reducing risk of
mismatch (PPM) with
EVOLUT™ TAVI SYSTEM
PATIENT PROSTHESIS MISMATCH (PPM) MATTERS
PPM IMPACTS MORTALITY AND STRUCTURAL VALVE DEGENERATION
Degeneration (SVD) RISK
WHAT IS PATIENT PROSTHESIS MISMATCH (PPM)?
EVOLUTTM TAVI HAS LOWER Patient Prosthesis Mismatch (PPM) RATES THAN SAPIEntm 34
Patient Prosthesis Mismatch (PPM) occurs when the effective orifice area (EOA) of a normally functioning prosthesis is too small in relation to the patient’s body size.3
SUPRA-ANNULAR VALVES HAVE A LARGER EFFECTIVE ORIFICE AREA (EOA)3
- A large Effective Orifice Area (EOA) may improve activity tolerance4 which may allow a faster return to activity.5,6,7
- A large Effective Orifice Area (EOA) helps avoid Patient Prosthesis Mismatch (PPM), which correlates to better long-term survival.8
- A large Effective Orifice Area (EOA) provides improved flow, less resistance, and better long-term durability.2,8
Evoluttm TAVi Platform consistent, single-digit gradients
7.1 mm Hg
EvolutTM PRO Clinical Study at 1 year10
8.3 mm Hg
SURTAVI Study at 1 year11
8.1 mm Hg
FORWARD Study at 1 year12
9.1 mm Hg
CoreValveTM Pivotal High Risk at 1 year13
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.
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. 7Ruel 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.
Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Curr Treat Options Cardio Med. November 2016;18(11):67.
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.
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
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.
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.
Pibarot P, Dumesnil JG. Prosthesis-patient mismatch: definition, clinical impact, and prevention. Heart. August 2006;92(8):1022-1029.
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.
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.
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.
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.
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.
The commercial name of the Evolut™ R device is Medtronic CoreValve™ Evolut™ R System, and the commercial name of the Evolut™ PRO device is Medtronic CoreValve™ Evolut PRO System.