新型球囊扩张式经导管主动脉瓣膜系统在猪模型中的基础实验研究
DOI:
CSTR:
作者:
作者单位:

1.清华大学 机械工程系;2.澎立检测技术上海有限公司

作者简介:

通讯作者:

中图分类号:

基金项目:


Experimental Study of a novel balloon-expandable transcatheter aortic valve system in porcine model
Author:
Affiliation:

1.Tsinghua University;2.PharmaLegacy Laboratories

Fund Project:

  • 摘要
  • |
  • 图/表
  • |
  • 访问统计
  • |
  • 参考文献
  • |
  • 相似文献
  • |
  • 引证文献
  • |
  • 资源附件
  • |
  • 文章评论
    摘要:

    目的:本研究旨在通过动物实验,全面评估新型球囊扩张式经导管主动脉瓣膜在生物体内的生物相容性、抗钙化性及长周期植入稳定性。方法:选取27只体重约45kg的健康普通实验白猪作为实验动物。术前对其进行全面体检并给予相应预处理,包括药物治疗和消毒等。在无菌手术条件下,经股动脉血管通路将装载于球囊导管输送系统上的瓣膜原位植入猪主动脉瓣位置,术后密切观察动物生命体征、饮食及活动情况,并给予持续药物治疗。在即刻、30d、90d、180d等时间节点,通过超声心动检查、数字减影血管造影(Digital Subtraction Angiography, DSA)检查评估瓣膜植入后的血流动力学指标、植入位置及对周边心脏结构是否有影响等情况;完成上述检查后,在相应的随访点对动物心脏及主要脏器组织进行取材,通过组织病理学染色,分析组织炎症反应、血栓评分、钙化程度以及内皮化程度。通过X射线拍照和Micro-CT扫描,评价瓣膜支架结构完整性和瓣叶钙化情况。结果:实验最终23只动物纳入有效分析。成功植入瓣膜的动物术后恢复良好,生命体征平稳。随访检查显示,主动脉瓣血流速度、跨瓣压差和瓣叶运动等指标正常或逐渐改善,支架位置稳定,血管保持通畅。组织学分析表明,植入部位组织炎症细胞浸润程度较轻,无血栓形成,钙化面积占比低,支架完整性良好,瓣叶钙化程度低。统计学分析结果显示,各项指标均符合预期,差异具有统计学意义(P<0.05)。结论:新型球囊扩张式经导管主动脉瓣膜系统在动物实验中展现出良好的生物相容性、抗钙化性及植入稳定性,为后续开展临床试验奠定了坚实基础,有望提升经导管主动脉瓣膜置入术(Transcatheter Aortic Valve Implantation, TAVI)对中国患者的治疗效果,推动国产TAVI器械的技术进步,为心血管疾病治疗领域带来新的突破和发展机遇。

    Abstract:

    Objective: This study aimed to evaluate the Biocompatibility, anti-calcification, and long-term stability of a novel balloon-expandable transcatheter aortic valve in vivo. Method: 27 healthy white pigs weighing about 45 kg were selected as experimental animals. Preoperative physical examination and appropriate pre-treatment, including drug treatment and disinfection, were performed. Under aseptic surgical conditions, the valve loaded on the balloon catheter delivery system was implanted into the porcine aortic valve position through the femoral artery vascular access. After the operation, the vital signs, diet and activity of the animals were closely observed, and give continuous drug treatment. At immediate, 30D, 90D, 180D, etc. , echocardiography and Digital Subtraction Angiography (DSA) were performed to assess the Hemodynamics of the implanted valve, the location of the valve, and the impact on the surrounding cardiac structures, at the corresponding follow-up points, the animal heart and major organ tissues were sampled, and the tissue inflammatory response, thrombus score, calcification degree and endothelialization degree were analyzed by histopathology staining. X-ray and Micro-CT were used to evaluate the structural integrity of the valve stent and the calcification of the valve leaflets. Results: Finally, 23 animals were included in the valid analysis. The animals with successful valve implantation recovered well and had stable vital signs. The follow-up examination showed that the aortic valve blood flow velocity, transvalvular pressure difference and leaflet motion were normal or gradually improved, the stent position was stable, and the vessel remained unobstructed. Histological analysis showed that the tissue at the implantation site had mild inflammatory cell infiltration, no thrombosis, low calcification area, good stent integrity, and low calcification of the valve leaflets. The results of statistical analysis showed that all the indicators were in line with expectations, and the differences were statistically significant(P<0.05). Conclusion: The new balloon-expandable transcatheter aortic valve system has shown good Biocompatibility, anti-calcification and implant stability in animal experiments, laying a solid foundation for subsequent clinical trials, it is expected to improve the therapeutic effect of Transcatheter Aortic Valve Implantation (TAVI) on Chinese patients and promote the technological progress of domestic TAVI devices, to bring new breakthroughs and development opportunities in the field of cardiovascular disease treatment.

    参考文献
    相似文献
    引证文献
引用本文
分享
相关视频

文章指标
  • 点击次数:
  • 下载次数:
  • HTML阅读次数:
  • 引用次数:
历史
  • 收稿日期:2025-06-11
  • 最后修改日期:2025-07-24
  • 录用日期:2025-11-04
  • 在线发布日期:
  • 出版日期:
文章二维码
防诈骗提示!请勿点击不明链接或添加个人微信。编辑部所有邮箱后缀均为@cnilas.org
关闭