Division of Thoracic and Cardiovascular Surgery (G.A., I.L.K.), University of Virginia, Charlottesville.
Division of Cardiology (D.S.L.), University of Virginia, Charlottesville.
Circulation. 2019 Jan 2;139(1):37-47. doi: 10.1161/CIRCULATIONAHA.117.031733.
Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System).
Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality ≥12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated.
A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3±10.5 years; Society of Thoracic Surgeons risk, 10.2±6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR ≤2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR ≤2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients ( P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% ( P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure ( P<0.0001).
Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling.
https://www.clinicaltrials.gov . Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.
继发性二尖瓣反流（SMR）发生在没有器质性二尖瓣疾病的情况下，可能随着左心室扩张或重塑而发展，或由于瓣叶牵曳导致合闭不全，最常见于瓣下装置的顶部和侧部牵拉，伴晚期环状扩张。SMR 的最佳治疗方法尚不清楚。本研究旨在评估 EVEREST II（血管内瓣缘对缘修复研究）研究性器械豁免计划中所有接受 MitraClip 治疗的 SMR 患者的 1 年裁定结局，该计划包括随机临床试验、前瞻性高危登记册和 REALISM 持续准入登记册（MitraClip 系统多中心研究）。
EVEREST II 中招募的 3+/4+ SMR 患者根据非高手术风险（非 HR）和高手术风险（HR）状态进行分层（定义为胸外科协会死亡率风险≥12%或预先确定的危险因素）。评估 1 年时的临床、超声心动图和功能结局。
共有 616 例 SMR 患者（482 例 HR，134 例非 HR；平均年龄 73.3±10.5 岁；胸外科协会死亡率风险 10.2±6.9%）接受了 MitraClip 治疗。基线时，80.5%的患者处于纽约心脏协会（NYHA）心功能分级 III/IV 级。30 天主要不良事件包括死亡（3.6%）、卒中和肾衰竭（各 2.3%）。出院时，88.8%的患者 MR≤2+。1 年时，有 139 例死亡，Kaplan-Meier 估计的无死亡率为 76.8%。大多数存活患者（84.7%）仍处于 MR≤2+和 NYHA 心功能 I/II 级（83.0%）。HR 患者和非 HR 患者的 1 年 Kaplan-Meier 生存率分别为 74.1%和 86.4%（P=0.0175）。1 年时，两组均实现了相似的 MR 减少（MR≤2+，84.0%与 87.0%）和左心室舒张末期容积的改善（-8.0 mL 与-12.7 mL），而 HR 和非 HR 患者的 NYHA 心功能 I/II 级分别为 80.1%和 91.8%（P=0.008）。在 HR 患者中，心力衰竭住院的年发生率从术前的 0.68 降至术后 12 个月的 0.46（P<0.0001）。
在继发性二尖瓣反流患者中，经导管二尖瓣修复术联合 MitraClip 治疗具有可接受的安全性，可降低 MR 严重程度、改善症状和改善心室重塑。
https://www.clinicaltrials.gov。独特标识符：NCT00209274、NCT01940120 和 NCT01931956。
