Reconstruction and analysis of K-Clip surgery process based on finite element method_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

SHI Hao ¹ , OUYANG Wenbin ¹ , LI Shiguo ¹ , LI Qi ¹ , ZHANG Fengwen ¹ , LIU Yao ¹ , LU Wenxin ¹ , LIU Chang ² , ZHANG Shaojie ² ,  PAN Xiangbin ¹

1. Department of Structural Heart Disease, National Center for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Health Commission Key Laboratory of Cardiovascular Regeneration Medicine, Key Laboratory of Innovative Cardiovascular Devices, Chinese Academy of Medical Sciences, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, 100037, P. R. China;
2. Shanghai Huihe Medical Technology Co., Ltd, Shanghai, 201612, P. R. China;

Corresponding author：

PAN Xiangbin, Email: panxiangbin@fuwaihospital.org

Keywords：

Tricuspid regurgitation; annulus repair; K-Clip; numerical simulation

DOI：

10.7507/1007-4848.202304042

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To investigate the effects of different types of tricuspid regurgitation, implantation positions, and device models on the treatment outcomes of K-Clip for tricuspid regurgitation using numerical simulations. Methods Three-dimensional reconstruction of the heart model was performed based on CT images. Two different regurgitation orifices were obtained by modifying the standard parameterized tricuspid valve leaflets and chordae tendineae. The effects of different K-Clip models at different implantation positions (posterior leaflet midpoint, anterior-posterior commissure, anterior leaflet midpoint, posterior septal commissure) were simulated using commercial explicit dynamics software Ls-Dyna. Conclusion For the two types of regurgitation in this study, clipping at the posterior leaflet midpoint resulted in a better reduction of the regurgitation orifice (up to 75% reduction in area). Higher clamping forces were required for implantation at the anterior leaflet midpoint and posterior septal commissure, which was unfavorable for the smooth closure of the clipping components. There was no statistical difference in the treatment outcomes between the 18T and 16T K-Clip components, and the 16T component required less clamping force. Therefore, the use of the 16T K-Clip component is recommended.

Citation： SHI Hao, OUYANG Wenbin, LI Shiguo, LI Qi, ZHANG Fengwen, LIU Yao, LU Wenxin, LIU Chang, ZHANG Shaojie, PAN Xiangbin. Reconstruction and analysis of K-Clip surgery process based on finite element method. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(1): 44-50. doi: 10.7507/1007-4848.202304042 Copy

1.	Topilsky Y, Maltais S, Medina Inojosa J, et al. Burden of tricuspid regurgitation in patients diagnosed in the community setting. JACC Cardiovasc Imaging, 2019, 12(3): 433-442.
2.	Benfari G, Antoine C, Miller WL, et al. Excess mortality associated with functional tricuspid regurgitation complicating heart failure with reduced ejection fraction. Circulation, 2019, 140(3): 196-206.
3.	Mangieri A, Latib A. Transcatheter innovations in tricuspid regurgitation: Cardioband. Prog Cardiovasc Dis, 2019, 62(6): 482-485.
4.	Freixa X, Arzamendi D, Del Trigo M, et al. The TriClip system for edge-to-edge transcatheter tricuspid valve repair. A Spanish multicenter study. Rev Esp Cardiol (Engl Ed), 2022, 75(10): 797-804.
5.	Fam NP, Braun D, von Bardeleben RS, et al. Compassionate use of the PASCAL transcatheter valve repair system for severe tricuspid regurgitation: A multicenter, observational, first-in-human experience. JACC Cardiovasc Interv, 2019, 12(24): 2488-2495.
6.	郑帆, 张晓春, 陈莎莎, 等. 应用K-Clip系统经导管治疗左心瓣膜置换术后重度三尖瓣反流1例. 中国介入心脏病学杂志, 2022, 30(6): 467-470.
7.	Lee AP, Ni Y, Lam YY. Imaging for transcatheter tricuspid annuloplasty using the K-Clip device. Circ Cardiovasc Imaging, 2023, 16(6): e015033.
8.	Liu Y, Li W, Zhou D, et al. Real-time monitoring and step-by-step guidance for transcatheter tricuspid annuloplasty using transesophageal echocardiography. J Cardiovasc Dev Dis, 2022, 9(12): 415.
9.	Sturla F, Redaelli A, Puppini G, et al. Functional and biomechanical effects of the edge-to-edge repair in the setting of mitral regurgitation: Consolidated knowledge and novel tools to gain insight into its percutaneous implementation. Cardiovasc Eng Technol, 2015, 6(2): 117-140.
10.	Galili L, White Zeira A, Marom G. Numerical biomechanics modelling of indirect mitral annuloplasty treatments for functional mitral regurgitation. R Soc Open Sci, 2022, 9(1): 211464.
11.	Gasparotti E, Vignali E, Mariani M, et al. Image-based modelling and numerical simulations of the Cardioband® procedure for mitral valve regurgitation repair. Comput Methods Appl Mech Eng, 2022, 394: 114941.
12.	Dabiri Y, Yao J, Sack KL, et al. Tricuspid valve regurgitation decreases after MitraClip implantation: Fluid structure interaction simulation. Mech Res Commun, 2019, 97: 96-100.
13.	Rodés-Cabau J, Hahn RT, Latib A, et al. Transcatheter therapies for treating tricuspid regurgitation. J Am Coll Cardiol, 2016, 67(15): 1829-1845.
14.	Johnson EL, Laurence DW, Xu F, et al. Parameterization, geometric modeling, and isogeometric analysis of tricuspid valves. Comput Methods Appl Mech Eng, 2021, 384: 113960.
15.	方红荣, 唐陶, 章湘明, 等. 基于实验的心肌被动力本构模型. 力学学报, 2008, 40(3): 355-363.
16.	Avanzini A, Donzella G, Libretti L. Functional and structural effects of percutaneous edge-to-edge double-orifice repair under cardiac cycle in comparison with suture repair. Proc Inst Mech Eng H, 2011, 225(10): 959-971.
17.	Lau KD, Díaz-Zuccarini V, Scambler P, et al. Fluid-structure interaction study of the edge-to-edge repair technique on the mitral valve. J Biomech, 2011, 44(13): 2409-2417.
18.	Carmody CJ, Burriesci G, Howard IC, et al. An approach to the simulation of fluid-structure interaction in the aortic valve. J Biomech, 2006, 39(1): 158-169.

