title: Evaluation of the decellularized pulmonary valve homograft (SynerGraft).
abstract: OBJECTIVE
  Rejection is thought to contribute to the degeneration of valved homografts. A novel cryopreserved decellularized homograft valve (SynerGraft; CryoLife, Inc.) offers the unique opportunity to gain new insight into the immunology of homograft implantation and its significance for valve function.
  
  
  METHODS
  Twenty-four patients (group I; mean age 37 +/- 11 years) underwent implantation of a pulmonary SynerGraft and were examined at one and six months postoperatively; 22 patients (group II; mean age 41 +/- 17 years) with conventional homografts served as controls. Temperature, C-reactive protein (CRP) levels and white blood cell count (WBC) were studied perioperatively. Follow up included echocardiography and anti-human leukocyte antigen (HLA) class I antibody determination.
  
  
  RESULTS
  Significantly lower temperatures were measured in group I (p = 0.019). CRP level and WBC each increased postoperatively, but did not differ between groups. During follow up, none of the SynerGraft patients became positive for anti-HLA antibodies, compared with 66% of controls (p = 0.011). Homograft diameter and valve orifice area were decreased significantly at one month after surgery in groups I and II (25 +/- 1 versus 18 +/- 3 mm; 25 +/- 1 versus 19 +/- 2 mm, respectively; p <0.001 both groups). Transvalvular pressure gradients significantly increased during follow up.
  
  
  CONCLUSIONS
  Implantation of the SynerGraft pulmonary homograft appeared safe, and though evidence was found of a reduced immunologic response after SynerGraft implantation this (unexpectedly) did not translate into any hemodynamic advantage. Hence, factors other than rejection appear as the main contributions to the observed functional changes.
authors.affiliation: Department for Cardiac Surgery, University Hospital, Medical University of Luebeck, Germany.
authors.forename: J F Matthias
authors.initials: JF
authors.lastname: Bechtel
authors.forename: Michael
authors.initials: M
authors.lastname: Müller-Steinhardt
authors.forename: Claudia
authors.initials: C
authors.lastname: Schmidtke
authors.forename: Anja
authors.initials: A
authors.lastname: Brunswik
authors.forename: Ulrich
authors.initials: U
authors.lastname: Stierle
authors.forename: Hans-Hinrich
authors.initials: HH
authors.lastname: Sievers
mesh_terms: D000328:Adult; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D016022:Case-Control Studies; D015925:Cryopreservation; D005260:Female; D006084:Graft Rejection; D006085:Graft Survival; D006349:Heart Valve Diseases / Q000000981:diagnostic imaging / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011336:Probability; D011379:Prognosis; D011446:Prospective Studies; D011664:Pulmonary Valve / Q000601:surgery*; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D014463:Ultrasonography