Experimental Study on the Ultrasound Visibility of a Novel Interventional Catheter and Delivery System: In Vitro and Animal Experiments_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

LI Ziping ¹ , OUYANG Wenbin ¹ , LIU Zizheng ¹ , ZHOU Ning ¹ , DONG Jie ¹ , WANG Shouzheng ¹ ,  PAN Xiangbin ^1,2

1. Department of Structural Heart Disease, Fuwai Hospital & National Center for Cardiovascular Disease, State key laboratory of cardiovascular disease, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Beijing, 100037, P. R. China;
2. Department of Structural Heart Disease, Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences, Shenzhen Medical Academy of Research and Translation (SMART), Shenzhen, 518107, Guangdong, P. R. China Corrresponding author: PAN Xiangbin, Email: panxiangbin@fuwaihospital.org;

Corresponding author：

PAN Xiangbin, Email: panxiangbin@fuwaihospital.org

Keywords：

Ultrasound-guided catheter; ultrasound-guided delivery system; ultrasound imaging; in vitro characterization; animal experiment

DOI：

10.7507/1007-4848.202510049

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Objective To assessment of the echogenicity of the ultrasound-guided catheter and its associated delivery system. Methods The study consisted of in vitro characterization experiments and animal studies. In the in vitro phase, the acoustic and mechanical properties of the ultrasound-guided catheter were compared with those of the traditional MPA2 catheter, including parameters such as echo intensity, recognizability, and angle dependence. In the animal experiments, a ventricular septal defect (VSD) model was established in miniature pigs to compare the procedural performance of the ultrasound-guided delivery system versus the conventional system. Evaluation indicators included the time required for the system to cross the VSD, the detection rate of the system within the right ventricle, and the occurrence of intraoperative complications. Results The ultrasound-guided catheter demonstrated a significantly higher mean echo intensity than the MPA2 catheter[ (237.3±1.8) dB vs. (190.9±13.1) dB, P<0.001] and a markedly improved recognizability rate (82.3%±5.6% vs. 26.7±3.2%, P<0.001), along with better angle independence and image quality. In animal experiments, the ultrasound-guided delivery system significantly reduced the time required to cross the VSD (18.5±5.7 min vs. 30.3±4.5 min, P<0.001) and substantially increased the detection rate within the right ventricle (100% vs. 30%). No severe complications occurred in any experimental animal. Conclusion The ultrasound-guided catheter and its corresponding delivery system exhibited superior ultrasound visibility and operational performance in both in vitro and animal experiments, indicating strong potential for clinical application.

1.	Pan XB, Ou-Yang WB, Pang KJ, et al. Percutaneous closure of atrial septal defects under transthoracic echocardiography guidance without fluoroscopy or intubation in children. J Interv Cardiol, 2015, 28(4): 390-395.
2.	潘湘斌, 李守军, 胡盛寿, 等. 经胸超声心动图引导房间隔缺损封堵术的可行性. 中华心血管病杂志, 2014, 42(9): 744-747.Pan X, Li S, Hu S, et al. Feasibility of transcatheter closure of atrial septal defect under the guidance of transthoracic echocardiography. Zhonghua Xin Xue Guan Bing Za Zhi, 2014, 42(9): 744-747.
3.	Liu J, Tang M, Niu G, et al. Initial experience of transoesophageal echocardiography-guided percutaneous pulsed field ablation of atrial fibrillation. Open Heart, 2025, 12(1): e003214.
4.	Ou-Yang WB, Li SJ, Wang SZ, et al. Echocardiographic guided closure of perimembranous ventricular septal defects. Ann Thorac Surg, 2015, 100(4): 1398-1402.
5.	Xie Y, Wang S, Zhao G, et al. Percutaneous aortic balloon valvuloplasty under echocardiographic guidance solely. J Thorac Dis, 2020, 12(2): 477-483.
6.	Hua W, Huang H, Chen X, et al. Complete radiation-free, transthoracic echocardiography-guided, leadless pacemaker implantation. Eur Heart J Case Rep, 2025, 9(5): ytaf069.
7.	Luo Z, Zhang H, Xie Y, et al. Clinical application of a fully ultrasound-guided transapical transcatheter mitral valve replacement device. JACC Cardiovasc Interv, 2020, 13(14): e161-e162.
8.	Patel H, Raisinghani A, DeMaria A. Echocardiography in transcatheter structural heart disease interventions. Prog Cardiovasc Dis, 2018, 61(5-6): 423-436.
9.	董靖, 董捷, 常钧科, 潘湘斌. 无放射引导技术在结构性心脏病介入治疗中的应用进展. 广西医科大学学报, 2024, 41(10): 1513-1517.Dong J, Dong J, Chang JK, Pan XB. Advances in the application of radiation-free guidance technology in interventional therapy for structural heart diseases. J Guangxi Med Univ, 2024, 41(10): 1513-1517.
10.	潘湘斌. 超声引导经皮介入治疗结构性心脏病的探索和发展前景. 中国胸心血管外科临床杂志, 2018, 25(4): 359-361.Pan XB. Exploration and future prospects of ultrasound-guided percutaneous intervention for structural heart disease. Chin J Clin Thorac Cardiovasc Surg, 2018, 25(4): 359-361.
11.	冯天捷, 赵广智, 董靖, 等. 经胸超声心动图结合三维标测系统引导零射线心房颤动射频导管消融术的探索研究. 中国循环杂志, 2025, 40(4): 374-379.Feng TJ, Zhao GZ, Dong J, et al. Exploratory study of zero-fluoroscopy atrial fibrillation radiofrequency catheter ablation guided by transthoracic echocardiography combined with three-dimensional mapping. Chin Circ J, 2025, 40(4): 374-379.
12.	李守军. 先天性心脏病的单纯超声引导下经皮介入治疗现状与展望. 中国循环杂志, 2015, 30(11): 1033-1034.Li SJ. Current status and prospect of percutaneous intervention for congenital heart disease under pure ultrasound guidance. Chin Circ J, 2015, 30(11): 1033-1034.
13.	段福建, 龚俊松, 康文英, 等. 全超声引导用于经导管二尖瓣缘对缘手术的应用研究. 临床心血管病杂志, 2023, 39(6): 576-578.Duan FJ, Gong JS, Kang WY, et al. Application of fully ultrasound guidance in transcatheter mitral edge-to-edge repair. J Clin Cardiovasc Dis, 2023, 39(6): 576-578.
14.	国家卫生健康委员会国家结构性心脏病介入质量控制中心, 国家心血管病中心结构性心脏病介入质量控制中心, 中华医学会心血管病学分会先心病经皮介入治疗指南工作组, 中华医学会胸心血管外科学分会先心病经皮介入治疗指南工作组. 常见先天性心脏病经皮介入治疗指南(2021版). 中华医学杂志, 2021, 101(23): 1833-1854.National Center for Structural Heart Disease Intervention Quality Control, National Center for Cardiovascular Diseases, Chinese Society of Cardiology, Chinese Society for Thoracic and Cardiovascular Surgery. Guideline for percutaneous intervention of common congenital heart diseases (2021 edition). Chin Med J, 2021, 101(23): 1833-1854.
15.	Deng RD, Zhang FW, Zhao GZ, et al. A novel double-balloon catheter for percutaneous balloon pulmonary valvuloplasty under echocardiographic guidance only. J Cardiol, 2020, 76(3): 236-243.
16.	刘垚, 温彬, 张凤文, 等. 新型导丝系统在超声引导房间隔缺损封堵术中的应用价值. 中国胸心血管外科临床杂志, 2019, 26(2): 165-168.Liu Y, Wen B, Zhang FW, et al. Clinical value of a novel guidewire system in ultrasound-guided atrial septal defect closure. Chin J Clin Thorac Cardiovasc Surg, 2019, 26(2): 165-168.
17.	Patrianakos AP, Zacharaki AA, Skalidis EI, et al. The growing role of echocardiography in interventional cardiology: The present and the future. Hellenic J Cardiol, 2017, 58(1): 17-31.
18.	Zhu D, Chen X, Su M, et al. First-in-man study of robotic-assisted transcatheter edge-to-edge repair. JACC Cardiovasc Interv, 2025, 18(8): 953-955.
19.	Zhu D, Wang S, Ou-Yang W, et al. First-in-man experience of robotic-assisted transcatheter edge-to-edge repair with pure echo guidance. JACC Cardiovasc Interv, 2024, 17(15): 1505-1506.
20.	江红, 刘则烨, 潘湘斌. 人工智能在心血管手术围术期应用的研究进展. 中国胸心血管外科临床杂志, 2025, 32(1): 54-59.Jiang H, Liu ZY, Pan XB. Research progress of artificial intelligence in the perioperative management of cardiovascular surgery. Chin J Clin Thorac Cardiovasc Surg, 2025, 32(1): 54-59.

