Randomized (CO)mparison of (TRI)fecta and (P)erimount Magna Ease Supraannular Aortic Xenografts-CO.TRI.P Study

Thorac Cardiovasc Surg. 2019 Jun;67(4):266-273. doi: 10.1055/s-0038-1637011. Epub 2018 May 1.

Abstract

Background: Modern supraannular aortic xenografts offer a special design, thus providing maximized opening area for improved hemodynamics. The aim of this study was a prospectively randomized comparison of the Trifecta and the Perimount Magna Ease valves based on metric annulus sizing.

Methods: A total of 100 patients with aortic stenosis undergoing aortic valve replacement (AVR) with or without concomitant procedures were prospectively included. After decalcification of the annulus, stratified intraoperative randomization was performed. The diameter of the aortic annulus was measured using metric Hegar dilators and randomization was based on this metric annulus diameter. Exercise echocardiography was performed at 10-month follow-up.

Results: Mean age was 69 years, with 36% female. Predominant implanted valve sizes were 23 mm (39%) and 25 mm (32%). Unadjusted mean pressure gradient was significantly lower and effective orifice area larger for the Trifecta group (10.8 ± 5 vs. 13.2 ± 4 mm Hg, p = 0.02 and 1.93 ± 0.39 vs. 1.70 ± 0.30 cm2, p = 0.002) at discharge. In patients with small annuli, based on the metric annulus size there were no significant differences in gradients or the orifice area. At exercise echocardiography follow-up, there were no significant hemodynamic differences between both prostheses.

Conclusions: The Trifecta and the Perimount Magna Ease prostheses both show excellent hemodynamic performance after AVR. In patients with larger annuli, the Trifecta valve seems to be even superior to the Magna Ease, which may be advantageous in obese patients.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aortic Valve / diagnostic imaging
  • Aortic Valve / pathology*
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / surgery*
  • Bioprosthesis*
  • Calcinosis / diagnostic imaging
  • Calcinosis / physiopathology
  • Calcinosis / surgery*
  • Echocardiography, Stress / methods
  • Exercise Test
  • Female
  • Germany
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis*
  • Hemodynamics
  • Heterografts
  • Humans
  • Male
  • Prospective Studies
  • Prosthesis Design
  • Recovery of Function
  • Time Factors
  • Treatment Outcome

Supplementary concepts

  • Aortic Valve, Calcification of