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| Long Term Animal Experimental Study on a Heterogeneous Tricuspid Annuloplasty Ring Madeof a Hyperelastic Nitinol |
| Jia Liujun1, Yue Guangxin1, He Ting1, Jiang Xin2, Zhang Qi1, Fan Junying1, Song Jiangping1* |
1(Animal Experimental Centre, Beijing Key Laboratory of Preclinical Research and Evaluation for Cardiovascular Implant Materials, State Key Laboratory of Cardiovascular Disease, National Centre for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China)
2(PerMedos Medical Technology Co., Ltd, Shanghai 201100, China) |
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Abstract To evaluate whether a heterogeneous 3D tricuspid annuloplasty ring made of a hyperelastic nitinol can work effectively for a long time after implantation and to reveal its biocompatibility, 12 experimental samples (PerMed rings) and 9 control samples (Edward MC3 rings) were implanted into 21 small tailed Han sheep under circulation bypass. Pre-implantation, and at post implantation day (PID) 90 and PID 180, body weight was taken to assess animal growth, blood was collected for complete blood count, blood chemistries and free hemoglobin test to monitor infection and observe the interaction between the “rings” and blood, and the tricuspid valve function, cardiac structural changes, and thrombus formation was evaluated through transthoracic echocardiography (TTE). Then the animals were euthanized according to the plan, the integrity and local pathological changes, the local inflammatory response level and endothelialization of the prosthesis were evaluated by autopsy, histopathology, and SEM. Animals of both groups had good weight gain after surgery, with BW reaching (51.7±4.5) kg and (55.5±5.2) kg at post implantation day 180. Complete blood count showed there was no infection. Both types of prostheses did not cause hematolysis, abnormal changes in blood cells or hepatic/nephric dysfunction. TTE revealed that TVPG of animals from each group below 5 mmHg throughout the experiment, the tricuspid valves all worked normally, and no thrombus was detected. The pathology results showed all prostheses remained intact structures, closely adhered to the recipient tricuspid annulus, and did not break, crack, or deform, both types of rings had intact fibrous sacs on their surfaces. The local inflammatory response scores were (4.7±1.5) and (5.4±2.2) and the endothelialization rates were (74%±38%) and (82%±29%), respectively at post implantation day 180. The above results indicated that the heterogeneous tricuspid annuloplasty ring made of a hyperelastic Nitinol maintained tricuspid valve function safely and effectively for a long time, and with good blood compatibility and biocompatibility after being implanted into the small tailed Han sheep.
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Received: 25 April 2024
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Corresponding Authors:
*E-mail:fwsongjiangping@126.com
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[1] Yang Lifan, Chen Haiyan, Pan Wenzhi, et al. Analyses for prevalence and outcome of tricuspid regurgitation in China: an echocardiography study of 134,874 patients [J]. Cardiology, 2019, 142(1): 40-46.
[2] 吕俊兴, 吴永健. 三尖瓣反流预后评估的研究进展 [J]. 中国心血管病研究, 2023, 21(5): 440-445.
[3] Chorin E, Rozenbaum Z, Topilsky Y, et al. Tricuspid regurgitation and long-term clinical outcomes [J]. Eur Heart J Cardiovasc Imaging, 2020, 21(2): 157-165.
[4] 赵鹏英. 国产三尖瓣人工软环在功能性三尖瓣关闭不全中的临床应用 [D]. 兰州: 兰州大学,2017.
[5] Haese CE, Mathur M, Malinowski M, et al. Geometric data of commercially available tricuspid valve annuloplasty devices [J]. Data in Brief, 2024, 52: 110051.
[6] Lee H, Kimb J, Jung JH, et al. Mid-term outcomes of tricuspid annuloplasty using the Tri-Ad Adams tricuspid annuloplasty ring [J]. Interact Cardio Vasc Thorac Surg, 2024, 39(1): ivae131.
[7] Cho SK, Park CH, Shinb H, et al. Suture tie-down forces and cyclic contractile forces after undersized tricuspid annuloplasty using a Tri-Ad Adams tricuspid annuloplasty ring in an ovine model [J]. Interact Cardio Vasc Thorac Surg, 2023, 37(1): ivad121.