1. Pan XB, Ou-Yang WB, Pang KJ, et al. Percutaneous closure of atrial septal defects under transthoracic echocardiography guidance without fluoroscopy or intubation in children. J Interv Cardiol, 2015, 28(4): 390-395.
2. 潘湘斌, 李守军, 胡盛寿, 等. 经胸超声心动图引导房间隔缺损封堵术的可行性. 中华心血管病杂志, 2014, 42(9): 744-747.Pan X, Li S, Hu S, et al. Feasibility of transcatheter closure of atrial septal defect under the guidance of transthoracic echocardiography. Zhonghua Xin Xue Guan Bing Za Zhi, 2014, 42(9): 744-747.
3. Liu J, Tang M, Niu G, et al. Initial experience of transoesophageal echocardiography-guided percutaneous pulsed field ablation of atrial fibrillation. Open Heart, 2025, 12(1): e003214.
4. Ou-Yang WB, Li SJ, Wang SZ, et al. Echocardiographic guided closure of perimembranous ventricular septal defects. Ann Thorac Surg, 2015, 100(4): 1398-1402.
5. Xie Y, Wang S, Zhao G, et al. Percutaneous aortic balloon valvuloplasty under echocardiographic guidance solely. J Thorac Dis, 2020, 12(2): 477-483.
6. Hua W, Huang H, Chen X, et al. Complete radiation-free, transthoracic echocardiography-guided, leadless pacemaker implantation. Eur Heart J Case Rep, 2025, 9(5): ytaf069.
7. Luo Z, Zhang H, Xie Y, et al. Clinical application of a fully ultrasound-guided transapical transcatheter mitral valve replacement device. JACC Cardiovasc Interv, 2020, 13(14): e161-e162.
8. Patel H, Raisinghani A, DeMaria A. Echocardiography in transcatheter structural heart disease interventions. Prog Cardiovasc Dis, 2018, 61(5-6): 423-436.
9. 董靖, 董捷, 常钧科, 潘湘斌. 无放射引导技术在结构性心脏病介入治疗中的应用进展. 广西医科大学学报, 2024, 41(10): 1513-1517.Dong J, Dong J, Chang JK, Pan XB. Advances in the application of radiation-free guidance technology in interventional therapy for structural heart diseases. J Guangxi Med Univ, 2024, 41(10): 1513-1517.
10. 潘湘斌. 超声引导经皮介入治疗结构性心脏病的探索和发展前景. 中国胸心血管外科临床杂志, 2018, 25(4): 359-361.Pan XB. Exploration and future prospects of ultrasound-guided percutaneous intervention for structural heart disease. Chin J Clin Thorac Cardiovasc Surg, 2018, 25(4): 359-361.
11. 冯天捷, 赵广智, 董靖, 等. 经胸超声心动图结合三维标测系统引导零射线心房颤动射频导管消融术的探索研究. 中国循环杂志, 2025, 40(4): 374-379.Feng TJ, Zhao GZ, Dong J, et al. Exploratory study of zero-fluoroscopy atrial fibrillation radiofrequency catheter ablation guided by transthoracic echocardiography combined with three-dimensional mapping. Chin Circ J, 2025, 40(4): 374-379.
