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 Favors warfarin 0.3 0.6 0.9 1.2 1.5 Favors other Rx W vs Placebo W vs Wlow dose W vs Aspirin W vs Aspirin + Clop W vs Ximelagatran W vs Dabigatran 110 W vs Rivaroxaban W vs Dabigatran 150 Category 1.8 2.0 Modified from Camm AJ. EHJ 2009;30:2554-5 12 8 9 4

Bleeding Risks with Old and New Drugs P=.31 P=.003 Bleeding Risk % per year 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 6

LAA: Pre-Procedure Patient Selection CHA2DS2 (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 CHA2DS2-VASc (1-5) and HAS-BLED Score History of Prior Cardiac Intervention Tolerance to oral anticoagulation, dependence on DAPT Screening TEE

CHA2DS2 Score and Stroke Rate Annual Risk of Stroke Adapted from Gage et al, JAMA 2001;285:2864–2870

Camm et al, European Heart Journal doi:10.1093/eurheartj/ehq278 CHA2DS2-VASc 2010 ESC AF Guidelines now call for use of CHA2DS2-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/ehq278

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 HAS-BLED 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.” 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! Camm et al, European Heart Journal doi:10.1093/eurheartj/ehq278 Pisters R, et al Chest 2010; 138:1093-100

LAA: Pre-Procedure Patient Selection CHADS2 (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 landmarks PA LAA LUPV LCx Laura DM et al JASE July 2014

LAA: Pre-Procedure Patient Selection CHADS2 (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 CHADS2 (1-5) and HAS-BLED Score History of Prior Cardiac Intervention Tolerance to oral anticoagulation, dependence on DAPT Screening TEE

Understanding anatomy of LAA 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 45 Degrees 90 Degrees 135 Degrees

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

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

Device sizing Orifice Landing zone Lobe height Landing zone 22x20mm Lobe Height/depth 23mm 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) (uncompressed diameter) 17-19 21 20-22 24 23-25 27 26-28 30 29-31 33 Device sizing is based on maximum LAA diameter Maximum LAA ostium range: 17 to 31mm Max LAA length should be equal to or greater than the ostium Select Size Maximum Measured LAA Ostium (mm) Minimum Measured LAA length mm Implant Diameter. Note: Use TEE and fluoro to confirm baseline measurements and select device size.

Thank you!