Experimental Study on a New Type of Chinese-Made Mitral Valve Clip System
Li Bin1, Luo Xiaokang1, Zhang Dong2, Luo Fuliang1, Li Bo1, Pan Wenzhi3, Tang Yue1*
1(Animal Experimental Center of State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100037, China) 2(Department of Thoracic Surgery, Beijing Jishuitan Hospital, Beijing 100035) 3(Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032)
Abstract We conducted an animal experiment to evaluate the feasibility and safety of a new type of Chinese-made mitral valve clip system. Fourteen pigs were divided into experimental group (n=10) and the control group (n=4). The experimental group was implanted with a new type of mitral valve clip, and the control group underwent traditional mitral valve repair. Echocardiography and blood testing were performed before and after operation. Tissue samples were taken from animals after euthanasia 140 days postoperatively. Pathological examination of heart and major organs were conducted. Results: In total, 8 animals in the experimental group and 4 animals in the control group reached the end of the experiment. No serious complications such as clip falling off, heart rupture, valve injury, intractable arrhythmia, viscera embolization, heart failure and death occurred in all animals. Echocardiography showed that all the clips were fixed at the mitral valve, and no statistically significant difference in mitral pressure gradient was found between the two groups. The implantation device had no significant influence on the hepatic and renal function. Pathological examination revealed chronic inflammation, mucinous degeneration and a small amount of bleeding in the leaflets around the clip. No damages to the mitral valve and heart tissue were observed. No thromboembolism was detected in the major organs. Conclusions: Animal experiments suggested that the new type of Chinese-made mitral valve clip system had good biocompatibility and could be effectively fixed at the mitral valve without causing serious complications.
Li Bin,Luo Xiaokang,Zhang Dong, et al. Experimental Study on a New Type of Chinese-Made Mitral Valve Clip System[J]. Chinese Journal of Biomedical Engineering, 2020, 39(1): 67-73.
[1] 王建安,刘先宝. 经导管心脏瓣膜疾病介入治疗进展及中国发展现状[J]. 中国医学前沿杂志(电子版),2015,7(1):21-25. [2] Barker CM. Percutaneous repair of mitral regurgitation[J]. Methodist Debakey Cardiovasc J,2017,13(3):114-119. [3] Rudolph V, Knap M, Franzen O, et al. Echocardiographic and clinical outcomes of MitraClip therapy in patients not amenable to surgery.[J]. Journal of the American College of Cardiology,2011,58(21):2190-2195. [4] Feldman T, Guerrero M. Transcatheter direct mitral valve annuloplasty: a brief review[J]. EuroIntervention,2015,11 (Suppl W):W53-W57. [5] Eugene H. Kirklin/Barratt-Boyes Cardiac Surgery[M]. London: Churchill Livingstone,2003:249-250. [6] 赵笑春. 二尖瓣夹合术治疗瓣膜关闭不全[J]. 中华心脏与心律电子杂志,2014(3):45-46. [7] Nombelafranco L, Urena M, Ribeiro HB, et al. Advances in percutaneous treatment of mitral regurgitation.[J]. Revista Espanola De Cardiologia, 2013,66(7):566-582. [8] 潘文志,钱菊英. 经皮二尖瓣修复术的现状和展望[J]. 中国心血管杂志,2013(6):416-419. [9] Maisano F, La Canna G, Colombo A, et al. The evolution from surgery to percutaneous mitral valve interventions: the role of the edge-to-edge technique[J]. J Am Coll Cardiol,2011,58(21):2174-2182. [10] Grasso C, Popolo AR. The PASCAL transcatheter mitral valve repair system for the treatment of mitral regurgitation: another piece to the puzzle of edge-to-edge technique.[J]. Journal of Thoracic Disease,2017,9(12):4856-4859. [11] Bail DH. Treatment of functional mitral regurgitation by percutaneous annuloplasty using the Carillon mitral contour system-currently available data state[J]. Journal of Interventional Cardiology,2017,30(2):156-162. [12] Harnek J, Webb JG, Kuck KH, et al. Transcatheter implantation of the MONARC coronary sinus device for mitral regurgitation: 1-year results from the EVOLUTION phase I study (Clinical Evaluation of the Edwards Lifesciences Percutaneous Mitral Annuloplasty System for the Treatment of Mitral Re[J]. JACC Cardiovascular Interventions,2011,4(1):115-122. [13] Siminiak T, Dankowski R, Baszko A, et al. Percutaneous direct mitral annuloplasty using the Mitralign Bident system: description of the method and a case report.[J]. Kardiologia Polska,2013,71(12):1287-1292. [14] Maisano F, Taramasso M, Nickenig G, et al. Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: Early results of the feasibility trial[J]. European Heart Journal,2016,37(10):817-825. [15] Colli A, Manzan E, Zucchetta F, et al. Transapical off-pump mitral valve repair with Neochord implantation: Early clinical results[J]. Int J Cardiol,2016,204:23-28. [16] Chiam PT, Ruiz CE. Percutaneous transcatheter mitral valve repair: a classification of the technology[J]. JACC Cardiovasc Interv,2011,4(1):1-13. [17] 诸葛瑞琪,吴永健. 退行性二尖瓣反流的临床治疗进展[J]. 中国心血管杂志,2017,22(4):300-303. [18] Fann JI, St Goar FG, Komtebedde J, et al. Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: Efficacy and healing response.[J]. Circulation,2004,110(8):988-993. [19] Luk A, Butany J, Ahn E, et al. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model.[J]. Cardiovascular Pathology,2009,18(5):279-285. [20] Sturla F, Vismara R, Jaworek M, et al. In vitro and in silico approaches to quantify the effects of the Mitraclip((R)) system on mitral valve function[J]. J Biomech,2017,50:83-92.
Zhang Dong Yang Baiqing Chen Haibo Wang Hongyue Yuan Weimin Yang Jianzhong Jia Liujun Luo Fuliang Yang Peng Tang Yue. Research of the CH-VAD Left Ventricular Assist Device in vivo[J]. Chinese Journal of Biomedical Engineering, 2016, 35(6): 705-711.
