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LAA CLOSURE: When, Who and How? A/Prof Michael Nguyen Fiona Stanley Hospital Perth, Australia When? • Approved for use in Europe in 2005 and in Asia in 2009 • Watchman device received expanded CE mark approval August 2012 “Watchman device is indicated for patients with atrial fibrillation (AF), and a contraindication to warfarin and the newer oral anticoagulants” • FDA approval – 2015 PROTECT-AF: Overview • Randomized FDA-IDE Trial – Can the WATCHMAN device replace Warfarin? • Efficacy Endpoint: – Stroke – CV death (& Unknown) – Systemic embolism Non-Valvular AF CHADs ≥ Randomization (1:2) • Safety Endpoint • Non-inferiority & Superiority – Bayesian Sequential Design – Analysis at 600 pt-yrs & every 150 pt-yrs thereafter 1500 pt-yr – Follow-up till years Warfarin Watchman Follow-Up PROTECT-AF: Inclusion/Exclusion Inclusion: – – – Paroxysmal / Persistent / Permanent AF CHADS ≥ (CHF, HTN, ≥75 yr, Diabetes, TIA/CVA) Eligible for long-term Warfarin therapy Exclusion – – – – – – – – – Mechanical valve or long-term Warfarin needed Contraindication to Warfarin TEE exclusion: anatomy, atheroma, MV stenosis, tumor Symptomatic Carotid disease LVEF < 30% ASD / Atrial septal repair or closure device CV/Ablation planned within 30 days Unable to take ASA / Plavix® LAA Obliterated PROTECT-AF: Primary Efficacy Endpoint PROTECT-AF: Primary Efficacy Endpoint Intention-to-Treat: All-Cause Mortality Hazard Ratio with Watchman, 0.66 (95% CI, 0.45 – 0.98) P = 0.0379 Primary Safety Endpoint: Components of the Safety Endpoint My Practice • Patients unable to take warfarin or NOACs – – – – Excessive bleeding (ie GI, ICH) Falls risk Labile INR Drug interactions • Patients with ischemic stroke on warfarin/NOACs • Patients preference (refusal to take oral anticoagulants) WATCHMAN Access System Double Curve Transseptal Access System • Double, Single, Anterior Curves • 14F O.D (4.7 mm), 12F I.D Single Curve Preformed curve shapes guide position in LAA • 75 cm working length WATCHMAN Delivery System Deployment Knob Core Wire Hemostasis Valve Constrained Device Distal Marker Band 12F O.D (compatible with all device sizes) Assessment of LAA Dimensions • Confirm the absence of LA/LAA thrombus • Measure LAA ostium in at least TEE views • • At deg (from left coronary artery to a point cm from tip of the LUPV limbus) • At 45, 90, 135 deg (from the top of the MV annulus to a point cm from tip of the LUPV limbus) Measure the approximate LAA usuable length from the ostium line to the apex of the LAA 3Determine proper 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 size should be >17mm or