Clinical Results for Cardiovascular Xenografts Treated With Novel Anticalcification Protocols

Glutaraldehyde (GA) generates cross-links between cardiovascular xenografts to obtain tissue stability and attenuate antigenicity. However, the long-term durability of GA-fixed cardiovascular xenografts treated with previous anticalcification strategies has remained a challenge because tissue phospholipids, free aldehyde groups of GA, and residual antigenicity contribute to calcification. This study aimed to assess the safety, efficacy, and clinical performance of a bovine pericardial scaffold treated with our novel anticalcification protocols (Periborn) in patients with cardiovascular diseases.

Bovine pericardia were decellularized with 0.25% sodium dodecyl sulfate, 0.5% Triton X-100, and treated with a space-filler with polyethylene glycol. These tissues were cross-linked with 0.5% GA in a 75% ethanol +5% octanol organic solvent and treated with glycine for detoxification to produce Periborn. Between July 2015 and April 2022, 451 Periborn patches were implanted in 352 cases for cardiovascular surgeries.

The mean age at the time of surgery was 22.74 ± 20.09 years (13 days-89.5 years), follow-up duration was 4.25 ± 2.56 years (17 days-8.6 years), and no patch-related mortalities were observed. Five patients were reoperated owing to patch-related complications including decreased mobility, erosion, pseudoaneurysm, and calcification, and the overall probability of freedom from Periborn-related reoperation was 99.4% ± 0.4% at 1 year, 98.6% ± 0.7% at 5 years, and 95.4% ± 3.2% at 9 years.

This retrospective study demonstrates the safety and efficacy of the tissue-engineered Periborn bovine pericardial scaffold for the surgical repair of various cardiovascular diseases. The excellent durability and hemodynamic performance of Periborn make our novel anti-calcification protocol attractive and may require long-term follow-up to confirm durability and further research.