title: Injectable tissue engineered pulmonary heart valve implantation into the pig model: A feasibility study.
abstract: BACKGROUND
  Transcatheter pulmonary valve replacement is currently performed in clinical trials, however limited by the use of glutaraldehyde treated bioprostheses. This feasibility study was performed to evaluate delivery-related tissue distortion during implantation of a tissue engineered (TE) heart valves.
  
  
  METHODS
  The injectable TE heart valve was mounted on a self-expanding nitinol stent (n=7) and delivered into the pulmonary position of seven pigs, (weight 26 to 31 kg), performing a sternotomy or limited lateral thoracotomy. Prior to implantation, the injectable TE heart valve was crimped and inserted into an applicator. Positioning of the implants was guided by fluoroscopy and after carefully deployment angiographic examination was performed to evaluate the correct delivered position. Hemodynamic measurements were performed by epicardial echocardiography. Finally, the animals were sacrificed and the injectable TE heart valves were inspected by gross examination and histological examination.
  
  
  RESULTS
  Orthotopic delivery of the injectable TE heart valves were all successful performed, expect in one were the valve migrated due to a discrepancy of pulmonary and injectable TE valve size. Angiographic evaluation (n=6) showed normal valve function, supported by epicardial echocardiography in which no increase flow velocity was measured, neither trans- nor paravalvular regurgitation. Histological evaluation demonstrated absence of tissue damage due to the delivery process.
  
  
  CONCLUSIONS
  Transcatheter implantation of an injectable TE heart valve seems to be possible without tissue distortion due to the delivery system.
authors.affiliation: Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany.
authors.forename: Franziska
authors.initials: F
authors.lastname: Schlegel
authors.affiliation: Dept. of Paediatrics, Heart Centre Leipzig, Leipzig, Germany.
authors.forename: Aida
authors.initials: A
authors.lastname: Salameh
authors.affiliation: Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany.
authors.forename: Katja
authors.initials: K
authors.lastname: Oelmann
authors.affiliation: Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany.
authors.forename: Michelle
authors.initials: M
authors.lastname: Halling
authors.affiliation: Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Dhein
authors.affiliation: Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany.
authors.forename: Friedrich W
authors.initials: FW
authors.lastname: Mohr
authors.affiliation: Cardiovascular Surgery, Charité Hospital, Medical University Berlin, Berlin, Germany.
authors.forename: Pascal M
authors.initials: PM
authors.lastname: Dohmen
mesh_terms: D000497:Alloys; D000818:Animals; D005240:Feasibility Studies; D005471:Fluoroscopy; D006349:Heart Valve Diseases / Q000601:surgery*; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006439:Hemodynamics; D015607:Stents; D013552:Swine; D023822:Tissue Engineering / Q000379:methods*
chemical_list: D000497:Alloys; C013616:nitinol