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Published on: October 16, 2021
Novel Direct Transcatheter Mitral Annuloplasty System: Preclinical Feasibility Study
Wanjiao Chen1, Yuliang Long1, Wei Li2
1Department of Cardiology, Zhongshan Hospital, Fudan University, Research Unit of Cardiovascular Techniques and Devices, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
None:
This study evaluated the novel L-Clip transcatheter mitral annuloplasty device in 18 porcine models, demonstrating its efficacy and safety. The device achieved 100% procedural success. Implantation times were a median of 28.4 minutes (22.7-34.1) for the first clip and 39.7 minutes (31.2-48.2) for the second. Significant immediate reductions were observed: annular area decreased 26% (from 13.4 cm2 [11.2-15.6] to 9.9 cm2 [7.5-12.3], P < 0.001), anteroposterior diameter decreased 31% (from 3.6 cm [3.2-4.0] to 2.5 cm [2.0-3.0], P < 0.001), and intercommissural distance decreased 17% (from 4.1 cm [3.8-4.4] to 3.4 cm [3.1-3.7], P < 0.001). Crucially, no mortality, valve damage, device displacement, embolism, or other serious adverse events occurred. The L-Clip system offers a user-friendly approach, achieving substantial annular reduction with an excellent safety profile in this model. These promising results support its potential as a minimally invasive alternative for functional mitral regurgitation, warranting further clinical investigation.
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