Department of Medicine, Division of Cardiology, Evanston Hospital, Evanston, Illinois.
Department of Medicine, Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California.
J Am Coll Cardiol. 2015 Dec 29;66(25):2844-2854. doi: 10.1016/j.jacc.2015.10.018.
In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surgery, but less effective reduction in MR at 1 year.
This study sought to evaluate the final 5-year clinical outcomes and durability of percutaneous mitral valve (MV) repair with the MitraClip device compared with conventional MV surgery.
Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the device or conventional MV surgery in a 2:1 ratio (178:80). Patients prospectively consented to 5 years of follow-up.
At 5 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the as-treated population was 44.2% versus 64.3% in the percutaneous repair and surgical groups, respectively (p = 0.01). The difference was driven by increased rates of 3+ to 4+ MR (12.3% vs. 1.8%; p = 0.02) and surgery (27.9% vs. 8.9%; p = 0.003) with percutaneous repair. After percutaneous repair, 78% of surgeries occurred within the first 6 months. Beyond 6 months, rates of surgery and moderate-to-severe MR were comparable between groups. Five-year mortality rates were 20.8% and 26.8% (p = 0.4) for percutaneous repair and surgery, respectively. In multivariable analysis, treatment strategy was not associated with survival.
Patients treated with percutaneous repair more commonly required surgery for residual MR during the first year after treatment, but between 1- and 5-year follow-up, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy endorse the durability of MR reduction with both repair techniques. (EVEREST II Pivotal Study High Risk Registry; NCT00209274).
在 EVEREST II 研究（经皮瓣环成形术治疗二尖瓣反流研究）中，与手术相比，新型经皮二尖瓣修复器械治疗二尖瓣反流的安全性更高，但在 1 年时降低二尖瓣反流的效果较差。
本研究旨在评估经皮二尖瓣（MV）修复术（使用 MitraClip 装置）与传统 MV 手术相比的最终 5 年临床结果和耐久性。
3+或 4+级 MR 患者按 2:1 的比例随机分配至器械治疗或传统 MV 手术组（178 例对 80 例）。患者前瞻性同意接受 5 年随访。
在治疗人群中，5 年时复合终点（无死亡、手术或 3+或 4+MR）的发生率分别为器械治疗组 44.2%和手术组 64.3%（p=0.01）。差异是由器械治疗组 3+至 4+MR 发生率增加（12.3%对 1.8%；p=0.02）和手术率增加（27.9%对 8.9%；p=0.003）驱动的。经皮修复后，78%的手术发生在 6 个月内。6 个月后，两组之间的手术和中重度 MR 发生率相当。经皮修复组的 5 年死亡率为 20.8%，手术组为 26.8%（p=0.4）。多变量分析显示，治疗策略与生存率无关。
在治疗后 1 年内，经皮治疗的患者因残余 MR 更常需要手术治疗，但在 1 年至 5 年随访期间，经皮或手术治疗二尖瓣功能障碍的手术率都较低，支持这两种修复技术降低二尖瓣反流的耐久性。（EVEREST II 关键研究高危注册研究；NCT00209274）
