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1、Transcatheter Aortic Valve Implantation: Recent Clinical Data,Hasan Jilaihawi, MD Cedars-Sinai Medical Center, Los Angeles,Objectives,To understand the devices and approaches available to treat aortic stenosis by transcatheter approach To be understand the clinical outcomes that are important after
2、Transcatheter Aortic Valve Implantation (TAVI) To be aware of recent clinical data pertaining to the above outcomes To appreciate the outstanding questions to be answered in future studies,First TAVI- Dr Anderson 1992,First Successful Transcatheter Aortic Valve Implant Antegrade Cribier-Edwards,Firs
3、t UK case 2007: Retrograde Corevalve 90 y old lady,TAVI: Designs,Edwards-Cribier / Edwards-Sapien COREVALVE Panaguia 3F SORIN CORAZONE SADRA Medical ValveXchange Direct Flow Lutter,TAVI: Post CE mark devices,Medtronic-CoreValve self expandable Porcine pericardium Retrograde Transaxillary 18 Fr No ra
4、pid pacing 10, 000+ patients,Edwards-Sapien Balloon expandable Bovine pericardium Retrograde (ante.) Transapical 22/24 Fr (soon 18/19Fr) Rapid pacing 10,000+ patients,Rapid evolution of the Corevalve device,Ongoing evolution of the Edwards design,Edwards-Sapien: Approaches,Medtronic Corevalve: Appro
5、aches,Transaxillary,Transfemoral,(Direct aortic),Corevalve or Edwards? A complementary approach to TAVI for optimal outcome,Jilaihawi et al, JACC Interventions, In press,TAVI Outcomes: What clinical results are important?,Procedural success Mortality Stroke, disabling stroke Myocardial infarction Va
6、scular complication Hemodynamic function Functional status Permanent pacemaker Quality of Life,TAVI: Clinical data sequence,Enrollment complete September 2009,Awaiting final approval Post CE registry ongoing,Post CE mark European nation registries,1. Improving procedural success,Summary: procedural
7、success,(n=279),(n=772),(n=833),(n=872),(n=248),(n=1038),(n=1483),Summary derived from multiple data EuroPCR 2010,2. Mortality: The standard is set high Open AVR is a safe procedure in selected elderly patients,Operative mortality in octogenarians prior to 2000 11.5% Logeais et al J Heart Valve Dise
8、ase 1995 13.7% Gehlot et al J Thorac Cardiovasc Surg 1996 8% Atkins et al Ann Thorac Surg 1997 16.7% Bloomstein et al Ann Thorac Surg 2001 AVR +/- other procedures in octogenarians is getting safer 8.5% Chiappini B 2004 115 octogenarians, AVR 71pts, AVR+CABG 44pts 8.8% Collart F 2005 213 octogenaria
9、ns, AVR 159pts, MVR 42pts, AVR+MVR 14 pts 4.6% David TE 2006 132 octogenarians, AVR 95 pts, MVR 36 selected patients 8 % Urso S 2007 100 octogenarians, isolated AVR 9% Melby SJ 2007 245 octogenarians, AVR 140 pts, AVR+CABG 105 pts 13% Kohl P 2007 220 octogenarians, AVR 162 pts, AVR+CABG 58 pts,2. Mo
10、rtality: Corevalve post CE mark expanded evaluation n=1483,Schuler TCT 2009,2. Mortality post Edwards SOURCE registry,Thomas et al, Circulation 2010,2. Mortality in SOURCE at 12 months,2. Mortality (30d) and learning curve Vancouver Edwards experience n=250,Webb TCT 2009,2. Registry summary: 30 day
11、mortality,(n=279),(n=772),(n=833),(n=872),(n=248),(n=1038),(n=1483),Summary derived from multiple data EuroPCR 2010,3. Stroke,Corevalve MRI study 73% clinically silent cerebral embolism Clinical symptoms of neurological deficits persisted in only 3.6% three months after TAVI.,Ghanem et al, JACC 2010
12、,3. Stroke,MRI study vs 21 surgical patients 10 Corevalve, 22 Edwards New foci of restricted diffusion on MRI in 84% of TAVI vs 48% AVR (p=0.011) No clinical strokes in TAVI arm vs 1 (5% in surgical) At 3 month MRI- no residual signal change associated with the majority (80%) of the foci detected in
13、 the periprocedural period,Kahlert et al, Circulation 2010,3. Summary: Stroke,(n=279),(n=772),(n=833),(n=872),(n=248),(n=1038),(n=1483),Summary derived from multiple data EuroPCR 2010,4. Myocardial infarction,No clear definition Incidence post TAVI not frequently mentioned in literature For coronary
14、 occlusion 0.9% in Corevalve post CE expanded evaluation 1.2% in French registry,5. Vascular complication- mortality REVIVE/REVIVAL,Vascular complication,No vascular complication,5. Vascular complications- SOURCE,Thomas, PCR 09,5. Femoral vascular complications now not associated with increased deat
15、h,SOURCE registry, Thomas, EuroPCR 2010,5. Summary: Vascular complication,(n=279),(n=772),(n=833),(n=872),(n=248),(n=1038),(n=1483),Summary derived from multiple data EuroPCR 2010,n/a,6. Hemodynamics PARTNER EU n=130,deBruyne TCT 2009,6. Valve area- Pooled Edwards,Pooled REVIVE, REVIVAL, TRAVERCE, P
16、ARTNER EU,6. Hemodynamics Corevalve,Schuler, TCT 2009,6. Hemodynamics prosthesis-patient mismatch,Stented,Stentless,Clavel JACC 2009,Jilaihawi EHJ 2009,Tzikas AJC 2010,7. Functional status and Corevalve,7. Functional status- Edwards PARTNER EU,deBruyne TCT 2009,8. Pacemaker- PARTNER EU,1Dawkins et a
17、l, Ann Thorac Surg,deBruyne TCT 2009,8. Corevalve- pacemaker,Serruys, TCT 2009,Edwards TAVI outcomes,Leon TCT 2009,9. Quality of life- PARTNER EU,deBruyne TCT 2009,9. Corevalve QOL,Ussia et al, EHJ 2009,FDA,“Percutaneous valve technology qualifies as enough of a departure from current standard of ca
18、re clinical practice that any device of this nature will need to be evaluated through a randomized, controlled clinical trial”,US PARTNER,Leon TCT 2009,TAVI outcomes? Recent clinical data,Procedural success 95% Mortality Around 10 % or less Stroke 5 % Myocardial infarction coronary obstruction aroun
19、d 1% Vascular complication around 5-10% Hemodynamic function- AVA1.5 sqcm, better than surgical valve Permanent pacemaker 10% Edwards vs 20-30% Corevalve Functional status improved in majority Quality of Life improved in majority,Will outcomes continue to improve with ongoing improvements in device
20、design? eg. Edwards Novaflex delivery system,Conclusion,Recent clinical data support the use of TAVI in the treatment of severe aortic stenosis in high risk or inoperable surgical candidates Data currently is based on non-randomized registries Future randomized studies will answer important outstanding questions Who should have TAVI vs surgery? Who should have Corevalve vs Edwards vs new valves? Who should have Transfemoral vs Transapical vs other approaches?,谢谢!,,谢谢!,