Experimental study on the ultrasound visibility of a novel interventional catheter and delivery system: <i>In vitro</i> 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, 518057, Guangdong, P. R. ChinaCorrresponding 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

Video：

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Objective To assess 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 (100.0% vs. 30.0%). No severe complications occurred in any experimental animal. Conclusion The ultrasound-guided catheter and its corresponding delivery system exhibite superior ultrasound visibility and operational performance in both in vitro and animal experiments, indicating strong potential for clinical application.

Citation： LI Ziping, OUYANG Wenbin, LIU Zizheng, ZHOU Ning, DONG Jie, WANG Shouzheng, PAN Xiangbin. 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, 2026, 33(5): 784-790. doi: 10.7507/1007-4848.202510049 Copy

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, 李守軍, 胡盛壽, 等. 經胸超聲心動圖引導房間隔缺損封堵術的可行性. 中華心血管病雜志, 2014, 42(9): 744-747.Pan XB, Li SJ, Hu SS, et al. Feasibility of transcatheter closure of atrial septal defect under the guidance of transthoracic echocardiography. Chin J Cardiol, 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, 常鈞科, 等. 無放射引導技術在結構性心臟病介入治療中的應用進展. 廣西醫科大學學報, 2024, 41(10): 1513-1517.Dong J, Dong J, Chang JK, et al. 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. 超聲引導經皮介入治療結構性心臟病的探索和發展前景. 中國胸心血管外科臨床雜志, 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.	馮天捷, 趙廣智, 董靖, 等. 經胸超聲心動圖結合三維標測系統引導零射線心房顫動射頻導管消融術的探索研究. 中國循環雜志, 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.	李守軍. 先天性心臟病的單純超聲引導下經皮介入治療現狀與展望. 中國循環雜志, 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, 龔俊松, 康文英, 等. 全超聲引導用于經導管二尖瓣緣對緣手術的應用研究. 臨床心血管病雜志, 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.	國家衛生健康委員會國家結構性心臟病介入質量控制中心, 國家心血管病中心結構性心臟病介入質量控制中心, 中華醫學會心血管病學分會先心病經皮介入治療指南工作組, 等. 中華醫學雜志, 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). Natl Med J China, 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.	劉垚, 溫彬, 張鳳文, 等. 新型導絲系統在超聲引導房間隔缺損封堵術中的應用價值. 中國胸心血管外科臨床雜志, 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.	江紅, 劉則燁, 潘湘斌. 人工智能在心血管手術圍術期應用的研究進展. 中國胸心血管外科臨床雜志, 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, 李守軍, 胡盛壽, 等. 經胸超聲心動圖引導房間隔缺損封堵術的可行性. 中華心血管病雜志, 2014, 42(9): 744-747.Pan XB, Li SJ, Hu SS, et al. Feasibility of transcatheter closure of atrial septal defect under the guidance of transthoracic echocardiography. Chin J Cardiol, 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, 常鈞科, 等. 無放射引導技術在結構性心臟病介入治療中的應用進展. 廣西醫科大學學報, 2024, 41(10): 1513-1517.Dong J, Dong J, Chang JK, et al. 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. 超聲引導經皮介入治療結構性心臟病的探索和發展前景. 中國胸心血管外科臨床雜志, 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. 馮天捷, 趙廣智, 董靖, 等. 經胸超聲心動圖結合三維標測系統引導零射線心房顫動射頻導管消融術的探索研究. 中國循環雜志, 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. 李守軍. 先天性心臟病的單純超聲引導下經皮介入治療現狀與展望. 中國循環雜志, 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, 龔俊松, 康文英, 等. 全超聲引導用于經導管二尖瓣緣對緣手術的應用研究. 臨床心血管病雜志, 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. 國家衛生健康委員會國家結構性心臟病介入質量控制中心, 國家心血管病中心結構性心臟病介入質量控制中心, 中華醫學會心血管病學分會先心病經皮介入治療指南工作組, 等. 中華醫學雜志, 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). Natl Med J China, 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. 劉垚, 溫彬, 張鳳文, 等. 新型導絲系統在超聲引導房間隔缺損封堵術中的應用價值. 中國胸心血管外科臨床雜志, 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. 江紅, 劉則燁, 潘湘斌. 人工智能在心血管手術圍術期應用的研究進展. 中國胸心血管外科臨床雜志, 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

Experimental study on the ultrasound visibility of a novel interventional catheter and delivery system: In vitro and animal experiments

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