功能性二尖瓣反流心衰患者的 MitraClip 经皮疗法心血管疗效评估 (COAPT) 试验患者的肺静脉收缩期血流逆转和疗效

IF 1.4 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Structural Heart Pub Date : 2024-09-01 DOI:10.1016/j.shj.2024.100333

Chandrashekar Bohra MD , Federico M. Asch MD , Stamatios Lerakis MD , Stephen H. Little MD , Björn Redfors MD, PhD , Zhipeng Zhou MA , Yanru Li MS, MPH , Neil J. Weissman MD , Paul A. Grayburn MD , Saibal Kar MD , D. Scott Lim MD , William T. Abraham MD , JoAnn Lindenfeld MD , Michael J. Mack MD , Jeroen J. Bax MD, PhD , Gregg W. Stone MD

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引用次数: 0

摘要

背景心力衰竭（HF）和二尖瓣反流（MR）患者肺静脉（PV）血流模式的影响尚不确定。我们在 MitraClip 经皮疗法治疗心衰患者功能性二尖瓣反流的心血管结局评估（COAPT）试验（NCT01626079）中研究了肺静脉血流模式，在该试验中，心衰和中重度或重度功能性二尖瓣反流患者被随机分配到使用 MitraClip 装置进行经导管边缘到边缘修补术（TEER），并同时接受指导性医疗疗法（GDMT）与单独接受 GDMT 治疗。我们试图评估基线 PV 收缩期血流反向（PVSFR）在重度 MR 的 HF 患者中的预后作用，并确定 PVSFR 的存在是否能区分 COAPT 试验患者中最有可能从 TEER 中获益的患者。结果526/614（85.7%）例患者的基线PV血流模式可评估，其中48.9%有PVSFR。PVSFR 患者的 MR 更严重，搏出量和心输出量减少，右心室功能障碍更严重，血液动力学更差。通过多变量分析，PVSFR 并非2 年全因死亡或心衰住院（HFH）的独立预测因素。在有 PVSFR 和没有 PVSFR 的患者中，TEER 与单独使用 GDMT 相比，2 年全因死亡和 HFH 发生率的降低幅度相似（Pinteraction = 0.40 和 0.12）。结论在 COAPT 试验中，PVSFR 识别出患有严重 MR 和晚期心脏病的 HF 患者。有 PVSFR 和没有 PVSFR 的患者在接受 TEER 治疗后，死亡率和高房颤患者人数持续减少，生活质量和功能能力得到改善。临床试验注册ClinicalTrial.gov IdentifierNCT01626079。

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Pulmonary Vein Systolic Flow Reversal and Outcomes in Patients From the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) Trial

Background

The implications of pulmonary vein (PV) flow patterns in patients with heart failure (HF) and mitral regurgitation (MR) are uncertain. We examined PV flow patterns in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial (NCT01626079), in which patients with HF and moderate-to-severe or severe functional MR were randomized to transcatheter edge-to-edge repair (TEER) with the MitraClip device plus guideline-directed medical therapy (GDMT) vs. GDMT alone. We sought to evaluate the prognostic utility of baseline PV systolic flow reversal (PVSFR) in HF patients with severe MR and to determine whether the presence of PVSFR can discriminate patients most likely to benefit from TEER in COAPT trial patients.

Methods

Patients were categorized by the echocardiographic core laboratory-assessed baseline presence of PVSFR. Two-year outcomes were examined according to PVSFR and treatment.

Results

Baseline PV flow patterns were evaluable in 526/614(85.7%) patients, 48.9% of whom had PVSFR. Patients with PVSFR had more severe MR, reduced stroke volume and cardiac output, greater right ventricular dysfunction, and worse hemodynamics. By multivariable analysis, PVSFR was not an independent predictor of 2-year all-cause death, or heart failure hospitalization (HFH). The reductions in the 2-year rates of all-cause death and HFH with TEER compared with GDMT alone were similar in patients with and without PVSFR (P_interaction = 0.40 and 0.12, respectively). The effect of TEER on improving Kansas City Cardiomyopathy Questionnaire scores and 6-minute walk distance were also independent of PVSFR.

Conclusions

In the COAPT trial, PVSFR identified HF patients with severe MR and more advanced heart disease. Patients with and without PVSFR had consistent reductions in mortality, HFH, and improved quality-of-life and functional capacity after TEER.