title: A prospective, randomized comparison of 3 contemporary bioprosthetic aortic valves: should hemodynamic performance influence device selection?
abstract: OBJECTIVE
  Latest generation biologic aortic valve prostheses were designed to improve hemodynamic performance. We sought to determine whether there are clinically important early differences among these devices.
  
  
  METHODS
  Three hundred adults with severe aortic valve stenosis undergoing aortic valve replacement were randomized to receive the Edwards Magna, Sorin Mitroflow, or St. Jude Epic bioprostheses (n = 100, n = 101, n = 99, respectively). Early hemodynamic performance was studied by echocardiography.
  
  
  RESULTS
  Mean patient age was 76 ± 8 years and there were 203 men (68%). There were no significant differences in baseline characteristics among implant groups. Early mortality was 1.7%, and there were no differences in early adverse events. Postoperative echocardiography showed small but statistically significant differences overall between the Magna, Mitroflow, and Epic valves in mean gradient (14.2 mm Hg, 16.3 mm Hg, 16.5 mm Hg, respectively; P = .011), aortic valve area (2.05 cm(2), 1.88 cm(2), 1.86 cm(2), respectively; P = .012), and indexed aortic valve area (1.05 cm(2)/m(2), 0.97 cm(2)/m(2), 0.95 cm(2)/m(2), respectively; P = .012). Prosthetic performance was similar among all with a small (≤21 mm) aortic annulus. Patients who received the Magna device with a 23-mm annulus had slightly greater indexed aortic valve area; those with >23 mm had a slightly lower transprosthetic gradient. Analogous trends were found when data were stratified by either commercial implant size or echocardiography-determined aortic annulus size. Severe patient-prosthesis mismatch was infrequent overall and was similarly low among devices (P value not significant).
  
  
  CONCLUSIONS
  This prospective, randomized comparison reveals that there are small but consistent early postoperative hemodynamic differences among current third-generation porcine and pericardial aortic valve prostheses. The 3 valves studied performed equally well in patients with a small (≤21 mm) aortic annulus. The Magna valve had a slightly lower mean gradient in those with larger annular size (>23 mm). Longitudinal follow-up of these randomized cohorts is essential to determine late clinical implications of these early postoperative findings.
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn 55905, USA. suri.rakesh@mayo.edu
authors.forename: Rakesh M
authors.initials: RM
authors.lastname: Suri
authors.forename: Hector I
authors.initials: HI
authors.lastname: Michelena
authors.forename: Harold M
authors.initials: HM
authors.lastname: Burkhart
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Greason
authors.forename: Richard C
authors.initials: RC
authors.lastname: Daly
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Dearani
authors.forename: Soon J
authors.initials: SJ
authors.lastname: Park
authors.forename: Lyle D
authors.initials: LD
authors.lastname: Joyce
authors.forename: John M
authors.initials: JM
authors.lastname: Stulak
authors.forename: Thoralf M
authors.initials: TM
authors.lastname: Sundt
authors.forename: Zhuo
authors.initials: Z
authors.lastname: Li
authors.forename: Hartzell V
authors.initials: HV
authors.lastname: Schaff
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D016009:Chi-Square Distribution; D015150:Echocardiography, Doppler; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008910:Minnesota; D018579:Patient Selection; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome