Bohra Chandrashekar, Asch Federico M, Lerakis Stamatios, Little Stephen H, Redfors Björn, Zhou Zhipeng, Li Yanru, Weissman Neil J, Grayburn Paul A, Kar Saibal, Lim D Scott, Abraham William T, Lindenfeld JoAnn, Mack Michael J, Bax Jeroen J, Stone Gregg W
The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Medstar Health Research Institute, Washington, District of Columbia.
Struct Heart. 2024 Jun 26;8(5):100333. doi: 10.1016/j.shj.2024.100333. eCollection 2024 Sep.
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.
Patients were categorized by the echocardiographic core laboratory-assessed baseline presence of PVSFR. Two-year outcomes were examined according to PVSFR and treatment.
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 = 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.
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.
ClinicalTrial.gov IdentifierNCT01626079.
心力衰竭（HF）合并二尖瓣反流（MR）患者肺静脉（PV）血流模式的意义尚不确定。我们在心力衰竭合并功能性二尖瓣反流患者经皮二尖瓣夹合术治疗的心血管结局评估（COAPT）试验（NCT01626079）中研究了PV血流模式，该试验将HF合并中重度或重度功能性MR患者随机分为经导管缘对缘修复（TEER）联合MitraClip装置加指南指导的药物治疗（GDMT）组与单纯GDMT组。我们试图评估重度MR的HF患者基线肺静脉收缩期血流逆转（PVSFR）的预后价值，并确定PVSFR的存在是否能区分COAPT试验患者中最可能从TEER中获益的患者。
根据超声心动图核心实验室评估的基线PVSFR情况对患者进行分类。根据PVSFR和治疗情况检查两年的结局。
526/614（85.7%）例患者的基线PV血流模式可评估，其中48.9%有PVSFR。有PVSFR的患者MR更严重，每搏输出量和心输出量降低，右心室功能障碍更严重，血流动力学更差。通过多变量分析，PVSFR不是两年全因死亡或心力衰竭住院（HFH）的独立预测因素。与单纯GDMT相比，TEER使有和没有PVSFR的患者两年全因死亡和HFH发生率的降低相似（分别为P = 0.40和0.12）。TEER对改善堪萨斯城心肌病问卷评分和6分钟步行距离的作用也与PVSFR无关。
在COAPT试验中，PVSFR识别出重度MR和更晚期心脏病患者。有和没有PVSFR的患者在TEER后死亡率及HFH均持续降低，生活质量和功能能力得到改善。
ClinicalTrial.gov标识符NCT01626079。
