<i>In vitro</i> hydrodynamic performance testing of heart valve prosthesis and its clinical application_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

WANG Hao ¹ , ZHU Da ² , BAO Xiangyu ³ , HE Zhaoming ⁴ ,  LIU Li ⁵ ,  PAN Xiangbin ^2,6

1. Research Center of Fluid Machinery Engineering & Technology, Jiangsu University, Zhenjiang, 212013, Jiangsu, P. R. China;
2. Structural Heart Center, Fuwai Yunnan Cardiovascular Hospital, Kunming, 650000, P. R. China;
3. Shanghai Heartpartner Testing Equipment Co., Ltd, Shanghai, 200000, P. R. China;
4. Department of Mechanical Engineering, Texas Tech University, Lubbock, TX 79409, The United States of America;
5. National Institutes for Food and Drug Control, Beijing, 102629, P. R. China;
6. Structural Heart Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, 100037, P. R. China;

Corresponding author：

LIU Li, Email: liuli_7823@163.com; PAN Xiangbin, Email: xiangbin428@hotmail.com

Keywords：

Heart valve prosthesis; in vitro testing; hydrodynamic performance; ISO 5840 international standard

DOI：

10.7507/1007-4848.202111008

Video：

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The heart valve prosthesis must have excellent hydrodynamic performance which is usually tested in vitro, not in vivo. This paper comprehensively introduced the principles and methods of hydrodynamic performance in vitro testing, helping clinicians to understand valve performance parameters, evaluate valve applicability, and reduce clinical risk of the valve prosthesis. In vitro testing not only serves as the "gold standard" for valve prosthesis assessment, but also provides detailed data for design and optimization of the prosthesis. ISO 5840 defines the items and methods for valve in vitro testing, which consists of three parts: (1) pulsatile flow testing, which reproduces the pulsating flow of the valve prosthesis after implantation in the human body; (2) steady flow testing, which assesses valve forward flow resistance; (3) durability testing, which evaluates the durability of the valve prosthesis and determines the expected failure mode. In addition, the paper presented the differences between atrioventricular and aortic valve testing, the method of mitral valve testing, the differences between transcatheter and surgical valve testing, and the method of valve flow visualization.

Citation： WANG Hao, ZHU Da, BAO Xiangyu, HE Zhaoming, LIU Li, PAN Xiangbin. In vitro hydrodynamic performance testing of heart valve prosthesis and its clinical application. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2022, 29(3): 279-287. doi: 10.7507/1007-4848.202111008 Copy

