Clinical Results for Cardiovascular Xenografts Treated With Novel Anticalcification Protocols

Artif Organs. 2025 Apr 11. doi: 10.1111/aor.15010. Online ahead of print.

ABSTRACT

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.

PMID:40213904 | DOI:10.1111/aor.15010