Pepin Heart Institute, Florida Hospital Tampa, Tampa, Florida.
Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.
Catheter Cardiovasc Interv. 2019 Nov 15;94(6):820-826. doi: 10.1002/ccd.28203. Epub 2019 Apr 1.
To evaluate the safety and efficacy of percutaneous mitral valve repair for the management of functional mitral insufficiency.
Severe FMR is present in 25-30% of patients with heart failure and is an independent predictor of mortality and hospitalizations in patients with both ischemic and nonischemic cardiomyopathy. MitraClip therapy has been approved for high surgical risk patients with primary mitral regurgitation. Recent studies including two randomized trials have yielded conflicting results in terms of its clinical efficacy and outcomes for FMR. A quantitative evaluation and synthesis of this information are essential in elucidating the role of MitraClip repair for FMR.
We performed a literature search using PubMed, EMBASE, and Cochrane Central Register of Controlled Trials from September 2008 to September 2018. Studies comparing percutaneous mitral valve repair using the MitraClip device against conservative therapy for the management of functional mitral regurgitation were included.
Seven studies with 1,174 patients in MitraClip group and 1,015 patients in medical therapy group met inclusion criteria. The 12-month mortality in the MitraClip group was 18.4% compared with 25.9% in the medical therapy group (odds ratio [OR]: 0.65 [0.50, 0.86]; p < .002). The rate of readmission at 12 months was 29.9% in the MitraClip group compared with 54.1% in the medical therapy group (OR: 040 [0.32-0.49]; p < .0001. The prognostic efficacy of MitraClip repair appears to be more substantial over longer follow-up period over medical therapy alone.
Based on the results of this meta-analysis, percutaneous mitral valve repair with MitraClip appears to be superior to medical therapy for symptomatic moderate-to-severe functional mitral insufficiency. Further clinical research is needed to identify the ideal patient subgroups who receive maximum benefit with the MitraClip therapy.
评估经皮二尖瓣修复术治疗功能性二尖瓣关闭不全的安全性和疗效。
心力衰竭患者中有 25-30%存在严重的 FMR,且无论缺血性或非缺血性心肌病患者,FMR 都是死亡率和住院率的独立预测因素。MitraClip 疗法已被批准用于原发性二尖瓣反流高危手术患者。最近的研究包括两项随机试验,其在 FMR 的临床疗效和结果方面得出了相互矛盾的结果。对这些信息进行定量评估和综合分析对于阐明 MitraClip 修复术治疗 FMR 的作用至关重要。
我们使用 PubMed、EMBASE 和 Cochrane 对照试验中心注册数据库,从 2008 年 9 月至 2018 年 9 月进行了文献检索。纳入比较经皮二尖瓣修复术(使用 MitraClip 装置)与保守治疗治疗功能性二尖瓣反流的研究。
纳入了 7 项研究,MitraClip 组有 1174 例患者,药物治疗组有 1015 例患者。MitraClip 组的 12 个月死亡率为 18.4%,药物治疗组为 25.9%(优势比 [OR]:0.65 [0.50, 0.86];p < 0.002)。MitraClip 组 12 个月再入院率为 29.9%,药物治疗组为 54.1%(OR:0.40 [0.32-0.49];p < 0.0001)。与单独药物治疗相比,MitraClip 修复术的预后疗效在更长的随访期内更为显著。
基于这项荟萃分析的结果,经皮二尖瓣修复术(使用 MitraClip)似乎优于药物治疗,可用于治疗有症状的中重度功能性二尖瓣关闭不全。需要进一步的临床研究来确定接受 MitraClip 治疗获益最大的理想患者亚组。