Development and performance testing of a novel transcatheter tricuspid valve interventional device_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

WANG Qiuji ^1,2 , ZHAO Junfei ^1,2 , ZHONG Lishan ^1,2 , XIAO Shuo ^1,2,3 , ZHANG Chaolong ^1,2 , WANG Zhenzhong ^1,2 , FANG Dou ^1,2 , LI Yuxin ^1,2 , KE Yingjie ^1,2,4 , PANG Shanwen ^1,2 , QIU Junqiang ^1,2 , HE Biaochuan ^1,2 ,  HUANG Huanlei ^1,2,3

1. Department of Cardiac Surgery, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, 510080, P. R. China;
2. Guangdong Cardiovascular Institute, Guangzhou, 510030, P. R. China;
3. School of Medicine, South China University of Technology, Guangzhou, 510006, P. R. China;
4. Department of Cardiovascular Surgery, Guangdong Provincial People’s Hospital’s Nanhai Hospital, The Second People’s Hospital of Nanhai District, Foshan, 528000, Guangdong, P. R. China;

Corresponding author：

HUANG Huanlei, Email: hhuanlei@hotmail.com

Keywords：

Tricuspid regurgitation; interventional valve; device development; animal experiments

DOI：

10.7507/1007-4848.202308050

Video：

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Objective To develop a novel transcatheter tricuspid valve replacement device and test its performance. Methods The transcatheter tricuspid valve stent consisted of double-layer self-expanding nitinol stent, biotissue-derived bovine pericardial leaflets, and PTFE woven. The delivery system, mainly consisting of a handle control unit and a delivery sheath, was sent to the correct position via right atrium or jugular vein. The sheath had a visualization feature, and the handle control unit could realize the functions of stable release and partial recovery of the interventional valve. In addition, this study performed animal survival experiments on the basis of in vitro experiments. A large-white pig was used as the experimental animal. Cardiopulmonary bypass was established through median thoracotomy, then the right atrium was opened, and the interventional valve was released under direct vision without cardiac arrest. Approximately 1 month after interventional valve implantation, the maneuverability and stability of the interventional tricuspid device were evaluated by autopsy. Results Through the animal experiment, the interventional valve was successfully released, and the anchoring was satisfactory. Postoperative transthoracic echocardiography showed that the interventional valve opened and closed well, the flow rate of tricuspid valve was 0.6 m/s, and there was no obvious tricuspid regurgitation. One month after the operation, we dissected the large-white pig and found the interventional valve was not deformed or displaced, the leaflets were well aligned, and there was thrombus attachment in the groove between the inner and outer layers of the interventional valve. Conclusion Animal experiment shows that the novel device can stably and firmly attach to the tricuspid annulus, with good anchoring effect, and effectively reduce paravalvular leakage.

Citation： WANG Qiuji, ZHAO Junfei, ZHONG Lishan, XIAO Shuo, ZHANG Chaolong, WANG Zhenzhong, FANG Dou, LI Yuxin, KE Yingjie, PANG Shanwen, QIU Junqiang, HE Biaochuan, HUANG Huanlei. Development and performance testing of a novel transcatheter tricuspid valve interventional device. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(6): 885-890. doi: 10.7507/1007-4848.202308050 Copy