12. 李守军. 先天性心脏病的单纯超声引导下经皮介入治疗现状与展望. 中国循环杂志, 2015, 30(11): 1033-1034.Li SJ. Current status and prospect of percutaneous intervention for congenital heart disease under pure ultrasound guidance. Chin Circ J, 2015, 30(11): 1033-1034.
13. 段福建, 龚俊松, 康文英, 等. 全超声引导用于经导管二尖瓣缘对缘手术的应用研究. 临床心血管病杂志, 2023, 39(6): 576-578.Duan FJ, Gong JS, Kang WY, et al. Application of fully ultrasound guidance in transcatheter mitral edge-to-edge repair. J Clin Cardiovasc Dis, 2023, 39(6): 576-578.
14. 国家卫生健康委员会国家结构性心脏病介入质量控制中心, 国家心血管病中心结构性心脏病介入质量控制中心, 中华医学会心血管病学分会先心病经皮介入治疗指南工作组, 中华医学会胸心血管外科学分会先心病经皮介入治疗指南工作组. 常见先天性心脏病经皮介入治疗指南(2021版). 中华医学杂志, 2021, 101(23): 1833-1854.National Center for Structural Heart Disease Intervention Quality Control, National Center for Cardiovascular Diseases, Chinese Society of Cardiology, Chinese Society for Thoracic and Cardiovascular Surgery. Guideline for percutaneous intervention of common congenital heart diseases (2021 edition). Chin Med J, 2021, 101(23): 1833-1854.
15. Deng RD, Zhang FW, Zhao GZ, et al. A novel double-balloon catheter for percutaneous balloon pulmonary valvuloplasty under echocardiographic guidance only. J Cardiol, 2020, 76(3): 236-243.
16. 刘垚, 温彬, 张凤文, 等. 新型导丝系统在超声引导房间隔缺损封堵术中的应用价值. 中国胸心血管外科临床杂志, 2019, 26(2): 165-168.Liu Y, Wen B, Zhang FW, et al. Clinical value of a novel guidewire system in ultrasound-guided atrial septal defect closure. Chin J Clin Thorac Cardiovasc Surg, 2019, 26(2): 165-168.
17. Patrianakos AP, Zacharaki AA, Skalidis EI, et al. The growing role of echocardiography in interventional cardiology: The present and the future. Hellenic J Cardiol, 2017, 58(1): 17-31.
18. Zhu D, Chen X, Su M, et al. First-in-man study of robotic-assisted transcatheter edge-to-edge repair. JACC Cardiovasc Interv, 2025, 18(8): 953-955.
19. Zhu D, Wang S, Ou-Yang W, et al. First-in-man experience of robotic-assisted transcatheter edge-to-edge repair with pure echo guidance. JACC Cardiovasc Interv, 2024, 17(15): 1505-1506.
20. 江红, 刘则烨, 潘湘斌. 人工智能在心血管手术围术期应用的研究进展. 中国胸心血管外科临床杂志, 2025, 32(1): 54-59.Jiang H, Liu ZY, Pan XB. Research progress of artificial intelligence in the perioperative management of cardiovascular surgery. Chin J Clin Thorac Cardiovasc Surg, 2025, 32(1): 54-59.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Latest ArticlesExperimental Study on the Ultrasound Visibility of a Novel Interventional Catheter and Delivery System: In Vitro and Animal Experiments

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