• CoreValve US Pivotal Trial - Extreme Risk Iliofemoral : Study Results

    Jeffrey J. Popma, MD On Behalf of the CoreValve US Clinical Investigators Physician NameCompany/Relationship Jeffrey J. Popma, MD Research Grants- Cordis, Boston Scientific, Medtronic, Abbott, Abiomed,Covidien, eV3, Medical Advisory Board- Cordis, Boston Scientific, Covidien Conflict of Interest Constrained Portion Valve Function Intra-annular anchoring Mitigates paravalvular aortic regurgitation Supra-annular leaflet function Designed to avoid coronaries Maximizes Flow OutflowOrientation CoreValve Bioprosthesis * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Risk Determined by- Two Clinical Site Cardiac Surgeons and One Interventional Cardiologist Risk Confirmed by- Two Screening Committee Cardiac Surgeons and One Interventional Cardiologist Study Purpose Primary Endpoint- All Cause Mortality or Major Stroke at 12 Months * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Jeffrey Popma, BIDMC, Boston David Adams, Mt. Sinai, New York Steering Committee CS’s- Michael Reardon, G. Michael Deeb, Joseph Coselli, David Adams, Tom Gleason IC’s- James Hermiller, Steven Yakubov, Maurice Buchbinder, Jeffrey Popma Consultants- Blasé Carabello, Patrick Serruys Data & Safety Monitoring Board Chair- David Faxon, Brigham and Women’s Hospital Echo Core Laboratory Chair- Jae Oh, Mayo Clinic Rotational X-ray Core Laboratory Chair- Philippe Genereux, CRF Clinical Events Committee Chair- Donald Cutlip, HCRI ECG Core Laboratory Chair- Peter Zimetbaum, HCRI Quality of Life and Cost-Effective Assessments Chair- David J. Cohen, Mid-America Heart Institute Matt Reynolds, HCRI Pathology Core LaboratoryChair- Renu Virmani, CV Path Screening Committee Chair- Michael Reardon, David Adams, John Conte, G. Michael Deeb, Tom Gleason, Jeffrey Popma, Steven Yakubov Sponsor Medtronic, Inc. Study Administration * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Inclusion Criteria- Severe aortic stenosis- AVA = 0.8 cm2 or AVAI = 0.5 cm2/m2 AND mean gradient > 40 mm Hg or peak velocity > 4 m/sec at rest or with dobutamine stress (if LVEF < 50%) NYHA functional class II or greater Exclusion Criteria (selected)- Recent active GI bleed (3 mos), stroke (6 mos), or MI (30 days) Creatinine clearance < 20 mL/min Significant untreated coronary artery disease LVEF < 20% Life expectancy < 1 year due to co-morbidities Inclusion and Exclusion Criteria * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Chairman- Mike Reardon, MD Twice weekly phone call with a minimum of 2 Cardiac Surgeons and 1 Interventional Cardiologist Executive Summary to expedite review and document- STS PROM and incremental factors reviewed Independent review of transthoracic echocardiogram Independent review of chest/abdominal CTA findings Planned access route by clinical team Case by case telephone discussion with Heart Team Screening Committee * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal An objective performance goal (OPG) was used to estimate the risk of all-cause mortality or major stroke in patients treated with standard therapy OPG constructed from- Meta-analysis of 5 contemporary balloon valvuloplasty series ? random effects meta-analytic all-cause mortality or major stroke rate at 12 months = 42.7% (95% CI 34.0%-51.4%) 12-Month PARTNER B all-cause mortality or major stroke rate of 50.3% with a corresponding 95% lower confidence bound of 43.0% Objective Performance Goal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal H0- p MCS TAVR > 43% HA- p MCS TAVR < 43% Study Size- 487 patients to account for up to 10% drop out rate Sample Size Determination * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Analysis Cohort * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal 487 Patients Enrolled at 40 Participating Sites El Camino Mountain View, CA USC Los Angeles, CA Banner Phoenix, AZ Providence Spokane, WA Methodist Houston, TX Baylor Dallas, TX U of Kansas Kansas City, KS Iowa Heart Des Moines, IA Aurora St. Lukes Milwaukee, WI Loyola Maywood, IL Spectrum Grand Rapids, MI U of Michigan Ann Arbor, MI DetroitMedicalCenter Detroit, MI RiversideMethodist Columbus, OH Saint Vincent Indianapolis, IN U of Pitt Pittsburg, PA UH Case Cleveland, OH Inova Fairfax Falls Church, VA Johns Hopkins Baltimore, MD Pinnacle Wormleysburg, PA Geisinger Danville, PA Vanderbilt Nashville, TN Piedmont Atlanta, GA U of Miami Miami, FL Mount Sinai Miami, FL Wake Forest Winston Salem, NC Duke Durham, NC Morristown Morristown, NJ Mount Sinai Lenox Hill St. Francis Roslyn, NY North Shore Manhasset, NY Yale New Haven, CT Beth Israel Boston, MA St. Luke’s Houston, TX OhioState Columbus, OH Saint Joseph’s Atlanta, GA Kaiser Permanente Los Angeles, CA WashingtonHospital Center Washington, DC * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal VA Palo Alto VA Palo Alto, CA * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Prohibitive Chest Anatomy * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Baseline Co-Morbidities **Charlson Score- = 1 MI, CHF, PVD, CVD, dementia, chronic lung disease, connective tissue disease, ulcer, mild liver disease, DM; = 2 hemiplegia, mod-severe kidney disease, diabetes with end organ damage, leukemia, lymphoma; = 3 moderate or severe liver disease; = 6 metastatic solid tumor, AIDS * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Primary Endpoint * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * Extreme Risk Study | Iliofemoral Pivotal TCT 2013 LBCT * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * Percentages obtained from Kaplan Meier estimates * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Extreme Risk Study | Iliofemoral Pivotal TCT 2013 LBCT Primary Endpoint Predictors-I Extreme Risk Study | Iliofemoral Pivotal TCT 2013 LBCT Primary Endpoint Predictors-II * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Detailed analysis of co-morbidity, frailty, and disability confirmed unsuitability for surgical AVR The CoreValve Extreme Risk Study achieved its primary endpoint of a reduction in all cause mortality or major stroke at one year compared to a rigorously defined OPG Conclusions - I * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal Low rate of moderate/severe aortic regurgitation that improved over time No association of mild/moderate PVL on late mortality Improved outcomes in Continued Access Study Conclusions - II * TCT 2013 LBCT Extreme Risk Study | Iliofemoral Pivotal

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