Slide 1: Impact of Transcatheter or Surgical Aortic Valve Performance on 5-Year Outcomes
Impact of Transcatheter or Surgical Aortic Valve Performance on 5-Year Outcomes in Patients at ≥ Intermediate Risk Steven J. Yakubov, MD, MSCAI, FACC Riverside Methodist, Ohio Health, Columbus, OH, USA For the CoreValve – Evolut Clinical Investigators
Slide 2: Disclosure of Relevant Financial Relationships
Disclosure of Relevant Financial Relationships Within the prior 24 months, I have had a financial relationship with a company producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients: Nature of Financial Relationship Ineligible Company Research Support Bo
Slide 3: Background: Bioprosthetic valve performance
Background Valve performance, evaluated as bioprosthetic valve dysfunction (BVD) 1,2, is composed of: Bioprosthetic Structural valve deterioration (SVD) valve performance Non-structural valve dysfunction (NSVD) is a critical consideration when Clinical valve thrombosis evaluating TAVI durability, pa
Slide 4: Background and study objective
Background Standardized BVD criteria have not been independently verified nor been clinically validated. Study objective To evaluate the impact of valve performance, assessed by While some studies have shown the clinical importance BVD, on 5-year clinical outcomes of hemodynamic SVD 1,2, limited dat
Slide 5: Study definitions
Study definitions * Core lab if available, otherwise site-reported (expert review); † CEC adjudicated BVD, SVD, NSVD, and severe PVR rates were calculated using Fine-Gray regression with interval censoring and treating death as a competing risk. 4 Rate of severe PPM was estimated as a binomial propo
Slide 6: Study design
Study design Randomized controlled trial (RCT) subjects: Analysis 1: Cumulative CoreValve US high risk pivotal trial incidence of BVD Surgery (N=1148) and SURTAVI intermediate risk trial CoreValve/Evolut TAVI (N=1253) (N=2401) RCT subjects with addition of: CoreValve extreme risk single-arm trial Co
Slide 7: Implanted study population (N=5752)
Implanted study population (N=5752) CoreValve high risk & SURTAVI RCT CoreValve extreme risk & CAS non-RCT implanted subjects implanted subjects (N=2401) (N=3351) Surgery CoreValve/Evolut TAVI * CoreValve/Evolut TAVI † Evaluable for BVD Evaluable for BVD Evaluable for BVD (N=1117) (N=1227) (N=3262)
Slide 8: Baseline characteristics
Baseline characteristics Surgery RCT CoreValve/Evolut CoreValve/Evolut P value (n=1117) TAVI RCT (n=1227) TAVI Non-RCT (n=3262) (RCT only) Age, years 80.9 ± 6.3 80.9 ± 6.6 83.2 ± 7.9§ 0.88 Female sex 513 (45.9) 537 (43.8) 1486 (45.6) 0.29 Body surface area, m2 1.9 ± 0.2 1.9 ± 0.2 1.9 ± 0.3§ 0.64 STS
Slide 9: Analysis 1: BVD through 5 years
Analysis 1: BVD through 5 years Significantly lower rate of BVD with CoreValve/Evolut TAVI compared to surgery 20% CoreValve/Evolut TAVI RCT (N=1227) BVD cumulative incidence, % Surgery RCT (N=1117) 15.3% 15% 9.7% 10% 5% sHR, 0.57; 95%CI, 0.45 – 0.73; P<0.001 0% 0 1 2 3 4 5 Years post-procedure sHR
Slide 10: Analysis 1: Components of BVD
Analysis 1: Components of BVD 43% relative reduction of BVD with CoreValve/Evolut TAVI compared to surgery CoreValve/Evolut Surgery RCT sHR (95% CI) P value TAVI RCT (n=1227) (n=1117) BVD* 9.7 (106) 15.3 (154) 0.57 (0.45, 0.73) <0.001 SVD 2.4 (26) 4.5 (40) 0.54 (0.33, 0.88) 0.01 NSVD† 5.4 (65) 9.5 (
Slide 11: Analysis 1: BVD by annulus size
Analysis 1: BVD by annulus size Lower risk of BVD with CoreValve/Evolut TAVI compared to surgery for both small and large annuli patients CT annular diameter ≤ 23 mm CT annular diameter > 23 mm 19.5% 20% 20% BVD cumulative incidence, % BVD cumulative incidence, % sHR, 0.65; 95%CI, 0.49 – 0.86; P=0.0
Slide 12: Analysis 2: Association of BVD with 5-year clinical outcomes
Analysis 2: Association of BVD with 5-year clinical outcomes Significantly increased risk for death or hospitalization at 5 years in patients who develop BVD Pooled Surgery RCT and All CoreValve/Evolut TAVI* (N=5315) Adjusted HR (95% CI) P value All-cause mortality 1.49 (1.32, 1.68) <0.001 Cardiovas
Slide 13: Limitations
Limitations This is a higher risk, older patient population analyzed with a small number of BVD events, which was mitigated using a competing risk analysis. Although only 3% of patients were not evaluable for BVD, there are inherent limitations of a post-hoc pooled analysis (e.g., incomplete core-la
Slide 14: Summary
Summary Development of BVD, regardless of aortic valve replacement therapy, was associated with a significantly increased risk for worsened In patients with symptomatic clinical outcomes: In patients with symptomatic severeAS severe ASundergoing undergoing aortic aortic valve valve replacement,5-yea
Slide 15: Clinical implications
Clinical implications This is the first analysis to: Continuous monitoring of bioprosthesis hemodynamic performance is imperative to detect BVD and prevent increased Validate clinical criteria for risk of mortality or hospitalization. valve performance, as evaluated by a comprehensive, contemporary
Slide 16: Indications
Indications Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure The Medtronic Evolut PRO+, Evolut FX, and Evolut FX+ Systems are indicated for relief of aortic stenosis in patients with to the vapors. Damage may result
Slide 17: Medtronic contact details
710 Medtronic Parkway LifeLine ©2024 Medtronic. All rights reserved. Medtronic, Medtronic logo, Minneapolis, MN 55432-5604 CardioVascular Technical Support and Engineering the extraordinary are trademarks of Medtronic. All USA Toll-free: 877.526.7890 other brands are trademarks of a Medtronic compan