People who know, think Evolut First.
CoreValve™/Evolut™ is the first and only platform to outperform surgery in valve durability at five years.1
Hear from the experts
Clinical data
A decade of durability
NOTION trial 10-year results1
Statistically lower rates of moderate or greater structural valve deterioration (SVD)‡ out to 10-years versus surgery.
TAVI platform demonstrates statistically better durability versus surgery at 10 years in lower surgical risk patients.
Statistically lower bioprosthetic valve dysfunction (BVD)‡ vs. SAVR at 10 years.
The best durability.
CoreValve/Evolut TAVI is the first and only platform to demonstrate a durability and valve performance benefit over SAVR at 5 years in randomized clinical trials.†1
Devices used:
88% CoreValve
12% Evolut R
CoreValve and Evolut platforms pooled analysis:
Bioprosthetic valve dysfunction‡ out to 5 years1
The best TAVI vs. SAVR durability data yet.
The CoreValve™/Evolut™ TAVI system is the only TAVI platform to demonstrate a lower rate of SVD compared to SAVR at five years†1.
4.38% Surgery RCT (N = 971)
2.20% CoreValve™/Evolut™ RCT (N = 1,128)
Devices used:
88.5% CoreValve™ TAV
11.5% Evolut™ R
CoreValve™ and Evolut™ pooled analysis:
5-year SVD adjusted for competing risk of mortality†1
Medtronic TAVI platforms demonstrated significantly lower rates of structural valve deterioration (SVD)‡ vs. SAVR at five years1.
TAVI risks may include, but are not limited to: death, stroke, damage to the arteries, bleeding, and the need for a permanent pacemaker.
Supra-annular design benefits.
Valve durability for supra-annular, self-expandable TAV was found to be statistically better at five years vs. both SAVR and balloon-expandable TAV2.
At five years, supra-annular, self-expandable (SE) valves demonstrated:
- Lowest risk of structural valve deterioration (SVD) compared with balloon-expandable (BE) valves and SAVR
- Significantly stronger hemodynamics with larger EOAs and lower mean gradients versus BE valves
Study design
- Meta-analysis
- 10 randomized controlled trials
- 9,388 patients
- Follow-up 1 to 6 years
- Multiple devices§
5-year meta-analysis2
Structural valve deteriorationll
Only SE performs better than SAVR.
Comparison: others versus SAVR
(random effects model)
SE performs better than SAVR and BE.
Comparison: others versus self-expandable
(random effects model)
Longevity data that may surprise you.
Data show longevity after SAVR based on stratification by age and surgical risk groups.
- High risk/80 years at AVR: median survival < 6 years
- Intermediate risk/75 years at AVR: median survival 7–8 years
- Low risk/70 years at AVR: median survival 12–13 years
- Low risk/75 years at AVR: median survival ~10 years
- Low risk/80 years at AVR: median survival 8–10 years
Durability starts with design.
Built on a proven foundation.
With its supra-annular, self-expanding valve frame, Evolut™ TAVI is built on the original CoreValve™ platform, which has consistently shown strong EOAs and low gradients over time.
How did we design for durability?
More surface
Taller leaflet mounting allows for a greater distance between the commissure and the edge of the leaflet, distributing stress over a greater distance.
More height
By decoupling the native annular plane, where the sealing occurs, from the working portion of the prosthetic leaflets, you can facilitate circularity and maximize leaflet coaptation.
More room
The tall valve keeps the working portion above and unconstrained by the native annulus, allowing for a large effective orifice area.
*
™Third-party brands are trademarks of their respective owners.
†
In pooled analysis of intermediate- and high-risk patients. Devices used: CoreValve™ 88.5%/Evolut™ R 11.5%.
‡
Structural valve deterioration (SVD) was defined as an increase in mean gradient ≥ 10 mm Hg over five years with a mean gradient ≥ 20 mm Hg at last echo OR new onset/increase of central AR of ≥ moderate in severity.
§
CoreValve™, Evolut™ R, Evolut™ PRO, SAPIEN™*, SAPIEN 3, SAPIEN XT, and ACURATE neo™*.
||
Based on the longest available follow-up for each of the 10 studies used for this meta-analysis. SVD was defined by the respective authors of each paper.
References
1
Reardon MJ, et al. 5-Year Incidence, Timing and Predictors of Structural Valve Deterioration of Transcatheter and Surgical Aortic Bioprostheses: Insights from the CoreValve US Pivotal and SURTAVI Trials. Presented at ACC 2022. Updated data on file.
2
Ueyama H, Kuno T, Takagi H, et al. Meta-Analysis Comparing Valve Durability Among Different Transcatheter and Surgical Aortic Valve Bioprosthesis. Am J Cardiol. November 1, 2021;158:104-111.
3
Martinsson A, Nielsen SJ, Milojevic M, et al. Life Expectancy After Surgical Aortic Valve Replacement. J Am Coll Cardiol. November 30, 2021;78(22):2147-2157.
DISCLAIMER
See the CoreValve™ Evolut™ R, the CoreValve™ Evolut™ PRO and the Evolut™ PRO+ device manuals for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.
For applicable products, consult instructions for use on manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.
The commercial name of the Evolut™ R device is Medtronic CoreValve™ Evolut™ R System, the commercial name of the Evolut™ PRO device is Medtronic CoreValve™ Evolut™ PRO System, and the commercial name of the Evolut™ PRO+ device is Medtronic Evolut™ PRO+ System.
© 2020 Medtronic. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic™.* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.