1.	Alipour Symakani RS, Bartelds B, Merkus D, et al. Guiding interventions for secondary tricuspid regurgitation: Follow the intricate interplay between form and function. Cardiol Rev, 2023, 31(1): 7-15.
2.	Kusajima K, Fujita T, Hata H, et al. Long-term echocardiographic follow-up of untreated 2+ functional tricuspid regurgitation in patients undergoing mitral valve surgery. Interact Cardiovasc Thorac Surg, 2016, 23(1): 96-103.
3.	Boyaci A, Gokce V, Topaloglu S, et al. Outcome of significant functional tricuspid regurgitation late after mitral valve replacement for predominant rheumatic mitral stenosis. Angiology, 2007, 58(3): 336-342.
4.	Galloo X, Stassen J, Butcher SC, et al. Staging right heart failure in patients with tricuspid regurgitation undergoing tricuspid surgery. Eur J Cardiothorac Surg, 2022, 62(2): ezac290.
5.	Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation, 2014, 129(23): e521-e643.
6.	Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation, 2017, 135(25): e1159-e1195.
7.	Kaddoura R, Al-Badriyeh D, Abushanab D, et al. Percutaneous mitral-valve intervention for secondary mitral regurgitation: Data from real-life. Curr Probl Cardiol, 2023, 48(10): 101889.
8.	D'Onofrio A, Tessari C, Tarantini G, et al. Transapical TAVI: Survival, hemodynamics, devices and machine learning. Lessons learned after 10-year experience. Curr Probl Cardiol, 2023, 48(8): 101734.
9.	Rogers JH, Boyd WD, Bolling SF. Tricuspid annuloplasty with the Millipede ring. Prog Cardiovasc Dis, 2019, 62(6): 486-487.
10.	Rogers T, Ratnayaka K, Sonmez M, et al. Transatrial intrapericardial tricuspid annuloplasty. JACC Cardiovasc Interv, 2015, 8(3): 483-491.
11.	Fam NP, Ho EC, Zahrani M, et al. Transcatheter tricuspid valve repair with the PASCAL system. JACC Cardiovasc Interv, 2018, 11(4): 407-408.
12.	Navia JL, Kapadia S, Elgharably H, et al. First-in-human implantations of the navigate bioprosthesis in a severely dilated tricuspid annulus and in a failed tricuspid annuloplasty ring. Circ Cardiovasc Interv, 2017, 10(12): e005840.
13.	Lu F, Qiao F, Lv Y, et al. A radial force-independent bioprosthesis for transcatheter tricuspid valve implantation in a preclinical model. Int J Cardiol, 2020, 319: 120-126.
14.	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.
15.	Wild MG, Löw K, Rosch S, et al. Multicenter experience with the transcatheter leaflet repair system for symptomatic tricuspid regurgitation. JACC Cardiovasc Interv, 2022, 15(13): 1352-1363.
16.	Hahn RT, Kodali S, Fam N, et al. Early multinational experience of transcatheter tricuspid valve replacement for treating severe tricuspid regurgitation. JACC Cardiovasc Interv, 2020, 13(21): 2482-2493.
17.	Izumi C, Iga K, Konishi T. Progression of isolated tricuspid regurgitation late after mitral valve surgery for rheumatic mitral valve disease. J Heart Valve Dis, 2002, 11(3): 353-356.
18.	Lawlor MK, Ng V, Ahmed S, et al. Baseline characteristics and clinical outcomes of a tricuspid regurgitation referral population. Am J Cardiol, 2023, 196: 22-30.
19.	Lebehn MA, Hahn RT. Valvular heart failure due to tricuspid regurgitation: Surgical and transcatheter management options. Heart Fail Clin, 2023, 19(3): 329-343.
20.	Obayashi Y, Kato T, Yaku H, et al. Tricuspid regurgitation in elderly patients with acute heart failure: Insights from the KCHF registry. ESC Heart Fail, 2023, 10(3): 1948-1960.
21.	Sorajja P, Whisenant B, Hamid N, et al. Transcatheter repair for patients with tricuspid regurgitation. N Engl J Med, 2023, 388(20): 1833-1842.
22.	Mohamed MS, Al Ali O, Hashem A, et al. Trends and outcomes of transcatheter tricuspid valve repair and surgical tricuspid valve repair in patients with tricuspid valve regurgitation; A population based study. Curr Probl Cardiol, 2023, 48(7): 101714.
23.	Jost ZT, Nooli NP, Ali AE, et al. Three-dimensional echocardiography of the tricuspid valve. Front Cardiovasc Med, 2023, 10: 1114715.
24.	Girdauskas E, Lauer B, Kuntze T. Transapical tricuspid valve-in-ring implantation: An alternative approach to a challenging clinical scenario. Catheter Cardiovasc Interv, 2018, 91(5): 1005-1008.
25.	Mao Y, Liu Y, Meng X, et al. Treatment of severe tricuspid regurgitation induced by permanent pacemaker lead: Transcatheter tricuspid valve replacement with the guidance of 3-dimensional printing. Front Cardiovasc Med, 2023, 10: 1030997.
26.	Lu FL, Ma Y, An Z, et al. First-in-man experience of transcatheter tricuspid valve replacement with LuX-valve in high-risk tricuspid regurgitation patients. JACC Cardiovasc Interv, 2020, 13(13): 1614-1616.

