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A new transcatheter aortic valve replacement system for predominant aortic regurgitation
Lai Wei, M.D., Huan Liu, M.D., Liming Zhu, M.D., Ye Yang, M.D., Hong Luo, M.D., Kefang Guo, M.D., Xue Yang, M.D., Wei Sun, Ph.D., Weipeng Zhao, M.D., Chunsheng Wang, M.D..
Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China, Shanghai, China.

OBJECTIVE: This study introduces a newly designed trascatherter aortic valve for predominant aortic regurgitation without significant valvular calcification. (Figure 1, The structure of the new transcatheter aortic valve replacement system) It reports the results of the initial series of transapical implantations of this device and aims to offer guidance on technical aspects of the procedure.
METHODS: Four patients with native aortic regurgitation without significant valvular calcification (age 79 to 83 years, mean age 80.3±1.9 years) received transapical implantation of a self-expandable porcine valve into aortic position at our institution. All patients were considered high risk for surgical valve replacement (logistic Euro-SCORE: 22.15% to 44.44%, mean 30.41%±9.70%) after evaluation by an interdisciplinary heart team. Procedural and clinical outcomes were analyzed.
RESULTS: The implantation of the devices in these four patients was successful. All four cases were performed without the need of rapid pacing or cardiopulmonary bypass. No pre or post dilatation was performed. According to the aortic annulus diameter measured by MSCT and TEE, two 25-mm and two 27-mm prosthesis were implanted in these cases. There was no regurgitation or sternosis of the implanted valves in all four cases. The mean transvalvular gradient was 4±1.9 mmHg. The first two cases had no peri-valvular leak (PVL), the third and forth patient had mild and trace PVL respectively. There were no major post-operative complications occurred during the hospital stay and follow-up. There were no new-onset conduction disturbances in all four patients. Transthoracic echocardiographies were performed 30 days after surgery which showed normal working of all the implanted valves and no or only mild PVL in these cases.
CONCLUSIONS: This newly designed transapical TAVI system is effective and safe in treating the high risk patients with predominant aortic regurgitation without significant valvular calcification.

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