title: The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical study.
abstract: BACKGROUND
  The St Jude Medical Inc (St Paul, Minn) Trifecta valve is a novel aortic biological prosthesis that incorporates several design features, including a true supra-annular sewing cuff, a stent design that maximizes valve hemodynamics while minimizing leaflet stresses, and an ethanol-based anticalcification technology. This study establishes the safety and early clinical and hemodynamic performance of the Trifecta valve.
  
  
  METHODS
  The Trifecta bioprosthesis was implanted in 1014 eligible patients between 2007 and 2009 at 31 centers. The mean age of the population was 72.5 ± 9.0 years, of whom 650 (64.1%) were male and 364 (35.9%) were female. Eighty-two subjects (8.1%) had undergone previous open surgery. Indications for aortic valve replacement surgery included stenosis in 556 patients (54.8%), regurgitation in 61 patients (6.0%), and mixed pathology in 397 patients (39.2%).
  
  
  RESULTS
  The overall follow-up included 844.3 late patient-years. Early (≤ 30 day) mortality occurred in 18 patients (1.8%), and there were 23 late (≥ 31 days) deaths yielding a linearized mortality rate of 2.72% per late patient-year. There were 27 early thromboembolic events, including 8 (0.8%) strokes, 17 (1.7%) reversible neurologic events, and 2 (0.2%) systemic embolic events. There were no instances of early valve thrombosis, endocarditis, or clinically significant hemolysis. There were 16 late thromboembolic events (linearized rate of 1.90% per year of follow-up), including 4 strokes and 12 reversible neurologic events. In total, there were 5 late valve explants, including 1 structural deterioration and 4 prosthetic valve endocarditis cases. Overall, freedom from valve explant was 99.4% at 2 years. At the time of discharge, average mean gradients ranged from 9.3 to 4.1 mm Hg and effective orifice area ranged from 1.58 to 2.50 cm(2) for valve sizes 19 to 29 mm, respectively.
  
  
  CONCLUSIONS
  The St Jude Medical Trifecta valve is a unique pericardial bioprosthesis with design elements that provide excellent hemodynamic performance while providing ease of implantation. Long-term follow-up continues to confirm the promising results of this innovative bioprosthesis.
authors.affiliation: Division of Cardiovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pa. Electronic address: joseph.bavaria@uphs.upenn.edu.
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Bavaria
authors.affiliation: Division of Cardiovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pa.
authors.forename: Nimesh D
authors.initials: ND
authors.lastname: Desai
authors.affiliation: Division of Cardiovascular Surgery, St Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Anson
authors.initials: A
authors.lastname: Cheung
authors.affiliation: Department of Cardiac Surgery, Vanderbilt Medical Center, Nashville, Tenn.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Petracek
authors.affiliation: Mission Health and Hospitals, Asheville, NC.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Groh
authors.affiliation: Department of Cardiac Surgery, Herzzentrum Leipzig GmbH, Leipzig, Germany.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Borger
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.
authors.forename: Hartzell V
authors.initials: HV
authors.lastname: Schaff
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D002170:Canada; D020878:Device Removal; D005060:Europe; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010496:Pericardium / Q000637:transplantation*; D011183:Postoperative Complications / Q000401:mortality / Q000601:surgery; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
keywords: 35.2; EOA; EOAI; NYHA; New York Heart Association; PPM; TAVR; effective orifice area; effective orifice area index; patient–prosthesis mismatch; transcatheter aortic valve replacement