1.	2021-2026年中国心脏瓣膜市场供需现状及投资战略研究报告, 2021. Accessed on 2020-12-23. URL: https://m.huaon.com/detail/674484.html.
2.	中国生物医学工程学会体外循环分会. 2019年中国心外科手术和体外循环数据白皮书. 中国体外循环杂志, 2020, 18(4): 193-196.
3.	Harken DE, Soroff HS, Taylor WJ, et al. Partial and complete prostheses in aortic insufficiency. J Thorac Cardiovasc Surg, 1960, 40: 744-762.
4.	Yoganathan AP, He Z, Leo HL, et al. Heart valves, mechanical. Encyclopedia of Biomaterials and Biomedical Engineering, 2004: 737-745.
5.	International Organization for Standardization. ISO 5840-1: 2021. Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements. Geneva, Switzerland, 2021. URL: https://www.iso.org/standard/77033.html.
6.	李守彦. 从风险分析和FMEA看人工心脏瓣膜的体外测试方法的演变. 第二届生物材料与组织工程产品质量控制国际研讨会论文集. 2011: 35-39.
7.	Schoephoerster R, Chandran KB. Effect of systolic flow rate on the prediction of effective prosthetic valve orifice area. J Biomech, 1989, 22(6-7): 705-715.
8.	Floersch J, Evans MC, Midha PA. Ineffective orifice area: Practical limitations of accurate EOA assessment for low-gradient heart valve prostheses. Cardiovasc Eng Technol, 2021, 12(6): 598-605.
9.	Wu C, Saikrishnan N, Chalekian AJ, et al. In-vitro pulsatile flow testing of prosthetic heart valves: A round-robin study by the ISO Cardiac Valves Working Group. Cardiovasc Eng Technol, 2019, 10(3): 397-422.
10.	Wang H, Cui Z, Zhou Z, et al. A single-opening&closing valve tester for direct measurement of closing volume of the heart valve. Cardiovasc Eng Technol, 2021. [Epub ahead of print].
11.	Oertel F, Golczyk K, Pantele S, et al. Mitral valve restoration using the No-React(R) MitroFix™: A novel concept. J Cardiothorac Surg, 2012, 7: 82.
12.	Gillinov AM, Cosgrove DM. Current status of mitral valve repair. Am Heart Hosp J, 2003, 1(1): 47-54.
13.	Coutinho GF, Correia PM, Antunes MJ. Concomitant aortic and mitral surgery: To replace or repair the mitral valve? J Thorac Cardiovasc Surg, 2014, 148(4): 1386-1392.
14.	Qiu Z, Chen X, Xu M, et al. Is mitral valve repair superior to replacement for chronic ischemic mitral regurgitation with left ventricular dysfunction? J Cardiothorac Surg, 2010, 5: 107.
15.	Kosmas I, Aravanis N, Iakovou I, et al. Transcatheter management of valvular regurgitation beyond the aortic valve (mitral-tricuspid valve): Literature overview and future perspectives. Hellenic J Cardiol, 2020, 61(5): 299-305.
16.	Siefert AW, Siskey RL. Bench models for assessing the mechanics of mitral valve repair and percutaneous surgery. Cardiovasc Eng Technol, 2015, 6(2): 193-207.
17.	Oliveira D, Srinivasan J, Espino D, et al. Geometric description for the anatomy of the mitral valve: A review. J Anat, 2020, 237(2): 209-224.
18.	Micali LR, Qadrouh MN, Parise O, et al. Papillary muscle intervention vs. mitral ring annuloplasty in ischemic mitral regurgitation. J Card Surg, 2020, 35(3): 645-653.
19.	杨梦旭, 王颢, 荆腾, 等. 用于修复三尖瓣返流的三尖瓣塞离体试验研究. 排灌机械工程学报, 2020, 38(10): 1030-1036.
20.	Jimenez JH, Soerensen DD, He Z, et al. Effects of a saddle shaped annulus on mitral valve function and chordal force distribution: An in vitro study. Ann Biomed Eng, 2003, 31(10): 1171-1181.
21.	Vismara R, Pavesi A, Votta E, et al. A pulsatile simulator for the in vitro analysis of the mitral valve with tri-axial papillary muscle displacement. Int J Artif Organs, 2011, 34(4): 383-391.
22.	Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: First human case description. Circulation, 2002, 106(24): 3006-3008.
23.	Tamadon I, Mamone V, Huan Y, et al. ValveTech: A novel robotic approach for minimally invasive aortic valve replacement. IEEE Trans Biomed Eng, 2021, 68(4): 1238-1249.
24.	Cavallo A, Gasparotti E, Losi P, et al. Fabrication and in-vitro characterization of a polymeric aortic valve for minimally invasive valve replacement. J Mech Behav Biomed Mater, 2021, 115: 104294.
25.	刘丽, 万辰杰, 柯林楠, 等. 经导管瓣膜瓣中瓣模式下流体力学性能体外测试及评价. 北京生物医学工程, 2021, 40(4): 393-399.
26.	刘丽, 万辰杰, 李崇崇, 等. 经导管植入式人工心脏瓣膜体外脉动流性能研究. 中国药事, 2021, 35(1): 84-90.
27.	Sathananthan J, Hensey M, Landes U, et al. Long-term durability of transcatheter heart valves: Insights from bench testing to 25 years. JACC Cardiovasc Interv, 2020, 13(2): 235-249.
28.	Nitsche C, Kammerlander AA, Knechtelsdorfer K, et al. Determinants of bioprosthetic aortic valve degeneration. JACC Cardiovasc Imaging, 2020, 13(2 Pt 1): 345-353.
29.	Mehilli J. Lessons learned from in vitro durability testing of transcatheter heart valves. JACC Cardiovasc Interv, 2020, 13(2): 250-252.
30.	Midha PA, Raghav V, Okafor I, et al. The effect of valve-in-valve implantation height on sinus flow. Ann Biomed Eng, 2017, 45(2): 405-412.
31.	Ducci A, Pirisi F, Tzamtzis S, et al. Transcatheter aortic valves produce unphysiological flows which may contribute to thromboembolic events: An in-vitro study. J Biomech, 2016, 49(16): 4080-4089.
32.	Sadri V, Madukauwa-David ID, Yoganathan AP. In vitro evaluation of a new aortic valved conduit. J Thorac Cardiovasc Surg, 2021, 161(2): 581-590.
33.	Quiroz-Arita C, Blaylock ML, Gharagozloo PE, et al. Pilot-scale open-channel raceways and flat-panel photobioreactors maintain well-mixed conditions under a wide range of mixing energy inputs. Biotechnol Bioeng, 2020, 117(4): 959-969.
34.	Arjunon S, Ardana PH, Saikrishnan N, et al. Design of a pulsatile flow facility to evaluate thrombogenic potential of implantable cardiac devices. J Biomech Eng, 2015, 137(4): 045001.
35.	Piatti F, Sturla F, Marom G, et al. Hemodynamic and thrombogenic analysis of a trileaflet polymeric valve using a fluid-structure interaction approach. J Biomech, 2015, 48(13): 3641-3649.
36.	Wei ZA, Sonntag SJ, Toma M, et al. Computational fluid dynamics assessment associated with transcatheter heart valve prostheses: A position paper of the ISO Working Group. Cardiovasc Eng Technol, 2018, 9(3): 289-299.
37.	符珉瑞, 高斌, 常宇, 等. 血流动力学优化在人工心脏设计中的应用. 生物医学工程学杂志, 2020, 37(6): 1000-1011.

1. 2021-2026年中国心脏瓣膜市场供需现状及投资战略研究报告, 2021. Accessed on 2020-12-23. URL: https://m.huaon.com/detail/674484.html.
2. 中国生物医学工程学会体外循环分会. 2019年中国心外科手术和体外循环数据白皮书. 中国体外循环杂志, 2020, 18(4): 193-196.
3. Harken DE, Soroff HS, Taylor WJ, et al. Partial and complete prostheses in aortic insufficiency. J Thorac Cardiovasc Surg, 1960, 40: 744-762.
4. Yoganathan AP, He Z, Leo HL, et al. Heart valves, mechanical. Encyclopedia of Biomaterials and Biomedical Engineering, 2004: 737-745.
5. International Organization for Standardization. ISO 5840-1: 2021. Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements. Geneva, Switzerland, 2021. URL: https://www.iso.org/standard/77033.html.
6. 李守彦. 从风险分析和FMEA看人工心脏瓣膜的体外测试方法的演变. 第二届生物材料与组织工程产品质量控制国际研讨会论文集. 2011: 35-39.
7. Schoephoerster R, Chandran KB. Effect of systolic flow rate on the prediction of effective prosthetic valve orifice area. J Biomech, 1989, 22(6-7): 705-715.
8. Floersch J, Evans MC, Midha PA. Ineffective orifice area: Practical limitations of accurate EOA assessment for low-gradient heart valve prostheses. Cardiovasc Eng Technol, 2021, 12(6): 598-605.
9. Wu C, Saikrishnan N, Chalekian AJ, et al. In-vitro pulsatile flow testing of prosthetic heart valves: A round-robin study by the ISO Cardiac Valves Working Group. Cardiovasc Eng Technol, 2019, 10(3): 397-422.
10. Wang H, Cui Z, Zhou Z, et al. A single-opening&closing valve tester for direct measurement of closing volume of the heart valve. Cardiovasc Eng Technol, 2021. [Epub ahead of print].
11. Oertel F, Golczyk K, Pantele S, et al. Mitral valve restoration using the No-React(R) MitroFix™: A novel concept. J Cardiothorac Surg, 2012, 7: 82.
12. Gillinov AM, Cosgrove DM. Current status of mitral valve repair. Am Heart Hosp J, 2003, 1(1): 47-54.
13. Coutinho GF, Correia PM, Antunes MJ. Concomitant aortic and mitral surgery: To replace or repair the mitral valve? J Thorac Cardiovasc Surg, 2014, 148(4): 1386-1392.
14. Qiu Z, Chen X, Xu M, et al. Is mitral valve repair superior to replacement for chronic ischemic mitral regurgitation with left ventricular dysfunction? J Cardiothorac Surg, 2010, 5: 107.
15. Kosmas I, Aravanis N, Iakovou I, et al. Transcatheter management of valvular regurgitation beyond the aortic valve (mitral-tricuspid valve): Literature overview and future perspectives. Hellenic J Cardiol, 2020, 61(5): 299-305.
16. Siefert AW, Siskey RL. Bench models for assessing the mechanics of mitral valve repair and percutaneous surgery. Cardiovasc Eng Technol, 2015, 6(2): 193-207.
17. Oliveira D, Srinivasan J, Espino D, et al. Geometric description for the anatomy of the mitral valve: A review. J Anat, 2020, 237(2): 209-224.
18. Micali LR, Qadrouh MN, Parise O, et al. Papillary muscle intervention vs. mitral ring annuloplasty in ischemic mitral regurgitation. J Card Surg, 2020, 35(3): 645-653.
19. 杨梦旭, 王颢, 荆腾, 等. 用于修复三尖瓣返流的三尖瓣塞离体试验研究. 排灌机械工程学报, 2020, 38(10): 1030-1036.
20. Jimenez JH, Soerensen DD, He Z, et al. Effects of a saddle shaped annulus on mitral valve function and chordal force distribution: An in vitro study. Ann Biomed Eng, 2003, 31(10): 1171-1181.
