Bashir Hanad, Mendez-Hirata Gustavo, Simone Amy E, Garcia Santiago, Kereiakes Dean J
The Christ Hospital Heart and Vascular Institute and Edyth Lindner Center for Research and Education, Cincinnati, Ohio, USA.
JC Medical, Inc, Burlingame, California, USA.
JACC Case Rep. 2024 Nov 6;29(21):102670. doi: 10.1016/j.jaccas.2024.102670.
There is no Food and Drug Administration-approved dedicated transcatheter heart valve to treat native aortic regurgitation. Currently available data from ongoing clinical trials and compassionate use experiences in the United States provide echocardiographic and clinical outcomes to 1-year postprocedure. The case presents a 28-year-old man with severe aortic regurgitation successfully treated with J-Valve in 2019 (JC Medical, Inc). Long-term (5-year) outcomes demonstrate sustained valve hemodynamics and clinical stability, highlighting J-Valve as a promising minimally invasive alternative to surgery for high-risk patients with native aortic regurgitation.
目前尚无美国食品药品监督管理局批准的用于治疗原发性主动脉瓣反流的专用经导管心脏瓣膜。来自美国正在进行的临床试验和同情用药经验的现有数据提供了术后1年的超声心动图和临床结果。该病例为一名28岁患有严重主动脉瓣反流的男性，于2019年成功接受了J-Valve（JC Medical, Inc）治疗。长期（5年）结果显示瓣膜血流动力学持续良好且临床稳定，突出了J-Valve作为原发性主动脉瓣反流高危患者有前景的微创外科替代方案的地位。
