The new St Jude Trifecta versus Carpentier-Edwards Perimount Magna and Magna Ease aortic bioprosthesis: is there a hemodynamic superiority?

J Thorac Cardiovasc Surg. 2014 May;147(5):1553-60. doi: 10.1016/j.jtcvs.2013.05.045. Epub 2013 Jul 16.

Abstract

Objectives: The Trifecta valve (St Jude Medical, St Paul, Minn) is a new bioprosthetic heart valve designed for supra-annular aortic valve replacement. We compared the hemodynamic performance of the Trifecta against the Perimount-Magna and Magna-Ease valve prostheses (Edwards Lifesciences, Irvine, Calif) in a nonrandomized, observational, single-center study.

Methods: A total of 346 consecutive patients with aortic valve disease underwent aortic valve replacement between January 2003 and November 2011, with implantation of the Trifecta (group 1, n = 121), the Perimount-Magna (group 2, n = 126), or the Magna Ease bioprosthesis (group 3, n = 99). Clinical and hemodynamic data were prospectively recorded and compared. Hemodynamic performance was evaluated by transthoracic echocardiography, including mean pressure gradient (MPG) and aortic valve area (AVA) at baseline, discharge, and 6-month follow-up. A multivariate model of covariance analysis was constructed to further compare the primary study end points of MPG and AVA at 6-month follow-up.

Results: For all valve sizes, unadjusted MPGs did not differ (P = .08), but AVAs differed (P < .001) between groups at 6-month follow-up. After final adjustment by a multivariate model of covariance analysis, neither the MPGs (P = .16) nor the AVAs (P = .92) at 6 months postoperatively were influenced by the type of prosthesis used.

Conclusions: The present observational study is the first to compare the new Trifecta valve with well-established supra-annular aortic valve bioprostheses from a hemodynamic perspective. Although mean pressure gradients and aortic valve areas seem to be advantageous at 6-month follow-up with the new Trifecta valve, after multivariate covariance analysis, no influence of prosthesis type on mean pressure gradient or aortic valve area could be demonstrated.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery*
  • Bioprosthesis*
  • Chi-Square Distribution
  • Echocardiography, Doppler
  • Female
  • Germany
  • Heart Valve Diseases / diagnosis
  • Heart Valve Diseases / physiopathology
  • Heart Valve Diseases / surgery*
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis*
  • Hemodynamics*
  • Humans
  • Male
  • Multivariate Analysis
  • Predictive Value of Tests
  • Prosthesis Design
  • Retrospective Studies
  • Time Factors
  • Treatment Outcome