title: Do differences in early hemodynamic performance of current generation biologic aortic valves predict outcomes 1 year following surgery?
abstract: OBJECTIVE
  Small early postoperative hemodynamic differences were noted in a randomized comparison of 3 current-generation bioprosthetic aortic valves. Whether these differences persist and influence clinical outcomes 1 year following implantation is unknown.
  
  
  METHODS
  Three hundred adults with severe aortic stenosis undergoing valve replacement were randomized to receive the Epic (St Jude, St Paul, Minn) (n = 99), Magna (Edwards LifeSciences Inc, Irvine, Calif) (n = 100), or Mitroflow (Sorin Biomedica Spa, Saluggio, Italy) (n = 101) bioprostheses. Hemodynamic valve performance was examined by echocardiography at 1 year, and clinical outcomes were assessed in 241 patients (79 Epic, 77 Magna, and 85 Mitroflow; P = .437).
  
  
  RESULTS
  Mean age was 75 ± 8 years and 164 were men (68%). Between dismissal and 1 year there were 9 deaths (3.7%) (Epic: 3.7%, Magna: 5.0%, and Mitroflow: 2.3%; P = .654), 6 episodes of heart failure (2.5%) (Epic: 1.3%, Magna: 1.3%, and Mitroflow: 5.8%; P = .265), 27 instances of atrial fibrillation/flutter (11.2%) (Epic: 8.1%, Magna: 11.0%, and Mitroflow: 7.9%; P = .577) and no strokes/transient ischemic attacks. One-year echocardiography demonstrated small hemodynamic differences between Epic, Magna, and Mitroflow bioprostheses in mean gradient (15.2 ± 5.5, 12.3 ± 4.3, and 16.2 ± 5.7 mm Hg, respectively; P < .001) and indexed aortic valve area (0.93 ± 0.28, 1.04 ± 0.28, and 0.96 ± -0.26 cm(2)/m(2), respectively; P = .015). Several early trends persisted when stratifying data by echocardiographic annulus diameter, universal annulus size, and implant size, particularly with annular size ≥23 mm. Overall left ventricular mass index regression between dismissal and 1 year was -16.5 ± 28.1 g/m(2), and was similar among groups (P = .262). There were no aortic valve reoperations.
  
  
  CONCLUSIONS
  Despite midterm persistence of small hemodynamic differences amongst current-generation porcine and pericardial aortic valves, our prospective randomized comparison reveals that clinical outcomes and mass regression are equivalent between devices at 1 year. These encouraging trends must continue to be assessed during longitudinal follow-up.
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Nassir M
authors.initials: NM
authors.lastname: Thalji
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn. Electronic address: suri.rakesh@mayo.edu.
authors.forename: Rakesh M
authors.initials: RM
authors.lastname: Suri
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn.
authors.forename: Hector I
authors.initials: HI
authors.lastname: Michelena
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Greason
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Dearani
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Richard C
authors.initials: RC
authors.lastname: Daly
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Lyle D
authors.initials: LD
authors.lastname: Joyce
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: John M
authors.initials: JM
authors.lastname: Stulak
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Harold M
authors.initials: HM
authors.lastname: Burkhart
authors.affiliation: Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minn.
authors.forename: Zhuo
authors.initials: Z
authors.lastname: Li
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Hartzell V
authors.initials: HV
authors.lastname: Schaff
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; 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; D011183:Postoperative Complications / Q000401:mortality / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography