Medtronic Plc. · NYSE:MDT
Medtronic — Technical Presentation (February 2023)
20 slides from Medtronic's technical presentation, February 2023
Slide 1: 5-Year Incidence of Bioprosthetic Valve Dysfunction in Patients Randomized to Surgery or TAVR
5-Year Incidence of Bioprosthetic Valve Dysfunction in Patients Randomized to Surgery or TAVR: Insights from the CoreValve US Pivotal and SURTAVI Trials Steven J. Yakubov, MD Riverside Methodist, Ohio Health, Columbus, OH, USA For the CoreValve – Evolut Clinical Investigators
Slide 2: Disclosures
CoreValve-Evolut Pooled Analysis Disclosures Research support from Boston Scientific and Medtronic. Honoraria from Boston Scientific and Medtronic outside the submitted work. 2 Yakubov S, et al. Five-Year Incidence of Bioprosthetic Valve Dysfunction in Patients Randomized to Surgery or TAVR: Insight
Slide 3: Background
CoreValve-Evolut Pooled Analysis Background Long-term bioprosthetic valve performance is a critical consideration when evaluating the durability of transcatheter aortic valve replacement (TAVR), particularly in younger, low risk patients with longer life expectancies. The VARC-3 and EAPCI consensus
Slide 4: Background: SVD Cumulative Incidence
CoreValve-Evolut Pooled Analysis Background CoreValve/Evolut Surgery RCT (N=971) TAVR RCT (N=1128) A recent analysis with supra- 6% P = 0.004 annular, self-expanding TAVR 5% 4.38% bioprostheses demonstrated SVD Cumulative Incidence 4% a significantly lower 5-year rate of SVD* with TAVR vs. Surgery 3
Slide 5: Background
CoreValve-Evolut Pooled Analysis Background • A recent analysis with supra-annular, self-expanding TAVR bioprostheses demonstrated a significantly lower 5-year rate of SVD with TAVR vs. Surgery and reported an association between SVD and worse clinical outcomes.1 • Limited data exist on the incidenc
Slide 6: Study Objective
CoreValve-Evolut Pooled Analysis Study Objective To evaluate the incidence, outcomes and predictors of long-term valve performance, as assessed by 5-year BVD, in patients undergoing supra-annular, self-expanding TAVR or surgery 6 Yakubov S, et al. Five-Year Incidence of Bioprosthetic Valve Dysfuncti
Slide 7: Study Population and Definitions
CoreValve-Evolut Pooled Analysis Study Population and Definitions Datasets: CoreValve US high risk pivotal and SURTAVI intermediate risk randomized clinical trials Analysis 1: Cumulative incidence rate of valve performance (BVD) Analysis 2: Association of valve performance (BVD) with clinical outcom
Slide 8: Study Demographics
CoreValve-Evolut Pooled Analysis Study Demographics CoreValve US Pivotal and SURTAVI trials Surgery CoreValve/Evolut TAVR (N=2099) (N=971) (N=1128) Age, years 80.6 ± 6.3 80.9 ± 6.5 Male 527 (54.3) 632 (56.0) Body surface area, m2 1.9 ± 0.2 1.9 ± 0.2 STS-PROM, % 5.3 ± 2.5 5.2 ± 2.4 NYHA III/IV 639 (6
Slide 9: 5-Year Valve Performance
CoreValve-Evolut Pooled Analysis 5-Year Valve Performance Significantly lower rate of BVD with CoreValve/Evolut TAVR vs. Surgery through 5 years 20% Surgery (N=971) CoreValve/Evolut TAVR (N=1128)* HR, 0.50; 95%CI, 0.38-0.66; P<0.001† 14.2% BVD Cumulative Incidence 15% 10% 7.8% 5% 0% 0 1 2 3 4 *CoreV
Slide 10: Components of 5-Year Valve Performance
CoreValve-Evolut Pooled Analysis Components of 5-Year Valve Performance 2x lower SVD and 3x lower severe PPM with CoreValve/Evolut TAVR vs. Surgery CoreValve/ Surgery HR (95% CI) P value Evolut TAVR (N=971) (N=1128) BVD, % 7.8 14.2 0.50 (0.38, 0.66) <0.001 SVD 2.2 4.4 0.46 (0.27, 0.78) 0.004 NSVD* 4
Slide 11: 5-Year Valve Performance in Smaller Annular Diameters
CoreValve-Evolut Pooled Analysis 5-Year Valve Performance in Smaller (≤ 23 mm) Annular Diameters Significantly lower rate of BVD with CoreValve/Evolut TAVR vs. Surgery through 5 years in small annuli 20% 19.7% Surgery (N=218) CoreValve/Evolut TAVR (N=268) HR, 0.50; 95%CI, 0.38-0.66; P<0.001† BVD Cum
Slide 12: 5-Year Valve Performance in Larger Annular Diameters
CoreValve-Evolut Pooled Analysis 5-Year Valve Performance in Larger (> 23 mm) Annular Diameters Significantly lower rate of BVD with CoreValve/Evolut TAVR vs. Surgery through 5 years in a large annuli 20% Surgery (N=748) CoreValve/Evolut TAVR (N=856) HR, 0.60; 95%CI, 0.43-0.82; P=0.002 † BVD Cumulat
Slide 13: Worsened Clinical Outcomes in Patients who developed BVD
CoreValve-Evolut Pooled Analysis Worsened Clinical Outcomes in Patients who developed BVD HR (95% CI) P value Pooled Surgery and TAVR (N=2099) All-cause mortality 1.46 (1.13, 1.88) 0.004 Cardiovascular mortality 1.84 (1.34, 2.51) <0.001 Hospitalization for valve disease/worsening HF 1.67 (1.23, 2.26
Slide 14: Baseline Characteristics of Patients with and without BVD
CoreValve-Evolut Pooled Analysis Baseline Characteristics of Patients with and without BVD Pooled Surgery and CoreValve/Evolut TAVR Patients with BVD Patients without BVD (N=2099) (N=210) (N=1889) Age, years 79.5 ± 7.0 80.9 ± 6.3† Male 101 (48.1) 1058 (56.0)† Body surface area, m2 1.9 ± 0.2 1.9 ± 0.
Slide 15: Pre-procedure Predictors of 5-Year BVD
CoreValve-Evolut Pooled Analysis Pre-procedure Predictors of 5-Year BVD Univariable Model Multivariable Model§ Pooled Surgery and CoreValve/Evolut TAVR HR (95% CI) P value HR (95% CI) P value (N=2099) Age, years 0.97 (0.95, 0.99) 0.004 0.98 (0.96, 1.00) 0.02 Male 0.73 (0.56, 0.96) 0.03 0.61 (0.44, 0
Slide 16: Limitations
CoreValve-Evolut Pooled Analysis Limitations • Current follow-up is limited to 5 years. Ten-year follow-up is ongoing for the SURTAVI clinical trial. • Further analysis in younger patients is warranted. • The competing risk of mortality and inclusion of only randomized patients limited the number of
Slide 17: Conclusions
CoreValve-Evolut Pooled Analysis Conclusions • In patients with symptomatic severe AS undergoing aortic valve replacement, valve performance was superior at 5-years in patients undergoing TAVR compared to surgery (7.8% BVD TAVR vs. 14.2% BVD surgery; P<0.001). • This difference in valve performance
Slide 18: Clinical Implications
CoreValve-Evolut Pooled Analysis Clinical Implications • Long-term valve performance should be a key consideration in the selection of the first bioprosthesis, particularly in younger, low risk patients with longer life expectancies. • The CoreValve / Evolut supra-annular, self-expanding bioprosthes
Slide 19: 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 20: Medtronic contact details
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