Clinical Evidence Transcatheter Aortic Valve Hemodynamics

Clinical evidence demonstrates industry-leading hemodynamics

The Medtronic transcatheter aortic valve with a self-expanding, supra-annular design delivers industry-leading hemodynamics. See the recently released clinical evidence on our newest generation TAVI device as well as longer-term hemodynamic performance out to 5 years.

TAVI - Female patient smiling  - IMAGE

EOA Matters

TAVI Hemodynamics - Flat product image file

A large EOA (effective orifce area) reduces the likelihood of PPM (patient-prosthesis mismatch). Choose Evolut™ TAVI for larger EOAs — allowing patients to maintain a higher exercise capacity.1,2

Supra-annular valves have larger EOAs3

  • A large EOA may improve activity tolerance4 which may allow a faster return to activity.1,2,4     
  • A large EOA helps avoid PPM, which correlates to better long-term survival.5
  • A large EOA provides improved fow, less resistance, and better long-term durability.5,6

Evolut TAVI platform has consistent single-digit gradients

For each increase of 1 mm Hg in mean gradient, the relative risk of heart failure recurrence or heart failure-related death is increased by 6%.7

7.1 mm Hg

Evolut PRO Clinical Study at 1 year.8

8.1 mm Hg

FORWARD at 1 year10

8.3 mm Hg

SURTAVI at 1 year.9

9.1 mm Hg

CoreValve Pivotal High Risk at 1 year.11

Gradients Matter

Low Gradients

  • Are an indicator of more efficient blood fow12
  • Reduce stress on leaflets12

High gradients

  • Indicate a greater risk of mortality12
Tavi Product imagery with Round blue circle - image

Clinical Evidence across different Levels of Risk

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High Risk

Corevalve U.S. Pivotal high risk trial 5 years follow up randomized trial

At 5-year mark, a significantly better hemodynamic performance was sustained for CoreValve™ TAVI system over SAVR with less structural valve deterioration* than SAVR11,13.

TAVI Hemodynamics - Chart image

Intermediate Risk

Low Risk

Small Annulus Big Difference

Don’t send your patients home with residual gradients

Incidence of Mean Gradient ≥ 20 mm Hg

Echocardiographic outcomes following TAVI with SAPIEN 3 23 mm TAV vs. Evolut™ 26 mm TAV16

TAVI Hemodynamics - Chart image

Treat more patients
with Evolut PRO+ 

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Low Risk <br>
Indication

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Cusp Overlap
Technique

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Footnotes

*

SVD definition reference: Capodanno D, et al, Eur Heart J. 2017;38:3382-3390​.

NYHA Class 3 or 4.

References

1

Bleiziffer S, Eichinger WB, Hettich I, et al. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Heart. May 2008;94(5):637-641.

2

Van Slooten YJ, van Melle JP, Freling HG, et al. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Heart. January 2016;102(2):107-113.

3

Hahn RT, Leipsic J, Douglas PS, et al. Comprehensive Echocardiographic Assessment of Normal Transcatheter Valve Function. JACC Cardiovasc Imaging. Published online June 8, 2018.

4

Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. J Am Coll Cardiol. November 1, 1999;34(5):1609-1617.

5

Pibarot P, Dumesnil JG. Prosthesis-patient mismatch: definition, clinical impact, and prevention. Heart. August 2006;92(8):1022-1029.

6

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.

7

Ruel M, Rubens FD, Masters RG, et al. Late incidence and predictors of persistent or recurrent heart failure in patients with aortic prosthetic valves. J Thorac Cardiosvasc Surg. January 2004;127(1):149-159.

8

Williams MR, Qiao H, Forrest JK, et al. 1-Year Outcomes With The Evolut PRO Self-Expanding Repositionable Transcatheter Aortic Valve With Pericardial Wrap. Presented at ACC Annual Scientific Session and Expo; March 10-12, 2018; Orlando, FL.

9

Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. April 6, 2017;376(14):1321-1331.

10

Grube, et al. 1-year Outcomes Following Real-world Transcatheter Aortic Valve Implantation with a Self-Expanding Repositionable Valve: Results from the FORWARD Study. Presented at EuroPCR 2018; Paris, France.

11

Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis. N Engl J Med. May 8, 2014;370(19):1790-1798.

12

Ribeiro HB, Lerakis S, Gilard M, et al. Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis: The TOPAS-TAVI Registry. J Am Coll Cardiol. March 27, 2018 71(12):1297-1308.

13

Gleason TG, Reardon MJ, Popma JJ, et al. 5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients. J Am Coll Cardiol. 2018 December 2018;72(22):2687-2696.

14

Van Mieghem NM. 5-year clinical and echocardiographic outcomes from the randomized SURTAVI trial. Presented at TCT 2021; November 5, 2021; Orlando, FL.

15

John K. Forrest, M.D. on behalf of the Evolut Low Risk Investigators. The Evolut Low Risk Trial Complete 2-year Follow-up. Presented at EuroPCR 2021.

16

Ring ME, et al. Comparison of Echocardiographic Outcomes Following Transcatheter Aortic Valve Replacement with Edwards S3 23 mm versus Medtronic Evolut 26 mm Valves. Poster presented at ACC 2020.