title: Midterm Durability and Hemodynamic Performance of a Third-Generation Bovine Pericardial Prosthetic Aortic Valve: The Leipzig Experience.
abstract: BACKGROUND
  The Trifecta valve (St. Jude Medical, St. Paul, MN) is a stented bovine pericardial bioprosthesis for aortic valve replacement (AVR). Implantation experience and midterm follow-up of this valve have not yet been reported from a large single-center cohort.
  
  
  METHODS
  We retrospectively analyzed data from 918 patients (73.2 ± 6.5 years; logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE], 13.2 ± 14.3) who underwent AVR. Analyses addressed implantation safety, short- and long-term survival, and hemodynamic valve performance.
  
  
  RESULTS
  Concomitant procedures were performed in 54.9% of the patients. Low cardiac output syndrome, postoperative bleeding requiring transfusion or reoperation, and acute renal failure requiring temporary hemodialysis occurred at rates of 4.3%, 7.0%, and 11.7%, respectively. At discharge, 44 patients (4.8%) were identified with moderate prosthesis-patient mismatch (PPM) and none was identified with severe PPM. Mean follow-up was 2.7 ± 1.6 years (maximum, 7.4 years). Survival at 30 days was 88.7% and 92.0% for all patients and patients with isolated AVR, respectively; 5-year overall survival for these groups was 73.4% and 82.2%, respectively. Myocardial infarction (odds ratio [OR], 78; 95% confidence interval [CI], 20.8-294) and inotropic medication (OR, 6.8; 95% CI, 3.2-14.5) were the strongest independent predictors for long-term mortality. Five-year freedom from structural valve deterioration (SVD) was 97.9% ± 1.5%. Left ventricular ejection fraction (LVEF) after implantation was similar to baseline and was stable over time (range, 58.9%-62.3%). The mean gradient improved substantially (39.3 mm Hg at baseline versus 9.4 mm Hg at 6 months).
  
  
  CONCLUSIONS
  This large single-center cohort shows the easy and safe implantation, adequate hemodynamic performance, and satisfactory durability of the Trifecta valve at midterm follow-up.
authors.affiliation: Heart Surgery Heart Center, Leipzig, Germany. Electronic address: sven.lehmann@medizin.uni-leipzig.de.
authors.forename: Sven
authors.initials: S
authors.lastname: Lehmann
authors.affiliation: Heart Surgery Heart Center, Leipzig, Germany.
authors.forename: Anna
authors.initials: A
authors.lastname: Meyer
authors.affiliation: Heart Surgery Heart Center, Leipzig, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Schroeter
authors.affiliation: Cardiology Heart Center, Leipzig, Germany.
authors.forename: Madlen
authors.initials: M
authors.lastname: Uhlemann
authors.affiliation: Heart Surgery Heart Center, Leipzig, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Fischer
authors.affiliation: Heart Surgery Heart Center, Leipzig, Germany.
authors.forename: Sergey
authors.initials: S
authors.lastname: Leontyev
authors.affiliation: Heart Surgery Heart Center, Leipzig, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Garbade
authors.affiliation: Heart Surgery Heart Center, Leipzig, Germany.
authors.forename: David
authors.initials: D
authors.lastname: Holzhey
authors.affiliation: Heart Surgery Heart Center, Leipzig, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Misfeld
authors.affiliation: Heart Surgery Heart Center, Leipzig, Germany.
authors.forename: Friedrich-Wilhelm
authors.initials: FW
authors.lastname: Mohr
mesh_terms: D000368:Aged; D000818:Animals; D001021:Aortic Valve / Q000601:surgery; D001705:Bioprosthesis; D002417:Cattle; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation / Q000706:statistics & numerical data; D012189:Retrospective Studies