Safety profile of decellularized, cryopreserved pulmonary allografts when used in the aortic position for neonatal arch reconstruction.

Cryopreserved pulmonary allograft is frequently used to reconstruct the hypoplastic aortic arch. A decellularized graft preparation is available as an alternative reconstructive material. This case series profiles our experience using this material for neonatal aortic arch reconstruction. Data from 14 patients who received decellularized pulmonary allograft (DCPA) from 2001 to 2003 included the following: diagnosis; age at implantation; perioperative complications (graft bleeding or dehiscence); intermediate-term results, including infection, recurrent arch gradient (>10 mmHg), graft calcification, or aneurysm; need for graft removal; and cause of death. Eleven (79%) patients survived their initial procedure. Median follow-up was 26 (range: 1-110) months. No early graft dehiscence was reported. No child developed aortic arch obstruction or graft calcification. Twelve patients (86%) underwent postoperative cardiac catheterizations with no measurable arch gradient. No intermediate-term aneurysm, dehiscence, or graft removal occurred. Three early deaths were due to arrhythmia, non-shunt-related hypoxia, and renal failure, and one, intermediate-term death was respiratory syncytial virus related. This series found that DCPA reconstructed arches have a low adverse event profile. No complications occurred. Because this graft material, which may be less immunogenic, has important implications for this subgroup, who are at increased future transplant risk, larger trials evaluating longer-term safety and immunogenicity are warranted.