Eberhard Grube MD, FACC, FSCAI
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1 3 rd TAVI Summit Seoul, August 9/10, 2013 Eberhard Grube MD, FACC, FSCAI University Hospital, Dept of Medicine II, Bonn, Germany y p, p,, y Hospital Alemão Oswaldo Cruz, São Paulo, Brazil Stanford University, Palo Alto, California, USA
2 Eberhard Grube MD Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Physician Name Eberhard Grube, MD Company/Relationship Medtronic, CoreValve: C, SB, AB, OF Sadra Medical: E, C, SB, AB Direct Flow: C, SB, AB Mitralign: AB, SB, E Boston Scientific: C, SB, AB Biosensors: E, SB, C, AB Cordis: AB Abbott Vascular: AB Valtech: E, SB, Claret: SB Keystone Medical: SB
3 1,015 patients enrolled from March 2010 to July year follow up 44 centres 12 countries in Western Europe, Asia and South America All centres had conducted at least 40 TAVI procedures prior to the study and had a Heart Team in place Clinical endpoints reported according to VARC As treated analysis CoreValve ADVANCE Methods
4 CoreValve ADVANCE Endpoints Primary Endpoint Major Adverse Cardiac & Cerebrovascular Events (MACCE) at 30 days post procedure MACCE defined as a composite of All cause mortality Myocardial Infarction (Q wave and non Q wave) Emergent Cardiac Surgery or Percutaneous Re intervention Stroke AdditionalClinical Endpoints (VARC) Cardiovascular Mortality Bleeding Vascular Complications Acute KidneyInjury New Pacemaker Implantation
5 CoreValve ADVANCE Study Oversight 100% of all Patients were monitored All Primary Endpoint events adjudicated by an Independent clinical events committee consisting oftavi experienced interventional cardiologists and cardiac surgeons using VARC I definitions All cerebrovascular events adjudicated by an independent neurologist Adjudication of events utilized all available relevant source documents; including neuroimaging and systematic NIH Stroke Scale assessments Core laboratory for systematic review and assessment of EKGs and procedure angiograms g Site reported echocardiographic data
6 CoreValve ADVANCE Baseline Characteristics
7 *measured by angiography CoreValve ADVANCE Procedural Results
8 *Kaplan Meier Estimates CoreValve ADVANCE Primary Endpoint
9 CoreValve ADVANCE 1 Year Stroke
10 CoreValve ADVANCE Type and Timing of Stroke 996 patients implanted
11 CoreValve ADVANCE Additional VARC I Endpoints *Kaplan Meier Estimates New AKI that occurred outside of the 72 hr post TAVI window are included
12 CoreValve ADVANCE 1 Year Survival
13 CoreValve ADVANCE Survival by EuroSCORE
14 CoreValve ADVANCE NYHA Symptom Status
15 CoreValve ADVANCE Valve Performance
16 CoreValve ADVANCE Paravalvular Leak
17 *At discharge CoreValve ADVANCE Survival by AR*
18 CoreValve ADVANCE Conduction Disturbance & Pacemaker Outcomes Core Lab Recorded Data 1 Month 1 Year N=996 % % New Pacemaker Implantation* AccuTrak Delivery System* Pre AccuTrak Delivery System* New LBBB New Atrial Fibrillation *Kaplan Meier Estimates Prior pacemakers not excluded from the denominator
19 CoreValve ADVANCE Impact of LBBB on Survival There was no significant difference in survival between those patients with a new LBBB post implant and those without % Freedom from All ca ause Mor rtality (%) % 91.5% 90.6% 86.4% Patients without Implanted Pacemakers P value (log rank) = Post Implant LBBB NoPost Implant LBBB Number at risk: 82.9% Months Post Procedure
20 CoreValve ADVANCE Impact of Permanent Pacemaker Implant on Survival There was no significant difference in survival between those patients with a post implant pacemaker and those without % Freedom from All cause Mo ortality (% ) % 87.0% 87.6% Patients without Implanted Pacemakers P value (log rank) = Post implant pacemaker No post implant pacemaker Number at risk: % 81.6% Months Post Procedure
21 CoreValve ADVANCE Summary and Conclusions Medtronic CoreValve ADVANCE is one of the largest real world TAVI trials performed in multiple experienced centres. One year outcomes continue to demonstrate low 1 year mortality lowstroke rates at 1 year low rates of AR and PVL at 1 year mild AR with iththe same low mortality rate as those patients t with no AR improved valve performance
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