BACKGROUND Moderate secondary mitral regurgitation (SMR) represents a subgroup of heart failure (HF) patients with treatment restricted to medical therapy. Outcomes in patients with moderate SMR treated with mitral transcatheter edge-to-edge repair (M-TEER) are less well known. OBJECTIVES The aim of this study was to assess the safety and effectiveness of M-TEER in subjects with moderate SMR using the EXPANDed studies. METHODS One-year outcomes in subjects from the EXPANDed studies (EXPAND [A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices] and EXPAND G4 [A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System] MitraClip studies) with baseline moderate SMR (2+), per echocardiographic core laboratory (ECL) assessment, were compared with subjects with baseline severe SMR (≥3+). RESULTS There were 335 subjects with moderate SMR and 525 with severe SMR at baseline per ECL review. Baseline characteristics were similar between the 2 subgroups. After treatment with M-TEER, significant MR reduction was achieved in both groups. Significant left ventricular (LV) reverse remodeling was observed through 1 year, with a >20 mL decrease in LV end-diastolic and end-systolic volumes on average in the moderate SMR group. Significant 1-year improvements in NYHA functional class (>78% NYHA functional class I or II) and quality of life (>20 points on the Kansas City Cardiomyopathy Questionnaire-Overall Summary) were observed in subjects with moderate SMR. Similarly, low rates of major adverse events, all-cause mortality, and HF hospitalizations were observed between the 2 subgroups through 1 year. CONCLUSIONS In the EXPANDed studies, subjects with moderate SMR treated with M-TEER had improvements similar to subjects with severe SMR in quality of life and positive LV remodeling at 1 year. Future studies are needed to evaluate if M-TEER would be beneficial for HF patients with moderate SMR.

中文翻译：

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评估二尖瓣 TEER 在心力衰竭患者中度继发性二尖瓣反流治疗中的应用。


背景技术中度继发性二尖瓣反流（SMR）代表心力衰竭（HF）患者的一个亚组，其治疗仅限于药物治疗。中度 SMR 患者接受二尖瓣经导管边对边修复术 (M-TEER) 治疗的结果鲜为人知。目的 本研究的目的是使用 EXPANDed 研究评估 M-TEER 在中度 SMR 受试者中的安全性和有效性。方法 扩展研究对象的一年结果（EXPAND [评估下一代 MitraClip 设备性能和安全性的现实体验的当代前瞻性研究] 和 EXPAND G4 [安全性和安全性的上市后研究评估] MitraClip G4 系统的性能] 根据超声心动图核心实验室 (ECL) 评估，将基线中度 SMR (2+) 的 MitraClip 研究）与基线重度 SMR (≥3+) 的受试者进行比较。结果 根据 ECL 审查，基线时有 335 名受试者患有中度 SMR，525 名受试者患有重度 SMR。两个亚组之间的基线特征相似。使用 M-TEER 治疗后，两组的 MR 均显着降低。一年内观察到显着的左心室 (LV) 逆转重塑，中度 SMR 组的 LV 舒张末期和收缩末期容积平均减少 >20 mL。在中度 SMR 的受试者中观察到 NYHA 功能分级（>78% NYHA 功能分级 I 或 II）和生活质量（堪萨斯城心肌病问卷总体总结的>20 分）显着改善。同样，在 1 年期间，两个亚组之间的主要不良事件、全因死亡率和心力衰竭住院率均较低。 结论 在扩展研究中，接受 M-TEER 治疗的中度 SMR 受试者在生活质量和 1 年时左室重塑呈阳性方面与重度 SMR 受试者具有相似的改善。未来的研究需要评估 M-TEER 是否对中度 SMR 的心力衰竭患者有益。