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Transcatheter Aortic Valve Replacement with a Repositionable Self-expanding Bioprosthesis in Patients With Severe Aortic Stenosis Suboptimal for Surgery:

Published byBruno Blankenship Modified over 7 years ago

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Presentation on theme: "Transcatheter Aortic Valve Replacement with a Repositionable Self-expanding Bioprosthesis in Patients With Severe Aortic Stenosis Suboptimal for Surgery:"— Presentation transcript:

1 Transcatheter Aortic Valve Replacement with a Repositionable Self-expanding Bioprosthesis in Patients With Severe Aortic Stenosis Suboptimal for Surgery: One-Year Results from the Evolut R US Pivotal Study Jeffrey J. Popma, MD, For the Evolut R US Clinical Study Investigators

2 Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Financial Relationship Company Institutional Grants Medtronic Medical Advisory Board Boston Scientific Consultant; Non vested equity Direct Flow Medical Abbott Vascular 2 2 2

3 Background The Evolut R transcatheter aortic valve (TAV) is a self-expanding bioprosthesis that provides a low (14F equivalent*) profile delivery system, conformable annular sealing, and the ability to re-sheath and reposition during deployment. *16 F for the Evolut R 34 mm valve Evolut R 1 Year TCT2016

4 Objective To evaluate the one-year safety and efficacy of the Evolut R system for the treatment of severe aortic stenosis in patients deemed high or extreme risk for surgical aortic valve replacement Evolut R 1 Year TCT2016

5 Catheter Delivery System
Evolut R System Catheter Delivery System 14Fr-equivalent profile Inline Sheath Capsule Loading System Transcatheter Valve Supra-annular design, optimized sealing Evolut R 1 Year TCT2016

6 Evolut R Inclusion Criteria
Severe aortic stenosis defined as an aortic valve area ≤ 1.0 cm2 or aortic valve index ≤ 0.6 cm2/m2 and either a mean aortic valve gradient > 40 mm Hg or a peak aortic valve velocity > 4.0 m/sec, at rest or with dobutamine NYHA II or greater Deemed at high or extreme surgical risk Evolut R 1 Year TCT2016

7 Evolut R Exclusion Criteria
Gastrointestinal hemorrhage precluding anticoagulation End state renal disease Left ventricular ejection fraction < 20% Recent percutaneous coronary or peripheral intervention Life expectancy < 1 year due to comorbidities Evolut R 1 Year TCT2016

8 Evolut R Study Methods CT imaging for valve sizing and vascular access
23 mm, 26 mm and 29 mm Evolut R with perimeter- based diameters between 18 – 26 mm Local Heart Team that included cardiac surgery and interventional cardiology determined risk National Screening Committee to confirm eligibility Independent Echocardiographic Core Laboratory (Mayo Clinic, Rochester, MN) CEC adjudicated VARC II definitions Evolut R 1 Year TCT2016

9 Investigational Sites
NYU-Langone Medical Center–New York, NY J. Slater, M. Williams Columbia University Medical Center–New York, NY I. George, S. Kodali Duke University Medical Center–Durham, NC J. K. Harrison, G.C. Hughes University of Michigan Health Systems–Ann Arbor, MI S. Chetcuti, G.M. Deeb Morristown Memorial Hospital–Morristown, NJ J. Brown, R. Kipperman Beth Israel Deaconess Medical Center–Boston, MA K. Khabbaz, J. Popma Yale New Haven Hospital–Haven, CT J. Forrest, A. Mangi Aurora St. Luke’s Medical Center–Milwaukee, WI T. Bajwa, D. O’Hair Baylor Heart and Vascular Hospital–Dallas, TX E. Hebeler, R. Stoler Spectrum Health Hospitals–Grand Rapids, MI J. Heiser, W. Merhi Methodist DeBakey Heart & Vascular–Houston, TX N. Kleiman, M. Reardon Riverside Methodist Hospital–Columbus, OH D. Watson, S. Yakubov Washington Hospital Center–Washington, DC C. Schults, R. Waksman University of Pittsburgh Medical Center–Pittsburgh, PA T. Gleason, JS Lee St. Francis Hospital–Roslyn, NY G. Petrossian, N. Robinson University of Southern California–Los Angeles, CA R. Matthews, V. Starnes St. Vincent Heart Center of Indiana–Indianapolis, IN D. Heimansohn, J. Hermiller Pinnacle Health–Wormleysburg, PA B. Maini, M Mumtaz University of Kansas Hospital–Kansas City, KS P. Tadros, G. Zorn Detroit Medical Center Cardiovascular Group–Detroit, MI S. Henry, T. Schreiber The Johns Hopkins Hospital–Baltimore, MD J. Conte, J. Resar The Mount Sinai Health System–New York, NY D. Adams, S. Sharma Banner Good Samaritan–Phoenix, AZ T. Byrne, M. Caskey Evolut R 1 Year TCT2016 9

