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Transcatheter Aortic Valve IMPLANTATION (TAVI)
The Medtronic Evolut™ platform is designed for valve durability, because the best reintervention is the one that never needs to happen.
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?
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 implantation have been linked to:
CoreValve™ and Evolut™ TAVI systems are the only platform to demonstrate a durability benefit over SAVR at five years.*6
Medtronic TAVI 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.
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 the videos below, experts discuss the impact of TAVI on the emerging low-risk patient population.
Round Table Interview - London Valves Video 2023 - (12:44)
Round Table Interview - London Valves Video 2023
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SMART Trial Women EuroPCR LBCT - Video - (12:02)
SMART Trial sub analysis in Women late break clinical trial at EuroPCR 2024 - Video recording
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How will the Smart Trial results impact our practice and decision making in TAVI?
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.
DISCLAIMER
The material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).
Please note that the intended use of a product may vary depending on geographical approvals. See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.
For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.
If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website 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. Medtronic products placed on European markets bear the CE mark.
For any further information, contact your local Medtronic representative.
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