Evaluation of the decellularized pulmonary valve homograft (SynerGraft).
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.
Bechtel
J F Matthias
JF
Department for Cardiac Surgery, University Hospital, Medical University of Luebeck, Germany.
Müller-Steinhardt
Michael
M
Schmidtke
Claudia
C
Brunswik
Anja
A
Stierle
Ulrich
U
Sievers
Hans-Hinrich
HH
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