Animal study of a novel designed transcatheter aortic valve replacement system_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

CHEN Song ¹ , SUN Ming ¹ , GAO Liping ¹ , LIU Zehui ¹ , MING Tingbo ¹ , LIU Tangjie ¹ , ZHANG Changdong ^1,2 ,  SHANG Xiaoke ^1,2,3

1. Corporate technology center of Hubei Province, Wuhan Vickor Medical Technology Co., Ltd, Wuhan, 430205, P. R. China;
2. Department of Cardiovascular Surgery, Xiehe Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, Hubei, P. R. China;
3. Laboratory of Cardiac Dynamics and Assisted Technology, School of Life and Health Sciences, Hubei University of Technology, Wuhan, 430068, P. R. China;

Corresponding?author：

SHANG Xiaoke, Email: sxs_sxk@163.com

Keywords：

Transcatheter aortic valve replacement; aortic regurgitation; animal experiment

DOI：

10.7507/1007-4848.202509059

Video：

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Objective To preliminarily explore the safety and efficacy of the Docs Valve transcatheter aortic valve replacement system. Methods A total of 26 healthy adult sheep were selected and divided into an experimental group (n=18) and a control group (n=8). The experimental group underwent transcatheter aortic valve implantation (TAVI) via the transfemoral vascular approach, and were further subdivided into acute and chronic subgroups based on the timing of examination and anatomical exploration. Animals in the acute subgroup received anatomical exploration immediately postoperatively, while those in the chronic subgroup underwent the same exploration at 1, 3, and 6 months postoperatively. Valve position, paravalvular leak (PVL), and artificial valve leaflet tissue were observed at immediately post-operation (n=5), 1 month post-operation (n=2), 3 months post-operation (n=2), and 6 months post-operation (n=9). The control group received surgical replacement with a biological prosthetic valve, with corresponding examinations performed at 6 months postoperatively. The safety and efficacy of the valve system were analyzed using echocardiography, anatomical examination, and pathological examination. Results Seventeen sheep in the experimental group successfully completed TAVI, and 4 sheep in the control group successfully underwent surgical replacement, all surviving to the final observation period. During follow-up, valve morphology and position were normal, ultrasound imaging was clear, and the trends of changes in hemodynamics and left ventricular function were similar between the two groups. In the experimental group, 4 cases (4/17) of moderate paravalvular leakage occurred during follow-up; in the control group, 2 cases (2/4) of moderate paravalvular leakage and 1 case (1/4) of moderate regurgitation were noted. Anatomical examination revealed no thrombi, vegetations, or calcifications in either group; extensive endothelialization was observed on stents and valve leaflets, with a small amount of calcium deposition in the experimental group. Pathological examination showed no thrombus formation in core organs or brain tissues in either group. Conclusion The results of this animal control trial preliminarily confirm the safety and efficacy of the Docs Valve transcatheter aortic valve replacement system. However, due to the limited sample size of the control group, the conclusions require further verification in larger sample sizes.

