Abstract 9142: Performance of Synergraft Decellularized Pulmonary Allografts Compared With Standard Cryopreserved Allografts: Results from Multi-Institutional Data
Objectives: Cryopreserved pulmonary allografts frequently demonstrate early valve failure and structural degeneration believed to be related in part to an immune response mounted against HLA specific to the transplanted tissue. SynerGraft processing (CryoLife Inc., Kinnesaw, GA) decellularizes the allograft and therefore reduces its immunogenicity. Previous data comparing standard allograft to SynerGraft has been from single institutions and included limited numbers of patients. The purpose of this project was to assess the durability of the SynerGraft-processed allografts compared with standard cryopreserved allografts using data from multiple institutions.
Methods: A multi-institutional review was performed of all CryoValves implanted between 2001 and 2010. One hundred sixty-three SynerGraft patients and 124 standard allograft controls were evaluated. Demographics, survival, reintervention, and echocardiographic findings were analyzed.
Results: Mean age (months) was 208 ± 198 versus 151 ± 172 (p=N.S.), mean weight (kg) was 45 ± 36 versus 35 ± 33 (p=0.12), and mean valve diameter (mm) was 22.1 ± 5.8 versus 19.5 ± 6.1 (p=<0.05), for SynerGraft and standard allografts, respectively. At a mean echo follow up (months) of 60 ± 34 versus 59 ± 35, mean gradient (mm Hg) was 20.7 ± 15.7 versus 27.3 ± 18.8 mmHg for the (p<0.05). Mean insufficiency grade (0-4) at last follow-up was 1.8 for SynerGraft and 2.3 for standard allograft (p<0.001), and for patients under the age of 24 months was 2.4 for SynerGraft and 3.2 for the standard allograft (p=0.01). By Kaplan-Meier analysis, 8-year freedom from reintervention was 82% for SynerGraft and 60% for the standard allograft (p=0.001). Eight-year freedom from insufficiency was 76% for SynerGraft and 47% for the standard allograft (p<0.001). There was no statistically significant difference in survival.
Conclusions: When compared to standard allografts, SynerGrafts demonstrate superior freedom from significant insufficiency and stenosis at a similar follow up period with lower rates of need for reintervention.
- © 2012 by American Heart Association, Inc.