People who know,
think Evolut™ First.
The evidence points to Evolut TAVR.
The best durability.
Only CoreValve™/Evolut TAVR has shown a durability benefit over SAVR in multi-centered, randomized clinical trials out to 5 years1 and 10 years.2
Durability starts
with design.
Catch Dr. Rizik's insights on the performance of the CoreValve/Evolut platform and explore how our design contributes to these outcomes.
A decade of durability.
The CoreValve platform demonstrates statistically better durability versus surgery at 10 years.†2
Statistically lower rates of moderate or greater structural valve deterioration (SVD) out to 10 years versus surgery.‡
SVD out to 10 years
|
|
Moderate SVD |
Severe SVD |
|---|---|---|
| CoreValve TAVR |
19.4 |
3.1 |
| SAVR |
36.0 |
11.0 |
| p-value |
0.0012 |
0.014 |
†In patients at lower surgical risk over the age of 70. Devices used: CoreValve 100%.
‡Structural valve deterioration3 was defined as moderate or severe hemodynamic SVD (Mean gradient ≥ 20 mm Hg or Mean gradient ≥ 10 mm Hg change from index discharge or moderate/severe intra-prosthetic aortic regurgitation [AR]-new or worsening from discharge).
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
Performance that matters.
CoreValve/Evolut TAVR demonstrates statistically better durability and valve performance versus SAVR at 5 years.§4
Devices used:
88% CoreValve
12% Evolut R
CoreValve/Evolut platform pooled analysis:
Bioprosthetic valve dysfunction|| out to 5 years4
§In pooled analysis of intermediate- and high-risk patients.
||Bioprosthetic valve dysfunction (BVD) was defined as3,5: SVD6(mean gradient ≥ 10 mm Hg increase from discharge/30 days AND ≥ 20 mm Hg at last echo or new onset/increase of ≥ moderate intraprosthetic aortic regurgitation), NSVD (30-day severe PPM at 30-day/discharge5or severe PVR through 5 years), clinical valve thrombosis, and endocarditis.
TAVR 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.
Built on a proven foundation.
With its supra-annular, self-expanding valve frame, Evolut TAVR 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.
Connect with us on social.
Twitter
@MDT_StructHeart
LinkedIn
Medtronic Cardiac and Vascular
Stay informed.
Sign up to get the latest information and resources from Medtronic on treating aortic stenosis and the Evolut™ platform.
*
™Third-party brands are trademarks of their respective owners.
†
In patients at lower surgical risk over the age of 70. Devices used: CoreValve 100%.
‡
Structural valve deterioration3 was defined as moderate or severe hemodynamic SVD (Mean gradient ≥ 20 mm Hg or Mean gradient ≥ 10 mm Hg change from index discharge or moderate/severe intra-prosthetic aortic regurgitation [AR]-new or worsening from discharge).
§
In pooled analysis of intermediate- and high-risk patients.
||
Bioprosthetic valve dysfunction (BVD) was defined as3,5: SVD6 (mean gradient ≥ 10 mm Hg increase from discharge/30 days AND ≥ 20 mm Hg at last echo or new onset/increase of ≥ moderate intraprosthetic aortic regurgitation), NSVD (30-day severe PPM at 30-day/discharge5 or severe PVR through 5 years), clinical valve thrombosis, and endocarditis.
References
1
O'Hair D, Yakubov SJ, Grubb KJ, et al. Structural valve deterioration after self-expanding transcatheter or surgical aortic valve implantation in patients at intermediate or high risk. JAMA Cardiol. February 1, 2023;8(2):111–119.
2
Jørgensen T. Ten-year follow-up after transcatheter or surgical aortic valve implantation in severe aortic valve stenosis. Presented at ESC Congress; August 2023.
3
Capodanno D, Petronio AS, Prendergast B, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. December 1, 2017;38(45):3382-3390.
4
Yakubov S, et al. Five-Year Incidence of Bioprosthetic Valve Dysfunction in Patients Randomized to Surgery or TAVR: Insights From the CoreValve US Pivotal and SURTAVI Trials. Presented at CRT; February 2023.
5
VARC-3 Writing Committee; Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. May 14, 2021;42(19):1825-1857.
6
Adapted from VARC-3 Writing Committee, et al. and Capodanno D, et al.