1.	Shu C, Chen S, Qin T, et al. Prevalence and correlates of valvular heart diseases in the elderly population in Hubei, China. Sci Rep, 2016, 6: 27253.
2.	Barbanti M, Laterra G, Maisano F. Transcatheter treatment of pure aortic regurgitation. Nat Rev Cardiol, 2024, 21(9): 597-598.
3.	國家心血管病中心, 國家結構性心臟病介入質控中心, 中華醫學會心血管病學分會, 等. 經導管主動脈瓣置換術臨床實踐指南. 中華醫學雜志, 2023, 103(12): 886-900.National Center for Cardiovascular Diseases, National Center for Quality Control of Structural Heart Disease Intervention, Chinese Society of Cardiology, et al. Chinese guideline for the clincal application of transcatheter aortic valve replacement. Natl Med J China, 2023, 103(12): 886-900.
4.	中國醫師協會心血管內科醫師分會結構性心臟病學組, 亞太結構性心臟病俱樂部. 中國經導管主動脈瓣置換術臨床路徑專家共識 (2024版). 中國循環雜志, 2024, 39(11): 1041-1057.Structural Cardiology Committee of Cardiovascular Physicians Branch, Chinese Medical Doctor Association, Asia Pacific Structural Heart Disease Club. Expert consensus on clinical pathway for transcatheter aortic valve replacement in China (2024 edition). Chin Circ J, 2024, 39(11): 1041-1057.
5.	Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol, 2021, 77(4): e25-e197.
6.	Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. EuroIntervention, 2022, 17(14): e1126-e1196.
7.	Kedhi E, Hermanides RS, Dambrink JE, et al. Transcatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and complex or multivessel coronary disease (TCW): an international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial. Lancet, 2025, 404(10471): 2593-2602.
8.	Genereux P, Schwartz A, Oldemeyer JB, et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med, 2025, 392(3): 217-227.
9.	Rodes-Cabau J, Ribeiro HB, Mohammadi S, et al. Transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis and small aortic annulus: a randomized clinical trial. Circulation, 2024, 149(9): 644-655.
10.	陳鑒濤, 張怡, 馮康倪, 等. 經導管主動脈瓣置換術治療重度單純自體主動脈瓣反流患者療效觀察. 浙江大學學報(醫學版), 2025, 54(4): 529-540.Chen JT, Zhang Y, Feng KN, et al. Clinical efficacy and safety of transcatheter aortic valve replacement for patients with severe pure native aortic regurgitation. J Zhejiang Univ (Med Sci), 2025, 54(4): 529-540.
11.	李岳環, 周佳衛, 羅天戈, 等. 超大瓣環單純主動脈瓣反流的經導管主動脈瓣置換術經驗. 中國心血管病研究, 2025, 23(4): 310-315.Li YH, Zhou JW, Luo TG, et al. Experience in transcatheter aortic valve replacement for isolated aortic regurgitation in patients with oversized annulus. Chin J Cardiovasc Res, 2025, 23(4): 310-315.
12.	Vahl TP, Thourani VH, Makkar RR, et al. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. Lancet, 2024, 403(10435): 1451-1459.
13.	Huded CP, Allen KB, Chhatriwalla AK. Counterpoint: challenges and limitations of transcatheter aortic valve implantation for aortic regurgitation. Heart, 2021, 107(24): 1942-1945.
14.	劉路路, 康哲鋒, 肖博文, 等. 應用Ken-Valve經心尖入路經導管主動脈瓣置換術治療單純主動脈瓣重度反流一例. 中國胸心血管外科臨床雜志, 2022, 29(8): 1078-1082.Liu LL, Kang ZF, Xiao BW, et al. Transapical transcatheter aortic valve replacement using Ken-Valve for pure severe aortic regurgitation: a case report. Chin J Clin Thorac Cardiovasc Surg, 2022, 29(8): 1078-1082.
15.	Jin M, Zhang H, Zhou Q, et al. Transcatheter aortic valve implantation for severe aortic regurgitation using the J-Valve system: a midterm follow-up study. Catheter Cardiovasc Interv, 2024, 104(5): 1052-1059.
16.	Zhu D, Chen Y, Guo Y, et al. Transapical transcatheter aortic valve implantation using a new second-generation TAVI system - J-Valve for high-risk patients with aortic valve diseases: initial results with 90-day follow-up. Int J Cardiol, 2015, 199: 155-162.
17.	Schneeberger Y, Seiffert M, Schaefer A, et al. TAVI for pure non-calcified aortic regurgitation using a self-expandable transcatheter heart valve. Front Cardiovasc Med, 2021, 8: 743579.
18.	Liu H, Liu S, Lu Y, et al. Transapical transcatheter aortic valve implantation for predominant aortic regurgitation with a self-expandable valve. J Thorac Dis, 2020, 12(3): 538-549.
19.	Akinseye OA, Pathak A, Ibebuogu UN. Aortic valve regurgitation: a comprehensive review. Curr Probl Cardiol, 2018, 43(8): 315-334.
20.	Noble S, Mauler-Wittwer S. TAVR as an alternative to SAVR for pure native aortic regurgitation. Can J Cardiol, 2024, 40(2): 316-325.
21.	Roy DA, Schaefer U, Guetta V, et al. Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation. J Am Coll Cardiol, 2013, 61(15): 1577-1584.
22.	Testa L, Latib A, Rossi ML, et al. CoreValve implantation for severe aortic regurgitation: a multicentre registry. EuroIntervention, 2014, 10(6): 739-745.
23.	Sanchez-Luna JP, Martin P, Dager AE, et al. Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation. EuroIntervention, 2023, 19(7): 580-588.
24.	Poletti E, De Backer O, Scotti A, et al. Transcatheter aortic valve replacement for pure native aortic valve regurgitation: the PANTHEON international project. JACC Cardiovasc Interv, 2023, 16(16): 1974-1985.
25.	Gogia S, Vahl TP, Thourani VH, et al. Cardiac computed tomography angiography anatomical characterization of patients screened for a dedicated transfemoral transcatheter valve system for primary aortic regurgitation. Struct Heart, 2023, 7(3): 100164.

