No thromboembolic events occurred during 1-year follow- up. Conclusion: LAA occlusion with the Watchman device and AF ablation can be combined successfully and safely in a single procedure. The Watchman does not interfere with a repeated ablation. Swaans et al., J Am Heart Assoc. 2012;1:e002212 5

9/8/2012 LAA Isolation Improves Ablation Outcomes Can you improve Efficacy Rates of AF Ablation with Concomitant LAA Exclusion? Left Atrial Appendage : An Underrecognized Trigger Site of Atrial Fibrillation Luigi Di Biase, J. David Burkhardt, Prasant Mohanty, Javier Sanchez, Sanghamitra Mohanty, Rodney Horton, G. Joseph Gallinghouse, Shane M. Bailey, Jason D. Zagrodzky, Pasquale Santangeli, Steven Hao, Richard Hongo, Salwa Beheiry, Sakis Themistoclakis, Aldo Bonso, Antonio Rossillo, Andrea Corrado, Antonio Raviele, Amin Al-Ahmad, Paul Wang, Jennifer E. Cummings, Robert A. Schweikert, Gemma Pelargonio, Antonio Dello Russo, Michela Casella, Pietro Santarelli, William R. Lewis and Andrea Natale Circulation . 2010;122:109-118 Electrical Isolation of LAA with the Consequences of Electrical Isolation LARIAT Suture Delivery Device of LAA with RFCA • Mechanical standstill 18 Mean Unipolar LAA Voltage 16 • Thrombus formation 14 P < 0.001 12 10 8 6 11.0 mV LAA 4 2 thrombus 3.2 mV 0 Baseline LAA ligation 10 of 30 patients had complete abolition of LAA electrical activity after acute ligation. 6

9/8/2012 LAA ligation and PVI in Patients with Holter Data Persistent AF • 28 of 29 patients did not have atrial fibrillation Cox Maze III at FU holter at 1 year. • Subjectively all patients felt better Feasibility Study of Concominant LAA Conclusion Ligation and PVI • There is rationale for LAA exclusion as part of • UCSF, KUH the AF treatment strategy. • 8 patients at each site have had LAA • Which LAA exclusion device used will be ligation/PVI dependent on LAA closure efficacy and • Persistent AF patients associated complications • Studies will be needed to determine if LAA • UCSF: 5 of 10 in sinus rhythm. All feel better. • 1 additional patients who enrolled in study did exclusion improves stroke and AF ablation outcomes. not proceed to PVI due to feeling better. Pt is in atrial flutter. 7