Asgar Anita W, Tang Gilbert H L, Rogers Jason H, Rottbauer Wolfgang, Morse M Andrew, Denti Paolo, Mahoney Paul, Rinaldi Michael J, Asch Federico M, Zamorano Jose L, Dong Melody, Huang Rong, Lindenfeld Joann, Maisano Francesco, von Bardeleben Ralph Stephan, Kar Saibal, Rodriguez Evelio
Montreal Heart Institute, Montreal, Quebec, Canada.
Department of Cardiovascular Surgery, Mount Sinai Health System, New York, New York, USA.
JACC Heart Fail. 2025 Feb;13(2):213-225. doi: 10.1016/j.jchf.2024.08.001. Epub 2024 Sep 11.
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.
The aim of this study was to assess the safety and effectiveness of M-TEER in subjects with moderate SMR using the EXPANDed studies.
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+).
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.
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.
中度继发性二尖瓣反流(SMR)是心力衰竭(HF)患者中的一个亚组,治疗仅限于药物治疗。经导管二尖瓣边缘对边缘修复术(M-TEER)治疗中度SMR患者的结局鲜为人知。
本研究旨在使用EXPANDed研究评估M-TEER治疗中度SMR患者的安全性和有效性。
将EXPANDed研究(EXPAND[一项评估新一代MitraClip装置性能和安全性真实世界经验的当代前瞻性研究]和EXPAND G4[MitraClip G4系统安全性和性能的上市后研究评估]MitraClip研究)中经超声心动图核心实验室(ECL)评估基线为中度SMR(2+)的受试者的1年结局,与基线为重度SMR(≥3+)的受试者进行比较。
根据ECL评估,基线时共有335例中度SMR受试者和525例重度SMR受试者。两个亚组的基线特征相似。M-TEER治疗后,两组的二尖瓣反流均显著减少。观察到两组在1年内均有显著的左心室(LV)逆向重构,中度SMR组LV舒张末期和收缩末期容积平均减少>20 mL。中度SMR受试者在纽约心脏协会(NYHA)功能分级(>78%为NYHA I或II级)和生活质量(堪萨斯城心肌病问卷-总体摘要得分>20分)方面有显著的1年改善。同样,两个亚组在1年内的主要不良事件、全因死亡率和HF住院率均较低。
在EXPANDed研究中,接受M-TEER治疗的中度SMR受试者在1年时的生活质量改善和左心室正向重构与重度SMR受试者相似。未来需要开展研究以评估M-TEER对中度SMR HF患者是否有益。