1. Shu C, Chen S, Qin T, et al. Prevalence and correlates of valvular heart diseases in the elderly population in Hubei, China. Sci Rep, 2016, 6: 27253.
2. Barbanti M, Laterra G, Maisano F. Transcatheter treatment of pure aortic regurgitation. Nat Rev Cardiol, 2024, 21(9): 597-598.
3. 國家心血管病中心, 國家結構性心臟病介入質控中心, 中華醫學會心血管病學分會, 等. 經導管主動脈瓣置換術臨床實踐指南. 中華醫學雜志, 2023, 103(12): 886-900.National Center for Cardiovascular Diseases, National Center for Quality Control of Structural Heart Disease Intervention, Chinese Society of Cardiology, et al. Chinese guideline for the clincal application of transcatheter aortic valve replacement. Natl Med J China, 2023, 103(12): 886-900.
4. 中國醫師協會心血管內科醫師分會結構性心臟病學組, 亞太結構性心臟病俱樂部. 中國經導管主動脈瓣置換術臨床路徑專家共識 (2024版). 中國循環雜志, 2024, 39(11): 1041-1057.Structural Cardiology Committee of Cardiovascular Physicians Branch, Chinese Medical Doctor Association, Asia Pacific Structural Heart Disease Club. Expert consensus on clinical pathway for transcatheter aortic valve replacement in China (2024 edition). Chin Circ J, 2024, 39(11): 1041-1057.
5. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol, 2021, 77(4): e25-e197.
6. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. EuroIntervention, 2022, 17(14): e1126-e1196.
7. Kedhi E, Hermanides RS, Dambrink JE, et al. Transcatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and complex or multivessel coronary disease (TCW): an international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial. Lancet, 2025, 404(10471): 2593-2602.
8. Genereux P, Schwartz A, Oldemeyer JB, et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med, 2025, 392(3): 217-227.
9. Rodes-Cabau J, Ribeiro HB, Mohammadi S, et al. Transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis and small aortic annulus: a randomized clinical trial. Circulation, 2024, 149(9): 644-655.
10. 陳鑒濤, 張怡, 馮康倪, 等. 經導管主動脈瓣置換術治療重度單純自體主動脈瓣反流患者療效觀察. 浙江大學學報(醫學版), 2025, 54(4): 529-540.Chen JT, Zhang Y, Feng KN, et al. Clinical efficacy and safety of transcatheter aortic valve replacement for patients with severe pure native aortic regurgitation. J Zhejiang Univ (Med Sci), 2025, 54(4): 529-540.
11. 李岳環, 周佳衛, 羅天戈, 等. 超大瓣環單純主動脈瓣反流的經導管主動脈瓣置換術經驗. 中國心血管病研究, 2025, 23(4): 310-315.Li YH, Zhou JW, Luo TG, et al. Experience in transcatheter aortic valve replacement for isolated aortic regurgitation in patients with oversized annulus. Chin J Cardiovasc Res, 2025, 23(4): 310-315.
12. Vahl TP, Thourani VH, Makkar RR, et al. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. Lancet, 2024, 403(10435): 1451-1459.
13. Huded CP, Allen KB, Chhatriwalla AK. Counterpoint: challenges and limitations of transcatheter aortic valve implantation for aortic regurgitation. Heart, 2021, 107(24): 1942-1945.
14. 劉路路, 康哲鋒, 肖博文, 等. 應用Ken-Valve經心尖入路經導管主動脈瓣置換術治療單純主動脈瓣重度反流一例. 中國胸心血管外科臨床雜志, 2022, 29(8): 1078-1082.Liu LL, Kang ZF, Xiao BW, et al. Transapical transcatheter aortic valve replacement using Ken-Valve for pure severe aortic regurgitation: a case report. Chin J Clin Thorac Cardiovasc Surg, 2022, 29(8): 1078-1082.
15. Jin M, Zhang H, Zhou Q, et al. Transcatheter aortic valve implantation for severe aortic regurgitation using the J-Valve system: a midterm follow-up study. Catheter Cardiovasc Interv, 2024, 104(5): 1052-1059.
16. Zhu D, Chen Y, Guo Y, et al. Transapical transcatheter aortic valve implantation using a new second-generation TAVI system - J-Valve for high-risk patients with aortic valve diseases: initial results with 90-day follow-up. Int J Cardiol, 2015, 199: 155-162.
17. Schneeberger Y, Seiffert M, Schaefer A, et al. TAVI for pure non-calcified aortic regurgitation using a self-expandable transcatheter heart valve. Front Cardiovasc Med, 2021, 8: 743579.
18. Liu H, Liu S, Lu Y, et al. Transapical transcatheter aortic valve implantation for predominant aortic regurgitation with a self-expandable valve. J Thorac Dis, 2020, 12(3): 538-549.
19. Akinseye OA, Pathak A, Ibebuogu UN. Aortic valve regurgitation: a comprehensive review. Curr Probl Cardiol, 2018, 43(8): 315-334.
20. Noble S, Mauler-Wittwer S. TAVR as an alternative to SAVR for pure native aortic regurgitation. Can J Cardiol, 2024, 40(2): 316-325.
21. Roy DA, Schaefer U, Guetta V, et al. Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation. J Am Coll Cardiol, 2013, 61(15): 1577-1584.
22. Testa L, Latib A, Rossi ML, et al. CoreValve implantation for severe aortic regurgitation: a multicentre registry. EuroIntervention, 2014, 10(6): 739-745.
23. Sanchez-Luna JP, Martin P, Dager AE, et al. Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation. EuroIntervention, 2023, 19(7): 580-588.
24. Poletti E, De Backer O, Scotti A, et al. Transcatheter aortic valve replacement for pure native aortic valve regurgitation: the PANTHEON international project. JACC Cardiovasc Interv, 2023, 16(16): 1974-1985.
25. Gogia S, Vahl TP, Thourani VH, et al. Cardiac computed tomography angiography anatomical characterization of patients screened for a dedicated transfemoral transcatheter valve system for primary aortic regurgitation. Struct Heart, 2023, 7(3): 100164.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

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