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
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1. 清华大学 机械工程系,北京 100084;2. 康迪泰科(北京)医疗科技有限公司,北京 101300;3. 澎立检测技术(上海)有限公司,上海 201401

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Experimental study of novel balloon-expandable transcatheter aortic valve system in a porcine model
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1.Department of Mechanical Engineering, Tsinghua University, Beijing 100084, China;2. CardioTek Medical (Beijing) CO. ,LTD. , Beijing 101300, China;3. PharmaLegacy Laboratories, Shanghai 201401, China

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    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 只体质量约 45 kg 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、30、90、180 d 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,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 To evaluate the biocompatibility, anti-calcification, and long-term stability of a novel balloon-expandable transcatheter aortic valve in pigs in vivo. Methods Twenty-seven healthy white pigs weighing approximately 45 kg were selected as experimental animals. Preoperative physical examination and appropriate pretreatment, including drug treatment and disinfection, were performed. Under aseptic surgical conditions, a valve loaded on the balloon catheter delivery system was implanted into the porcine aortic valve position via femoral artery vascular access. The animals’ vital signs, diet, and activity were then observed and continuous drug treatment was administered. Echocardiography and digital subtraction angiography were performed immediately and at 30, 90 and 180 d, to assess the hemodynamics and location of the valve, and the impact on the surrounding cardiac structures. Hearts and major organ tissues were sampled at the corresponding follow-up points, and the tissue inflammatory response, thrombus score, calcification degree, and endothelialization degree were analyzed by histopathology staining. The structural integrity of the valve stent and calcification of the valve leaflets were evaluated by X-ray and micro-computed tomography. Results Twenty-three animals were included in the final analysis. Pigs with successful valve implantation recovered well and had stable vital signs. Follow-up examination showed that the aortic valve blood flow velocity, transvalvular pressure difference, and leaflet motion were all 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. All the result were in line with expectations, and the differences were statistically significant ( P<0. 05). Conclusions The new balloon-expandable transcatheter aortic valve system shows good biocompatibility, anti-calcification, and implant stability in animal experiments, laying a solid foundation for subsequent clinical trials. This system is expected to improve the therapeutic effect of transcatheter aortic valve implantation (TAVI) and promote the technological progress of domestic TAVI devices, to bring new breakthroughs and development opportunities in the field of cardiovascular disease treatment.

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蔡涛,吕见,方刚.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[J].中国实验动物学报,2025,33(11):1636~1647.

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  • 收稿日期:2025-06-11
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