Vakil Kairav, Roukoz Henri, Sarraf Mohammad, Krishnan Balaji, Reisman Mark, Levy Wayne C, Adabag Selcuk
Division of Cardiology, University of Minnesota, Minneapolis, Minnesota.
Catheter Cardiovasc Interv. 2014 Jul 1;84(1):129-36. doi: 10.1002/ccd.25347. Epub 2014 Jan 7.
The MitraClip® system is a newer percutaneous device that has shown promising results but data on its safety and efficacy in low- and high-surgical risk populations continues to evolve. We performed a systematic review of the published studies reporting the safety and efficacy of MitraClip® implantation for treatment of moderate to severe and severe mitral regurgitation (MR).
Reviewers independently searched for relevant articles in Medline and abstracted clinical information based on pre-defined criteria and end-points. Patients were classified as low- or high-surgical risk for conventional mitral valve (MV) surgery based on Society of Thoracic Surgeons score, EuroSCORE, or surgeon discretion. Primary safety outcome was 30-day mortality and primary efficacy outcomes were freedom from death, ≥3+ MR, and requirement for MV surgery during follow-up.
Immediate and long-term outcomes of 16 studies, including 2980 patients (age 73.7 ± 0.6 years; 63.3% males) receiving the MitraClip®, were analyzed. Acute procedural success rate was 91.4% with a procedural mortality of 0.1%. Mortality at 30 days and long-term (310 days) follow-up was 4.2 and 15.8%, respectively and was significantly higher in the high-risk group (P = 0.003 and 0.019, respectively). Incidence of major procedural adverse outcomes was relatively low with blood transfusion accounting for most events. At follow-up, the number of patients with ≥3+ MR reduced from 96.3% to 14.7% (P < 0.001), and those with NYHA class III/IV reduced from 83.2% to 23.4% (P < 0.001).
MitraClip® implantation for moderate to severe or severe MR appears to be safe with a very low procedural mortality. There is significant improvement in functional outcomes although long-term mortality is high, especially in high surgical risk patients.
MitraClip®系统是一种较新的经皮装置，已显示出有前景的结果，但关于其在低手术风险和高手术风险人群中的安全性和有效性的数据仍在不断发展。我们对已发表的报告MitraClip®植入治疗中度至重度和重度二尖瓣反流（MR）的安全性和有效性的研究进行了系统评价。
reviewers独立在Medline中搜索相关文章，并根据预先定义的标准和终点提取临床信息。根据胸外科医师协会评分、欧洲心脏手术风险评估系统（EuroSCORE）或外科医生的判断，将患者分类为传统二尖瓣（MV）手术的低手术风险或高手术风险。主要安全结局是30天死亡率，主要有效性结局是随访期间无死亡、无≥3+级MR以及无需进行MV手术。
分析了16项研究的即刻和长期结局，包括2980例接受MitraClip®的患者（年龄73.7±0.6岁；63.3%为男性）。急性手术成功率为91.4%，手术死亡率为0.1%。30天和长期（310天）随访时的死亡率分别为4.2%和15.8%，高危组显著更高（分别为P = 0.003和0.019）。主要手术不良结局的发生率相对较低，输血占大多数事件。随访时，≥3+级MR患者的数量从96.3%降至14.7%（P < 0.001），纽约心脏协会（NYHA）III/IV级患者的数量从83.2%降至23.4%（P < 0.001）。
MitraClip®植入治疗中度至重度或重度MR似乎是安全的，手术死亡率非常低。尽管长期死亡率较高，尤其是在高手术风险患者中，但功能结局有显著改善。