[8] Algarni KD, Alfonso J, Pragliola C, et al. Long-term outcomes of tricuspid valve repair: the influence of the annuloplasty prosthesis [J]. Ann Thorac Surg, 2021, 112:1493-500.
[9] Ton-Nu TT, Levine RA, Handschumacher MD, et al. Geometric determinants of functional tricuspid regurgitation: Insights from 3-dimensional echocardiography [J]. Circulation, 2006, 114(2): 143-149.
[10] Fukuda S, Saracino G, Matsumura Y, et al. Three-Dimensional Geometry of the tricuspid annulus in healthy subjects and in patients with functional tricuspid regurgitation: a real-time, 3-dimensional echocardiographic study [J]. Circulation, 2006, 114(Suppl I): I492-I498.
[11] Hahn RT, Badano LP, Bartko PE, et al. Tricuspid regurgitation: recent advances in understanding pathophysiology, severity grading and outcome [J]. Eur Heart J Card Img, 2022, 23:913-929.
[12] Iwasieczko A, Gaddam M, Gaweda B, et al. Valvular complex and tissue remodelling in ovine functional tricuspid regurgitation [J]. Eur J Cardio-Thorac, 2023, 63(5): ezad115.
[13] Jeong DS, Kim KH. Tricuspid annuloplasty using the MC3 ring for functional tricuspid regurgitation [J]. Circ J, 2010, 74(2): 278-283.
[14] Yoda M, Tanabe H, Kadoma Y, et al. Mid-term results of tricuspid annuloplasty using the MC3 ring for secondary tricuspid valve regurgitation [J]. Interact Cardiovasc Thorac Surg, 2011, 13(1):7-10.
[15] Choi JW, Kim KH, Kim SH, et al. Long-term results of tricuspid annuloplasty using MC3 ring for functional tricuspid regurgitation [J]. Circ J, 2018, 82:2358-2363.
[16] Malinowski M, Jazwiec T, Quay N, et al. The influence of tricuspid annuloplasty prostheses on ovine annular geometry and kinematics [J]. J Thorac Cardiovasc Surg, 2021,161:e191-e207.
[17] Kania-Olejnik P, Malinowski M, Rausch MK, et al. Ovine tricuspid annular dynamics and three-dimensional geometry during acute atrial fibrillation [J]. PLoS ONE, 2024, 19(10): e0302805.
[18] Salgo IS, Gorman JH, Gorman RC, et al. Effect of annular shape on leaflet curvature in reducing mitral leaflet stress [J]. Circulation, 2002, 106(6):711-717.
[19] Mathur M, Jazwiec T, Meador WD, et al. Tricuspid valve leaflet strains in the beating ovine heart [J]. Biomech Model Mechanobiol, 2019, 18(5):1351-1361.
[20] Jensen MO, Jensen H, Levine RA, et al. Saddle-shaped mitral valve annuloplasty rings improve leaflet coaptation geometry [J]. J Thorac Cardiovasc Surg, 2011, 142(3):697-703.
[21] Haese CE, Mathur M, Lin CY, et al. Impact of tricuspid annuloplasty device shape and size on valve mechanics-a computational study [J]. J Thorac Cardiovasc Surg, 2024, 17:111-120.
[22] Pfannmüller B, Doesn′t T, Eberhardt K, et al. Increased risk of dehiscence after tricuspid valve repair with rigid annuloplasty rings [J]. J Thorac Cardiovasc Surg, 2012, 143(5):1050-1055.
[23] Yiu KH, Wong A, Pu L, et al. Prognostic value of preoperative right ventricular geometry and tricuspid valve tethering area in patients undergoing tricuspid annuloplasty [J]. Circulation, 2014, 129(1):87-92.
[24] 国家市场监督管理总局 国家标准化管理委员会. GB/T 16886.4-2022/ISO 10993-4: 2017医疗器械生物学评价第4部分:与血液相互作用试验选择 [S/OL]. 北京: 中国标准出版社, 2022.
[25] Malinowski M, Jazwiec T, Ferguson H, et al. Tricuspid leaflet kinematics after annular size reduction in ovine functional tricuspid regurgitation [J]. J Thorac Cardiovasc Surg, 2022, 164(6): e353-e366. |
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