4/17/2015 Current Concepts in Cardiovascular Disease Kwabena Mawulawde, MD, FACS, FACC, FCCP, FAHA Attending Cardiothoracic Surgeon New Mexico Heart Institute 4/11/2015 No Disclosure 1 4/17/2015 The Left Atrial Appendage: To Ligate or not to Ligate? • Atrial Fibrillation: – 1% to 2% of the general population – Fivefold increase next 40 years – 5x risk of stroke with than without – 90% strokes are ischemic – 15% to 20% associated with AF • Left atrial appendage – 90% of detected thrombi AF – “Our most lethal human attachment” Johnson WD, et.al : Eur J CTS 2000; 17:718 – Left Atrial Appendage Occlusion Study • Randomized study 2 4/17/2015 The LAA and Strokes / US All Strokes (100%) 90% Ischemic 10% Hemorrhagic 20% are Associated with Afib 95% have LAA Thrombi = ~130,000 Strokes / yr. Source; Maze IV Training Course 7/2014 slide deck Why the LAA and not the RAA… RAA 1. 2. LAA http://medical-dictionary.thefreedictionary.com/Virchow's+triad Dr. James Cox – LAA Exclusion Rationale (Video) 3 4/17/2015 Patients Considered for Mechanical Closure of LAA • Interventional Approach – Watchman, Lariat, Amplatzer plug • Surgical Approach Candidates for Closure • Contraindication to oral anticoagulation (OAC) • Catheter ablation for AF 4 4/17/2015 Candidates for closure • Cardiac surgical patients Hx of A.Fib. – 3 Categories: CABG, aortic valve, mitral valve – 60,000-100,000/annually in USA, OR AF AATS independent survey questionnaire -AF ignored by surgeons amid concerns of increase risk All patients undergoing cardiac surgery • Perioperative AF: risk of stroke; increase hospitalization; 30 day mortality. • AHA/ACC/ESC: have recommended surgical LAA closure in cardiac surgical patients “…who are at high risk for developing post-op AF.” • Two thirds of patients will not develop postoperative AF • Remaining one third is almost impossible to identify preoperatively. • Closure with external clip in all patients? • Cost/benefit as a deterrent. – Perioperative strokes 5 4/17/2015 AtriClip Gillinov-Cosgrove LAA Clip Product Codes: CGC135, CGC140, CGC145, CGC150 510(k) Number: K131107 - 5/14/2013 Indication: The AtriClip Gillinov-Cosgrove LAA Clip is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial as well as thoracotomy (single or multiple). Source: “20140306 – AtriCure Products & IFU’s (w/competitors), slide 60”; Dennis Hong AtriClip Gillinov-Cosgrove™ Selection Guide Product Codes: CGG1 Class I Device Indication: The AtriClip® Gillinov-Cosgrove™ Selection Guide (Guide) is intended to be used as an accessory to the AtriClip® LAA Exclusion System with preloaded Gillinov-Cosgrove™ Clip (Clip). Source: “20140306 – AtriCure Products & IFU’s (w/competitors), slide 62”; Dennis Hong 6 4/17/2015 AtriClip FLEX Available in US as of 9/15/2014 “A MORE FLEXIBLE SOLUTION FOR THE MOST WIDELY PLACED LAA EXCLUSION DEVICE IN THE WORLD” •Flexible 6cm shaft •Plunger Grip •Available in four sizes Key Features AtriClip Science Parallel beams • Follows natural orientation of appendage orifice • Equalizes force over the length of appendage Nitinol springs • Dynamic compression force (continues to close over time) • Force is proportional to tissue thickness and an order of magnitude less than staplers or suture 7 4/17/2015 Summary • Left Atrial Appendage – Thrombus formation – 130K strokes/yr. – 1/3 surgical patients develop atrial fibrillation – Ligate or not to Ligate? – Cardiac surgery + AF: concomitant Maze. Key Features 7 day in growth, porcine model AtriClip Science Polyester fiber sleeve • Encourages rapid tissue in growth • Provides stability while LAA is reabsorbed Human Endocardial View at 4 months • Yields smooth healing of the endocardium at the LAA LA junction Courtesy Marc Gerdisch, MD 8
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