HEMODYNAMICS

Evolut TAVR Platform
Supra-annular, self-expanding valve design delivers better hemodynamics1 — that go above and beyond.

   Indications, Safety, and Warnings

EOA MATTERS

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

DOWNLOAD EOA CHART
EOA Matters Comparison

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 flow, less resistance, and better long-term durability.5,6

Evolut TAVR Platform 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 year8

8.3 mm Hg

SURTAVI at 1 year9

8.1 mm Hg

FORWARD at 1 year10

9.1 mm Hg

CoreValve Pivotal High Risk at 1 year11

GRADIENTS MATTER

Low gradients

  • Are an indicator of more efficient blood flow12
  • Reduce stress on leaflets12

High gradients

  • Indicate a greater risk of mortality12

SEE THE EVIDENCE

PATIENT- PROSTHESIS MISMATCH MATTERS

PPM impacts mortality and valve durability

REVIEW THE PROOF

19%

Increase in 1-year mortality in patients with severe PPM13

2.3X

Increased risk of valve deterioration in patients with moderate/severe PPM6

Evolut TAV has lower PPM rates than Sapien™* 3.14

WHAT IS PATIENT PROSTHESIS MISMATCH (PPM)?

PPM occurs when the effective orifice area (EOA) of a normally functioning prosthesis is too small in relation to the patient’s body size.15

PPM Chart comparing Evolut R/PRO to Sapien 3

CHOICE

EXTEND

REGISTRY<sup>14</sup>

Incidence of PPM 30 Days
After TAVR

†NYHA Class 3 or 4.

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

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. December 4, 2018;72(22):2701-2711.

14

Abdelghani M, Allali A, Kaur J, et al. Impact of prosthesis-iteration evolution and sizing practice on the incidence of prosthesis–patient mismatch after transcatheter aortic valve replacement. Catheter Cardiovasc Interv. April 1, 2019;93(5):971-979.

15

Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Curr Treat Options Cardio Med. November 2016;18(11):67.

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