title: The TRIBECA study: (TRI)fecta (B)ioprosthesis (E)valuation versus (C)arpentier Magna-Ease in (A)ortic position.
abstract: OBJECTIVE
  To determine whether the Trifecta bioprosthetic aortic valve produces postoperative haemodynamic results comparable with or better than those of the Magna Ease aortic valve bioprosthesis.
  
  
  METHODS
  We retrospectively reviewed the medical records of patients who had undergone aortic valve replacement with Trifecta or Magna Ease prostheses at eight European institutions between January 2011 and May 2013, and analysed early postoperative haemodynamic performance by means of echocardiography.
  
  
  RESULTS
  A total of 791 patients underwent aortic valve replacement (469 Magna Ease, 322 Trifecta). Haemodynamic variables were evaluated on discharge and during the follow-up (minimum 6 months, maximum 12 months). The mean gradient and the indexed effective orifice area (IEOA) were as follows: 10 mmHg [interquartile range (IQR): 8-13] and 1.10 cm(2)/m(2) (IQR: 0.95-1.27) for Trifecta; 16 mmHg (IQR: 11-22) and 0.96 cm(2)/m(2) (IQR: 0.77-1.13) for Magna Ease (P < 0.001). These significant differences were maintained across all valve sizes. Similar statistically significant differences were found when patients were matched and/or stratified for preoperative characteristics: body-surface area, ejection fraction, mean gradients and valve size. Severe prosthesis-patient mismatch (IEOA: <0.65 cm(2)/m(2)) was detected in 2 patients (0.6%) with Trifecta and 40 patients (8.5%) with Magna Ease (P < 0.001).
  
  
  CONCLUSIONS
  The haemodynamic performance of the Trifecta bioprosthesis was superior to that of the Magna Ease valve across all conventional prosthesis sizes, with almost no incidence of severe patient-prosthesis mismatch. The long-term follow-up is needed to determine whether these significant haemodynamic differences will persist, and influence clinical outcomes.
authors.affiliation: Department of Cardiology, Thoracic and Vascular Sciences, University of Padua, Padua, Italy colli.andrea.bcn@gmail.com.
authors.forename: Andrea
authors.initials: A
authors.lastname: Colli
authors.affiliation: Division of Cardiac Surgery, San Giovanni Battista Hospital 'Molinette', University of Turin, Turin, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Marchetto
authors.affiliation: Division of Cardiac Surgery, San Giovanni Battista Hospital 'Molinette', University of Turin, Turin, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Salizzoni
authors.affiliation: Division of Cardiac Surgery, San Giovanni Battista Hospital 'Molinette', University of Turin, Turin, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Rinaldi
authors.affiliation: Cardiac Surgery Department, S.Orsola-Malpighi Hospital, University of Bologna, Parma, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Di Marco
authors.affiliation: Cardiac Surgery Department, S.Orsola-Malpighi Hospital, University of Bologna, Parma, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Pacini
authors.affiliation: Cardiac Surgery Department, S.Orsola-Malpighi Hospital, University of Bologna, Parma, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Di Bartolomeo
authors.affiliation: Department of Clinical and Experimental Medicine, Cardiac Surgery Unit, University of Parma, Parma, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Nicolini
authors.affiliation: Department of Clinical and Experimental Medicine, Cardiac Surgery Unit, University of Parma, Parma, Italy.
authors.forename: Tiziano
authors.initials: T
authors.lastname: Gherli
authors.affiliation: Department of Clinical Sciences and Community Health, Cardiac Surgery, University of Milan, Centro Cardiologico Monzino Hospital, Milan, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Agrifoglio
authors.affiliation: Cardio-Thoracic and Vascular Department, University Hospital of Terni, Terni, Italy.
authors.forename: Valentino
authors.initials: V
authors.lastname: Borghetti
authors.affiliation: Cardio-Thoracic and Vascular Department, University Hospital of Terni, Terni, Italy.
authors.forename: Georgette
authors.initials: G
authors.lastname: Khoury
authors.affiliation: Cardio-Thoracic and Vascular Department, University Hospital of Terni, Terni, Italy.
authors.forename: Marcella
authors.initials: M
authors.lastname: De Paolis
authors.affiliation: Department of Cardiac Surgery, Ospedale dell'Angelo, Venezia-Mestre, Italy.
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Zoffoli
authors.affiliation: Department of Cardiac Surgery, Ospedale dell'Angelo, Venezia-Mestre, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Mangino
authors.affiliation: Centre of Cardiothoracic Surgery, S. João Hospital, Porto, Portugal.
authors.forename: Mario Jorge
authors.initials: MJ
authors.lastname: Amorim
authors.affiliation: Department of Cardiology, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.
authors.forename: Erica
authors.initials: E
authors.lastname: Manzan
authors.affiliation: Department of Cardiology, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Zucchetta
authors.affiliation: Department of Clinical and Diagnostic Medicine and Public Health, University of Modena and Reggio Emilia, Padua, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Balduzzi
authors.affiliation: Department of Cardiology, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.
authors.forename: Gino
authors.initials: G
authors.lastname: Gerosa
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D004452:Echocardiography / Q000401:mortality; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods / Q000401:mortality; D006439:Hemodynamics / Q000502:physiology; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D017755:Prosthesis Fitting; D012189:Retrospective Studies
keywords: Aortic valve replacement; Bioprosthesis; Magna Ease; Patient–prosthesis mismatch; Tissue valve; Trifecta