Ulm University Heart Center, University of Ulm, Ulm, Germany.
University Medical Center of Johannes Gutenberg University, Mainz, Germany.
Eur J Heart Fail. 2024 Jul;26(7):1495-1503. doi: 10.1002/ejhf.3250. Epub 2024 May 10.
This analysis aimed to compare the clinical outcomes associated with heart failure (HF) readmissions and to identify associations with HF hospitalizations (HFH) in patients treated with the MitraClip™ NTR/XTR System in the EXPAND study.
The global, real-world EXPAND study enrolled 1041 patients with primary or secondary mitral regurgitation (MR) treated with the MitraClip NTR/XTR System. Echocardiograms were analysed by an independent echocardiographic core laboratory. The study population was stratified into HFH and No-HFH groups based on the occurrence of HFH 1 year post-index procedure. Clinical outcomes including MR severity, New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and all-cause mortality were compared (HFH: n = 181; No-HFH: n = 860). Both groups achieved consistent 1-year MR reduction to ≤1+ (HFH vs. No-HFH: 87.3% vs. 89.5%, p = 0.6) and significant 1-year improvement in KCCQ scores (+16.5 vs. +22.3, p = 0.09) and NYHA functional class. However, more patients in the No-HFH group had 1-year NYHA class ≤II (HFH vs. No-HFH: 67.9% vs. 81.9%, p < 0.01). All-cause mortality at 1 year was 36.8% in the HFH group versus 10.4% in the No-HFH group (p < 0.001). The HFH rate decreased by 63% at 1 year post-M-TEER versus 1 year pre-treatment (relative risk 0.4, p < 0.001). Independent HFH associations were MR ≥2+ at discharge, HFH 1 year prior to treatment, baseline NYHA class ≥III, baseline tricuspid regurgitation ≥2+, and baseline left ventricular ejection fraction ≤40%.
This study reports the impact of HFH on clinical outcomes post-treatment in the EXPAND study. Results demonstrate that the occurrence of HFH was associated with worse 1-year survival, and treatment with the MitraClip system substantially reduced HFH and improved patient symptoms and quality of life.
本分析旨在比较与心力衰竭(HF)再入院相关的临床结局,并确定与接受 MitraClip™ NTR/XTR 系统治疗的患者的 HF 住院(HFH)相关的关联。
这项全球性、真实世界的 EXPAND 研究纳入了 1041 例接受 MitraClip NTR/XTR 系统治疗的原发性或继发性二尖瓣反流(MR)患者。通过独立的超声心动图核心实验室对超声心动图进行分析。根据索引手术后 1 年 HFH 的发生情况,将研究人群分为 HFH 和 No-HFH 组。比较临床结局,包括 MR 严重程度、纽约心脏协会(NYHA)功能分级、堪萨斯城心肌病问卷(KCCQ)评分和全因死亡率(HFH:n=181;No-HFH:n=860)。两组均在 1 年内实现了持续的 MR 减轻至≤1+(HFH 与 No-HFH:87.3%与 89.5%,p=0.6)和 KCCQ 评分(+16.5 与+22.3,p=0.09)和 NYHA 功能分级的显著 1 年改善。然而,No-HFH 组中有更多患者在 1 年内达到 NYHA 分级≤II(HFH 与 No-HFH:67.9%与 81.9%,p<0.01)。HFH 组 1 年全因死亡率为 36.8%,No-HFH 组为 10.4%(p<0.001)。M-TEER 后 1 年的 HFH 发生率比治疗前 1 年降低了 63%(相对风险 0.4,p<0.001)。HFH 的独立关联因素包括出院时 MR≥2+、治疗前 1 年内发生 HFH、基线 NYHA 分级≥III、基线三尖瓣反流≥2+和基线左心室射血分数≤40%。
本研究报告了 EXPAND 研究中 HFH 对治疗后临床结局的影响。结果表明,HFH 的发生与 1 年生存率较差相关,接受 MitraClip 系统治疗可显著降低 HFH,并改善患者症状和生活质量。