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?
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.
Taller leaflet mounting allows for a greater distance between the commissure and the edge of the leaflet, distributing stress over a greater distance.
The tall valve keeps the working portion above and unconstrained by the native annulus (supra-annular), allowing for a large effective orifice area (EOA).
Large EOAs mean less restriction of blood through the valve.
Less restriction leads to low gradients (mean systolic gradient).
Large EOAs have been correlated to less patient-prosthesis mismatch (PPM).
Less PPM and low gradients after aortic valve replacement have been linked to:
CoreValve™ and Evolut™ TAVR systems are the only platform to demonstrate a durability benefit over SAVR at five years.*6
Medtronic TAVR platforms demonstrated significantly lower rates of structural valve deterioration (SVD)† versus SAVR at five years.
* 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.
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.
Valves with low stable gradients tend to be more durable and less affected by SVD. The CoreValve/Evolut platform has demonstrated excellent hemodynamic results compared with balloon-expandable valves and SAVR across clinical trials.
In this video series, experts discuss the impact of TAVR on the emerging low-risk patient population in the United States.
Playford D, Stewart S, Celermajer D, et al. Poor Survival with Impaired Valvular Hemodynamics After Aortic Valve Replacement: The National Echo Database Australia Study. J Am Soc Echocardiogr. 2020;33(9):1077–1086.e1.
Herrmann HC, Daneshvar SA, Fonarow GC, et al. Prosthesis-Patient Mismatch in Patients Undergoing Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry. J Am Coll Cardiol. 2018;72(22):2701–2711.
Anand V, Ali MA, Naser J, et al. Incidence, Mechanisms, and Predictors of Mean Systolic Gradients ≥20 mm Hg after Transcatheter Aortic Valve Implantation. Am J Cardiol. 2020;125(6):941–947.
O’Hair D. Presented at American College of Cardiology 70th Annual Scientific Session & Expo. May 2021.
Søndergaard L, Ihlemann N, Capodanno D, et al. Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk. J Am Coll Cardiol. 2019;73(5):546–553.
Reardon M. 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.