How to Screen Patients for LAAC Maurice Buchbinder

How to Screen Patients for LAAC Maurice Buchbinder, MDCM, FACC, FSCAI Medical Director Foundation for Cardiovascular Medicine San Diego, California Professor of Clinical Medicine Stanford Hospital and Clinics Stanford, California

Disclosures Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement with the organization(s) listed below. BSCI • Scientific Advisory Board Member • Speaker Bureau • Equity Ownership

Introduction • Left atrial appendage (LAA) exclusion with the Watchman device has emerged as an alternative to oral anti-coagulation for prevention of stroke in patients with non valvular atrial fibrillation • To achieve successful LAA exclusion and avoid complications, understanding optimal patient selection and detailed procedural steps is essential

Stroke Prevention: Anticoagulant Effect Meta-analysis of ischemic stroke or systemic embolism Category W vs Placebo W vs Wlow dose W vs Aspirin + Clop W vs Ximelagatran W vs Dabigatran 110 0 0. 3 0. 6 W vs Rivaroxaban W vs Favors warfarin Dabigatran Modified from Camm AJ. EHJ 2009; 30: 2554 -5 0. 9 1. 2 1. 5 1. 8 2. 0 Favors other Rx

Bleeding Risks with Old and New Drugs RE-LY Study P=. 31 5. 0 Bleeding Risk % per year 4. 0 3. 4 P=. 003 3. 1 2. 7 3. 0 2. 0 1. 0 0. 0 Warfarin Dabigatran (150 Mg) Dabigatran (110 mg) Connolly SJ, et. al. , N Engl J Med. 2009 Sep 17; 361(12): 1139 -51.

Thromboembolism versus Haemorrhage Bleeding risk ? Left Atrial Occlusion Device 3 -4% pa Thromboembolic risk 1 -2% pa

LAA: Pre-Procedure • Patient Selection – CHA 2 DS 2 (1 -5) and HAS-BLED Score – History of Prior Cardiac Intervention – Tolerance to oral anticoagulation, dependence on DAPT – Screening imaging TEE/CT

LAA: Pre-Procedure • Patient Selection – CHA 2 DS 2 -VASc (1 -5) and HAS-BLED Score – History of Prior Cardiac Intervention – Tolerance to oral anticoagulation, dependence on DAPT – Screening TEE

CHA 2 DS 2 Score and Stroke Rate Annual Risk of Stroke 20% 18. 2% 18% 15% 12. 5% 13% 10% 8. 5% 8% 5. 9% 5% 3% 4. 0% 1. 9% 2. 8% 0% 0 1 2 3 4 Adapted from Gage et al, JAMA 2001; 285: 2864– 2870 5 6

CHA 2 DS 2 -VASc • 2010 ESC AF Guidelines now call for use of CHA 2 DS 2 -VASc score • Recommend oral anticoagulation for score 2 or greater and either anticoagulation or aspirin for score =1 Camm et al, European Heart Journal doi: 10. 1093/eurheartj/ehq 278

Anticoagulation and Bleeding “An assessment of bleeding risk should be part of the patient assessment before starting anticoagulation. . . It would seem reasonable to use the HASBLED score to assess bleeding risk in AF patients, whereby a score of ≥ 3 indicates ‘high risk’, and some caution and regular review of the patient is needed following the initiation of antithrombotic therapy, whether with VKA or aspirin. ” Camm et al, European Heart Journal doi: 10. 1093/eurheartj/ehq 278 Pisters R, et al Chest 2010; 138: 1093 -100 According to HAS-BLED, 61% of pts currently on warfarin for AF are at “moderate” risk of bleeding and additional 19% are at “high” risk!

LAA: Pre-Procedure • Patient Selection – CHADS 2 (1 -5) and HAS-BLED Score – History of Prior Cardiac Intervention – Tolerance to oral anticoagulation, dependence on DAPT – Screening TEE

LAA: Pre-Procedure • Unlike with other devices like the LARIAT™ implantation of the Watchman device is not limited by previous open chest procedures • In patients with previous surgical cardiac interventions, it is important to ensure that attempt at partial or total appendage exclusion was not performed

LAA: Pre-Procedure Understanding anatomy of LAA PA ◆landmarks LAA LUPV LCx Laura DM et al JASE July 2014

LAA: Pre-Procedure • Patient Selection – CHADS 2 (1 -5) and HAS-BLED Score – History of Prior Cardiac Intervention – Tolerance to oral anticoagulation, dependence on DAPT – Screening TEE

LAA: Pre-Procedure • Particular to the Watchman™, continued oral anticoagulation for 45 days following implantation is recommended • Although small non randomized series have tested the successful use of DUAL ANTI - PLATELET therapy, in lieu of oral anticoagulation, the recommendation remains part of the approved IFU

LAA: Pre-Procedure • Patient Selection – CHADS 2 (1 -5) and HAS-BLED Score – History of Prior Cardiac Intervention – Tolerance to oral anticoagulation, dependence on DAPT – Screening TEE

Understanding anatomy of LAA morphology: orifice neck lobe 450 PA PV

LAA: Pre-Procedure • Baseline TEE – – – – Appendage Size (width-length) Absence of Thrombus Single versus multiple lobes Appendage Tilting Fossa Ovalis Anterior-Posterior Appearance Height Between LAA/Fossa (single vs. Double Curve guide) – Relation between appendage and Left pulmonary vein

Baseline Echo Assessment Understand LAA Anatomy The Wind Sock Type LAA is an anatomy in which one dominant lobe of sufficient length is the primary structure. The Chicken Wing Type LAA is an anatomy whose main feature is a sharp bend in the dominant lobe of the LAA anatomy at some distance from the perceived LAA ostium. The Broccoli Type LAA is an anatomy whose main feature is an LAA that has limited overall length with more complex internal characteristics.

Baseline TEE Images Agitated Saline

Baseline TEE Images TEE of LAA at 45 Degrees

Baseline TEE Measurements 0 Degrees 90 Degrees 45 Degrees 135 Degrees

Understanding anatomy of LAA ◆landmarks Circumflex Artery Warfarin Ridge LAA orifice Atrial Septum L. Circumflex artery R LAA L N IAS inferoposterior Surgical view MV Warfarin ridge

Understanding anatomy of LAA cactus windsock 1350 PA chicken wing PV cauliflower 450

Device sizing Orifice Landing zone Lobe height Landing zone 22 x 20 mm Lobe Height/depth 23 mm ◆Measure widest diameter in cardiac cycle ◆LAA in sinus rhythm → (usually end systole) ◆Fluid status, volume loading

WATCHMAN Device Selection Maximum LAA Ostium (mm) Device Size (mm) 17 -19 21 20 -22 24 23 -25 27 26 -28 30 29 -31 33 (uncompressed diameter) • Device sizing is based on maximum LAA diameter • Maximum LAA ostium range: 17 to 31 mm • Max LAA length should be equal to or greater than the ostium

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