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Medtronic — Technical Presentation (March 2023)
22 slides from Medtronic's technical presentation, March 2023
Slide 1: Transcatheter vs. Surgical Aortic Valve Replacement in Low Risk Patients: 3-Year Outcomes
Transcatheter vs. Surgical Aortic Valve Replacement in Low Risk Patients: 3-Year Outcomes from the Evolut Low Risk Trial John K. Forrest, MD Director of Interventional Cardiology | Director of Structural Heart Program | Yale University School of Medicine | Yale New Haven Health System @johnkforrest
Slide 2: Disclosures
3-Year Outcomes from the Evolut Low Risk Trial Disclosures Within the past 12 months, I have had a financial interest/arrangement or affiliation with the organization(s) listed below Financial Relationship Company Research grants, consulting fees, Medtronic, Edwards Lifesciences honoraria, speakers
Slide 3: Study Administration
3-Year Outcomes from the Evolut Low Risk Trial Study Administration Principal Investigators: John Forrest, Michael Reardon Executive Committee: G. Michael Deeb, Michael Reardon, Steven Yakubov Steering Committee: David Adams, Stanley Chetcuti, G. Michael Deeb, John Forrest, John Heiser, William Merh
Slide 4: Background
3-Year Outcomes from the Evolut Low Risk Trial Background • Now approved for all patients with severe symptomatic aortic stenosis regardless of surgical risk, TAVR has become the dominant form of AVR in the US. • Current ACC/AHA guidelines recommend that heart teams utilize a shared decision-making
Slide 5: Background: Evolut Low Risk and PARTNER 3
3-Year Outcomes from the Evolut Low Risk Trial Background Evolut Low Risk – 2 years5 • Data in low-risk patients have shown promising short-term mortality, stroke, and recovery benefits, and understanding how durable these results are will help to guide the shared decision-making process. PARTNER 3
Slide 6: Study Design
3-Year Outcomes from the Evolut Low Risk Trial Study Design Patients with Severe AS Clinical events Committee Low risk of death (<3%) from surgery Adjudicated all endpoints Anatomy suitable for both TAVR and SAVR Echo Core Laboratory Evaluation all echocardiograms Screening Committee Confirmed eligi
Slide 7: Participating Sites in the United States (61)
3-Year Outcomes from the Evolut Low Risk Trial Participating Sites in the United States (61) 7 Forrest JK, et al. Transcatheter Versus Surgical Aortic Valve Replacement in Aortic Stenosis Patients at Low Surgical Risk: 3-Year Outcomes from the Evolut Low Risk Trial. Presented at ACC; March 2023.
Slide 8: Participating Sites in Australia, Canada, Europe, Japan and New Zealand (25)
3-Year Outcomes from the Evolut Low Risk Trial Participating Sites in Australia, Canada, Europe, Japan and New Zealand (25) 8 Forrest JK, et al. Transcatheter Versus Surgical Aortic Valve Replacement in Aortic Stenosis Patients at Low Surgical Risk: 3-Year Outcomes from the Evolut Low Risk Trial. Pr
Slide 9: Baseline Characteristics
3-Year Outcomes from the Evolut Low Risk Trial Baseline Characteristics Evolut TAVR Surgery Mean ± SD or % (N=730) (N=684) Age 74.1 ± 5.8 73.7 ± 5.9 Female 36.4 34.1 Left ventricular ejection fraction, % 61.7 ± 7.9 61.9 ± 7.7 STS-PROM score, % 2.0 ± 0.7 1.9 ± 0.7 NYHA class III/IV 24.9 28.2 Hyperten
Slide 10: Primary Endpoint: All-Cause Mortality or Disabling Stroke
3-Year Outcomes from the Evolut Low Risk Trial Primary Endpoint: All-Cause Mortality or Disabling Stroke 20% Evolut TAVR Surgery 3 Years All-Cause Mortality or Disabling Δ -2.9% 15% P=0.051 HR 0.70 95% CI (0.49 – 1.00) 2 Years 10.4% Stroke 1 Year Δ -2.0% 10% 30 Days Δ -1.8% P=0.084 Δ -1.8% P=0.006 P
Slide 11: All-Cause Mortality and Disabling Stroke