10 Study Administration Co-Principal Investigators J. Popma, Beth Israel Deaconess Medical Center, Boston M. Williams, New York University-Langone, New York Screening Committee J. Conte, G.M. Deeb, T. Gleason, J. Popma, M. Reardon, M. Williams, S. Yakubov Echo Core Laboratory Chair: J. Oh, Mayo Clinic, Rochester, MN Data & Safety Monitoring Board J. L. Pomar, The Thorax Institut, Barcelona J. Tijssen, University of Amsterdam P. De Jaegere, Erasmus MC, Rotterdam Clinical Events Committee Chair: I. David, Holy Cross Hospital, Ft. Lauderdale Sponsor Medtronic Evolut R 1 Year TCT2016

11 Attempted Evolut R Implant N=241
Patient Disposition Attempted Evolut R Implant N=241 Died-6 Exited-2 30 Days N=233/233 (100%) Died-16 Exited-4 1- Year Evolut R N=198/213 (93.0%) Evolut R 1 Year TCT2016

12 Evolut R Baseline Characteristics
Age, years 83.3 ± 7.2 Female, % 68.5 STS – PROM, % 7.4 ± 3.4 NYHA Class III or IV, % 83.0 Previous CABG, % 23.2 Atrial fibrillation / atrial flutter, % 31.5 Diabetes mellitus, % 32.4 Chronic lung disease, % 54.0 Pre-existing PPI, % 16.6 Evolut R 1 Year TCT2016 12

13 Evolut R Baseline Characteristics
Severe aortic calcification, % 6.4 Frailty, % 69.7 Baseline Echocardiographic Findings Mean aortic valve gradient, mm Hg 48.6 ± 11.5 Maximal AV velocity, m/sec 4.5 Aortic valve area, cm2 0.6 ± 0.2 Left ventricular ejection fraction, % 59.3 Evolut R 1 Year TCT2016 13

14 Evolut R Procedural Outcomes
Characteristic N = 241 General anesthesia, % 80.7 Iliofemoral access approach, % 89.5 Valve Size Implanted, % 23 mm 1.3 26 mm 35.0 29 mm 63.7 Pre-TAVR balloon dilation, % 36.8 Post-implant balloon dilation, % 32.5 NCS Implant depth, mm 4.0 ± 2.3 LCS Implant depth, mm 5.2 ± 2.3 Evolut R 1 Year TCT2016

15 Evolut R 30-Day Outcomes Characteristic N = 241
Coronary obstruction, % 0.4 (N=1) More than 1 valve implanted, % 1.3 (N=3) Total Aortic Regurgitation, % None 26.3 Trace 35.5 Mild 32.5 Moderate 5.7 Severe Evolut R 1 Year TCT2016

16 Evolut R Valve Performance
Effective Orifice Area, cm2 Mean Gradient, mm Hg Gradient 237 222 223 183 EOA 211 198 205 157 Evolut R 1 Year TCT2016

