Department of Cardiology, Zhongshan Hospital, Fudan University, Research Unit of Cardiovascular Techniques and Devices, Chinese Academy of Medical Sciences.
National Clinical Research Center for Interventional Medicine.
Int Heart J. 2022;63(1):23-29. doi: 10.1536/ihj.21-225.
The ValveClamp system is a novel edge-to-edge mitral valve repair system that is designed for ease of operation. We aimed to report the 1-year outcomes of the early feasibility study of this system.Patients with severe degenerative mitral regurgitation (MR) at higher surgical risk and who received transapical ValveClamp implantation were followed for 1 year for clinical and echocardiographic outcomes.Twelve patients (mean age, 76.5 ± 6.3 years; mean Society of Thoracic Surgery score, 6.9 ± 1.9%) were enrolled at three sites in China. At 1 year, no patient died, received reoperation, or had long-term complications. Of the 12 patients with MR of 3+ or 4+ at baseline, 11 patients (91.67%) remained with MR ≤ 2+ at 1 year, and no patient had mitral stenosis. Significant reductions in maximum MR area (from 15.1 ± 6.51 cm to 4.45 ± 1.85 cm, P < 0.001), effective orifice area (from 4.34 ± 0.34 cm to 2.38 ± 0.45 cm, P < 0.001), and vena contracta width (from 8.03 ± 1.11 to 3.38 ± 2.11 mm, P < 0.001) were observed. The left cardiac dimensions were decreased, especially the mitral valve annulus diameter (from 34.79 ± 4.27 mm to 31.42 ± 2.81 mm, P < 0.05). Of the 12 patients with baseline New York Heart Association functional class III/IV, all patients experienced an improvement of at least one class (P < 0.05).Our study provides evidence that transapical ValveClamp implantation in high-risk patients with severe degenerative MR is safe and feasible, with good efficacy in the mid-long term.
ValveClamp 系统是一种新颖的瓣对瓣二尖瓣修复系统，设计用于操作简便。我们旨在报告该系统早期可行性研究的 1 年结果。在较高手术风险的严重退行性二尖瓣反流（MR）患者中，接受经心尖 ValveClamp 植入的患者接受了 1 年的临床和超声心动图随访，以评估其结果。在中国的三个中心共纳入了 12 名患者（平均年龄 76.5 ± 6.3 岁；平均胸外科医师协会评分 6.9 ± 1.9%）。在 1 年时，没有患者死亡、再次接受手术或发生长期并发症。在基线时 MR 为 3+或 4+的 12 名患者中，有 11 名（91.67%）患者在 1 年时的 MR 为 ≤ 2+，且没有患者出现二尖瓣狭窄。最大 MR 面积（从 15.1 ± 6.51 cm 减小至 4.45 ± 1.85 cm，P < 0.001）、有效瓣口面积（从 4.34 ± 0.34 cm 减小至 2.38 ± 0.45 cm，P < 0.001）和收缩期瓣口宽度（从 8.03 ± 1.11 减小至 3.38 ± 2.11 mm，P < 0.001）显著降低。左心腔尺寸减小，特别是二尖瓣瓣环直径（从 34.79 ± 4.27 mm 减小至 31.42 ± 2.81 mm，P < 0.05）。在基线时为纽约心脏病协会心功能分级 III/IV 的 12 名患者中，所有患者的心功能分级至少提高了 1 级（P < 0.05）。我们的研究结果表明，在高风险的严重退行性 MR 患者中，经心尖 ValveClamp 植入是安全且可行的，且在中期到长期疗效较好。
