title: Long-term clinical outcomes 15 years after aortic valve replacement with the Freestyle stentless aortic bioprosthesis.
abstract: BACKGROUND
  The Freestyle stentless aortic root bioprosthesis has excellent hemodynamics and durability through 10 years. The purpose of this report is to present clinical outcomes in a large multicenter cohort through 15 years.
  
  
  METHODS
  The multicenter evaluation of the Freestyle valve began in 1992 at 21 centers in North America and Europe. In 1997, a long-term study continued, including 725 patients from 8 of the original centers; clinical outcomes data after 10 years have continued to be collected at 6 of 8 centers.
  
  
  RESULTS
  Patient age was 71.7±7.9 years. There were 402 (55.4%) men and 323 (44.6%) women. Total follow-up was 5,491.2 patient-years. There were 52 late reoperations, with explant of the bioprosthesis in 47 cases. Respective 10- and 15-year survival was 46.2%±2.3% and 25.9%±3.2%; freedom from valve-related death was 94.9%±1.5% and 92.7%±3.5%; freedom from reoperation was 92.3%±1.8% and 80.7%±5.0%; and freedom from explant owing to structural valve deterioration was 96.5%±1.3% and 83.3%±4.8%. Increased age was associated with higher risks of all-cause mortality and valve-related mortality and lower risks of reoperation and explant caused by structural valve deterioration.
  
  
  CONCLUSIONS
  In this long-term, multicenter, observational study, the Freestyle stentless aortic root bioprosthesis offered good clinical outcomes in terms of survival, freedom from valve-related mortality, freedom from reoperation, and freedom from structural valve deterioration. The Freestyle valve is a viable option for use in patients undergoing bioprosthetic aortic valve replacement and for anticipated desire for long-term durability.
authors.affiliation: Department of Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan. Electronic address: dbach@med.umich.edu.
authors.forename: David S
authors.initials: DS
authors.lastname: Bach
authors.affiliation: Department of Cardiothoracic Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: Neal D
authors.initials: ND
authors.lastname: Kon
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome
keywords: 35