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REDUCING RISK OF PATIENT-PROSTHESIS MISMATCH WITH EVOLUT™ TAVR SYSTEM

A recently published paper by Herrmann, et al.1 used STS/ACC TVT RegistryTM* data to examine the frequency and predictors of PPM and its associated outcomes.

The data shows that severe PPM is associated with higher mortality and that patient outcomes may improve when PPM is reduced.


Effect on Survival after TAVR with PPM†1

Survival After TAVR

PPM Impacts Mortality1 & Structural Valve Degeneration (SVD)2

Mortality Risk

1.2x

Patients with
severe PPM (indexed
EOA < 0.65 cm2/m2)
experienced a 20%
increase in mortality.1

HF Rehospitalization

1.4x

Patients with
iEOA < 0.85 cm2/m2 experienced a 44%
increase in heart failure hospitalizations.1

SVD Risk

2.3x

Moderate/severe PPM is independently associated with 2.3-fold increase in the risk of structural valve degeneration.2


REDUCING RISK OF PPM THROUGH VALVE DESIGN AND DEVICE SELECTION

Design Matters

  • The supra-annular, self-expanding Evolut platform allows for large EOAs and low rates of PPM.
  • The difference in hemodynamics between the self-expanding and balloon-expandable platform is significant in the small annulus.3
Evolut R Valve

Evlout™ R valve

Sapien 3 Valve

Sapien 3™* valve

The Evolut TAVR platform achieves large EOAs by having a valve design that reduces obstruction to the blood flowing through the annulus.


Device Selection Matters

Predictors of Severe PPM1

Predictors of Severe PPM

Valve Sizes at Elevated Risk of PPM

Elevated Risk of PPM

†† TAV-in-SAV only


The analysis set for this data included all patients enrolled in the registry between January 1, 2014, and March 31, 2017, and included all U.S. Medtronic and Edwards commercial valves.

© 2018 Medtronic. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. TM*Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. 


1

Herrmann HC, Daneshvar SA, Fonarow GC, et al. Prosthesis-Patient Mismatch in 62,125 Patients Following Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry. J Am Coll Cardiol. Published online September 23, 2018.

2

Flameng W, Herregods MC, Vercalsteren M, Herijgers P, Bogaerts K, Meuris B. Prosthesis-patient mismatch predicts structural valve degeneration in bioprosthetic heart valves. Circulation. May 18, 2010;121(19):2123-2129.

3

Rogers T, et al. Choice of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Impacts Hemodynamics Differently According to Aortic Annular Size. Am J Cardiol.2017;119(6):900-904.