3-Year Outcomes from the Evolut Low Risk Trial All-Cause Mortality and Disabling Stroke All-Cause Mortality Disabling Stroke 40% 15% TAVR Surgery 30% All-Cause Mortality TAVR Surgery Disabling Stroke 10% Log-rank p value = 0.19 Log-rank p value = 0.161 20% 5% 10% 8.3% 3.4% 6.3% 2.3% 0% 0% 0 6 12 18
Slide 12: Death or Disabling Stroke by Baseline Demographics
3-Year Outcomes from the Evolut Low Risk Trial 3-Year Death or Disabling Stroke by Baseline Demographics KM rate at 3 years P value for Variable HR (95% CI) Evolut Interaction Surgery TAVR Age, years 0.95 < 75 5.7 8.0 0.71 (0.40-1.26) ≥ 75 9.1 13.0 0.68 (0.43-1.07) Sex 0.41 Male 7.8 11.7 0.64 (0.41-
Slide 13: Clinical Outcomes Through 3-Years
3-Year Outcomes from the Evolut Low Risk Trial Clinical Outcomes Through 3-Years Evolut TAVR Surgery Kaplan-Meier estimate, % Log-rank P Value (N=730) (N=684) All-cause mortality, disabling stroke, or AV hospitalization 13.2 16.8 0.050 AV hospitalizationa 7.4 9.2 0.20 Myocardial infarction 3.4 2.3 0
Slide 14: Valve Performance at 3 Years
3-Year Outcomes from the Evolut Low Risk Trial Valve Performance at 3 Years % (n)a Evolut TAVR Surgery Log-rank P Value Paravalvular Regurgitation N=541 N=447 None/trace 78.7 97.3 ≥ Mild 21.3 2.7 <0.001 ≥ Moderate 0.9 0.2 0.16 Prosthesis-Patient Mismatch (VARC-3) N=489 N=394 None 89.4 74.9 Moderate
Slide 15: All-Cause Mortality or Disabling Stroke in the TAVR Cohort by PVR
3-Year Outcomes from the Evolut Low Risk Trial 3-Year All-Cause Mortality or Disabling Stroke in the TAVR Cohort by PVR Landmarked at 1-Month Echo 20% PVR ≥ Mild at 1 month PVR None/trace at 1 month All-Cause Mortality or 15% Log-rank p value = 0.40 Disabling Stroke 10% 8.6% 7.0% 5% 0% 0 6 12 18 24
Slide 16: Valve Hemodynamics to 3-Years
3-Year Outcomes from the Evolut Low Risk Trial Valve Hemodynamics to 3-Years Significantly better MG and EOA with TAVR at all follow-up timepoints (p < 0.01) 3.0 TAVR Surgery 60.0 2.5 2.2 2.2 2.2 2.2 Effective Orifice Area, cm2 50.0 Mean Gradient, mm Hg 44.8 2.0 44.2 2.1 2.0 2.0 40.0 2.0 1.5 30.0 1.
Slide 17: KCCQ Overall Summary Score
3-Year Outcomes from the Evolut Low Risk Trial KCCQ Overall Summary Score 100 TAVR 95 88.6 90.6 90.1 89.7 Surgery 90 90.5 90.4 90.1 85 80 75 78.7 70 69.4 65 68.6 60 Baseline 1 Month 1 Year 2 Years 3 Years Change from Baseline Evolut TAVR 20.0 ± 21.1 21.6 ± 20.6 20.9 ± 20.8 20.1 ± 20.6 Surgery 9.2 ±
Slide 18: Summary
3-Year Outcomes from the Evolut Low Risk Trial Summary • At 3 years, the rate of all-cause mortality or disabling stroke after TAVR with the Evolut Valve compared favorably to surgery. • The absolute difference between treatment arms remained consistent with a 30% relative reduction in hazard (p = 0
Slide 19: Limitations
3-Year Outcomes from the Evolut Low Risk Trial Limitations • Patients with bicuspid aortic valves were excluded • Patients had to have anatomy suitable for both TAVR and SAVR • These are 3-year results and longer-term data are needed to evaluate the impact that valve design, hemodynamics, new pacema
Slide 20: Clinical Implications
3-Year Outcomes from the Evolut Low Risk Trial Clinical Implications • These results provide physicians, patients and heart teams important data to aid in the shared decision-making process. • The excellent valve performance and durable outcomes out to 3 years in low- risk patients affirms the role
Slide 21: Indications
Indications Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to The Medtronic CoreValve™ Evolut™ R, Evolut™ PRO+, and Evolut™ FX Systems are indicated for relief of aortic stenosis in patients with the vapors. Damage
Slide 22: Medtronic contact information
710 Medtronic Parkway LifeLine ©2023 Medtronic. All rights reserved. Medtronic, Medtronic logo, Minneapolis, MN 55432-5604 CardioVascular Technical Support and Engineering the extraordinary are trademarks of Medtronic. USA Toll-free: 877.526.7890 ™*Third-party brands are trademarks of their respecti