1. Alipour Symakani RS, Bartelds B, Merkus D, et al. Guiding interventions for secondary tricuspid regurgitation: Follow the intricate interplay between form and function. Cardiol Rev, 2023, 31(1): 7-15.
2. Kusajima K, Fujita T, Hata H, et al. Long-term echocardiographic follow-up of untreated 2+ functional tricuspid regurgitation in patients undergoing mitral valve surgery. Interact Cardiovasc Thorac Surg, 2016, 23(1): 96-103.
3. Boyaci A, Gokce V, Topaloglu S, et al. Outcome of significant functional tricuspid regurgitation late after mitral valve replacement for predominant rheumatic mitral stenosis. Angiology, 2007, 58(3): 336-342.
4. Galloo X, Stassen J, Butcher SC, et al. Staging right heart failure in patients with tricuspid regurgitation undergoing tricuspid surgery. Eur J Cardiothorac Surg, 2022, 62(2): ezac290.
5. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation, 2014, 129(23): e521-e643.
6. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation, 2017, 135(25): e1159-e1195.
7. Kaddoura R, Al-Badriyeh D, Abushanab D, et al. Percutaneous mitral-valve intervention for secondary mitral regurgitation: Data from real-life. Curr Probl Cardiol, 2023, 48(10): 101889.
8. D'Onofrio A, Tessari C, Tarantini G, et al. Transapical TAVI: Survival, hemodynamics, devices and machine learning. Lessons learned after 10-year experience. Curr Probl Cardiol, 2023, 48(8): 101734.
9. Rogers JH, Boyd WD, Bolling SF. Tricuspid annuloplasty with the Millipede ring. Prog Cardiovasc Dis, 2019, 62(6): 486-487.
10. Rogers T, Ratnayaka K, Sonmez M, et al. Transatrial intrapericardial tricuspid annuloplasty. JACC Cardiovasc Interv, 2015, 8(3): 483-491.
11. Fam NP, Ho EC, Zahrani M, et al. Transcatheter tricuspid valve repair with the PASCAL system. JACC Cardiovasc Interv, 2018, 11(4): 407-408.
12. Navia JL, Kapadia S, Elgharably H, et al. First-in-human implantations of the navigate bioprosthesis in a severely dilated tricuspid annulus and in a failed tricuspid annuloplasty ring. Circ Cardiovasc Interv, 2017, 10(12): e005840.
13. Lu F, Qiao F, Lv Y, et al. A radial force-independent bioprosthesis for transcatheter tricuspid valve implantation in a preclinical model. Int J Cardiol, 2020, 319: 120-126.
14. 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.
15. Wild MG, Löw K, Rosch S, et al. Multicenter experience with the transcatheter leaflet repair system for symptomatic tricuspid regurgitation. JACC Cardiovasc Interv, 2022, 15(13): 1352-1363.
16. Hahn RT, Kodali S, Fam N, et al. Early multinational experience of transcatheter tricuspid valve replacement for treating severe tricuspid regurgitation. JACC Cardiovasc Interv, 2020, 13(21): 2482-2493.
17. Izumi C, Iga K, Konishi T. Progression of isolated tricuspid regurgitation late after mitral valve surgery for rheumatic mitral valve disease. J Heart Valve Dis, 2002, 11(3): 353-356.
18. Lawlor MK, Ng V, Ahmed S, et al. Baseline characteristics and clinical outcomes of a tricuspid regurgitation referral population. Am J Cardiol, 2023, 196: 22-30.
19. Lebehn MA, Hahn RT. Valvular heart failure due to tricuspid regurgitation: Surgical and transcatheter management options. Heart Fail Clin, 2023, 19(3): 329-343.
20. Obayashi Y, Kato T, Yaku H, et al. Tricuspid regurgitation in elderly patients with acute heart failure: Insights from the KCHF registry. ESC Heart Fail, 2023, 10(3): 1948-1960.
21. Sorajja P, Whisenant B, Hamid N, et al. Transcatheter repair for patients with tricuspid regurgitation. N Engl J Med, 2023, 388(20): 1833-1842.
22. Mohamed MS, Al Ali O, Hashem A, et al. Trends and outcomes of transcatheter tricuspid valve repair and surgical tricuspid valve repair in patients with tricuspid valve regurgitation; A population based study. Curr Probl Cardiol, 2023, 48(7): 101714.
23. Jost ZT, Nooli NP, Ali AE, et al. Three-dimensional echocardiography of the tricuspid valve. Front Cardiovasc Med, 2023, 10: 1114715.
24. Girdauskas E, Lauer B, Kuntze T. Transapical tricuspid valve-in-ring implantation: An alternative approach to a challenging clinical scenario. Catheter Cardiovasc Interv, 2018, 91(5): 1005-1008.
25. Mao Y, Liu Y, Meng X, et al. Treatment of severe tricuspid regurgitation induced by permanent pacemaker lead: Transcatheter tricuspid valve replacement with the guidance of 3-dimensional printing. Front Cardiovasc Med, 2023, 10: 1030997.
26. Lu FL, Ma Y, An Z, et al. First-in-man experience of transcatheter tricuspid valve replacement with LuX-valve in high-risk tricuspid regurgitation patients. JACC Cardiovasc Interv, 2020, 13(13): 1614-1616.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Development and performance testing of a novel transcatheter tricuspid valve interventional device

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