title: Ten years of clinical results with a tissue-engineered pulmonary valve.
abstract: BACKGROUND
  This study was performed to collect prospective safety and effectiveness data from a tissue-engineered heart valve implanted for reconstruction of the right ventricular outflow tract during the Ross operation.
  
  
  METHODS
  From May 2000 until June 2002, 11 consecutive patients, mean age 39.6 ± 10.3 years, received a tissue-engineered heart valve (additive and logistic European System for Cardiac Operative Risk Evaluation, respectively, 3.3 ± 1.3 and 2.8% ± 1.4%). Two to four weeks prior to the Ross operation a piece of forearm vein or saphenous vein was harvested to isolate, characterize, and expand endothelial cells. A cryopreserved pulmonary allograft was decellularized, coated, and seeded with autologous vascular endothelial cells, using a specially developed bioreactor. Cell seeding density was 1.1 × 10(5) ± 0.5 × 10(5) cells/cm(2) with a viability of 93.2% ± 2.1%.
  
  
  RESULTS
  All patients survived surgery. Postoperatively no fever of unknown origin was evident. Currently all patients are in New York Heart Association class I. Evaluation of the tissue-engineered heart valve by transthoracic echocardiography showed a mean pressure gradient of 5.4 ± 2.0 mm Hg at 10 years. Multislice computed tomography showed no calcification up to 10 years.
  
  
  CONCLUSIONS
  Tissue-engineered heart valves showed excellent hemodynamic performance and may prevent degeneration during long-term follow-up.
authors.affiliation: Department of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, Leipzig, Germany. pascal.dohmen@yahoo.de
authors.forename: Pascal M
authors.initials: PM
authors.lastname: Dohmen
authors.forename: Alexander
authors.initials: A
authors.lastname: Lembcke
authors.forename: Sebastian
authors.initials: S
authors.lastname: Holinski
authors.forename: Axel
authors.initials: A
authors.lastname: Pruss
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Konertz
mesh_terms: D000328:Adult; D001705:Bioprosthesis; D002452:Cell Count; D002478:Cells, Cultured; D015925:Cryopreservation / Q000379:methods; D042783:Endothelial Cells / Q000166:cytology / Q000637:transplantation; D004730:Endothelium, Vascular / Q000166:cytology* / Q000637:transplantation; D005260:Female; D005500:Follow-Up Studies; D006085:Graft Survival; D006349:Heart Valve Diseases / Q000601:surgery*; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D011664:Pulmonary Valve / Q000637:transplantation*; D012189:Retrospective Studies; D013997:Time Factors; D023822:Tissue Engineering / Q000379:methods*; D014184:Transplantation, Homologous; D016896:Treatment Outcome