title: St. Jude Medical Trifecta aortic valve: results from a prospective regional multicentre registry.
abstract: BACKGROUND
  The Trifecta aortic bioprosthesis (St. Jude Medical, Inc., St. Paul, MN, USA) is a stented pericardial heart valve with excellent preliminary results. Aim of the study was to evaluate its early clinical and hemodynamic performances in a multicenter regional registry.
  
  
  METHODS
  Between January 2011 and June 2012, 178 consecutive patients undergoing aortic valve replacement with the Trifecta bioprosthesis were prospectively enrolled at 9 Italian centers. Clinical and echocardiographic data were collectedat discharge, 6-months and at 1-year postoperatively.
  
  
  RESULTS
  The average age was 75.4 ± 7.7 years,and 95 (53 %) were men. Indication for valve replacement included stenosis in 123 patients (69 %), mixed lesions in 25 (14 %), and regurgitation in 30 (17 %). Ninety-three (52 %) patients were in NYHA functional class III/ IV. Hospital mortality accounted for 5 (2.8 %) patients. No valve-related perioperative complications were encountered. Median follow-up was 20.5 months (range: 1-34). Early (≤6 months) complications included one thromboembolic event, one major bleeding, and 3 endocarditis (2 explants). Two late (>6 months) thromboembolic events and two endocarditis (1 explant) were registered. No valve thrombosis or structural deterioration were observed after discharge. At 30-months, freedom from all-cause mortality was 87 %, freedom from valve-related mortality 99.4 %, freedom from endocarditis 97.5 %, and freedom from valve explants 98 %. At 1-year, mean gradients ranged from 8 to 16 mmHg, and effective orifice area indexes from 1.0 to 1.2 cm(2)/m(2) for valve sizes from 19 to 27 mm, respectively. No patients had severe prosthesis-patient mismatch.
  
  
  CONCLUSIONS
  Trifecta bioprosthesis provided favourable clinical and hemodynamic results over time.
authors.affiliation: Department of Cardiovascular sciences, Clinical Science Wing, University of Leicester, Glenfield Hospital, Leicester, United Kingdom. giovannimariscalco@yahoo.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Mariscalco
authors.affiliation: Cardiac Surgery Clinic, University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Mariani
authors.affiliation: Section of Cardiac Surgery, Department of Cardiovascular Disease, Cliniche Humanitas Gavazzeni, Bergamo, Italy.
authors.forename: Samuele
authors.initials: S
authors.lastname: Bichi
authors.affiliation: Department of Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Biondi
authors.affiliation: Department of Cardio-Thoracic and Vascular Surgery, Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Blasio
authors.affiliation: Department of Cardiovascular sciences, Clinical Science Wing, University of Leicester, Glenfield Hospital, Leicester, United Kingdom.
authors.forename: Paolo
authors.initials: P
authors.lastname: Borsani
authors.affiliation: Cardiac Surgery Clinic, University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Corti
authors.affiliation: Cardiac Surgery Unit, Cardio-Thoraco-Vascular Department, Niguarda Cà Granda Hospital, Milan, Italy.
authors.forename: Benedetta
authors.initials: B
authors.lastname: De Chiara
authors.affiliation: Department of Cardiovascular sciences, Clinical Science Wing, University of Leicester, Glenfield Hospital, Leicester, United Kingdom.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Gherli
authors.affiliation: Department of Cardiac Surgery, Ospedale Civile di Legnano, Legnano, Italy.
authors.forename: Cristian
authors.initials: C
authors.lastname: Leva
authors.affiliation: Cardiac Surgery Unit, Cardio-Thoraco-Vascular Department, Niguarda Cà Granda Hospital, Milan, Italy.
authors.forename: Claudio Francesco
authors.initials: CF
authors.lastname: Russo
authors.affiliation: Cardiac Surgery Unit, Alessandro Manzoni Hospital of Lecco, Lecco, Italy.
authors.forename: Giordano
authors.initials: G
authors.lastname: Tasca
authors.affiliation: Cardio-Cerebro-Vascular Department, 'L. Sacco' University General Hospital, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Vanelli
authors.affiliation: Department of Cardio-Thoracic and Vascular Surgery, Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.affiliation: Cardio-Cerebro-Vascular Department, 'L. Sacco' University General Hospital, Milan, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Antona
authors.affiliation: Department of Cardiac Surgery, Ospedale Civile di Legnano, Legnano, Italy.
authors.forename: Germano
authors.initials: G
authors.lastname: Di Credico
authors.affiliation: Section of Cardiac Surgery, Department of Cardiovascular Disease, Cliniche Humanitas Gavazzeni, Bergamo, Italy.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Esposito
authors.affiliation: Cardiac Surgery Unit, Alessandro Manzoni Hospital of Lecco, Lecco, Italy.
authors.forename: Amando
authors.initials: A
authors.lastname: Gamba
authors.affiliation: Cardiac Surgery Unit, Cardio-Thoraco-Vascular Department, Niguarda Cà Granda Hospital, Milan, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Martinelli
authors.affiliation: Department of Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Menicanti
authors.affiliation: Cardiac Surgery Clinic, University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Paolini
authors.affiliation: Department of Cardiovascular sciences, Clinical Science Wing, University of Leicester, Glenfield Hospital, Leicester, United Kingdom.
authors.forename: Cesare
authors.initials: C
authors.lastname: Beghi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors