The history of pulsatile flow experiment of prosthetic heart valve: The 70th anniversary of the application of prosthetic heart valves_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

QI Liang ^1,2 , ZHANG Minzu ³ , SONG Bing ^1,2 ,  QIANG Yan ³

1. The First School of Clinical Medicine, Lanzhou University, Lanzhou, 730000, P. R. China;
2. Department of Cardiovascular Surgery, The First Hospital of Lanzhou University, Lanzhou, 730000, P. R. China;
3. School of Energy and Power Engineering, Lanzhou University of Technology, Lanzhou, 730050, P. R. China;

Corresponding author：

QIANG Yan, Email: 43161012@163.com

Keywords：

Prosthetic heart valve; pulsatile flow experiment; experimental pulse duplicator; fluid dynamics; review

DOI：

10.7507/1007-4848.202207021

Video：

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The pulsatile flow experiment can not only evaluate the preclinical safety and risk of prosthetic heart valve (PHV) but also play an important role in the computational model and fluid simulation, providing an experimental basis for the performance optimization of PHV. This paper mainly reviews the development and the latest progress of PHV pulsatile flow experiments and the characteristics of experimental pulse duplicator, and discuss the research direction of pulsatile flow experiments, expecting a further development in this field.

Citation： QI Liang, ZHANG Minzu, SONG Bing, QIANG Yan. The history of pulsatile flow experiment of prosthetic heart valve: The 70th anniversary of the application of prosthetic heart valves. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(3): 473-477. doi: 10.7507/1007-4848.202207021 Copy

1.	Hufnagel CA, Harvey WP. The surgical correction of aortic regurgitation. Bull Georgetown Univ Med Center, 1953, 4: 60-61.
2.	Cervantes J. Fiftieth anniversary of the first aortic valve prosthesis implantation. Langenbecks Arch Surg, 2003, 388(5): 366-367.
3.	ISO 5840-1: 2021: Cardiovascular implants-cardiac valve prostheses. Geneva, Switzerland, 2021.
4.	GB 12279-2008/ISO 5840: 1996, 心血管植入物人工心脏瓣膜. 中国国家标准化管理委员会: 中国标准出版社, 2008.
5.	Yoganathan AP, Corcoran WH, Harrison EC. Pressure drops across prosthetic aortic heart valves under steady and pulsatile flow—In vitro measurements. J Biomech, 1979, 12(2): 153-164.
6.	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.
7.	McMillan IK, Daley R, Matthews MB. The movement of aortic and pulmonary valves studied post mortem by colour cinematography. Br Heart J, 1952, 14(1): 42-46.
8.	Davila JC, Trout RG, Sunner JE, et al. A simple mechanical pulse duplicator for cinematography of cardiac valves in action. Ann Surg, 1956, 143(4): 544-551.
9.	Hufnagel CA, Conrad PW. The direct approach for the correction of aortic insufficiency. JAMA, 1961, 178: 275-279.
10.	Knott E, Reul H, Knoch M, et al. In vitro comparison of aortic heart valve prostheses. Part 1: Mechanical valves. J Thorac Cardiovasc Surg, 1988, 96(6): 952.
11.	Temple LJ, Serafin R, Calvert NG, et al. Principles of fluid mechanics applied to some situations in the human circulation and particularly to the testing of valves in a pulse duplicator. Thorax, 1964, 19(3): 261-267.
12.	Bjork VO, Intonti F, MEISSL A. A mechanical pulse duplicator for testing prosthetic mitral and aortic valves. Thorax, 1962, 17(3): 280-283.
13.	Steinmetz GP, May KJ, Mueller V, et al. An improved accelerated fatigue machine and pulse simulator for testing and developing prosthetic cardiac valves. J Thorac Cardiovasc Surg, 1964, 47(2): 186-198.
14.	Davey TB, Kaufman B, Smeloff EA. Pulsatile flow studies of prosthetic heart valves. J Thorac Cardiovasc Surg, 1966, 51(2): 264-267.
15.	Smeloff EA, Huntley AC, Davey TB, et al. Comparative study of prosthetic heart valves. J Thorac Cardiovasc Surg, 1966, 52(6): 841-848.
16.	Kaster RL, Mantini E, Tanaka S, et al. Analysis of dynamic characteristics of heart valves in a pulse duplication-analog computer system. Biomed Sci Instrum, 1968, 4: 112-118.
17.	Wieting DW, Hall CW, Kreisle LF, et al. Design of a system for analyzing flow behavior of prosthetic human heart valves. Cardiovasc Res Center Bull, 1966, 5(2): 41.
18.	Wieting DW, Hall CW, Liotta D, et al. Dynamic flow behavior of artificial heart valves. Prosthetic Heart Valv, 1969: 34-39.
19.	Bellhouse BJ, Bellhouse FH. Mechanism of closure of the aortic valve. Nature, 1968, 217(5123): 86-87.
20.	Bellhouse BJ, Reid KG. Fluid mechanics of the aortic valve. Br Heart J, 1969, 31(3): 391.
21.	Westerhof N, Elzinga G, Sipkema P. An artificial arterial system for pumping hearts. J Appl Physiol, 1971, 31(5): 776-781.
22.	Nico W, Lankhaar JW, Westerhof BE. The arterial windkessel. Med & Biol Engineer & Comp, 2009, 47(2): 131-141.
23.	Wright JT, Temple LJ. An improved method for determining the flow characteristics of prosthetic mitral heart valves. Thorax, 1971, 26(1): 81-88.
24.	Duff WR, Fox RW. Prosthetic cardiac valves: An in vitro study. J Thorac Cardiovasc Surg, 1972, 63(1): 131-142.
25.	Hwang NH, Hussain AK, Hui PW, et al. Turbulent flow through a natural human mitral valve. J Biomech, 1977, 10(1): 59-67.
26.	Cornhill JF. An aortic-left ventricular pulse duplicator used in testing prosthetic aortic heart valves. J Thorac Cardiovasc Surg, 1977, 73(4): 550.
27.	Yoganathan AP, Corcoran WH, Harrison EC, et al. The Björk-Shiley aortic prosthesis: Flow characteristics, thrombus formation and tissue overgrowth. Circulation, 1978, 58(1): 70-76.
28.	Yoganathan AP, Corcoran WH, Harrison EC. In vitro velocity measurements in the vicinity of aortic prostheses. J Biomech, 1979, 12(2): 135-152.
29.	Gentle RC. The role of simulation studies in cardiac valve prosthesis design. 1978, 7(2): 101-106.
30.	Scotten LN, Walker DK, Brownlee RT. Construction and evaluation of a hydromechanical simulation facility for the assessment of mitral valve prostheses. J Med Eng Technol, 1979, 3(1): 11-18.
31.	ISO 5840: 1984, Implants for surgery-cardiovascular implants-cardiac valve prostheses. Geneva, Switzerland: 1984.
32.	Reul H. In vitro evaluation of artificial heart valves. In: Ghista DN (Ed). Advances in Cardiovascular Physics. Basel: S.Karger, 1983. 16-30.
33.	Yoganathan AP , Harrison EC, Franch RH. The current status of prosthetic heart valves. In: Gebelein CG (Ed). Polymeric Materials and Artificial Organs. Washington, DC: ACS Publications, 1984.
34.	Reul H, Giersiepen M, Knott E. In vitro testing of bioprostheses. ASAIO transactions, 1988, 34(4): 1033-1039.
35.	Reul H, Giersiepen M, Knott E. Laboratory testing of prosthetic heart valves. Eng Med, 1987, 16(2): 67-76.
36.	Chandran KB, Khalighi B, Chen CJ, et al. Effect of valve orientation on flow development past aortic valve prostheses in a model human aorta. J Thorac Cardiovasc Surg, 1983, 85(6): 893.
37.	Chandran KB, Schoephoerster R, Dellsperger KC. Effect of prosthetic mitral valve geometry and orientation on flow dynamics in a model human left ventricle. J Biomech, 1989, 22(1): 51-65.
38.	刁颖敏, 席葆树. 人工心脏主动脉瓣膜的定常流实验研究. 北京生物医学工程, 1982, 1: 23-28.
39.	Abdallah SA, Su CS, Hwang NH. Dynamic performance of heart valve prostheses and the testing loop characteristics. Trans Am Soc Artif Intern Organs, 1983, 29: 296-300.
40.	Wieting DW. In vitro testing of heart valves: Evolution over the past 25 years. Ann Thorac Surg, 1989, 48(3 Suppl): S12-S13.
41.	Wu ZJ, Hwang NH. Ventricular pressure slope and bileaflet mechanical heart valve closure. ASAIO J, 1995, 41(3): M763-M767.
42.	Ferrari G, De Lazzari C, Mimmo R, et al. A computer controlled mock circulatory system for mono- and biventricular assist device testing. International journal of artificial organs, 1998, 21(1): 26.
43.	陈君楷, 樊瑜波, 袁支润. 人体血液循环的一种计算机模拟及应用. 中国生物医学工程学报, 1992, 1: 27-35.
44.	樊瑜波, 陈君楷, 袁支润. 人工心瓣脉动流模拟试验中, 主动脉根部压力、流量波形重建的理论与方法. 生物医学工程学杂志, 1992, 3: 243-248.
45.	Lee JH, Rygg AD, Kolahdouz EM, et al. Fluid-structure interaction models of bioprosthetic heart valve dynamics in an experimental pulse duplicator. Ann Biomed Eng, 2020, 48(5): 1475-1490.
46.	Yoganathan AP, Chandran KB, Sotiropoulos F. Flow in prosthetic heart valves: State-of-the-art and future directions. Ann Biomed Eng, 2005, 33(12): 1689-1694.
47.	Borazjani I, Ge L, Sotiropoulos F. Curvilinear immersed boundary method for simulating fluid structure interaction with complex 3D rigid bodies. J Comput Phys, 2008, 227(16): 7587-7620.
48.	Dasi LP, Ge L, Simon HA, et al. Vorticity dynamics of a bileaflet mechanical heart valve in an axisymmetric aorta. Physics of fluids (1994), 2007, 19(6): 67105.
49.	Dasi LP, Simon HA, Sucosky P, et al. Fluid mechanics of artificial heart valves. Clin Exp Pharmacol Physiol, 2009, 36(2): 225-237.
50.	Ge L, Sotiropoulos F. A numerical method for solving the 3D unsteady incompressible navier-stokes equations in curvilinear domains with complex immersed boundaries. J Comput Phys, 2007, 225(2): 1782-1809.
51.	Sotiropoulos F, Borazjani I. A review of state-of-the-art numerical methods for simulating flow through mechanical heart valves. Med Biol Eng Comput, 2009, 47(3): 245-256.
52.	Lee JH, Scotten LN, Hunt R, et al. Bioprosthetic aortic valve diameter and thickness are directly related to leaflet fluttering: Results from a combined experimental and computational modeling study. JTCVS Open, 2021, 6: 60-81.
53.	Mirco R, Manzoni E, Lionello M, et al. Automation of the peripheral resistance valve in a hydro-mechanical cardiovascular pulse duplicator system. Control Eng Pract, 2021, 116: 104929.
54.	ISO 5840-2: 2015: Cardiovascular implants: Cardiac valve prostheses. Part 2: Surgically implanted heart valve substitutes. Geneva, Switzerland, 2015.
55.	Li C, Tang D, Yao J, et al. Porcine and bovine aortic valve comparison for surgical optimization: A fluid-structure interaction modeling study. Int J Cardiol, 2021, 334: 88-95.
56.	Cai L, Zhang R, Li Y, et al. The comparison of different constitutive laws and fiber architectures for the aortic valve on fluid-structure interaction simulation. Front Physiol, 2021, 12: 682893.
57.	Nitti A, De Cillis G, de Tullio MD. Numerical investigation of turbulent features past different mechanical aortic valves. J Fluid Mecha, 2022, 940: A43.

1. Hufnagel CA, Harvey WP. The surgical correction of aortic regurgitation. Bull Georgetown Univ Med Center, 1953, 4: 60-61.
2. Cervantes J. Fiftieth anniversary of the first aortic valve prosthesis implantation. Langenbecks Arch Surg, 2003, 388(5): 366-367.
3. ISO 5840-1: 2021: Cardiovascular implants-cardiac valve prostheses. Geneva, Switzerland, 2021.
4. GB 12279-2008/ISO 5840: 1996, 心血管植入物人工心脏瓣膜. 中国国家标准化管理委员会: 中国标准出版社, 2008.
5. Yoganathan AP, Corcoran WH, Harrison EC. Pressure drops across prosthetic aortic heart valves under steady and pulsatile flow—In vitro measurements. J Biomech, 1979, 12(2): 153-164.
6. 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.
7. McMillan IK, Daley R, Matthews MB. The movement of aortic and pulmonary valves studied post mortem by colour cinematography. Br Heart J, 1952, 14(1): 42-46.
8. Davila JC, Trout RG, Sunner JE, et al. A simple mechanical pulse duplicator for cinematography of cardiac valves in action. Ann Surg, 1956, 143(4): 544-551.
9. Hufnagel CA, Conrad PW. The direct approach for the correction of aortic insufficiency. JAMA, 1961, 178: 275-279.
10. Knott E, Reul H, Knoch M, et al. In vitro comparison of aortic heart valve prostheses. Part 1: Mechanical valves. J Thorac Cardiovasc Surg, 1988, 96(6): 952.
11. Temple LJ, Serafin R, Calvert NG, et al. Principles of fluid mechanics applied to some situations in the human circulation and particularly to the testing of valves in a pulse duplicator. Thorax, 1964, 19(3): 261-267.
12. Bjork VO, Intonti F, MEISSL A. A mechanical pulse duplicator for testing prosthetic mitral and aortic valves. Thorax, 1962, 17(3): 280-283.
13. Steinmetz GP, May KJ, Mueller V, et al. An improved accelerated fatigue machine and pulse simulator for testing and developing prosthetic cardiac valves. J Thorac Cardiovasc Surg, 1964, 47(2): 186-198.
14. Davey TB, Kaufman B, Smeloff EA. Pulsatile flow studies of prosthetic heart valves. J Thorac Cardiovasc Surg, 1966, 51(2): 264-267.
15. Smeloff EA, Huntley AC, Davey TB, et al. Comparative study of prosthetic heart valves. J Thorac Cardiovasc Surg, 1966, 52(6): 841-848.
16. Kaster RL, Mantini E, Tanaka S, et al. Analysis of dynamic characteristics of heart valves in a pulse duplication-analog computer system. Biomed Sci Instrum, 1968, 4: 112-118.
17. Wieting DW, Hall CW, Kreisle LF, et al. Design of a system for analyzing flow behavior of prosthetic human heart valves. Cardiovasc Res Center Bull, 1966, 5(2): 41.
18. Wieting DW, Hall CW, Liotta D, et al. Dynamic flow behavior of artificial heart valves. Prosthetic Heart Valv, 1969: 34-39.
19. Bellhouse BJ, Bellhouse FH. Mechanism of closure of the aortic valve. Nature, 1968, 217(5123): 86-87.
20. Bellhouse BJ, Reid KG. Fluid mechanics of the aortic valve. Br Heart J, 1969, 31(3): 391.
21. Westerhof N, Elzinga G, Sipkema P. An artificial arterial system for pumping hearts. J Appl Physiol, 1971, 31(5): 776-781.
22. Nico W, Lankhaar JW, Westerhof BE. The arterial windkessel. Med & Biol Engineer & Comp, 2009, 47(2): 131-141.
23. Wright JT, Temple LJ. An improved method for determining the flow characteristics of prosthetic mitral heart valves. Thorax, 1971, 26(1): 81-88.
24. Duff WR, Fox RW. Prosthetic cardiac valves: An in vitro study. J Thorac Cardiovasc Surg, 1972, 63(1): 131-142.
25. Hwang NH, Hussain AK, Hui PW, et al. Turbulent flow through a natural human mitral valve. J Biomech, 1977, 10(1): 59-67.
26. Cornhill JF. An aortic-left ventricular pulse duplicator used in testing prosthetic aortic heart valves. J Thorac Cardiovasc Surg, 1977, 73(4): 550.
27. Yoganathan AP, Corcoran WH, Harrison EC, et al. The Björk-Shiley aortic prosthesis: Flow characteristics, thrombus formation and tissue overgrowth. Circulation, 1978, 58(1): 70-76.
28. Yoganathan AP, Corcoran WH, Harrison EC. In vitro velocity measurements in the vicinity of aortic prostheses. J Biomech, 1979, 12(2): 135-152.
29. Gentle RC. The role of simulation studies in cardiac valve prosthesis design. 1978, 7(2): 101-106.
30. Scotten LN, Walker DK, Brownlee RT. Construction and evaluation of a hydromechanical simulation facility for the assessment of mitral valve prostheses. J Med Eng Technol, 1979, 3(1): 11-18.
31. ISO 5840: 1984, Implants for surgery-cardiovascular implants-cardiac valve prostheses. Geneva, Switzerland: 1984.
32. Reul H. In vitro evaluation of artificial heart valves. In: Ghista DN (Ed). Advances in Cardiovascular Physics. Basel: S.Karger, 1983. 16-30.
33. Yoganathan AP , Harrison EC, Franch RH. The current status of prosthetic heart valves. In: Gebelein CG (Ed). Polymeric Materials and Artificial Organs. Washington, DC: ACS Publications, 1984.
34. Reul H, Giersiepen M, Knott E. In vitro testing of bioprostheses. ASAIO transactions, 1988, 34(4): 1033-1039.
35. Reul H, Giersiepen M, Knott E. Laboratory testing of prosthetic heart valves. Eng Med, 1987, 16(2): 67-76.
36. Chandran KB, Khalighi B, Chen CJ, et al. Effect of valve orientation on flow development past aortic valve prostheses in a model human aorta. J Thorac Cardiovasc Surg, 1983, 85(6): 893.
37. Chandran KB, Schoephoerster R, Dellsperger KC. Effect of prosthetic mitral valve geometry and orientation on flow dynamics in a model human left ventricle. J Biomech, 1989, 22(1): 51-65.
38. 刁颖敏, 席葆树. 人工心脏主动脉瓣膜的定常流实验研究. 北京生物医学工程, 1982, 1: 23-28.
39. Abdallah SA, Su CS, Hwang NH. Dynamic performance of heart valve prostheses and the testing loop characteristics. Trans Am Soc Artif Intern Organs, 1983, 29: 296-300.
40. Wieting DW. In vitro testing of heart valves: Evolution over the past 25 years. Ann Thorac Surg, 1989, 48(3 Suppl): S12-S13.
41. Wu ZJ, Hwang NH. Ventricular pressure slope and bileaflet mechanical heart valve closure. ASAIO J, 1995, 41(3): M763-M767.
42. Ferrari G, De Lazzari C, Mimmo R, et al. A computer controlled mock circulatory system for mono- and biventricular assist device testing. International journal of artificial organs, 1998, 21(1): 26.
43. 陈君楷, 樊瑜波, 袁支润. 人体血液循环的一种计算机模拟及应用. 中国生物医学工程学报, 1992, 1: 27-35.
44. 樊瑜波, 陈君楷, 袁支润. 人工心瓣脉动流模拟试验中, 主动脉根部压力、流量波形重建的理论与方法. 生物医学工程学杂志, 1992, 3: 243-248.
45. Lee JH, Rygg AD, Kolahdouz EM, et al. Fluid-structure interaction models of bioprosthetic heart valve dynamics in an experimental pulse duplicator. Ann Biomed Eng, 2020, 48(5): 1475-1490.
46. Yoganathan AP, Chandran KB, Sotiropoulos F. Flow in prosthetic heart valves: State-of-the-art and future directions. Ann Biomed Eng, 2005, 33(12): 1689-1694.
47. Borazjani I, Ge L, Sotiropoulos F. Curvilinear immersed boundary method for simulating fluid structure interaction with complex 3D rigid bodies. J Comput Phys, 2008, 227(16): 7587-7620.
48. Dasi LP, Ge L, Simon HA, et al. Vorticity dynamics of a bileaflet mechanical heart valve in an axisymmetric aorta. Physics of fluids (1994), 2007, 19(6): 67105.
49. Dasi LP, Simon HA, Sucosky P, et al. Fluid mechanics of artificial heart valves. Clin Exp Pharmacol Physiol, 2009, 36(2): 225-237.
50. Ge L, Sotiropoulos F. A numerical method for solving the 3D unsteady incompressible navier-stokes equations in curvilinear domains with complex immersed boundaries. J Comput Phys, 2007, 225(2): 1782-1809.
51. Sotiropoulos F, Borazjani I. A review of state-of-the-art numerical methods for simulating flow through mechanical heart valves. Med Biol Eng Comput, 2009, 47(3): 245-256.
52. Lee JH, Scotten LN, Hunt R, et al. Bioprosthetic aortic valve diameter and thickness are directly related to leaflet fluttering: Results from a combined experimental and computational modeling study. JTCVS Open, 2021, 6: 60-81.
53. Mirco R, Manzoni E, Lionello M, et al. Automation of the peripheral resistance valve in a hydro-mechanical cardiovascular pulse duplicator system. Control Eng Pract, 2021, 116: 104929.
54. ISO 5840-2: 2015: Cardiovascular implants: Cardiac valve prostheses. Part 2: Surgically implanted heart valve substitutes. Geneva, Switzerland, 2015.
55. Li C, Tang D, Yao J, et al. Porcine and bovine aortic valve comparison for surgical optimization: A fluid-structure interaction modeling study. Int J Cardiol, 2021, 334: 88-95.
56. Cai L, Zhang R, Li Y, et al. The comparison of different constitutive laws and fiber architectures for the aortic valve on fluid-structure interaction simulation. Front Physiol, 2021, 12: 682893.
57. Nitti A, De Cillis G, de Tullio MD. Numerical investigation of turbulent features past different mechanical aortic valves. J Fluid Mecha, 2022, 940: A43.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

The history of pulsatile flow experiment of prosthetic heart valve: The 70th anniversary of the application of prosthetic heart valves

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