17 Hemodynamics by Valve Size*
Aortic-Valve Area, cm2 AV Mean Gradient, mm Hg Evolut R 1 Year TCT2016 *Excluding 3 patients implanted with the 23 mm

18 Left Ventricular Mass Regression
Left Ventricular Mass, gm Evolut R 1 Year TCT2016

19 Evolut R New York Heart Association
Percentage of Patients Evolut R 1 Year TCT2016

20 Evolut R Paravalvular Regurgitation
Percent of Evaluable Echocardiograms Evolut R 1 Year TCT2016

21 Evolut R 1-Year Outcomes
Outcome (KM rates) 30 Days 1 Year All-cause mortality, % 2.5 8.6 Cardiovascular mortality, % 7.0 All stroke, % 5.0 7.7 Disabling stroke, % 3.3 5.1 Non disabling stroke, % 1.7 3.9 TIA, % 0.8 All-cause mortality or disabling stroke, % 5.4 11.9 Evolut R 1 Year TCT2016 21

22 Evolut R 1-Year Outcomes
Outcome (KM rates) 30 Days 1 Year Major vascular complications, % 7.5 Life-threatening or disabling bleeding, % 7.1 9.3 Major bleeding, % 5.0 10.1 Permanent pacemaker implanted, % 16.4 18.2 There were no instances of embolization or migration, valve dysfunction requiring repeat procedure, endocarditis or valve thrombosis Evolut R 1 Year TCT2016 22

23 Evolut R Expanded Size Range
Evolut R 23 mm , 26 mm, 29 mm CE and FDA Approved Evolut R 34 mm FDA Approved 18–20 mm 20–23mm 23–26 mm 26–30 mm Patient Annulus Diameter Range (mm) Evolut R 1 Year TCT2016

24 Evolut R Baseline Characteristics – 34 mm
Age, years 80.3 ± 8.1 Male, % 100 STS – PROM, % 4.8 ± 2.2 NYHA Class III or IV, % 86.7 Previous CABG, % 26.7 Atrial fibrillation / atrial flutter, % Diabetes mellitus, % 33.3 Chronic lung disease, % 66.7 Pre-existing PPI, % 13.3 Evolut R 1 Year TCT2016

25 Evolut R Procedural Outcomes – 34 mm
Characteristic, % N = 15 General anesthesia, % 60.0 Iliofemoral access approach, % 100 Pre-TAVR balloon dilation performed, % 73.3 Post implant dilation performed, % 46.7 More than 1 valve implanted, % Coronary obstruction, % Implant depth (non-coronary), % 5.7 ± 2.3 Implant depth (left), % 6.5 ± 2.6 Evolut R 1 Year TCT2016

26 Evolut R 30 Day Outcomes – 34 mm
Outcome (KM rates) N=15 All-cause mortality, % All stroke, % Major vascular complications, % Life-threatening or disabling bleeding, % Stage 2 or 3 AKI, % Permanent pacemaker implanted, % 2 (13.3) Embolization or migration, % Valve thrombosis, % Repeat valve intervention, % Evolut R 1 Year TCT2016

27 Evolut R Valve Performance – 34 mm
Effective Orifice Area, cm2 Mean Gradient, mm Hg Evolut R 1 Year TCT2016

28 Evolut R Paravalvular Regurgitation – 34 mm
Percent (no.) of Evaluable Echocardiograms Evolut R 1 Year TCT2016

29 Evolut R Clinical Summary
The Evolut R transcatheter aortic valve (TAV) is a self-expanding bioprosthesis that provides a low (14F equivalent/16 F for 34 mm TAV) profile delivery system, conformable annular sealing, and the ability to reposition during deployment. Early 30-day clinical outcomes are sustained 1 year post-TAVR with low all-cause mortality (8.6%) and disabling stroke (5.1%) in patients deemed high or greater risk for surgery. Favorable early 30-day results with the 34 mm Evolut R 1 Year TCT2016

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