title: Hemodynamic performance of the St. Jude Medical Epic Supra aortic stented valve.
abstract: OBJECTIVE
  The study aim was to evaluate the hemodynamic performance of the St. Jude Medical Epic Supra bioprosthesis during the early six-month follow up period, and to confirm the safety and efficacy of the valve by collecting details of adverse events and NYHA functional classification.
  
  
  METHODS
  Fifty-seven patients undergoing aortic valve replacement (AVR) with the Epic Supra valve between September 2007 and January 2009 at three centers in Canada were evaluated for the study. The subjects were monitored preoperatively, at discharge, and at six months postoperatively. Echocardiographic data were available from 50 subjects at the six-month follow up. In order to prevent observer variability, all echocardiograms were sent to an independent Echocardiography Core Laboratory (ECL) for interpretation of the data.
  
  
  RESULTS
  The mean subject age was 74 years. Concomitant coronary artery bypass grafting (CABG) was performed in 44% of the procedures. The mean pressure gradients were 11.2, 12.5, 10.8, 8.4 and 11.3 mmHg, respectively, for valves sized 19 mm (n = 2), 21 mm (n = 20), 23 mm (n = 22), 25 mm (n = 5) and 27 mm (n = 1). The average effective orifice areas (EOAs) were 1.44, 1.57, 1.69, 1.93 and 1.81 cm2 for the .valves sized 19, 21, 23, 25 and 27 mm, respectively.
  
  
  CONCLUSIONS
  The results of the six-month echocardiographic follow up indicated that the Epic Supra valve offered excellent hemodynamic performance in the 21, 23 and 25 mm sizes. However, additional data are still required for the 19 and 27 mm valves to characterize their performance. The mean gradients and EOA-values were comparable to those of other supra-annular stented tissue valves. The EOA index indicated an absence of prosthesis-patient mismatch, with values in all subjects at or near 0.85 cm2/m2. The percentage of subjects without aortic insufficiency (AI) at follow up was 92%; only four subjects showed trivial AI.
authors.affiliation: Foothills Medical Centre, Calgary, Alberta, Canada. Andrew.Maitland@albertahealthservices.ca
authors.forename: Andrew
authors.initials: A
authors.lastname: Maitland
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Hirsch
authors.forename: Edward A
authors.initials: EA
authors.lastname: Pascoe
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000209:etiology / Q000503:physiopathology; D001705:Bioprosthesis; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D002170:Canada; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000150:complications / Q000601:surgery; D005260:Female; D006349:Heart Valve Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography