No abstract

This study suggests that the midterm performance of SGs may be superior to that of SCAs. Decellularization of the cryopreserved allografts may provide a more durable option for patients who need RVOT reconstruction. Further long-term follow-up is needed to see whether this decellularization process improves long-term allograft durability.

Background. Structural deterioration of allografts over time is believed to be related at least in part, to an immune response mounted against human leukocyte antigen specific to the transplanted tissue. SynerGraft processing is a technology that decellularizes an allograft leaving only connective tissue therefore reducing immunogenicity and potentially increasing durability of the implant.Methods. We performed a retrospective review of one hundred sixty-three SynerGraft patients and one hundred twenty four standard allograft controls from three medical centers. Patient demographics were tabulated and conduit stenosis and insufficiency were measured by echocardiography.Results. There were twenty-eight deaths (SG, 15/163 9% vs standard, 13/124 11%; P= 0.72) but no death was attributed to structural failure of the conduit. The actuarial survival for Synergraft versus standard cohorts was not different at 5 and 10 yrs. Among the 274 hospital survivors, 17% SG versus 42% standard had evidence for significant conduit dysfunction at the most recent follow-up or before conduit replacement. Freedom from conduit dysfunction was significantly worse at 10 years in the standard group (58%) as compared with SG (83%, P<001).Conclusions. This study represents a multi-institutional retrospective comparison of Synergraft and standard cryopreserved allografts used in RVOT reconstruction in a broad range of patient ages. Our results demonstrate that at an intermediate to long term follow-up, conduit dysfunction and pulmonary insufficiency and stenosis are higher among patients receiving standard allografts. We postulate that the improved durability of SG is related to decreased immunogenicity of the SG technology.