title: Introduction of a flexible polymeric heart valve prosthesis with special design for aortic position.
abstract: OBJECTIVE
  Current prosthetic heart valves necessitate permanent anticoagulation or have limited durability and impaired hemodynamic performance compared to natural valves. Recently a polymeric valve prostheses with special design for mitral position demonstrated excellent in vitro and in vivo results with improved durability and no need for permanent anticoagulation. In this study, a respective flexible polymeric aortic valve is presented and in vitro and in vivo results are reported.
  
  
  METHODS
  The aortic prosthesis (ADIAM lifescience AG, Erkelenz, Germany) is entirely made of polycarbonaturethane. The tri-leaflet flexible prosthesis mimicks the natural aortic valve and has a diminished pressure loss and reduced stress and strain peaks at the commissures. The valve underwent long-term in vitro testing and in vivo-testing in a growing calve animal model (20 weeks, 7 aortic valves) and was compared to two different commercial bioprostheses.
  
  
  RESULTS
  The polymeric aortic heart valve substitute demonstrated excellent in vitro and in vivo hemodynamics. Five/seven animals with aortic PCU-prostheses had an excellent clinical long-term course. The explanted valves showed a variable degree of calcification. Two of the seven animals died at 27 and 77 days due to pannus overgrowth causing severe LVOTO without degeneration of the valve itself. Both animals with commercial bioprostheses had to be sacrificed because of congestive heart failure related to structural degeneration of the bioprosthesis after 10 and 30 days of implantation. There was no increased thrombogenity of the PCU valves compared to bioprostheses.
  
  
  CONCLUSIONS
  The new flexible polymeric aortic valve prosthesis is superior to current bioprostheses in animal testing.
authors.affiliation: Department of Cardiac Surgery, Ludwig-Maximilians-University, University Hospital Grosshadern, Marchioninistr. 15, D-81377 Munich, Germany. sabine.daebritz@med.uni-muenchen.de
authors.forename: Sabine H
authors.initials: SH
authors.lastname: Daebritz
authors.forename: Bernd
authors.initials: B
authors.lastname: Fausten
authors.forename: Benita
authors.initials: B
authors.lastname: Hermanns
authors.forename: Joerg
authors.initials: J
authors.lastname: Schroeder
authors.forename: Jan
authors.initials: J
authors.lastname: Groetzner
authors.forename: Ruediger
authors.initials: R
authors.lastname: Autschbach
authors.forename: Bruno J
authors.initials: BJ
authors.lastname: Messmer
authors.forename: Jörg S
authors.initials: JS
authors.lastname: Sachweh
mesh_terms: D000818:Animals; D001021:Aortic Valve / Q000601:surgery*; D001705:Bioprosthesis; D002417:Cattle; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D008422:Materials Testing / Q000379:methods; D011140:Polyurethanes; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016896:Treatment Outcome
chemical_list: D011140:Polyurethanes