二尖瓣夹子
医学
功能性二尖瓣反流
二尖瓣反流
心力衰竭
心脏病学
内科学
生活质量(医疗保健)
二尖瓣修补术
射血分数
队列
心肌梗塞
缺血性心肌病
前瞻性队列研究
外科
护理部
作者
Ralph Stephan von Bardeleben,Paul Mahoney,Michael A. Morse,Matthew J. Price,Paolo Denti,Francesco Maisano,Jason H. Rogers,Michael Rinaldi,Federico De Marco,William Rollefson,Bassem Chehab,Mathew Williams,Guillaume Leurent,Federico M. Asch,Evelio Rodríguez
标识
DOI:10.1016/j.jcin.2023.09.029
摘要
The fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated. The aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system. EXPAND G4 is an ongoing prospective, multicenter, international, single-arm study that enrolled subjects with primary and secondary MR. One-year outcomes included MR severity (echocardiographic core laboratory assessed), heart failure hospitalization, all-cause mortality, functional capacity (NYHA functional class), and quality of life (Kansas City Cardiomyopathy Questionnaire). A total of 1,164 subjects underwent M-TEER from 2020 to 2022. At 1 year, there was a durable reduction in MR to mild or less in 92.6% and to none or trace in 44.2% (P < 0.0001 vs baseline). Few subjects had major adverse events through 1 year (<2% for myocardial infarction, surgical reintervention, or single-leaflet device attachment). The 1-year Kaplan-Meier estimates for all-cause mortality and heart failure hospitalization were 12.3% and 16.9%. Significant improvements in functional capacity (NYHA functional class I or II in 82%; P < 0.0001 vs baseline) and quality of life (18.5-point Kansas City Cardiomyopathy Questionnaire overall summary score improvement; P < 0.0001) were observed. M-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to ≤1+ in more than 90% of patients and concomitant improvements in functional status and quality of life.
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