21. Vismara R, Pavesi A, Votta E, et al. A pulsatile simulator for the in vitro analysis of the mitral valve with tri-axial papillary muscle displacement. Int J Artif Organs, 2011, 34(4): 383-391.
22. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: First human case description. Circulation, 2002, 106(24): 3006-3008.
23. Tamadon I, Mamone V, Huan Y, et al. ValveTech: A novel robotic approach for minimally invasive aortic valve replacement. IEEE Trans Biomed Eng, 2021, 68(4): 1238-1249.
24. Cavallo A, Gasparotti E, Losi P, et al. Fabrication and in-vitro characterization of a polymeric aortic valve for minimally invasive valve replacement. J Mech Behav Biomed Mater, 2021, 115: 104294.
25. 刘丽, 万辰杰, 柯林楠, 等. 经导管瓣膜瓣中瓣模式下流体力学性能体外测试及评价. 北京生物医学工程, 2021, 40(4): 393-399.
26. 刘丽, 万辰杰, 李崇崇, 等. 经导管植入式人工心脏瓣膜体外脉动流性能研究. 中国药事, 2021, 35(1): 84-90.
27. Sathananthan J, Hensey M, Landes U, et al. Long-term durability of transcatheter heart valves: Insights from bench testing to 25 years. JACC Cardiovasc Interv, 2020, 13(2): 235-249.
28. Nitsche C, Kammerlander AA, Knechtelsdorfer K, et al. Determinants of bioprosthetic aortic valve degeneration. JACC Cardiovasc Imaging, 2020, 13(2 Pt 1): 345-353.
29. Mehilli J. Lessons learned from in vitro durability testing of transcatheter heart valves. JACC Cardiovasc Interv, 2020, 13(2): 250-252.
30. Midha PA, Raghav V, Okafor I, et al. The effect of valve-in-valve implantation height on sinus flow. Ann Biomed Eng, 2017, 45(2): 405-412.
31. Ducci A, Pirisi F, Tzamtzis S, et al. Transcatheter aortic valves produce unphysiological flows which may contribute to thromboembolic events: An in-vitro study. J Biomech, 2016, 49(16): 4080-4089.
32. Sadri V, Madukauwa-David ID, Yoganathan AP. In vitro evaluation of a new aortic valved conduit. J Thorac Cardiovasc Surg, 2021, 161(2): 581-590.
33. Quiroz-Arita C, Blaylock ML, Gharagozloo PE, et al. Pilot-scale open-channel raceways and flat-panel photobioreactors maintain well-mixed conditions under a wide range of mixing energy inputs. Biotechnol Bioeng, 2020, 117(4): 959-969.
34. Arjunon S, Ardana PH, Saikrishnan N, et al. Design of a pulsatile flow facility to evaluate thrombogenic potential of implantable cardiac devices. J Biomech Eng, 2015, 137(4): 045001.
35. Piatti F, Sturla F, Marom G, et al. Hemodynamic and thrombogenic analysis of a trileaflet polymeric valve using a fluid-structure interaction approach. J Biomech, 2015, 48(13): 3641-3649.
36. Wei ZA, Sonntag SJ, Toma M, et al. Computational fluid dynamics assessment associated with transcatheter heart valve prostheses: A position paper of the ISO Working Group. Cardiovasc Eng Technol, 2018, 9(3): 289-299.
37. 符珉瑞, 高斌, 常宇, 等. 血流动力学优化在人工心脏设计中的应用. 生物医学工程学杂志, 2020, 37(6): 1000-1011.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

In vitro hydrodynamic performance testing of heart valve prosthesis and its clinical application

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