1. Topilsky Y, Maltais S, Medina Inojosa J, et al. Burden of tricuspid regurgitation in patients diagnosed in the community setting. JACC Cardiovasc Imaging, 2019, 12(3): 433-442.
2. Benfari G, Antoine C, Miller WL, et al. Excess mortality associated with functional tricuspid regurgitation complicating heart failure with reduced ejection fraction. Circulation, 2019, 140(3): 196-206.
3. Mangieri A, Latib A. Transcatheter innovations in tricuspid regurgitation: Cardioband. Prog Cardiovasc Dis, 2019, 62(6): 482-485.
4. Freixa X, Arzamendi D, Del Trigo M, et al. The TriClip system for edge-to-edge transcatheter tricuspid valve repair. A Spanish multicenter study. Rev Esp Cardiol (Engl Ed), 2022, 75(10): 797-804.
5. Fam NP, Braun D, von Bardeleben RS, et al. Compassionate use of the PASCAL transcatheter valve repair system for severe tricuspid regurgitation: A multicenter, observational, first-in-human experience. JACC Cardiovasc Interv, 2019, 12(24): 2488-2495.
6. 郑帆, 张晓春, 陈莎莎, 等. 应用K-Clip系统经导管治疗左心瓣膜置换术后重度三尖瓣反流1例. 中国介入心脏病学杂志, 2022, 30(6): 467-470.
7. Lee AP, Ni Y, Lam YY. Imaging for transcatheter tricuspid annuloplasty using the K-Clip device. Circ Cardiovasc Imaging, 2023, 16(6): e015033.
8. Liu Y, Li W, Zhou D, et al. Real-time monitoring and step-by-step guidance for transcatheter tricuspid annuloplasty using transesophageal echocardiography. J Cardiovasc Dev Dis, 2022, 9(12): 415.
9. Sturla F, Redaelli A, Puppini G, et al. Functional and biomechanical effects of the edge-to-edge repair in the setting of mitral regurgitation: Consolidated knowledge and novel tools to gain insight into its percutaneous implementation. Cardiovasc Eng Technol, 2015, 6(2): 117-140.
10. Galili L, White Zeira A, Marom G. Numerical biomechanics modelling of indirect mitral annuloplasty treatments for functional mitral regurgitation. R Soc Open Sci, 2022, 9(1): 211464.
11. Gasparotti E, Vignali E, Mariani M, et al. Image-based modelling and numerical simulations of the Cardioband® procedure for mitral valve regurgitation repair. Comput Methods Appl Mech Eng, 2022, 394: 114941.
12. Dabiri Y, Yao J, Sack KL, et al. Tricuspid valve regurgitation decreases after MitraClip implantation: Fluid structure interaction simulation. Mech Res Commun, 2019, 97: 96-100.
13. Rodés-Cabau J, Hahn RT, Latib A, et al. Transcatheter therapies for treating tricuspid regurgitation. J Am Coll Cardiol, 2016, 67(15): 1829-1845.
14. Johnson EL, Laurence DW, Xu F, et al. Parameterization, geometric modeling, and isogeometric analysis of tricuspid valves. Comput Methods Appl Mech Eng, 2021, 384: 113960.
15. 方红荣, 唐陶, 章湘明, 等. 基于实验的心肌被动力本构模型. 力学学报, 2008, 40(3): 355-363.
16. Avanzini A, Donzella G, Libretti L. Functional and structural effects of percutaneous edge-to-edge double-orifice repair under cardiac cycle in comparison with suture repair. Proc Inst Mech Eng H, 2011, 225(10): 959-971.
17. Lau KD, Díaz-Zuccarini V, Scambler P, et al. Fluid-structure interaction study of the edge-to-edge repair technique on the mitral valve. J Biomech, 2011, 44(13): 2409-2417.
18. Carmody CJ, Burriesci G, Howard IC, et al. An approach to the simulation of fluid-structure interaction in the aortic valve. J Biomech, 2006, 39(1): 158-169.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Reconstruction and analysis of K-Clip surgery process based on finite element method

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