Clinical Results for Cardiovascular Xenografts Treated With Novel Anticalcification Protocols

IF 2.3 3区医学 Q3 ENGINEERING, BIOMEDICAL

Artificial organs Pub Date : 2025-04-11 DOI:10.1111/aor.15010

Hong-Gook Lim, Chang Ha Lee, Jae Hong Lim, Eung Re Kim, Yong Jin Kim

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引用次数: 0

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.

Abstract Image

查看原文本刊更多论文

新型抗钙化方案治疗心血管异种移植的临床结果。

背景：戊二醛（GA）在心血管异种移植物之间产生交联，以获得组织稳定性和减弱抗原性。然而，用先前的抗钙化策略治疗GA固定心血管异种移植物的长期耐久性仍然是一个挑战，因为组织磷脂、GA的游离醛基团和残留的抗原性有助于钙化。本研究旨在评估用我们的新型抗钙化方案（Periborn）治疗心血管疾病患者的牛心包支架的安全性、有效性和临床表现。方法：用0.25%十二烷基硫酸钠、0.5% Triton X-100对牛心包进行脱细胞处理，并用聚乙二醇填充物处理。这些组织在75%乙醇+5%辛醇有机溶剂中与0.5% GA交联，然后用甘氨酸进行脱毒处理，得到Periborn。2015年7月至2022年4月，352例心血管手术中植入了451块Periborn贴片。结果：手术时平均年龄为22.74±20.09岁（13天-89.5年），随访时间为4.25±2.56年（17天-8.6年），无贴片相关死亡。5例患者因补片相关并发症（包括活动能力下降、侵蚀、假性动脉瘤和钙化）再次手术，围生相关再手术的总体概率为1年99.4%±0.4%，5年98.6%±0.7%，9年95.4%±3.2%。结论：本回顾性研究证明了组织工程牛心包支架用于各种心血管疾病的外科修复的安全性和有效性。Periborn优异的耐久性和血流动力学性能使我们的新型抗钙化方案具有吸引力，可能需要长期随访以确认耐久性和进一步研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Artificial organs 工程技术-工程：生物医学

CiteScore

4.30

自引率

12.50%

发文量

303

审稿时长

4-8 weeks

期刊介绍： Artificial Organs is the official peer reviewed journal of The International Federation for Artificial Organs (Members of the Federation are: The American Society for Artificial Internal Organs, The European Society for Artificial Organs, and The Japanese Society for Artificial Organs), The International Faculty for Artificial Organs, the International Society for Rotary Blood Pumps, The International Society for Pediatric Mechanical Cardiopulmonary Support, and the Vienna International Workshop on Functional Electrical Stimulation. Artificial Organs publishes original research articles dealing with developments in artificial organs applications and treatment modalities and their clinical applications worldwide. Membership in the Societies listed above is not a prerequisite for publication. Articles are published without charge to the author except for color figures and excess page charges as noted.