Prospectively randomized evaluation of stented xenograft hemodynamic function in the aortic position

Circulation. 2004 Sep 14;110(11 Suppl 1):II74-8. doi: 10.1161/01.CIR.0000138947.63799.89.

Abstract

Background: Standard stented aortic xenograft valves have not yet been compared regarding their hemodynamic function using a stratified intraoperative randomization protocol.

Methods and results: 100 patients were prospectively included after intraoperative metric sizing of the decalcified aortic annulus. They received Mosaic (M) or Perimount (P) aortic valve replacement. Patient age was 73+/-5 years, 51 were female, and New York Heart Association (NYHA) functional class was 2.8+/-0.5. The 21-mm annulus group consisted of 5 (M)/7 (P) patients, the 23-mm annulus group of 20 (M)/20 (P), the 25-mm annulus group of 18 (M)/19 (P), and the 27-mm annulus group of 4 (M)/7 (P) patients, respectively. Hemodynamic function was evaluated using transthoracic echocardiography before discharge and at follow-up (438+/-352 days). Surgery was uncomplicated in all patients. Labeled valve sizes were 0.93 (M) and 1.05 (P) mm smaller than the annulus diameters (p=NS). In-hospital mortality was 5%, all nonvalve-related. Transvalvular blood flow velocities and transvalvular pressure gradients were significantly lower in the 25 P versus the 25 M group at baseline and in the 23 P and 25 P groups at follow-up. There was a significant regression of left ventricular mass index in all patients at follow-up. However, left ventricular mass regression was more pronounced after P aortic valve replacement.

Conclusions: Labeled sizes of prosthetic heart valves implanted are smaller than the true aortic annulus. Both standard aortic xenografts compared in this prospectively randomized trial provide a sufficient hemodynamic and functional outcome.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Animals
  • Aortic Valve / surgery*
  • Aortic Valve Stenosis / surgery*
  • Bioprosthesis* / standards
  • Body Surface Area
  • Calcinosis / prevention & control
  • Cattle
  • Coated Materials, Biocompatible
  • Death, Sudden, Cardiac / epidemiology
  • Detergents / administration & dosage
  • Equipment Design
  • Female
  • Follow-Up Studies
  • Heart Valve Prosthesis* / standards
  • Hemodynamics*
  • Hospital Mortality
  • Humans
  • Hypertrophy, Left Ventricular / etiology
  • Hypertrophy, Left Ventricular / surgery
  • Infections / epidemiology
  • Male
  • Multiple Organ Failure / epidemiology
  • Postoperative Complications / epidemiology
  • Prospective Studies
  • Stents*
  • Stroke / epidemiology
  • Surface-Active Agents / administration & dosage
  • Sus scrofa
  • Treatment Outcome

Substances

  • Coated Materials, Biocompatible
  • Detergents
  • Surface-Active Agents