Performance of SynerGraft Decellularized Pulmonary Homograft in Patients Undergoing a Ross Procedure

Background. In the Ross aortic valve replacement (AVR), a pulmonary allograft normally replaces the autotransplanted pulmonary valve. Despite the Ross advantages vs other AVR procedures, there has been a small but unpredictable risk of early structural allograft valve deterioration, usually manifested by shrinkage and right ventricular outflow tract obstruction. This study analyzed our results of the Ross AVR using a new CryoValve SynerGraft (Cryo-Life Inc, Kennesaw, GA) decellularized pulmonary allograft (SGDPA) and compared it with the standard cryopreserved allograft (SCA) used during the same period. Methods. Between 2000 and 2009, 29 patients received a SGDPA and 34 received the SCA during Ross AVR. Patients were a mean age at implant of 28.6 +/- 16.0 years (range, 4 months to 58 years). Retrospective data included reported adverse events, and the most recent hemodynamic data were collected. Results. No early or late deaths or significant morbid events occurred during the mean follow-up of 4.9 +/- 2.7 years (range, 2 months to 9 years). No patient required conduit reoperation. The median peak gradient at discharge was 12 mm Hg and was not significant at last follow-up. No deterioration in conduit valve function occurred in the SGDPA group. Mild conduit regurgitation developed in several SCA patients, and one patient had moderate regurgitation. No patient reached our definition of conduit dysfunction (peak gradient: 40 mm Hg or > 2+ regurgitation). Conclusions. The SGDPA conduit is an alternative to the SCA for the Ross AVR. The early clinical and hemodynamic results are encouraging but were not significantly different from the SCA. SynerGraft technology may provide a more durable option for patients who need right ventricular outflow tract reconstruction. Further long-term follow-up is needed to see if this decellularization process improves long-term allograft durability. (Ann Thorac Surg 2011;91:416-23) (C) 2011 by The Society of Thoracic Surgeons