4/19/2014 LAA CLOSURE DO WE REALLY NEED A NEW DEVICE DESIGN Reda AbuElatta MD,FSCAI Madinah Cardiac Center Almadeina Almunawara SACIS-2014 Conflict of Interest Statement NON 1 4/19/2014 We have a growing number of options to consider, including medications and invasive procedures… AF If I can’t be in sinus rhythm, I want to be safe from having a stroke. 2 4/19/2014 DEFINING STROKE RISK – CHADS2 SCORE CHADS2 Risk Score CHADS2 score Patients (n = 1733) Adjusted stroke rate %/year CHF 1 Hypertension 1 0 120 1.9 Age > 75 1 1 463 2.8 Diabetes 1 2 523 4.0 Stroke or TIA 2 3 337 5.9 4 220 8.5 5 65 12.5 6 5 18.2 Modified from ESC AF Guidelines http://www.escardio.org/guidelines-surveys/esc-guidelines/GuidelinesDocuments/guidelines-afib-FT.pdf REDEFINING RISK - CHA2DS2VASC CHA2DS2-Vasc Risk Score CHF or LVEF < 40% 1 Hypertension 1 Age >65 ; > 75 years 1/2 Diabetes Stroke/Thromboembolism 1 2 Vascular Disease 1 Sex: Female 1 CHA2DS2V Patients (n Adjusted asc = 7329) stroke rate (%/year) score 0 1 0 1 422 1.3 2 1230 2.2 3 1730 3.2 4 1718 4.0 5 1159 6.7 6 679 9.8 7 294 9.6 8 82 12.7 9 14 15.2 3 4/19/2014 LAA AS SOURCE IN AF During AF, hypo-contractile LAA causes stagnation of blood flow in trabeculated cavity TEE-based risk factors: Enlarged LAA Reduced LAA inflow and outflow velocities Spontaneous Echo contrast Blackshear: Ann Thoracic Surg 61, 1996 Johnson: Eur J Cardiothoracic Surg 17, 2000 Fagan: Echocardiography 17, 2000 WHY NOT SIMPLY EXCLUDE THE LAA FROM THE CARDIAC CIRCULATION? 4 4/19/2014 LAA EXTERNAL VIEW (Pictures Courtesy Prof. D. Sanchez Quintana) Extra-appendicular Pectinate Muscle Extra-appendicular Pectinate Muscle Extra-appendicular Pectinate Muscle Major Cardiac vein Circunflex artery 5 4/19/2014 LAA Closure Devices Endocardial • PLAATO • Watchman • ACP Amulet • Coherex • Sideris Patch • Occlutech • pfm Medical • Lifetech • Gore • Cardia Epicardial • SentreHeart • AEGIS • AtriCure • Medtronic Watchman Occluder • • • • Nitinol PET membrane with pores Hooks 21, 24, 27, 30, 33 mm 6 4/19/2014 Amplatzer Cardiac Plug • Distal lobe (16-30mm) • • Disk (20-36mm) • 9, 10 or 13F sheath Lobe length 6.5mm CardioVascular Center Frankfurt CVC AMPLATZER CARDIAC PLUG Feature Sizes (mm) ACP 16 Disc Ø 18 20 Lobe Length Lobe diameter 16-30mm Lobe length 6.5mm Disk diameter 20-36mm 9, 10 or 13F sheath 22 24 Lobe + 4mm 26 4mm SW Ø 0.006” # SW Pairs 6 Oversizing 1.5-3.0mm Disc End Screw PKG 30 6.5mm Waist Length Sheath (Fr) 28 Lobe + 6mm 9 10 13 Protruding Partially pre-loaded 7 4/19/2014 Procedural guidance : AMPLATZER® Cardiac Plug AMPLATZER® Cardiac Plug - Notice of Availability - Caution: Investigational device. Limited by Federal (U.S.) law to investigational use. TEE EVALUATION 16 8 4/19/2014 17 DEVICE POSITIONING AND DEPLOYEMENT 18 9 4/19/2014 FINAL RELEASE 19 Final Deployment of Disc : X plane TEE ( 45 and 135 degrees) 10 4/19/2014 Before LAA occlusion with ACP plug After Amulet • • • • • • • • Pre-loaded Recessed end screw Larger disc diameter Longer lobe length Longer waist length Larger sizes up to 34mm Stiffer stabilizing wires (.0065) More stabilizing wires on larger devices CardioVascular Center Frankfurt CVC 11 4/19/2014 ACP2 Design Feature Comparison Feature Sizes (mm) ACP 16 Disc Ø 18 20 22 24 Lobe + 4mm Lobe Length Waist Length SW Ø Amulet 26 30 16 18 20 22 34 7.5mm 10mm 4mm 5.5mm 6 1.5-3.0mm 9 31 6.5mm Oversizing Disc End Screw 28 Lobe + 7mm 8mm 0.006” Sheath (Fr) 25 Lobe + 6mm # SW Pairs PKG 28 Lobe + 6mm 10 0.0065” 6 8 3-5mm 13 Protruding 10 3-6mm 12 ACP Amulet Partially pre-loaded 14 Recessed Fully pre-loaded RECESSED END SCREW uniform surface in the left atrium less risk of thrombus formation Preclinical canine model: Mature and stable neointima covering the device surface (arrows); the device was filled by organized thrombus (asterisk). 90 day cohort (H&E) 12 4/19/2014 FLEXIBLE DELIVERY CABLE Delivery cable includes an 0.014” inner wire Enables visualization of final device placement prior to release INCREASED STABILITY More stabilizing wires in larger devices increased stability ACP Amulet 13 4/19/2014 Final security check prior device release S C A R SEALING of the LAA OS CONCAVITY of the disc ANGLE between disc and lobe REST COMPRESSION of the lobe LAA OCCLUSION - CONCLUSIONS Protective strategies for AF patients continue to evolve with growing number of options. PROTECT AF provided first randomized evidence that LAA closure may not only be beneficial, but prove to be superior to warfarin. Best “mousetrap” yet to be determined Consider the individual risks/needs of each pt. THE VARIATION IN LAA MAKES ALWAYS NO SINGLE IDEAL DEVICE ALL SHOULD SHARE THE CONCEPTS – SAFETY – AFFECTIVENESS – USER FRIENDLY 14 4/19/2014 29 15
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