Ziyad M. Hijazi, MD, FACC George M. Eisenberg, Professor
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1 Ziyad M. Hijazi, MD, FACC George M. Eisenberg, Professor University of Chicago Comer Children s s Hosp Chicago, IL
2 DISCLOSURE AID CONSULTANT TO EDWARDS VES TRAVELS EXPENSES FOR EDWARD
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4 The Edwards Sapien THV of three Bovine pericardial leaflets stainless steel, 14 mm long, maximal diam m. n: ZMED-II ; Requires Fr sheath for
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6 The Edwards Sapien THV lex catheter to enhance steerability & hability of the system.
7 g Modalities for Pre-clinical Evalu bench testing ydrodynamic functional testing under pulmonary p ated delivery system and PHV tracking to nary conduit valve delivery system testing acute animal stu chronic animal study 20 week survival eployed into native pulmonary valve eployed into simulated conduit
8 HV Hydrodynamic Functional Testing functional valve testing onary artery pressure 3 and 26mm valves ell has over 10 yrs under aortic pressures. Mean Pressure Drop (mmhg) PHV Performance at Pulmona Cardiac Output (L/
9 QuickTime and a Cinepak decompressor are needed to see this picture.
10 QuickTime and a Cinepak decompressor are needed to see this picture.
11 Human Aortic Experience cases implanted with no fractures!! ithstand aortic pressures.will be good for ry hypertension cases! e will be soon available in 20, 23, 26 and 29mm
12 Vitro Delivery System and PHV Testin e delivery system for lve replacement culating catheter to er to PA al testing in glass
13 Vivo Delivery System Tracking to PA system testing from vein in swine (40-50 Kg) system articulates ct PHV past tricuspid sitioned within native ary valve
14 Protocol 2: Chronic Animal PHV implantation into PA conduit kg), total 4/8 survived conduit impla urgical death caused by early technical pr ent. HV Placement in Conduit PHV Placement in Condu
15 still functioned oyment. Protocol 2: Chronic Animal PHV implantation into PA conduit urvival PHV implantation to 20 weeks surv th occurred during implantation - not PHV healing response was as expected oper placement of PHV into one conduit - PHV over conduit leaflets val Con
16 Percutaneous Pulmonary ProtocolImplantation 2: Chronic Animal Valve PHV implantation into PA conduit d healing response y revealed calcified conduit wall and no obs calcification
17 First Human Case iversity of Chicago December 13th, 20 a 16 yr old boy with BAV alloon aortic valvuloplasty X2 3 Ross Operation
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19 First Human Case iversity of Chicago December 13th, 20 3 Ross Operation /03 back to the OR pleural effusion /03 back to OR mediastinitis and tampona 3 back to OR for debridement 2/23/03
20 First Human Case iversity of Chicago December 13th, 20 back to OR emergently with severe SVC ction. Change of homograft and autograft mografts. ome 2/13/04 t. ell 7/25/05 found to have obstruction of R
21 Cath 7/25/05
22 st thing JR needed was ano open heart surgery!!!
23 eived FDA Approval to proc percutaneous valve! Thoug was not easy!
24 Cath 12/13/05
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26 QuickTime and a Video decompressor are needed to see this picture.
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28 Case 2 4 yr., male D-TGA, VSD, PS 82: BAS, left BTS 83: revision of BT 83: Blalock-Hanlon atrial septectomy 84: Rt.. BTS 87: Rastelli: : 21 mm pulmonary homograft with dacron tube extension
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31 QuickTime and a Video decompressor are needed to see this picture.
32 The Melody Valve P Stent: at least 16% fracture rate!!! ne e case of near fatal embolization of the fractu nt requiring emergency surgery. e largest diameter is???22mm, although the ine jugular valve is 18mm so, what happens expand it to 22mm????
33 Conclusions he Edwards Sapien THV Valve will be super Melody valve! inical trials with the Sapien THV in the aortic ition has demonstrated excellent function and ability ials with the Edwards Sapien THV will mence soon.
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35 Acknowledgment sen Sirimanne, Rajesh Khanna,, David Taylor, ia,, Bella Felsen,, Luanne Bailey, Assaf Bash, H Whitin,, Bruce Stambaugh and Dr. Jane Olin fro Edwards Lifesciences & The IMM Research Staff Paris, France & r. John Webb and his staff from St. Paul s s Hosp &
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