Cleveland Clinic, Ohio 44195, USA.
J Am Coll Cardiol. 2012 Jan 10;59(2):130-9. doi: 10.1016/j.jacc.2011.08.067.
The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate.
Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR.
Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care.
Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034).
The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).
EVEREST II（经皮二尖瓣缘对缘修复）高危研究（HRS）评估了 MitraClip 装置（雅培血管，加利福尼亚州圣克拉拉）在外科死亡率高的高危患者中治疗严重二尖瓣反流（MR）的安全性和有效性。
外科死亡率高的严重 MR（3 至 4+）的患者可能受益于经皮二尖瓣瓣叶修复，这是一种降低 MR 的潜在更安全的方法。
入组了严重症状性 MR 和估计外科死亡率≥12%的患者。回顾性地确定了同时筛选但未入组的可比患者组，并征得同意，以比较标准治疗患者的生存率。
78 例患者接受了 MitraClip 手术。他们的平均年龄为 77 岁，超过 50%的患者曾接受过心脏手术，46 例为功能性 MR，32 例为退行性 MR。MitraClip 装置在 96%的患者中成功放置。HRS 和同期对照组中方案预测的外科死亡率分别为 18.2%和 17.4%，胸外科医生协会计算器估计的死亡率分别为 14.2%和 14.9%。HRS 和对照组的 30 天手术相关死亡率分别为 7.7%和 8.3%（p=NS）。HRS 组和同期对照组的 12 个月生存率分别为 76%和 55%（p=0.047）。在具有匹配基线和 12 个月数据的存活患者中，78%的患者 MR 分级≤2+。左心室舒张末期容积从 172ml 改善至 140ml，收缩末期容积从 82ml 改善至 73ml（均 p=0.001）。89%的患者基线时 NYHA 心功能分级为 III/IV，74%的患者为 I/II（p<0.0001）。生活质量改善（SF-36 生理成分评分从 32.1 增加至 36.1[ p=0.014]，心理成分评分从 45.5 增加至 48.7[p=0.065]），12 个月时。在具有匹配数据的存活患者中，充血性心力衰竭的年住院率从 0.59 降至 0.32（p=0.034）。
MitraClip 装置降低了大多数被认为外科死亡率高的患者的 MR，导致 12 个月时临床症状改善和左心室反向重构显著。（经皮二尖瓣修复系统的关键研究[EVEREST II]；NCT00209274）。
